DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group 1, species A (a capsule with two halves, Figs. 45-46) and Group 2, species A (an electrolytically detachable coupler with a ball and socket coupling, Figs. 50-53) in the reply filed on 04/23/2026 is acknowledged.
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.
Claim(s) 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harks (US 20140052241 A1), herein referenced to as “Harks” in view of Eskuri (US 20180055477 A1, herein referenced to as “Eskuri”, and Sandhu et al (US 20120158011 A1), herein referenced to as “Sandhu”.
Claim 11
Harks discloses: A delivery system guided valve replacement system (see [0006]) for delivering a medical device 80 (see [0001], delivery of a prosthetic valve and Fig. 4, [0028]) to a native heart valve within a patient's body, the delivery system guided valve replacement system comprising: a delivery apparatus 70 (see [0005] and [0056], see also [0047], insertion of catheter within the patient) configured to deliver the medical device 80 to the native heart valve (see [0051], proper positioning and orientation of the prosthetic valve during the heart valve replacement procedure) within the patient's body, the delivery apparatus 70 including an elongate shaft 70 (a catheter is an elongate shaft) configured to retain (see [0047], [0051], and [0047]) the medical device 80.
Harks does not explicitly disclose: a nose cone positioned distal to the elongate shaft; one or more sensors positioned on the nose cone and configured to sense a spatial relationship between the nose cone and an inner wall of the patient's vasculature; at least one motor configured to deflect the elongate shaft within the patient's vasculature; and a processor configured to control the at least one motor to deflect the elongate shaft within the patient's vasculature based on signals from the one or more sensors of the spatial relationship between the nose cone and the inner wall of the patient's vasculature while the elongate shaft is continuing to be advanced through the patient's vasculature.
However, Eskuri in a similar field of invention teaches a delivery system 100 (see Figs. 1A-2B) for a medical device 120 (see Figs. 1A-2B) with an elongate shaft 104 (see Figs. 1A-2B). Eskuri further teaches: a nose cone 105 (see Figs. 1A-2B, [0012]) positioned distal to the elongate shaft 104; one or more sensors 207 (see Figs. 1A-2B, [0020]-[0021]) positioned on the nose cone 105 and configured to sense a spatial relationship between the nose cone 105 and an inner wall of the patient's vasculature (see [0006] and [0019]-[0021], image resolution, which displays the spatial relationship between 105 and the patient’s vasculature).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Harks to incorporate the teachings of Eskuri and teach a delivery system for a medical device with a nose cone positioned distal to the elongate shaft; one or more sensors positioned on the nose cone and configured to sense a spatial relationship between the nose cone and an inner wall of the patient's vasculature. Motivation for such can be found in Eskuri as this allows for imaging from inside the patient to provide internal images of the heart during the procedure of valve replacement (see [0004] and [0005]).
The combination of Harks and Eskuri does not explicitly teach: at least one motor configured to deflect the elongate shaft within the patient's vasculature; and a processor configured to control the at least one motor to deflect the elongate shaft within the patient's vasculature based on signals from the one or more sensors of the spatial relationship between the nose cone and the inner wall of the patient's vasculature while the elongate shaft is continuing to be advanced through the patient's vasculature.
However, Sandhu in a similar field of invention teaches a delivery system with an elongate shaft the elongate shaft of 406 of a delivery apparatus 406 (see Figs. 3A-3B) with extending the shaft within a patient’s vasculature (see [0049], within the vasculature of a patient) with one or more sensors (see [0054]-[0055], proximity sensors on the catheter). Sandhu further teaches: at least one motor 304 + 312 (see Figs. 3A-3B, [0040], electric motor driven lead screw) configured to deflect the elongate shaft the elongate shaft of 406 (see [0039]) within the patient's vasculature; and a processor (see [0054], automatically implement response actions such as to alter device speed or alternatively cut power to the RCGS motors, see also [0026], RGCS controls translation and distal bending and virtual rotation of a catheter) configured to control the at least one motor 304 + 312 to deflect the elongate shaft the elongate shaft of 406 within the patient's vasculature (see [0077] and [0095], changing catheter deflection when entering a yellow proximity zone) based on signals from the one or more sensors (see [0054]-[0055], proximity sensors on the catheter)of the spatial relationship between the catheter (see [0054]-[0055], distance to nearest body tissue) and the inner wall of the patient's vasculature (see [0077] and [0095]) while the elongate shaft is continuing to be advanced (see [0077] and [0095]) through the patient's vasculature (see [0077] and [0095]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Harks and Eskuri to incorporate the teachings of Sandhu and have a method for deployment of a prosthetic replacement heart valve with a robotic control via a catheter have a method of controlling the catheter to bend through the feedback of sensors to avoid contacting the surface of the patient’s vasculature. Motivation for such can be found in Sandhu as this control system with control of the motors that control the pull wires that control the catheters can ensure the location of the catheter is always kept at a prudently safe distance from any unexpected anatomical structure and to do so automatically (see [0054]).
