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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 8/08/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 20 is objected to because of the following informalities:
Regarding claim 20, the limitation “backward” should be replaced with “backward.” to add punctuation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 10 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 8 recites the limitation "the deformation parameter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Further regarding claim 8¸ the claim recites the deformation parameter “indicative of” but does not incorporate the recitation into a method step and therefore it is not clear as to the scope of the claim. This renders the claim unclear and indefinite.
Claim 10 recites the limitation "the deformation parameter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 9, 11, and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Danna et al. (WO2021/127475) hereinafter Danna (see attached WO publication for citations).
Regarding claim 1, Danna teaches:
A method for localizing an endoscope in a body part of a patient (abstract; [0059]), the method comprising:
(a) obtaining a sequence of electromagnetic (EM) data ([0057]-[0058], EM sensors provide EM sensor position data; [0067]-[0068], EM sensor and EM tracking data; [0069], “The stream data may comprise a variety of types of data including, without limitation: time series data such as spatio-temporal point measurements generated by the EM sensor.”; [0070]-[0072]);
(b) generating an EM data-based path based at least in part on the sequence of the EM data ([0071], “creating an association between the EM space and model (e.g., CT) space. During the second phase, an initial transformation matrix between the EM space and CT space may be generated based at least in part on the translation information generated in the first phase and real-time sensor data. In some cases, data points (e.g., EM data) utilized in the second phase may be collected when the catheter is navigating inside the trachea and/or a child branch along a predefined navigation path. The predefined navigation path may be defined in the CT space. As described elsewhere herein, EM data may include information about the orientation, position and error data.”; see also [0072]-[0083]);
(c) identifying one or more path hypotheses based at least in part on a data point from the sequence of EM data ([0071], “The predefined navigation path may be defined in the CT space. As described elsewhere herein, EM data may include information about the orientation, position and error data. The CT space or the coordinate frame of the anatomical model may be generated in a pre-operative procedure or during a surgical operation. Such sensor data points may be used to establish a plane in space, and establish a set of associations between the EM space and CT space based on a set of directional distances traveled (e.g., both orientation and length) in the EM space and CT space respectively. The set of associations may be generated based at least in part on the time series data such as the spatio-temporal data points generated by the EM sensor.”; see also [0072]-[0083]), wherein the one or more path hypotheses have a shape based on a biological model of the body part of the patient ([0070], “a registration transformation between the EM field and the patient model (e.g., coordinate frames of the luminal network model) may be identified. This translational transformation in the second phase may include an initial translation transformation matrix”; [0071], “The predefined navigation path may be defined in the CT space. As described elsewhere herein, EM data may include information about the orientation, position and error data. The CT space or the coordinate frame of the anatomical model may be generated in a pre-operative procedure or during a surgical operation. Such sensor data points may be used to establish a plane in space, and establish a set of associations between the EM space and CT space based on a set of directional distances traveled (e.g., both orientation and length) in the EM space and CT space respectively. The set of associations may be generated based at least in part on the time series data such as the spatio-temporal data points generated by the EM sensor.”, which forms one or more path hypotheses based upon the biological model based upon the CT data anatomical model; see also [0072]-[0083]);
(d) generating one or more deformed paths by mapping the one or more path hypotheses to the EM data-based path using an optimization algorithm ([0008], “The adaptive navigation algorithm may be capable of identifying a registration or mapping between the coordinate frame of the 3D model (e.g., a coordinate frame of the CT scanner used to generate the model) and the coordinate frame of the EM field (e.g., of the EM field generator) with on-the-fly updates capability.”; [0054], “One or more processors of the signal processing unit may be configured to further overlay treatment locations (e.g., lesion) on the real-time fluoroscopic image/video. For example, the processing unit may be configured to generate an augmented layer comprising augmented information such as the location of the treatment location or target site. In some cases, the augmented layer may also comprise graphical marker indicating a path to this target site. The augmented layer may be a substantially transparent image layer comprising one or more graphical elements (e.g., box, arrow, etc). The augmented layer may be superposed onto the optical view of the