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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claim 14 objected to because of the following informalities: “to a third inner strut plurality of inner struts” should read “to a third inner strut of the plurality of inner struts”. Appropriate correction is required.
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, 8-10, 12, 14-16, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neumann (20220257367).
With regards to claim 1, Neumann discloses a prosthetic heart valve comprising: a link (710) extending along an axial direction (FIG 29); and a radially expandable frame (702) comprising: a plurality of struts (704) comprising a plurality of inner struts (inner 704 in FIG 29) pivotally attached to a plurality of outer struts (outer 704 in FIG 29) at a plurality of pivot nodes (see annotated figure 29 below); a first pivot node (combination of struts with 732) of the plurality of pivot nodes (see annotated figure 29 below) pivotally connecting a first inner strut (see annotated figure 29 below) of the plurality of inner struts to a first outer strut (see annotated figure 29 below) of the plurality of outer struts (see annotated figure 29 below) at the first pivot node (combination of struts with 732, [0388]), and the first pivot node (combination of struts with 732) is attached to the link (FIG 32); and a second pivot node (combination of struts with 730) of the plurality of pivot nodes pivotally connecting a second inner strut (see annotated figure 29 below) of the plurality of inner struts to a second outer strut (see annotated figure 29 below) of the plurality of outer struts at the second pivot node (combination of struts with 730, [0387]), and the second pivot node (combination of struts with 730) is slidably connected to the link ([0389]), wherein the second pivot node (combination of struts with 730) is configured to move relative to the link along the axial direction (734, 736, [0389]).
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With regards to claim 8, Neumann discloses the prosthetic heart valve of claim 1, wherein the first pivot node comprises a first pivot pin (732) extending through an aperture of the first inner strut (see annotated figure 29 above) and an aperture of the first outer strut (see annotated figure 29 above) to pivotally connect the first inner strut to the first outer strut (FIG 29, [0383]), and the second pivot node comprises a second pivot pin (730) extending through an aperture of the second inner strut (see annotated figure 29 above) and an aperture of the second outer strut (see annotated figure 29 above) to pivotally connect the second outer strut to the second inner strut (FIG 29, [0383]).
With regards to claim 9, Neumann discloses the prosthetic heart valve of claim 8, wherein the first pivot pin (732) extends through an aperture in the link (710, FIG 32) to attach the first pivot node to the link (FIG 29).
With regards to claim 10, Neumann discloses the prosthetic heart valve of claim 8, wherein the link (712) comprises an axial slot (738) extending along the axial direction (FIG 32), and the second pivot pin extends through the axial slot to slidingly connect the second pivot node to the link (FIG 32, [0390]).
With regards to claim 12, Neumann discloses the prosthetic heart valve of claim 10, wherein the axial slot (738) is configured to lock a position of the second pivot pin within the axial slot (762, [0409], [0390]).
With regards to claim 14, Neumann discloses the prosthetic heart valve of claim 1, wherein the plurality of pivot nodes (see annotated figure 29 above) further comprises an intermediate pivot node (see annotated figure 29 above) positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut of the plurality of inner struts at the intermediate pivot node (FIG 29).
With regards to claim 15, Neumann discloses the prosthetic heart valve of claim 14, wherein the intermediate pivot node comprises an intermediate pivot pin (732) extending through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut ([0388]).
With regards to claim 16, Neumann discloses the prosthetic heart valve of claim 10, wherein the plurality of pivot nodes (see annotated figure 29 above) further comprises an intermediate pivot node (see annotated figure 29 above) positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node (FIG 29), and the intermediate pivot node is slidably connected to the link, wherein the intermediate pivot node is configured to move relative to the link along the axial direction (FIG 29, FIG 32, given that the intermediate pivot node is connected to the second pivot node and the second pivot node is configured to move relative to the link along the axial direction, the intermediate pivot node is configured to do so as well).
With regards to claim 19, Neumann discloses the prosthetic heart valve of claim 1, further comprising a plurality of leaflets (22), wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint (24) that is connected to the second pivot node (30) ([0407]), wherein the commissural joint is configured to move together with the second pivot node relative to the link (34) along the axial direction (FIG 1).
With regards to claim 20, Neumann discloses the prosthetic heart valve of claim 19, further comprising an inner skirt ([0277], [03847]) at least partially circumscribing an interior area defined by the radially expandable frame ([0277], (“mounted on the inner surface”), the plurality of leaflets (22) each comprise a margin of attachment to the inner skirt ([0277], [03847]), wherein the inner skirt is mounted relative to the radially expandable frame (“mounted on the inner surface”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (20220257367) in view of Dvorsky (20220280295).