The combination of Harks, Eskuri, and Sandhu further teaches: signals from the one or more sensors of the spatial relationship between the nose cone and the inner wall of the patient’s vasculature (Harks as combined by Eskuri has proximity sensors on the nose cone and is further modified with Sandhu to include a processor that utilizes the data from the proximity sensors to deflect the catheter with a motor to avoid the inner walls of the patient’s vasculature).
Claim 12
The combination of Harks, Eskuri, and Sandhu teaches: The delivery system of claim 11, see 103 rejection above. Sandhu further teaches: further comprising one or more pull wires independent four-wire steering control (see Fig. 4A, [0039] and [0043]) for the at least one motor 304 + 312 (see Figs. 3A-3B, [0040], electric motor driven lead screw) to operate to deflect (see [0026], [0039], and [0043]) the elongate shaft the shaft of 406 within the patient's vasculature.
Claim 15
The combination of Harks, Eskuri, and Sandhu teaches: The delivery system of claim 11, see 103 rejection above. Sandhu further teaches: wherein the processor is configured to control the at least one motor (see [0054], automatically implement response actions such as to alter device speed or alternatively cut power to the RCGS motors, see also [0026], RGCS controls translation and distal bending and virtual rotation of a catheter) to avoid or retract from the inner wall of the patient's vasculature (see [0077] and [0095], changing catheter deflection when entering a yellow proximity zone) based on the signals.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harks in view of Eskuri and Sandhu as applied to claim 11 above, and further in view of Mendelson et al (US 20170348099 A1), herein referenced to as “Mendelson”.
Claim 13
The combination of Harks, Eskuri, and Sandhu teaches: The delivery system of claim 11, see 103 rejection above. The combination of Harks, Eskuri, and Sandhu does not explicitly teach: wherein the elongate shaft includes a retractable capsule configured to retain the medical device.
However, Mendelson in a similar field of invention teaches a delivery system 120 (see Figs. 2-6) with an elongate shaft 140 (see Figs. 2-6) and a medical device 100 (see Figs. 2-6). Mendelson further teaches: wherein the elongate shaft 140 includes a retractable capsule 148 (see Figs. 2-6, [0070]) configured to retain the medical device 100 (see Figs. 2-6, [0070] and [0073]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Harks to incorporate the teachings of Mendelson and teach a delivery system with the elongate shaft includes a retractable capsule configured to retain the medical device. Motivation for such can be found in Mendelson as the capsule can assist in minimizing traumatic contact between the prosthesis/medical device and bodily structures of the patient during delivery (see [0073]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harks in view of Eskuri, Sandhu, and Mendelson as applied to claim 13 above, and further in view of Sadan (US 20190290376 A1), herein referenced to as “Sadan”.
Claim 14
The combination of Harks, Eskuri, Sandhu, and Mendelson teaches: The delivery system of claim 13, see 103 rejection above. The combination of Harks, Eskuri, Sandhu, and Mendelson does not explicitly teach: wherein the processor is configured to control the at least one motor to retract the retractable capsule.