optical images or video stream captured by the fluoroscopy (tomosynthesis) imaging system, and/or displayed on the display device. The transparency of the augmented layer allows the optical image to be viewed by a user with graphical elements overlay on top of. In some cases, both the segmented lesion images and an optimum path for navigation of the elongate member to reach the lesion may be overlaid onto the real time tomosynthesis images. This may allow operators or users to visualize the accurate location of the lesion as well as a planned path of the bronchoscope movement. In some cases, the segmented and reconstructed images (e.g. CT images as described elsewhere) provided prior to the operation of the systems described herein may be overlaid on the real time images.” The optimum path for navigation overlaid on the images form the one or more deformed paths based upon the path hypotheses acquired by the EM data and processing; see also [0055]-[0058]; [0068]-[0083]); and
(e) selecting a deformed path from the one or more deformed paths based at least in part on a probability associated with each of the one or more path hypotheses and determining a location for a tip of the endoscope based on the selected deformed path ([0054], “The transparency of the augmented layer allows the optical image to be viewed by a user with graphical elements overlay on top of. In some cases, both the segmented lesion images and an optimum path for navigation of the elongate member to reach the lesion may be overlaid onto the real time tomosynthesis images. This may allow operators or users to visualize the accurate location of the lesion as well as a planned path of the bronchoscope movement.”; [0058]; [0059], “a user interface for visualizing a virtual airway 509 overlaid with an optimal path 503, location of the tip of the catheter 501, and lesion location 505. In this example, the location of the tip of the catheter is displayed in real-time relative to the virtual airway model 509 thereby providing visual guidance. As shown in the example of FIG. 5, during robotic bronchoscope driving, the optimal path 503 may be displayed and overlaid onto the virtual airway model. As described above, the virtual airway model may be constructed based on the real-time fluoroscopic image/video (and location data of the imaging system). In some cases, a view of the real-time fluoroscopic image/video 507 may also be displayed on the graphical user interface. In some cases, users may also be permitted to access the camera view or image/video 511 captured by the bronchoscope in real time.” Which provides real time guidance of location of a tip of the endoscope; see also [0055]-[0057]; [0068]-[0083]).
Regarding claim 2, Danna teaches all of the limitations of claim 1. Danna further teaches:
wherein, prior to (c), the EM data-based path is translated into a coordinate frame of the biological model ([0033], medical device coordinate frame (EM data based path) with the 3D model coordinate frame; [0043]; [0067], “The EM field is stationary relative to the EM field generator, and a coordinate frame of a 3D model of the luminal network (e.g., CT space) can be mapped to a coordinate frame of the EM field.”; [0068]-[0069]; [0070], “For example, a registration transformation between the EM field and the patient model (e.g., coordinate frames of the luminal network model) may be identified.”).
Regarding claim 3, Danna teaches all of the limitations of claim 1. Danna further teaches:
wherein the biological model comprises one or more airways ([0055], virtual airway model; [0056]; [0058]-[0059]).
Regarding claim 4, Danna teaches all of the limitations of claim 3. Danna further teaches:
wherein the EM data are acquired while navigating the tip of the endoscope along the one or more airways forward or backward ([0069], “the EM sensor data points may be collected when the distal tip is placed inside the subject such as the bronchus or trachea and travels along a known direction.” Known direction forms either moving forward or backward within the airways during use).
Regarding claim 7, Danna teaches all of the limitations of claim 1. Danna further teaches:
wherein the body part is a lung and the endoscope is a bronchoscope ([0041]-[0044], bronchoscope for imaging of the lung; [0045]-[0047]; [0054]-[0059]).
Regarding claim 9, Danna teaches all of the limitations of claim 1. Danna further teaches:
wherein the biological model of the body part of the patient is generated based on a computed tomography (CT) scan ([0033], 3D model from CT scanner data; [0043]-[0044]; [0055]-[0064]).
Regarding claim 11, Danna teaches all of the limitations of claim 1. Danna further teaches:
wherein the one or more path hypotheses are within a predetermined location range from the latest data point of the sequence of EM data, within a threshold of measurement error or deformation, or above a threshold of the possibility ([0071], “an initial transformation matrix between the EM space and CT space may be generated based at least in part on the translation information generated in the first phase and real-time sensor data. In some cases, data points (e.g., EM data) utilized in the second phase may be collected when the catheter is navigating inside the trachea and/or a child branch along a predefined navigation path. The predefined navigation path may be defined in the CT space” If the catheter is within the “predefined navigation path” this forms a predetermined location range between the latest data point of the EM data nad the one or more path hypotheses and teaches to the claim alternative; see also [0072]-[0083]).
