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 . Claims 1-20 are pending and examined below.
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) 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pisani et al. (US 20230218390 A1) hereinafter, Pisani.
Regarding claim 17, Pisani teaches
a prosthetic heart valve (2, Fig. 27) comprising:
an annular frame (1, Fig. 27) comprising a plurality of interconnected struts (4, Fig. 27); and
an outer skirt (5, Fig. 27) disposed on an outer surface of the annular frame (1, Fig. 27) and detachably secured to at least a portion of the plurality of interconnected struts (4, Fig. 27); wherein
the outer skirt (5, Fig. 27) is detachably secured to the portion of the plurality of interconnected struts via at least one retaining suture (82, Fig. 15D) and one or more pull sutures (81, Fig. 15D), the retaining suture (82, Fig. 15D) and one or more pull sutures (81, Fig. 15D) arranged along a suture line (where 81 and 82 is stitched is the suture line, Fig. 15D), the retaining suture (82, Fig. 15D) forming a plurality of stitches (multiples of 82 forms a plurality of stitches, Fig. 15D) extending through the outer skirt (5, Fig. 27) and over the one or more pull sutures (81, Fig. 15D).
Regarding claim 18, Pisani teaches
a prosthetic heart valve (2, Fig. 27) comprising:
an annular frame (1, Fig. 27) comprising a plurality of interconnected struts (4, Fig. 27) and a plurality of anchoring projections (projections at 11 end, see annotated Fig. 22B below); and
an outer skirt (5, Fig. 27) disposed on an outer surface of the annular frame (1, Fig. 27) and covering at least a portion of the plurality of anchoring projections, the outer skirt detachably secured to at least a portion of the plurality of interconnected struts; wherein
the outer skirt (5, Fig. 27) is configured to detach from the portion of the plurality of interconnected struts (4, Fig. 27) and enable separation of the annular frame (1, Fig. 27) from the outer skirt (5, Fig. 27),
the plurality of anchoring projections (projections at 11 end, see annotated Fig. 22B below) on the outer surface of the annular frame (1, Fig. 27) being exposed after separation of the annular frame and the outer skirt (5, Fig. 27).
The phrase “…the outer skirt is configured to detach from the portion of the plurality of interconnected struts and enable separation of the annular frame from the outer skirt” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
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.
Claim(s) 1-3, 6-10, 12-13, 16, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pisani in view Bourang et al. (US 20070088431 A1) hereinafter, Bourang.
Regarding claim 1, Pisani teaches a prosthetic heart valve (2, Fig. 27) comprising:
an annular frame (1, Fig. 27) comprising a plurality of interconnected struts (4, Fig. 27); and
an outer skirt (5, Fig. 27) disposed on an outer surface of the annular frame (1, Fig. 27) and detachably secured to at least a portion of the plurality of interconnected struts (4, Fig. 27); wherein
the outer skirt (5, Fig. 27) is detachably secured to the portion of the plurality of interconnected struts (4, Fig. 27) via at least one retaining suture (82, Fig. 15D) and one or more pull sutures (81, Fig. 15D), the retaining suture (82, Fig. 15D) and one or more pull sutures (81, Fig. 15D) arranged along a suture line (where 81 and 82 is stitched is the suture line, Fig. 15D), the retaining suture (82, Fig. 15D) forming a plurality of stitches (multiples of 82 forms a plurality of stitches, Fig. 15D) extending through the outer skirt (5, Fig. 27) and over the one or more pull sutures (81, Fig. 15D); and wherein
the outer skirt (5, Fig. 27) is configured to detach from the portion of the plurality of interconnected struts (4, Fig. 27) and enable separation of the annular frame (1, Fig. 27) from the outer skirt (5, Fig. 27) via removal of the one or more pull sutures (81, Fig. 15D) from the suture line and withdrawal of the plurality of stitches (multiples of 82 forms a plurality of stitches, Fig. 15D) through the outer skirt (5, Fig. 27).
The phrase “…the outer skirt is configured to detach from the portion of the plurality of interconnected struts and enable separation of the annular frame from the outer skirt via removal of the one or more pull sutures from the suture line and withdrawal of the plurality of stitches through the outer skirt” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
Pisani teaches the pull wire but does not disclose specifically removal of the one or more pull sutures. However, Bourang teaches a heart valve delivery system is provided wherein a prosthetic valve is carried on a valve catheter (abstract, Bourang) wherein
removal of the one or more pull sutures (234, Fig. 20) from the suture line and withdrawal of the plurality of stitches (238, Fig. 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani by incorporating the pull suture as taught by Bourang in order to quickly and easily detach the sutures from the prosthetic valve (¶0080, Bourang).
