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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first layer of valve flap material” and “second layer of valve flap material” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Based on the applicant’s arguments regarding these limitations, the depiction and proper antecedent basis of the terms are necessary for understanding of the invention.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 1-7, 10-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andrea (WO2022/046588A1).
In regard to claim 1, Andrea discloses a replacement heart valve (heart valve 704; fig 35B) adapted to be implanted at an implantation site, the replacement heart valve (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 replacement heart valve (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.
Andrea 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 2, Andrea discloses the replacement heart valve of claim 1, and further discloses the radiopaque indicator 700 is visible under fluoroscopy, and thus able to indicate orientation of the replacement heart valve, while the replacement heart valve (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 replacement heart valve of claim 1, and further discloses the radiopaque indicator 700 is visible under fluoroscopy, and thus able to indicate orientation of the replacement heart valve, after replacement heart valve has been at least partially deployed from the delivery device. [0050-0051; 0252; Figure 34]
In regard to claim 4, Andrea discloses the replacement heart valve 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 replacement heart valve 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 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 7, Andrea discloses the replacement heart valve of claim 1, and further discloses the radiopaque indicator 700 comprises tantalum. [0305]
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 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)
However, Andrea 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 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 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]
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(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 valve material. [0053: valve, skirt and leaflets (therefore entire valve structure) can comprise bovine; pericardial tissue]
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].
Further, since the material of Kuetting becomes part of the valve of Andrea, the bovine material becomes bovine valve material through its use.
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
Response to Arguments
In regard to the 102(a)(1) rejection of claims 1-5, 7-8, 12-14 and 16-18 as anticipated by Andrea (WO2022/046588A1), the applicant’s arguments have been fully considered. The applicant states that claim 1 has been amended to include the features of claims 8-9. The applicant argues that 744 is not a layer of valve flap material and that the indicator is not secured to the flaps. [0350] states that 744 is an elongate flap. The paragraph further states that sutures are used to secure the commissure tabs of the adjacent leaflets to the attachment member 746. These are flaps attached to the valve itself and therefore valve flap material under the broadest reasonable interpretation. It is unclear if the applicant is trying to claim leaflets instead of valve flaps or try to claim use of the same material? It is suggested to clarify the claim language.
In regard to the 103(a) rejection of claims 6, 9-11 and 15 as unpatentable over Andrea, no further arguments have been presented.
In regard to the 103(a) rejection of claims 6, 9-11 and 15 as unpatentable over Andrea in view of Kuetting (2021/0236282A1), no further arguments have been presented.
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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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