With regards to claim 2, Neumann discloses the prosthetic heart valve of claim 1, but fails to disclose wherein each inner strut of the plurality of inner struts comprises a sinusoidal series of curved segments, and each outer strut of the plurality of outer struts comprises a sinusoidal series of curved segments.
Dvorsky discloses a prosthetic heart valve (300) with a radially expandable frame (302) and a plurality of inner and outer struts (FIG 8, [0093]). Dvorsky teaches that each inner strut of the plurality of inner struts (FIG 8, [0093]) comprises a sinusoidal series of curved segments (FIG 9, [0100]), and each outer strut of the plurality of outer struts (FIG 8, [0093]) comprises a sinusoidal series of curved segments (FIG 9, [0100]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Neumann’s prosthetic heart valve to include that each inner strut of the plurality of inner struts comprises a sinusoidal series of curved segments, and each outer strut of the plurality of outer struts comprises a sinusoidal series of curved segments, as taught by Dvorsky, in order to provide resistance against deformation during expansion or use of the valve ([0100]).
With regards to claim 3, Neumann as modified by Dvorsky discloses the prosthetic heart valve of claim 2, wherein an inflection location (328) between adjacent curved segments of the sinusoidal series of curves segments (FIG 9, [0100]) of another inner strut of the plurality of inner struts (FIG 8, [0093]) is pivotally connected to an inflection location (328) between adjacent curved segments of the sinusoidal series of curved segments (FIG 9, [0100]) of another outer strut of the plurality of outer struts (FIG 8, [0093]) at another pivot node of the plurality of pivot nodes (FIG 8).
With regards to claim 4, Neumann as modified by Dvorsky discloses the prosthetic heart valve of claim 2, wherein the radially expandable frame (302) is configured to be radially expanded to radially expanded orientation (FIG 8) where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts (FIG 8, [0100]) each face a corresponding convex surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts (FIG 8, [0100]), and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts (FIG 8, [0100]) each face a corresponding convex surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts (FIG 8, [0100]).
With regards to claim 5, Neumann as modified by Dvorsky discloses the prosthetic heart valve of claim 2, wherein the radially expandable frame (302) is configured to be radially retracted to a radially retracted orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts (FIG 8, [0100]) each face a corresponding concave surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts (FIG 8, [0100], where the structure is configured to have this orientation when retracted), and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts (FIG 8, [0100]) each face a corresponding concave surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts (FIG 8, [0100], where the structure is configured to have this orientation when retracted).
With regards to claim 6, Neumann as modified by Dvorsky discloses the prosthetic heart valve of claim 2, further comprising an outer skirt ([0277], [03847]) at least partially circumscribing an outer periphery defined by the radially expandable frame ([0277], “mounted on the outer surface”), wherein the outer skirt is mounted relative to the radially expandable frame ([0277], “mounted on the outer surface”).
With regards to claim 7, Neumann as modified by Dvorsky discloses the prosthetic heart valve of claim 6, wherein the outer skirt is directly attached to the plurality of outer struts and/or the plurality of inner struts with a plurality of sutures ([0277]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (20220257367) as applied to claim 10 above, and further in view of Gurovich (20240207046).
With regards to claim 11, Neumann discloses the prosthetic heart valve of claim 10, wherein the axial slot (738) comprises a closed slot with a first axial closed end (742) and a second axial end (opposite 742), wherein the first axial closed end (742) is axially positioned between the second axial end (opposite 742) and the first pivot node (732, FIG 32). Neumann fails to disclose a second axial closed end. In an alternate embodiment, Neumann teaches that the axial slot (738) can have any of various shapes.
Gurovich also discloses a prosthetic heart valve (100) with support members (120) and axial slots (164). Gurovich teaches that both the first and second axial ends of the axial slot are closed (FIG 3, [0093]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Neumann’s prosthetic heart valve to include a second axial closed end, as taught by Gurovich, in order to contain portions of the valvular structure ([0093]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Neumann (20220257367).
With regards to claim 13, Neumann discloses the prosthetic heart valve of claim 10, but fails to disclose wherein the axial slot (738) comprises at least one protrusion defining a seat to lock the second pivot pin (730) within the seat. In an alternate embodiment, Neumann discloses the axial slot (738) comprises at least one protrusion (820) defining a seat to lock the second pivot pin (730) within the seat (FIG 49). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Neumann’s prosthetic heart valve to include that the axial slot comprises at least one protrusion defining a seat to lock the second pivot pin within the seat, as taught by the alternative embodiment, in order to prevent further movement ([0431]).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neumann (20220257367) as applied to claim 16 above, and further in view of Schmid (20100211159).