Regarding claim 14, Danna teaches all of the limitations of claim 1. Danna further teaches:
wherein mapping the one or more path hypotheses to the EM data-based path comprises applying the optimization algorithm to determine a deformation and shape alignment between the one or more path hypotheses and the EM data-based path ([0008], “adaptive navigation algorithm may be capable of identifying a registration or mapping between the coordinate frame of the 3D model (e.g., a coordinate frame of the CT scanner used to generate the model) and the coordinate frame of the EM field (e.g., of the EM field generator) with on-the-fly updates capability”; [0054], “One or more processors of the signal processing unit may be configured to further overlay treatment locations (e.g., lesion) on the real-time fluoroscopic image/video. For example, the processing unit may be configured to generate an augmented layer comprising augmented information such as the location of the treatment location or target site. In some cases, the augmented layer may also comprise graphical marker indicating a path to this target site. The augmented layer may be a substantially transparent image layer comprising one or more graphical elements (e.g., box, arrow, etc). The augmented layer may be superposed onto the optical view of the optical images or video stream captured by the fluoroscopy (tomosynthesis) imaging system, and/or displayed on the display device. The transparency of the augmented layer allows the optical image to be viewed by a user with graphical elements overlay on top of. In some cases, both the segmented lesion images and an optimum path for navigation of the elongate member to reach the lesion may be overlaid onto the real time tomosynthesis images. This may allow operators or users to visualize the accurate location of the lesion as well as a planned path of the bronchoscope movement. In some cases, the segmented and reconstructed images (e.g. CT images as described elsewhere) provided prior to the operation of the systems described herein may be overlaid on the real time images”).
Regarding claim 15, Danna teaches all of the limitations of claim 1. Danna further teaches:
wherein the deformed path selected from the one or more deformed path paths is associated with the highest probability ([0054], “The transparency of the augmented layer allows the optical image to be viewed by a user with graphical elements overlay on top of. In some cases, both the segmented lesion images and an optimum path for navigation of the elongate member to reach the lesion may be overlaid onto the real time tomosynthesis images. This may allow operators or users to visualize the accurate location of the lesion as well as a planned path of the bronchoscope movement”, Optimum path forms one associated with highest probability; [0059], “a user interface for visualizing a virtual airway 509 overlaid with an optimal path 503, location of the tip of the catheter 501, and lesion location 505. In this example, the location of the tip of the catheter is displayed in real-time relative to the virtual airway model 509 thereby providing visual guidance. As shown in the example of FIG. 5, during robotic bronchoscope driving, the optimal path 503 may be displayed and overlaid onto the virtual airway model. As described above, the virtual airway model may be constructed based on the real-time fluoroscopic image/video (and location data of the imaging system). In some cases, a view of the real-time fluoroscopic image/video 507 may also be displayed on the graphical user interface. In some cases, users may also be permitted to access the camera view or image/video 511 captured by the bronchoscope in real time” optimal path forms a highest probability for a procedure).
Regarding claim 16, Danna teaches all of the limitations of claim 15. Danna further teaches:
wherein the highest probability is determined based at least in part normalized probabilities associated with each of the one or more path hypotheses ([0075], “the error minimization operation may include using singular value decomposition to calculate the best fit transform. For example, the singular value decomposition may be applied to a set of associations to calculate the best transformation. The singular value decomposition method may be used to calculate a solution to a total least squares minimization problem.” Forms a best transformation as the highest probability through calculations that at least in part normalize probabilities; see also [0065]-[0083]).
