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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: The drawings fail to include the element number 108 for the tissue-based sidewall.
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. 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 Objections
Claim 7 is objected to because of the following informalities:
Claim 7 appears to contain a typographical error in the phrase “wherein the thickened issue” in line 1. This line should instead read “wherein the thickened tissue”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-14, 18, and 29-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation “wherein the attachment between at least one commissure and the conduit” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “wherein the attachment between at least one commissure and the conduit” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the radiopaque structure” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the thickened outflow edge” and “the thickened inflow edge" in lines 1-2. There is insufficient antecedent basis for these limitations in the claim.
Claim 29 recites the limitation “a leaflet assembly comprising a plurality of leaflets as in claim 22” in line 1. There in insufficient antecedent basis for this limitation in the claim. Claims 30-31 are also rendered indefinite due to their dependency from indefinite claim 29.
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, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), herein after referred to as Nguyen, in view of Sarac et al. (US 7547322 B2), herein after referred to as Sarac.
Regarding claim 1, Nguyen discloses an implantable heart valve device (10), 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), 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. 4 illustrates leaflets 60 joined together at a portion of their cusp edge forming a plurality of commissures 84) and that the free edges of leaflet assembly are capable of coapting together (fig. 6 illustrates free edges of a leaflet assembly 14 coapting together). Nguyen fails to disclose a conduit formed of animal tissue into a cylindrical shape having a side wall with an inner face and an outer face or that the cusp edge of each leaflet of the leaflet assembly is further connected with an inner face of the sidewall.
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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 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).
Regarding claim 2, Nguyen in view of Sarac disclose the invention as claimed as discussed above 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 disclose the invention as claimed as discussed above 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 discloses 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 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 disclose the invention as claimed as discussed above 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 disclose the invention as claimed as discussed above 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 disclose the invention as claimed as discussed above with respect to claim 6. Nguyen further discloses that the thickened issue 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 disclose the invention as claimed as discussed above 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 disclose the invention as claimed as discussed above 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).
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 to include thickened tissue that incorporates a biocompatible filler as taught by an alternate embodiment (110) in order to reinforce the leaflets commissures (col. 2 lines 17-20).
Regarding claim 10, Nguyen in view of Sarac disclose the invention as claimed as discussed above 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 disclose the invention as claimed as discussed above 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 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 disclose the invention as claimed as discussed above 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 disclose the invention as claimed as discussed above 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 (col. 11 lines 4-9 disclose forming a clearance between the wall/frame 112 and articulation portions of a leaflet with spirals 168 to reduce the contact between them).
Regarding claim 16, Nguyen in view of Sarac disclose the invention as claimed as discussed above 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 disclose the invention as claimed as discussed above 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 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).
Regarding claim 19, Nguyen in view of Sarac disclose the invention as claimed as discussed above with respect to claim 1. 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 disclose the invention as claimed as discussed above with respect to claim 1. 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), herein referred to as Nguyen, in view of Sarac et al. (US 7547322 B2), herein referred to as Sarac, as applied to claim 1 above, and in further view of Peredo et al. (US 6254636 B1), herein referred to as Peredo.
Regarding claim 5, Nguyen and Sarac disclose the invention as claimed as discussed above with respect to claim 1. Nguyen also discloses that the cusp edge of at least one leaflet has a tissue sleeve attached thereupon (col. 6 lines 31-35 disclose and fig. 14 illustrates a leaflet 60 with a reinforcing strip/sleeve 68 attached on the cusp edge). Nguyen fails to disclose a sleeve attached to the cusp edge of a leaflet that is 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 tissue sleeve 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).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), herein after referred to as Nguyen, in view of Sarac et al. (US 7547322 B2), herein after referred to as Sarac, as applied to claims 1 and 12 above, and in further view of Spenser et al. (US 20030114913 A1), herein referred to as Spenser.
Regarding claim 13, Nguyen in view of Sarac disclose the invention as claimed as discussed above with respect to claim 1, but fails to disclose that the attachment between at least one commissure and the conduit wall is marked with a radiopaque structure. Spenser also discloses an implantable heart valve device (paragraph 0002), comprising: a conduit (22) formed of into a cylindrical shape having a side wall with an inner face and an outer face (fig. 1), 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 (fig. 9a annotated below), and that the free edges of leaflet assembly are capable of coapting together (fig. 9a illustrates free edges of a leaflet assembly coapting or closed). Spenser teaches that the attachment between at least one commissure and the conduit wall is marked with a radiopaque structure (paragraph 0187 discloses and fig. 14 illustrates incorporating radiopaque metal markers 232/230).
