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, 11, and 17 have been amended.
Claims 1-20 are pending.
Claim Objections
Claims 1, 11, 17, and 20 are objected to because of the following informalities:
Each of claims 1, 11, and 17 recite “magnetic resonance image (MRI) scanner.” The appropriate phrase is “magnetic resonance imaging (MRI) scanner.”
Claim 11 recites “…determining a location of a sensor within the patient; causing display of a location of a portion of a catheter in the 3D model based on the determined position of the sensor;….” Unless mistaken, Examiner believes “the determined position” should read “the determined location.”
Claim 17 uses the conjunction “and” after the step of “causing display of the location…,” despite there being multiple steps after. Please remove the “and.”
Claim 20 recites “wherein the additional MRI image data sets are focused to the area proximate the sensor.” A similar recitation was deleted in claim 17 in Applicant’s amendments and replaced with “the second MRI image data set defining a reduced scan volume around a distal portion of the catheter.” Thus, “the area proximate the sensor” in claim 20 should either be changed to “an area proximate the sensor” or to something more similar to what is now recited in claim 17.
Appropriate correction is required.
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.
Claims 17-20 are 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.
Claim 17 recites “…receiving second magnetic resonance signals and generating a second MRI image data set, the second magnetic resonance signals having a field strength of between 20 micro-Tesla and 0.1 Tesla, and the second MRI image data set defining a reduced scan volume around a distal portion of the catheter….”
Applicant’s disclosure does not support micro-Tesla (i.e., µT). Paragraph [0048] supports milli-Tesla. “However, it is believed that some low field strength MRI scanners (e.g., 0.2 T) and very low field strength MRI scanners (e.g., 0.1 T, 50 mT, and 20 mT) scanners can be operated without the potentially damaging heating effects.”
See Section 112(b) rejection below for Examiner’s interpretation of claim 17.
Claims 18-20 depend directly or indirectly from claim 17 are rejected under Section 112(a) based on their dependency.
The following is a quotation of the first paragraph of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites “…receiving second magnetic resonance signals and generating a second MRI image data set, the second magnetic resonance signals having a field strength of between 20 micro-Tesla and 0.1 Tesla, and the second MRI image data set defining a reduced scan volume around a distal portion of the catheter….”
Claim 17 is not clear because the detected second MR signals cannot have a field strength. Instead, the second MR signals are generated within a magnetic field having a certain field strength that is created by the MRI scanner. (see, e.g., [0048] of Applicant’s disclosure).
Claims 18-20 depend directly or indirectly from claim 17 are rejected under Section 112(a) based on their dependency.
To address both the Section 112(a) and (b) issues, and for purposes of a compact prosecution, Examiner is interpreting the relevant limitation as “…receiving second magnetic resonance signals from the MRI scanner and generating a second MRI image data set, wherein the MRI scanner has a field strength of between 20 milli-Tesla and 0.1 Tesla for the second magnetic resonance signals, the second MRI image data set defining a reduced scan volume around a distal portion of the catheter….”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite or similarly recite:
[a] generating an MRI image data set;
[b] generating a three-dimensional (3D) model from the MRI image data set;
[c] generating a pathway through the 3D model to a target;
[d] determining a location of a sensor [or distal portion of a catheter] within the patient [or 3D model];
[e] updating a displayed location of the portion of the catheter;
[f] generate a second MRI image data set in which the second MRI image data set defines a reduced scan volume around a distal portion of the catheter [with claim 17 also specifying the field strength];
[i] updating a relative position of a distal end of the catheter and the target in the 3D model.
Claim limitation [a] and [f], as drafted and under their broadest reasonable interpretation, recite a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, generating MRI images involves acquiring k-space and reconstructing images by applying an inverse Fourier transform and linear systems. (see also, e.g., Burnett v. Panasonic Corp., 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) (non-precedential) (claims reciting a formula to convert geospatial coordinates into natural numbers are patent ineligible).
Claim limitation [b], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, generating a 3D model involves segmenting a volume and extracting isosurfaces using various formulas and often smoothing/registration.
Claim limitation [c], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, generating a pathway requires building centerlines and calculating shortest-path searches that avoid collisions.
Claim limitations [d], [e], and [i], as drafted and under their broadest reasonable interpretation, recite a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, determining a location of an object within a space (and then updating that location) involves estimating poses of the object in six degrees of freedom (DOF) using tracking data, which involves various complex formulas, and then mapping the poses to the space with a rigid transform.
The next question is to consider whether the claims integrate the judicial exception into a practical application. A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. (MPEP 2106.04(d)). In this case, some additional elements/steps to consider include (1) a catheter configured for navigation within the luminal network; (2) a sensor for tracking the catheter; (3) a computing device including a processor and computer readable memory with instructions; (4) receiving magnetic resonance signals from a magnetic resonance image (MRI) scanner; (5) causing display of a location of a portion of a catheter in the 3D model based on the determined position of the sensor; and (6) receiving second magnetic resonance signals; (7) receiving signals from a sensor incorporated in the catheter; (8) receiving an indication of a distal end of the catheter in the second MRI image data set.
Here, the judicial exception is not integrated into a practical application. The catheter limitation (1) does no more than generally link the judicial exception to a particular technological environment (i.e., surgical navigation). (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(h)). Claims limitations (2), (7), and (8) to the sensor and receiving sensor signals are merely reciting words equivalent to “apply it” with the judicial exceptions. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). Claim limitation (3) recite a processor and a memory that merely include instructions to implement the abstract idea on a computer and/or merely use a computer as a tool to perform an abstract idea. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). The claim limitations (4), (6), (7), (8) to receiving signals/data recite insignificant extra-solution activity (i.e., pre-solution activity) that does not impose meaningfully limits on the claim. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(g)). The claim limitation (5) to displaying information (e.g., graphical representation over image) recite insignificant extra-solution activity (i.e., post-solution activity) that does not impose meaningfully limits on the claim. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(g)).
The claims do not include additional elements/steps that are sufficient to amount to significantly more than the judicial exception. A shared quality of the additional elements and/or steps is that they do not recite any meaningful limitation that transforms the judicial exception into a patent-eligible application. (MPEP 2106.05(II)). As explained above, claim limitation (1) only generally links the judicial exception to a particular technological environment; claim limitations (2), (7), and (8) merely recite words equivalent to “apply it”; claim limitation (3) recites generic elements for computing; and claim limitations (4), (6), (7), (8) recite insignificant extra-solution activity. Moreover, many of the claim limitations are well-understood, routine, conventional activities/elements that are previously known to the industry and specified at a high level of generality such that they do not meaningfully limit the claims. (MPEP 2106.05(A)). (see, e.g., Section 103 rejections below).
Accordingly, claims 1, 11, and 17 do not include patent-eligible subject matter.
Dependent claims 2-10, 12-16, and 18-20 also fail to recite patent-eligible subject matter.
Claims 2 and 11 recite displaying an updated relative position of an object. These are similar to claim limitations [d], [e], and [i] discussed above and recite a mathematical concept. (MPEP 2106.04(a)(2)(I).