With regards to claim 17, Neumann discloses that prosthetic heart valve of claim 16, wherein the intermediate pivot node (see annotated figure 29 above) comprises an intermediate pivot pin (see annotated figure 29 above), but fails to disclose that it is extending through the axial slot to slidingly connect the intermediate pivot node to the link.
Schmid discloses an expandable stent (FIG 22) with a link (30d1) and an axial slot (44d1). Schmid teaches a second pivot pin (40d22) and an intermediate pivot pin (40d12) extending through the axial slot to slidingly connect the intermediate pivot node to the link (FIG 22). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Neumann’s prosthetic heart valve to include an intermediate pivot pin extending through the axial slot to slidingly connect the intermediate pivot node to the link, as taught by Schmid, in order to facilitate better interconnection of struts ([0042]).
With regards to claim 18, Neumann in view of Schmid discloses the prosthetic heart valve of claim 17, wherein the intermediate pivot pin (732) extends through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut ([0388]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, of copending Application No. 18/533,327 (reference application) as shown in the table below.
Instant Application
18/533,327
1. A prosthetic heart valve comprising: a link extending along an axial direction; and a radially expandable frame comprising: a plurality of struts comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes; a first pivot node of the plurality of pivot nodes pivotally connecting a first inner strut of the plurality of inner struts to a first outer strut of the plurality of outer struts at the first pivot node, and the first pivot node is attached to the link; and a second pivot node of the plurality of pivot nodes pivotally connecting a second inner strut of the plurality of inner struts to a second outer strut of the plurality of outer struts at the second pivot node, and the second pivot node is slidably connected to the link, wherein the second pivot node is configured to move relative to the link along the axial direction.
1. A prosthetic heart valve comprising: a link extending along an axial direction; and a radially expandable frame comprising: a plurality of struts comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes; a first pivot node of the plurality of pivot nodes pivotally connecting a first inner strut of the plurality of inner struts to a first outer strut of the plurality of outer struts at the first pivot node, and the first pivot node is attached to the link; and a second pivot node of the plurality of pivot nodes pivotally connecting a second inner strut of the plurality of inner struts to a second outer strut of the plurality of outer struts at the second pivot node, and the second pivot node is slidably connected to the link, wherein the second pivot node is configured to move relative to the link along the axial direction
8. The prosthetic heart valve of claim 1, wherein the first pivot node comprises a first pivot pin extending through an aperture of the first inner strut and an aperture of the first outer strut to pivotally connect the first inner strut to the first outer strut, and the second pivot node comprises a second pivot pin extending through an aperture of the second inner strut and an aperture of the second outer strut to pivotally connect the second outer strut to the second inner strut.
2. The prosthetic heart valve of claim 1, wherein the first pivot node comprises a first pivot pin extending through an aperture of the first inner strut and an aperture of the first outer strut to pivotally connect the first inner strut to the first outer strut, and the second pivot node comprises a second pivot pin extending through an aperture of the second inner strut and an aperture of the second outer strut to pivotally connect the second outer strut to the second inner strut.
9. The prosthetic heart valve of claim 8, wherein the first pivot pin extends through an aperture in the link to attach the first pivot node to the link.
3. The prosthetic heart valve of claim 2, wherein the first pivot pin extends through an aperture in the link to attach the first pivot node to the link.
10. The prosthetic heart valve of claim 8, wherein the link comprises an axial slot extending along the axial direction, and the second pivot pin extends through the axial slot to slidingly connect the second pivot node to the link.
4. The prosthetic heart valve of claim 2, wherein the link comprises an axial slot extending along the axial direction, and the second pivot pin extends through the axial slot to slidingly connect the second pivot node to the link.
11. The prosthetic heart valve of claim 10, wherein the axial slot comprises a closed slot with a first axial closed end and a second axial closed end, wherein the first axial closed end is axially positioned between the second axial closed end and the first pivot node.
5. The prosthetic heart valve of claim 4, wherein the axial slot comprises a closed slot with a first axial closed end and a second axial closed end, wherein the first axial closed end is axially positioned between the second axial closed end and the first pivot node.
12. The prosthetic heart valve of claim 10, wherein the axial slot is configured to lock a position of the second pivot pin within the axial slot.
6. The prosthetic heart valve of claim 4, wherein the axial slot is configured to lock a position of the second pivot pin within the axial slot.
13. The prosthetic heart valve of claim 10, wherein the axial slot comprises at least one protrusion defining a seat to lock the second pivot pin within the seat.
7. The prosthetic heart valve of claim 4, wherein the axial slot comprises at least one protrusion defining a seat to lock the second pivot pin within the seat.
14. The prosthetic heart valve of claim 1, wherein the plurality of pivot nodes further comprises an intermediate pivot node positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node.