Regarding claim 2, Pisani teaches
wherein each of the one or more pull sutures (81, Fig. 15D) comprises an end region (portion at 83, Fig. 15B) that extends beyond the suture line, the end region being attached to an attachment region (84, Fig. 15) at one or more of the annular frame (1, Fig. 27), the outer skirt, or a valvular structure disposed within an interior of the annular frame; and wherein
the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures (81, Fig. 15B) from the suture line.
The phrase “…the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures from the suture line” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
Pisani teaches the pull wire but does not disclose specifically the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures. However, Bourang teaches
the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures (¶0103, Bourang).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani by incorporating the pull suture as taught by Bourang in order to quickly and easily detach the sutures from the prosthetic valve (¶0080, Bourang).
Regarding claim 3, Pisani teaches
wherein the end region (portion at 83, Fig. 15B) is releasably attached at the attachment region (84, Fig. 15) via one or more of an adhesive, a suture, a knot (83, Fig. 15B), or an elastic band.
Regarding claim 6, Pisani teaches
wherein the one or more pull sutures are comprised of one or more of PTFE, ePTFE, or prolene (¶0148).
Regarding claim 7, Pisani teaches
wherein the at least one retaining suture comprises UHMPE force fiber (¶0148).
Regarding claim 8, Pisani teaches
wherein the at least one retaining suture extends through pre-formed openings (45, Fig. 39) in the outer skirt (5, Fig. 39).
Regarding claim 9, Pisani teaches
wherein each stitch extends through a single opening in the outer skirt (stitch may be provided, ¶0375).
Regarding claim 10, Pisani teaches
wherein the outer skirt comprises two or more skirt portions (51 & 52, Fig. 18B), adjacent ones of the two or more skirt portions having an overlapping region therebetween, the suture line extending through at least a portion of the overlapping region (suture line along 1, Fig. 18B).
Regarding claim 12, Pisani teaches
wherein the plurality of stitches further extend around the portion of the plurality of interconnected struts (4, Fig. 15B, assembly of outer skirt to struts, ¶0327).
Regarding claim 13, Pisani teaches
wherein the plurality of stitches (multiples of 82 forms a plurality of stitches, Fig. 15D) are configured to remain attached to the portion of the plurality of interconnected struts (4, Fig. 27) after separation of the annular frame from the outer skirt (5, Fig. 27) during an explant procedure (outer skirt can be removed and the stitches remain in place).
The phrase “…the plurality of stitches are configured to remain attached to the portion of the plurality of interconnected struts after separation of the annular frame from the outer skirt during an explant procedure” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
Regarding claim 16, Pisani teaches
wherein the outer skirt comprises at least one fused edge (53, Fig. 18B), and wherein the fused edge is folded over an exterior surface of the prosthetic heart valve to create a folded edge (folded at 7, Fig. 18B), wherein the folded edge is secured to adjacent struts of the plurality of interconnected struts via the at least one retaining suture and the one or more pull sutures (outer skirt edge is affixed to the inner skirt and the stent-structure, Fig. 18B, ¶0342).
Regarding claim 19, Pisani teaches
wherein the outer skirt (5, Fig. 27) is detachably secured to the portion of the plurality of interconnected struts via at least one retaining suture (82, Fig. 15D) and one or more pull sutures (81, Fig. 15D), the retaining suture (82, Fig. 15D) and one or more pull sutures (81, Fig. 15D) arranged along a suture line (where 81 and 82 is stitched is the suture line, Fig. 15D), the retaining suture (82, Fig. 15D) forming a plurality of stitches (multiples of 82 forms a plurality of stitches, Fig. 15D) extending around the portion of the plurality of interconnected struts (4, Fig. 27), through the outer skirt (5, Fig. 27), and over the one or more pull sutures (81, Fig. 15D), and wherein the outer skirt can be detached from the annular frame via removal of the one or more pull sutures (81, Fig. 15D) from the suture line and withdrawal of the plurality of stitches through the outer skirt.
Pisani teaches the pull wire but does not disclose specifically removal of the one or more pull sutures. However, Bourang teaches
removal of the one or more pull sutures (234, Fig. 20) from the suture line and withdrawal of the plurality of stitches (238, Fig. 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani by incorporating the pull suture as taught by Bourang in order to quickly and easily detach the sutures from the prosthetic valve (¶0080, Bourang).
