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 .
Response to Amendment
The Amendment filed 05/19/26 has been entered. Claims 1, 3-5, 7, 9-12, 14, and 16-20 have been amended. Claims 1-20 are addressed in the following office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/21/26 was filed after the mailing date of the non final Office action on 02/24/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 5, 7-10, and 16-18 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Correction is required. Claim 5 is interpreted as depending from any one of claims 1-3, Claim 7 is interpreted as depending from any one of claims 1-3, Claims 8 is interpreted as depending from any one of claims 1-3, Claim 9 is interpreted as depending from any one of claims 1-3, Claim 10 is interpreted as depending from any one of claims 1-3, Claim 16 is interpreted as depending from any one of claims 11-13, Claim 17 is interpreted as depending from any one of claims 11-13, and claim 18 is interpreted as depending from any one of claims 11-13.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 20 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Concerning claim 9, applicant’s original disclosure fails to divulge “wherein each of the first, third, and fourth radiopaque markers are aligned with a respective commissure of a plurality of commissures of the prosthetic heart valve”. Applicant’s original disclosure details several embodiments with only 1 or 2 markers aligning with 1 or 2 respective commissures, not 3 markers aligning with 3 respective commissures. Hence, the limitation is considered new matter.
Concerning claim 20, applicant’s original disclosure fails to divulge “wherein each of the first, third, and fourth radiopaque markers are aligned with a respective commissure of a plurality of commissures of the prosthetic heart valve”. Applicant’s original disclosure details several embodiments with only 1 or 2 markers aligning with 1 or 2 respective commissures, not 3 markers aligning with 3 respective commissures. Hence, the limitation is considered new matter.
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 1-2, 4-6, 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, all references are cited in the previous office action.
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), and wherein the assembly includes a plurality of radiopaque markers comprising a first radiopaque marker (204) aligned with a commissure of the prosthetic heart valve (Par. 0045) and a second radiopaque marker (204) disposed on a distal end portion of the delivery apparatus [i.e. radiopaque marker on the distal portion of element 200], axially offset from the radially compressed prosthetic heart valve [i.e. the radiopaque markers on element 200 are distal to the prosthesis] (Fig. 6; 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 in the selected imaging view and one or more of the plurality of radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation; and if the one or more of the plurality of 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 the first radiopaque marker suspended within a cell of a frame of the prosthetic heart valve; and the second radiopaque marker circumferentially offset from the first radiopaque marker.
In the analogous art of stents, Lombardi teaches (Figs. 8-9) wherein a first radiopaque marker (130) suspended within a cell of a frame (140) of the prosthetic heart valve (Col. 11, lines 55-67 & Col. 12, lines 1-3). Note, the single first radiopaque marker, taught by Lombardi, can only align with a single second radiopaque marker 204, taught by Bell. Hence, the first radiopaque would be circumferentially offset from two of the markers 204, one of which is considered the claimed second radiopaque marker.
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 suspended within a cell of a frame of the prosthetic heart valve; and the second radiopaque marker circumferentially offset from the first radiopaque marker. 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 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 of the plurality of radiopaque markers in the fluoroscopic image indicates that the prosthetic heart valve is not in the desired rotational orientation, rotating the assembly until the second radiopaque marker 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 second radiopaque marker is centered along.
Lombardi teaches (Figs. 11-12) the method step of: rotating the assembly until second radiopaque marker 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 second 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 of the plurality of 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 plurality of radiopaque markers includes third and fourth radiopaque markers [i.e. two of the markers 204 in figure 6], wherein each of the first, third, and fourth radiopaque markers are aligned with a respective commissure of a plurality of commissures of the 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, and where the commissure is secured to the cell (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 7 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 Bracken et al. (US 2016/0302754).
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 where the non-coronary cusp and the left coronary cusp of the native heart valve are arranged opposite one another in the fluoroscopic image and are each overlapped by a portion of the right coronary cusp of the native heart valve.
