DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 2/2/26 have been fully considered but they are not persuasive.
Applicant argues that Adebar does not teach the newly introduced claim features in claim 1, lines 32-40. As detailed in infra rejection, contrary to Applicant’s contention, Adebar teaches the alleged claim features. For example, Adebar paragraphs [0059]-[0066], [0075]-[0077], Figs. 4-5C and 8 (or paragraphs [0078]-[0100], Figs. 9-11B) disclose comparing the shape information captured at a first position (or a first/measured model) with the shape information captured at a second position advanced in the distal direction from the first position (or a second/predicted model) using a 3D movement threshold around the distal tip of the elongate device. If the comparison is within the threshold, the shape information captured at a second position (or the second/predicted model) is valid and is used to define the shape information at the second position. If the comparison exceeds the threshold, the shape information captured at a second position (or the second/predicted model) is invalid and the control system acts to prevent its use to define the shape information at the second position.
These steps are repeated for each distal advancement of the elongate device, e.g., shape information is captured at a third position (or a third/predicted model) advanced in the distal direction from the valid second position and from the first position The further shape information captured at the third position (or the third/predicted model) is analogous to the “second pathway portion for the live 3D shape extending distally away from a distal end of the second reference shape when the second reference shape is disposed within a threshold boundary extending around the first pathway portion” recited in claim 1, lines 33-36.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adebar et al. (U.S. Pub. No. 2020/0297442), hereinafter “Adebar,” incorporating by reference in its entirety Childlers et al. (U.S. Pub. No. 2006/0013523, corresponding to U.S. patent application Ser. No. 11/180,389) in Adebar, [0043], hereinafter “Childlers.”
Regarding claim 1, Adebar discloses a medical device system (medical instrument system, [0040]), comprising:
a medical device (elongate device, [0041]; optical fiber shape sensor, [0043]) comprising:
an elongate probe (elongate device, [0041]); and
an optical fiber (optical fiber shape sensor, [0043]) having one or more of core fibers extending along the elongate probe (multiple optical fiber cores extending along the elongate device, [0043]), each of the one or more core fibers including a plurality of optical sensors distributed along the longitudinal length (multiple optical fiber cores including Fiber Bragg Gratings, [0043]) and each sensor of the plurality of sensors being configured to (i) reflect a light signal of a different spectral width based on received incident light (FBGs are coupled with a reflectometer where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, Childlers, [0035]-[0036]), and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber (FBGs provide strain measurements according to bending of the optical fiber, [0043]; FBGs are coupled with a reflectometer where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, wherein the modulation of light is used to determine the strain experienced by the optical fiber, Childlers, [0035]-[0036]; see also strain measurements, Childlers, [0039]-[0042]); and
a console including one or more processors and a non-transitory computer- readable medium having stored thereon logic, when executed by the one or more processors, causes operations (control system includes at least one computer processor and a non-transitory machine-readable medium storing the instructions to implement the process, [0037]) including:
determining a live three-dimensional (3D) shape of the elongate probe during insertion of the elongate probe within a patient body (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, [0043], [0044], [0060], [0075], [0079]-[0094], Figs. 5A-5C, 10A-10F), wherein determining includes:
providing an incident light signal to the optical fiber (reflectometer provides incident light upon the FBGs, Childlers, [0035]-[0036]);
receiving reflected light signals of different spectral widths of the incident light by one or more of the plurality of optical sensors (reflectometer captures reflected light where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, Childlers, [0035]-[0036]); and
processing the reflected light signals associated with the one or more of core fibers to determine the live 3D shape (FBGs provide strain measurements according to bending of the optical fiber, [0043]; strain measurements from the shape measurement system including the history of the pose of the elongate probe is used to reconstruct the shape of the flexible body of the elongate device including the current pose, [0043], [0044], [0060], [0075], [0079]-[0094], Figs. 5A-5C, 10A-10F; FBGs are coupled with a reflectometer where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, wherein the modulation of light is used to determine the strain experienced by the optical fiber, Childlers, [0035]-[0036]; see also strain measurements, Childlers, [0039]-[0042]);