However, Sadan in a similar field of invention teaches a delivery system for a medical device 30 + 64 (see Figs. 1A-2 and 10A-10B) with at least one motor nano motor (see [0037]) and a processor 74 (see Fig. 2, [0084]). Sadan further teaches: wherein the processor 74 is configured to control the at least one motor nano motor (see [0084], controls nano motor, [0037]) to retract the retractable capsule (see [0037], frame opening/closing, which closing is a retracting motion).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Harks, Sandhu, and Mendelson to incorporate the teachings of Sadan and teach a delivery system for delivering a medical device with the processor is configured to control the at least one motor to retract the retractable capsule. Motivation for such can be found in Sadan as this allows for control of the retractable capsule to allow for fine tuning adjustment that will prevent peri valvular leakages (see [0037]).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harks in view of Eskuri (variant interpretation) and Sandhu.
Claim 16
Harks discloses: A delivery system guided valve replacement system (see [0006]) for delivering a medical device 80 (see [0001], delivery of a prosthetic valve and Fig. 4, [0028]) to a native heart valve within a patient's body, the delivery system guided valve replacement system comprising: a delivery apparatus 70 (see [0005] and [0056], see also [0047], insertion of catheter within the patient) configured to deliver the medical device 80 to the native heart valve (see [0051], proper positioning and orientation of the prosthetic valve during the heart valve replacement procedure) within the patient's body, the delivery apparatus 70 including an elongate shaft 70 (a catheter is an elongate shaft) configured to retain (see [0047], [0051], and [0047]) the medical device 80.
Harks does not explicitly disclose: a retractable capsule configured to retain the medical device; one or more sensors positioned on the capsule and configured to sense a spatial relationship between the capsule and an inner wall of the patient's vasculature; at least one motor configured to deflect the elongate shaft within the patient's vasculature; and a processor configured to control the at least one motor to deflect the elongate shaft within the patient's vasculature based on signals from the one or more sensors of the spatial relationship between the retractable capsule and the inner wall of the patient's vasculature while the elongate shaft is continuing to be advanced through the patient's vasculature.
However, Eskuri in a similar field of invention teaches a delivery system 100 (see Figs. 1A-2B) for a medical device 120 (see Figs. 1A-2B) . Eskuri further teaches: a retractable capsule 104 (see Figs. 1A-2B, [0014], 104 meets the definition of a capsule according to the online Oxford Learners dictionary as “a small plastic container with a substance or liquid inside”, in this case 104 is a small plastic container with the implant inside, hence meeting the definition) configured to retain the medical device 120; one or more sensors 207 (see Figs. 1A-2B, [0020]-[0021]) positioned on the capsule 104 (see Figs. 1A-2B, 207 is pointed/senses towards 104, hence is positioned on 104 by sensing in that direction) and configured to sense a spatial relationship between the capsule 104 and an inner wall of the patient's vasculature (see [0006] and [0019]-[0021], image resolution, which displays the spatial relationship between 105 and the patient’s vasculature).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Harks to incorporate the teachings of Eskuri and teach a delivery system for a medical device with a retractable capsule configured to retain the medical device; one or more sensors positioned on the capsule and configured to sense a spatial relationship between the capsule and an inner wall of the patient's vasculature. Motivation for such can be found in Eskuri as this allows for imaging from inside the patient to provide internal images of the heart during the procedure of valve replacement (see [0004] and [0005]).
The combination of Harks and Eskuri does not explicitly teach: at least one motor configured to deflect the elongate shaft within the patient's vasculature; and a processor configured to control the at least one motor to deflect the elongate shaft within the patient's vasculature based on signals from the one or more sensors of the spatial relationship between the retractable capsule and the inner wall of the patient's vasculature while the elongate shaft is continuing to be advanced through the patient's vasculature.