In the same field of endeavor, which is prosthetic heart valves, Bracken teaches wherein the selected imaging view is a three-cusp imaging view where the non-coronary cusp and the left coronary cusp of the native heart valve are arranged opposite one another in the fluoroscopic image and are each overlapped by a portion of the right coronary cusp of the native heart valve (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 where the non-coronary cusp and the left coronary cusp of the native heart valve are arranged opposite one another in the fluoroscopic image and are each overlapped by a portion of the right coronary cusp of the native heart valve. Doing so would provide optimal viewing angle of the x-ray C-arm system for TAVR procedures (Par. 0057), as taught by Bracken.
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), cited in previous office action.
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, all cited in the previous office action.
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 a plurality of radiopaque markers comprising a first radiopaque marker (204) that is aligned with a commissure of the prosthetic heart valve (Par. 0045) and a second radiopaque marker (204) disposed on a distal end portion of the delivery apparatus [i.e. radiopaque marker on the distal portion of element 200], axially offset from the prosthetic heart valve [i.e. the radiopaque markers on element 200 are distal to the prosthesis] (Fig. 6; 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 one or more of the plurality of radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation; and if the one or more of the plurality of 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 the first radiopaque marker that is not directly attached to struts defining a frame of the prosthetic heart valve and the second radiopaque marker circumferentially offset from the first radiopaque marker.
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. Note, the method step of determining would be based in part on the fluoroscopic image in the cusp overlap imaging view as a result of Tangs teaching.
In the analogous art of stents, Lombardi teaches (Figs. 8-9) a first radiopaque marker (103) that 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). Note, the single first radiopaque marker, taught by Lombardi, can only align with a single second radiopaque marker 204, taught by Bell. Hence, the first radiopaque would be circumferentially offset from two markers of the second radiopaque marker.
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 that is not directly attached to struts defining a frame of the prosthetic heart valve and the second radiopaque marker circumferentially offset from the first radiopaque marker. 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 first 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 first 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 first 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 first 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 cusp 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 first 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), cited in the previous office action.
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 first radiopaque marker that is aligned with the commissure is oval-shaped.
In the analogous art of intraluminal device, Gladdish teaches wherein the first 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 first 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 Bracken et al. (US 2016/0302754), 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 a first radiopaque marker (204) on the prosthetic heart valve (Par. 204) and a second radiopaque marker (204) disposed on a distal end portion of the delivery apparatus [i.e. radiopaque marker on the distal portion of element 200], axially offset from the prosthetic heart valve [i.e. the radiopaque markers on element 200 are distal to the prosthesis] (Fig. 6; 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 one or more of the first and second radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation; and if the one or more of the first and second 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, wherein in the three-cusp imaging view the non-coronary cusp and the left coronary cusp of the native heart valve are arranged opposite one another in the fluoroscopic image and are each overlapped by a portion of the right coronary cusp of the native heart valve; and the second radiopaque marker circumferentially offset from the first radiopaque marker.
In the same field of endeavor, which is prosthetic heart valves, Bracken teaches the method step: receiving a fluoroscopic image in a three-cusp imaging view, wherein in the three-cusp imaging view the non-coronary cusp and the left coronary cusp of the native heart valve are arranged opposite one another in the fluoroscopic image and are each overlapped by a portion of the right coronary cusp of the native heart valve (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, wherein in the three-cusp imaging view the non-coronary cusp and the left coronary cusp of the native heart valve are arranged opposite one another in the fluoroscopic image and are each overlapped by a portion of the right coronary cusp of the native heart valve. Doing so would provide optimal viewing angle of the x-ray C-arm system for TAVR procedures (Par. 0057), as taught by Bracken. Note, the method step of determining would be based in part on the fluoroscopic image in the three-cusp overlap imaging view as a result of Brackens teaching.