capturing a first reference shape, the first reference shape including at least a portion of the live 3D shape (shape information is captured continuously as the elongate device is advanced distally within the anatomic passageway, including at a first position, [0059], [0061], Figs. 4-5C; see also shape information of the first/measured model at a first position captured as the elongate device is advanced distally within the anatomic passageway, [0079], [0082]-[0085], [0090], [0093]-[0094], Figs. 9-11B); and
defining a first pathway portion for the live 3D shape extending distally away from a distal end of the first reference shape (threshold movement value may be realized as a shape in three-dimensions around the distal tip of the elongate device in the first position and includes a movement threshold extending in the direction of insertion/withdrawal (I/O), i.e., distally away from the distal end, [0061]-[0062], [0064]-[0066], Figs. 4-5C; see also threshold difference between first/measured model and second/predicted model, [0085], Figs. 9-10C; see also measurement zone and/or patient movement threshold including a divergence/deviation in a direction parallel to the table or in a linear direction along the insertion axis, i.e., extending distally away from a distal end of the first model, [0089], [0093]-[0099], Figs. 10C-11B);
capturing a second reference shape, the second reference shape including at least a portion of the live 3D shape, wherein the second reference shape is captured after distal displacement of the elongate probe following the capturing of the first reference shape (shape information is captured continuously as the elongate device is advanced distally within the anatomic passageway, including at a second position captured after distal advancement of the elongate device following the capturing of the shape information at the first position, [0059], [0061]-[0062], [0064], [0065]-[0066], Figs. 4-5C; see also shape information of the second/predicted model is captured for a second position of the distal advancement of the elongate device following the capturing of the shape information of the first/measured model at a first position, [0080]-[0081], [0082]-[0085], [0091]-[0094], Figs. 9-11B);
comparing the second reference shape with the first reference shape (shape information captured at the second position is compared to the shape information captured at the first position to determine whether the distal tip of the elongate device is above or below the threshold movement values of the shape, [0059], [0061]-[0066], [0075]-[0077], Figs. 4-5C and 8; see also comparing the shape information of the second/predicted model to the shape information of the first model to determine whether the distal tip of the elongate device is above or below the patient movement threshold/measurement zone, [0085], [0089], [0093]-[0099], Figs. 9-11B); and as a result of the comparison:
defining a second pathway portion for the live 3D shape extending distally away from a distal end of the second reference shape when the second reference shape is disposed within a threshold boundary extending around the first pathway portion (use the shape information at the second position captured after distal advancement of the elongate device following the capturing of the shape information at the first position as the moved position when the shape information at the second position is disposed within a threshold movement value of the shapes to define the shape information at the second position, [0061]-[0064], [0066], Figs. 4-5C; see also using the shape information of the second/predicted model of the distal advancement of the elongate device following the capturing of the shape information of the first/measured model as the moved position when the shape information of the second/predicted model is disposed within a patient movement threshold/measurement zone to define the shape information at the second position, [0085], [0089], [0093], [0098], Figs. 9-11B; steps of defining a first position and a second position are performed repeatedly/continuously as the elongate device is driven/advanced in the distal direction for multiple times and insertion distances, i.e., shape information (or a third/predicted model) is captured at least at a third position advanced in the distal direction from the valid second position (i.e., the new current/measured position) and from the first position (i.e., a previous time/insertion distance), [0059], [0065]-[0066], [0075]-[0077], [0079], [0081]-[0082], [0087]-[0091], [0096], Figs. 4, 5C, 9, 10A-10F, 11B), and
preventing definition of the second pathway portion when the second reference shape deviates from the first reference shape beyond the threshold boundary (use of the shape information at the second position is prevented when the shape information at the second position deviates from the shape information captured at the first position beyond a threshold movement value of the shapes, [0061]-[0064], [0066], [0075]-[0077], Figs. 4-5C and 8; see also use of the shape information of the second/predicted model is prevented when the shape position of the second/predicted model deviates from the shape information of the first/measured model beyond a patient movement threshold/measurement zone, [0085], [0094], [0095], [0098], [0099], [0100], Figs. 9-11B).
