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.
Response to Arguments
Applicant’s arguments filed 6/19/26, with respect to the rejection(s) of claim(s) 1, 8-13, 15-16, 19 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Desrosiers (20170231765).
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, 8-13, 15-16, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desrosiers (20170231765).
Regarding claim 1, Desrosiers discloses a retention socket (126) for retaining a prosthetic aortic valve (102) in a delivery device (Fig. 5A), comprising: a pair of retention recess (170a, 170b) each positioned on an external surface of the retention socket (FIG 8), one retention recess of the pair of retention recesses (170a) engages with a first paddle (118) of the prosthetic aortic valve (FIG 5A) so that the first paddle is restrained axially ([0068]), and another retention recess of the pair of retention recesses (170b) engages with a second paddle (118) of the prosthetic aortic valve that can move axially ([0068]), the retention socket (126) is rotatable relative to a longitudinal axis of the delivery device ([0055]).
Regarding claim 8, Desrosiers discloses the retention socket of claim 1, wherein pair of retention recesses are symmetrically positioned on opposite sides of an external surface of the retention socket (FIG 7, [0057]).
Regarding claim 9, Desrosiers discloses the retention socket of claim 8, wherein the first paddle (118) and the second paddle (118) are respectively detachably locked into one of the pair of retention recesses, ([0059]), each retention recess has an axis of symmetry along which a length of the paddle engaging with that recess extends (FIG 7).
Regarding claim 10, Desrosiers discloses the retention socket of claim 9, wherein a length along the axis of one of the pair of retention recesses (170b) is greater than a length along the axis of the paddle (118) engaging with that retention recess (FIG 5A, [0068]), and a length along the axis of the other retention recess (170a) equals the length along the axis of the paddle (118, [0068]) 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 ([0073]).
Regarding claim 11, Desrosiers discloses a device (104) for delivering a prosthetic aortic valve (102) into an implantation site (FIG 15), comprising: a proximal end locatable in proximity to a clinician (FIG 1); a distal end locatable distant from the clinician (FIG 1); an inner shaft (128); and a retention socket (126; FIG 8) including a retention recess (170a, 170b) positioned on an external surface of the retention socket (FIG 8), the retention recess engaging with a paddle or other retention feature (118) of the prosthetic aortic valve (FIG 5A), the retention socket is rotatable relative to a longitudinal axis of the device ([0055]), the socket is arranged around the inner shaft (FIG 1), the socket freely rotates relative to the inner shaft to allow selective axial orientation of the prosthetic aortic valve within the delivery device ([0055]).
Regarding claim 12, Desrosiers discloses the device of claim 11, wherein the prosthetic aortic valve (102) has a first paddle (118) connected to a frame (FIG 5A), the first paddle engaged with the retention recess (FIG 5A).
Regarding claim 13, Desrosiers discloses the device of claim 12, wherein the first paddle (118) fits the retention recess (170a) and is restrained axially ([0068]), and further comprising a second paddle (118, which fits into 170b) that can move axially ([0068]).
Regarding claim 15, Desrosiers discloses the device of claim 11, further comprising a handle (122) connected to a capsule (FIG 1) such that when a torque is applied to a section of a handle attached to an outer shaft (124) and to the capsule (126) relative to a section of the handle attached to an inner shaft (128), by the clinician, the torque is transferred to the capsule ([0055]).
Regarding claim 16, Desrosiers 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 (FIG 5A) such that the torque is transferred through friction from the capsule to the prosthetic valve and to the socket engaged with the paddle ([0055]).
Regarding claim 19, Desrosiers discloses the device of claim 12, wherein the first paddle (118) has a sliding anchor (118) sliding in the retention recess (FIG 5A, 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 Desrosiers (20170231765), as applied to claims 1 and 11 above, and further in view of Creaven (20150025622).
Regarding claim 3, Desrosiers 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 Desrosiers’ 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, Desrosiers 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 Desrosiers’ 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, Desrosiers 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, Desrosiers 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 Desrosiers’ 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, Desrosiers 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 Desrosiers’ 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 Desrosiers (20170231765) in view of Creaven (20150025622) as applied to claim 4 above, and further in view of Zhou (20190029820).
Regarding claim 6, Desrosiers 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 Desrosiers’ 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 Desrosiers (20170231765) in view of Popp (20220008200).
Regarding claim 17, Desrosiers 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 the inner shaft component distal of the retention socket with clearance to the inner shaft.
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 clearance 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 Desrosiers’ 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, Desrosiers as modified by Popp discloses the device of claim 17, wherein the floating coil allows the implant to rotate freely around the inner shaft upon the capsule and implant being rotated relative to the inner shaft (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 shaft [0172]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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