Regarding claim 17, Danna teaches:
A system for localizing an endoscope in a body part of a patient, the system comprising: a memory storing computer-executable instructions; one or more processors in communication with the endoscope and configured to execute the computer-executable instructions ([0009]; [0011]-[0013]; [0038]; abstract) to:
(a) obtain a sequence of electromagnetic (EM) data ([0057]-[0058], EM sensors provide EM sensor position data; [0067]-[0068], EM sensor and EM tracking data; [0069], “The stream data may comprise a variety of types of data including, without limitation: time series data such as spatio-temporal point measurements generated by the EM sensor.”; [0070]-[0072]);
(b) generate an EM data-based path based at least in part on the sequence of the EM data ([0071], “creating an association between the EM space and model (e.g., CT) space. During the second phase, an initial transformation matrix between the EM space and CT space may be generated based at least in part on the translation information generated in the first phase and real-time sensor data. In some cases, data points (e.g., EM data) utilized in the second phase may be collected when the catheter is navigating inside the trachea and/or a child branch along a predefined navigation path. The predefined navigation path may be defined in the CT space. As described elsewhere herein, EM data may include information about the orientation, position and error data.”; see also [0072]-[0083]);
(c) identify one or more path hypotheses based at least in part on a data point from the sequence of EM data ([0071], “The predefined navigation path may be defined in the CT space. As described elsewhere herein, EM data may include information about the orientation, position and error data. The CT space or the coordinate frame of the anatomical model may be generated in a pre-operative procedure or during a surgical operation. Such sensor data points may be used to establish a plane in space, and establish a set of associations between the EM space and CT space based on a set of directional distances traveled (e.g., both orientation and length) in the EM space and CT space respectively. The set of associations may be generated based at least in part on the time series data such as the spatio-temporal data points generated by the EM sensor.”; see also [0072]-[0083]), wherein the one or more path hypotheses have a shape based on a biological model of the body part of the patient ([0070], “a registration transformation between the EM field and the patient model (e.g., coordinate frames of the luminal network model) may be identified. This translational transformation in the second phase may include an initial translation transformation matrix”; [0071], “The predefined navigation path may be defined in the CT space. As described elsewhere herein, EM data may include information about the orientation, position and error data. The CT space or the coordinate frame of the anatomical model may be generated in a pre-operative procedure or during a surgical operation. Such sensor data points may be used to establish a plane in space, and establish a set of associations between the EM space and CT space based on a set of directional distances traveled (e.g., both orientation and length) in the EM space and CT space respectively. The set of associations may be generated based at least in part on the time series data such as the spatio-temporal data points generated by the EM sensor.”, which forms one or more path hypotheses based upon the biological model based upon the CT data anatomical model; see also [0072]-[0083]);
(d) generate one or more deformed paths by mapping the one or more path hypotheses to the EM data-based path using an optimization algorithm ([0008], “The adaptive navigation algorithm may be capable of identifying a registration or mapping between the coordinate frame of the 3D model (e.g., a coordinate frame of the CT scanner used to generate the model) and the coordinate frame of the EM field (e.g., of the EM field generator) with on-the-fly updates capability.”; [0054], “One or more processors of the signal processing unit may be configured to further overlay treatment locations (e.g., lesion) on the real-time fluoroscopic image/video. For example, the processing unit may be configured to generate an augmented layer comprising augmented information such as the location of the treatment location or target site. In some cases, the augmented layer may also comprise graphical marker indicating a path to this target site. The augmented layer may be a substantially transparent image layer comprising one or more graphical elements (e.g., box, arrow, etc). The augmented layer may be superposed onto the optical view of the optical images or video stream captured by the fluoroscopy (tomosynthesis) imaging system, and/or displayed on the display device. The transparency of the augmented layer allows the optical image to be viewed by a user with graphical elements overlay on top of. In some cases, both the segmented lesion images and an optimum path for navigation of the elongate member to reach the lesion may be overlaid onto the real time tomosynthesis images. This may allow operators or users to visualize the accurate location of the lesion as well as a planned path of the bronchoscope movement. In some cases, the segmented and reconstructed images (e.g. CT images as described elsewhere) provided prior to the operation of the systems described herein may be overlaid on the real time images.” The optimum path for navigation overlaid on the images form the one or more deformed paths based upon the path hypotheses acquired by the EM data and processing; see also [0055]-[0058]; [0068]-[0083]); and
(e) select a deformed path from the one or more deformed paths based at least in part on a probability associated with each of the one or more path hypotheses and determining a location for a tip of the endoscope based on the selected deformed path ([0054], “The transparency of the augmented layer allows the optical image to be viewed by a user with graphical elements overlay on top of. In some cases, both the segmented lesion images and an optimum path for navigation of the elongate member to reach the lesion may be overlaid onto the real time tomosynthesis images. This may allow operators or users to visualize the accurate location of the lesion as well as a planned path of the bronchoscope movement.”; [0058]; [0059], “a user interface for visualizing a virtual airway 509 overlaid with an optimal path 503, location of the tip of the catheter 501, and lesion location 505. In this example, the location of the tip of the catheter is displayed in real-time relative to the virtual airway model 509 thereby providing visual guidance. As shown in the example of FIG. 5, during robotic bronchoscope driving, the optimal path 503 may be displayed and overlaid onto the virtual airway model. As described above, the virtual airway model may be constructed based on the real-time fluoroscopic image/video (and location data of the imaging system). In some cases, a view of the real-time fluoroscopic image/video 507 may also be displayed on the graphical user interface. In some cases, users may also be permitted to access the camera view or image/video 511 captured by the bronchoscope in real time.” Which provides real time guidance of location of a tip of the endoscope; see also [0055]-[0057]; [0068]-[0083]).