Regarding claim 2, Adebar discloses the medical device is one of an intravascular device, an endoscope, a biopsy device, a drainage catheter, a surgery device, a tissue ablation device, or a kidney stone removal device (endoscope, [0040]; intravascular device, biopsy catheter, treatment/surgical device, kidney calices device, [0047]; ablation device, [0058]).
Regarding claim 3, Adebar discloses the operations further include rendering an image of the reference shape on a display of the console (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, for display, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B).
Regarding claim 4, Adebar discloses the operations further include rendering an image of the pathway on the display (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, for display, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B; prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, for display, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B; note at least Figs. 5B, 5C, 10A-11B depict both the one or more historical, first/reference and predicted models in a display; see also real-time position information display, [0048]).
Regarding claim 5, Adebar discloses the operations further include rendering an image of the live 3D shape in combination with the image of the pathway on the display (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, for display, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B; prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, for display, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B; note at least Figs. 5B, 5C, 10A-11B depict both the one or more historical, first/reference and predicted models in a display; see also real-time psotion information display, [0048]).
Regarding claim 6, Adebar discloses the operations further include: comparing the live 3D shape with the reference shape; and as a result of the comparison, detecting an insertion and/or withdrawal displacement of the elongate probe (insertion or retraction distance/depth from comparing the current position with one or more reference models, [0055], [0079], [0088], [0089], [0091]).
Regarding claim 7, Adebar discloses the operations further include: capturing a plurality of reference shapes of the live 3D shape (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B), and defining the pathway in accordance with the plurality of reference shapes (prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B; note at least Figs. 5B, 5C, 10A-11B depict both the one or more historical, first/reference and predicted models in a display).
Regarding claim 8, Adebar discloses the operations further include: defining a buffer zone for the live 3D shape, the buffer zone extending radially away from the pathway (prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B);
comparing the live 3D shape with the buffer zone (compare the prediction/prediction model and the first/reference models including the current pose to detect deviation in three-dimensions around the distal tip of the first/reference models, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B); and
as a result of the comparison, providing a notification when a portion of the live 3D shape exceeds the buffer zone (provide a message/warning to the user when the deviation exceeds the three-dimensional threshold, [0075]-[0077], [0099]).
Regarding claim 9, Adebar discloses the system is communicatively coupled with an imaging system (control system receives captured preoperative or intraoperative images from an imaging system, [0039], [0060], [0075]), and
the operations further include: receiving image data from the imaging system (control system receives captured preoperative or intraoperative images, [0039], [0060], [0075]); and
defining the pathway in accordance with the image data (defining the medical instrument position relative to surrounding anatomy of the passageway from captured preoperative or intraoperative images, [0039], [0060], [0075]).
Regarding claim 10, Adebar discloses the imaging system includes one or more of an ultrasound imaging system, a magnetic resonance imaging (MRI) system, a computed tomography (CT) imaging system, an X-ray system, an X-ray system including fluoroscopy, or an electro-anatomical mapping system (CT scan, [0067], [0084]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Adebar as applied to claim 1 above, and further in view of Messerly (U.S. Pub. No. 2018/0289927), hereinafter “Messerly.”
Regarding claim 12, Adebar does not appear to disclose the elongate probe includes one or more sensors configured to detect physiological conditions including one or more of a body temperature, a fluid pressure, or an ECG signal.
