DETAILED ACTION
Amendment received 24 October 2024 is acknowledged. Claims 1, 3, 8-14, 18, and 21-30 are pending and have been considered as follows.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 8-14, 18, and 21-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As per Claim 1, it is not clear whether “selectable” in line 4 modifies only “visualization-based reference frame” or whether all of the “visualization-based reference frame”, “anatomic-based reference frame”, and “image plane reference frame” are “selectable”. Clarification is required. Claims 3, 8-14, 18, 21-28 depending from Claim 1 are therefore rejected.
As per Claim 1, “the selected reference frame” in line 9-10, 13-14, and 15-16 lacks proper antecedent basis in that the method does not recite “selecting a reference frame” or “a selected reference frame”. Clarification is required. Claims 3, 8-14, 18, 21-28 depending from Claim 1 are therefore rejected.
As per Claim 1, “the selected reference frame movement target” in line 15-16 lacks proper antecedent basis in that the method does not recite “selecting a reference frame movement target” or “a selected reference frame movement target”. Clarification is required. Claims 3, 8-14, 18, 21-28 depending from Claim 1 are therefore rejected.
As per Claim 29, it is not clear whether “selectable” in line 9 modifies only “visualization-based reference frame” or both “visualization-based reference frame” and “anatomical-based reference frame”. Clarification is required. Claim 30 depending from Claim 29 is therefore rejected.
As per Claim 29, “the imaging system” in line 10 lacks proper antecedent basis in that the claim does not previously recite “an imaging system”. Clarification is required. Claim 30 depending from Claim 29 is therefore rejected.
As per Claim 29, “an imaging system” in line 11 does not clearly relate back to “an imaging system” in line 10. Clarification is required. Claim 30 depending from Claim 29 is therefore rejected.
As per Claim 29, “selected reference frame” in line 12-13, and 16-17 lacks clear antecedent basis in that the operations do not recite “selecting a reference frame” or “a selected reference frame”. Clarification is required. Claim 30 depending from Claim 29 is therefore rejected.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 8, 10-14, 18, 21, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace (US Pub. No. 2020/0229920) in view of Johnson (US Pub. No. 2019/0183591).
As per Claim 1, Wallace discloses a method comprising:
positioning a cardiac valve implant (as per “replacement heart valves” in ¶22; as per “mitral valve replacement 555” in ¶34) in proximity to a cardiac valve annulus (as per “native valve 107” in ¶27; as per “delivery device 101 centered in the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33) of a patient, wherein the cardiac valve implant (as per “replacement heart valves” in ¶22; as per “mitral valve replacement 555” in ¶34) is supported on a distal end of a robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701), wherein the robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701) comprises a visualization-based reference frame (as per “ultrasound image is taken down the longitudinal axis 124” in ¶27) and an anatomical-based reference frame (as per “x-ray image is taken down the plane 122 of mitral valve 107” in ¶27) (Figs. 1-2, 3, 6-7; ¶22-33, 36, 38);
depicting an image (as per “the view of the x-ray imaging sensor 150a,b” in ¶28) of the cardiac valve implant (as per “replacement heart valves” in ¶22; as per “mitral valve replacement 555” in ¶34) using a fluoroscopic imaging system (as per “x-ray sensor 150a,b” in ¶27; as per visualization from a live image source like … fluoroscopy” in ¶5) with a movable (as per “the first imaging modality (e.g., x-ray imaging sensor 150a, b) is maneuvered” in ¶28) c-arm (as per “an x-ray sensor 150a,b (150a, is the emitter while 150b is the detector, which can be part of a c-arm 152)” in ¶27), the image (as per “the view of the x-ray imaging sensor 150a,b” in ¶28) comprising an image plane reference frame (as per “the x-ray image is taken down the plane 122” in ¶27) (Figs. 1-2, 5A; ¶22-34);
utilizing an angle (as per “the first imaging modality (e.g., x-ray imaging sensor 150a, b) is maneuvered” in ¶28; as per “the user can input the angles of the first imaging modality … into the control system for the robotic arm” in ¶41) of the c-arm (as per “an x-ray sensor 150a,b (150a, is the emitter while 150b is the detector, which can be part of a c-arm 152)” in ¶27) to align (as per “the delivery device 101 can be pivoted until it is orthogonal to the plane 122 of the mitral valve” in ¶32) the robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701) to the imaging system (as per “x-ray sensor 150a,b” in ¶27; as per visualization from a live image source like … fluoroscopy” in ¶5) (Figs. 1-2, 5A, 7; ¶22-34, 38-41),
