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 .
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.
Claims 1-6 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2015/0209140), in view of Lombardi et al. (US 5,824,042) and Rowe et al. (US 2009/0319037) in the alternative.
Regarding claim 1, an invention relating to prosthetic heart valves, Bell discloses (Fig. 6) a method comprising: advancing a distal end portion of an assembly toward a native heart valve (Par. 0045), wherein the assembly comprises a delivery apparatus [i.e. transluminal delivery tools] and a prosthetic heart valve (20) radially compressed around the delivery apparatus (Par. 0045), wherein the assembly includes one or more radiopaque markers (204), and wherein a first radiopaque marker of the one or more radiopaque markers is aligned with a commissure of the prosthetic heart valve (Par. 0045); receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve (Par. 0045); determining, based on the fluoroscopic image and one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation; and if the one or more radiopaque markers in the fluoroscopic image indicates that the prosthetic heart valve is not in the desired rotational orientation, rotating the assembly until the prosthetic heart valve is in the desired rotational orientation [i.e. aligning the markers with native commissures] (Par. 0045). However, Bell fails disclose wherein a first radiopaque marker of the one or more radiopaque markers is suspended within a cell of a frame of the prosthetic heart valve.
In the analogous art of stents, Lombardi teaches (Figs. 8-9) wherein a first radiopaque marker (130) of the one or more radiopaque markers is suspended within a cell of a frame (140) of the prosthetic heart valve (Col. 11, lines 55-67 & Col. 12, lines 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have wherein a first radiopaque marker of the one or more radiopaque markers is suspended within a cell of a frame of the prosthetic heart valve. Doing so would provide imagable bodies that are clearly visible when the prosthesis is deployed, and can also be sized to produce distinct images even when the frame is compressed within a delivery catheter, but will not interfere with the radial expansion of the frame during deployment (Abstract), as taught by Lombardi.
In the alternative and in the same field of endeavor, which is prosthetic heart valves, Rowe teaches receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve (Par. 0071).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have the method step of: receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve. Doing so would allow monitoring of the position of the guide catheter and the support stent relative to the aortic valve, as well as the position of other elements of the system (Par. 0071), as taught by Rowe.
Regarding claim 2, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of claim 1. Bell discloses (Fig. 3) wherein a cell (40) is defined by four angled and interconnected struts (72-78) of the frame (Par. 0024 & 0034).
Regarding claim 3, Bell, as modified by Lombardi and Rowe in the alternative, discloses wherein the first radiopaque marker is secured to a fabric attachment member that is arranged across the cell [i.e. element 132, see Lombardi figure 8; column 11, lines 55-67; and column 12, lines 1-3].
Regarding claim 4, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of any one of claims 1-3. Bell further discloses wherein rotating the assembly includes, if the one or more radiopaque markers in the fluoroscopic image indicates that the prosthetic heart valve is not in the desired rotational orientation, rotating the assembly until one of the one or more radiopaque markers is centered (Par. 0045). However, Bell fails further disclose a guidewire extending through a shaft of the delivery apparatus, which the rotating assembly with the one of the one or more radiopaque markers is centered along.
Lombardi teaches (Figs. 11-12) the method step of: rotating the assembly until one of the one or more radiopaque markers is centered along a guidewire (134) extending through a shaft of the delivery apparats (Col. 12, lines 48-53).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have a guidewire extending through a shaft of the delivery apparatus, which the rotating assembly with the one of the one or more radiopaque markers is centered along. Doing so would provide imagable bodies that are clearly visible when the prosthesis is deployed, and can also be sized to produce distinct images even when the frame is compressed within a delivery catheter, but will not interfere with the radial expansion of the frame during deployment (Abstract), as taught by Lombardi.
Regarding claim 5, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of any one of claims 1-4. Bell discloses further comprising, once the one or more radiopaque markers in the fluoroscopic image indicates that the prosthetic heart valve is in the desired rotational orientation, radially expanding and implanting the prosthetic heart valve in the native heart valve such that commissures of the prosthetic heart valve are aligned with commissures of the native heart valve (Abstract & Par. 0045).