However, in the same field of endeavor of shape sensing using gratings, Messerly teaches the elongate probe includes one or more sensors configured to detect physiological conditions of the patient (strain sensors used to determine temperature and pressure, [0020], [0045], [0050], [0055], [0061]; ECG sensor, [0021], [0023]) including one or more of a body temperature, a fluid pressure, a blood flow rate, or an ECG signal (ECG used to provide tip guidance, [0023]; temperature used to determine insertion length, [0055]; temperature and venous pressure used to determine whether catheter is within the true lumen, [0061]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Messerly’s known technique of providing temperature, pressure, or ECG sensors in addition to shape sensing sensors to determine the position of the medical instrument to Adebar’s known apparatus using shape sensors to determine the position of the medical instrument to achieve the predictable result that such additional information may assist the user in real-time to in guiding and placing the medical device as desired within the patient. See, e.g., Messerly, [0020].
Claims 13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Adebar as applied to claim 1 above, and further in view of Bydlon et al. (U.S. Pub. No. 2024/0383133), hereinafter “Bydlon.”
Regarding claim 13, Adebar does not appear to disclose the operations further include defining the pathway in accordance with one or more reference shapes captured during insertion of previous elongate probes.
However, in the same field of endeavor of shape sensing using gratings, Bydlon teaches the operations further include defining the pathway in accordance with one or more reference shapes captured during insertion of previous elongate probes (machine learning model to determine the path of a medical instrument, arm, using previous shape measurement data from historical data of insertion of previous medical instruments, [0012]-[0016]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Bydlon’s known technique of using historical data of medical instrument insertion in other patients/procedures to Adebar’s known apparatus using previous data of the medical instrument insertion to achieve the predictable result using both historical and acquired data of the medical instrument insertion improves the refinement of the model used to determine the medical instrument position from shape measurements such that the model can categorize a broader range of medical instrument conditions. See, e.g., Bydlon, [0396].
Regarding claim 26, Adebar does not appear to disclose the threshold boundary is defined using a machine learning model, the machine learning model is trained on historical data of pathways through patient vasculatures, the machine learning model takes, as an input, data corresponding to the first reference shape, the machine learning model defines probabilities for valid subsequent reference shapes, and the threshold boundary is defined based on the defined probabilities.
However, in the same field of endeavor of shape sensing using gratings, Bydlon teaches the threshold boundary is defined using a machine learning model (machine learning algorithm determines uncertainty value/prediction error that defines probabilities for valid current/new shape measurements, [0012], [0122]-[0123], [0157], [0218], [0278], [0280], [0313]-[0317], [0368], [0380]-[0387], [0395]-[0396]; threshold is defined based on the uncertainty value/prediction error, [0122]-[0123], [0157], [0218], [0278], [0280], [0380]-[0387]),
the machine learning model is trained on historical data of pathways through patient vasculatures (machine learning model to determine the path of a medical instrument, arm, using previous shape measurement data from historical data of insertion of previous medical instruments, [0012]-[0016], [0093]-[0106], [0133], [0162]; path of medical instrument, arm, is through the patient vasculatures, [0008], [0068], [0070], [0072], [0082], [0089], [0093], [0122], [0179], [0285], [0313], [0337], [0338], [0340], [0344], [0357]),
the machine learning model takes, as an input, data corresponding to the first reference shape (machine learning algorithm takes, as an input, data corresponding to previous shape measurements, [0012]-[0018], [0078], [0096]-[0097], [0108]-[0115], [0128]-[0130], [0133]-[0135], [0358]-[0366]),
the machine learning model defines probabilities for valid subsequent reference shapes (machine learning algorithm determines uncertainty value/prediction error that defines probabilities for valid predicted subsequent shape measurements based on the previous shape measurements input into the machine learning algorithm, [0012], [0122]-[0123], [0157], [0218], [0278], [0280], [0313]-[0317], [0368], [0380]-[0387], [0395]-[0396]), and
the threshold boundary is defined based on the defined probabilities (threshold is defined based on the uncertainty value/prediction error, [0122]-[0123], [0157], [0218], [0278], [0280], [0380]-[0387]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Bydlon’s known technique of using a machine learning algorithm to predict subsequent shape measurements based on an input previous shape measurement and defining an uncertainty value/prediction error threshold to determine whether the predicted shape measurements are valid to Adebar’s known apparatus of using an algorithm to compare shape measurements to a previous shape measurement and defining a warning motion threshold to determine whether the shape measurements are valid to achieve the predictable result using both historical and acquired data of the medical instrument insertion in a machine learning algorithm improves the refinement of the model used to determine the medical instrument position from shape measurements such that the model can categorize a broader range of medical instrument conditions. See, e.g., Bydlon, [0396].
