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) submitted on 02/13/2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments filed on 01/15/2026 have been fully considered.
In the Arguments/Remarks:
Re: Rejection of Claim 1 Under 35 U.S.C. 102(a)(1)
Applicant submits, beginning on page 6, of applicant’s remarks that Mansi fails to teach “storing a trajectory of catheter movement during control of a robotic catheter system by an operator” and “moving, automatically or semi-automatically, the imaging catheter by the robotic catheter system in a patient, the moving being along the trajectory”. However, Examiner respectfully disagrees. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, the limitation “storing a trajectory of catheter movement during control of a robotic catheter system by an operator” is disclosed by Mansi. Examiner notes that Mansi discloses in paragraph 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation.”. Mansi further discloses in paragraph 28 “At step 204, a graph defining paths between a plurality of configurations of a robotic catheter navigation system is constructed based on the received instructions.”. Examiner notes that the user inputs the instructions to steer the catheter and a graph that defines paths of the catheter is constructed based on the received instructions. Examiner submits under the broadest reasonable interpretation (BRI) of the claim, that the applicant’s arguments regarding Mansi failing to teach/suggest/disclose “storing a trajectory of catheter movement during control of a robotic catheter system by an operator” is respectfully unpersuasive.
Applicant further argues that Mansi fails to teach or suggest “moving, automatically or semi-automatically, the imaging catheter by the robotic catheter system in a patient, the moving being along the trajectory”. Examiner respectfully disagrees. Mansi discloses in paragraph 35 “At step 208, the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph.”. Examiner submits that the path from the graph was generated based on the inputted instructions as mention previously in paragraphs 27-28. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Re: Rejection of Claim 2 Under 35 U.S.C. 103
Applicant argues, beginning on page 8 of applicant’s remarks, that the combination of Mansi and Hauck fails to teach “wherein storing the trajectory of catheter movement comprises receiving an input of a start point and an input of an end point from the operator, and recording a navigation of the imaging catheter by the operator along the trajectory with the robotic catheter system, and wherein moving comprises repeating the navigation of the imaging catheter along the trajectory between the start point and end point without the operator performing the navigation”. However, examiner respectfully disagrees. Regarding the limitation of “and wherein moving comprises repeating the navigation of the imaging catheter along the trajectory between the start point and end point without the operator performing the navigation”, under the broadest reasonable interpretation (BRI) of the claim Mansi discloses in paragraphs 35-37 this limitation. In paragraph 35 Mansi discloses “At step 208, the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph.” And in paragraph 37 Mansi further discloses “In one embodiment, steps 206, 208, and optionally 210 may be repeated any number of times (e.g., as requested by the user) to repeatedly recover other views of the patient associated with other target configurations of the plurality of configurations.”. Examiner submits that the determined path in the graph is based on the operators inputs as previously stated in paragraphs 27-28. Examiner further submits that in paragraph 37, Mansi states steps 206, 208 and 210 may be repeated any number of times as requested by the user, step 208 is when the catheter is automatically steered along the path to recover the respective view. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Applicant further argues that “Furthermore, a PHOSITA would not have been motivated to combine references because they teach fundamentally different and technically incompatible systems.”. Examiner respectfully disagrees. Both Hauck and Mansi respectively disclose methods/processes of navigating catheters accurately and precisely through a patient’s body to the locations of diagnostic interest. Examiner submits that adding the feature of a user inputting a starting point and ending point to a desired navigation path of the catheter would not require a complete redesign. Mansi already discloses a starting configuration and target configuration in paragraph 34 “The path in the graph is determined from a start configuration q.sub.s (which is the current configuration q.sub.n) to the target configuration q.sub.t. Since each of the plurality of configurations is already represented in graph g, a search algorithm is applied to identify a sequence of edges that forms the path between q.sub.s and q.sub.t.”. Examiner further submits that it would be obvious to a PHOSITA to add a feature of user inputting the start and endpoint. See MPEP 2143.B. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that the combination of Mansi and Hauck does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Re: Rejection of Claim 15 Under 35 U.S.C. 103
Applicant argues, beginning on page 11 of applicant’s remarks, that Mansi fails to teach “a memory configured to store a trajectory”. Examiner respectfully disagrees. Mansi states in paragraph 98 “Systems, apparatuses, and methods described herein may be implemented using digital circuitry, or using one or more computers using well-known computer processors, memory units, storage devices, computer software, and other components. Typically, a computer includes a processor for executing instructions and one or more memories for storing instructions and data.”. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Applicant further argues that Mansi fails to teach “path recorded by previously controlling the steerable catheter by an operator”. Examiner respectfully disagrees. Examiner submits similar rationale was provided in the arguments for claim 1 (see Re: Rejection of Claim 1 above). Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Applicant further argues that Mansi fails to teach or suggest “a processor configured to navigate the steerable catheter in a rewind along the trajectory.”. Examiner respectfully disagrees. Mansi discloses in paragraph 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc.” and in paragraph 41 “The user may provide instructions through voice based commands, such as, e.g., rotate, up, down, left, right, backwards, forward, next view, previous view, mitral valve, etc. Such voice based commands are connected to related catheter controls. In this manner, the catheter may be controlled through discrete actions whose amplitude can be adjusted through voice based commands.”. Examiner submits that Mansi discloses in paragraph 41 that the voice commands used to control the catheter contain backwards and previous view. The argued limitation of claim 15 recites “a processor configured to navigate the steerable catheter in a rewind along the trajectory”. Examiner submits that the operator giving the command for the catheter to go backwards even a miniscule amount, under BRI, would disclose the argued limitation. The claim does not recite “rewind along the entire trajectory” or the like, the claim recites “rewind along the trajectory”. The user can command the catheter to travel to a certain point then give the command to go backwards to get a better image of a previous portion. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Applicant further argues that “Examiner’s motivation to modify Mansi is legally insufficient”. Examiner disagrees with the applicant’s remarks. The examiner cited the motivation “in order to avoid any possible damage/harm to the area/vessel when the catheter is controlled to travel in a rewind/reverse/backwards path.” Examiner submits that it would be obvious to a PHOSITA to have a catheter, when reversing or exiting to rewind/reverse itself along the same way it entered to safely move within the patient without causing any unnecessary harm. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Re: Rejection of Claim 20 Under 35 U.S.C. 102(a)(1)
Applicant argues, beginning on page 12 of applicant’s remarks, that Mansi fails to teach/disclose “memory configured to store… previously used trajectory recorded during a previous operation… by an operator” and “processor configured… to move an intracardiac echocardiography catheter along the previously used trajectory.” Examiner respectfully disagrees. Similar limitations have been argued and addressed in claims 1, 2, and 15 (see rationale above).
Re: Rejection of the Dependent Claims in view of Mansi
Applicant argues, beginning on page 13 of applicant’s remarks, that Mansi fails to teach every limitation of the dependent claims. Examiner respectfully disagrees.
Regarding claim 4, Applicant argues that Mansi does not teach “wherein storing the trajectory comprises storing the trajectory as motor positions or imaging catheter positions.”. Mansi discloses in paragraph 40 that instructions in a coordinate system associated with the patient for steering the catheter are received and these are then used to control the catheter for imaging means and the like. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Regarding claim 5, Applicant argues that Mansi does not teach “wherein acquiring the trajectory of catheter movement comprises receiving a user designation of the trajectory.”. Examiner submits that Mansi discloses in paragraph 33 “At step 206, a path in the graph to a target configuration of the plurality of configurations of the robotic catheter navigation system is determined. The target configuration may be received as user input from the user. For example, the user may select one of the plurality of configurations as the target configuration. In another example, the user may select a view from the library V of the views, and the configuration associated with the selected view is the target configuration.”. Mansi discloses that during step 206 a user can input the target configuration in order for a trajectory of a catheter to be used. The trajectory is based on user input. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Regarding claim 6, Applicant argues that Mansi does not teach “wherein receiving the user designation comprises receiving user input of way points within a boundary on a graphics user interface.”. Examiner submits that Mansi further discloses in paragraph 41 “In another example, the user input device is an inertial sensor to estimate movement in four degrees of freedom. The inertial sensor may be implemented within a device, such as, e.g., a joystick, a tablet, a phone, etc. Alternatively, the inertial sensor may be attached to the user (e.g., to the arm of the user) and turned on and off through, e.g., a button, a specific gesture, voice control, etc.”. Mansi discloses that the inputs of the target configurations can be input by the user on a tablet and/or phone. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Regarding claim 7, Applicant argues that Mansi does not teach “wherein moving the imaging catheter comprises moving the imaging catheter to waypoints on the trajectory in response to activation for each of the waypoints by a user, an interval of the waypoints input by the operator.”. Mansi discloses in paragraph 30 “The graph may be constructed as a topological graph g(V,E), where V denotes vertices representing the plurality of configurations q.sub.i and E denotes edges representing paths (q.sub.i, q.sub.j) between the plurality of configurations q.sub.i. To construct graph g(V,E), as instructions for steering the catheter are received (at step 202), the catheter moves within the patient and a plurality of configurations q.sub.n are saved. Each configuration q.sub.n may be saved in response to input from the user or may be automatically saved (e.g., at predefined time intervals).”. Examiner submits under BRI of the claim, the plurality of configurations that are input by the user are used to move the catheter with predetermined time intervals along a trajectory. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Regarding claim 8, Applicant argues that Mansi does not teach “wherein the waypoints comprise one or more waypoints interpolated from others of the waypoints.”. Examiner submits applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Regarding claim 9, Applicant argues that Mansi does not teach “wherein moving the imaging catheter comprises repeating movement of the imaging catheter over the trajectory multiple times.”. Mansi discloses in paragraph 37 “steps 206, 208, and optionally 210 may be repeated any number of times (e.g., as requested by the user) to repeatedly recover other views of the patient associated with other target configurations of the plurality of configurations.”. Mansi also discloses in paragraph 35 “At step 208, the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration.”. Mansi states that steps 206, 208 and 210 may be repeated any number of times and at step 208 is when the catheter is to be steering along the path/trajectory. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Regarding claims 10, 11 and 21, Applicant argues that “the rejections are improper as they are based on a misunderstanding of the claimed “rewind” and “reversing” functionality.” Examiner has addressed this argument in the Re: Rejection of claim 15 (see above). Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Regarding claim 13, Applicant argues that Mansi does not teach “further comprising receiving user selection of the trajectory from a library of trajectories.”. Mansi discloses in paragraph 28 “a graph defining paths between a plurality of configurations of a robotic catheter navigation system is constructed based on the received instructions. Each of the plurality of configurations are associated with a respective view of the patient. The plurality of configurations of the robotic catheter navigation system may represent bookmarks or presets of the robotic catheter navigation system to the various views of the patient. In one example, the robotic catheter navigation system is robotic catheter navigation system 100 of FIG. 1.” Examiner submits that the graph is being interpreted as a library due to it holding a plurality of configurations and using the configurations to control the catheter. Examiner submits that under the broadest reasonable interpretation (BRI) of the claim, that Mansi does teach/disclose the argued limitation. Therefore, applicant’s arguments are unpersuasive.
Regarding claim 14, Applicant argues that Mansi does not teach “wherein moving the imaging catheter comprises moving the imaging catheter at an interval between waypoints, the interval input by the operator.”. Examiner notes see argument response in claim 7 as the claims were rejected under similar premise.
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 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 and 4-14 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansi (US 2021/0145412 A1).
Regarding claim 1, Mansi teaches a method for robotic control of an imaging catheter, the method comprising: storing a trajectory of catheter movement during control of a robotic catheter system by an operator [(see at least Fig.2, paragraphs 27-37) As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc.” As in 28 “At step 204, a graph defining paths between a plurality of configurations of a robotic catheter navigation system is constructed based on the received instructions. Each of the plurality of configurations are associated with a respective view of the patient. The plurality of configurations of the robotic catheter navigation system may represent bookmarks or presets of the robotic catheter navigation system to the various views of the patient.” As in 30 “The graph may be constructed as a topological graph g(V,E), where V denotes vertices representing the plurality of configurations q.sub.i and E denotes edges representing paths (q.sub.i, q.sub.j) between the plurality of configurations q.sub.i. To construct graph g(V,E), as instructions for steering the catheter are received (at step 202), the catheter moves within the patient and a plurality of configurations q.sub.n are saved. Each configuration q.sub.n may be saved in response to input from the user or may be automatically saved (e.g., at predefined time intervals).” As in 35 “At step 208, the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph” As in 37 “steps 206, 208, and optionally 210 may be repeated any number of times (e.g., as requested by the user) to repeatedly recover other views of the patient associated with other target configurations of the plurality of configurations.”]; acquiring the trajectory [(see at least paragraph 22, abstract) As in 22 “FIG. 1 shows an exemplary robotic catheter navigation system 100, in accordance with one or more embodiments. Robotic catheter navigation system 100 comprises a catheter 108, a base 116, a catheter handle housing 102, an access point base 112, an access point guide 114, and an arm 110. In one embodiment, catheter 108 is an ICE catheter for performing an ICE procedure, but may be any other suitable catheter.” As in abstract “Instructions for steering a catheter within a patient are received”] Examiner notes Mansi discloses that the user/operator inputs steering instructions for the catheter. A graph defining paths between a plurality of configurations of the robotic catheter system is constructed based on the received instructions. Each of the plurality of configurations are associated with a respective view of the patient. A path is then determined within the graph based on the user steering inputs and configuration. Then the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration.; moving, automatically or semi-automatically, the imaging catheter by the robotic catheter system in a patient, the moving being along the trajectory [(see at least paragraph 35) “the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph.”]; and displaying an image from the imaging catheter, the image of the patient while the imaging catheter is on the trajectory. [(see at least paragraphs 35-36) As in 36 “At step 210, optionally, an image of the recovered respective view of the patient is generated and the generated image is output. For example, the generated image can be output by displaying the generated image on a display device of a computer system, storing the generated image on a memory or storage of a computer system, or by transmitting the generated image to a remote computer system.”]
Regarding claim 4, Mansi teaches wherein storing the trajectory comprises storing the trajectory as motor positions or imaging catheter positions. [(see at least paragraphs 40-42) As in 40 “At step 402, instructions in a coordinate system associated with a patient for steering a catheter are received. The coordinate system associated with the patient may be a coordinate system associated with a heart of the patient or any other anatomical object of interest of the patient. The coordinate system associated with the patient may be an (X,Y,Z) Cartesian coordinate system. In one example, the catheter is catheter 102 of FIG. 1.” As in 42 “At step 404, the received instructions in the coordinate system associated with the patient are transformed into a configuration of a robotic catheter navigation system. In one example, the robotic catheter navigation system is robotic catheter navigation system 100 of FIG. 1.”]
Regarding claim 5, Mansi teaches wherein acquiring the trajectory of catheter movement comprises receiving a user designation of the trajectory. [(see at least paragraph 33) “At step 206, a path in the graph to a target configuration of the plurality of configurations of the robotic catheter navigation system is determined. The target configuration may be received as user input from the user. For example, the user may select one of the plurality of configurations as the target configuration.”]
Regarding claim 6, Mansi teaches wherein receiving the user designation comprises receiving user input of way points within a boundary on a graphics user interface. [(see at least paragraph 41) “The instructions may be received from a user (e.g., cardiologist, clinician, or any other user). In order to provide the instructions in the coordinate system associated with the patient, the user provides the instructions via a user input device, instead of manipulating knobs of a robotic catheter navigation system. In one example, the user input device is a joystick having four degrees of freedom. In another example, the user input device is an inertial sensor to estimate movement in four degrees of freedom. The inertial sensor may be implemented within a device, such as, e.g., a joystick, a tablet, a phone, etc. Alternatively, the inertial sensor may be attached to the user (e.g., to the arm of the user) and turned on and off through, e.g., a button, a specific gesture, voice control, etc. In another example, the user input device is a camera system comprising one or more cameras, such as, e.g., an RGBD (red green blue depth) camera or a stereo camera. Such a camera system may be used to recognize hand gestures of the user to control the catheter. For example, hand translation along the an (X,Y,Z) coordinate system of the cameras, along with hand rotation with respect to the arm axis, can be recognized and directly mapped to catheter controls.”]
Regarding claim 7, Mansi teaches wherein moving the imaging catheter comprises moving the imaging catheter to waypoints on the trajectory in response to activation for each of the waypoints by a user, an interval of the waypoints input by the operator. [(see at least paragraphs 30) “The graph may be constructed as a topological graph g(V,E), where V denotes vertices representing the plurality of configurations q.sub.i and E denotes edges representing paths (q.sub.i, q.sub.j) between the plurality of configurations q.sub.i. To construct graph g(V,E), as instructions for steering the catheter are received (at step 202), the catheter moves within the patient and a plurality of configurations q.sub.n are saved. Each configuration q.sub.n may be saved in response to input from the user or may be automatically saved (e.g., at predefined time intervals). For each configuration cm, if configuration cm is not the same as the prior configuration q.sub.prior, a new vertex of g is inserted representing configuration q.sub.n and the new vertex is connected to existing vertices of g having a distance that satisfies (e.g., is less than) a density parameter threshold ∈. The distance between vertices may be calculated as a Euclidean distance (assuming 1 mm≡1°) or any other suitable distance metric.”]
Regarding claim 8, Mansi teaches wherein the waypoints comprise one or more waypoints interpolated from others of the waypoints. [(see at least paragraphs 44, 9) As in 44 “the configuration of the robotic catheter navigation system comprises a configuration of left/right parameter ϕ.sub.1, anterior/posterior parameter ϕ.sub.2, rotation parameter ϕ.sub.3, and distance parameter d.sub.4 of the robotic catheter navigation system for rotating the catheter. To transform the received instructions in the coordinate system associated with the patient to a configuration of the robotic catheter navigation system for rotating the catheter, a kinematics model is applied to model the bending geometry of the catheter. The kinematics model comprises a forward kinematics model f of the catheter and an inverse kinematics model f.sup.−1 of the catheter, which are estimated during a prior offline stage such that rotation along the catheter axis ϕ=f (ϕ.sub.1, ϕ.sub.2, ϕ.sub.3, d.sub.4). The user directly defines the rotation ϕ using the user input device and the corresponding parameters ϕ.sub.1, ϕ.sub.2, ϕ.sub.3, d.sub.4 are estimated by applying the inverse kinematics model f.sup.−1 of the catheter. Accordingly, the user performs the catheter sweep for rotating the catheter without having to perform the manipulations for defining parameters ϕ.sub.1, ϕ.sub.2, ϕ.sub.3, d.sub.4 directly on robotic catheter navigation system.”]
Regarding claim 9, wherein moving the imaging catheter comprises repeating movement of the imaging catheter over the trajectory multiple times. [(see at least paragraphs 35-37) As in 37 “In one embodiment, steps 206, 208, and optionally 210 may be repeated any number of times (e.g., as requested by the user) to repeatedly recover other views of the patient associated with other target configurations of the plurality of configurations.”]
Regarding claim 10, Mansi teaches wherein moving the imaging catheter comprises reversing or progressing along the trajectory in response to operator input. [(see at least paragraphs 26-27) As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc.”]
Regarding claim 11, Mansi teaches wherein reversing along the trajectory comprises reversing to a point along the trajectory having a view indicated by the operator. [(see at least paragraph 41) “The user may provide instructions through voice based commands, such as, e.g., rotate, up, down, left, right, backwards, forward, next view, previous view, mitral valve, etc. Such voice based commands are connected to related catheter controls. In this manner, the catheter may be controlled through discrete actions whose amplitude can be adjusted through voice based commands. Other user input devices are also contemplated.”]
Regarding claim 12, Mansi teaches wherein moving the imaging catheter comprises moving by the robotic catheter system in synchronization with heart motion. [(see at least paragraph 63) “The robotic catheter navigation system may be configured to steer the catheter based on the tracked object of interest. In one embodiment, the robotic catheter navigation system may steer the catheter based on the tracked object of interest to compensate for motion of the object of interest (e.g., due to breathing, heartbeat, etc.) to maintain the object of interest in the field of view”]
Regarding claim 13, Mansi teaches further comprising receiving user selection of the trajectory from a library of trajectories. [(see at least paragraphs 28,5) As in 28 “At step 204, a graph defining paths between a plurality of configurations of a robotic catheter navigation system is constructed based on the received instructions. Each of the plurality of configurations are associated with a respective view of the patient.”] Examiner notes that the graph is being interpreted as a library of trajectories as it defines a plurality of possible paths.
Regarding claim 14, Mansi teaches wherein moving the imaging catheter comprises moving the imaging catheter at an interval between waypoints, the interval input by the operator. [(see at least paragraph 30) “The graph may be constructed as a topological graph g(V,E), where V denotes vertices representing the plurality of configurations q.sub.i and E denotes edges representing paths (q.sub.i, q.sub.j) between the plurality of configurations q.sub.i. To construct graph g(V,E), as instructions for steering the catheter are received (at step 202), the catheter moves within the patient and a plurality of configurations q.sub.n are saved. Each configuration q.sub.n may be saved in response to input from the user or may be automatically saved (e.g., at predefined time intervals).”]
Regarding claim 20, Mansi teaches a catheter control system comprising: a memory configured to store instructions and a previously used trajectory, the previously used trajectory recorded during a previous operation of the catheter by an operator [(see at least paragraphs 27-37) As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc.” As in 30 “The graph may be constructed as a topological graph g(V,E), where V denotes vertices representing the plurality of configurations q.sub.i and E denotes edges representing paths (q.sub.i, q.sub.j) between the plurality of configurations q.sub.i. To construct graph g(V,E), as instructions for steering the catheter are received (at step 202), the catheter moves within the patient and a plurality of configurations q.sub.n are saved. Each configuration q.sub.n may be saved in response to input from the user or may be automatically saved (e.g., at predefined time intervals).”, as in 98 “Systems, apparatuses, and methods described herein may be implemented using digital circuitry, or using one or more computers using well-known computer processors, memory units, storage devices, computer software, and other components. Typically, a computer includes a processor for executing instructions and one or more memories for storing instructions and data” As in 35 “At step 208, the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph.”] and a processor configured by the instructions to control the robotic catheter system to move an intracardiac echocardiography catheter along the previously used trajectory. [(see at least paragraphs 20,27) As in 20 “The present invention generally relates to methods and systems for assisted steering of ICE (intracardiac echocardiogram) catheters….Such manipulations are virtual manipulations accomplished in the memory or other circuitry/hardware of a computer system. Accordingly, is to be understood that embodiments of the present invention may be performed within a computer system using data stored within the computer system.” As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc.”]
Regarding claim 21, Mansi teaches wherein the processor is configured to control the robotic catheter system to move the intracardiac echocardiography catheter in reverse along the previously used trajectory as a rewind to a previous view. [(see at least Fig.2, paragraphs 25-27) As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc”]
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mansi in view of Hauck (US 2007/0198008 A1).
Regarding claim 2, Mansi teaches wherein moving comprises repeating the navigation of the imaging catheter along the trajectory between the start point and end point without the operator performing the navigation. [(see at least paragraphs 35-37) As in 35 “the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph.” As in 37 “steps 206, 208, and optionally 210 may be repeated any number of times (e.g., as requested by the user) to repeatedly recover other views of the patient associated with other target configurations of the plurality of configurations.”]
Mansi does not explicitly teach wherein storing the trajectory of catheter movement comprises receiving an input of a start point and an input of an end point from the operator, and recording a navigation of the imaging catheter by the operator along the trajectory with the robotic catheter system.
However, Hauck teaches wherein storing the trajectory of catheter movement comprises receiving an input of a start point and an input of an end point from the operator, and recording a navigation of the imaging catheter by the operator along the trajectory with the robotic catheter system [(see at least paragraph 14) “a method of navigating a medical device through a body of a patient includes: providing a topography of at least a portion of the body; accepting user input defining a navigation path including a plurality of waypoints on the topography, the plurality of waypoints including a first waypoint and a final waypoint”]
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 teachings of Mansi to incorporate the teachings of Hauck of acquiring the trajectory of catheter movement comprises receiving an input of a start point and an input of an end point from an operator, and recording a navigation of the imaging catheter by the operator along the trajectory with the robotic catheter system in order to navigate a medical device/catheter accurately and precisely through a patient's body to the locations of diagnostic interest. [(Hauck 8)]
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mansi.
Regarding claim 15, Mansi teaches a control system for a steerable catheter [(see at least Fig.1)], the control system comprising: a robotic system for operation of the steerable catheter [(see at least paragraph 22) “FIG. 1 shows an exemplary robotic catheter navigation system 100, in accordance with one or more embodiments. Robotic catheter navigation system 100 comprises a catheter 108, a base 116, a catheter handle housing 102, an access point base 112, an access point guide 114, and an arm 110. In one embodiment, catheter 108 is an ICE catheter for performing an ICE procedure, but may be any other suitable catheter”]; a memory configured to store a trajectory along which the robotic system navigates the steerable catheter [(see at least paragraphs 5,20) As in 5 “A graph defining paths between a plurality of configurations of a robotic catheter navigation system is constructed based on the received instructions. Each of the plurality of configurations are associated with a respective view of the patient. A path is determined in the graph to a target configuration of the plurality of configurations of the robotic catheter navigation system. The catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration.”], the trajectory comprising a path recorded by previously controlling the steerable catheter by an operator [(see at least Fig.2, paragraphs 27-37) As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc.” As in 30 “The graph may be constructed as a topological graph g(V,E), where V denotes vertices representing the plurality of configurations q.sub.i and E denotes edges representing paths (q.sub.i, q.sub.j) between the plurality of configurations q.sub.i. To construct graph g(V,E), as instructions for steering the catheter are received (at step 202), the catheter moves within the patient and a plurality of configurations q.sub.n are saved. Each configuration q.sub.n may be saved in response to input from the user or may be automatically saved (e.g., at predefined time intervals).” As in 35 “At step 208, the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph.”]; and a processor configured to cause the robotic system to navigate the steerable catheter in a rewind. [(see at least Fig.2, paragraphs 25-27, 41) As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation. However, the user may provide the instructions via any other user input device, such as, e.g., a joystick, an inertial sensor, a camera system, a voice recognition system, etc” As in 41 “The user may provide instructions through voice based commands, such as, e.g., rotate, up, down, left, right, backwards, forward, next view, previous view, mitral valve, etc. Such voice based commands are connected to related catheter controls. In this manner, the catheter may be controlled through discrete actions whose amplitude can be adjusted through voice based commands. Other user input devices are also contemplated.”]
Mansi does not explicitly state navigating the steerable catheter in a rewind along the trajectory, however Mansi does teach controlling the catheter to move backwards/rewind/reverse and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to navigate the steerable catheter in a rewind along the trajectory in order to avoid any possible damage/harm to the area/vessel when the catheter is controlled to travel in a rewind/reverse/backwards path.
Regarding claim 16, Mansi teaches wherein the processor is configured to cause the navigation along the trajectory in steps, a step size configured by input from the operator and the navigation for each step being in response to user activation. [(see at least paragraphs 26) As in 26 “FIG. 2 shows a method 200 for automatic view recovery for assisted catheter steering, in accordance with one or more embodiments. Method 200 will be described with continued reference to robotic catheter navigation system 100 of FIG. 1. In one example, the steps of method 200 are performed by controller 118 of FIG. 1 for assisted steering of catheter 108. However, the steps of method 200 may be performed by any suitable computing device or devices, such as, e.g., computer 802 of FIG. 8.” As in 27 “At step 202, instructions for steering a catheter within a patient are received. The instructions for steering the catheter may be received from a user (e.g., a cardiologist, a clinician, or any other user). The user may provide the instructions for steering the catheter in any suitable manner. In one embodiment, the user manipulates knobs (e.g., knobs 106) of a robotic catheter navigation system to steer the catheter to define an anterior/posterior tip bending, a left/right tip bending, a rotation, and a translation.”]
Regarding claim 17, Mansi teaches wherein the steerable catheter comprises an imaging catheter where a sequence of images is generated as the robotic system navigates the imaging catheter along the trajectory, and wherein the processor is configured to cause the robotic system to navigate the imaging catheter to a point along the trajectory associated with one of the images in the sequence. [(see at least paragraphs 34-35) “The path in the graph is determined from a start configuration q.sub.s (which is the current configuration q.sub.n) to the target configuration q.sub.t. Since each of the plurality of configurations is already represented in graph g, a search algorithm is applied to identify a sequence of edges that forms the path between q.sub.s and q.sub.t. In one embodiment, the search algorithm is a discrete A* search algorithm, but may be any other suitable algorithm.” As in 35 “At step 208, the catheter is automatically steered within the patient based on the determined path in the graph to recover the respective view of the patient associated with the target configuration. The trajectory from the current position of the catheter is automatically generated based on the path in the graph”]
Regarding claim 18, Mansi teaches wherein the processor is configured to store the trajectory in the memory as the operator controls the robotic system. [(see at least paragraph 98) “Systems, apparatuses, and methods described herein may be implemented using digital circuitry, or using one or more computers using well-known computer processors, memory units, storage devices, computer software, and other components. Typically, a computer includes a processor for executing instructions and one or more memories for storing instructions and data.”]
Regarding claim 19, Mansi teaches wherein the processor is configured to store the trajectory in the memory [(see at least paragraph 98)], the trajectory created with a user interface receiving input of waypoints within a boundary. [(see at least paragraph 57) “The (X,Y,Z) Cartesian coordinates input by the user in the heart coordinate system O.sub.heart are transformed into the parameters ϕ.sub.1, ϕ.sub.2, ϕ.sub.3, d.sub.4 of the robotic catheter navigation system by applying the inverse of the transformations M heart and M transducer and by applying the inverse kinematics model f.sup.−1 of the catheter. In this way, a user control imaging directly from the heart coordinate system, achieving hand-eye coordination and a more intuitive navigation inside the cardiac chambers.”]
The Examiner has cited particular paragraphs or columns and line numbers in the references applied to the claims above for the convenience of the Applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the Applicant in preparing responses, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner. See MPEP 2141.02 [R-07.2015] VI. A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed Invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert, denied, 469 U.S. 851 (1984). See also MPEP §2123.
Conclusion
THIS ACTION IS MADE FINAL. 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 MOHAMMED YOUSEF ABUELHAWA whose telephone number is (571)272-3219. The examiner can normally be reached Monday-Friday 8:30-5:00 with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wade Miles can be reached at 571-270-7777. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED YOUSEF ABUELHAWA/Examiner, Art Unit 3656
/WADE MILES/Supervisory Patent Examiner, Art Unit 3656
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