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 discloses further comprising third and fourth radiopaque markers disposed on the prosthetic heart valve [i.e. two of the markers 204 that could be would be located on the prosthetic in addition to the markers already on the capsule in figure 6], wherein each of the first, third, and fourth radiopaque markers are aligned with a respective commissure of a plurality of commissures of the prosthetic heart valve (Par. 0045).
Allowable Subject Matter
Claim 3 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Cited prior art references fail to disclose wherein the first radiopaque marker is secured to an individual fabric attachment member that is arranged across only the cell and secured to the four angled struts. Modifying the prior art to include the missing limitations wouldn't have been obvious because the modification would only be motivated by hindsight. Furthermore, a teaching reference with this missing structure could not be found.
Response to Arguments
Applicant’s arguments, see page 9, filed 05/19/26, with respect to the rejections of claims 7 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of newly cited prior art.
Applicant's remaining arguments filed 05/19/26 have been fully considered but they are not persuasive.
Concerning claim 1, applicant argues the cited references fail to disclose or suggest, alone or in combination, at least, advancing a distal end portion of an assembly toward a native heart valve, wherein the assembly comprises a delivery apparatus and a prosthetic heart valve radially compressed around the delivery apparatus, and wherein the assembly includes a plurality of radiopaque markers comprising a first radiopaque marker suspended within a cell of a frame of the prosthetic heart valve and aligned with a commissure of the prosthetic heart valve and a second radiopaque marker disposed on a distal end portion of the delivery apparatus, axially offset from the radially compressed prosthetic heart valve and circumferentially offset from the first radiopaque marker; 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; and determining, based on the fluoroscopic image in the selected imaging view and one or more of the plurality of radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation. Examiner respectfully disagrees. Refer to the updated rejection of claims 1 above which explains how the previously cited prior art discloses the newly recited limitations.
Concerning claim 11, applicant argues the cited references fail to disclose or suggest, alone or in combination, at least, advancing a distal end portion of an assembly toward a native heart valve, wherein the assembly comprises a delivery apparatus and a prosthetic heart valve mounted on the delivery apparatus in a radially compressed configuration, wherein the assembly includes a plurality of radiopaque markers comprising a first radiopaque marker that is aligned with a commissure of the prosthetic heart valve and is not directly attached to struts defining a frame of the prosthetic heart valve and a second radiopaque marker disposed on a distal end portion of the delivery apparatus, axially offset from the prosthetic heart valve and circumferentially offset from the first radiopaque marker; receiving a fluoroscopic image in a cusp overlap imaging view of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve; and determining, based on the fluoroscopic image in the cusp overlap imaging view and one or more of the plurality of radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation. Examiner respectfully disagrees. Refer to the updated rejection of claims 11 above which explains how the previously cited prior art discloses the newly recited limitations.
Concerning claim 19, the cited references fail to disclose or suggest, alone or in combination, at least, advancing a distal end portion of an assembly toward a native heart valve, wherein the assembly comprises a delivery apparatus and a prosthetic heart valve radially compressed around the delivery apparatus, wherein the assembly includes a first radiopaque marker on the prosthetic heart valve and a second radiopaque marker disposed on a distal end portion of the delivery apparatus, axially offset from the prosthetic heart valve and circumferentially offset from the first radiopaque marker; receiving a fluoroscopic image in a three-cusp imaging view of the prosthetic heart valve on the delivery apparatus at or proximate to the native heart valve, wherein in the three-cusp imaging view the non-coronary cusp and the left coronary cusp of the native heart valve are arranged opposite one another in the fluoroscopic image and are each overlapped by a portion of the right coronary cusp of the native heart valve; and determining, based on the fluoroscopic image in the three-cusp imaging view and one or more of the first and second radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation. Examiner respectfully disagrees. Refer to the updated rejection of claims 19 above which explains how the previously cited prior art and newly cited art discloses the newly recited limitations.
Conclusion
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.
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
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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