8. The prosthetic heart valve of claim 1, wherein the plurality of pivot nodes further comprises an intermediate pivot node positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node.
15. The prosthetic heart valve of claim 14, wherein the intermediate pivot node comprises an intermediate pivot pin extending through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut.
9. The prosthetic heart valve of claim 8, wherein the intermediate pivot node comprises an intermediate pivot pin extending through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut.
16. The prosthetic heart valve of claim 10, wherein the plurality of pivot nodes further comprises an intermediate pivot node positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node, and the intermediate pivot node is slidably connected to the link, wherein the intermediate pivot node is configured to move relative to the link along the axial direction.
10. The prosthetic heart valve of claim 4, wherein the plurality of pivot nodes further comprises an intermediate pivot node positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node, and the intermediate pivot node is slidably connected to the link, wherein the intermediate pivot node is configured to move relative to the link along the axial direction
17. The prosthetic heart valve of claim 16, wherein the intermediate pivot node comprises an intermediate pivot pin extending through the axial slot to slidingly connect the intermediate pivot node to the link.
11. The prosthetic heart valve of claim 10, wherein the intermediate pivot node comprises an intermediate pivot pin extending through the axial slot to slidingly connect the intermediate pivot node to the link.
18. The prosthetic heart valve of claim 17, wherein the intermediate pivot pin extends through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut.
12. The prosthetic heart valve of claim 11, wherein the intermediate pivot pin extends through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut.
19. The prosthetic heart valve of claim 1, further comprising a plurality of leaflets, wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint that is connected to the second pivot node, wherein the commissural joint is configured to move together with the second pivot node relative to the link along the axial direction.
13. The prosthetic heart valve of claim 1, further comprising a plurality of leaflets, wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint that is connected to the second pivot node, wherein the commissural joint is configured to move together with the second pivot node relative to the link along the axial direction.
As shown in the mapping above, claims 1-13 of the reference application 18/533,327 includes all of the limitations of claims 1, 8-19 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10, 14-15, 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15 of copending Application No. 18/912,138 (reference application) as shown in the table below.
Instant Application
18/912,138
1. A prosthetic heart valve comprising: a link extending along an axial direction; and a radially expandable frame comprising: a plurality of struts comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes; a first pivot node of the plurality of pivot nodes pivotally connecting a first inner strut of the plurality of inner struts to a first outer strut of the plurality of outer struts at the first pivot node, and the first pivot node is attached to the link; and a second pivot node of the plurality of pivot nodes pivotally connecting a second inner strut of the plurality of inner struts to a second outer strut of the plurality of outer struts at the second pivot node, and the second pivot node is slidably connected to the link, wherein the second pivot node is configured to move relative to the link along the axial direction.
1. A prosthetic heart valve comprising: a link extending along a link axis; and a radially expandable frame comprising: a plurality of struts comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes; a first pivot node of the plurality of pivot nodes pivotally connecting a first inner strut of the plurality of inner struts to a first outer strut of the plurality of outer struts at the first pivot node, and the first pivot node is attached to the link; and a second pivot node of the plurality of pivot nodes pivotally connecting a second inner strut of the plurality of inner struts to a second outer strut of the plurality of outer struts at the second pivot node, and the second pivot node is slidably connected to the link, wherein the second pivot node is configured to move relative to the link along the link axis.
2. The prosthetic heart valve of claim 1, wherein each inner strut of the plurality of inner struts comprises a sinusoidal series of curved segments, and each outer strut of the plurality of outer struts comprises a sinusoidal series of curved segments.
2. The prosthetic heart valve of claim 1, wherein each inner strut of the plurality of inner struts comprises a sinusoidal series of curved segments, and each outer strut of the plurality of outer struts comprises a sinusoidal series of curved segments.
3. The prosthetic heart valve of claim 2, wherein an inflection location between adjacent curved segments of the sinusoidal series of curves segments of another inner strut of the plurality of inner struts is pivotally connected to an inflection location between adjacent curved segments of the sinusoidal series of curved segments of another outer strut of the plurality of outer struts at another pivot node of the plurality of pivot nodes.
3. The prosthetic heart valve of claim 2, wherein an inflection location between adjacent curved segments of the sinusoidal series of curves segments of another inner strut of the plurality of inner struts is pivotally connected to an inflection location between adjacent curved segments of the sinusoidal series of curved segments of another outer strut of the plurality of outer struts at another pivot node of the plurality of pivot nodes.
4. The prosthetic heart valve of claim 2, wherein the radially expandable frame is configured to be radially expanded to radially expanded orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding convex surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts, and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding convex surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts.
