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 .
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.
Election/Restrictions
Applicant’s election without traverse of claims 1-19 in the reply filed on 1/28/26 is acknowledged. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 17 and 18 are objected to because of the following informalities: typographical errors.
Claim 17 should be amended to “the floating coil is positioned on an inner shaft component distal of the retention socket with clearance to the inner
Claim 18 should be amended to “to rotate freely around the inner shaft component upon the capsule and implant being rotated relative to the inner shaft.”
Appropriate correction is required.
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.
Claim(s) 1-2, 8-13, 15-16, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (20120078350).
Regarding claim 1, Wang discloses a retention socket (30d) for retaining a prosthetic aortic valve (1) in a delivery device (Fig. 6A), comprising: a retention recess (36d, 38) positioned on an external surface of the retention socket (FIG 6A), the retention recess (36d, 38) engaging with a paddle or other retention feature (4, 2) of the prosthetic aortic valve (FIG 6A), the retention socket (30d) is rotatable relative to a longitudinal axis of the delivery device ([0074]).
Regarding claim 2, Wang discloses the retention socket of claim 1, wherein the retention recess fits the paddle so that the paddle is restrained axially (FIG 6A).
Regarding claim 8, Wang discloses the retention socket of claim 1, wherein the retention recess is one of a pair of retention recesses symmetrically positioned on opposite sides of an external surface of the retention socket (FIG 6C, [0078]).
Regarding claim 9, Wang discloses the retention socket of claim 8, wherein each of the retention recesses (36d) engage with a paddle (4) of the prosthetic aortic valve (1) and the paddle is detachably locked into the retention recess ([0077], “configured to receive” implies non permanence), each retention recess has an axis of symmetry along which a length of the paddle engaging with that recess extends (FIG 6A).
Regarding claim 10, Wang discloses the retention socket of claim 9, wherein a length along the axis of one of the pair of retention recesses (36d) is greater than a length along the axis of the paddle (4) engaging with that retention recess (Fig. 6A), and a length along the axis of the other retention recess (38) equals the length along the axis of the paddle (2) engaging with that other retention recess to allow the paddle engaging with the recess of larger length one degree of freedom of movement, while the paddle engaging the other retention recess cannot move axially upon the delivery device undergoing a bend in a plane of deflection associated to that pair of retention recesses. (The paddle engaging with the recess of large length is capable of one degree of freedom of movement when undergoing a bend, while the paddle engaging in the other retention recess is not capable of this movement, because pocket 41d creates space to allow for deflection while bending along that axis).
Regarding claim 11, Wang discloses a device (10) for delivering a prosthetic aortic valve (1) into an implantation site (Fig. 1A), comprising: a proximal end locatable in proximity to a clinician (FIG 1A); a distal end locatable distant from the clinician (FIG 1A); and a retention socket (30d; Fig. 6A) including a retention recess (36d) positioned on an external surface of the retention socket, the retention recess engaging with a paddle or other retention feature (4, 2) of the prosthetic aortic valve (FIG 6A), the retention socket is rotatable relative to a longitudinal axis of the device ([0074]).
Regarding claim 12, Wang discloses the device of claim 11, wherein the prosthetic aortic valve (1) has a first paddle (2) connected to a frame (Fig 6A), the first paddle engaged with the retention recess (portion 38 of recess 36d).
Regarding claim 13, Wang discloses the device of claim 12, wherein the first paddle (2) fits the retention recess and is restrained axially (the lack of space in recess 38 causes the paddle to be restrained axially), and further comprising a second paddle (4) that can move axially (Fig. 6A).
Regarding claim 15, Wang discloses the device of claim 11, further comprising a handle connected to a capsule (22; [0043]) such that when a torque is applied to a section of a handle attached to an outer shaft (40d) and to the capsule (22) relative to a section of the handle attached to an inner shaft (50d), by the clinician, the torque is transferred to the capsule ([0043], as the handle is connected to the capsule, any torque applied to the handle will be transferred to the capsule).
Regarding claim 16, Wang discloses the device of claim 15, wherein the capsule is connected to the prosthetic valve by an outward force exerted by the prosthetic aortic valve on the capsule such that the torque is transferred through friction from the capsule to the prosthetic valve and to the socket (30d) engaged with the paddle (2, 4), the socket (30d) is configured to freely rotate relative to the inner shaft ([0074]).
Regarding claim 19, Wang discloses the device of claim 12, wherein the first paddle (2) has a sliding anchor (4) sliding in the retention recess (FIG 6A, where the paddle has the ability to slide given the extra space provided).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-5, 7, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20120078350), as applied to claims 1and 11 above, and further in view of Creaven (20150025622).
