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
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)(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) 21-30, 32-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yohanan et al. U.S. Publication 2013/0150956 A1.
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Regarding Claim 21, Yohanan et al. discloses a transcatheter valve prosthesis as seen in Figure 15 comprising: a stent 302 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve (paragraphs [0044], [0093-0094]), the stent 400 including an inflow portion formed proximate to an inflow end 314 of the stent, the inflow portion including a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts, a plurality of side openings being defined by the plurality of crowns and the plurality of struts, wherein endmost inflow side openings and endmost inflow crowns are formed at the inflow end of the stent, an outflow portion formed proximate to an outflow end of the stent, the outflow portion including a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts, wherein endmost outflow crowns are formed at the outflow end of the stent; and a prosthetic valve 304 disposed within and secured to the stent via a margin of attachment 368 (paragraphs [0081] and [0090]), the prosthetic valve being configured to substantially block blood flow in one direction to regulate blood flow through a central lumen of the stent, wherein the margin of attachment extends from the inflow end of the stent to the outflow end of the stent.
Regarding Claim 22, Yohanan et al. discloses wherein the margin of attachment 368 extends along the struts of the inflow portion of the stent (see Figures 1 and 13 and paragraph [0090]).
Regarding Claim 23, Yohanan et al. discloses wherein the prosthetic valve 304 includes three leaflets 308 (paragraph [0071]) and wherein the margin of attachment 368 of each leaflet has a concave shape (as seen in Figures 13 and 19 and paragraph [0090]).
Regarding Claim 24, Yohanan et al. discloses wherein each leaflet 308 is sutured to at least the struts of the inflow portion of the stent along the margin of attachment (paragraph [0090] and as seen in Figures 1 and 13).
Regarding Claim 25, Yohanan et al. discloses wherein the stent further includes a transition portion extending between the inflow portion and the outflow portion (see annotated Figure 15 above), the transition portion including a plurality of axial frame members, wherein at least two axial frame members of the plurality of axial frame members are commissure posts having a first end connected to a single crown at an outflow end of the inflow portion and an unattached second end disposed within the outflow portion such that a pair of struts of the outflow portion intersect each commissure post at a mid-portion thereof (as seen in the annotated Figure 15 above).
Regarding Claim 26, Yohanan et al. discloses wherein the margin of attachment extends along each commissure post 322.
Regarding Claim 27, Yohanan et al. discloses wherein the prosthetic valve includes three leaflets 308 (paragraph [0071]), and adjoining pairs of the leaflets are attached to one another to form commissures, and wherein each commissure 334 is sutured to a commissure post 322 along the margin of attachment 368 (as seen in Figure 13).
Regarding Claim 28, Yohanan et al. discloses wherein the prosthetic valve includes three leaflets (paragraph [0045] and as seen in Figures 13-14), and wherein the transition portion includes a total of six axial frame members, with three of the six axial frame members being commissure posts (as seen in the annotated Figure 15 above), each axial frame member disposed approximately halfway between a pair of adjacent endmost outflow crowns, and wherein the commissure posts are aligned with and attached to a respective commissure of the three leaflets of the prosthetic valve (as seen in Figures 13-14, 16 and 20-21).
Regarding Claim 29, Yohanan et al. discloses wherein each commissure post 322 extends substantially parallel to a central longitudinal axis of the stent (as seen in Figure 15 above).
Regarding Claim 30, Yohanan et al. discloses wherein the transition portion includes a total of six axial frame members and a total of six endmost outflow side openings are formed at the outflow end of the stent (as seen in the annotated Figure 15 above), each endmost outflow side opening being defined by two struts of the outflow portion, four struts of the inflow portion, and two axial frame members of the transition portion (as seen in the annotated Figure 15 above).
Regarding Claim 32, Yohanan et al. discloses wherein the total of the endmost inflow crowns is twice the total of the endmost outflow crowns (as seen in Figure 15 above, there are 12 inflow crowns and 6 outflow crowns).
Regarding Claim 33, Yohanan et al. discloses wherein the inflow portion includes at least three rows of struts 370 and crowns formed between adjacent pairs of said struts and the outflow portion includes a single row of struts 302 and crowns formed between adjacent pair of said struts (as seen in the annotated Figure 15 above).
Regarding Claim 34, Yohanan et al. discloses wherein the stent further includes a plurality of axial frame members, wherein the at least three rows of the inflow portion are formed between an inflow end of the axial frame members and an inflow end of the stent, and wherein the outflow portion is coupled to an outflow end of the axial frame members, wherein exactly two struts of the plurality of struts of the outflow portion are disposed between adjacent axial frame members, at least two axial frame members of the plurality of axial frame members being commissure posts having a first end connected to a single crown at an outflow end of the inflow portion and an unattached second end disposed within the outflow portion such that a pair of struts of the outflow portion intersect each commissure post at a mid-portion thereof (as seen in the annotated Figure 15 above).
Regarding Claim 35, Yohanan et al. discloses wherein the plurality of axial frame members includes exactly six axial frame members, wherein three of the six axial frame members are commissure posts 322 and three of the six axial frame members are axial struts, and wherein each of the axial struts is disposed between adjacent commissure posts (as seen in the annotated Figure 15 above).
Regarding Claim 36, Yohanan et al. discloses wherein one of the at least three rows of struts 370 and crowns of the inflow portion includes crowns coupled to inflow end of the axial frame member, wherein the one row includes at least four struts between adjacent axial frame members (as seen in the annotated Figure 15 above).