However, Sandhu in a similar field of invention teaches a delivery system with an elongate shaft the elongate shaft of 406 of a delivery apparatus 406 (see Figs. 3A-3B) with extending the shaft within a patient’s vasculature (see [0049], within the vasculature of a patient) with one or more sensors (see [0054]-[0055], proximity sensors on the catheter). Sandhu further teaches: at least one motor 304 + 312 (see Figs. 3A-3B, [0040], electric motor driven lead screw) configured to deflect the elongate shaft the elongate shaft of 406 (see [0039]) within the patient's vasculature; and a processor (see [0054], automatically implement response actions such as to alter device speed or alternatively cut power to the RCGS motors, see also [0026], RGCS controls translation and distal bending and virtual rotation of a catheter) configured to control the at least one motor 304 + 312 to deflect the elongate shaft the elongate shaft of 406 within the patient's vasculature (see [0077] and [0095], changing catheter deflection when entering a yellow proximity zone) based on signals from the one or more sensors (see [0054]-[0055], proximity sensors on the catheter)of the spatial relationship between the catheter (see [0054]-[0055], distance to nearest body tissue) and the inner wall of the patient's vasculature (see [0077] and [0095]) while the elongate shaft is continuing to be advanced (see [0077] and [0095]) through the patient's vasculature (see [0077] and [0095]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Harks and Eskuri to incorporate the teachings of Sandhu and have a method for deployment of a prosthetic replacement heart valve with a robotic control via a catheter have a method of controlling the catheter to bend through the feedback of sensors to avoid contacting the surface of the patient’s vasculature. Motivation for such can be found in Sandhu as this control system with control of the motors that control the pull wires that control the catheters can ensure the location of the catheter is always kept at a prudently safe distance from any unexpected anatomical structure and to do so automatically (see [0054]).
The combination of Harks, Eskuri, and Sandhu further teaches: signals from the one or more sensors of the spatial relationship between the retractable capsule and the inner wall of the patient’s vasculature (Harks as combined by Eskuri has proximity sensors on the retractable capsule and is further modified with Sandhu to include a processor that utilizes the data from the proximity sensors to deflect the catheter with a motor to avoid the inner walls of the patient’s vasculature).
Claim 17
The combination of Harks, Eskuri, and Sandhu teaches: The delivery system of claim 16, see 103 rejection above. Sandhu further teaches: further comprising one or more pull wires independent four-wire steering control (see Fig. 4A, [0039] and [0043]) for the at least one motor 304 + 312 (see Figs. 3A-3B, [0040], electric motor driven lead screw) to operate to deflect (see [0026], [0039], and [0043]) the elongate shaft the shaft of 406 within the patient's vasculature.
Claim 18
The combination of Harks, Eskuri, and Sandhu teaches: The delivery system of claim 16, see 103 rejection above. Sandhu further teaches: wherein the one or more sensors comprise proximity sensors (see [0054]-[0055], proximity sensors on the catheter).
Claim 19
The combination of Harks, Eskuri, and Sandhu teaches: The delivery system of claim 16, see 103 rejection above. Eskuri further teaches: wherein the one or more sensors are configured to sense the spatial relationship between the retractable capsule 104 and the inner wall of the patient's vasculature utilizing ultrasound signals (will not be examined here due to being an optional claim limitation), echo signals (will not be examined here due to being an optional claim limitation), or visual identification (see [0006] and [0019]-[0021], image resolution, which displays the spatial relationship between 105 and the patient’s vasculature).
Claim 20
The combination of Harks, Eskuri, and Sandhu teaches: The delivery system of claim 16, see 103 rejection above. Sandhu further teaches: wherein the processor is configured to control the at least one motor (see [0054], automatically implement response actions such as to alter device speed or alternatively cut power to the RCGS motors, see also [0026], RGCS controls translation and distal bending and virtual rotation of a catheter) to avoid or retract from the inner wall of the patient's vasculature (see [0077] and [0095], changing catheter deflection when entering a yellow proximity zone) based on the signals.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, and 11-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
A method of advancing a prosthetic replacement heart valve through a patient's vasculature in an atraumatic manner, the method comprising: advancing a guide wire through the patient's vasculature and into a heart chamber; advancing an elongate shaft of a catheter through the patient's vasculature over the guide wire to deliver the prosthetic replacement heart valve to a native heart valve, the prosthetic replacement heart valve being disposed along a distal end portion of the elongate shaft, the catheter including at least one motor for deflecting the distal end portion of the elongate shaft of the catheter within the patient's vasculature with one or more pull wires during advancement through the patient's vasculature for reducing contact with an inner wall of a blood vessel, wherein one or more proximity sensors are positioned along a nose cone for sensing a lateral distance between the nose cone and the inner wall of the blood vessel, wherein the nose cone has a tapered shape and is disposed distal to the elongate shaft during advancement; providing, with a processor, control of the at least one motor to deflect the distal end portion of the elongate shaft of the catheter with the one or more pull wires while continuing to advance the elongate shaft through the patient's vasculature for steering the elongate shaft through the patient's vasculature in an atraumatic manner, wherein the at least one motor deflects the distal end portion with the one or more pull wires based on signals from the one or more proximity sensors of the lateral distance between the nose cone and the inner wall of the blood vessel while the elongate shaft of the catheter continues to be advanced, the signals provided as feedback to the processor; and radially expanding the prosthetic replacement heart valve within the native heart valve to deploy the prosthetic replacement heart valve to the native heart valve from the distal end portion of the elongate shaft of the catheter.