4. The prosthetic heart valve of claim 2, wherein the radially expandable frame is configured to be radially expanded to radially expanded orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding convex surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts, and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding convex surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts.
5. The prosthetic heart valve of claim 2, wherein the radially expandable frame is configured to be radially retracted to a radially retracted orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding concave surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts, and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding concave surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts.
5. The prosthetic heart valve of claim 2, wherein the radially expandable frame is configured to be radially retracted to a radially retracted orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding concave surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts, and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding concave surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts.
6. The prosthetic heart valve of claim 2, further comprising an outer skirt at least partially circumscribing an outer periphery defined by the radially expandable frame, wherein the outer skirt is mounted relative to the radially expandable frame.
6. The prosthetic heart valve of claim 2, further comprising an outer skirt at least partially circumscribing an outer periphery defined by the radially expandable frame, wherein the outer skirt is mounted relative to the radially expandable frame.
7. The prosthetic heart valve of claim 6, wherein the outer skirt is directly attached to the plurality of outer struts and/or the plurality of inner struts with a plurality of sutures.
7. The prosthetic heart valve of claim 6, wherein the outer skirt is directly attached to the plurality of outer struts and/or the plurality of inner struts with a plurality of sutures.
8. The prosthetic heart valve of claim 1, wherein the first pivot node comprises a first pivot pin extending through an aperture of the first inner strut and an aperture of the first outer strut to pivotally connect the first inner strut to the first outer strut, and the second pivot node comprises a second pivot pin extending through an aperture of the second inner strut and an aperture of the second outer strut to pivotally connect the second outer strut to the second inner strut.
8. The prosthetic heart valve of claim 1, wherein the first pivot node comprises a first pivot pin extending through an aperture of the first inner strut and an aperture of the first outer strut to pivotally connect the first inner strut to the first outer strut, and the second pivot node comprises a second pivot pin extending through an aperture of the second inner strut and an aperture of the second outer strut to pivotally connect the second outer strut to the second inner strut.
9. The prosthetic heart valve of claim 8, wherein the first pivot pin extends through an aperture in the link to attach the first pivot node to the link.
9. The prosthetic heart valve of claim 8, wherein the first pivot pin extends through an aperture in the link to attach the first pivot node to the link.
10. The prosthetic heart valve of claim 8, wherein the link comprises an axial slot extending along the axial direction, and the second pivot pin extends through the axial slot to slidingly connect the second pivot node to the link.
11. The prosthetic heart valve of claim 8, wherein the link comprises an axial slot extending along the link axis, and the second pivot pin extends through the axial slot to slidingly connect the second pivot node to the link.
14. The prosthetic heart valve of claim 1, wherein the plurality of pivot nodes further comprises an intermediate pivot node positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node.
12. The prosthetic heart valve of claim 1, wherein the plurality of pivot nodes further comprises an intermediate pivot node positioned between the first pivot node and the second pivot node to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node.
15. The prosthetic heart valve of claim 14, wherein the intermediate pivot node comprises an intermediate pivot pin extending through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut.
13. The prosthetic heart valve of claim 12, wherein the intermediate pivot node comprises an intermediate pivot pin extending through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut.
19. The prosthetic heart valve of claim 1, further comprising a plurality of leaflets, wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint that is connected to the second pivot node, wherein the commissural joint is configured to move together with the second pivot node relative to the link along the axial direction.
14. The prosthetic heart valve of claim 1, further comprising a plurality of leaflets, wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint that is connected to the second pivot node, wherein the commissural joint is configured to move together with the second pivot node relative to the link along the link axis.
20. The prosthetic heart valve of claim 19, further comprising an inner skirt at least partially circumscribing an interior area defined by the radially expandable frame, the plurality of leaflets each comprise a margin of attachment to the inner skirt, wherein the inner skirt is mounted relative to the radially expandable frame.
15. The prosthetic heart valve of claim 14, further comprising an inner skirt at least partially circumscribing an interior area defined by the radially expandable frame, the plurality of leaflets each comprise a margin of attachment to the inner skirt, wherein the inner skirt is mounted relative to the radially expandable frame.
As shown in the mapping above, claims 1-9, 11-15 of the reference application 18/912,138 includes all of the limitations of claims 1-10, 14-15, 19-20 of the instant application. Claims 1 and 19 of the instant application differs from claim 1 and 14 of the reference application in that it recites an “axial direction” instead of a “link axis.” However, the reference application at paragraph [0067] defines the “link axis” as the “axial direction.” Thus, claims 1 and 19 of the instant application are anticipated by claims 1 and 14 of the reference application, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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