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 04/29/2026 has been entered. Claims 1-4, 6-22, and 24-31 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 12/29/2025.
Response to Arguments
Applicant’s arguments filed 04/29/2026 have been fully considered but they are not persuasive in part.
In response to applicant’s argument that Nguyen and Sarac fail to make obvious the device of claim 1 and the leaflet of claim 22 wherein “a rounded portion of the cusp edge of each leaflet of the leaflet assembly is further connected with an inner face of the sidewall via a reinforcing tissue sleeve, wherein the rounded portion of the cusp edge is opposite of the free edge, wherein the reinforcing tissue sleeve is attached to an inflow side of the rounded portion of the cusp edge and to the inner face of the sidewall”, as recited in amended claim 1, a new grounds of rejection is presented below in further view of Peredo.
In response to the applicant’s argument that Nguyen, Sarac, and Peredo each fail to teach or appreciate the use of a reinforcement tissue sleeve attached to the inflow side of the rounded cusp and using the reinforcement tissue sleeve to attach the rounded cusp to an inner wall of a tissue conduit, as included in amended claim 22, the applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). It is the examiner’s position that Peredo teaches a reinforcement tissue sleeve (12) attached to the inflow side of a rounded cusp (see fig. 1) capable of attaching to an inner face of a tissue conduit as claimed (Fig. 1 illustrates and col. 5 lines 13-16 discloses that the base portion of tissue-based leaflets, or rounded cusp, are coupled with a rim strip/sleeve and form a double layer of biocompatible material (see col. 3 lines 43-44), i.e. the biocompatible materials/tissues used in Peredo would facilitate attachment to a tissue conduit and furthermore provide the tissue conduit with a plurality of layers of biocompatible material at the leaflet-sleeve-conduit joining area, thereby providing reinforcement. Furthermore, Peredo discloses that the leaflets and rim strip/sleeve receive sutures for attachment to one another, i.e. a suitable attachment method for a biocompatible sleeve to a tissue conduit).
In response to the applicant’s argument that the “rim strip” 12 of Peredo is not a reinforcement sleeve but merely a means of connecting three leaflets together because it extends up to the free edge of a leaflet and is necessarily configured as a single strip to attach all three leaflets together and the later argument that Peredo cannot simply replace the PET reinforcing strip of Nguyen because the “rim strip” of Peredo does not provide reinforcement (see new grounds of rejection below). It is the examiner’s position that Peredo discloses that the rim strip 12 rests on the rounded ends/cusps of the leaflets forming a second layer of tissue and is used as a reinforcing rim strip/sleeve (col. 4 lines 63-67). Therefore, the rim strip or sleeve 12 of Peredo is capable of providing reinforcement to a leaflet cusp.
The applicant also argues that Peredo lacks a tissue-based conduit and thus does not provide any suggestion that the rim strip is configured for attachment to a conduit. It is the examiner’s position that Peredo teaches a reinforcement tissue sleeve (12) attached to the inflow side of a rounded cusp (see fig. 1) capable of attaching to an inner face of a tissue conduit as claimed (Fig. 1 illustrates and col. 5 lines 13-16 discloses that the base portion of tissue-based leaflets, or rounded cusp, are coupled with a rim strip/sleeve and form a double layer of biocompatible material (see col. 3 lines 43-44), i.e. the biocompatible materials/tissues used in Peredo would facilitate attachment to a tissue conduit and furthermore provide the tissue conduit with a plurality of layers of biocompatible material at the leaflet-sleeve-conduit joining area, thereby providing reinforcement. Furthermore, Peredo discloses that the leaflets and rim strip/sleeve receive sutures for attachment to one another, i.e. a suitable attachment method for a biocompatible sleeve to a tissue conduit).
The applicant also argues that Nguyen fails to teach that tissue can provide reinforcement at the rounded cusp edge and be used to attach the rounded cusp of the leaflet to a tissue-based conduit. However, it is the examiner’s position that Nguyen when modified by Sarac and Peredo would provide a reinforcement sleeve made of tissue as taught by Peredo that is considered capable of providing reinforcement at a rounded cusp edge and used to attach the rounded cusp of the leaflet of a conduit, and more specifically a tissue conduit as taught by Sarac (see new grounds of rejection below).