A delivery system for delivering a medical device to a native heart valve within a patient's body, the delivery system comprising: a delivery apparatus configured to deliver the medical device to the native heart valve within the patient's body, the delivery apparatus including an elongate shaft configured to retain the medical device; a nose cone positioned distal to the elongate shaft; one or more proximity sensors positioned on the nose cone and configured to sense a lateral distance between the nose cone and an inner wall of the patient's vasculature; at least one motor configured to deflect the elongate shaft within the patient's vasculature; and a processor configured to control the at least one motor to deflect the elongate shaft within the patient's vasculature based on signals from the one or more proximity sensors of the lateral distance between the nose cone and the inner wall of the patient's vasculature while the elongate shaft is continuing to be advanced through the patient's vasculature.
The delivery system of claim 1, further comprising one or more pull wires for the at least one motor to operate to deflect the elongate shaft within the patient's vasculature.
A method of advancing a prosthetic replacement heart valve through a patient's vasculature in an atraumatic manner, the method comprising: advancing a guide wire through the patient's vasculature and into a heart chamber; advancing an elongate shaft of a catheter through the patient's vasculature over the guide wire to deliver the prosthetic replacement heart valve to a native heart valve, the prosthetic replacement heart valve being disposed along a distal end portion of the elongate shaft, the catheter including at least one motor for deflecting the distal end portion of the elongate shaft of the catheter within the patient's vasculature with one or more pull wires during advancement through the patient's vasculature for reducing contact with an inner wall of a blood vessel, wherein one or more proximity sensors are positioned along a nose cone for sensing a lateral distance between the nose cone and the inner wall of the blood vessel, wherein the nose cone has a tapered shape and is disposed distal to the elongate shaft during advancement; providing, with a processor, control of the at least one motor to deflect the distal end portion of the elongate shaft of the catheter with the one or more pull wires while continuing to advance the elongate shaft through the patient's vasculature for steering the elongate shaft through the patient's vasculature in an atraumatic manner, wherein the at least one motor deflects the distal end portion with the one or more pull wires based on signals from the one or more proximity sensors of the lateral distance between the nose cone and the inner wall of the blood vessel while the elongate shaft of the catheter continues to be advanced, the signals provided as feedback to the processor; and radially expanding the prosthetic replacement heart valve within the native heart valve to deploy the prosthetic replacement heart valve to the native heart valve from the distal end portion of the elongate shaft of the catheter.
11. A delivery system for delivering a medical device to a native heart valve within a patient's body, the delivery system comprising:a delivery apparatus configured to deliver the medical device to the native heart valve within the patient's body, the delivery apparatus including an elongate shaft configured to retain the medical device;a nose cone positioned distal to the elongate shaft;one or more sensors positioned on the nose cone and configured to sense a spatial relationship between the nose cone and an inner wall of the patient's vasculature;at least one motor configured to deflect the elongate shaft within the patient's vasculature; and a processor configured to control the at least one motor to deflect the elongate shaft within the patient's vasculature based on signals from the one or more sensors of the spatial relationship between the nose cone and the inner wall of the patient's vasculature while the elongate shaft is continuing to be advanced through the patient's vasculature.
12. The delivery system of claim 11, further comprising one or more pull wires for the at least one motor to operate to deflect the elongate shaft within the patient's vasculature.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
2. The method of claim 1, wherein the processor provides an output that is provided as an indicator on an output device, wherein the output device comprises one or more of a display screen, a light, a speaker, or a haptic device, and wherein the indicator indicates a condition of the catheter or a condition of the patient's body.