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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 in view of Sarac 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 disclose the invention as claimed as discussed above with respect to claim 12, but fails to disclose the rigid structure or the radiopaque structure is a 4-hole bar. Spenser also discloses an implantable heart valve device (paragraph 0002), comprising: a conduit (22) formed of into a cylindrical shape having a side wall with an inner face and an outer face (fig. 1), 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 (fig. 9a annotated above), and that the free edges of leaflet assembly are capable of coapting together (fig. 9a illustrates free edges of a leaflet assembly coapting or closed). Spenser teaches that the rigid structure (fig. 9f illustrates a rigid structure 128 with up to 5 holes) or the radiopaque structure (230/232) is a 4-hole bar (fig. 14a illustrates a radiopaque structure with up to 6 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 to include a rigid structure or the radiopaque 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).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), herein after referred to as Nguyen, in view of Sarac et al. (US 7547322 B2), herein after referred to as Sarac, as applied to claim 17 above, and in further view of Edwin et al. (WO 2007137211 A2), herein referred to as Edwin.
Regarding claim 18, Nguyen in view of Sarac disclose the invention as claimed as discussed above 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).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), herein after referred to as Nguyen, in view of Sarac et al. (US 7547322 B2), herein after referred to as Sarac, as applied to claim 1 above, and in further view of Schreck et al. (US 8349000 B2), herein referred to as Schreck.
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 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).
Regarding claim 22, Nguyen discloses a leaflet (60) for use within an implantable heart valve device (10), comprising: a sheet of tissue (col. 6 lines 40-41 disclose and fig. 1 illustrates an inner leaflet assembly 14 formed of animal tissue comprising a plurality of leaflets 60) having a free edge connected, a cusp edge, and a belly, the cusp edge contoured in a rounded line (annotated fig. 14 above illustrates a leaflet with a free edge connected to a rounded cusp edge and a belly); wherein the free edge and the cusp edge are connected at two points forming two corners that are commissure meeting points (fig. 14 annotated below illustrates the free edge and cusp edge forming two corners that are commissure meeting points). Nguyen discloses an alternate embodiment (110) where each commissure meeting point is for attachment with at least one other leaflet to form a commissure (fig. 19 above illustrates three leaflets 160 where the commissure point of one leaflet joins the commissure point of another forming a commissure 184) and where 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).
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 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 (col 10. lines 65-66 and col. 11 lines 1-3).
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Regarding claim 24, Nguyen discloses the invention as claimed as discussed above 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. 21 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. 21 illustrates a side tab 166 rolled onto the outflow face of the leaflet 160).
Regarding claim 25, Nguyen discloses the invention as claimed as discussed above 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. 21 illustrates spiraled or thickened tissue 168 attached together and attached upon the outflow face of the leaflet 160 at its commissure 184 with sutures 188).
Regarding claim 26, Nguyen discloses the invention as claimed as discussed above with respect to claim 22. Nguyen also 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 27, Nguyen discloses the invention as claimed as discussed above 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 discloses the invention as claimed as discussed above 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 the invention as claimed as discussed above with respect to claim 22. Nguyen also 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. 21 illustrates two leaflets 160 joined with sutures 188 through their spiraled tabs 166 on their cusp edges 164 to form a plurality of commissures 184).
Regarding claim 30, Nguyen discloses the invention as claimed as discussed above with respect to claim 29. Nguyen further discloses an implantable heart valve (10) with 3 leaflets (60).
Regarding claim 31, Nguyen discloses the invention as claimed as discussed above with respect to claim 29. Nguyen further discloses 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 (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).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US 8568475 B2), herein referred to as Nguyen, as applied to claim 22 above, and further in view of Peredo et al. (US 6254636 B1), herein referred to as Peredo.
Regarding claim 23, Nguyen discloses the invention as claimed as discussed above with respect to claim 22. Nguyen also discloses that the cusp edge of at least one leaflet has a tissue sleeve attached thereupon (col. 6 lines 31-35 disclose and fig. 14 illustrates a leaflet 60 with a reinforcing strip/sleeve 68 attached on the cusp edge). Nguyen fails to disclose a sleeve attached to the cusp edge of a leaflet that is specifically made of tissue.
Peredo also discloses a leaflet (11) for use within an implantable heart valve device (col. 3 lines 21-23 discloses an aortic valve assembly), comprising: a sheet of 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 that is contoured in a rounded line). Peredo teaches that 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 commissure meeting point), wherein each commissure meeting point is for attachment with at least one other leaflet to form a commissure (fig. 8 also illustrates leaflets attached and forming commissures 51). Peredo further 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 to include a leaflet with a tissue sleeve 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).
Conclusion
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/A.G.B/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774