The applicant also argues that the tissue-based “rim-strip” of Peredo is incompatible with the leaflets of Nguyen because it extends up the free edge of the leaflets and disrupts the connection of Nguyen’s commissures to the post of the frame. However, it is the Examiner’s position that Nguyen’s prosthetic heart valve already discloses a sleeve at the cusp edge of an appropriate size and length that does not disrupt the connection of commissures to the post of the frame. Therefore, a sleeve with undisruptive dimensions like the sleeve disclosed in Nguyen as modified to be made of tissue, as taught by Peredo, would provide a compatible tissue sleeve.
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.
Claims 1-4, 6-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), in view of Sarac et al. (US 7547322 B2), and Peredo et al. (US 6254636 B1).
Regarding claim 1, Nguyen discloses an implantable heart valve device (10), comprising: a conduit (12/16) formed into a cylindrical shape having a side wall with an inner face and an outer face (see figs. 1/18); and an inner leaflet assembly formed of animal tissue comprising a plurality of leaflets (col. 6 lines 40-41 disclose and fig. 1 illustrates an inner leaflet assembly formed of animal tissue comprising a plurality of leaflets 60), each leaflet having a cusp edge, a free edge, and a belly (fig. 14 annotated below illustrates a leaflet with a cusp edge, a free edge, and a belly); wherein an adjoining portion of the cusp edge of each leaflet is connected with the adjoining portion of the cusp edge of another leaflet to form a plurality of commissures, wherein the adjoining portion is adjacent to the free edge (fig. 13 illustrates an adjoining portion/tab 16 of the cusp edge. Fig. 15 illustrates and col. 7 lines 21-23 disclose that leaflets are connected to each other at an adjoining portion/tab 16. Furthermore, fig. 13 illustrates that the adjoining portion/tab 16 is adjacent to a free edge); wherein a rounded portion of the cusp edge of each leaflet of the leaflet assembly is further connected with an inner face of the sidewall via a reinforcing sleeve (fig. 14 illustrates a rounded portion of the cusp edge comprising a sleeve and col. 6 lines 31-35 disclose that the leaflets can be attached to the inner face of a skirt, i.e. a conduit, via a reinforcing sleeve), wherein the rounded portion of the cusp edge is opposite of the free edge (fig. 14 illustrates that a rounded portion of the cusp edge is opposite of a free edge), wherein the reinforcing tissue sleeve is attached to an inflow side of the rounded portion of the cusp edge and to the inner face of the sidewall (fig. 14 illustrates and col. 6 lines 35-36 disclose that the leaflet is sandwiched between a skirt and the reinforcing sleeve, i.e. sandwiched between the inner face of a sidewall of the skirt conduit and a reinforcing
sleeve on an inflow side); and wherein the free edges of leaflet assembly are capable of coapting
together (fig. 6 illustrates free edges of a leaflet assembly 14 coapting together).
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Nguyen fails to teach a conduit made specifically of animal tissue. Sarac also discloses an implantable heart valve device (col. 4 lines 10-11), an inner leaflet assembly formed of animal tissue comprising a plurality of leaflets, each leaflet having a cusp edge, a free edge, and a belly (col. 4 lines 57-61 disclose and figs. 14-15 annotated below illustrate an inner leaflet assembly formed of animal tissue wherein each leaflet has a cusp edge, free edge, and belly), and that the free edges of leaflet assembly are capable of coapting together (col. 15 lines 37-38 disclose coaptable free edges).
Sarac teaches a conduit formed of animal tissue into a cylindrical shape having a side wall with an inner face and an outer face (col. 7 lines 17-25 disclose and fig. 1 illustrates a conduit formed of animal tissue 14 into a cylindrical shape with an inner and outer face) and that the cusp edge of each leaflet of the leaflet assembly is further connected with an inner face of the sidewall (col. 16 lines 40-44 disclose and fig. 15 illustrates the rolled cusp edge of each leaflet is attached to the inner face of the sidewall).