Regarding claim 6, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of claim 5. Bell further discloses wherein radially expanding and implanting the prosthetic heart valve in the native heart valve includes inflating a balloon of the delivery apparatus to radially expand the prosthetic heart valve (Par. 0025).
Regarding claim 9, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of any one of claims 1-8. Bell further discloses (Fig. 6) wherein the one or more radiopaque markers includes the first radiopaque marker and a second radiopaque marker that is disposed on a distal end portion of the delivery apparatus [i.e. the capsule (200)], offset from the radially compressed prosthetic heart valve (Par. 0045).
Regarding claim 10, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of any one of claims 1-9. Bell further discloses wherein the first radiopaque marker is secured to the commissure of the prosthetic heart valve (Par. 0045). However, Bell fails to disclose the first radiopaque marker is secured with one or more stitches.
Lombardi further teaches the first radiopaque marker is secured to the fabric of the prosthetic device with one or more stitches (Col. 11, lines 55-58).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have the first radiopaque marker is secured with one or more stitches. Doing so would provide imagable bodies that are clearly visible when the prosthesis is deployed, and can also be sized to produce distinct images even when the frame is compressed within a delivery catheter, but will not interfere with the radial expansion of the frame during deployment (Abstract), as taught by Lombardi.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2015/0209140), in view of Lombardi et al. (US 5,824,042) and Rowe et al. (US 2009/0319037) in the alternative, as applied to claim 5 above, and further in view of Bishop et al. (US 2011/0144690).
Regarding claim 7, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of any one of claims 1-6. Bell fails to disclose wherein the selected imaging view is a three-cusp imaging view.
In the same field of endeavor, which is prosthetic heart valves, Bishop teaches wherein the selected imaging view is a three-cusp imaging view (Par. 0057).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell, in view of Lombardi and Rowe in the alternative, to have wherein the selected imaging view is a three-cusp imaging view. Doing so would provide optimal viewing angle of the x-ray C-arm system for TAVR procedures (Par. 0057), as taught by Bishop.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2015/0209140), in view of Lombardi et al. (US 5,824,042) and Rowe et al. (US 2009/0319037) in the alternative, as applied to any one of claims 1-6 above, and further in view of Tang et al. (“Cusp-Overlap” View Simplifies Fluoroscopy-Guided Implantation of Self-Expanding Valve in Transcatheter Aortic Valve Replacement. J Am Coll Cardiol Intv. 2018 Aug, 11 (16) 1663–1665).
Regarding claim 8, Bell, as modified by Lombardi and Rowe in the alternative, discloses the method of any one of claims 1-6. Bell fails disclose wherein the selected imaging view is a cusp overlap view where the right coronary cusp and the left coronary cusp of the native heart valve overlap one another in the fluoroscopic image.
In the same field of endeavor, which is prosthetic heart valves, Tang teaches wherein the selected imaging view is a cusp overlap view where the right coronary cusp and the left coronary cusp of the native heart valve overlap one another in the fluoroscopic image (Pg. 1665, para. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell, in view of Lombardi and Rowe in the alternative, to have wherein the selected imaging view is a cusp overlap view where the right coronary cusp and the left coronary cusp of the native heart valve overlap one another in the fluoroscopic image. Doing so would simplify fluoroscopy-guided implantation of self-expanding valve (Tittle & Pg. 1665, para. 4), as taught by Tang.
Claims 11-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2015/0209140), in view of Tang et al. (“Cusp-Overlap” View Simplifies Fluoroscopy-Guided Implantation of Self-Expanding Valve in Transcatheter Aortic Valve Replacement. J Am Coll Cardiol Intv. 2018 Aug, 11 (16) 1663–1665), Lombardi et al. (US 5,824,042), and Rowe et al. (US 2009/0319037) in the alternative.