Claims 3 and 13 recite receiving signals to generate another image. These are similar to claim limitations [a] and [f] and recites a mathematical concept. (MPEP 2106.04(a)(2)(I) and similar to additional elements (4), (6), (7), (8) (i.e., receive data) that recites insignificant pre-solution activity. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(g)).
Claim 4 recites determining whether more targets exist in the 3D model. The claim limitation is merely determining whether another target exists in order to repeat the recited operations of the processor. This merely recites insignificant extra-solution activity, which could be considered post-solution or pre-solution. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(g)). In any case, it does not recite any meaningful limitation that transforms the judicial exception into a patent-eligible application.
Claim 5 recites displaying a 3D model and a pathway to a second target. This is similar to the additional element (5). Displaying information (e.g., graphical representation over image) is an insignificant extra-solution activity (i.e., post-solution activity) that does not impose meaningfully limits on the claim. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(g)).
Claim 6 recites a magnetic resonance scanner generating the magnetic resonance signals. However, this does no more than generally link the judicial exception to a particular technological environment (i.e., surgical navigation). (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(h)).
Claims 7 and 14 recite that the sensor is an EM sensor and that an EM field is generated and (in claim 14) determining a location of the sensor. These limitations do no more than generally link the judicial exception to a particular technological environment (i.e., surgical navigation). (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(h)).
Claims 8, 9, 15, and 16 recite limitations that specify what is generating the EM field (e.g., mat or MRI scanner). However, these are standard elements often used to generate EM fields for tracking and do not impose a meaningful limitation on the judicial exception. They also recite well-understood, routine, and conventional activities/elements. (MPEP 2106.05(A)). (see discussion of COVIDIEN and ROTH in Section 103 rejection of claims 8, 9, 15, and 16 below).
Claims 10 and 18 recite that the sensor is an inertial measurement unit. Again, this is a standard element used for tracking that does not impose a meaningful limitation on the judicial exception. (MPEP 2106.04(d)). They also recite well-understood, routine, conventional activities/elements that are previously known to the industry and specified at a high level of generality such that they do not meaningfully limit the claims. (MPEP 2106.05(A)). (see discussion of KREUCKER in Section 103 rejection of claims 10 and 18 below).
Claim 19 recites that the updated displayed position of the distal portion of the catheter is employed to eliminate drift of the IMU. This recitation relates to the intended purpose of an action and does not impose a meaningful limitation on the judicial exception. (MPEP 2106.04(d)).
Claim 20 repeats many of the steps/operations discussed above but are “focused to the area proximate the sensor.” This recitation is a well-understood, routine, conventional activity that is previously known to the industry such that it does not meaningfully limit the claim. (MPEP 2106.05(A)). (see, e.g., discussion of GUTTMAN in Section 103 rejections below).
Accordingly, none of the claims recite patent-eligible subject matter.
RESPONSE TO APPLICANT’S ARGUMENTS:
Applicant argues on pages 6 and 7 of the Response dated 5/12/2026 that the claims recite a unique integration of a judicial exception into an integrated application. More specifically, Applicant argues that the added claim limitation in which the second MRI image data set “defin[es] a reduced scan volume around a distal portion of the catheter” integrates the judicial exception into a practical application. (page 7 of Response). Examiner disagrees.
Applicant alleges that “the reduced scan volume reduces the time required to acquire the MRI image data and the duration of the procedure, rendering the use of MRI more suitable for intra-procedural imaging during the navigation of the catheter.” However, the claims do not recite any limitation with respect to time (e.g., real-time, live, during a medical procedure, etc.) nor do the claims recite that the updated model is displayed to the user such that the user could use the updated position for navigating during a medical procedure. Claim 1 merely clarifies that more data is gathered to generate MRI image data sets. In other words, the claims essentially recite multiple steps of collecting data, analyzing data, and generating a display based on the data analysis. These claims are often held to be abstract ideas, especially when the claim limitations are recited at a high level of generality. (see, e.g., Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) and AI Visualize, Inc. v. Nuance Communications, Inc., 97 F. 4th 1371 (2024), which stated: “We have explained that the steps of obtaining, manipulating, and displaying data, particularly when claimed at a high level of generality, are abstract concepts.”). The catheter is the one physical object that links this navigation to surgical navigation. However, the catheter and the process that is carried out by the computing device are recited at a high level of generality.
“A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” (MPEP 2106.04(d)). As explained above, the various claim limitations do not meaningfully limit the judicial exception. The catheter only generally links the judicial exception to a particular technological environment. The other claim limitations recite words equivalent to “apply it,” generic computing elements, or insignificant extra-solution activity. Lastly, many of the claim limitations are well-understood, routine, conventional activities/elements that are previously known to the industry. As such, the claims do not impose a meaningful limit on the judicial exception.
Accordingly, the claims do not recite patent-eligible subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over International Publ. No. WO 2010/144419 A2 (hereinafter “GUTTMAN”) and U.S. Patent Appl. Publ. No. 2015/0374260 A1 (hereinafter “GOVARI”) and U.S. Patent Appl. Publ. No. 2018/0055582 A1 (hereinafter “KRIMSKY”).
With respect claim 1 (and in light of the Section 112(b) rejection), GUTTMAN teaches a system for luminal navigation (“MRI guided cardiac interventional systems….,” Abstract, but GUTTMAN also describes embodiments being applicable for “the tracheobronchopulmonary structure (structures including the lungs and the tracheobronchial tree),” ([0196])), the system includes a catheter ([0063]: “flexible intrabody medical device 80,” also called “catheter 80” elsewhere in GUTTMAN) configured for navigation within a luminal network of a patient ([0196] describes embodiments being used for procedures involving a heart, a tracheobronchopulmonary structure among others), the catheter including a sensor ([0063] “tracking members 82 can comprise miniature tracking coils, passive markers and/or a receive antenna”); and a computing device including a processor and computer readable memory (Figure 36, [0178]: “data processing system [includes a] “processor 410” that communicates with “memory 414”), the memory storing thereon instructions ([0170]: “Computer program code for carrying out…”) that when executed by the processor perform operations discussed below.
GUTTMAN also teaches that the computing device is configured to receive magnetic resonance signals from a magnetic resonance image (MRI) scanner and to generate an MRI image data set ([0007]: “obtain MR image data and generate a series of near real time (RT) MRI images of target anatomy of a patient during a surgical procedure…”); generate a three-dimensional (3D) model from the MRI image data set (see [0007]: “render near RT interactive visualizations of the at least one flexible medical device in the 3-D [MRI] image space with at least one near RT [MRI] image of target patient anatomical structure and a registered pre-acquired volumetric model of the target anatomical structure of the patient.” (emphasis added)). GUTTMAN also teaches that the computing device is configured to determine a location of the sensor within the patient (block 204 in Figure 34, see also [0159]: “X, Y, Z coordinate locations are electronically identified in 3-D MRI image space for each of the tracking coils using the tracking signals (block 204).”; cause display of a location of a portion of the catheter in the 3D model (block 210 in Figure 34, see also [0159]: “Near real time (RT) visualizations of the medical device are generated showing: (a) the model of the patient's anatomy; (b) a physical representation of at least a distal end portion of the medical device using the identified locations of the tracking coils....”(emphasis added)); and update the displayed location of the portion of the catheter; receive second magnetic resonance signals and generate a second MRI image data set; receive an indication of a distal end of the catheter in the second MRI image data set; and update a relative position of a distal end of the catheter and the target in the 3D model. (Id., see also [0138]: “The MRI Scanner 10S (Figures 1-3) can be operated substantially continuously to provide image data that can be used to generate updated maps 100M in the visualizations upon request or automatically. This operation can be ‘in the background’, e.g., transparent to the user so as not to slow down the procedure while providing updated image and tracking data during the course of the procedure.”).