receiving a movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) from a user (as per “the robotic arm 703 can include a user interface” in ¶40) relative to the reference frame (as per “ultrasound image is taken down the longitudinal axis 124” in ¶27; as per “the x-ray image is taken down the plane 122 of the mitral valve 107” in ¶27; as per “x-ray image is taken down the plane 122” in ¶27) (Figs. 1-2, 5A, 7; ¶22-34, 38-43);
calculating a movement target (as per “the arm 703 can follow the user’s input to move in or out” in ¶43) based on the movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) wherein linear movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) is translated into device inputs corresponding to compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) aligned along an axis (124, 122) of the reference frame (as per “ultrasound image is taken down the longitudinal axis 124” in ¶27; as per “the x-ray image is taken down the plane 122 of the mitral valve 107” in ¶27; as per “x-ray image is taken down the plane 122” in ¶27) (Figs. 1-2, 5A, 7; ¶22-34, 38-43); and
actuating (as per “controlled movement with a user interface” in ¶41) the robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701) in accordance with the reference frame movement target (as per “the arm 703 can follow the user’s input to move in or out” in ¶43) to perform the compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) (Figs. 1-2, 5A, 7; ¶22-34, 38-43),
wherein the anatomical-based reference frame (as per “the x-ray image is taken down the plane 122 of the mitral valve 107” in ¶27) comprises device inputs corresponding to compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) aligned to perpendicularity (as per 124), depth (as per “the depth of insertion of the delivery device 103 is set” in ¶34) or centrality (as per “Once the depth, angle, and centrality of the mitral valve have been set, then the valve can be deployed” in ¶35; as per “the arm 703 can follow the user’s input to move in or out” in ¶43) relative to a valve opening (as per “mitral valve orifice” in ¶28, 30, 32) of the cardiac valve annulus (as per “native valve 107” in ¶27; as per “delivery device 101 centered in the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33) (Figs. 1-2, 3, 6-7; ¶22-34, 38-43).
Wallace does not expressly disclose wherein a reference frame is selectable or selected.
Johnson discloses a robotic surgical system that includes a user console (100) having at least one user display (130) configured to display a view of a surgical site (Fig. 1A; ¶34, 36). A user may populate various panels of the display (130) with different applications by selecting which applications are visible and where within an application layout (Figs. 5A-F; ¶58-67). In one embodiment, the display (130) includes one or more real-time image data from devices capturing images of the surgical worksite during a surgical procedure (¶74). In this way, the surgical staff is able to make better treatment decisions (¶71, 74). Like Wallace, Johnson is concerned with surgical control systems.
Therefore, from these teachings of Wallace and Johnson, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson to the system of Wallace since doing so would enhance the system by aiding surgical staff with making treatment decisions. Applying the teachings of Johnson to the system of Wallace would result in a system that operates “wherein a reference frame is selectable or selected” in that the system of Wallace would be adapted to include display functionality as per Johnson.
As per Claim 3, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace further discloses wherein in the anatomical-based reference frame (as per “x-ray image is taken down the plane 122 of mitral valve 107” in ¶27), actuating the robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701) includes modifying at least one of a pitch and a yaw (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) of the cardiac valve implant (as per “replacement heart valves” in ¶22; as per “mitral valve replacement 555” in ¶3) relative to the longitudinal axis (124) of the cardiac valve annulus (as per “native valve 107” in ¶27; as per “delivery device 101 centered in the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33) (Figs. 1-2, 5A, 7; ¶3, 22-34, 38-43).