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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 the implantable heart valve of Nguyen to include a conduit formed of animal tissue into a cylindrical shape having a side wall with an inner face and outer face and connect the cusp edge of each leaflet of the leaflet assembly with an inner face of the sidewall as taught by Sarac as in order to engage and create an interference fit between an implantable heart valve and the inner surface of a body lumen (col. 10 lines 18-32). Additionally, this modification achieves predictable results of a forming a working valve for placement in bodily passages.
Nguyen fails to teach a reinforcing sleeve specifically made of tissue. Peredo discloses an implantable heart valve device (col. 3 lines 21-23 discloses an aortic valve assembly), a leaflet assembly formed of animal tissue comprising a plurality of leaflets (col. 4 lines 11-12 disclose and fig. 3 illustrates a plurality of leaflets made of animal tissue), each leaflet having a cusp edge, a free edge, and a belly (fig. 4 illustrates a leaflet with a free edge connected to a belly and a cusp edge); wherein a portion of the cusp edge of each leaflet is connected with a portion of a cusp edge of another leaflet to form a plurality of commissures (fig. 8 illustrates a leaflet with a free edge and cusp edge connecting to form a plurality of commissure). Peredo teaches that the cusp edge of at least one leaflet has a tissue sleeve (12) attached thereupon (col. 4 lines 29-32 disclose and fig. 8 illustrates a rim strip or sleeve attached to the cusp edge of a leaflet 11 made of tissue).
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 the implantable heart valve of Nguyen in view of Sarac to include a leaflet with a sleeve specifically made of tissue attached to the cusp edge, as taught by Peredo, in order to provide reinforcement along the cusp edge or curved leaflet base ends (Peredo col. 5 lines 43-44).
Regarding claim 2, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Nguyen further discloses the inner leaflet consists of 2, 3, 4, or 5 leaflets (with 3 leaflets 60).
Regarding claim 3, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Nguyen further discloses that each leaflet (60) of the inner leaflet assembly comprises a sheet of tissue (col. 6 lines 40-41 disclose and fig. 1 illustrates an inner leaflet assembly formed of animal tissue comprising a plurality of leaflets 14) having a free edge connected, a cusp edge, and a belly, the cusp edge contoured in a rounded line (fig. 14 illustrates a leaflet with a free edge connected to a rounded cusp edge and a belly as annotated above), and that the free edge and the cusp edge are connected at two points forming two corners that are commissure meeting points (fig. 14 above illustrates the free edge and cusp edge forming two corners that are commissure meeting points). Nguyen teaches an alternate embodiment (110) where each commissure meeting point is the connection location with at least one other leaflet to form a commissure (fig. 19, annotated below, illustrates three leaflets 114 where the commissure point of one leaflet joins the commissure point of another forming a commissure 184); and wherein each commissure meeting point incorporates thickened tissue on an outflow face of the sheet of tissue (fig. 19 illustrates a commissure meeting point with thickened tissue 166 on the outflow face of the sheet of tissue).
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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 the implantable heart valve (10) of Nguyen in view of Sarac and Peredo to include commissure meeting points for the attachment with at least one other leaflet to form a commissure and to include a commissure meeting point that incorporates thickened tissue on an outflow face of the sheet of tissue, as taught by an alternate embodiment (110), in order to form reinforced commissures that prolong the life of the valve (Nguyen col 10. lines 65-66 and col. 11 lines 1-3).
Regarding claim 4, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Nguyen further discloses that the free edge of each leaflet has length that is between about 1.1X and 2X longer than the minimum distance for coaptation between the leaflet’s commissures (Fig. 6 illustrates leaflets 60 in a closed position where coaptation occurs along more than half of one leaflet free edge. Therefore, the free edge is between 1.1 to 2 times longer than the minimum distance for coaptation).
Regarding claim 6, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Nguyen further discloses that at least one commissure of the plurality of commissures 184 incorporates thickened tissue 168 on an outflow face of at least one leaflet of the inner leaflet assembly (fig. 19 above illustrates inner leaflet assembly with commissures 184 that incorporate thickened tissue 168 on the outflow face of a leaflet 114).
Regarding claim 7, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 6. Nguyen further discloses that the thickened tissue is a side tab or a top tab 166 that is extended from the commissure meeting points (fig. 19 above) and is rolled or folded back onto the outflow face of the leaflet (fig. 4 illustrates a side tab folded onto the outflow face and fig. 21 illustrates a side tab 166 rolled onto the outflow face of the leaflet 160).