GUTTMAN does not explicitly teach that the second MRI image data set defines a reduced scan volume around a distal portion of the catheter. However, GUTTMAN is generally concerned with improving navigation for the user during a medical procedure. For example, GUTTMAN teaches that user may wish to view a “close-up” image in which “the associated image is shown enlarged relative to a global image or typical navigation view to show local tissue.” ([0054]). Moreover, the system enables a user to “rotate and zoom” the visualization while tracking a tip of the device. ([0091], see also [0092]-[0093]). GUTTMAN further teaches that the use can request a “high resolution or enlarged view” ([0111]) and Figures 22A-22B even illustrate close-up MRI views of the device’s tip.
In the same field of endeavor, GOVARI teaches a method includes displaying a position of a distal end of a medical probe that is being navigated in an organ of a patient on a three-dimensional (3D) map of the organ. (Abstract). “Embodiments of the present invention that are described herein below provide a method and system to obtain real-time imaging of the vicinity of the catheter's distal end during navigation, using a 3D magnetic position tracking map. Instead of acquiring a complete 3D MRI model, which is not feasible to perform in real time, the disclosed techniques acquire and display a MRI slice in a selected plane of interest which contains the catheter's distal end. By settling for an image at a specific plane, the physician can be provided with an overlaid image of an MRI slice on the magnetic position map in real-time.” ([0016]). GOVARI specifically teaches that the MRI slice has a finite thickness (e.g., 3 millimeters). GOVARI’s embodiments are “applicable for any minimally-invasive medical procedures such as laparoscopy or endoscopy, and are not limited to cardiac applications.” ([0018]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GUTTMAN system such that the second MRI image data set defines a reduced scan volume around a distal portion of the catheter. GUTTMAN strongly suggests a system that is configured to display, in real-time, images of a distal portion of a catheter. GOVARI teaches a method of acquiring an MRI slice (having a finite thickness) that contains the catheter's distal end. One of ordinary skill in the art would have been motivated to use GOVARI’s method of automatically imaging the distal end to enable real-time navigation using a 3D MRI model. There would have been a reasonable expectation of success as GUTTMAN and GOVARI teach navigation systems for MRI models.
NOTE: Examiner is interpreting GUTTMAN’s MRI slice with a “finite thickness” as a reduced scan volume around a distal portion of the catheter. Applicant does not define the term “reduced scan volume.” (see MPEP 2111 regarding the broadest reasonable interpretation). Nevertheless, even if “reduced scan volume” meant at least two slices forming a reduced scan volume, one having ordinary skill in the art would be motivated to modify the system to make such a reduced scan volume (i.e., one formed from at least two slices). A person having ordinary skill in the art would know that GOVARI is not limited to only two imaging options (i.e., a complete 3D MRI model or a single MRI slice). Instead, a person having ordinary skill in the art would know that there is a predictable tradeoff between the size of the 3D MRI image and the acquisition time. For those circumstances in which a larger anatomical context near the distal end is desired, one having ordinary skill in the art would configure the system to provide (or enable the user to request) a larger scan volume at the distal end.
GUTTMAN does not explicitly teach a computing device that is configured to generate a pathway through the 3D model to a target. However, GUTTMAN does describe that “[e]mbodiments of the present invention can be configured to guide and/or place flexible intrabody diagnostic and/or interventional devices in an MRI environment (e.g., interventional medical suite) to any desired internal region of interest of a subject, typically via a natural lumen and/or tortuous path…”. (emphasis added) ([0069]). Moreover, GUTTMAN describes presenting “with additional visual indicators and a ‘target’ navigational indicia (e.g., mark) for visual help in navigation to the site.” ([0131], Figure 23).
In the same field of endeavor, KRIMSKY teaches “methods for planning a procedure for treatment of lung tissue. An exemplary method includes generating a three-dimensional (3D) model of the luminal network, displaying the 3D model of the luminal network…, determining an access path between the target location and the identified point in the luminal network,…and displaying the access path and the calculated risk of injury for the access path on the 3D model.” (Abstract). The image data used to make the model and determine the access path includes magnetic resonance imaging (MRI) image data. ([0050]). KRIMSKY determines one or more access paths to the target location and displays the access paths along with a calculated risk of injury for each path. ([0066]).
It would have been obvious to one having ordinary skill in the art to modify/program the GUTTMAN system such that the computing device generates a pathway through the 3D model to a target. One having ordinary skill in the art would be motivated to modify the system to reduce the risk of injury during the operation. GUTTMAN suggests providing pathways to the user for guidance to a target, and KRIMSKY teaches how to generate multiple paths along with calculated risks for the user to consider before proceeding. There would be a reasonable expectation of success as KRIMSKY teaches that pathways can be generated using MRI data.
With respect to claim 2, GUTTMAN teaches that the instructions when executed by the processor cause the display of the updated relative position of the distal end of the catheter and the target in the 3D model. “[T]he visualizations can be electronically rotated based on user input and electronically selectively altering a view of the displayed visualization based on user input so that the visualization includes the at least one flexible device with (a) only a near RT image of the target anatomy, (b) both the near RT image of the anatomy and the registered model of the anatomical structure, or (c) only the registered model of the anatomical structure (block 214).” (emphasis added) ([0161]). As explained above, the near real-time images “RT MR images” are updated throughout the procedures, thereby providing an “updated relative position” of the distal end of the catheter. (see, e.g., Figure 34, [0159], and [0138]).
With respect to claim 3 (depending from claim 2), GUTTMAN teaches that the instructions when executed by the processor receive third magnetic resonance signals to form a third MRI image to confirm placement of the catheter, a biopsy tool, or a therapy tool in the target. As explained above, the near real-time images “RT MR images” are updated throughout the procedures, thereby providing an “third magnetic resonance signals to form a third MRI image” of the distal end of the catheter. (see, e.g., Figure 34, [0159], and [0138]). Moreover, GUTTMAN teaches that catheter can be another device, such as a biopsy tool. “To be clear, while detailed drawings of exemplary flexible devices 80 are shown for tracking coils for transseptal needles (septal puncture kit components)and mapping and/or ablation catheters for cardiac use, embodiments of the invention are not intended to be limited to these devices nor to cardiac use… For example, the device can be implemented as injection catheters or diagnostic biopsy needles and the like for any target anatomical location in the body” (emphasis added) ([0072).