Claims 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Adebar (incorporating Childlers in its entirety) in further view of Messerly.
Regarding claim 14, Adebar discloses a method for detecting placement of a medical device within a patient body (a method of determining a state/location of an elongate medical instrument within a patient, Abstract, [0039]), the method comprising:
providing the medical device coupled with a medical device system (medical instrument system and elongate medical instrument, [0040]-[0041]), the medical device including an elongate probe configured for insertion within the patient body (elongate medical instrument for insertion into the body, [0038], [0041]):
determining a live three-dimensional (3D) shape of the elongate probe inserted within the patient body (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, [0043], [0044], [0060], [0075], [0079]-[0094], Figs. 5A-5C, 10A-10F), wherein determining the live 3D shape includes:
providing an incident light signal (FBGs are coupled with a reflectometer where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, Childlers, [0035]-[0036]) to an optical fiber extending along the elongate probe (multiple optical fiber cores including Fiber Bragg Gratings extending along the elongate device, [0043]), wherein the optical fiber includes a one or more of core fibers (multiple optical fiber cores, [0043]), each of the one or more of core fibers including a plurality of reflective gratings distributed along a longitudinal length of a corresponding core fiber (multiple optical fiber cores including Fiber Bragg Gratings, [0043]) and each of the plurality of reflective gratings being configured to (i) reflect a light signal of a different spectral width based on received incident light (FBGs are coupled with a reflectometer where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, Childlers, [0035]-[0036]), and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber (FBGs provide strain measurements according to bending of the optical fiber, [0043]; FBGs are coupled with a reflectometer where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, wherein the modulation of light is used to determine the strain experienced by the optical fiber, Childlers, [0035]-[0036]; see also strain measurements, Childlers, [0039]-[0042]);
receiving reflected light signals of different spectral widths of the incident light by one or more of the plurality of reflective gratings (reflectometer captures reflected light where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, Childlers, [0035]-[0036]); and
processing the reflected light signals associated with the one or more of core fibers to determine the three-dimensional shape of the elongate probe inserted within the patient body (FBGs provide strain measurements according to bending of the optical fiber, [0043]; strain measurements from the shape measurement system including the history of the pose of the elongate probe is used to reconstruct the shape of the flexible body of the elongate device including the current pose, [0043], [0044], [0060], [0075], [0079]-[0094], Figs. 5A-5C, 10A-10F; FBGs are coupled with a reflectometer where a narrow frequency band of light is reflected from the FBGs based upon the modulation period formed in the core, wherein the modulation of light is used to determine the strain experienced by the optical fiber, Childlers, [0035]-[0036]; see also strain measurements, Childlers, [0039]-[0042]);
capturing a first reference shape, the first reference shape including at least a portion of the live 3D shape (shape information is captured continuously as the elongate device is advanced distally within the anatomic passageway, including at a first position, [0059], [0061], Figs. 5B and 5C; see also first model, [0079], [0082]-[0085], [0090], [0093]-[0094]); and
defining a first pathway portion for the live 3D shape, the first pathway portion extending distally away from a distal end of the first reference shape (threshold movement value may be realized as a shape in three-dimensions around the distal tip of the elongate device in the first position and includes a movement threshold extending in the direction of insertion/withdrawal (I/O), i.e., distally away from the distal end, [0061]-[0062], [0064]-[0066], Figs. 4-5C; see also threshold difference between first/measured model and second/predicted model, [0085], Figs. 9-10C; see also measurement zone and/or patient movement threshold including a divergence/deviation in a direction parallel to the table or in a linear direction along the insertion axis, i.e., extending distally away from a distal end of the first model, [0089], [0093]-[0099], Figs. 10C-11B);
