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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7, 8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido et al (US 2017/0086971).
Braido et al discloses the following limitations:
Claim 1. A prosthetic heart valve (900) (Figs. 9A, 9B) comprising:
an annular frame (906) comprising a plurality of interconnected struts (920), the plurality of interconnected struts comprising a plurality of axially extending window struts (925a, 925b, 925c) forming a plurality of commissure windows (openings seen in features 925a, 925b, 925c; wherein [0041] discusses the features as one or more eyelets for suturing) spaced apart around the frame ([0065]); and
an outer skirt (912) disposed around an outer surface of the frame ([0066]; abluminal surface), the outer skirt comprising:
a first edge portion (bottom edge in Fig. 9B);
a second edge portion (top edge in Fig. 9B) arranged at an intermediate portion of the frame that is disposed between a first end (bottom end in Fig. 9A) and a second end of the frame (top end in Fig. 9A; it can be seen in Fig. 9A that the second edge portion (top edge) of the outer skit 912 extends only to an intermediate portion of the frame 906 and not to the second end (top end) of the frame); and
one or more extension portions (dark shading of skirt 912 at each of commissure features 925a, 925b, 925c) extending axially from the second edge portion and over at least a portion of a respective commissure window of the plurality of commissure windows (Fig. 9B; bold lines defining the three fragments F1, F2, F3 of skirt 912 show that each fragment has an extension portion covering completely the commissure features 925a, 925b, 925c).
Claim 2. The prosthetic heart valve of claim 1, wherein the plurality of interconnected struts includes a circumferentially extending row of first struts (952) defining the first end of the frame, wherein the first edge portion is secured to the first struts, and wherein the second edge portion is secured to the intermediate portion of the frame ([0065]; at least indirectly secured as the cuff is attached to the frame).
Claim 7. A prosthetic heart valve (900) (Figs. 9A, 9B) comprising:
an annular frame (906) comprising a plurality of commissure features (925a, 925b, 925c) ([0065]);
a plurality of leaflets (310) arranged within an interior of the frame and secured to one another at adjacent ends to form commissures, wherein each commissure is connected to a respective commissure feature of the frame (discussed in more details in [0039]-[0041] as standard and known in the art; i.e. “the commissure between adjacent leaflets 178 attached to commissure features 166”); and
an outer skirt (912) disposed around an outer surface of the frame ([0066]; abluminal surface), the outer skirt comprising:
a first edge portion (bottom edge in Fig. 9B);
a second edge portion (top edge in Fig. 9B) arranged at an intermediate portion of the frame that is disposed between a first end (bottom end in Fig. 9A) and a second end of the frame (top end in Fig. 9A; it can be seen in Fig. 9A that the second edge portion (top edge) of the outer skit 912 extends only to an intermediate portion of the frame 906 and not to the second end (top end) of the frame); and
a plurality of extension portions (dark shading of skirt 912 at each of commissure features 925a, 925b, 925c) extending axially from the second edge portion, each extension portion covering at least a portion of a corresponding commissure on an exterior of the frame (Fig. 9B; bold lines defining the three fragments F1, F2, F3 of skirt 912 show that each fragment has an extension portion covering completely the commissure features 925a, 925b, 925c).
Claim 8. The prosthetic heart valve of claim 7, wherein each extension portion is formed as a flap that has a width and length sized to cover a width and at least a portion of a length of the corresponding commissure (Fig. 9B).
Claim 10. The prosthetic heart valve of claim 7, wherein the prosthetic heart valve includes three commissures and three extension portions (Fig. 9B), wherein the first edge portion is secured to the first end of the frame, and wherein the first end is an inflow end of the frame, and wherein the second end is an outflow end of the frame ([0065]; at least indirectly secured as the cuff is attached to the frame).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6, 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al in view of Levi et al (US 2012/0123529).
Claim 6. Braido et al discloses the invention substantially as claimed above, including a plurality of leaflets (310) arranged within an interior of the frame (discussed in more details in [0039]-[0041] as standard and known in the art; i.e. “the commissure between adjacent leaflets 178 attached to commissure features 166”) but fails to disclose each leaflet of the plurality of leaflets comprises two commissure tabs disposed on opposite sides of the leaflet and a cusp edge portion extending between the two commissure tabs, wherein commissure tabs of adjacent leaflets are paired together to form commissures, wherein each commissure extends through and is secured to a corresponding commissure window such that a portion of the commissure extends radially outward from the commissure window on an exterior of the frame, and wherein each extension portion extends over and covers at least a portion of a corresponding commissure. Instead, Braido et al discloses suturing the leaflet commissures to the commissure windows ([0041]).
However, in the same field of endeavor, Levi et al teaches a prosthetic heart valve (10) comprising an annular frame (12) having a plurality of axially extending window struts (30) forming a plurality of commissure windows (20), and a plurality of leaflets (40), wherein each leaflet of the plurality of leaflets comprises two commissure tabs (112) disposed on opposite sides of the leaflet and a cusp edge portion extending between the two commissure tabs (Figs. 1-3), wherein commissure tabs of adjacent leaflets are paired together to form commissures, wherein each commissure extends through and is secured to a corresponding commissure window such that a portion of the commissure extends radially outward from the commissure window on an exterior of the frame (Figs. 30-33; [0080]-[0083]). Therefore, since both Braido et al and Levi et al are directed to mechanisms of attaching leaflet commissures to commissure windows of a stent frame, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute one known mechanism (suturing through eyelet of Braido et al) with another (using commissure tabs and extending each commissure radially outward through a commissure window of Levi et al) to achieve the predictable result of providing an attachment means of the leaflet commissures to the frame in a manner that will allow the prosthetic heart valve to be compressed and expanded for delivery. The modification would result in each extension portion extending over and covering at least a portion of a corresponding commissure since Braido et al illustrates in Fig. 9B that the skit 912 covers the exterior of the entirety of the commissure features of the frame.