Regarding claim 18, Danna teaches all of the limitations of claim 17. Danna further teaches:
wherein, prior to (c), the EM data-based path is translated into a coordinate frame of the biological model ([0033], medical device coordinate frame (EM data based path) with the 3D model coordinate frame; [0043]; [0067], “The EM field is stationary relative to the EM field generator, and a coordinate frame of a 3D model of the luminal network (e.g., CT space) can be mapped to a coordinate frame of the EM field.”; [0068]-[0069]; [0070], “For example, a registration transformation between the EM field and the patient model (e.g., coordinate frames of the luminal network model) may be identified.”).
Regarding claim 19, Danna teaches all of the limitations of claim 17. Danna further teaches:
wherein the biological model comprises one or more airways ([0055], virtual airway model; [0056]; [0058]-[0059]).
Regarding claim 20, Danna teaches all of the limitations of claim 19. Danna further teaches:
wherein the EM data are acquired while navigating the tip of the endoscope along the one or more airways forward or backward ([0069], “the EM sensor data points may be collected when the distal tip is placed inside the subject such as the bronchus or trachea and travels along a known direction.” Known direction forms either moving forward or backward within the airways during use).
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Danna as applied to claim 1 above, and further in view of Soper et al. (U.S. Pub. No. 20200046431) hereinafter Soper.
Regarding claim 5, primary reference Danna teaches all of the limitations of claim 1. Primary reference Danna further fails to teach:
wherein the EM data-based path is generated by applying binned filtering and/or time-wise filtering to the EM data
However, the analogous art of Soper of a method of registering a model of anatomic passageways of a patient (abstract) teaches:
wherein the EM data-based path is generated by applying binned filtering and/or time-wise filtering to the EM data ([0057], binned filtering of the measured points of EM tracking; [0072], calibration on tracked points; [0073]-[0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the EM tracking and path determination method of Danna to incorporate the application of filtering as taught by Soper because it provides for separate data structures to store series of data points based upon time-based markers such as the respiratory phases during a breathing cycle (Soper, [0057]). This provides for higher accuracy in measurements across different phases, and better monitoring of patient movement during a procedure.
Regarding claim 6, the combined references of Danna and Soper teach all of the limitations of claim 5. Primary reference Danna further teaches:
wherein the EM data-based path comprises a sequence of points distributed evenly in both spatial and temporal domain and is indicative of a driving trajectory of the tip of the endoscope ([0069], “ stream data collected when the catheter is driven in a known direction. The stream data may comprise a variety of types of data including, without limitation: time series data such as spatio-temporal point measurements generated by the EM sensor. In some cases, the time series data may be collected when the catheter is driven in a known direction that may or may not be inside a patient body” Across a stream of data in a known direction with time-series point measurements form a sequence of spaced points in both time and spatial domain, and indicates movement (driving trajectory) of tip of endoscope; [0067]-[0068]; [0070]-[0072]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Danna as applied to claim 1 above, and further in view of Barak et al. (WO2022/123577) hereinafter Barak (see attached WO publication for citations).
Regarding claim 8, primary reference Danna teaches all of the limitations of claim 1. Primary reference Danna further fails to teach:
wherein the deformation parameter indicative of a deformation of the body part due to a motion of the patient
However, the analogous art of Barak of a system and method for tracking movement of a catheter within a lung (abstract) teaches:
wherein the deformation parameter indicative of a deformation of the body part due to a motion of the patient (page 7, lines 4-7, access measurements of body motion and modify orientations of airways based upon the motion (deformation parameter); page 25, lines 13-19, lung deformation parameters are utilized for modeling of the deformation of the lungs as in page 25, line 20 through page 26, line 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the EM tracking and path determination method of Danna to incorporate the deformation parameter as taught by Barak because lung deformation may cause expansion or shrinkage during breathing, and while change throughout a procedure with a bronchoscope (Barak, page 25, lines 13-19). By accurately modeling these movements using a deformation parameter, better accuracy during procedures can be achieved, leading to improved clinical outcomes.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Danna as applied to claim 1 above, and further in view of Ye et al. (WO2023/161848) hereinafter Ye (see attached WO Publication for citations).