capturing a second reference shape, the second reference shape including at least a portion of the live 3D shape, wherein the second reference shape is captured after distal displacement of the elongate probe following the capturing of the first reference shape (shape information is captured continuously as the elongate device is advanced distally within the anatomic passageway, including at a second position captured after distal advancement of the elongate device following the capturing of the shape information at the first position, [0059], [0061]-[0062], [0064], [0065]-[0066], Figs. 4-5C; see also shape information of the second/predicted model is captured for a second position of the distal advancement of the elongate device following the capturing of the shape information of the first/measured model at a first position, [0080]-[0081], [0082]-[0085], [0091]-[0094], Figs. 9-11B);
comparing the second reference shape with the first reference shape (shape information captured at the second position is compared to the shape information captured at the first position to determine whether the distal tip of the elongate device is above or below the threshold movement values of the shape, [0059], [0061]-[0066], [0075]-[0077], Figs. 4-5C and 8; see also comparing the shape information of the second/predicted model to the shape information of the first model to determine whether the distal tip of the elongate device is above or below the patient movement threshold/measurement zone, [0085], [0089], [0093]-[0099], Figs. 9-11B); and as a result of the comparison:
defining a second pathway portion for the live 3D shape extending distally away from a distal end of the second reference shape when the second reference shape is disposed within a threshold boundary extending around the first pathway portion (use the shape information at the second position captured after distal advancement of the elongate device following the capturing of the shape information at the first position as the moved position when the shape information at the second position is disposed within a threshold movement value of the shapes to define the shape information at the second position, [0061]-[0064], [0066], Figs. 4-5C; see also using the shape information of the second/predicted model of the distal advancement of the elongate device following the capturing of the shape information of the first/measured model as the moved position when the shape information of the second/predicted model is disposed within a patient movement threshold/measurement zone to define the shape information at the second position, [0085], [0089], [0093], [0098], Figs. 9-11B; steps of defining a first position and a second position are performed repeatedly/continuously as the elongate device is driven/advanced in the distal direction for multiple times and insertion distances, i.e., shape information (or a third/predicted model) is captured at least at a third position, advanced in the distal direction from the valid second position (i.e., the new current/measured position) and from the first position (i.e., a previous time/insertion distance), [0059], [0065]-[0066], [0075]-[0077], [0079], [0081]-[0082], [0087]-[0091], [0096], Figs. 4, 5C, 9, 10A-10F, 11B), and
preventing definition of the second pathway portion when the second reference shape deviates from the first reference shape beyond the threshold boundary (use of the shape information at the second position is prevented when the shape information at the second position deviates from the shape information captured at the first position beyond a threshold movement value of the shapes, [0061]-[0064], [0066], [0075]-[0077], Figs. 4-5C and 8; see also use of the shape information of the second/predicted model is prevented when the shape position of the second/predicted model deviates from the shape information of the first/measured model beyond a patient movement threshold/measurement zone, [0085], [0094], [0095], [0098], [0099], [0100], Figs. 9-11B).
However, Adebar does not appear to disclose determining one or more physiological conditions of the patient.
However, in the same field of endeavor of shape sensing using gratings, Messerly teaches determining one or more physiological conditions of the patient (strain sensors used to determine temperature and pressure, [0020], [0045], [0050], [0055], [0061]; ECG sensor, [0021], [0023]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Messerly’s known technique of providing temperature, pressure, or ECG sensors in addition to shape sensing sensors to determine the position of the medical instrument to Adebar’s known process of using shape sensors to determine the position of the medical instrument to achieve the predictable result that such additional information may assist the user in real-time to in guiding and placing the medical device as desired within the patient. See, e.g., Messerly, [0020].