With respect to claim 4 (depending from claim 3), GUTTMAN teaches that the instructions when executed by the processor determine whether more targets exist in the 3D model. GUTTMAN teaches that the map can show “locations of target and actual ablation sites (in different colors).” ([0137]). As such, the system determines whether more targets exist after biopsy/therapy of the prior target. (see also [0165]: “Optionally, the tissue characterization map can be displayed with the (planned) indicated target ablation locations in a first color, intensity and/or opacity along with an updated tissue characterization map with MR image data showing actual ablated tissue locations in a different color (side by side or one over the other) (block 332).”).
With respect to claim 5 (depending from claim 4), GUTTMAN does not explicitly teach the limitations of claim 5. However, KRIMSKY teaches that the instructions when executed by the processor cause the display of the 3D model and a pathway to a second target. “[T]he method proceeds to step S446 where a determination is made if there are additional target locations for which access paths have to be determined. If there are additional target locations, the method returns to step S410.” ([0069]). Upon returning to step 410, the method proceeds to display another pathway to the next target. (Figure 4B, S438, [0066]).
It would have been obvious to one having ordinary skill in the art to modify/program the GUTTMAN system such that the computing device generates another pathway through the 3D model to a target and displays that pathway. One having ordinary skill in the art would modify the system to reduce the risk of injury during the operation. GUTTMAN suggests providing pathways to the user for guidance to a target, and KRIMSKY teaches how to generate multiple paths along with calculated risks for the user to consider before proceeding. There would be a reasonable expectation of success as KRIMSKY teaches that pathways can be generated using MRI data.
With respect to claim 6, GUTTMAN teaches that the system further comprises a magnetic resonance scanner generating the magnetic resonance signals. (“MRI Scanner 10” in Figure 29 and described at [0082]).
With respect claim 11, GUTTMAN teaches a method of navigating a catheter to a target within a patient (“MRI guided cardiac interventional systems….,” Abstract, but GUTTMAN also describes embodiments being applicable for “the tracheobronchopulmonary structure (structures including the lungs and the tracheobronchial tree),” GUTTMAN also teaches that the method includes receiving magnetic resonance signals from a magnetic resonance image (MRI) scanner and generating an MRI image data set ([0007]: “obtain MR image data and generate a series of near real time (RT) MRI images of target anatomy of a patient during a surgical procedure…”); generating a three-dimensional (3D) model from the MRI image data set (see [0007]: “render near RT interactive visualizations of the at least one flexible medical device in the 3-D [MRI] image space with at least one near RT [MRI] image of target patient anatomical structure and a registered pre-acquired volumetric model of the target anatomical structure of the patient.” GUTTMAN also teaches that the method includes determining a location of a sensor within the patient (block 204 in Figure 34, see also [0159]: “X, Y, Z coordinate locations are electronically identified in 3-D MRI image space for each of the tracking coils using the tracking signals (block 204).”; ([0063]: “tracking members 82 can comprise miniature tracking coils, passive markers and/or a receive antenna.”); causing display of a location of a portion of a catheter in the 3D model based on the determined position of the sensor (block 210 in Figure 34, see also [0159]: “Near real time (RT) visualizations of the medical device are generated showing: (a) the model of the patient's anatomy; (b) a physical representation of at least a distal end portion of the medical device using the identified locations of the tracking coils....”); and updating a displayed location of the portion of the catheter; receiving second magnetic resonance signals and generate a second MRI image data set; receiving an indication of a distal end of the catheter in the second MRI image data set; and updating a relative position of a distal end of the catheter and the target in the 3D model. (Id., see also [0138]: “The MRI Scanner 10S (Figures 1-3) can be operated substantially continuously to provide image data that can be used to generate updated maps 100M in the visualizations upon request or automatically. This operation can be ‘in the background’, e.g., transparent to the user so as not to slow down the procedure while providing updated image and tracking data during the course of the procedure.”).
GUTTMAN does not explicitly teach that the second MRI image data set defines a reduced scan volume around a distal portion of the catheter. However, GUTTMAN is generally concerned with improving navigation for the user during a medical procedure. For example, GUTTMAN teaches that user may wish to view a “close-up” image in which “the associated image is shown enlarged relative to a global image or typical navigation view to show local tissue.” ([0054]). Moreover, the system enables a user to “rotate and zoom” the visualization while tracking a tip of the device. ([0091], see also [0092]-[0093]). GUTTMAN further teaches that the use can request a “high resolution or enlarged view” ([0111]) and Figures 22A-22B even illustrate close-up MRI views of the device’s tip.
In the same field of endeavor, GOVARI teaches a method includes displaying a position of a distal end of a medical probe that is being navigated in an organ of a patient on a three-dimensional (3D) map of the organ. (Abstract). “Embodiments of the present invention that are described herein below provide a method and system to obtain real-time imaging of the vicinity of the catheter's distal end during navigation, using a 3D magnetic position tracking map. Instead of acquiring a complete 3D MRI model, which is not feasible to perform in real time, the disclosed techniques acquire and display a MRI slice in a selected plane of interest which contains the catheter's distal end. By settling for an image at a specific plane, the physician can be provided with an overlaid image of an MRI slice on the magnetic position map in real-time.” ([0016]). GOVARI specifically teaches that the MRI slice has a finite thickness (e.g., 3 millimeters). GOVARI’s embodiments are “applicable for any minimally-invasive medical procedures such as laparoscopy or endoscopy, and are not limited to cardiac applications.” ([0018]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GUTTMAN system such that the second MRI image data set defines a reduced scan volume around a distal portion of the catheter. GUTTMAN strongly suggests a system that is configured to display, in real-time, images of a distal portion of a catheter. GOVARI teaches a method of acquiring an MRI slice (having a finite thickness) that contains the catheter's distal end. One of ordinary skill in the art would have been motivated to use GOVARI’s method of automatically imaging the distal end to enable real-time navigation using a 3D MRI model. There would have been a reasonable expectation of success as GUTTMAN and GOVARI teach navigation systems for MRI models.
NOTE: Examiner is interpreting GUTTMAN’s MRI slice with a “finite thickness” as a reduced scan volume around a distal portion of the catheter. Applicant does not define the term “reduced scan volume.” (see MPEP 2111 regarding the broadest reasonable interpretation). Nevertheless, even if “reduced scan volume” meant at least two slices forming a reduced scan volume, one having ordinary skill in the art would be motivated to modify the system to make such a reduced scan volume (i.e., one formed from at least two slices). A person having ordinary skill in the art would know that GOVARI is not limited to only two imaging options (i.e., a complete 3D MRI model or a single MRI slice). Instead, a person having ordinary skill in the art would know that there is a predictable tradeoff between the size of the 3D MRI image and the acquisition time. For those circumstances in which a larger anatomical context near the distal end is desired, one having ordinary skill in the art would configure the system to provide (or enable the user to request) a larger scan volume at the distal end.
