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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-8, 12-14, 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrea (WO2022/046588A1).
In regard to claim 1, Andrea discloses an implantable medical device (heart valve 704) adapted to be implanted at an implantation site, the implantable medical device (heart valve 704) capable of being implanted in more than one rotational orientation (round, therefore capable of being rotated to implant in multiple orientations), the implantable medical device (heart valve 704) comprising:
an expandable body (stent 710) that is adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment [0003-0004: valve is expanded, radially expanded];
and a radiopaque indicator 700 disposed relative to the expandable body (stent 710) (see fig 35A), the radiopaque indicator 700 adapted to have a first appearance if viewed in a first rotational orientation and a second, different appearance if viewed in a second rotational orientation that is different from the first rotational orientation. This limitation is interpreted as best understood to mean the marker is not symmetrical. As shown in figure 35A, the indicator is not symmetrical and will have a different appearance depending on which orientation the indicator is viewed in.
In regard to claim 2, Andrea discloses the implantable medical device of claim 1, and further discloses the radiopaque indicator 700 is visible under fluoroscopy, and thus able to indicate orientation of the implantable medical device, while the implantable medical device (heart valve 704) remains within a delivery device being used to deliver the implantable medical device. [0050-0051:fluoroscopic image; 0252: align the marker under fluoroscopy; Figure 34]
In regard to claim 3, Andrea discloses the implantable medical device of claim 1, and further discloses the radiopaque indicator 700 is visible under fluoroscopy, and thus able to indicate orientation of the implantable medical device, after the implantable medical device has been at least partially deployed from the delivery device. [0050-0051; 0252; Figure 34]
In regard to claim 4, Andrea discloses the implantable medical device of claim 1, and further discloses the radiopaque indicator 700 comprises a shape emulating an alphanumeric character. (35A: lowercase ‘e’)
In regard to claim 5, Andrea discloses the implantable medical device of claim 4, and further discloses the radiopaque indicator 700 comprises a shape emulating an alphanumeric character when viewed from a front of the shape (figure 35A, lowercase ‘e’) and appears as an asymmetric mirror image of the alphanumeric character when viewed from a back of the shape. Viewing from the reverse would be a mirror image. Figures 35A-B [0293: mirror images in two orientations]
In regard to claim 7, Andrea discloses the implantable medical device of claim 1, and further discloses the radiopaque indicator 700 comprises tantalum. [0305]
In regard to claim 8, Andrea discloses the implantable medical device of claim 1, and further discloses the medical device comprising a replacement heart valve. 704 (fig 35B)
In regard to claim 12, Andrea discloses a replacement cardiac valve 704 adapted to be implanted within a native cardiac valve annulus [0006], the replacement cardiac valve 704 capable of being implanted in more than one rotational orientation (since the valve is round, capable of being implanted in more than one rotational orientation), the replacement cardiac valve 704 comprising:
an expandable body (710, stent) that is adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, [0003-0004: valve is expanded, radially expanded];
the expandable body 710 including a plurality of replacement valve commissure posts 712;
a valve material 716 secured relative to the plurality of replacement valve commissure posts 712, with the valve material 716 forming a valve cusp (716 is a cusp or leaflet [0310]) between each of the plurality of replacement valve commissure posts 712;
and a radiopaque indicator 700 disposed relative to one of the plurality of replacement valve commissure posts 712, the radiopaque indicator 700 adapted to provide an indication of a rotational orientation of the replacement cardiac valve relative to the native cardiac valve annulus. (figure 35A, since the indicator is asymmetric it will provide an orientation depending how the indicator is viewed)
In regard to claim 13, Andrea discloses the replacement cardiac valve of claim 12, and further discloses the native cardiac valve comprises an aortic valve 202 [0188];
the replacement cardiac valve 704 comprises a replacement aortic valve [0309: similar to valve 10 of figure 1; [0184: figure 1, aortic valve];
and the radiopaque indicator 700 is adapted to provide an indication of a relative position of each of the plurality of commissure posts 712 relative to coronary arteries proximate the native aortic valve annulus. (figure 35A; the indicator 700 is asymmetric and will therefore be capable of providing orientations of the valve and posts relative to any anatomy nearby)
In regard to claim 14, Andrea discloses the replacement cardiac valve of claim 12, and further discloses the radiopaque indicator 700 is secured relative to the valve material 716. (figure 35A-B, secured using material 706)
In regard to claim 16, Andrea discloses the replacement cardiac valve of claim 12, and further discloses the radiopaque indicator 700 is positioned such that the radiopaque indicator 700 is visible under fluoroscopy before and during deployment of the replacement cardiac valve. [0050-0051; figures 34A-B]
In regard to claim 17, Andrea discloses the replacement cardiac valve of claim 12, and further discloses the radiopaque indicator 700 comprises a shape emulating an alphanumeric character when viewed from a position in front of the shape (lowercase ‘e’ as shown in figures 35A-B) and appears as an asymmetric mirror image of the alphanumeric character when viewed from a position behind the shape. A lowercase ‘e’ should be an asymmetric mirror image when viewed from behind. [0322; 0341: reflection asymmetric along an axis]
In regard to claim 18, Andrea discloses the replacement cardiac valve of claim 17, and further discloses the shape comprises one of a "C" shape [0293], an "B" shape, an "F" shape, a "J" shape, a "K" shape, an "L" shape, a "P" shape, an "R" shape, or a "Z" shape.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6, 9-11, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andrea (WO2022046588A1).