Regarding claim 15, Adebar discloses further comprising rendering an image of the reference shape on a display of the medical device system (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, for display, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B).
Regarding claim 16, Adebar discloses rendering an image of the pathway on the display (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, for display, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B; prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, for display, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B; note at least Figs. 5B, 5C, 10A-11B depict both the one or more historical, first/reference and predicted models in a display; see also real-time psotion information display, [0048]).
Regarding claim 17, Adebar discloses rendering an image of the live 3D shape in combination with the image of the pathway on the display (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, for display, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B; prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, for display, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B; note at least Figs. 5B, 5C, 10A-11B depict both the one or more historical, first/reference and predicted models in a display; see also real-time psotion information display, [0048]).
Regarding claim 18, Adebar discloses comparing the live 3D shape with the reference shape; and as a result of the comparison, detecting an insertion and/or withdrawal displacement of the elongate probe (insertion or retraction distance/depth from comparing the current position with one or more reference models, [0055], [0079], [0088], [0089], [0091]).
Regarding claim 19, Adebar discloses capturing a plurality of reference shapes of the live 3D shape, and defining the pathway in accordance with the plurality of reference shapes (history of the pose of the elongate probe determined using the shape sensor is used to reconstruct the shape of the flexible body of the elongate device including the current pose, such as one or more first/reference models, [0043], [0044], [0060], [0075], [0079]-[0098], Figs. 4-11B), and defining the pathway in accordance with the plurality of reference shapes (prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B; note at least Figs. 5B, 5C, 10A-11B depict both the one or more historical, first/reference and predicted models in a display).
Regarding claim 20, Adebar discloses defining a buffer zone for the live 3D shape, the buffer zone extending radially away from the pathway (prediction/predicted model of the pose of the elongate probe determined based on the first/reference models to detect deviation in three-dimensions around the distal tip of the first/reference models, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B);
comparing the live 3D shape with the buffer zone (compare the prediction/prediction model and the first/reference models including the current pose to detect deviation in three-dimensions around the distal tip of the first/reference models, [0061]-[0062], [0075], [0079]-[0098], Figs. 4-11B); and
as a result of the comparison, providing a notification when a portion of the live 3D shape exceeds the buffer zone (provide a message/warning to the user when the deviation exceeds the three-dimensional threshold, [0075]-[0077], [0099]).
Regarding claim 21, Adebar discloses coupling the medical device system with an imaging system (control system receives captured preoperative or intraoperative images from an imaging system, [0039], [0060], [0075]);
receiving image data from the imaging system (control system receives captured preoperative or intraoperative images, [0039], [0060], [0075]); and
defining the pathway in accordance with the image data (defining the medical instrument position relative to surrounding anatomy of the passageway from captured preoperative or intraoperative images, [0039], [0060], [0075]).
Regarding claim 22, Adebar discloses the imaging system includes one or more of an ultrasound imaging system, a magnetic resonance imaging (MRI) system, a computed tomography (CT) imaging system, an X-ray system, an X-ray system including fluoroscopy, or an electro-anatomical mapping system (CT scan, [0067], [0084]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Adebar in further view of Messerly as in claim 14 above, and further in view of Kim et al. (U.S. Pub. No. 2016/0296122), hereinafter “Kim.”
Regarding claim 24, Adebar does not appear to disclose the one or more physiological conditions: are detected via one or more sensors of the elongate probe, and include a blood flow rate and one or more of a body temperature, a blood pressure, or an ECG signal.
