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.
Claims 1-5, 7-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hacohen et al. (Pub. No.: US 2017/0065407).
Hacohen et al. (hereinafter, Hacohen) discloses a prosthetic valve comprising:
a body member 82 comprising a first end and a second end, the body member defining a conduit and being configured to assume a compressed configuration (fig. 4A) and an expanded configuration (fig. 4B), a lateral dimension of the body member being larger in the expanded configuration than that in the compressed configuration (fig. 4A-4C)
an elongate member 92 having a first end associated with the first end of the body member (fig. 4A-C), the elongate member being configured to move between a longitudinal orientation (fig. 4A) and a diametrical orientation (fig. 4B-4C); and
a covering 82 coupled to the elongate member and configured to cover at least a portion of the conduit at the first end of the body member when the elongate member is in the diametrical orientation (fig. 4B-4C).
For claim 2, Hacohen discloses the prosthetic valve of claim 1, wherein: when the prosthetic valve is in the expanded configuration (fig. 4B-4C), the prosthetic valve is configured to alternate between an open state (fig. 4C) and a closed state (fig. 4B), when the prosthetic valve is in the open state, at least a portion of the covering is configured to be spaced from the first end of the body member to open the first end to fluid flow (fig. 4C), and when the prosthetic valve is in the closed state, the covering is configured to close off the first end of the body member from fluid flow (fig. 4A).
For claim 3, Hacohen discloses the prosthetic valve of claim 1, wherein, when the prosthetic valve is in the expanded configuration (fig. 4B-4C), the body member forms a cylindrical shape and the elongate member is configured to be positioned across a diameter of the first end of the body member (fig. 4B-4C), and the first and second ends of the elongate member are configured to be coupled to diametrically opposing positions on the first end of the body member (fig. 4B-4C).
For claim 4, Hacohen discloses the prosthetic valve of claim 1, wherein the elongate member 92 is rotatably coupled to the first end of the body member (fig. 4A-4B, para. 85).
For claim 5, Hacohen discloses the prosthetic valve of claim 4, wherein the prosthetic valve comprises a hinge connector rotatably coupling the first end of the elongate member 92 and the first end of the body member (bending area is considered a hinge connector, fig. 4A-4B, para. 85).
For claim 7, Hacohen discloses the prosthetic valve of claim 1, wherein, when the prosthetic valve is in the expanded configuration, a second end of the elongate member is coupled to the first end of the body member (fig. 4B-4C).
For claim 8, Hacohen discloses the prosthetic valve of claim 1, wherein the covering is in a rolled configuration while the prosthetic valve is in the compressed configuration, the rolled configuration comprising a longitudinal axis parallel to that of the body member (fig. 4A).
For claim 9, Hacohen discloses the prosthetic valve of claim 1, wherein: the covering is one leaflet 84, the one leaflet being coupled to the elongate member 92 along a longitudinal dimension of the elongate member, and when the prosthetic valve is in the expanded configuration and the closed state, the one leaflet is configured to be positioned over the first end of the body member to close off the fluid flow (fig. 4B).
For claim 10, Hacohen discloses the prosthetic valve of claim 1, wherein: the covering 84 comprises a first leaflet and a second leaflet (on either side of the elongate member 92), each of the first and second leaflets being coupled to the elongate member along a longitudinal dimension of the elongate member, and when the prosthetic valve is in the expanded configuration and the closed state, the first and second leaflets are each configured to cover a corresponding portion of the first end of the body member to close off the fluid flow (fig. 4B).
For claim 11, Hacohen discloses the prosthetic valve of claim 10, wherein: the first and second leaflets are each rotatably coupled to the elongate member, and when the prosthetic valve is in the open state, the first and second leaflets are configured to be pivotally rotated around the elongate member and away from the first end of the body member (fig. 4C).
For claim 12, Hacohen discloses the prosthetic valve of claim 1, wherein the first end of the body member comprises an atraumatic configuration (rounded struts, see fig. 4A-C).
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 6, 13-15, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hacohen et al. (Pub. No.: US 2017/0065407) in view of Duerig et al. (Pub. No.: US 2002/0138135).
For claim 6, Hacohen does not specify the elongate member is integral with the body member. Hacohen does teach the elongate member and body member comprise shape memory material (e.g., para. 59). Duerig teaches an integral elongate member 108 formed of shape memory material (e.g., para. 33). Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the elongate member of Hacohen as integral with the body member as taught by Duerig as an obvious expedient which would reduce manufacturing complexity.
