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 .
Allowable Subject Matter
Claims 1-10 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art Barash et al. discloses a prosthetic valve comprising: a radially expandable and compressible annular frame comprising at least a first strut and an adjacent second strut, wherein the first and second struts overlap each other at a pivot joint and radial expansion or compression of the annular frame causes the first strut to pivot relative to the second strut at the pivot joint; a valvular structure comprising at least first and second leaflets configured to permit the flow of blood from an inflow end to an outflow end of the prosthetic valve assembly and block the flow of blood from the outflow end to the inflow end of the prosthetic valve assembly; and a plurality of knots coupling the plurality of leaflets to the annular frame. However, Barash et al. does not expressly disclose wherein the first strut comprises a first strut segment and a second strut segment separated by the pivot joint, the second strut comprises a third strut segment and a fourth strut segment separated by the pivot joint and wherein the plurality of knots comprise an anchor knot attached to the second strut segment, wherein the first end knot is connected to the anchor knot by a first suture transition section, and the anchor knot is connected to the second end knot by a second suture transition section.
Claims 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:
The closest prior art Barash et al. does not expressly disclose nor render obvious wherein the first locking knot is connected to the second locking knot by a first suture transition section, and the second locking knot is connected to the third locking knot by a second suture transition section.
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barash et al. U.S. Publication 2019/0105153 A1.
Regarding Claim 11, Barash et al. discloses a prosthetic valve comprising a radially expandable and compressible annular frame 22 as seen in Figure 2 comprising at least a first strut 32a and an adjacent second strut 32b (as seen in Figure 2), wherein the first strut 32a overlaps the second strut 32b at a pivot joint and radial expansion or compression of the annular frame causes the first strut to pivot relative to the second strut 32a, 32b at the pivot joint (paragraphs [0028-0029], [0175-0176], [0178], [0187-0187]) for the purpose of having an angled orientation of a strut in relationship to a neighboring strut to allow radial expansion and compressibility of the annular frame and allow for varying plastic deformation between the plurality of struts (paragraph [0077]); a valvular structure 24 comprising at least first and second leaflets configured to permit the flow of blood from an inflow end to an outflow end of the prosthetic valve and block the flow of blood from the outflow end to the inflow end of the prosthetic valve (paragraph [0190]); and a suture attaching the first leaflet to the first strut and the second leaflet to the second strut (as seen in Figures 2 and 7, paragraph [0201]) and wherein the suture comprises three interconnected locking knots that are respectively attached to three of the four strut segments (as seen in Figure 2). However, Barash does not expressly disclose wherein the first and second struts comprise four strut segments connected by the pivot joint. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Barash’s plurality of struts forming pairs of first and second struts to further include four struts connected by the pivot joint, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. U.S. Publication 2016/0374802 A1 in view of White WO2010/011699 A2.
Regarding Claim 17, Levi et al. discloses a prosthetic valve 10 comprising a radially expandable and compressible annular frame 12 comprising a plurality of struts 22 interconnected with each other at a plurality joints (as seen in Figures 1-5, the struts overlaps and paragraph [0055]); a valvular structure 14 comprising at least one leaflet configured to permit the flow of blood from an inflow end to an outflow end of the prosthetic valve and block the flow of blood from the outflow end to the inflow end of the prosthetic valve (paragraph [0052] and as seen in Figures 1-3); and an attachment member 72/16 connected to a cusp edge portion (region by 154, see paragraph [0065]) of the leaflet (as seen in Figures 21-26 and 37-39 and paragraphs [0052], [0065] discloses the skirt 16 and reinforcing attachment member 72 collectively form a sleeve) and wrapped around a selected strut of the frame to form inner and outer layers of the attachment member that are sutured to each other (as seen in Figures 37-41 and paragraphs [0083-0084] discloses the outer skirt 18 and inner skirt 16 can be sutured together to form a continuous sleeve). However, Levi et al. does not expressly disclose a plurality of struts interconnected with each other at a plurality pivot joints. White teaches a prosthetic heart valve 120 as seen in Figures 13-15 in the same field of endeavor comprising a frame having a plurality of struts 11 interconnected to each other at joints (intersections of struts), wherein the joints pivot (page 14, lines 10-31) for the purpose of having an angled orientation of a strut in relationship to a neighboring strut enabling the leaflets to be attached to the frame in a triangular configuration that offers structural integrity and durability to the leaflets (page 15, lines 1-11). 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 Levi’s struts to be interconnected with each other at a plurality of pivot points as taught by White for the purpose of having an angled orientation of a strut in relationship to a neighboring strut enabling the leaflets to be attached to the frame in a triangular configuration that offers structural integrity and durability to the leaflets.
Regarding Claim 18, Levi et al. discloses wherein the selected strut comprises a plurality of strut segments between adjacent joints along the length of the selected strut (as seen in Figures 37-43), wherein attachment member 72, 16 comprises a plurality of flaps 164, each of which is wrapped around one of the strut segments (as seen in Figures 42-43 and paragraph [0084]).
Regarding Claim 19, Levi et al. discloses wherein the flaps 164 are spaced apart from each other to define gaps 164 therebetween, and wherein the gaps are aligned with the pivot joints (as seen in Figures 42-43 and paragraph [0084]).
Regarding Claim 20, Levi et al. discloses further comprising a skirt 16 sutured to the cusp edge portion of the leaflet 14, and wherein the cusp edge portion of the leaflet is sandwiched between the skirt and the attachment member 72 (as seen in Figures 36-38 and paragraph [0065]).
Conclusion
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774