3. The delivery system of claim 1, further comprising an output device comprising one or more of a display screen, a light, a speaker, or a haptic device, and wherein the processor is configured to provide an output that is provided as an indicator on the output device, and wherein the indicator indicates a condition of the delivery apparatus or a condition of the patient's body.
Claims 4 and 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
7. The method of claim 1, further comprising: providing an input with a control device to the processor to cause the processor to actuate at least a portion of the catheter; and adjusting the input utilizing the processor to avoid or retract from the inner wall of the blood vessel based on the signals from the one or more proximity sensors of the lateral distance between the nose cone and the inner wall of the blood vessel.
4. The delivery system of claim 1, wherein the processor is configured to control the at least one motor to avoid or retract from the inner wall of the patient's vasculature based on the signals.
15. The delivery system of claim 11, wherein the processor is configured to control the at least one motor to avoid or retract from the inner wall of the patient's vasculature based on the signals.
Claims 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
4. The method of claim 1, wherein the catheter further comprises one or more sensors on the elongate shaft that sense a condition of the patient's body comprising one or more of a blood pressure within the patient's body or a blood flow within the patient's body, and wherein the processor controls the at least one motor to deploy the prosthetic replacement heart valve to the native heart valve.
5. The delivery system of claim 1, wherein the processor is configured to control the at least one motor to deploy the medical device from the elongate shaft to the native heart valve.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 12, or 13 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
11. The method of claim 1, wherein the one or more proximity sensors sense the lateral distance between the nose cone and the inner wall of the blood vessel utilizing ultrasound signals.
12. The method of claim 1, wherein the one or more proximity sensors sense the lateral distance between the nose cone and the inner wall of the blood vessel utilizing echo signals.
13. The method of claim 1, wherein the one or more proximity sensors sense the lateral distance between the nose cone and the inner wall of the blood vessel utilizing visual identification.
6. The delivery system of claim 1, wherein the one or more proximity sensors are configured to sense the lateral distance between the nose cone and the inner wall of the patient's vasculature utilizing ultrasound signals, echo signals, or visual identification.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
5. The method of claim 1, wherein the catheter includes a handle coupled to a proximal end of the elongate shaft, and wherein the catheter comprises a self-contained unit including the processor, the at least one motor, and a power source for providing power to the processor and the at least one motor.
7. The delivery system of claim 1, further comprising a handle coupled to a proximal end of the elongate shaft, and further comprising a power source positioned within the handle and configured to provide power to the processor and the at least one motor.
Claims 8 and 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
21. The method of claim 1, wherein the one or more proximity sensors are a first one or more proximity sensors, and a second one or more proximity sensors are positioned on a retractable capsule of the elongate shaft surrounding the prosthetic replacement heart valve, the second one or more proximity sensors for sensing a distance between the distal end portion of the elongate shaft and the inner wall of the patient's vasculature.
8. The delivery system of claim 1, wherein the elongate shaft includes a retractable capsule configured to retain the medical device.
13. The delivery system of claim 11, wherein the elongate shaft includes a retractable capsule configured to retain the medical device.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
22. The method of claim 1, wherein the prosthetic replacement heart valve comprises an expandable frame and a tissue-based valve body supported by the expandable frame, wherein the tissue-based valve body provides one-way blood flow for replacing a function of the native heart valve.
10. The delivery system of claim 1, further comprising the medical device, the medical device including an expandable frame and a tissue-based valve body supported by the expandable frame.
Claims 9 and 14 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12295839 B2 in view of Sadan (US 20190290376 A1), herein referenced to as “Sadan”.
Patent no. / application # claims
Pending claims
21. The method of claim 1, wherein the one or more proximity sensors are a first one or more proximity sensors, and a second one or more proximity sensors are positioned on a retractable capsule of the elongate shaft surrounding the prosthetic replacement heart valve, the second one or more proximity sensors for sensing a distance between the distal end portion of the elongate shaft and the inner wall of the patient's vasculature.
9. The delivery system of claim 8, wherein the processor is configured to control the at least one motor to retract the retractable capsule.
14. The delivery system of claim 13, wherein the processor is configured to control the at least one motor to retract the retractable capsule.
U.S. Patent No. 12295839 B2 does explicitly teach: wherein the processor is configured to control the at least one motor to retract the retractable capsule.