Regarding claim 11, an invention relating to prosthetic heart valves, Bell discloses (Fig. 6) a method comprising: advancing a distal end portion of an assembly toward a native heart valve (Par. 0045), wherein the assembly comprises a delivery apparatus [i.e. transluminal delivery tools] and a prosthetic heart valve (20) mounted on the delivery apparatus in a radially compressed configuration (Par. 0045), wherein the assembly includes one or more radiopaque markers (204), and wherein one radiopaque marker of the one or more radiopaque markers is aligned with a commissure of the prosthetic heart valve (Par. 0045); receiving a fluoroscopic image of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve (Par. 0045); determining, based on the fluoroscopic image and the one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation; and if the one or more radiopaque markers in the fluoroscopic image indicates that the prosthetic heart valve is not in the desired rotational orientation, rotating the assembly until the prosthetic heart valve is in the desired rotational orientation [i.e. aligning the markers with native commissures] (Par. 0045). However, Bell fails to disclose the method of: receiving a fluoroscopic image in a cusp overlap imaging view; and wherein one radiopaque marker of the one or more radiopaque markers is not directly attached to struts defining a frame of the prosthetic heart valve.
In the same field of endeavor, which is prosthetic heart valves, Tang teaches a method of: receiving a fluoroscopic image in a cusp overlap imaging view (Pg. 1665, para. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have the method of: receiving a fluoroscopic image in a cusp overlap imaging view. Doing so would simplify fluoroscopy-guided implantation of self-expanding valve (Tittle & Pg. 1665, para. 4), as taught by Tang.
In the analogous art of stents, Lombardi teaches (Figs. 8-9) wherein one radiopaque marker of one or more radiopaque markers (103) is not directly attached to struts defining a frame (140) of the prosthetic heart valve (Col. 11, lines 55-67 & Col. 12, lines 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell, in view of Lombardi, to have wherein one radiopaque marker of the one or more radiopaque markers is not directly attached to struts defining a frame of the prosthetic heart valve. Doing so would provide imagable bodies that are clearly visible when the prosthesis is deployed, and can also be sized to produce distinct images even when the frame is compressed within a delivery catheter, but will not interfere with the radial expansion of the frame during deployment (Abstract), as taught by Lombardi.
In the alternative and in the same field of endeavor, which is prosthetic heart valves, Rowe teaches receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve (Par. 0071).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have the method step of: receiving a fluoroscopic image of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve. Doing so would allow monitoring of the position of the guide catheter and the support stent relative to the aortic valve, as well as the position of other elements of the system (Par. 0071), as taught by Rowe.
Regarding claim 12, Bell, as modified by Tang, Lombardi, and Rowe in the alternative, discloses the method of claim 11. Bell further discloses (Fig. 3) a cell (40) is defined by a plurality of interconnected and angled struts (72-78) of the frame of the prosthetic heart valve (Par. 0024 & 0034). However, Bell fails to disclose wherein the one radiopaque marker that is aligned with the commissure is arranged within the cell of the frame of the prosthetic heart valve.
Lombardi further teaches (Figs. 8-9) wherein the one radiopaque marker (130) is arranged within a cell of the frame (140) of the prosthetic heart valve, wherein the cell is defined by a plurality of interconnected and angled struts of the frame of the prosthetic heart valve (see annotated figure below; Col. 11, lines 55-67 & Col. 12, lines 1-3).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell, in view of Tang, Lombardi, and Rowe in the alternative, to have wherein the one radiopaque marker that is aligned with the commissure is arranged within the cell of the frame of the prosthetic heart valve. Doing so would provide imagable bodies that are clearly visible when the prosthesis is deployed, and can also be sized to produce distinct images even when the frame is compressed within a delivery catheter, but will not interfere with the radial expansion of the frame during deployment (Abstract), as taught by Lombardi.
Regarding claim 13, Bell, as modified by Tang, Lombardi, and Rowe in the alternative, discloses wherein the cell is diamond-shaped [i.e. frame 140, see Lombardi figure 8].
Regarding claim 14, Bell, as modified by Tang, Lombardi, and Rowe in the alternative, discloses wherein the one radiopaque marker is secured to an attachment member that is arranged across the cell of the frame of the prosthetic heart valve [i.e. element 132, see Lombardi figure 8; column 11, lines 55-67; and column 12, lines 1-3].