GUTTMAN does not explicitly teach a method that includes generating a pathway through the 3D model to a target. However, GUTTMAN does describe that “[e]mbodiments of the present invention can be configured to guide and/or place flexible intrabody diagnostic and/or interventional devices in an MRI environment (e.g., interventional medical suite) to any desired internal region of interest of a subject, typically via a natural lumen and/or tortuous path…”. (emphasis added) ([0069]). Moreover, GUTTMAN describes presenting “with additional visual indicators and a ‘target’ navigational indicia (e.g., mark) for visual help in navigation to the site.” ([0131], Figure 23).
In the same field of endeavor, KRIMSKY teaches “methods for planning a procedure for treatment of lung tissue. An exemplary method includes generating a three-dimensional (3D) model of the luminal network, displaying the 3D model of the luminal network…, determining an access path between the target location and the identified point in the luminal network,…and displaying the access path and the calculated risk of injury for the access path on the 3D model.” (Abstract). The image data used to make the model and determine the access path includes magnetic resonance imaging (MRI) image data. ([0050]). KRIMSKY determines one or more access paths to the target location and displays the access paths along with a calculated risk of injury for each path. ([0066]).
It would have been obvious to one having ordinary skill in the art to modify/program the GUTTMAN method generates a pathway through the 3D model to a target. One having ordinary skill in the art would modify the system to reduce the risk of injury during the operation. GUTTMAN suggests providing pathways to the user for guidance to a target, and KRIMSKY teaches how to generate multiple paths along with calculated risks for the user to consider before proceeding. There would be a reasonable expectation of success as KRIMSKY teaches that pathways can be generated using MRI data.
With respect to claim 12, GUTTMAN teaches that the method includes causing display of the updated relative position of the distal end of the catheter and the target in the 3D model. “[T]he visualizations can be electronically rotated based on user input and electronically selectively altering a view of the displayed visualization based on user input so that the visualization includes the at least one flexible device with (a) only a near RT image of the target anatomy, (b) both the near RT image of the anatomy and the registered model of the anatomical structure, or (c) only the registered model of the anatomical structure (block 214).” (emphasis added) ([0161]). As explained above, the near real-time images “RT MR images” are updated throughout the procedures, thereby providing an “updated relative position” of the distal end of the catheter. (see, e.g., Figure 34, [0159], and [0138]).
With respect to claim 13 (depending from claim 12), GUTTMAN teaches that the method includes receiving third magnetic resonance signals to form a third MRI image to confirm placement of the catheter, a biopsy tool, or a therapy tool in the target. As explained above, the near real-time images “RT MR images” are updated throughout the procedures, thereby providing an “third magnetic resonance signals to form a third MRI image” of the distal end of the catheter. (see, e.g., Figure 34, [0159], and [0138]). Moreover, GUTTMAN teaches that catheter can be another device, such as a biopsy tool. “To be clear, while detailed drawings of exemplary flexible devices 80 are shown for tracking coils for transseptal needles (septal puncture kit components)and mapping and/or ablation catheters for cardiac use, embodiments of the invention are not intended to be limited to these devices nor to cardiac use… For example, the device can be implemented as injection catheters or diagnostic biopsy needles and the like for any target anatomical location in the body” (emphasis added) ([0072).
Claims 7, 8, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over International Publ. No. WO 2010/144419 A2 (hereinafter “GUTTMAN”) and U.S. Patent Appl. Publ. No. 2015/0374260 A1 (hereinafter “GOVARI”) and U.S. Patent Appl. Publ. No. 2018/0055582 A1 (hereinafter “KRIMSKY”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2018/0049693 A1 (hereinafter “COVIDIEN”).
With respect to claims 7 and 8 (depending from claim 7), GUTTMAN does not explicitly teach the limitations of claims 7 and 8. However, COVIDIEN teaches that the sensor is an electromagnetic sensor and a transmitter mat can cause the generation of an electromagnetic field.
In the same field of endeavor, COVIDIEN teaches a “[s]ystem 10 [that] generally includes an operating table 40 configured to support a patient “P”, a bronchoscope 50 configured for insertion through the patient's mount into the patient's airways, monitoring equipment 60 coupled to the bronchoscope 50 for displaying video images received from bronchoscope 50, a tracking system 70 including a tracking module 72, a plurality of reference sensors 74, and a transmitter mat 76.” (emphasis added) ([0070]). “[A] sensor 100 d (FIGS. 2A, 3A, and 4A) that, in conjunction with tracking system 70 (FIG. 1)….” ([0059]). “A transmitter mat 76 is positioned beneath the patient “P” and is a transmitter of electromagnetic radiation. Transmitter mat 76 includes a stack of three substantially planar rectangular loop antennas (not shown) configured to be connected to drive circuitry (not shown).” ([0076]).
It would have been obvious to one having ordinary skill in the art to either replace the sensor in GUTTMAN or incorporate the EM sensor from COVIDIEN and to generate an electromagnetic field using the transmitter mat. One would have been motivated to use the EM sensor as it can be used with MRI and offer redundancy for other tracking systems. There would have been a reasonable expectation of success as COVIDIEN teaches they can be used with surgical navigation.
With respect to claims 14 and 15 (depending from claim 14), GUTTMAN does not explicitly teach the limitations of claims 14 and 15. However, COVIDIEN teaches generating an electromagnetic field and determining a location of the sensor in the electromagnetic field or a transmitter mat causing the generation of an electromagnetic field.
In the same field of endeavor, COVIDIEN teaches a “[s]ystem 10 [that] generally includes an operating table 40 configured to support a patient “P”, a bronchoscope 50 configured for insertion through the patient's mount into the patient's airways, monitoring equipment 60 coupled to the bronchoscope 50 for displaying video images received from bronchoscope 50, a tracking system 70 including a tracking module 72, a plurality of reference sensors 74, and a transmitter mat 76.” (emphasis added) ([0070]). “[A] sensor 100 d (FIGS. 2A, 3A, and 4A) that, in conjunction with tracking system 70 (FIG. 1)….” ([0059]). “A transmitter mat 76 is positioned beneath the patient “P” and is a transmitter of electromagnetic radiation. Transmitter mat 76 includes a stack of three substantially planar rectangular loop antennas (not shown) configured to be connected to drive circuitry (not shown).” (emphasis added) ([0076]).
It would have been obvious to one having ordinary skill in the art to either replace the sensor (e.g., tracking coils) in GUTTMAN with or add the EM sensor from COVIDIEN and to generate an electromagnetic field using the transmitter mat. One would have been motivated to use the EM sensor and mat system as it can be used with MRI and offer redundancy for other tracking systems. There would have been a reasonable expectation of success as COVIDIEN teaches they can be used with surgical navigation.
Claims 7, 9, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over International Publ. No. WO 2010/144419 A2 (hereinafter “GUTTMAN”) and U.S. Patent Appl. Publ. No. 2015/0374260 A1 (hereinafter “GOVARI”) and U.S. Patent Appl. Publ. No. 2018/0055582 A1 (hereinafter “KRIMSKY”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2010/0280353 A1 (hereinafter “ROTH”).