Claim 9. Braido et al discloses the invention substantially as claimed above, but fails to disclose each commissure protrudes radially outward from the respective commissure feature and the outer surface of the frame such that each extension portion covering the corresponding commissure forms an outer covering for the frame that gradually tapers in a radial direction from the extension portion covering the commissure to the second edge portion of the outer skirt. Instead, Braido et al discloses suturing the leaflet commissures to the commissure windows ([0041]).
However, in the same field of endeavor, Levi et al teaches each commissure protrudes radially outward from the respective commissure feature (commissure window 20) and the outer surface of the frame (Figs. 30-33; [0080]-[0083]). Therefore, since both Braido et al and Levi et al are directed to mechanisms of attaching leaflet commissures to commissure windows of a stent frame, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute one known mechanism (suturing through eyelet of Braido et al) with another (protruding radially outward through a commissure window of Levi et al) to achieve the predictable result of providing an attachment means of the leaflet commissures to the frame in a manner that will allow the prosthetic heart valve to be compressed and expanded for delivery. The modification would result in each extension portion covering the corresponding commissure forming an outer covering for the frame that gradually tapers in a radial direction from the extension portion covering the commissure to the second edge portion of the outer skirt since Braido et al illustrates in Fig. 9B that the skit 912 covers the exterior of the entirety of the commissure features of the frame. It would have been obvious to one of ordinary skill in the art that the presence of the commissure extending through the commissure window would cause the covering to gradually taper outward as there is now material (commissure) on the exterior of the frame where the skirt is (similar to what is illustrated in Fig. 9 of Applicant’s figures).
Claim 11. Braido et al discloses the invention substantially as claimed above, including wherein the annular frame comprises a plurality of interconnected struts (920), wherein the plurality of commissure features is a plurality of axially extending window struts (925a, 925b, 925c) spaced apart around the frame ([0066]), each axially extending window strut defining a commissure window (eyelet in [0041]), and wherein is secured to the commissure window of a respective axially extending window strut ([0041]; sutured) but fails to disclose each commissure extends through the commissure window.
However, in the same field of endeavor, Levi et al teaches each commissure protrudes radially outward from the respective commissure feature (commissure window 20) and the outer surface of the frame (Figs. 30-33; [0080]-[0083]). Therefore, since both Braido et al and Levi et al are directed to mechanisms of attaching leaflet commissures to commissure windows of a stent frame, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute one known mechanism (suturing through eyelet of Braido et al) with another (protruding radially outward through a commissure window of Levi et al) to achieve the predictable result of providing an attachment means of the leaflet commissures to the frame in a manner that will allow the prosthetic heart valve to be compressed and expanded for delivery.
Allowable Subject Matter
Claims 17-20 allowed.
Claims 3-5, 12-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: In regard to dependent claims 3, 4 and 12, the closest prior art of record, Braido et al, discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed prosthetic heart valve comprising, inter alia, the structures as required by claims 3, 4 and 12. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
In regard to claim 17, the closest prior art of record, Braido et al (US 2016/0361160; hereinafter as “Braido ‘160”), discloses a prosthetic heart valve (2100) comprising: an annular frame (2106) comprising a plurality of interconnected struts (2130 and struts making up cells 2122) and having an inflow end (bottom end) and an outflow end (upper end); and an skirt (2112) disposed around a surface of the frame, the outer skirt comprising: an inflow edge portion (bottom edge portion in Fig. 21) disposed at the inflow end; an outflow edge portion (top edge portion in Fig. 21) disposed at an intermediate portion of the frame (Fig. 3A illustrates an example of the frame, wherein the skirt only extends to an intermediate portion of the frame); a plurality of extension portions (portion of skirt 2112 extending to commissure features 5125 for example illustrated in Fig. 15; Fig. 22B also shows the outline of the skirt having the extension portions) extending axially from the outflow edge portion and spaced circumferentially apart from one another, wherein each extension portion extends toward the outflow end of the frame; and a first stitch line (S21) extending circumferentially along an inflow portion of the outer skirt that includes the inflow edge portion ([0065]) and a second stitch line (triangular stitch line near where P21 is labeled in Fig. 21), and wherein the first stitch line and the second stitch line are spaced axially apart from one another, and each comprise a plurality of in-and-out stitches. Braido ‘160 discloses the skirt may be on the outer surface and therefore be considered an outer skit ([0031]). The prior art of record does not disclose or fairly suggest either singly or in combination the claimed prosthetic heart valve comprising, inter alia, the second stitch extending circumferentially along the inflow portion of the outer sit that includes the inflow edge portion. Instead, the second stitch line is spaced a distance from the inflow portion and on the outflow edge portion of the skirt. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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