As per Claim 8, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace further discloses wherein the cardiac valve annulus (as per “native valve 107” in ¶27; as per “delivery device 101 centered in the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33) is a mitral valve annulus (as per “the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33).
As per Claim 10, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace further discloses decoupling (as per “Once the depth, angle, and centrality of the mitral valve have been set, then the valve can be deployed” in ¶35) the cardiac valve implant (as per “replacement heart valves” in ¶22; as per “mitral valve replacement 555” in ¶34) from the distal end of the robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701) such that the cardiac valve implant (as per “replacement heart valves” in ¶22; as per “mitral valve replacement 555” in ¶34) is retained within the cardiac valve annulus (as per “native valve 107” in ¶27; as per “delivery device 101 centered in the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33) (Figs. 1-2, 5A, 7; ¶22-34, 38-43).
As per Claim 11, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace further discloses wherein calculating the movement target (as per “the arm 703 can follow the user’s input to move in or out” in ¶43) comprises translating the movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) into device joint input (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) (Figs. 1-2, 5A, 7; ¶22-34, 38-43).
As per Claim 12, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 11. Wallace further discloses wherein the movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) corresponds to a compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) (Figs. 1-2, 5A, 7; ¶22-34, 38-43).
As per Claim 13, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace further discloses wherein the compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) comprises a device insertion motion (as per “the arm 703 can follow the user’s input to move in or out” in ¶43; as per translational degrees of freedom in “The positioning arm 603 can include six degrees of freedom” in ¶36 and “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) and a device steering motion (as per rotational degrees of freedom in “The positioning arm 603 can include six degrees of freedom” in ¶36 and “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38).
As per Claim 14, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 13. Wallace further discloses wherein the device steering motion (as per rotational degrees of freedom in “The positioning arm 603 can include six degrees of freedom” in ¶36 and “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) is at least one of a proximal steering motion (as per 633d) and a distal steering motion (as per 633f) (Figs. 6-7; ¶36-38).
As per Claim 18, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace further discloses receiving a movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) from the user (as per “the robotic arm 703 can include a user interface” in ¶40) corresponding to direct joint control of one or more actuators (as per “arm 703 includes six movable (e.g., motorized) connections or joints 777a-f” in ¶38) of the robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701).
As per Claim 21, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace does not expressly disclose switching (as per “switched” in ¶42) between the anatomical reference frame (as per “the image from the first imaging modality (e.g., the x-ray sensor 150a,b) that is aligned with the mitral valve plane 122” in ¶32) (as per Figs. 5A-C) and the image plane reference frame (as per “the x-ray image is taken down the plane 122 of the mitral valve 107” in ¶27) (as per Fig. 4; ¶29, 42).
As per Claim 28, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace further discloses wherein vertical movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) directly corresponds to movement in a vertical direction of a depicted screen image (as per Fig. 4; ¶33), and horizontal movement input (per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) directly corresponds to movement in a horizontal direction of the depicted image (as per Fig. 4; ¶33).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace (US Pub. No. 2020/0229920) in view of Johnson (US Pub. No. 2019/0183591), further in view of Strommer (US Pub. No. 2007/0173861).
As per Claim 9, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace does not expressly disclose at least one of selectively furling and selectively unfurling the cardiac valve implant in response to a corresponding user input.
See rejection of Claim 1 for discussion of teachings of Johnson.