With respect to claims 7 and 9 (depending from claim 7), GUTTMAN does not explicitly teach to cause the generation of an electromagnetic field and the sensor is an electromagnetic sensor or explicitly teach wherein a magnetic coil of the MRI scanner generates the electromagnetic field.
However, ROTH teaches a method of “[t]racking based on the gradient fields of magnetic resonance imaging (MRI) scanners based on passive operation of the tracking system without any change of the scanner's hardware or mode of operation.” (Abstract). To this end, ROTH uses a sensor having three orthogonal coils. (see, e.g., “sensor 20” in Figure 4). ROTH notes that the “invention has significant advantages over existing methodologies. Compared with stereotaxis, either the frame or frameless techniques, the new methodology enables the use of devices like catheters or surgical instrumentation without the need for direct line of sight with the device and under realtime MRI.” ([0030]).
ROTH’s invention provides “a technique to create a custom MRI pulse sequence is disclosed. Through this technique any standard pulse sequence of the scanner can be modified to include gradient activations specifically designated for tracking.” (Abstract). Furthermore, it has broad applicability within “Interventional MRI: The sensor can be used with various devices, like miniature tools for minimally invasive surgery, catheters inside blood vessels, rigid and flexible endoscopes, biopsy and aspiration needles.” ([0094]). “Another potential application is to use the information of the location and orientation of the device in order to enable display of the MRI images in reference to the device local coordinate system, as if the operator is looking through the device and in the direction of the tip, similar to the use of optical endoscopes.” (Id).
It would have been obvious to one having ordinary skill in the art to incorporate the ROTH sensor and technique with the GUTTMAN system such that the sensor is an electromagnetic sensor and a magnetic coil of the MRI scanner generates the electromagnetic field. One would be motivated to use the ROTH sensor and technique because it eliminates one component (e.g., the separate EM field generator) while offering redundancy to the tracking coils of GUTTMAN and also enabling the “display of the MRI images in reference to the device local coordinate system, as if the operator is looking through the device and in the direction of the tip” as taught in ROTH. ([0094]). There would be a reasonable expectation of success as ROTH teaches that the invention can be incorporated into MRI scanners and used for surgical navigation.
With respect to claims 14 and 16 (depending from claim 14), GUTTMAN does not explicitly teach generating an electromagnetic field and determining a location of the sensor in the electromagnetic field (claim 14), wherein the sensor is an electromagnetic sensor and a magnetic coil of the MRI scanner generates the electromagnetic field (claim 16).
However, ROTH teaches a method of “[t]racking based on the gradient fields of magnetic resonance imaging (MRI) scanners based on passive operation of the tracking system without any change of the scanner's hardware or mode of operation.” (Abstract). To this end, ROTH uses a sensor having three orthogonal coils. (see, e.g., “sensor 20” in Figure 4) the location of which can be determined in the electromagnetic field. ([0048]). ROTH notes that the “invention has significant advantages over existing methodologies. Compared with stereotaxis, either the frame or frameless techniques, the new methodology enables the use of devices like catheters or surgical instrumentation without the need for direct line of sight with the device and under realtime MRI.” ([0030]).
ROTH’s invention provides “a technique to create a custom MRI pulse sequence is disclosed. Through this technique any standard pulse sequence of the scanner can be modified to include gradient activations specifically designated for tracking.” (Abstract). Furthermore, it has broad applicability within “Interventional MRI: The sensor can be used with various devices, like miniature tools for minimally invasive surgery, catheters inside blood vessels, rigid and flexible endoscopes, biopsy and aspiration needles.” ([0094]). “Another potential application is to use the information of the location and orientation of the device in order to enable display of the MRI images in reference to the device local coordinate system, as if the operator is looking through the device and in the direction of the tip, similar to the use of optical endoscopes.” (Id).
It would have been obvious to one having ordinary skill in the art to incorporate the ROTH sensor and technique with the GUTTMAN system such that the sensor is an electromagnetic sensor and a magnetic coil of the MRI scanner generates the electromagnetic field. One would be motivated to use the ROTH sensor and technique because it eliminates one component (e.g., the separate EM field generator) while offering redundancy to the tracking coils of GUTTMAN and also enabling the “display of the MRI images in reference to the device local coordinate system, as if the operator is looking through the device and in the direction of the tip” as taught in ROTH. ([0094]). There would be a reasonable expectation of success as ROTH teaches that the invention can be incorporated into MRI scanners and used for surgical navigation.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over International Publ. No. WO 2010/144419 A2 (hereinafter “GUTTMAN”) and U.S. Patent Appl. Publ. No. 2015/0374260 A1 (hereinafter “GOVARI”) and U.S. Patent Appl. Publ. No. 2018/0055582 A1 (hereinafter “KRIMSKY”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0142374 A1 (hereinafter “KRUECKER”).
With respect to claim 10, GUTTMAN does not explicitly teach wherein the sensor is an inertial measurement unit.
KRUECKER teaches medical navigation systems in which the system “employs inertial-based tracking methods and selectively employs image-based tracking methods to track medical imaging devices.” ([0001]). KRUECKER describes alternative tracking systems that use various technologies but also explains that those can be expensive and suggests motion-based tracking as an option. However, “motion-based inertial tracking devices experience bias which can lead to tracking inaccuracies.” ([0002]). “When using motion-based inertial tracking system for medical device tracking, the pose of the medical device may not always be tracked accurately over extended periods of time.” ([0003]). To address this concern, “[e]mbodiments of the present system may provide a system and method for acquiring image-based information and employing this image-based information to correct bias errors in inertial-based sensors of imaging devices for position tracking.” ([0005]). Embodiments “may reduce the need for highly-complex and expensive inertial or non-inertial sensors (such as electro-magnetic tracking sensors) and may allow the implementation of simple, low-cost inertial sensors.”
In KRUECKER, “[t]he system 100 may include one or more of a medical imaging device (MID)… an inertial measurement unit (IMU) 111, and a tracking corrector 106 communicatively coupled to each other via any suitable wired and/or wireless methods.” ([0032]). KRUECKER’s system employs periodic bias correction using image data. ([0005]).
It would have been obvious to one having ordinary skill in the art to use an inertial measurement unit (IMU) as the sensor in the GUTTMAN system. One would be motivated to use an IMU with KRUECKER’s technique because electro-magnetic tracking sensors can be expensive whereas KRUECKER’s method permits low-cost IMUs. There would have been a reasonable expectation of success as KRUECKER teaches that the IMU can be incorporated into tracking systems for surgical navigation.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over International Publ. No. WO 2010/144419 A2 (hereinafter “GUTTMAN”) and U.S. Patent Appl. Publ. No. 2015/0374260 A1 (hereinafter “GOVARI”) and Lufkin RB, Gronemeyer DH, Seibel RM. Interventional MRI: update. European Radiology. 1997 Nov;7(Suppl 5):S187-200 (hereinafter “LUFKIN”) and U.S. Patent Appl. Publ. No. 2018/0055582 A1 (hereinafter “KRIMSKY”).