In regard to claim 6, Andrea meets the claim limitations as discussed in the rejection of claim 4, but does not teach in the embodiment of figure 35A-B that the radiopaque indicator comprises a rectilinear cross-sectional profile.
In the embodiment shown in figures 33 and 34A-B, the radiopaque indicator 650 comprises a rectilinear cross-sectional profile (see figures 34A-B).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the indicator of figures 33, 34A-B in the embodiment of figure 35A-B through functional substitution since it appears either indicator would work equally well. MPEP 2144.06II
In regard to claim 9, Andrea meets the claim limitations as discussed in the rejection of claim 8, but does not teach the two layers of flap material in the embodiment of figure 35A.
In the embodiment of figure 101A, Andrea teaches the replacement heart valve 704 comprises a first layer of valve flap material 746 and a second layer of valve flap material 744,
and the radiopaque indicator 750 is secured to the first layer 746 and/or the second layer 744 of valve flap material. (Figures 101A-C; [0352-0354]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the suturing method and flaps of the embodiment of figure 101A in the embodiment of figure 35A because this simplifies the process of assembly of the heart valve, saving time and assembly costs [0357].
In regard to claim 10, Andrea meets the claim limitations as discussed in the rejection of claim 9.
In the embodiment of figure 35A, Andrea does not teach suturing the radiopaque indicator to the first or second layer of flap material.
However, in the embodiment of figure 101A, Andrea teaches the radiopaque indicator 750 is sutured to the first layer 746 and/or the second layer 744 of valve flap material. (figure 101A; [0352-0354]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the suturing method and flaps of the embodiment of figure 101A in the embodiment of figure 35A because this simplifies the process of assembly of the heart valve, saving time and assembly costs [0357].
In regard to claim 11, Andrea meets the claim limitations as discussed in the rejection of claim 9, but in the embodiment of figure 35A, does not teach the indicator is disposed between the first and second layer of valve flap material.
In the embodiment of figure 101A, Andrea teaches the radiopaque indicator 750 is disposed between the first layer of valve flap material 746 and the second layer of valve flap material 744.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the suturing method and flaps of the embodiment of figure 101A in the embodiment of figure 35A because this simplifies the process of assembly of the heart valve, saving time and assembly costs [0357].
In regard to claim 15, Andrea meets the claim limitations as discussed in the rejection of 12, but in the embodiment of figures 35A-B does not teach the indicator is sutured to the valve material.
In the embodiment of figure 101A, Andrea teaches the radiopaque indicator 750 is sutured to the valve material and/or one of the replacement valve commissure posts. [0317: marker can be sutured to different attachment members; 0324: marker 750 can be sewn; 0326: sewn to the struts]
Claim(s) 19- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andrea (WO2022046588A1) in view of Kuetting (2021/0236282A1).
In regard to claim 19, Andrea discloses a replacement aortic valve 704 adapted to be implanted within a native aortic valve having a plurality of native commissures, [0184]
the replacement aortic valve 704 capable of being implanted in more than one rotational orientation (round, therefore capable of being rotated for implantation), the replacement aortic valve 704 comprising:
an expandable body (710, stent) that is adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment, [0003-0004: valve is expanded, radially expanded];
the expandable body 710 including a plurality of replacement valve commissure posts 702;
a first layer of a valve material 746 disposed on a first side of the plurality of replacement valve commissure posts [0337-0349; attaches to struts 712];
a second layer of a valve material 744 disposed on a second side of the plurality of replacement valve commissure posts [0337-0349; attaches to struts 712];
and a radiopaque indicator 750 disposed between the first layer of bovine material 746 and the second layer of bovine material 744, (see fig 101A) the radiopaque indicator 750 adapted to provide an indication of a rotational orientation of the replacement aortic valve relative to the native aortic valve. (figures 101A; asymmetric therefore will provide an indication of rotational orientation relative to any anatomy).
However, while Andrea teaches the leaflets may be bovine [0170], Andrea remains silent to the material of the first and second layers.
Kuetting teaches the first and second layers are bovine. [0053: valve, skirt and leaflets (therefore entire valve structure) can comprise bovine]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the first and second layers as bovine as taught by Kuetting because the material is biocompatible and allows efficient force distribution [0053].
In regard to claim 20, Andrea meets the claim limitations as discussed in the rejection of claim 19, and further teaches the radiopaque indicator 750 comprises tantalum. [0305]
Andrea further teaches that the indicator can be shaped as a letter of the alphabet [0321: shaped as a letter of the alphabet] but does not specifically teach the letter is an “L” shape.
It appears that specifically choosing the letter “L” is no more than design choice, with any asymmetric letter working equally well. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use an “L” shape instead of an “e” shape. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04I
Further, patentable novelty cannot be principally predicated on mere printed matter and arrangements thereof, but must reside basically in physical structure. See MPEP 2111.05
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774