For claim 13, Hacohen discloses a prosthetic valve comprising:
a body member 82 comprising a first end and a second end, the body member defining a conduit extending therethrough and being configured to assume a compressed configuration (fig. 4A) and an expanded configuration (fig. 4B), a lateral dimension of the body member being larger in the expanded configuration than that in the compressed configuration (fig. 4A-C)
a first elongate member 92 comprising a first end and a second end, the first end of the first elongate member being associated with the first end of the body member at a first position on the first end of the body member (fig. 4A-C);
a second elongate member comprising a first end and a second end, the first end of the second elongate member being associated with the first end of the body member at a second position on the first end of the body member (not disclosed), the first and second elongate members being configured to move between a longitudinal orientation and a diametrical orientation (fig. 4A-4B, para. 85); and
a first covering 82 coupled to the first elongate member and a second covering coupled to the second elongate member, the first and second coverings being configured to at least partially cover respective portions of the conduit at the first end of the body member when the first and second elongate members are in the diametrical orientation (fig. 4B-C).
As provided in italicized text above, Hacohen lacks a separate first and second elongate members. Duerig teaches using first and second elongate members 108 to support a flexible pivoting heart valve (fig. 8). It would have been obvious to have modified the single elongate member 92 of Hacohen to the two elongate member 108 configuration taught by Duerig for the purpose of lowering the profile of the compressed valve. This modification would have occurred using known methods and would have yielded predictable results.
For claim 14, Hacohen in view of Duerig teaches the prosthetic valve of claim 13, wherein: when the prosthetic valve is in the expanded configuration, the prosthetic valve is configured to alternate between an open state and a closed state, when the prosthetic valve is in the open state, at least a portion of the first and second coverings are configured to be spaced from the first end of the body member to open the first end to fluid flow (fig. 4C, Duerig fig. 8, para. 46), and when the prosthetic valve is in the closed state, the first and second coverings are configured to be positioned over respective portions of the first end of the body member to close off the first end fluid flow (fig. 4B, Duerig fig. 8).
For claim 15, Duerig teaches the prosthetic valve of claim 13, wherein, when the prosthetic valve is in the expanded configuration, the first and second elongate members are positioned across respective portions of the first end of the body member (fig. 8).
For claim 19, Duerig teaches the prosthetic valve of claim 13, wherein: the first covering comprises a first leaflet and the second covering comprises a second leaflet, the first leaflet being coupled to the first elongate member along a longitudinal dimension of the first elongate member and the second leaflet being coupled to the second elongate member along a longitudinal dimension of the second elongate member, and when the prosthetic valve is in the expanded configuration and the closed state, the first and second leaflets are each configured to cover a corresponding portion of the first end of the body member to close off fluid flow through the first end (fig. 8).
For claim 20, Duerig teaches the prosthetic valve of claim 13, wherein: the first and second coverings are each rotatably coupled to the respective elongate member, and when the prosthetic valve is in the open state, the first and second coverings are configured to be pivotally rotated around the respective elongate member and away from the first end of the body member (fig. 8, para. 46).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hacohen et al. (Pub. No.: US 2017/0065407) in view of Duerig et al. (Pub. No.: US 2002/0138135), further in view of Butter (Pub. No.: US 2021/0298897).
For claim 16, Hacohen and Duerig are explained supra, however, the combination does not specify the prosthetic valve of claim 13, wherein, when the prosthetic valve is in the expanded configuration, the first and second elongate members comprise a stacked configuration and are positioned across a same portion of the first end of the body member. Butter teaches prosthetic leaflets with overlapping leaflet edges (e.g., fig. 2). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the leaflets of Hacohen and Duerig with overlapping ends as taught by Butter for the purpose of providing a larger coaptation area to ensure valve closure. This modification would have occurred using known methods and would have yielded predictable results.
For claim 17, Duerig teaches the prosthetic valve of claim 16, wherein: the first end and second end of the first elongate member are coupled to opposing positions on the first end of the body member, and the first end and the second end of the second elongate member are coupled to opposing positions on the first end of the body member (e.g., fig. 6). It would have been obvious to have modified Hacohen to include the valve as configured in Duerig fig. 6 as an obvious alternate valve design suitable for use as a prosthetic valve for one-way blood flow.
For claim 18, Duerig teaches when the prosthetic valve is in the expanded configuration, the body member forms a cylindrical shape, and the first and second elongate members are configured to be positioned across a diameter of the body member (e.g., fig. 6),
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774