Regarding claim 10, primary reference Danna teaches all of the limitations of claim 1. Primary reference Danna further fails to teach:
wherein the deformation parameter is indicative of a deformation due to CT-to-body-divergence
However, the analogous art of Ye of a system and method for tracking movement of a instrument within a patient (abstract) teaches:
wherein the deformation parameter is indicative of a deformation due to CT-to-body-divergence ([0067], CT-to-body divergence compensation)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the EM tracking and path determination method of Danna to incorporate the deformation due to CT-to-body divergence as taught by Ye because error can be introduced when using an intraoperative model for location estimation and compensation of the reconstruction for CT-to-body divergence can lead to improved accuracy and better instrument positioning (Ye, [0067]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Danna as applied to claim 1 above, and further in view of Srinivasan et al. (U.S. Pub. No. 20190365486) hereinafter Srinivasan.
Regarding claim 12, primary reference Danna teaches all of the limitations of claim 1. Primary reference Danna further fails to teach:
wherein each of the one or more path hypotheses comprises at least a portion of a centerline of an airway of the biological model
However, the analogous art of Srinivasan of a path-based navigation system for tubular networks (abstract) teaches:
wherein each of the one or more path hypotheses comprises at least a portion of a centerline of an airway of the biological model ([0111], “FIG. 12 is a simplified example model of a portion of a luminal network for describing aspects of this disclosure related to path-based location estimation. In particular, FIG. 12 depicts a model 1200 of a simplified luminal network including a skeleton 1205, which may be defined by a centerline of the luminal network, and a navigational path 1210 which traverses a portion of the model 1200.”; [0112]-[0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the EM tracking and path determination method of Danna to incorporate the centerline of the airway for path estimation as taught by Srinivasan because luminal network distances and locations may be defined and estimated by the centerline of the lumen (Srinivasan, [0111]). By using this estimation, additional path-based estimations of the distal end of the instrument can be predicted, leading to better predictions of actual location relative to patient anatomical regions of interest.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Danna as applied to claim 1 above, and further in view of Glossop (U.S. Pub. No. 20060184016) hereinafter Glossop.
Regarding claim 13, primary reference Danna teaches all of the limitations of claim 1. Primary reference Danna further fails to teach:
further comprising dynamically adding or removing a path hypothesis as the tip of the endoscope is driving through the body part
However, the analogous art of Glossop of a navigation of a medical instrument to a target location within a lung (abstract) teaches:
further comprising dynamically adding or removing a path hypothesis as the tip of the instrument is driving through the body part ([0095]; [0096], “ advancing tracked guidewire 809 may proceed by identifying the intended path of the guidewire and navigating the path by carefully rotating the guidewire so that the leading bend of the wire is pointed into and subsequently advanced into the bronchial branch of interest. FIGS. 9A-9E illustrate utilizing a leading bend of a wire or instrument to navigate a through a branched or arboreal path. Such navigation is begun as guidewire 809 is advanced into a bronchial pathway 811 as illustrated in FIG. 9A. FIGS. 9B and 9C illustrate guidewire 809 being pushed downward, keeping the direction of the tip pointing in the direction of target 803. If the tip of guidewire 809 appears to be traveling in an undesirable side branch 813, as shown in FIG. 9D, guidewire 809 can be rotated (it has suitable torque conversion properties for such rotation) so that the bent tip points into a desired pathway, withdrawn from the errant path (side branch 813), and advanced toward target 803”. As the guidewire changes into a side branch and then re-rotated back into a desired pathway, this forms a dynamic removing of a path hypothesis as the real-time tracking and adjustment of the tracked instrument ([0095]) is performed throughout a procedure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the EM tracking and path determination method of Danna to incorporate the dynamic real-time adjustment of path hypothesis as taught by Glossop because instruments may travel down the wrong lumen side branches, and real-time tracking path updates enables pullback rearwards to the target lumen of interest and increases tracking accuracy throughout all procedure movements (Glossop, [0095]-[0096]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798