Regarding claim 8, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 6. Nguyen further discloses that the thickened tissue (168) is layers of tissue (col. 9 lines 58-60 disclose rolling the leaflets side tab 166 to form multiple layers of tissue) attached together and attached upon the outflow face of the leaflet 160 at its commissure (fig. 21 illustrates spiraled or thickened tissue attached to the outflow face of a leaflet with sutures 188).
Regarding claim 9, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 6. Nguyen further discloses that the thickened tissue incorporates a biocompatible filler (col. 9 lines 12-23 disclose and fig. 22 illustrates thickened tissue 168 incorporating a biocompatible filler or insert 186).
Regarding claim 10, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 9. Nguyen further discloses that the biocompatible filler comprises nitinol, cobalt-chromium, titanium, stainless steel, poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether sulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), or polycaprolactone (PCL) (col. 9 lines 22-28 disclose that a biocompatible filler or insert 186 may comprise a variety of natural and/or synthetic biocompatible materials including PET).
Regarding claim 11, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 6. Nguyen further discloses that the thickened tissue 168 has thickness of about 1.5X, 2X, 2.5X, 3X, 4X, or 5X the thickness of the leaflet (col. 9 lines 58-60 disclose rolling the leaflets side tab 166 to form spirals or thickened tissue 168 and further rolling the side tab to increase the number of side tab layers and size of the spiral).
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 the implantable heart valve (10) of Nguyen in view of Sarac and Peredo to include thickened tissue that has a thickness of about 1.5X, 2X, 2.5X, 3X, 4X, or 5X the thickness of the leaflet, as taught by an alternate embodiment (110), in order to improve strength and durability (col. 11 lines 38-41).
Regarding claim 12, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Nguyen further discloses that the attachment between at least one commissure and the conduit wall is reinforced with a rigid structure (fig. 19 illustrates commissures 184 attached to attachment posts 118 on a frame/conduit using sutures 190).
Regarding claim 15, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Nguyen further discloses that the inner leaflet assembly is assembled within the conduit such that the free edges and bellies of each leaflet are mitigated from contacting an inner wall of the conduit when implanted and functioning, wherein the thickened tissue at each commissure meeting point is bulky; wherein the bulkiness of the thickened tissue is configured to mitigate the free edges and bellies of each leaflet from contacting the inner wall of the conduit (col. 11 lines 4-9 disclose forming a clearance between the wall/frame 112 and articulation portions of a leaflet with spirals/bulky structures 168 to reduce the contact between them).
Regarding claim 16, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Sarac further teaches that the conduit (formed of 14) is formed from a sheet of tissue connected at two opposite edges to form the cylindrical shape (col. 8 lines 33-39 disclose and fig. 4c illustrates a sheet of tissue 14 connected at two opposite edges 42 and 44 to form a cylindrical shape).
Regarding claim 17, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1. Sarac further teaches an alternate embodiment (fig. 19) in which the conduit comprises a plurality of sheets of tissue layered and connected together to form a thickened conduit wall (fig. 19 illustrates a plurality of sheets of tissue 14a layered and connected forming a thickened conduit wall).
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 the implantable heart valve of Nguyen in view of Sarac and Peredo to include a conduit comprising a plurality of sheets of layered and connected tissue, as taught by the alternate embodiment of Sarac, in order to form a thickened conduit wall (col. 17, lines 55-60).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), in view of Sarac et al. (US 7547322 B2), and Peredo et al. (US 6254636 B1), as applied to claims 1 and 12 above, and in further view of Spenser et al. (US 20030114913 A1).
Regarding claim 13, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 1, but fails to disclose the conduit wall is marked with a radiopaque structure at an attachment between the conduit wall and at least one leaflet. Spenser also discloses an implantable device comprising an inner leaflet assembly (see abstract and fig. 14). Spenser teaches that the conduit wall is marked with a radiopaque structure at an attachment between the conduit wall and at least one leaflet (figs. 14 and 14a-c illustrate a conduit wall, e.g. a stent’s conduit, marked with radiopaque structures 235 between the wall and leaflets).