However, Sadan in a similar field of invention teaches a delivery system for a medical device 30 + 64 (see Figs. 1A-2 and 10A-10B) with at least one motor nano motor (see [0037]) and a processor 74 (see Fig. 2, [0084]). Sadan further teaches: wherein the processor 74 is configured to control the at least one motor nano motor (see [0084], controls nano motor, [0037]) to retract the retractable capsule (see [0037], frame opening/closing, which closing is a retracting motion).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. 12295839 B2 to incorporate the teachings of Sadan and teach a delivery system for delivering a medical device with the processor is configured to control the at least one motor to retract the retractable capsule. Motivation for such can be found in Sadan as this allows for control of the retractable capsule to allow for fine tuning adjustment that will prevent peri valvular leakages (see [0037]).
Claims 16-18 and 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 21 of U.S. Patent No. 12295839 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because see the table below for similar language.
Patent no. / application # claims
Pending claims
A method of advancing a prosthetic replacement heart valve through a patient's vasculature in an atraumatic manner, the method comprising: advancing a guide wire through the patient's vasculature and into a heart chamber; advancing an elongate shaft of a catheter through the patient's vasculature over the guide wire to deliver the prosthetic replacement heart valve to a native heart valve, the prosthetic replacement heart valve being disposed along a distal end portion of the elongate shaft, the catheter including at least one motor for deflecting the distal end portion of the elongate shaft of the catheter within the patient's vasculature with one or more pull wires during advancement through the patient's vasculature for reducing contact with an inner wall of a blood vessel, wherein one or more proximity sensors are positioned along a nose cone for sensing a lateral distance between the nose cone and the inner wall of the blood vessel, wherein the nose cone has a tapered shape and is disposed distal to the elongate shaft during advancement; providing, with a processor, control of the at least one motor to deflect the distal end portion of the elongate shaft of the catheter with the one or more pull wires while continuing to advance the elongate shaft through the patient's vasculature for steering the elongate shaft through the patient's vasculature in an atraumatic manner, wherein the at least one motor deflects the distal end portion with the one or more pull wires based on signals from the one or more proximity sensors of the lateral distance between the nose cone and the inner wall of the blood vessel while the elongate shaft of the catheter continues to be advanced, the signals provided as feedback to the processor; and radially expanding the prosthetic replacement heart valve within the native heart valve to deploy the prosthetic replacement heart valve to the native heart valve from the distal end portion of the elongate shaft of the catheter.
21. The method of claim 1, wherein the one or more proximity sensors are a first one or more proximity sensors, and a second one or more proximity sensors are positioned on a retractable capsule of the elongate shaft surrounding the prosthetic replacement heart valve, the second one or more proximity sensors for sensing a distance between the distal end portion of the elongate shaft and the inner wall of the patient's vasculature.
16. A delivery system for delivering a medical device to a native heart valve within a patient's body, the delivery system comprising: a delivery apparatus configured to deliver the medical device to the native heart valve within the patient's body, the delivery apparatus including an elongate shaft having a retractable capsule configured to retain the medical device; one or more sensors positioned on the retractable capsule and configured to sense a spatial relationship between the retractable capsule and an inner wall of the patient's vasculature; at least one motor configured to deflect the elongate shaft within the patient's vasculature; and a processor configured to control the at least one motor to deflect the elongate shaft within the patient's vasculature based on signals from the one or more sensors of the spatial relationship between the retractable capsule and the inner wall of the patient's vasculature while the elongate shaft is continuing to be advanced through the patient's vasculature.
17. The delivery system of claim 16, further comprising one or more pull wires for the at least one motor to operate to deflect the elongate shaft within the patient's vasculature.
18. The delivery system of claim 16, wherein the one or more sensors comprise proximity sensors.
20. The delivery system of claim 16, wherein the processor is configured to control the at least one motor to avoid or retract from the inner wall of the patient's vasculature based on the signals.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kostrzewski et al (US 20180263714 A1) teaches robotic navigation of a surgical systems using spatial sensing
Salahieh et al (US 20090054969 A1) teaches a delivery system for a valve device
Strommer et al (US 20050197557 A1) teaches automatic guiding of a distal end of a guidewire
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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