With respect claim 17 (and in light of the Section 112 rejections), GUTTMAN teaches a method of navigating a catheter to a target within a patient (“MRI guided cardiac interventional systems….,” Abstract, but GUTTMAN also describes embodiments being applicable for “the tracheobronchopulmonary structure (structures including the lungs and the tracheobronchial tree),” GUTTMAN also teaches that the method includes receiving magnetic resonance signals from a magnetic resonance image (MRI) scanner and generating an MRI image data set ([0007]: “obtain MR image data and generate a series of near real time (RT) MRI images of target anatomy of a patient during a surgical procedure…”); generating a three-dimensional (3D) model from the MRI image data set (see [0007]: “render near RT interactive visualizations of the at least one flexible medical device in the 3-D [MRI] image space with at least one near RT [MRI] image of target patient anatomical structure and a registered pre-acquired volumetric model of the target anatomical structure of the patient.” GUTTMAN also teaches that the method includes determining a location of a distal portion of a catheter within the 3D model (204 in Figure 34, see also [0159]: “X, Y, Z coordinate locations are electronically identified in 3-D MRI image space for each of the tracking coils using the tracking signals (block 204).”; ([0063] “tracking members 82 can comprise miniature tracking coils, passive markers and/or a receive antenna.”); causing display of the location of at least the distal portion of a catheter in the 3D model (210 in Figure 34, see also [0159]: “Near real time (RT) visualizations of the medical device are generated showing: (a) the model of the patient's anatomy; (b) a physical representation of at least a distal end portion of the medical device using the identified locations of the tracking coils....”); receiving signals from a sensor incorporated in the catheter (204 in Figure 34, see also [0159]: “X, Y, Z coordinate locations are electronically identified in 3-D MRI image space for each of the tracking coils using the tracking signals (block 204).”; updating a displayed location of at least a portion of the catheter based on the received signals; receiving second magnetic resonance signals and generate a second MRI image data set, and updating a displayed position of the distal portion of the catheter in the 3D model based on the second MRI image data set. (Id., see also [0138]: “The MRI Scanner 10S (Figures 1-3) can be operated substantially continuously to provide image data that can be used to generate updated maps 100M in the visualizations upon request or automatically. This operation can be ‘in the background’, e.g., transparent to the user so as not to slow down the procedure while providing updated image and tracking data during the course of the procedure.”).
GUTTMAN also teaches that the method includes wherein the second MRI image data set is focused to an area proximate the sensor. In the same field of endeavor, GUTTMAN teaches “During the procedure, as the distal end of the device 80 (e.g., ablation catheter) approaches a location that corresponds to a target treatment (e.g., ablation) site 55t, the circuit 60c (e.g., MR Scanner 10S) can automatically select scan planes that “snap to” the tip and/or distal end portion location using a scan plane defined “on the fly” based on the calculated location of the distal end portion of the device (typically selected so that the slice includes a region offset from and/or projected forward a distance beyond the device such as between about 0-4 mm, typically about 1-2 mm) and/or using one or more of the preset scan planes associated with that location to obtain real-time MR image data of the associated tissue.” (emphasis added) ([0124]).
GUTTMAN does not explicitly teach that the second MRI image data set defines a reduced scan volume around a distal portion of the catheter. However, GUTTMAN is generally concerned with improving navigation for the user during a medical procedure. For example, GUTTMAN teaches that user may wish to view a “close-up” image in which “the associated image is shown enlarged relative to a global image or typical navigation view to show local tissue.” ([0054]). Moreover, the system enables a user to “rotate and zoom” the visualization while tracking a tip of the device. ([0091], see also [0092]-[0093]). GUTTMAN further teaches that the use can request a “high resolution or enlarged view” ([0111]) and Figures 22A-22B even illustrate close-up MRI views of the device’s tip.
In the same field of endeavor, GOVARI teaches a method includes displaying a position of a distal end of a medical probe that is being navigated in an organ of a patient on a three-dimensional (3D) map of the organ. (Abstract). “Embodiments of the present invention that are described herein below provide a method and system to obtain real-time imaging of the vicinity of the catheter's distal end during navigation, using a 3D magnetic position tracking map. Instead of acquiring a complete 3D MRI model, which is not feasible to perform in real time, the disclosed techniques acquire and display a MRI slice in a selected plane of interest which contains the catheter's distal end. By settling for an image at a specific plane, the physician can be provided with an overlaid image of an MRI slice on the magnetic position map in real-time.” ([0016]). GOVARI specifically teaches that the MRI slice has a finite thickness (e.g., 3 millimeters). GOVARI’s embodiments are “applicable for any minimally-invasive medical procedures such as laparoscopy or endoscopy, and are not limited to cardiac applications.” ([0018]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the GUTTMAN system such that the second MRI image data set defines a reduced scan volume around a distal portion of the catheter. GUTTMAN strongly suggests a system that is configured to display, in real-time, images of a distal portion of a catheter. GOVARI teaches a method of acquiring an MRI slice (having a finite thickness) that contains the catheter's distal end. One of ordinary skill in the art would have been motivated to use GOVARI’s method of automatically imaging the distal end to enable real-time navigation using a 3D MRI model. There would have been a reasonable expectation of success as GUTTMAN and GOVARI teach navigation systems for MRI models.
NOTE: Examiner is interpreting GUTTMAN’s MRI slice with a “finite thickness” as a reduced scan volume around a distal portion of the catheter. Applicant does not define the term “reduced scan volume.” (see MPEP 2111 regarding the broadest reasonable interpretation). Nevertheless, even if “reduced scan volume” meant at least two slices forming a reduced scan volume, one having ordinary skill in the art would be motivated to modify the system to make such a reduced scan volume (i.e., one formed from at least two slices). A person having ordinary skill in the art would know that GOVARI is not limited to only two imaging options (i.e., a complete 3D MRI model or a single MRI slice). Instead, a person having ordinary skill in the art would know that there is a predictable tradeoff between the size of the 3D MRI image and the acquisition time. For those circumstances in which a larger anatomical context near the distal end is desired, one having ordinary skill in the art would configure the system to provide (or enable the user to request) a larger scan volume at the distal end.
Neither GUTTMAN nor GOVARI explicitly teach that the MRI scanner has a field strength of between 20 milli-Tesla and 0.1 Tesla for the second magnetic resonance signals.
In the same field of endeavor, LUFKIN describes various interventional MRI systems. “Current designs of interventional MRI scanners emphasize maximum direct access to the patient so that therapy, monitoring and anesthesia can be achieved.” (S188, right column). One such system is the “Toshiba ACCESS (Toshiba Medical Systems) 0.064 Tesla scanner which has an open four sided permanent magnet design with extensive horizontal access….” (S188, right column). Notably, the strength of the filed for the Toshiba system is 0.064 Tesla (i.e., between 20 milli-T and 0.1 T).
It would have been obvious to one having ordinary skill in the art at the time of filing to combine the modified GUTTMAN visualization system with the MRI Scanner of LUFKIN. One of ordinary skill in the art could have added an open, four-sided MRI scanner having a field strength between 20 milli-T and 0.1 T using known methods to enable interventional procedures, such as luminal network procedures. In combination, each element would perform the same function as it does separately. Moreover, one of ordinary skill in the art would have recognized that the results of the combination were predictable.