Regarding claim 15, Bell, as modified by Tang, Lombardi, and Rowe in the alternative, discloses wherein the attachment member is arranged across only the cell of the frame and is secured to the plurality of interconnected and angled struts [see Lombardi column 4, lines 54-60].
Regarding claim 17, Bell, as modified by Tang, Lombardi, and Rowe in the alternative, discloses wherein the cusp overlap imaging view is a right/left cusp overlap imaging view wherein the right coronary cups and the left coronary cusp of the native heart valve overlap one another [see Tang page 1665, paragraph 2].
Regarding claim 18, Bell, as modified by Tang, Lombardi, and Rowe in the alternative, discloses the method of any one of claims 11-17. Bell further discloses wherein the one radiopaque marker is secured to the commissure of the prosthetic heart valve (Par. 0045).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2015/0209140), in view of Tang et al. (“Cusp-Overlap” View Simplifies Fluoroscopy-Guided Implantation of Self-Expanding Valve in Transcatheter Aortic Valve Replacement. J Am Coll Cardiol Intv. 2018 Aug, 11 (16) 1663–1665), Lombardi et al. (US 5,824,042), and Rowe et al. (US 2009/0319037) in the alternative, as applied to any one of claims 11-15 above, and further in view of Gladdish, JR. et al. (US 2002/0193867).
Regarding claim 16, Bell, as modified by Tang, Lombardi, and Rowe in the alternative, discloses the method of any one of claims 11-15. Bell fails to further disclose wherein the one radiopaque marker that is aligned with the commissure is oval-shaped.
In the analogous art of intraluminal device, Gladdish teaches wherein the one radiopaque marker that is aligned with the commissure is oval-shaped (Par. 0066).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell, in view of Tang, Lombardi, and Rowe in the alternative, to have wherein the one radiopaque marker that is aligned with the commissure is oval-shaped. Doing so would provide a reduced profile without reduction in radiopacity and a reduction in the effects of galvanic corrosion (Par. 0066), as taught by Gladdish.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2015/0209140), in view of Bishop et al. (US 2011/0144690), and Rowe et al. (US 2009/0319037) in the alternative.
Regarding claim 19, an invention relating to prosthetic heart valves, Bell discloses (Fig. 6) a method comprising: advancing a distal end portion of an assembly toward a native heart valve (Par. 0045), wherein the assembly comprises a delivery apparatus [i.e. transluminal delivery tools] and a prosthetic heart valve (20) radially compressed around the delivery apparatus (Par. 0045), wherein the assembly includes one or more radiopaque markers (204), and wherein one radiopaque marker of the one or more radiopaque markers is arranged on the prosthetic heart valve (Par. 204); receiving a fluoroscopic image of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve (Par. 0045); determining, based on the fluoroscopic image and the one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation; and if the one or more radiopaque markers in the fluoroscopic image indicates that the prosthetic heart valve is not in the desired rotational orientation, rotating the assembly until the prosthetic heart valve is in the desired rotational orientation [i.e. aligning the markers with native commissures] (Par. 0045). However, Bell fails to disclose the method step: receiving a fluoroscopic image in a three-cusp imaging view.
In the same field of endeavor, which is prosthetic heart valves, Bishop teaches wherein the method step: receiving a fluoroscopic image in a three-cusp imaging view (Par. 0057).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have the method step: receiving a fluoroscopic image in a three-cusp imaging view. Doing so would provide optimal viewing angle of the x-ray C-arm system for TAVR procedures (Par. 0057), as taught by Bishop.
In the alternative and in the same field of endeavor, which is prosthetic heart valves, Rowe teaches receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve (Par. 0071).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bell to have the method step of: receiving a fluoroscopic image of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve. Doing so would allow monitoring of the position of the guide catheter and the support stent relative to the aortic valve, as well as the position of other elements of the system (Par. 0071), as taught by Rowe.
Regarding claim 20, Bell, as modified by Bishop and Rowe in the alternative, discloses the method of claim 19. Bell further discloses (Fig. 6) wherein another one of the one or more radiopaque markers is arranged on a distal end portion [i.e. the capsule (200)] of a shaft of the delivery apparatus (Par. 0045).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771