Strommer discloses a moving mechanism (326) to advance a valve replacement catheter (160) toward a cardiac valve (110) through the ventricular system (Figs. 1, 5; ¶50, 60-62). The valve replacement catheter (160) includes a valve fixation device in the form of an inflatable ballon (162) surrounded by a stent (166) and by an artificial heart valve (Figs. 1A, 5; ¶62). The moving mechanism (326) is under the control of a controller (324) and cooperates with a joystick (322) for receiving user inputs (Fig. 5; ¶114-115, 132). In operation, a medical staff member: positions the artificial heart valve at the anatomic position of the cardiac valve (110); activates the valve fixation device (e.g., by inflating the inflatable balloon 162); and deflates the balloon (162) thereby fixing in place the stent (166) together with the artificial valve (Fig. 2; ¶70-75, 82-89). In this way, the system reduces guess work (¶75-77). Like Wallace, Strommer is concerned with surgical systems.
Therefore, from these teachings of Wallace, Johnson, and Strommer, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Strommer to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and reducing guess work. Applying the teachings of Johnson Strommer to the system of Wallace would result in a system that operates by “at least one of selectively furling and selectively unfurling the cardiac valve implant in response to a corresponding user input” in that the system of Wallace would be adapted to include display functionality as per Johnson and further adapted to include a fixation device as per Strommer.
Claims 22-27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace (US Pub. No. 2020/0229920) in view of Johnson (US Pub. No. 2019/0183591), further in view of Zhao (US Pub. No. 2014/0187949).
As per Claim 22, the combination of Wallace and Johnson teaches or suggests all limitations of Claim 1. Wallace does not expressly disclose wherein the robotic catheter system further comprises a pre-determined guide path.
See rejection of Claim 1 for discussion of teachings of Johnson.
Zhao discloses teleoperated interventional system (100) for use in surgical procedures that includes a manipulator assembly (102), an interventional instrument (104), a master assembly (106), a control device (112), and a display system (111) (Fig. 1; ¶25-29). The manipulator assembly (102) operates the instrument (104) to perform procedures on the patient (P) and the master assembly (106) allows the surgeon to view the interventional site and control the manipulator assembly (102) via display system (111) and the master assembly (106) (¶25-26). The system (100, 200) includes a navigation system (210) that determines a navigational path for the interventional instrument (104), monitors the instrument (104) as it moves through the anatomical system, and allows the clinician to modify a planned path (Fig. 2; ¶36, 52-53). In this way, the system facilitates determination of a planned instrument deployment location (¶3). Like Wallace, Zhao is concerned with surgical systems.
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system “wherein the robotic catheter system further comprises a pre-determined guide path” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the planning system of Zhao.
As per Claim 23, the combination of Wallace, Johnson, and Zhao teaches or suggests all limitations of Claim 22. Wallace does not expressly disclose receiving movement input to automatically return the robot catheter system to the pre-determined delivery path.
See rejection of Claim 1 for discussion of teachings of Johnson.
See rejection of Claim 22 for discussion of teachings of Zhao. In one embodiment, the clinician can allow computer-controlled navigation of the interventional instrument along the suggested navigational path (¶57).
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system “receiving movement input to automatically return the robot catheter system to the pre-determined delivery path” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the planning and navigation system of Zhao.
As per Claim 24, the combination of Wallace, Johnson, and Zhao teaches or suggests all limitations of Claim 23. Wallace does not expressly disclose receiving movement input to advance the robotic catheter system along the pre-defined delivery path.
See rejection of Claim 1 for discussion of teachings of Johnson.
See rejection of Claim 22 for discussion of teachings of Zhao. In one embodiment, the interventional instrument (104) includes an interventional tool (228) that is advanced to perform a surgical procedure (Figs. 3-4; ¶49, 53).
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system “receiving movement input to advance the robotic catheter system along the pre-defined delivery path” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the surgical system of Zhao.
As per Claim 25, the combination of Wallace, Johnson, and Zhao teaches or suggests all limitations of Claim 23. Wallace does not expressly disclose receiving movement input to backtrack the robotic catheter system along the pre-defined delivery path.
See rejection of Claim 1 for discussion of teachings of Johnson.
