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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 1/6/2026 is acknowledged.
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 1-9, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (Pub. No.: US 2018/0177594) in view of Bortlein et al. (Pub. No.: US 2014/0214157).
Patel et al. (hereinafter, Patel) discloses a docking device for a prosthetic heart valve (abstract), the docking device comprising:
an inflow end 30;
an outflow end 20 (e.g., fig. 8, 19);
a support structure disposed between the inflow end and the outflow end (central coils between 20 and 30, e.g., fig. 8, 19), the support structure comprising:
an inflow section extending from the inflow end of the docking device toward the outflow end of the docking device and configured to be positioned on an inflow side of a native heart valve (fig. 8, portion within the atria); and
an outflow section extending between the outflow end of the docking device and the inflow section of the support structure and configured to be positioned on an outflow side of the native heart valve (fig. 8, portion within the ventricle), wherein the outflow section comprises a first portion, a second portion, and a third portion, wherein the first portion extends distally from the inflow section to the third portion, wherein the third portion extends distally from the first portion to the second portion, and wherein the second portion extends distally from the third portion to the outflow end of the docking device (portions can be arbitrarily assigned to the ventricular portion); and
an expandable sleeve 1180 that covers at least a portion of the support structure (fig. 19), wherein the expandable sleeve is movable from a compressed position to an expanded position when a crimping pressure is released, and wherein in the expanded position, the expandable sleeve extends at least 100 degrees over the first portion of the outflow section of the support structure (fig. 19).
Patel describes the covering 1180 as a braided layer which inherently includes some level of expandability due to the nature of braided material, however, Patel does not fairly teach or suggest that covering 1180 is movable from a compressed position to an expanded position when a crimping pressure is released. Bortlein et al. (hereinafter, Bortlein) teaches an elongate clamping member 80 (e.g., fig. 4-5, 10a-b, 11a-d) disposed at the exterior of the connection channel wall structure (ventricular portion of the mitral valve, see fig. 10a, 10b), and has a selectively changeable outer diameter (e.g., para. 59) for the purpose of anchoring a heart valve prosthesis and sealing the leaflets against the prosthesis against blood flow (e.g., para. 60). It would have been obvious to have provided the cover 1180 of Patel with a changeable diameter as taught by Bortein for the purpose of providing customizable anchoring with a prosthetic valve and for the purpose of sealing against blood flow leakage around the prosthetic valve. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Patel discloses the docking device of claim 1, wherein the expandable sleeve extends over the first portion of the outflow section at least 100 degrees from the inflow section of the support structure towards the outflow end of the docking device and is configured to extend to and directly physically contact the third portion of the outflow section of the support structure when the expandable sleeve is in the expanded position (e.g., fig. 19, noting that the “portions” may be defined to satisfy this limitation).
For claim 3, Patel discloses the docking device of claim 1, wherein the expandable sleeve extends over the inflow section of the support structure at least 100 degrees from the outflow section of the support structure towards the inflow end of the docking device (e.g., fig. 19, noting that the “sections” may be defined to satisfy this limitation).
For claim 4, Patel discloses the docking device of claim 1, wherein the expandable sleeve comprises a single continuous sleeve that extends between the inflow section and the outflow section of the support structure (e.g., fig. 19).
For claim 5, Patel discloses the docking device of claim 4, wherein the expandable sleeve comprises a first portion that extends over the inflow section of the support structure, a second portion that extends over the outflow section of the support structure, and an intermediate portion that is disposed between the first portion and the second portion (e.g., fig. 19, noting the “sections” may be defined to satisfy this limitation).
For claim 6, Patel discloses the docking device of claim 5, wherein the expandable sleeve is tapered in the intermediate portion, such that the intermediate portion is narrower than the first portion and the second portion of the expandable sleeve (e.g., fig. 19, para. 144, noting that the intermediate portion may be defined as the narrow segment 1140).
For claim 7, Patel discloses the docking device of claim 5, where the intermediate portion extends at least 45 degrees from the inflow section of the support structure over the first portion of the outflow section of the support structure towards the outflow end of the support structure (e.g., fig. 19, noting the sections may be defined to satisfy this limitation).
For claim 8, Patel discloses the docking device of claim 1, wherein the expandable sleeve comprises a proximal end and a distal end, and wherein the expandable sleeve extends towards the inflow end of the docking device from the distal end to the proximal end, and wherein the expandable sleeve is coupled to the support structure at the distal end (e.g., para. 144, fig. 19).
For claim 9, Patel discloses the docking device of claim 8, wherein the expandable sleeve is tapered at the distal end (e.g., fig. 17, noting that the distal end may be defined at a tapered segment).
For claim 17, Patel discloses the docking device of claim 1, wherein the first portion of the support structure has a different geometry than the third portion of the support structure (e.g., fig. 19).
For claim 18, Patel discloses the docking device of claim 17, wherein the first portion has a different shape than the third portion of the support structure when viewed in a plane perpendicular to a longitudinal axis of the docking device (e.g., fig. 19).
For claim 19, Patel discloses the docking device of claim 17, wherein the first portion has a different size than the third portion of the support structure when viewed in a plane perpendicular to a/the longitudinal axis of the docking device (e.g., fig. 19, first portion may be the narrow segment 1140).
For claim 20, Patel discloses the docking device of claim 19, wherein the first portion is larger than the third portion of the support structure when viewed in the plane perpendicular to the longitudinal axis of the docking device (the portions may be defined such that the first portion is larger than the third portion).
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774