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 the implantable heart valve of Nguyen in view of Sarac and Peredo to include that the attachment between at least one commissure and the conduit wall is marked with a radiopaque structure, as taught by Spenser, in order to observe the device as its being placed in its required location (Spenser paragraph 0187).
Regarding claim 14, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 12, but fails to disclose that the rigid structure is a 4-hole bar. Spenser also discloses an implantable device comprising an inner leaflet assembly (see abstract and fig. 14). Spenser teaches that the rigid structure is a 4-hole bar (fig. 9f illustrates a rigid structure 128 with up to 5 holes).
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 the implantable heart valve of Nguyen in view of Sarac and Peredo to include a rigid structure that is a 4-hole bar or up to 6 holes or bores, as taught by Spenser, in order to stitch or tie the valve assembly at the beams or support structures (Spenser paragraph 0024).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), in view of Sarac et al. (US 7547322 B2), and Peredo et al. (US 6254636 B1), as applied to claim 17 above, and in further view of Edwin et al. (WO 2007137211 A2).
Regarding claim 18, Nguyen in view of Sarac and Peredo disclose the invention as claimed as discussed with respect to claim 17. Sarac fails to disclose that the thickened conduit wall, thickened outflow edge, or thickened inflow edge incorporates a biocompatible filler.
Edwin discloses a thickened conduit wall, a thickened outflow edge and a thickened inflow edge (fig. 2 illustrates a thickened conduit wall where the thickened wall extends from a first edge to a second edge forming thickened edges). Edwin teaches the thickened conduit wall, outflow edge, and inflow edge incorporate a biocompatible filler (paragraph 040 discloses and fig. 1 illustrates a conduit/graft/stent wherein the wall is formed of tissue 1 and a biocompatible layer 2). Edwin further teaches that the layering of tissue and a biocompatible material, such as PTFE, may have a variety of configurations such as a biocompatible filler/layer in-between two tissue layers (paragraph 069).
Edwin teaches structures analogous to a conduit for a heart valve such as a stent or graft for use of opening the lumen of a blood vessel. 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 the implantable heart valve of Nguyen in view of Sarac to include a thickened wall, thickened outflow edge, or thickened inflow edge that incorporates a biocompatible filler as taught by Edwin to provide strength and durability required for constant movement of the valve (Edwin 057).
Regarding claim 19, Nguyen in view of Sarac, Peredo, and Edwin disclose the invention as claimed as discussed with respect to claim 18. Sarac further teaches that the conduit 10 has an outflow edge that incorporates rolled, folded, or layered tissue to form thickened outflow edge (fig. 5 illustrates an outflow edge with folded tissue forming a thickened outflow edge).
Regarding claim 20, Nguyen in view of Sarac, Peredo, and Edwin disclose the invention as claimed as discussed with respect to claim 18. Sarac further teaches that the conduit 10 has an inflow edge that incorporates rolled, folded, or layered tissue to form thickened inflow edge (fig. 5 illustrates an inflow edge with folded tissue forming a thickened inflow edge).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), in view of Sarac et al. (US 7547322 B2), and Peredo et al. (US 6254636 B1), as applied to claim 1 above, and in further view of Schreck et al. (US 8349000 B2).
Regarding claim 21, Nguyen in view of Sarac disclose the invention as claimed as discussed above with respect to claim 1. Schreck also discloses an implantable heart valve device (20) with a leaflet assembly formed of animal tissue (col. 5 lines 35-37) comprising a plurality of leaflets (32), leaflet having a cusp edge (124), a free edge (126), and a belly (fig. 9), and free edges (126) of leaflet assembly are capable of coapting together (col 8 lines 8-12). Schreck teaches a conduit has an outflow edge that is contoured with at least one recessed portion (fig. 6 illustrates a conduit with an outflow edge that is contoured with at least one recessed portion 114) in between a pair of adjacent commissures (112).
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 the implantable heart valve of Nguyen in view of Sarac and Peredo to include a conduit that has an outflow edge that is contoured with at least one recessed portion in between a pair of adjacent commissures as taught by Schreck to mimic the natural contour of leaflet attachment and provide continuous support along leaflets cusp edge (col. 1 lines 47-51).