See rejection of Claim 22 for discussion of teachings of Zhao. In one embodiment, the interventional instrument (104) includes an interventional tool (228) that is retracted when the surgical procedure is complete (Figs. 3-4; ¶49, 53).
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system “receiving movement input to backtrack the robotic catheter system along the pre-defined delivery path” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the surgical system of Zhao.
As per Claim 26, the combination of Wallace, Johnson, and Zhao teaches or suggests all limitations of Claim 22. Wallace does not expressly disclose wherein the robotic catheter system further comprises a pre-determined removal path.
See rejection of Claim 1 for discussion of teachings of Johnson.
See rejection of Claim 22 for discussion of teachings of Zhao. In one embodiment, the interventional instrument (104) includes an interventional tool (228) that is retracted when the surgical procedure is complete (Figs. 3-4; ¶49, 53).
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system “wherein the robotic catheter system further comprises a pre-determined removal path” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the surgical system of Zhao.
As per Claim 27, the combination of Wallace, Johnson, and Zhao teaches or suggests all limitations of Claim 26. Wallace does not expressly disclose wherein at least a portion of the pre-determined removal path is normal to the cardiac valve annulus so as to clear a released cardiac valve implant.
See rejection of Claim 1 for discussion of teachings of Johnson.
See rejection of Claim 22 for discussion of teachings of Zhao. In one embodiment, the interventional instrument (104) includes an interventional tool (228) that is retracted when the surgical procedure is complete (Figs. 3-4; ¶49, 53).
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system “wherein at least a portion of the pre-determined removal path is normal to the cardiac valve annulus so as to clear a released cardiac valve implant” in that the system of Wallace that performs operations relative to the annulus of mitral valve leaflets (441, 443) would be adapted to include display functionality as per Johnson features and further adapted to include features of the surgical system of Zhao.
As per Claim 29, Wallace discloses a system comprising:
an interface (as per “user interface” in ¶40) for communicating with a robotic catheter (101, 103; 603, 613, 601; 703, 713, 701), wherein the robotic catheter (101, 103; 603, 613, 601; 703, 713, 701) is adapted for delivery of a cardiac valve implant (as per “replacement heart valves” in ¶22; as per “mitral valve replacement 555” in ¶34) disposed on a distal end of the robotic catheter (101, 103; 603, 613, 601; 703, 713, 701) to a cardiac valve annulus (as per “native valve 107” in ¶27; as per “delivery device 101 centered in the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33) (Figs. 1-2, 6-7; ¶22-33, 36, 38-41);
one or more processors (as per “computer controlled” in ¶38); and
a non-transitory computer-readable storage medium (as per “robotic control systems” in ¶39) that stores instructions (as per “pre-programmed sequence” in ¶39), and operations of:
providing a visualization-based (as per “ultrasound image is taken down the longitudinal axis 124” in ¶27) and anatomical-based reference frames (as per “x-ray image is taken down the plane 122 of mitral valve 107” in ¶27) (Figs. 1-2, 3, 6-7; ¶22-33, 36, 38);
receiving angle information (as per “the user can input the angles of the first imaging modality (e.g., the x-ray sensor 150a,b) into the control system” in ¶41) regarding the imaging system (as per “x-ray sensor 150a,b” in ¶27; as per visualization from a live image source like … fluoroscopy” in ¶5) to align the robotic catheter system (101, 103; 603, 613, 601; 703, 713, 701) to an imaging system (as per “x-ray sensor 150a,b” in ¶27; as per visualization from a live image source like … fluoroscopy” in ¶5) (Figs. 1-2, 6-7; ¶22-33, 36, 38-41);
receiving a movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) from a user (as per “the robotic arm 703 can include a user interface” in ¶40) relative to reference frame (as per “ultrasound image is taken down the longitudinal axis 124” in ¶27, as per “x-ray image is taken down the plane 122 of mitral valve 107” in ¶27) (Figs. 1-2, 5A, 7; ¶22-34, 38-43);
