Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-7, 10 and 18 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Frater (US-5415667).
Claim 1: discloses a prosthetic heart valve for implantation at a valve annulus, comprising: an annular support structure (30); and a plurality of at least two leaflets (33, 34, 36A, 36B) attached to the support structure (30) such that the leaflets open and close about a coaptation location.
Claim 3: Frater discloses the valve of claim 1, wherein the valve includes four leaflets and wherein the leaflets include a first pair of leaflets (36A, 36B) having a first surface area and a second pair of leaflets (34, 35) having a second surface are greater than the first surface area (paragraph 16, anterior leaflet/cusp is 1/3 of the swing ring/support structure (30) opening, posterior and lateral cusps 2/3, thus the anterior and posterior cusps would have surface greater than the surface area of lateral cusps (36A, 36B) based on the shape and dimension of the support structure (30).
Claims 4: Frater discloses the valve of claim 1, wherein the valve includes four leaflets and wherein the leaflets include three leaflets having surface areas that are substantially the same and a fourth leaflet (33 anterior cusp/leaflet that has a surface area different than the three leaflets 34, 36a, 36B, claim 2).
Claim 5: Frater discloses the valve of claim 1, wherein the support structure comprises a frame or stent having a substantially circular shape (claim 2).
Claim 6: Frater discloses the valve of claim 1, wherein the support structure comprises a frame or stent having a generally D-shape (claim 3).
Claim 7: Frater discloses the valve of claim 1, wherein the support structure has an annular shape lying substantially within a plane (figs. 1-4).
Claim 10: Frater discloses the valve of claim 1, further comprising a suture ring (44) attached to the support structure (30).
Claims 18: Frater discloses the valve of claim 1, wherein the support structure (30) comprises one or more features for chordal attachment (38).
Claim(s) 1-4, 6, 8-15, and 21 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Johnson (US 7455689 B2).
Claim 1: Johnson discloses a prosthetic heart valve for implantation at a valve annulus, comprising: an annular support structure (102, 112, 122); and a plurality of at least two leaflets (104a-d, 114a-d, 124a-d) attached to the support structure such that the leaflets open and close about a coaptation location.
Claims 2: Johnson discloses the valve of claim 1, wherein the leaflets (104b and 104d) are substantially symmetrical and have surface areas that are substantially the same (Fig. 10).
Claim 3: Johnson discloses the valve of claim 1, wherein the valve includes four leaflets and wherein the leaflets include a first pair of leaflets (104b and 104d) having a first surface area and a second pair of leaflets (104a and 104b) having a second surface are greater than the first surface area (Figs. 11-12).
Claim 4: Johnson discloses the valve of claim 1, wherein the valve includes four leaflets and wherein the leaflets include three leaflets (124b-d) having surface areas that are substantially the same and a fourth leaflet (124a) that has a surface area different than the three leaflets (Fig. 12).
Claim 6: Johnson discloses the valve of claim 1, wherein the support structure comprises a frame or stent having a generally D-shape (Figs. 10-12).
Claim 8: Johnson discloses the valve of claim 1, wherein the support structure has a non-planar shape about its periphery (claim 1, and 11).
Claim 9: Johnson discloses the valve of claim 1, wherein the support structure has a non-planar shape similar to a native mitral valve annulus (claim 1, and 11).
Claim 10: Johnson discloses the valve of claim 1, further comprising a suture ring (38) attached to the support structure.
Claim 11: Johnson discloses the valve of claim 1, wherein the support structure comprises one of a frame or stent formed from synthetic material (Column 6).
Claim 12: Johnson discloses the valve of claim 1, wherein the support structure comprises a stent configured for delivery during a transcatheter procedure (Column 6).
Claim 13: Johnson discloses the valve of claim 1, further comprising fabric (38) covering exposed surfaces of the support structure (Column 6).
Claim 14: Johnson discloses the valve of claim 1, wherein the leaflets are formed from synthetic, polymeric material (Column 5).