However, in the same field of endeavor of shape sensing using gratings, Messerly teaches the one or more physiological conditions: are detected via one or more sensors of the elongate probe (strain sensors used to determine temperature and pressure, [0020], [0045], [0050], [0055], [0061]; ECG sensor, [0021], [0023]), and include one or more of a body temperature, a blood pressure, or an ECG signal (ECG used to provide tip guidance, [0023]; temperature used to determine insertion length, [0055]; temperature and venous pressure used to determine whether catheter is within the true lumen, [0061]).
However, Adebar in further view of Messerly does not appear to teach the one or more physiological conditions include a blood flow rate.
However, in the same field of endeavor of shape sensing using gratings, Kim teaches the one ore more physiological conditions: are detected via one or more sensors of the elongate probe (sensor assembly has a tubular shape, [0011], Fig. 1; sensor assembly includes a flow sensor, [0136]-[0139]), and include a blood flow rate (flow sensor detects blood flow rate, [0136]-[0139]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Kim’s known technique of providing a flow sensor in addition to shape sensing sensors to Adebar in further view of Messerly’s known method of using temperature, pressure, or ECG sensors in addition to shape sensing sensors to determine the position of the medical instrument to achieve the predictable result that providing a flow rate sensor allows for monitoring and analysis of surgical procedures. See, e.g., Kim, [0138]-[0139].
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Adebar in further view of Messerly as applied to claim 14 above, and further in view of Bydlon.
Regarding claim 25, Adebar does not appear to disclose defining the pathway in accordance with one or more reference shapes captured during insertion of previous elongate probes.
However, in the same field of endeavor of shape sensing using gratings, Bydlon teaches defining the pathway in accordance with one or more reference shapes captured during insertion of previous elongate probes (machine learning model to determine the path of a medical instrument, arm, using previous shape measurement data from historical data of insertion of previous medical instruments, [0012]-[0016]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Bydlon’s known technique of using historical data of medical instrument insertion in other patients/procedures to Adebar’s known process of using previous data of the medical instrument insertion to achieve the predictable result using both historical and acquired data of the medical instrument insertion improves the refinement of the model used to determine the medical instrument position from shape measurements such that the model can categorize a broader range of medical instrument conditions. See, e.g., Bydlon, [0396].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Elhawary et al. (U.S. Pub. No. 2015/0141808), hereinafter “Elhawary,” discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and determining one or more of a blood flow rate using the plurality of FBGs to define the pathway.
Razavi et al. (U.S. Pub. No. 2011/0288405) discloses an elongate probe with a plurality of optical fiber shape sensors for determining the position of the elongate probe for display, and determining a blood flow, and blood pressure to determine the position.
Marell et al. (U.S. Pub. No. 2016/0349044) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and performing error correction using a deviation threshold from a predicted model and reference model.
Ramachandran et al. (U.S. Pub. No. 2015/0124264) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and performing error correction using a twist/radial deviation from a predicted model and reference model.
Zhao et al. (U.S. Pub. No. 2019/0365199) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and performing error correction using a deviation threshold from an anatomical model, predicted model and reference model.
Zhao (U.S. Pub. No. 2020/0000526) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and performing error correction using a deviation threshold from an anatomical model, predicted model and reference model.
Muller et al. (U.S. Pub. No. 2023/0346479) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and performing error correction using a deviation from a pre-planned trajectory and the reference and predicted model.
Van Roosbroeck (U.S. Pub. No. 2022/0110508) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display.
Graetzel et al. (U.S. Pub. No. 2020/0046434) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and performing error correction using a deviation from robotic sensor information and the reference and predicted model.
Popovic (U.S. Pub. No. 2012/0283747) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe, determining the historical path of the elongate probe and the current position for display, and performing error correction using a deviation from robotic sensor information and the reference and predicted model.
Bydlon et al. (U.S. Pub. No. 2022/0079683) discloses an elongate probe with a multicore optical fiber shape sensor with a plurality of FBGs for determining the shape and position of the elongate probe.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Johnathan Maynard whose telephone number is (571)272-7977. The examiner can normally be reached 10 AM - 6 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights