DETAILED CORRESPONDENCE
This action is in response to the filing of the Arguments submitted on
01/13/2026.
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 .
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.
Claim(s) 1, 2, 6 - 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 20100312095).
Claim 1, Jenkins discloses a method for robotic control of an imaging catheter, the method comprising: determining a plurality of views by the imaging catheter in a heart for transseptal puncture, the determining being selection of the views of the plurality in a pre-operative image [see at least p0016, p0022, p0024, p0095, p0107, p0112, p0116 - directed to MRI guided cardiac EP systems; display can be configured to display at least one volumetric model of at least a portion of a patient's heart; the system can be configured to register the at least one model to 3-D MRI imaging space prior to or during an MRI-guided procedure to electronically define locations of the at least one ablation site, the associated boundary limits and the at least one avoid zone in the 3-D imaging space; The planning map 137p with the marked or selected avoid zones 155 can be electronically registered to 3-D MRI image space prior to or at the start of a procedure; pre-acquired – used to generate data the model or map of the actual patient and can be obtained prior to the start of the procedure; The UI 25 can include a list of user selectable patient-specific images and/or maps including a plurality of tissue maps, typically including at least one, and more typically, several types of, tissue characterization maps (or data associated with such maps) associated with the procedure that can be selected for viewing by a user];
defining a trajectory of movement of the imaging catheter between the views of the plurality [see Figs 1 - 5, p0055, p0121 - 0122, different scan planes that are associated with a region of interest of a heart of a patient that can be used to obtain MR image data relevant to one or more target ablation paths during an interventional procedure];
registering the pre-operative image and the views of the plurality with a patient; [see p0015, p0024, p0028, p0083, p0105 – 0116- planning map 137p with the marked or selected avoid zones 155 can be electronically registered to 3-D MRI image space prior to or at the start of a procedure; pre-acquired – used to generate data the model or map of the actual patient and can be obtained prior to the start of the procedure; The UI 25 can include a list of user selectable patient-specific images and/or maps including a plurality of tissue maps, typically including at least one, and more typically, several types of, tissue characterization maps (or data associated with such maps) associated with the procedure that can be selected for viewing by a user];
displaying images from the imaging catheter at the views of the plurality [see Figs 2 – 3 and 7, p0136, display (20), a display 20 with a visualization 100v that includes the planning map 137p registered to the imaging space along with MRI image data 100MRI that an MR Scanner 10S can obtain while a patient is in the MR Scanner 10S typically just prior to or at the start of the MRI-guided interventional procedure].
Jenkins does not specifically teach moving, by a robotic catheter system, the imaging catheter between the views of the plurality along the trajectory in the patient based on the registration.
However, Jenkins discloses the ablation path boundary limits and associated preset scan planes for at least one target ablation path for an MRI-guided cardiac EP procedure can be electronically/programmatically defined in response to a user's indication of the target ablation path on a volumetric map of a patient's heart (typically prior to initiating an ablation procedure during pre-procedure planning) (block 350). The location of an intracardiac ablation catheter can be monitored and the system can also automatically obtain MR image data using one or more of the relevant preset scan planes (block 355). The location of the cardiac ablation catheter can be tracked during the procedure and illustrated on the map of the heart (block 360). During the procedure, typically as an ablation electrode approaches a location within or near the boundaries of the at least one target ablation path, the MRI Scanner uses one or more of the preset scan planes to generate substantially real-time MR image data of cardiac tissue of the patient and the catheter distal end portion (block 365)[see Figs 16 – 17, Fig 25, p0130, p0143, p0158, p0161, p0203, p0238 – p0239, p0246].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Jenkins, to include moving, by a robotic catheter system, the imaging catheter between the views of the plurality along the trajectory in the patient based on the registration, as suggested by Jenkins, with a reasonable expectation of success, for the purpose of providing a safety path without the collision of the anatomy.
Claim 2, Jenkins discloses method of claim 1, wherein displaying are performed intra-operatively based on pre-operative performance of determining.
Jenkins discloses a display (20), a display 20 with a visualization 100v that includes the planning map 137p registered to the imaging space along with MRI image data 100MRI that an MR Scanner 10S can obtain while a patient is in the MR Scanner 10S typically just prior to or at the start of the MRI-guided interventional procedure [see Figs 2 – 3 and 7, p0136].
Jenkins does not specifically disclose wherein moving are performed intra-operatively based on pre-operative performance of determining.
However, Jenkins discloses the ablation path boundary limits and associated preset scan planes for at least one target ablation path for an MRI-guided cardiac EP procedure can be electronically/programmatically defined in response to a user's indication of the target ablation path on a volumetric map of a patient's heart (typically prior to initiating an ablation procedure during pre-procedure planning) (block 350). The location of an intracardiac ablation catheter can be monitored and the system can also automatically obtain MR image data using one or more of the relevant preset scan planes (block 355). The location of the cardiac ablation catheter can be tracked during the procedure and illustrated on the map of the heart (block 360). During the procedure, typically as an ablation electrode approaches a location within or near the boundaries of the at least one target ablation path, the MRI Scanner uses one or more of the preset scan planes to generate substantially real-time MR image data of cardiac tissue of the patient and the catheter distal end portion (block 365)[see Figs 16 – 17, Fig 25, p0130, p0143, p0158, p0161, p0203, p0238 – p0239, p0246].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Jenkins, to include wherein moving are performed intra-operatively based on pre-operative performance of determining, as suggested by Jenkins, with a reasonable expectation of success, for the purpose of providing a safety path without the collision of the anatomy.
Claim 6, Jenkins discloses the method of claim 1, wherein defining comprises selecting the trajectory from a roadmap of motions confined to a boundary of the heart [see p0027 – p0031, p0055 - Fig 4, - methods for carrying out an MRI-guided therapy to treat cardiac disease or disorders. The methods include: (a) displaying at least one volumetric model of at least a portion of a heart of a patient; (b) allowing a user to mark and/or select target ablation sites on the displayed rendering; (c) electronically defining boundary limits for the target ablation sites in response to the marking step; then (d) electronically monitoring a position of a distal end portion of an ablation catheter in 3-D MRI imaging space; and (e) electronically generating an alert when the position of the distal end portion of the ablation catheter is determined to be at least one of: (i) within the defined boundary limits of a respective selected target ablation site and/or (ii) outside the defined boundary limits of a respective selected target ablation site during an MRI-guided therapy; different scan planes that are associated with a region of interest of a heart of a patient that can be used to obtain MR image data relevant to one or more target ablation paths during an interventional procedure].
Claim 7, Jenkins discloses the method of claim 1, wherein moving comprises moving from a first of the views to a second of the views [See Fig 16 and 17, p0198 illustrate two high-resolution active treatment views, both showing adjacent different views, shown as an axial (first view) and en face (second view) view of local tissue. For example, during an ablation mode the circuit can use a default viewing rule to display the near real time MR image data of the affected tissue during an active treatment, e.g., ablation, typically showing both en face and side views of the local tissue and treatment (ablation tip)].
Claim 8, Jenkins discloses the method of claim 1, wherein moving comprises moving in response to input of a user selection of one of the views [see p0215 - with user input, e.g. on a button press, the circuit 60c can define a plane tangent to the model surface for the en face view, or along this line for the axial view. Gating may be used. The axial view may be more robust as it cuts through the wall].
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 20100312095) in view of “Automated catheter tip repositioning for intra-cardiac echocardiography”, Young-Ho, Kim (as disclosed and presented by the Applicant) (hereinafter referred to as Kim).
Claim 4, Jenkins discloses the method of claim 1, but is silent to wherein determining comprises determining the views of the plurality as one or more views of one or more locations for the transseptal puncture and/or one or more views of a needle for performing the transseptal puncture.
However, Kim discloses The physician-operator began by pre-saving two ICE views from the RA relevant to the procedure (Fig. 6A and B). The puncture was achieved with a Versacross RF (Baylis Medical). The procedure was performed entirely with robotic ICE guidance (i.e., no fluoroscopy or other real--time imaging). After pre-saving of the two guiding views, the operator did not need to maneuver the ICE via joystick or manually for the remainder of the procedure. Automated view recovery was utilized to manipulate between the two pre--saved views as needed (with 5 transitions from view-to-view in each
experiment) [see Figs 6A – B and top of page 141 (right column)].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Jenkins, to include wherein determining comprises determining the views of the plurality as one or more views of one or more locations for the transseptal puncture and/or one or more views of a needle for performing the transseptal puncture, as suggested and taught by Kim, with a reasonable expectation of success, for the purpose of providing a safety path without the collision of the anatomy.
Claim 5, Jenkins discloses the method of claim 1, but is silent to wherein determining comprises defining locations and orientations of an ultrasound transducer of the imaging catheter in a pre-operative image.
However, Kim discloses the physician-operator manipulates the lCE catheter while surveying images via the ultrasound machine and saving desired views using joystick buttons [see Fig.1, top of page 1411].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Jenkins, to include determining comprises defining locations and orientations of an ultrasound transducer of the imaging catheter in a pre-operative image, as suggested and taught by Kim, with a reasonable expectation of success, for the purpose of providing a user with a selection of views of the pre-operative images obtained during the initial ICE survey, therefore a roadmap can be developed for a safety path to be determined without the collision of the anatomy.
Claim(s) 3, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 20100312095) in view of Buil (US 20240268894).
Claim 3, Jenkins discloses the method of claim 1, but is silent to wherein moving comprises automatic navigation in response to user activation input and without user control of the moving along the trajectory.
However, Buil discloses navigation operation instructions, for example during catheterization. The present invention relates in particular to a device for in-body navigation operation instructions, to a catheter system and to a method for providing in-body navigation operation instructions [see Summary and p0068-p0070].
Further disclosing, the operating instructions are translated according to the view provided to the user. Thus, the navigation part is handled by the device itself, and the burden to translate the navigation into actual (manual) action by the user to control the catheter movement is also handled by the device itself. The user can thus simply directly perform the operation instructions [p0084 – 85]. Also, the present invention can be used in any medical field where catheters are used to navigate through the vascular systems, in the context of treating patients through minimally invasive procedures. It can be used in hybrid cath labs, where such procedures are executed, and where additional image guided therapy equipment is present. The proposed guidance may also be used in combination with (autonomous) catheter robots, in which a surgeon can overrule if necessary and use the navigation guidance to continue manually [p0132].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Jenkins, to include wherein moving comprises automatic navigation in response to user activation input and without user control of the moving along the trajectory, as suggested and taught by Buil, with a reasonable expectation of success, for the purpose of providing navigational instructions that avoid creating damage in the patient, improves on the amount of time and effort a surgeon needs to mitigate risk to a patient and is developed for a safety path to be determined without the collision of the anatomy.
Claim 9, Jenkins discloses the method of claim 1, but is silent to wherein moving comprises hand-free moving of the imaging catheter.
However, Buil discloses navigation operation instructions, for example during catheterization. The present invention relates in particular to a device for in-body navigation operation instructions, to a catheter system and to a method for providing in-body navigation operation instructions; 3D information of the anatomy structure can be provided by a data storage, such as pre-operational image data. The 3D information of the anatomy structure can also be provided as live data, such as from live imaging [see Summary and p0045; p0068-p0070].
Further disclosing, the operating instructions are translated according to the view provided to the user. Thus, the navigation part is handled by the device itself, and the burden to translate the navigation into actual (manual) action by the user to control the catheter movement is also handled by the device itself. The user can thus simply directly perform the operation instructions [p0084 – 85, p0095 - 0099].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Jenkins, to include wherein moving comprises hand-free moving of the imaging catheter, as suggested and taught by Buil, with a reasonable expectation of success, for the purpose of providing navigational instructions that avoid creating damage in the patient, improves on the amount of time and effort a surgeon needs to mitigate risk to a patient and is developed for a safety path to be determined without the collision of the anatomy.
Claim 10, Jenkins discloses the method of claim 1, but is silent to wherein moving comprises swapping between different ones of the views.
However, Buil discloses navigation operation instructions, for example during catheterization. The present invention relates in particular to a device for in-body navigation operation instructions, to a catheter system and to a method for providing in-body navigation operation instructions; the anatomical data supply is further configured to provide data allowing at least two different views on the anatomy structure of the region of interest. The processor is configured to generate image data showing the tool tip in a different view dependent on at least one of the group of the operation instructions, and the complexity of approaching junctions abut. The term “different view” relates to a change of at least one of the group of viewing direction, viewing angle and viewing resolution. For example, the user, i.e. an operator, can switch from a neutral outside view to a view from the standpoint of the catheter tip. In an example, an automatic change is provided [see p0095 – p0130].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Jenkins, to include wherein moving comprises swapping between different ones of the views, as suggested and taught by Buil, with a reasonable expectation of success, for the purpose of providing navigational images that avoid creating damage in the patient, improves on the amount of time and effort a surgeon needs to mitigate risk to a patient and is developed for a safety path to be determined without the collision of the anatomy.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 11 – 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ninni (US 20220202500).
Claim 11, Ninni discloses a catheter control system comprising: a memory configured to store instructions; and a processor configured by the instructions to control a catheter robot to manipulate an intracardiac echocardiography catheter [see p0008, p0038 – a robot-assisted endoscope system has a steerable sheath configured to guide an imaging device and/or a surgical tool through a tool channel thereof. An actuator unit (kinematic actuator) provides an actuating force to the steerable sheath, so as to align the distal end of the sheath with a target site. One or more sensors arranged along the sheath detect a real-time position of the sheath in relation to the target site. A processor generates a virtual image of the real-time position of the sheath and/or the target site, and displays a ghost (non-real-time) position for a tool in the virtual image; during an endoscope procedure, the system processor or CPU 410 of computer system 400 is configured to perform operations based on computer-executable code pre-stored in the system's memory 411].
to swap views of the intracardiac echocardiography catheter intra-operatively based on pre-operative selection of the views [See p0038, p0056, p0074 Figs. 1 - 3 - robot-assisted endoscope system 1000 in which the steerable catheter sheath 110 is attached to the handle 200 and mounted in the robot platform 90. In this state, at step S1302, the system processor or CPU 410 of computer system 400 displays the patient information 421, a pre-operative image 424 and/or an intra-operative image 423 on display screen 420; The display screen 420 may include a graphical user interface (GUI) configured to display one or more of patient information 421, an endoscope live-image 422, an intra-operative image 423 (e.g., fluoroscopy), and a pre-operative image 424 (e.g., a slice image) of the patient 80; views using the recorded position, rather than the real-time position, if the user chooses to do so. For example, if one of the recorded positions was aiming at a specific part of the airway earlier in the procedure, the user can swap to the virtual first-person camera view at the recorded position/orientation to recall what was being inspected].
Claim 12, Ninni discloses the catheter control system of claim 11, further comprising the catheter robot [see at least p0056, Fig 3 - the robot-assisted endoscope system 1000 in which the steerable catheter sheath 110 is attached to the handle 200 and mounted in the robot platform 90].
Claim 13, Ninni discloses the catheter control system of claim 11, wherein the processor is configured to manipulate the intracardiac echocardiography catheter hands-free by a user in response to activation of the swap by the user [p0074 - after having removed the imaging device from the steerable catheter sheath 110 and when the actual interventional tool is being advanced through the sheath towards the target site, the system can provide virtual views using the recorded position, rather than the real-time position, if the user chooses to do so. For example, if one of the recorded positions was aiming at a specific part of the airway earlier in the procedure, the user can swap to the virtual first-person camera view at the recorded position/orientation to recall what was being inspected. A virtual first person camera view is placed at the tip of the EM-tracked catheter sheath within the 3D anatomical model, and this camera view should match the recorded endoscopic view obtained when the imaging device was first used].
Claim 14, Ninni discloses the catheter control system of claim 11, wherein the processor is configured to receive the selection of the views in pre-operative images, the selection defining a location and orientation for each of the views [see at least Figs, 3, 4A, 4B, p0010, p0016, p0038, p0056 - the processor displays a ‘ghost’ (non-real-time) position of the steerable sheath in a virtual image; the ghost image can be on or more of a true prior recorded position, or a proposed or desired position based on a procedure plan, or a still image of a virtual tool; the annotation, size, shape, color, or opacity of the ghost image as compared to the real-time position image. As used herein, the term “position” comprises both location and orientation information].
Claim 17, Ninni discloses the catheter control system of claim 11, further comprising a display configured to display ultrasound images of the views in sequence from the swap.
Ninni discloses a physician may use pre-operative and/or intra-operative imaging techniques, such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), ultrasound (US), or other similar techniques to safely guide surgical tools through or around internal structures and organs of a patient. Further teaching, at step S1302, the system processor or CPU 410 of computer system 400 displays the patient information 421, a pre-operative image 424 and/or an intra-operative image 423 on display screen 420; The display screen 420 may include a graphical user interface (GUI) configured to display one or more of patient information 421, an endoscope live-image 422, an intra-operative image 423 (e.g., fluoroscopy), and a pre-operative image 424 (e.g., a slice image) of the patient 80; views using the recorded position, rather than the real-time position, if the user chooses to do so. For example, if one of the recorded positions was aiming at a specific part of the airway earlier in the procedure, the user can swap to the virtual first-person camera view at the recorded position/orientation to recall what was being inspected [see
p0038, p0056, p0074 and Figs. 1 – 3].
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.
Claim(s) 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ninni (US 20220202500) in view of “Automated catheter tip repositioning for intra-cardiac echocardiography”, Young-Ho, Kim (as disclosed and presented by the Applicant) (hereinafter referred to as Kim).
Claim 15, Ninni discloses the catheter control system of claim 11, but is silent to wherein the processor is configured to perform the swap from a first of the views to a second of the views with the intracardiac echocardiography catheter following a trajectory based on optimization of a path length from the first view to the second view.
However, Kim discloses first, a roadmap that traces motor state configurations is generated while the operator manipulates the ICE catheter by joystick input with each unique configuration represented by a white dot and connected to neighboring configurations by an edge element. Second, a library of desired views is generated by labeling certain states within this roadmap. The colored dots (i.e., green. red, yellow, and purple dots) represents the bookmarked or saved state of the robot. Lastly, when the user specify the desired view in the library of views, then the robotic controller can return to any of these views by retracing a path along the roadmap from the current state to the desired state (optimizing the map)[see Fig.1d and top of page 1411, see below].
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It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Ninni, to include wherein the processor is configured to perform the swap from a first of the views to a second of the views with the intracardiac echocardiography catheter following a trajectory based on optimization of a path length from the first view to the second view, as suggested and taught by Kim, with a reasonable expectation of success, for the purpose of providing a user with a selection of views of the pre-operative images obtained during the initial ICE survey, therefore a roadmap can be developed for a safety path to be determined without the collision of the anatomy.
Claim 16, Ninni discloses the catheter control system of claim 11, but is silent to wherein the processor is configured to perform the swap from a first of the views for a transseptal puncture to a second of the views for the transseptal puncture.
However, Kim discloses The physician-operator began by pre-saving two ICE views from the RA relevant to the procedure (Fig. 6A and B). The puncture was achieved with a Versacross RF (Baylis Medical). The procedure was performed entirely with robotic ICE guidance (i.e., no fluoroscopy or other real--time imaging). After pre-saving of the two guiding views, the operator did not need to maneuver the ICE via joystick or manually for the remainder of the procedure. Automated view recovery was utilized to manipulate between the two pre--saved views as needed (with 5 transitions from view-to-view in each
experiment) [see Figs 6A – B and top of page 141 (right column)].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Ninni, to include wherein the processor is configured to perform the swap from a first of the views for a transseptal puncture to a second of the views for the transseptal puncture, as suggested and taught by Kim, with a reasonable expectation of success, for the purpose of providing a safety path without the collision of the anatomy.
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.
Claim(s) 18 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Buil (US 20240268894) in view of Jenkins (US 20100312095).
Claim 18, Buil discloses a control system for a steerable catheter, the control system comprising: a robotic system for operation of a steerable catheter; a memory configured to store a first view of a heart and a second view of the heart; the first view being a different location and/or orientation than the first view from within the heart, the first and second views being views of anatomy and/or devices for a medical procedure, the first and second views being defined in a pre-operative image [See Summary and p0045; p0068-p0070,p0084 – 85, p0095 – 0099 - navigation operation instructions, for example during catheterization/ heart. A device for in-body navigation operation instructions, to a catheter system and to a method for providing in-body navigation operation instructions; the anatomical data supply is further configured to provide data allowing at least two different views on the anatomy structure of the region of interest. The processor is configured to generate image data showing the tool tip in a different view dependent on at least one of the group of the operation instructions, and the complexity of approaching junctions abut. The term “different view” relates to a change of at least one of the group of viewing direction, viewing angle and viewing resolution. For example, the user, i.e. an operator, can switch from a neutral outside view to a view from the standpoint of the catheter tip. In an example, an automatic change is provided; 3D information of the anatomy structure can be provided by a data storage, such as pre-operational image data. The 3D information of the anatomy structure can also be provided as live data, such as from live imaging].
Buil does not specifically teach a processor configured to register the pre-operative image with a patient and to cause the robotic system to navigate the steerable catheter from the first view to the second view in response to activation by a user and based on the registration; and a display configured to display an image of the first view and an image of the second view.
However, Jenkins teaches a device for in-body navigation operation instructions is provided. The device comprises a position data supply, an anatomical data supply, a processor and an output. the system can be configured to register the at least one model to 3-D MRI imaging space prior to or during an MRI-guided procedure to electronically define locations of the at least one ablation site, the associated boundary limits and the at least one avoid zone in the 3-D imaging space [see p0045].
Also teaching, See Fig 16 and 17, p0198, illustrating two high-resolution active treatment views, both showing adjacent different views, shown as an axial (first view) and en face (second view) view of local tissue. For example, during an ablation mode the circuit can use a default viewing rule to display the near real time MR image data of the affected tissue during an active treatment, e.g., ablation, typically showing both en face and side views of the local tissue and treatment (ablation tip)].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Buil, to include a processor configured to register the pre-operative image with a patient and to cause the robotic system to navigate the steerable catheter from the first view to the second view in response to activation by a user and based on the registration; and a display configured to display an image of the first view and an image of the second view, as suggested and taught by with a reasonable expectation of success, for the purpose of providing a user with a selection of views of the pre-operative images obtained therefore creating roadmap for a safety path to be determined without the collision of anatomy.
Claim 19, Buil discloses the control system of claim 18, wherein the processor is configured to cause the navigation in response to input from the user, the navigation being hand-free by the user.
Buil discloses navigation operation instructions, for example during catheterization. The present invention relates in particular to a device for in-body navigation operation instructions, to a catheter system and to a method for providing in-body navigation operation instructions; 3D information of the anatomy structure can be provided by a data storage, such as pre-operational image data. The 3D information of the anatomy structure can also be provided as live data, such as from live imaging. [see Summary and p0045; p0068-p0070].
Further disclosing, the operating instructions are translated according to the view provided to the user. Thus, the navigation part is handled by the device itself, and the burden to translate the navigation into actual (manual) action by the user to control the catheter movement is also handled by the device itself. The user can thus simply directly perform the operation instructions [p0084 – 85, p0095 - 0099].
Claim 20, Buil discloses the control system of claim 18, but is silent to wherein the first view and the second view are stored in the memory as selections from a pre-operative image of the heart.
However, Jenkins teaches two high-resolution active treatment views, both showing adjacent different views, shown as an axial (first view) and en face (second view) view of local tissue. For example, during an ablation mode the circuit can use a default viewing rule to display the near real time MR image data of the affected tissue during an active treatment, e.g., ablation, typically showing both en face and side views of the local tissue and treatment (ablation tip) [ See Fig 16 and 17, p0198].
Further teaching, the data input can be provided as live data regarding the input of the current position data. In another example, the input of the current position data is provided from a data storage, for example for test or training purposes when handling a device in a model or simulation. The 3D information of the anatomy structure can be provided by a data storage, such as pre-operational image data. The 3D information of the anatomy structure can also be provided as live data, such as from live imaging [see p0045].
It would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the device in Buil, to include wherein the first view and the second view are stored in the memory as selections from a pre-operative image of the heart, as suggested and taught by Jenkins, with a reasonable expectation of success, for the purpose of providing a user with a selection of views of the pre-operative images obtained therefore creating roadmap for a safety path to be determined without the collision of anatomy.
Response to Arguments
Applicant's arguments filed 01/13/2026 have been fully considered but they are not persuasive.
The Applicant argues with respect to Clam 1:
A. Jenkins does not teach or suggest each and every limitation of claim 1.
Claim 1:
A method for robotic control of an imaging catheter, the method comprising: determining a plurality of views by the imaging catheter in a heart for transseptal puncture, the determining being selection of the views of the plurality in a pre-operative image; defining a trajectory of movement of the imaging catheter between the views of the plurality; registering the pre-operative image and the views of the plurality with a patient; moving, by a robotic catheter system, the imaging catheter between the views of the plurality along the trajectory in the patient based on the registration; and displaying images from the imaging catheter at the views of the plurality.
Claim 1 recites "determining a plurality of views by the imaging catheter in a heart
for transseptal puncture, the determining being selection of the views of the plurality in a pre- operative image."
Applicant argues:
Jenkins does not teach or suggest at least this limitation. Jenkins does disclose pre- acquired volumetric planning maps of cardiac anatomy that are registered to MRI space and selectable for display. However, Jenkins does not disclose "views by the imaging catheter" under a broadest reasonable interpretation consistent with the specification.
Jenkins also does not teach or suggest "registering the pre-operative image and the
views of the plurality with a patient."
Jenkins also does not teach or suggest "displaying images from the imaging catheter at the views of the plurality."
In response to Applicant:
Jenkins does not teach:
"views by the imaging catheter"
The Examiner disagrees. Jenkins discloses in some embodiments, Image data can also include image data obtained by a trans-esophageal antenna catheter during the procedure. See, e.g., U.S. Pat. No. 6,408,202, the contents of which are hereby incorporated by reference as if recited in full herein [see p0254]; the system/circuit can employ interactive application of non-selective saturation to show the presence of a contrast agent in near real-time scanning. This option can help, for example, during image-guided catheter navigation to target tissue that borders scar regions. See, e.g., Dick et al., Real Time MRI enables targeted injection of labeled stem cells to the border of recent porcine myocardial infarction based on functional and tissue characteristics, Proc. Intl. Soc. Mag. Reson. Med. 11, p. 365 (2003); Guttman et al., Imaging of Myocardial Infarction for Diagnosis and Intervention Using Real-Time Interactive MRI Without ECG-Gating or Breath-Holding, Mag. Reson. Med, 52: 354-361 (2004), and Dick and Guttman et al., Magnetic Resonance Fluoroscopy Allows Targeted Delivery of Mesenchymal Stem Cells to Infarct Borders in Swine, Circulation, 2003; 108:2899-2904, which describe, inter alia, imaging techniques used to show regions of delayed enhancement in (near) real-time scans. The contents of these documents are hereby incorporated by reference as if recited in full herein [see p0276].
Further, Jenkins discloses a display can be configured to display at least one volumetric model of at least a portion of a patient's heart; the system can be configured to register the at least one model to 3-D MRI imaging space prior to or during an MRI-guided procedure to electronically define locations of the at least one ablation site, the associated boundary limits and the at least one avoid zone in the 3-D imaging space; The planning map 137p with the marked or selected avoid zones 155 can be electronically registered to 3-D MRI image space prior to or at the start of a procedure; pre-acquired – used to generate data the model or map of the actual patient and can be obtained prior to the start of the procedure. This teaching is the same regardless of whether the display is used for MRI guided or during image-guided catheter navigation to target tissue that borders scar regions.
Further Applicant argues with respect to Claim 1:
Applicant argues Jenkins does not teach:
"defining a trajectory of movement of the imaging catheter between the views of the plurality."
The Examiner agrees, under the broadest reasonable interpretation, a "trajectory of movement of the imaging catheter between the views" requires a planned catheter motion path linking multiple predefined catheter imaging states.
Jenkins does disclose defining such a trajectory, either explicitly or inherently. Jenkins discloses the system includes a navigation view mode and an ablation view mode for some cardiac procedures; the system includes a navigation view mode and an ablation view mode for some cardiac procedures. The latter viewing mode can automatically be shown on the display 20 during an active ablation. The circuit 60c may also cause or direct the Scanner to use to "snap to" a scan plane proximate the device (e.g., catheter) tip or end location to obtain real-time MR image data of the associated tissue. The scan planes can be adjusted in response to movement of the device (as typically detected by tracking coils) prior to active treatment (e.g., ablation) if the physician decides the location is unsatisfactory. The snap to scan planes can be based on a calculated projected position of the distal end portion of the device [p0202 – p0203, teaching the navigation views can be viewed prior to active ablation].
Jenkins does teach different scan planes that are associated with a region of interest of a heart of a patient that can be used to obtain MR image data relevant to one or more target ablation paths during an interventional procedure, teaching that these target areas must be found via trajectory navigation. The navigation view mode and an ablation view mode for some cardiac procedures; the system includes a navigation view mode and an ablation view mode for some cardiac procedures. The latter viewing mode can automatically be shown on the display 20 during an active ablation.
The Examiner understands navigation of the device during navigation teaches "defining a trajectory of movement of the imaging catheter between the views of the plurality” as stated above, if the physician reviews the views prior to active treatment while navigating (trajectory) are unsatisfactory, these trajectories will be avoided or at least not used during the treatment.
Jenkins also does not teach or suggest "displaying images from the imaging catheter at the views of the plurality."
Since the Examiner has established that Jenkins does teach catheter imaging, it appears clear that any type, whether it is completed by the MRI tool, or catheter imaging tool this device in Jenkins is capable of displaying those images. In Jenkins, display 20, see at least Figures, 14 and 15, p0164, one GUI control 25c can be a slide control 50, on a lower portion of the display 20 that can allow a user to select whether to display RT-MRI (Real Time MRI images) 51 or a tissue characterization map 30, or combinations thereof (e.g., the slide can allow a fade-away display between the two types of images). The GUI control 50 may also be a toggle, a touch screen with direction sensitivity to pull in one direction or other graphic or physical inputs.
Applicant argues with respect to Claim 18:
B. Jenkins and Buil do not teach or suggest each and every limitation of claim 18.
Claim 18, A control system for a steerable catheter, the control system comprising: a robotic system for operation of a steerable catheter; a memory configured to store a first view of a heart and a second view of the heart, the first view being a different location and/or orientation than the first view from within the heart, the first and second views being views of anatomy and/or devices for a medical procedure, the first and second views being defined in a pre-operative image; a processor configured to register the pre-operative image with a patient and to cause the robotic system to navigate the steerable catheter from the first view to the second view in response to activation by a user and based on the registration; and a display configured to display an image of the first view and an image of the second view.
Applicant argues neither Buil or Jenkins teach "a memory configured to store a first view of a heart and a second view of the heart, the first view being a different location and/or orientation than the first view from within the heart, the first and second views being views of anatomy and/or devices for a medical procedure, the first and second views being defined in a pre-operative image."
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., defining, storing, or using discrete catheter views corresponding to catheter pose within the heart,) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues with respect to Claim 11:
C. Ninni does not teach or suggest each and every limitation of claim 11.
Claim 11, A catheter control system comprising: a memory configured to store instructions;
and a processor configured by the instructions to control a catheter robot to manipulate an intracardiac echocardiography catheter to swap views of the intracardiac echocardiography catheter intra-operatively based on pre-operative selection of the views.
Applicant argues that Ninni does not teach selecting a plurality of ICE imaging views pre-operatively and then, during the procedure, commanding a catheter robot to swap among those selected views.
The Examiner disagrees:
First, Ninni teaches an ultrasound tipped catheter robotically controlled to deploy an imaging device (e.g., a fiber-based probe or a miniaturized camera) through a tool channel of a protective sleeve or sheath (also referred to as a catheter sheath or catheter) to first obtain an image of a target site [see p0003 – p0006 – certainly covering, an ICE catheter].
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a stored set of pre - selected views defined before the procedure) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues Ninni does not “swap between predefined views. The "different view" concept in Ninni refers to changing viewing direction, angle, or resolution based on real-time navigation context, not swapping between discrete imaging views selected in advance.
Again, the Applicant relies on features that are not recited in the rejected Claim. Notably, “swap between predefined views.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “swap between predefined views.”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The claim teaches to swap views of the intracardiac echocardiography catheter intra-operatively based on pre-operative selection of the views.
Ninni discloses at step S1302, the system processor or CPU 410 of computer system 400 displays the patient information 421, a pre-operative image 424 and/or an intra-operative image 423 on display screen 420; The display screen 420 may include a graphical user interface (GUI) configured to display one or more of patient information 421, an endoscope live-image 422, an intra-operative image 423 (e.g., fluoroscopy), and a pre-operative image 424 (e.g., a slice image) of the patient 80; views using the recorded position, rather than the real-time position, if the user chooses to do so. For example, if one of the recorded positions was aiming at a specific part of the airway earlier in the procedure, the user can swap to the virtual first-person camera view at the recorded position/orientation to recall what was being inspected.
The Examiner understands Ninni discloses a robotically controlled surgical device with imaging through a catheter and or an MRI catheter imaging device; manipulate an intracardiac echocardiography catheter to swap views of the intracardiac echocardiography catheter intra-operatively based on pre-operative selection of the views is completed
Ninni further teaches, when combined with patient pre-operative imaging, image segmentation, and intra-operative device-to-image registration, the physician can visualize a virtual representation of the patient's organs and the catheter position throughout the procedure [see p0004 – teaching the surgeons ability to visualize many different images].
Further, in Ninni the system is configured to provide a virtual first-person camera view to align the real-time catheter position with a pre-recorded or planned ghost position. Planned being the operative word, such as “between predefined” views [see Figs 9A- 9B, p0080]. According to one embodiment, after having removed the imaging device from the steerable catheter sheath 110 and when the actual interventional tool is being advanced through the sheath towards the target site, the system can provide virtual views using the recorded position, rather than the real-time position, if the user chooses to do so. For example, if one of the recorded positions was aiming at a specific part of the airway earlier in the procedure, the user can swap to the virtual first-person camera view at the recorded position/orientation to recall what was being inspected [see Ninni, p0074 – teaching swap the camera view (that is swapping a view of what is seen with a view of what was recorded).
CONCLUSION
For at least the reasons presented above, the Examiner respectfully submits that the pending claims all stand rejected.
Additionally, the Examiner may have noted other parts of the same references that were submitted. As noted in the Non-Final rejection, the examiner has pointed out particular references contained in the prior art of record in the body of this action for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. Applicant should consider the entire prior art as applicable as to the limitations of the claims. It is respectfully requested from the applicant, in preparing the response, to consider fully the entire references 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.
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 RENEE MARIE LAROSE whose telephone number is (313)446-4856. The examiner can normally be reached M- F 8:30 am - 5 pm.
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/Renee LaRose/ Examiner, Art Unit 3657
/ABBY LIN/ Supervisory Patent Examiner, Art Unit 3657