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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 2-16 are moot in view of the new grounds for rejection. Applicant has amended claim 2 to recite the plurality of projections coupled to the leaflets wherein the projections are radially closer to each other in the closed position than the open position. In response to Applicant’s amendment, Examiner has added reference to Lane (U.S. Pat. No.: 5,037,434) to the rejection of claim 2.
Claim Objections
Claim 2 is objected to because of the following informalities:
In line 5, “and having and three extensions” appears to be a typographical error.
In line 6-7, “downstream and” appears to be a typographical error of ---downstream end.
In line 7, “valve each and each” appears to be a typographical error.
In line 11, “the curved interest interface” appears to be a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 2 has been amended to state “such that the plurality of projections coupled to the leaflets wherein the projections are radially closer to each other in the closed position than in the open position.” The specification is silent as to projections which are radially closer to each other in the closed position compared to the open position.
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 2-16 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.
Independent claim 2 has been amended to state “such that the plurality of projections coupled to the leaflets wherein the projections are radially closer to each other in the closed position than in the open position.” The limitation “the plurality of projections” lacks antecedent basis in the claims. Moreover, the limitation is indefinite as it is unclear whether the projections are the same feature as the three extensions, or are a different feature.
The limitation “such that the plurality of projections coupled to the leaflets wherein the projections are radially closer to each other in the closed position than the open position” is indefinite as it is unclear what “such that the plurality of projections coupled to the leaflets” means.
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.
Claims 2-16 are rejected under 35 U.S.C. 103 as being unpatentable over Moe et al. (U.S. Pat. No.: 6,613,086) in view of Lane (U.S. Pat. No.: 5,037,434).
Moe et al. (hereinafter, Moe) disclose a prosthetic heart valve (abstract), comprising:
a substantially cylindrical support structure (valve body 12) having a central axis oriented in the direction of blood flow through an interior of the support structure, an annular base portion (e.g., part of valve body 12 at sewing ring 20) having a circumference positioned to form an annular upstream edge that may be planar or curved (e.g., part of valve body 12 at sewing ring 20) and having three extensions 24 positioned about the periphery of the annular upstream edge of the annular base and that project towards a downstream [end] of the prosthetic valve (e.g., fig. 1) and each having a curved interface meeting and coinciding with an operable base of each leaflet and terminating in an apex (e.g., fig. 3);
a plurality of artificial leaflets 14, each leaflet having a movable part attached to the annular base at the curved interface along the upstream edge (fig. 1, 3) and a free edge 18 (seen in fig. 1) allowed to move independent of the support structure,
the movable part of each leaflet also having a central axis extending between the base and the free edge (e.g., fig. 3), wherein the movable part of each leaflet is each movable between a first, closed position, for preventing the flow of blood through an interior of the support structure (closed, e.g., fig. 3), and a second, open position, for maximizing the flow of blood through the interior of the support structure (e.g., open position), such that the plurality of projections coupled to the leaflets wherein the projections are radially closer to each other in the closed position than the open position (not disclosed) and wherein in the open position the free edges of the leaflets form an annular configuration concentric with the periphery of the annular base except at each apex (e.g., fig. 3, leaflet shape would result in an open position concentric with the support structure except at the apex due to the extra material at the coaptation point).
As best understood by examiner, Moe lacks projections which are radially closer in the closed position than the open position. Lane teaches flexible stent commissures which flex such that they are radially closer in the closed configuration (abstract) to distribute stress throughout the prosthetic valve and thereby improve implant longevity. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have included flexible commissures as taught by Lange with the prosthetic valve of Moe for the purpose of improving load distribution throughout the cardiac cycle. This modification would have occurred using known methods and would have yielded predictable results.