Regarding Claim 37, Yohanan et al. discloses wherein the plurality of axial frame members includes a plurality of axial struts and a plurality of commissure posts 322, wherein there are the same number of axial struts and commissure posts, wherein each of the axial struts is disposed between adjacent commissure posts (as seen in the annotated Figure 15 above).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan et al. U.S. Publication 2013/0150956 A1 in view of Tuval et al. U.S. Publication 2010/0121436 A1.
Regarding Claim 31, Yohanan et al. discloses a plurality of commissure posts 322 (see rejections above). However, Yohanan et al. does not expressly disclose wherein a directional marker is formed on the at least one commissure post, the directional marker being an axially non-symmetrical element or opening. Tuval et al. teaches a transcatheter valve prosthesis in the same field of endeavor comprising a stent 10 comprising an inflow end and an outflow end and a plurality of commissure posts 11 for coupling valve 104 to the stent structure 12/14, wherein the commissure posts comprises radiographic identifiers 16 that are axially non-symmetrical (as seen in Figure 10A-10B) to aid in radiographic positioning and rotational aligning of the commissural posts with respective native commissures (paragraphs [0038-0039], [0042] and [0088]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Yohanan’s commissure posts to further include axially non-symmetrical radiographic identifiers as taught by Tuval et al. for the purpose of aiding in radiographic positioning and rotational aligning of the commissural posts with respective native commissures.
Claim(s) 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan et al. U.S. Publication 2013/0150956 A1 in view of Braido et al. U.S. Publication 2014/0277389 A1.
Regarding Claim 38, Yohanan et al. discloses the first axial frame member being directly adjacent to the first commissure post, wherein the commissure post 322 is on an outflow end (see rejections above and annotated Figure 15 above). However, Yohanan et al. does not expressly disclose wherein a first outflow marker and a second outflow marker, wherein the first outflow marker is disposed on a first commissure post of the commissure posts of the stent and the second outflow marker is positioned on a first axial frame member of the axial frame members of the stent, the first axial frame member being directly adjacent to the first commissure post and further comprising: a plurality of radiopaque inflow markers disposed on the inflow portion of the stent, wherein the radiopaque inflow markers are circumferentially aligned with each other around a circumference of the stent; and a first outflow marker and a second outflow marker. Braido et al. teaches a transcatheter valve prosthesis (paragraph [0006]) in the same field of endeavor comprising an inflow portion including rows of struts and crows formed between adjacent pairs of struts (as seen in Figure4A-4C) and an outflow portion including a row of struts and crowns formed between pairs of said struts (as seen in Figures 4A-4C), wherein the outflow portion include a first outflow marker 9 on a first commissure post (as seen in Figures 7A-7B) for the purpose of providing orientation and indication of the position of the valve leaflet secured to the prosthetic valve frame at commissure posts (paragraph [0044-0045]) and a second outflow marker 9a positioned on the axial frame member (paragraph [0046] and as seen in Figures 7A-8B) for the purpose of delineating boundaries of the stent such as the upper and lower edges/ends of the prosthetic valve frame to enable the user to assume the end of the prosthetic valve frame does not protrude too far into the left ventricle (paragraph [0046]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Yohanan’s commissure posts and axial frame members to further include radiopaque markers as taught by Braido et al. for the purpose of providing orientation and indication of the position of the valve leaflet secured to the prosthetic valve frame at commissure posts and for delineating boundaries of the stent such as the upper and lower edges/ends of the prosthetic valve frame to enable the user to assume the end of the prosthetic valve frame does not protrude too far into the left ventricle.
Regarding Claim 39, Yohanan et al. does not expressly disclose wherein one of the first outflow marker and the second outflow marker is positioned closer to an outflow end of the stent relative to the other of the first outflow marker and the second outflow marker. Braido et al. teaches a transcatheter valve prosthesis (paragraph [0006]) in the same field of endeavor comprising an outflow portion including a row of struts and crowns formed between pairs of said struts (as seen in Figures 4A-4C), wherein the outflow portion include a first outflow marker 9 on a first commissure post (as seen in Figures 7A-7B) for the purpose of providing orientation and indication of the position of the valve leaflet secured to the prosthetic valve frame at commissure posts (paragraph [0044-0045]) and a second outflow marker 9a positioned on the axial frame member (paragraph [0046] and as seen in Figures 7A-8B) for the purpose of delineating boundaries of the stent such as the upper and lower edges/ends of the prosthetic valve frame to enable the user to assume the end of the prosthetic valve frame does not protrude too far into the left ventricle (paragraph [0046]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Yohanan’s commissure posts and axial frame members to further include radiopaque markers in different upper and lower edges as taught by Braido et al. for the purpose of providing orientation and indication of the position of the valve leaflet secured to the prosthetic valve frame at commissure posts and for delineating boundaries of the stent such as the upper and lower edges/ends of the prosthetic valve frame to enable the user to assume the end of the prosthetic valve frame does not protrude too far into the left ventricle.
Regarding Claim 40, Yohanan in view of Braido et al. discloses a transcatheter valve prosthesis comprising a marker on the commissure post and the axial frame members. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Yohanan’s first commissure post of the commissure posts include a marker disposed thereon and only the first axial frame member of the axial frame members includes a marker disposed thereon since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. The location and number of radiopaque parts involves routine skill in the art to access if additional markers are needed to determine the orientation of the valve leaflets or the direction of the frame member during implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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