GUTTMAN does not explicitly teach a method that includes generating a pathway through the 3D model to a target. However, GUTTMAN does describe that “[e]mbodiments of the present invention can be configured to guide and/or place flexible intrabody diagnostic and/or interventional devices in an MRI environment (e.g., interventional medical suite) to any desired internal region of interest of a subject, typically via a natural lumen and/or tortuous path…”. (emphasis added) ([0069]). Moreover, GUTTMAN describes presenting “with additional visual indicators and a ‘target’ navigational indicia (e.g., mark) for visual help in navigation to the site.” ([0131], Figure 23).
In the same field of endeavor, KRIMSKY teaches “methods for planning a procedure for treatment of lung tissue. An exemplary method includes generating a three-dimensional (3D) model of the luminal network, displaying the 3D model of the luminal network…, determining an access path between the target location and the identified point in the luminal network,…and displaying the access path and the calculated risk of injury for the access path on the 3D model.” (Abstract). The image data used to make the model and determine the access path includes magnetic resonance imaging (MRI) image data. ([0050]). KRIMSKY determines one or more access paths to the target location and displays the access paths along with a calculated risk of injury for each path. ([0066]).
It would have been obvious to one having ordinary skill in the art to modify/program the GUTTMAN method generates a pathway through the 3D model to a target. One having ordinary skill in the art would modify the system to reduce the risk of injury during the operation. GUTTMAN suggests providing pathways to the user for guidance to a target, and KRIMSKY teaches how to generate multiple paths along with calculated risks for the user to consider before proceeding. There would be a reasonable expectation of success as KRIMSKY teaches that pathways can be generated using MRI data.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over International Publ. No. WO 2010/144419 A2 (hereinafter “GUTTMAN”) and U.S. Patent Appl. Publ. No. 2015/0374260 A1 (hereinafter “GOVARI”) and Lufkin RB, Gronemeyer DH, Seibel RM. Interventional MRI: update. European Radiology. 1997 Nov;7(Suppl 5):S187-200 (hereinafter “LUFKIN”) and U.S. Patent Appl. Publ. No. 2018/0055582 A1 (hereinafter “KRIMSKY”) as applied to claim 17 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0142374 A1 (hereinafter “KRUECKER”).
With respect to claim 18, GUTTMAN does not explicitly teach wherein the sensor is an inertial measurement unit.
KRUECKER teaches medical navigation systems in which the system “employs inertial-based tracking methods and selectively employs image-based tracking methods to track medical imaging devices.” ([0001]). KRUECKER describes alternative tracking systems that use various technologies but also explains that those can be expensive and suggests motion-based tracking as an option. However, “motion-based inertial tracking devices experience bias which can lead to tracking inaccuracies.” ([0002]). “When using motion-based inertial tracking system for medical device tracking, the pose of the medical device may not always be tracked accurately over extended periods of time.” ([0003]). To address this concern, “[e]mbodiments of the present system may provide a system and method for acquiring image-based information and employing this image-based information to correct bias errors in inertial-based sensors of imaging devices for position tracking.” ([0005]). Embodiments “may reduce the need for highly-complex and expensive inertial or non-inertial sensors (such as electro-magnetic tracking sensors) and may allow the implementation of simple, low-cost inertial sensors.”
In KRUECKER, “[t]he system 100 may include one or more of a medical imaging device (MID)… an inertial measurement unit (IMU) 111, and a tracking corrector 106 communicatively coupled to each other via any suitable wired and/or wireless methods.” ([0032]). KRUECKER’s system employs periodic bias correction using image data. ([0005]).
It would have been obvious to one having ordinary skill in the art to use an inertial measurement unit (IMU) as the sensor in the GUTTMAN system. One would be motivated to use an IMU with KRUECKER’s technique because electro-magnetic tracking sensors can be expensive whereas KRUECKER’s method permits low-cost IMUs. There would have been a reasonable expectation of success as KRUECKER teaches that the IMU can be incorporated into tracking systems for surgical navigation.
With respect to claim 19, GUTTMAN does not explicitly teach wherein the updated displayed position of the distal portion of the catheter is employed to eliminate drift of the IMU.
KRUECKER’s primary concern is correcting for bias (i.e., drift). “However, any small error, bias or drift in acceleration and angular velocity may be accumulative over time and, thus, in the pose estimate, leading to deteriorating pose estimates over time.” ([0046]). Accordingly, KRUECKER teaches that “the sensors 112 are positioned as close to the image plane (i.e., as close to the tip of the probe 102) as possible, in order to minimize any errors introduced by extrapolating the motion/rotation (which was measured at the sensor position) to the image plane position.” ([0036]).
It would have been obvious to one having ordinary skill in the art to use the imaging (i.e., that shows the updated displayed position of the distal portion of the catheter) to eliminate drift of the IMU. One would be motivated to use an IMU with KRUECKER’s technique because electro-magnetic tracking sensors can be expensive whereas KRUECKER’s method permits low-cost IMUs and drift-correction for the tip of the tool, which can be the most important to follow. There would have been a reasonable expectation of success as KRUECKER teaches that the IMU can be incorporated into tracking systems for surgical navigation.
With respect to claim 20, GUTTMAN teaches further comprising receiving subsequent magnetic resonance signals and generating additional MRI image data sets, wherein the additional MRI image data sets are focused to the area proximate the sensor; and updating the displayed position of the distal portion of the catheter in the 3D model based on the second MRI image data set. ([0138]: “The MRI Scanner 10S (Figures 1-3) can be operated substantially continuously to provide image data that can be used to generate updated maps 100M in the visualizations upon request or automatically. This operation can be ‘in the background’, e.g., transparent to the user so as not to slow down the procedure while providing updated image and tracking data during the course of the procedure.”).
GUTTMAN also teaches wherein the second MRI image data set is focused to an area proximate the sensor. “During the procedure, as the distal end of the device 80 (e.g., ablation catheter) approaches a location that corresponds to a target treatment (e.g., ablation) site 55t, the circuit 60c (e.g., MR Scanner 10S) can automatically select scan planes that “snap to” the tip and/or distal end portion location using a scan plane defined “on the fly” based on the calculated location of the distal end portion of the device (typically selected so that the slice includes a region offset from and/or projected forward a distance beyond the device such as between about 0-4 mm, typically about 1-2 mm) and/or using one or more of the preset scan planes associated with that location to obtain real-time MR image data of the associated tissue.” ([0124]).
RESPONSE TO APPLICANT’S ARGUMENTS:
Applicant’s arguments with respect to the Section 103 rejections based on GUTTMAN and KRIMSKY have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-6778689-B1 teaches a real-time imaging and visualization method and system that “allows for very narrow FOV imaging for guidewire and catheter channels as well as full FOV imaging for roadmap image reconstruction. Thus, multiple FOV images are displayed together, improving visualization of the interventional device placement.” (Abstract).
Conclusion
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/JASON P GROSS/Examiner, Art Unit 3797 /SERKAN AKAR/Primary Examiner, Art Unit 3797
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