Claim 15: Johnson discloses the valve of claim 1, wherein the leaflets are formed from biological material (Column 5).
Claim 21: Johnson discloses a prosthetic heart valve for implantation at a valve annulus, comprising: an annular support structure (102, 112, 122); and a plurality of at least four leaflets (104a-d, 114a-d, 124a-d) attached to the support structure such that the leaflets open and close about a coaptation location.
Claim(s) 1, 6, 10-14, 19-21, and 42 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Lane et al. (US 11357622 B2)
Claim 1: Lane et al. disclose a prosthetic heart valve for implantation at a valve annulus, comprising: an annular support structure and a plurality of at least two leaflets (Fig. 8F) attached to the support structure such that the leaflets open and close about a coaptation location.
Claim 6: Lane et al. disclose the valve of claim 1, wherein the support structure comprises a frame or stent having a generally D-shape (Fig. 8F).
Claim 10: Lane et al. disclose the valve of claim 1, further comprising a suture ring (Fig. 5, Col. 13) attached to the support structure.
Claim 11 Lane et al. disclose the valve of claim 1, wherein the support structure comprises one of a frame or stent formed from synthetic material (Col. 11-13).
Claim 12: Lane et al. disclose the valve of claim 1, wherein the support structure comprises a stent configured for delivery during a transcatheter procedure (Col. 20-32).
Claim 13: Lane et al. disclose the valve of claim 1, further comprising fabric (pargarph 89) covering exposed surfaces of the support structure.
Claim 14: Lane et al. disclose the valve of claim 1, wherein the leaflets are formed from synthetic, polymeric material.
Claim 19: Lane et al. disclose the valve of claim 1, wherein the number of leaflets is at least six (Column 13, lines 38-56).
Claim 20: Lane et al. disclose the valve of claim 1, wherein the number of leaflets is at least five (Column 13, lines 38-56).
Claim 21: Lane et al. disclose a prosthetic heart valve for implantation at a valve annulus, comprising: an annular support structure; and a plurality of at least four leaflets attached to the support structure such that the leaflets open and close about a coaptation location (Fig. 8F).
Claim 42: Lane et al. disclose a method for making a customized prosthetic valve for implantation with a subject’s heart, comprising: selecting a desired number of leaflets for the bioprosthetic valve based on the configuration of the valve annulus of the subject’s heart; forming a support structure configured for implantation with the valve annulus; forming the number of leaflets; and attaching the leaflets to the support structure (Col 13-20).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frater (US-5415667) in view of Muralidhar et al. WO 2009126629 A1.
Frater discloses the claimed valve, including the claimed support structure, but does not expressly disclose that the support structure has a non-planar shape similar to a native mitral valve annulus.
Muralidhar et al. disclose an annuloplasty device comprising a generally triangular, non-planar ring configured for implantation in a heart valve annulus. Muralidhar et al. further teach that the ring may be made from a selected material and may be rigid, semi-flexible, or flexible, with stiffness varying along a continuum from rigid to flexible. In some embodiments, the ring may include a combination of rigid and flexible components aligned with specific anatomical landmarks of the valve annulus.
Muralidhar et al. further disclose that the triangular non-planar ring is configured to conform to the anatomical shape of the valve annulus. In particular, the ring is divided into anatomical segments corresponding to the valve annulus sections associated with the valve leaflets, including septal, posterior, and anterior segments. Each segment is shaped to conform to the corresponding anatomical portion of the valve annulus.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the support structure of Frater to have a non-planar annular shape conforming to the anatomical shape of a native valve annulus, as taught by Muralidhar et al., in order to improve anatomical fit, promote proper seating of the prosthesis, and better conform the prosthetic support to the native annular geometry. Such a modification would have amounted to the predictable use of a known non-planar annular valve-support configuration to improve the fit of a known prosthetic valve support at a native valve annulus. Accordingly, the combination of Frater and Muralidhar et al. renders claim 9 obvious.
Conclusion
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/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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