Claims 22 and 24-31 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2) in view of Peredo et al. (US 6254636 B1).
Regarding claim 22, Nguyen discloses a leaflet for use within an implantable heart valve device (160), comprising: a sheet of tissue (col. 11 lines 34-35) having a free edge connected, a cusp edge, and a belly, the cusp edge contoured in a rounded line (see fig. 24); wherein the free edge and the cusp edge are connected at two points forming two corners that are commissure meeting points (see fig. 23; corners/commissure meeting points 184 where commissure tabs 166 are located), wherein each commissure meeting point is for attachment with at least one other leaflet to form a commissure (fig. 23 illustrates leaflets connected to one another at commissure meeting points 184); wherein each commissure meeting point incorporates thickened tissue on an outflow face of the sheet of tissue (fig. 23 illustrate spiraled/thickened tissue on an outflow face); and wherein the cusp edge has an adjoining portion and rounded portion, wherein the rounded portion of the cusp edge is opposite of the free edge (fig. 24 illustrates a rounded portion 164 opposite to an upper free-edge). Nguyen’s embodiment of a leaflet structure (160) in figs. 24-23 fails to disclose that a sleeve is attached to an inflow side of the rounded portion of the cusp edge.
Nguyen teaches an alternate embodiment leaflet structure (60) in which a sleeve is attached to an inflow side of the rounded portion of the cusp edge (68; see fig. 14).
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 the leaflet structure of Nguyen’s embodiment 160 in fig. 24 to include that a sleeve is attached to an inflow side of the rounded portion of the cusp edge, as taught by Nguyen’s alternate embodiment, in order to provide further reinforcement such as providing reinforcement to the leaflets along an attachment region, e.g. suture line, to protect against tearing of the leaflets (Nguyen - col. 8 lines 1-3).
Nguyen as modified fails to disclose that a sleeve attached to an inflow side of the rounded portion of the cusp edge is specifically made of tissue and configured to attach to an inner face of a tissue conduit.
Peredo also discloses a leaflet for use within an implantable heart valve device, comprising: a sheet of tissue (col. 4 lines 11-12 disclose and fig. 3 illustrates a plurality of leaflets made of animal tissue) having a free edge connected, a cusp edge, and a belly, the cusp edge contoured in a rounded line (fig. 4 illustrates a leaflet with a free edge connected to a belly and a cusp edge contoured in a rounded line); wherein the free edge and the cusp edge are connected at two points forming two corners that are commissure meeting points (fig. 8 illustrates a leaflet with a free edge and cusp edge connecting to form a plurality of commissure); wherein a sleeve is attached to an inflow side of the rounded portion of the cusp edge (fig. 8 illustrates a rim strip or sleeve attached to the cusp edge of a leaflet 11). Peredo teaches that that the sleeve is specifically made of tissue (col. 4 lines 28-31). Peredo further teaches that the sleeve is capable of attaching to an inner face of a tissue conduit as fig. 1 illustrates and col. 5 lines 13-16 disclose that the base portion of tissue-based leaflets, or rounded cusp, are coupled with a rim strip/sleeve and form a double layer of biocompatible material (see col. 3 lines 43-44), i.e. the biocompatible materials/tissues used in Peredo would facilitate attachment to a tissue conduit and furthermore provide the tissue conduit with a plurality of layers of biocompatible material at the leaflet-sleeve-conduit joining area, thereby providing reinforcement. Furthermore, Peredo discloses that the leaflets and rim strip/sleeve receive sutures for attachment to one another, i.e. a suitable attachment method for a biocompatible sleeve to a tissue conduit.
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 the implantable heart valve of Nguyen to include a leaflet with a sleeve specifically made of tissue attached to the cusp edge and further that the sleeve is capable of attaching to an inner face of a tissue conduit, as taught by Peredo, in order to provide reinforcement along the cusp edge or curved leaflet base ends (Peredo col. 5 lines 43-44).