calculating a movement target (as per “the arm 703 can follow the user’s input to move in or out” in ¶43) based on the movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) wherein linear movement input (as per “the user can make an input to the robotic control system of the robotic arm 703 that places the arm 703 in a mode where the delivery device is allowed to move” in ¶43) is translated into device inputs corresponding to compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) aligned along an axis (124, 122) of the reference frame (as per “ultrasound image is taken down the longitudinal axis 124” in ¶27, as per “x-ray image is taken down the plane 122 of mitral valve 107” in ¶27) (Figs. 1-2, 5A, 7; ¶22-34, 38-43); and
transmitting a signal (as per “controlled movement with a user interface” in ¶41) based on the movement target (as per “the arm 703 can follow the user’s input to move in or out” in ¶43) to the robotic catheter (101, 103; 603, 613, 601; 703, 713, 701) via the interface (as per “user interface” in ¶40) to cause the robotic catheter (101, 103; 603, 613, 601; 703, 713, 701) to actuate in accordance with the movement target (as per “the arm 703 can follow the user’s input to move in or out” in ¶43) to perform the compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) (Figs. 1-2, 5A, 7; ¶22-34, 38-43);
wherein the anatomical-based reference frame (as per “the x-ray image is taken down the plane 122 of the mitral valve 107” in ¶27) comprises device inputs corresponding to compound device motion (as per “The positioning arm 603 can include six degrees of freedom” in ¶36; as per “the arm 703 can have five to seven degrees of freedom for positioning the mitral valve delivery system” in ¶38) aligned to perpendicularity (as per 124), depth (as per “the depth of insertion of the delivery device 103 is set” in ¶34) or centrality (as per “Once the depth, angle, and centrality of the mitral valve have been set, then the valve can be deployed” in ¶35; as per “the arm 703 can follow the user’s input to move in or out” in ¶43) relative to a valve opening (as per “mitral valve orifice” in ¶28, 30, 32) of the cardiac valve annulus (s per “native valve 107” in ¶27; as per “delivery device 101 centered in the annulus between the anterior mitral valve leaflet 443 and the posterior mitral valve leaflet 441” in ¶33) (Figs. 1-2, 3, 6-7; ¶22-34, 38-43).
Wallace does not expressly disclose:
wherein the instructions, when executed by the one or more processors, cause the one or more processors to perform the operations; and
wherein a reference frame is selectable or selected.
See rejection of Claim 1 for discussion of teachings of Johnson.
Zhao discloses teleoperated interventional system (100) for use in surgical procedures that includes a manipulator assembly (102), an interventional instrument (104), a master assembly (106), a control system (116), a control device (112), and a display system (111) (Fig. 1; ¶25-29, 33). The manipulator assembly (102) operates the interventional instrument (104) in perform various procedures on the patient (P) and the master assembly (106) allows the surgeon to view the interventional site and control the manipulator assembly (102) via display system (111) and the master assembly (106) (¶25-26). The control system (116) includes at least one processor for effecting control between the manipulator assembly (102) and the master assembly (106) and a computer-readable medium storing instructions to implement control of the system (¶33). The system (100, 200) includes a navigation system (210) that determines a navigational path for the interventional instrument (104), monitors the instrument (104) as it moves through the anatomical system, and allows the clinician to modify a planned path (Fig. 2; ¶36, 52-53). In this way, the system facilitates determination of a planned instrument deployment location (¶3). Like Wallace, Zhao is concerned with surgical systems.
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system:
“wherein the instructions, when executed by the one or more processors, cause the one or more processors to perform the operations” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the planning system of Zhao; and
“wherein a reference frame is selectable or selected” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the planning system of Zhao.
As per Claim 30, the combination of Wallace, Johnson, and Zhao teaches or suggests all limitations of Claim 29. Wallace does not expressly disclose wherein the non-transitory computer-readable storage medium further stores a predetermined delivery path and stores further instructions to receive movement input and advance the robotic catheter system along the pre-defined delivery path.