Regarding claim 3, Wang discloses the retention socket of claim 1, but fails to disclose a locking device locking rotation of the retention socket upon being rotated to an implantation angle.
Creaven also discloses a rotatable heart valve delivery system (FIG 2) comprising a retention socket (120). Creaven teaches a locking device ([0052]) locking rotation of the retention socket upon being rotated to an implantation angle ([0036]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s retention socket to include a locking device locking rotation of the retention socket upon being rotated to an implantation angle, as taught by Creaven, in order to bias the orientation to the appropriate implantation angle ([0038]).
Regarding claim 4, Wang discloses the retention socket of claim 1, but fails to disclose a marking indicating a rotation of the retention socket relative to a plane of a capsule of the delivery device.
Creaven also discloses a rotatable heart valve delivery system (FIG 2), and teaches that it comprises a marking (132) indicating a rotation of the retention socket (120) relative to a plane of a capsule (130, where the prosthetic value is attached to 130 [0031]) of the delivery device ([0032]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s retention socket to include a marking indicating a rotation of the retention socket relative to a plane of a capsule of the delivery device, as taught by Creaven, in order to be able to align markings to load the prosthetic valve ([0013]).
Regarding claim 5, Wang as modified by Creaven discloses the retention socket of claim 4, wherein the marking (122) indicates the rotation of the retention socket relative to a tip or a handle of the delivery device (the marking in modified Wang’s retention socket can indicate the rotation of the retention socket relative to a tip or a handle of the delivery device as the markings (122) are on a component that are stationary relative to an axially moving handle of the delivery device [0032]).
Regarding claim 7, Wang discloses the retention socket of claim 1, but fails to disclose an indexing feature around a circumference to index a plurality of degrees of rotation.
Creaven also discloses a rotatable heart valve delivery system (FIG 2), and teaches an indexing feature (124) around a circumference to index a plurality of degrees of rotation ([0034], where evenly spaced orientation markings 122 are rotationally oriented). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s retention socket to include an indexing feature around a circumference to index a plurality of degrees of rotation, as taught by Creaven, in order to be able to align markings to load the prosthetic valve ([0013], [0036]).
Regarding claim 14, Wang discloses the device of claim 11, but fails to disclose a marking aligned with a corresponding plane of deflection or inflexibility of the delivery device.
Creaven also discloses a rotatable heart valve delivery system (FIG 2), and teaches that it comprises a marking (122, 132) aligned with a corresponding plane of deflection or inflexibility of the delivery device (FIG 2, where 122 may not move [0032]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s retention socket to include a marking aligned with a corresponding plane of deflection or inflexibility of the delivery device, as taught by Creaven in order to be able to align markings to load the prosthetic valve ([0013]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20120078350) in view of Creaven (20150025622) as applied to claim 4 above, and further in view of Zhou (20190029820).
Regarding claim 6, Wang as modified by Creaven discloses the retention socket of claim 4, but fails to disclose that the plane of the capsule is a plane of anisotropic stiffness of the capsule.
Zhou also discloses a capsule to hold an implant (3, FIG 17), and teaches that the plane of the capsule is a plane of anisotropic stiffness of the capsule (FIG 17, [0096], where a wire support adds anisotropic stiffness to the capsule). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Wang’s retention socket to include that the plane of the capsule is a plane of anisotropic stiffness of the capsule, as taught by Zhou, in order to create selective reinforcement ([0096]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20120078350) in view of Popp (20220008200).
Regarding claim 17, Wang discloses the device of claim 15, but fails to disclose a floating coil between the inner shaft and an implant, the floating coil is positioned on an inner shaft component distal of the retention socket with a space to an inner sheath.
Popp also discloses a prosthetic heart valve delivery apparatus (FIG 8) comprising an inner shaft (104), and teaches a floating coil (2300) between the inner shaft (104) and an implant (10), the floating coil is positioned on an inner shaft component distal of the retention socket (106) with a space to an inner sheath (FIG 9, [103], [170], [172]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s retention socket to include a floating coil between the inner shaft and an implant, the floating coil is positioned on an inner shaft component distal of the retention socket with a space to an inner sheath, as taught by Popp, in order to allow the sheath to be moved upon rotation of the shaft ([0172]).
Regarding claim 18, Wang as modified by Popp discloses the device of claim 17, wherein the floating coil allows the implant to rotate freely around the inner sheath upon the capsule and implant being rotated relative to the inner sheath. (The coil in Popp’s rotatable heart valve delivery system is capable of allowing the implant to rotate freely around the inner sheath upon the capsule and the implant being rotated relative to the inner sheath because when the shaft 110 is rotated, there is corresponding axial movement of the sheath ([0172]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774