Regarding claim 24, Nguyen in view of Peredo disclose the invention as claimed as discussed with respect to claim 22. Nguyen also discloses that the thickened tissue is a side tab or a top tab that is extended from the commissure meeting points (fig. 23 illustrates side tabs 166 that extend from commissure meeting points 184) and is rolled or folded back onto the outflow face of the leaflet (fig. 23 illustrates a side tab 166 rolled onto the outflow face of the leaflet 160).
Regarding claim 25, Nguyen in view of Peredo disclose the invention as claimed as discussed with respect to claim 22. Nguyen also discloses wherein the thickened tissue is layers of tissue attached together and attached upon the outflow face of the leaflet at its commissure (fig. 23 illustrates spiraled or thickened tissue 168 and attached upon the outflow face of the leaflet 160 at its commissure 184 with sutures 188 (see col. 9 lines 12-15 for suture attachment)).
Regarding claim 26, Nguyen in view of Peredo disclose the invention as claimed as discussed with respect to claim 22. Nguyen also discloses that the thickened tissue incorporates a biocompatible filler (col. 9 lines 19-20 disclose and fig. 23 illustrates thickened tissue 168 incorporating a biocompatible filler or insert 186).
Regarding claim 27, Nguyen in view of Peredo disclose the invention as claimed as discussed with respect to claim 26. Nguyen also discloses that the biocompatible filler comprises nitinol, cobalt-chromium, titanium, stainless steel, poly(lactic-co-glycolic) acid (PLGA), polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), polyethylene terephthalate (PET), polyether sulfone (PES), polyglycolic acid (PGA), polylactic acid (PLA), poly-d-lactide (PDLA), poly-4-hydroxybutyrate (P4HB), or polycaprolactone (PCL) (col. 9 lines 22-28 disclose that a biocompatible filler or insert 186 may comprise a variety of natural and/or synthetic biocompatible materials including PET).
Regarding claim 28, Nguyen in view of Peredo disclose the invention as claimed as discussed with respect to claim 22. Nguyen also discloses that the thickened tissue 168 has thickness of about 1.5X, 2X, 2.5X, 3X, 4X, or 5X the thickness of the leaflet (col. 9 lines 58-60 disclose rolling the leaflets side tab 166 to form spirals or thickened tissue 168 and further rolling the side tab to increase the number of side tab layers and size of the spiral).
Regarding claim 29, Nguyen discloses a leaflet assembly comprising a plurality of leaflets (see Abstract), Nguyen as modified by Peredo discloses wherein each of the plurality of leaflets comprises the leaflet as in claim 22. Nguyen further discloses that a portion of the cusp edge of each leaflet is connected with a portion of a cusp edge of another leaflet to form a plurality of commissures (fig. 23 illustrates two leaflets 160 joined with sutures 188 through their spiraled tabs 166 on their cusp edges 164 forming a commissure 184; and the Abstract discloses a leaflet structure with a plurality of leaflets forming a plurality of commissures e.g. the commissure 184 in fig. 23).
Regarding claim 30, Nguyen in view of Peredo disclose the invention as claimed as discussed with respect to claim 29. Nguyen further discloses an implantable heart valve (10) with 3 leaflets (the Abstract discloses a plurality of leaflets forming commissures, i.e. 2 or more leaflets/a plurality).
Regarding claim 31, Nguyen in view of Peredo disclose the invention as claimed as discussed with respect to claim 29. The embodiment 160 of Nguyen’s leaflet assembly fails to disclose that the free edge of each leaflet has length that is between 1.1X and 2X longer than the minimum distance for coaptation between the leaflet’s commissures. Nguyen teaches an alternate embodiment in which the free edge of each leaflet has length that is between 1.1X and 2X longer than the minimum distance for coaptation between the leaflet’s commissures (Fig. 6 illustrates leaflets 60 coapting together where coaptation occurs along more than half the length of one leaflet’s free edge. Therefore, the free edge is between 1.1 to 2 times longer than the minimum distance for coaptation).
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 the leaflet assembly of Nguyen’s embodiment 160 in fig. 23 to include the free edge of each leaflet has length that is between 1.1X and 2X longer than the minimum distance for coaptation between the leaflet’s commissures as the modification merely involves a combination of known methods of creating a leaflet assembly that achieves predictable results of regulating blood flow through a valve.
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.
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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