Regarding claim 20, Pisani teaches
wherein each of the one or more pull sutures (81, Fig. 15D) comprises an end region (portion at 83, Fig. 15B) that extends beyond the suture line, the end region being releasably attached to an attachment region (84, Fig. 15) at one or more of the annular frame (1, Fig. 27), the outer skirt, or a valvular structure disposed within an interior of the annular frame; and wherein
the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures (81, Fig. 15B) from the suture line.
The phrase “…the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures from the suture line” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
Pisani teaches the pull wire but does not disclose specifically the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures. However, Bourang teaches
the end region is configured to be released from the attachment region and pulled to remove a corresponding pull suture of the one or more pull sutures (¶0103, Bourang).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani by incorporating the pull suture as taught by Bourang in order to quickly and easily detach the sutures from the prosthetic valve (¶0080, Bourang).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pisani in view Bourang and further in view of of Bapat et al. (US 20160296324 A1) hereinafter, Bapat.
Regarding claim 4, Pisani does not teach the end region comprises a marker. However, Bapat teaches a heart prosthesis (abstract, Bapat)
wherein the end region comprises a marker (marker 70, ¶0044, Bapat) configured to enable identification of a corresponding pull suture of the one or more pull sutures (¶0044, Bapat).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani by incorporating the marker as taught by Bapat in order to provide selected information associated with the heart valve (¶0044, Bapat).
Regarding claim 5, Pisani does not teach the marker comprises at least one of a colored marker or a radiopaque marker. However, Bapat teaches
wherein the marker (marker 70, ¶0044, Bapat) comprises at least one of a colored marker or a radiopaque marker attached to or disposed within the end region (materials impregnated with radiopaque or echogenic materials, including fabric sutures, ¶0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani and Bourang by incorporating the marker as taught by Bapat in order to provide selected information associated with the heart valve (¶0044, Bapat).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pisani in view of Bourang and further in view of Yang et al. (US 20240207047 A1) hereinafter, Yang.
Regarding claim 11, Pisani teaches
wherein the outer skirt (5, Fig. 27, Pisani) comprises a first outer skirt disposed on an inflow end portion (portion by 11, Fig. 27, Pisani) of the outer surface of the annular frame (1, Fig. 27, Pisani) and detachably secured to a first portion of the plurality of interconnected struts (4, Fig. 27, Pisani) forming the inflow end portion of the annular frame (outer skirt located inflow section, ¶0333, Pisani).
Pisani does not teach a second outer skirt disposed on an outflow end portion. However, Yang teaches a valve prosthesis (abstract, Yang)
wherein the prosthetic heart valve further comprises a second outer skirt (20, Fig. 4, Yang) disposed on an outflow end portion (12, Fig. 4, Yang) of the outer surface of the annular frame (10, Fig. 1, Yang) and detachably secured to a second portion of the plurality of interconnected struts forming the outflow end portion of the annular frame.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani and Bourang by incorporating the second skirt as taught by Yang in order to block blood from flowing through a gap between the valve prosthesis and the native tissue (¶0037, Yang).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pisani in view of Bourang and further in view of Levi et al. (US 20230143332 A1) hereinafter, Levi.
Regarding claim 14, Pisani teaches the outer skirt (5, Fig. 27, Pisani) skirt is further detachably secured to the portion of the plurality of interconnected struts (4, Fig. 27, Pisani). Pisani does not teach the outer skirt is further detachably secured to the portion of the plurality of interconnected struts via a plurality of non-penetrating stitches. However, Levi teaches
secured via a plurality of non-penetrating stitches (182, Fig. 18, Levi.), the plurality of non-penetrating stitches extending around the portion of the plurality of interconnected struts (111, Fig. 18, Levi.) and between the at least one retaining suture (144, Fig. 18, Levi.) and an interior surface of the outer skirt (¶0299, Levi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani and Bourang by incorporating the teachings above as taught by Levi in order to improve long-term durability of the leaflets and their attachment to the frame (¶0285, Levi).
Regarding claim 15, Pisani does not teach the plurality of stitches and the plurality of non-penetrating stitches are configured to remain attached to the portion of the plurality of interconnected struts after separation of the annular frame from the outer skirt. However, Levi teaches
wherein the plurality of stitches and the plurality of non-penetrating stitches are configured to remain attached to the portion of the plurality of interconnected struts after separation of the annular frame from the outer skirt during an explant procedure (¶0273, Levi).
The phrase “…the plurality of non-penetrating stitches are configured to remain attached to the portion of the plurality of interconnected struts after separation of the annular frame from the outer skirt during an explant procedure” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pisani and Bourang by incorporating the teachings above as taught by Levi in order to improve long-term durability of the leaflets and their attachment to the frame (¶0285, Levi).
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Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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