See rejection of Claim 29 for discussion of teachings of Zhao. Zhao further discloses wherein the interventional instrument (104) includes an interventional tool (228) that is advanced to perform a surgical procedure (Figs. 3-4; ¶49, 53).
Therefore, from these teachings of Wallace, Johnson, and Zhao, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Johnson and Zhao to the system of Wallace since doing so would enhance the system by: aiding surgical staff with making treatment decisions; and facilitating planning. Applying the teachings of Johnson and Zhao to the system of Wallace would result in a system “wherein the non-transitory computer-readable storage medium further stores a predetermined delivery path and stores further instructions to receive movement input and advance the robotic catheter system along the pre-defined delivery path” in that the system of Wallace would be adapted to include display functionality as per Johnson features and further adapted to include features of the planning system of Zhao.
Response to Arguments
Applicant's arguments filed 24 October 2025 have been fully considered as follows.
Applicant argues that “Claims 1 and 29 have been amended to further recite control modes for both a visualization-based reference frame and an anatomical-based reference frame” (page 6 of Amendment). However, no claim recites “control modes”. Accordingly, Applicant’s assertion involves unclaimed subject matter. Therefore, Applicant’s argument does not identify a proper basis for finding that any rejection is improper.
Applicant argues that the objections should not be maintained in view of the amendments (page 6 of Amendment). This argument is persuasive. Therefore, these objections are not maintained.
Applicant argues that rejections under 35 USC 112 should not be maintained in view of the amendments (page 6 of Amendment). This argument is persuasive regarding the previous rejections. However, the amendments necessitated new rejections under 35 USC 112 presented above.
Applicant argues that rejections under 35 USC 102 should not be maintained because “claim 1 has been amended to recite selectable drive modes” (page 7 of Amendment) and “Wallace fails to disclose a visual reference frame drive mode that is independent from the anatomical reference frame drive modes” (page 7 of Amendment). However, no claim recites “selectable drive modes” or “visual reference frame drive mode that is independent from the anatomical reference frame drive modes” as per Applicant’s arguments. Accordingly, Applicant’s assertion involves unclaimed subject matter and is not clearly relevant to the rejection of any claim. Therefore, Applicant’s argument does not identify a proper basis for finding that any rejection is improper. Nevertheless, rejections under 35 USC 102 are not maintained in view of the amendments. However, the amendments necessitated the new ground(s) of rejection under 35 USC 103 presented above.
Applicant argues that rejections under 35 USC 102 should not be maintained because “Wallace does not disclose the mapping of linear inputs to the visual reference frame … only for the anatomical reference frame (page 8 of Amendment). However, no claim recites “mapping” as per Applicant’s arguments. Accordingly, Applicant’s assertion involves unclaimed subject matter and is not clearly relevant to the rejection of any claim. Therefore, Applicant’s argument does not identify a proper basis for finding that any rejection is improper. Nevertheless, rejections under 35 USC 102 are not maintained in view of the amendments. However, the amendments necessitated the new ground(s) of rejection under 35 USC 103 presented above.
Applicant argues that rejections under 35 USC 103 should not be maintained because “the Strommer references also fails to remedy the omissions of the Wallace references” (page 9 of Amendment). However, no rejection involves an assertion that Strommer discloses subject matter as per the amendments. Accordingly, Applicant’s argument is moot.
Applicant argues that rejections under 35 USC 103 should not be maintained because “Zhao also fails to remedy this omission” (page 9 of Amendment). However, no rejection involves an assertion that Zhao discloses subject matter as per the amendments. Accordingly, Applicant’s argument is moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Verard (US Pub. No. 2004/0097805) and Maschke (US Pub. No. 2010/0114308) disclose surgical systems.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/STEPHEN HOLWERDA/Primary Examiner, Art Unit 3656