For claim 3, Moe discloses the prosthetic heart valve of claim 2, wherein each of the three extensions has an intersection with the base of each of the three leaflets to form a continuous curved interface (attachment curve 16) having convex portions on either side of each apex (not expressly disclosed). Moe teaches attachment curve 16 as seen in figure 3, which appears to include convex portions on either side of the apes 32, however this is not expressly disclosed. Lane teaches a prosthetic heart valve with commissures having convex portions on either side of each apex (e.g., fig. 3 at label 38 and label 40) as a suitable commissure shape, which forms a curved triangular appearance when covered as seen in figure 15. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Moe prosthetic valve with an attachment curve 16 including convex portions on either side of the apex as taught by Lane fig. 2 and 15 as an obvious design choice to provide a suitable commissure curvature and valve attachment profile to serve as the junction of the movable part of the leaflet with the valve body 12. This modification would have occurred using known methods and would have yielded predictable results.
For claim 4, Lane teaches the prosthetic heart valve of claim 3, wherein the convex portions comprise a midway point of the intersection between the annular base portion and each apex (e.g., fig. 2, 15, the convex portions are on either side of the apex and include a midway point of the intersection between the annular base portion and each apex).
For claim 5, Moe discloses the prosthetic heart valve of claim 2, wherein the support structure (valve body 12) comprises an annular base portion at an upstream, blood inlet end (end with sewing ring 20, see fig. 3).
For claim 6, Moe discloses the prosthetic heart valve of claim 2, wherein the support structure comprises a sewing cuff 20 at the annular base portion (e.g., fig. 3).
For claim 7, Moe discloses the prosthetic heart valve of claim 2, wherein the annular base portion is integrally formed with the base of the movable part of each leaflet (e.g., col. 4 lines 24-25).
For claim 8, Moe discloses the prosthetic heart valve of claim 2, wherein each of the artificial leaflets are polymeric (e.g., col. 4 lines 24-25).
For claim 9, Moe discloses the prosthetic heart valve of claim 2, wherein the prosthetic heart valve is not radially collapsible for placement into an intravascular delivery device (prosthetic heart valve is not collapsible).
For claim 10, Moe discloses the prosthetic heart valve of claim 2, wherein the prosthetic heart valve is not radially collapsible for placement in a trans-apical delivery device (prosthetic heart valve is not collapsible).
For claim 11, Moe discloses the prosthetic heart valve of claim 2, wherein the support structure and the plurality of leaflets are formed of the same material (e.g., col. 4 lines 24-25).
For claim 12, Lane teaches the prosthetic heart valve of claim 3, wherein the continuous curved interface on either side of each apex comprises three pairs of convex portions located between the annular base portion and the continuous curved interface proximate to either side of each apex (e.g., Lane fig. 2, 15).
For claim 13, Moe lacks the base of the movable part of each of the plurality of leaflets is sewn to the support structure. Lane teaches an alternate method of assembling a polymeric prosthetic heart valve whereby the valve body is wrapped in fabric and prosthetic leaflets are sewn onto the body (e.g., Lane, figs. 10-15). It would have been an obvious alternate design choice to attach prosthetic leaflets using stitching as taught by Lane which desirably allows the use of non-moldable leaflet material. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the Moe prosthetic heart valve to include leaflets sewn to the support structure as taught by Lane for the purpose of providing leaflets which are a different material than the remainder of the frame. This modification would have occurred using known methods and would have yielded predictable results.
For claim 14, Moe discloses the prosthetic heart valve of claim 2, wherein the base of the movable part of each of the three leaflets is a casting boundary between each leaflet and the support structure (col. 4 lines 20-25).
For claim 15, Moe lacks a scalloped terminus. Lane teaches a scalloped terminus (e.g., fig. 16) for the purpose of matching native aortic valve geometry. It would have been obvious to one of ordinary skill in the art to have modified the flat terminus of Moe to include a scalloped terminus as taught by Lane figure 16 in order to provide an inflow end of the frame which abuts the native aortic annulus shape which results in a better prosthetic valve fit. This modification would have occurred using known methods and would have yielded predictable results.
For claim 16, Moe discloses the prosthetic heart valve of claim 2, wherein the prosthetic heart valve is adapted for use as a prosthetic mitral valve (the prosthetic valve is fully capable of being implanted in this location) in the annular base portion has a flat terminus (e.g., fig. 3).
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774