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 .
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) 1-7 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 10,898,324 (Morrissey et al.) in view of USPAP 2021/0361453 (Longo et al.).
Morrissey discloses an implant delivery handle (1020) (Fig. 3A; abstract), comprising two conveyance sub-systems both oriented along an axial direction of a catheter assembly, wherein a distal one of the conveyance sub-systems (components operably coupled with deployment actuator 1021) is coupled to a proximal portion of an outer tube (1022) in the catheter assembly (col 9 - col 11), and a proximal one (hub actuator 1600) of the conveyance sub-systems is coupled to a proximal portion of an inner tube (1026) in the catheter assembly (col 10, lines 9-35). Each of the conveyance sub-systems comprises a synchronous conveying device (wherein the housing portion 1030 meets the broad requirement of a synchronous conveying device of the distal conveyance subsystem and the housing portion 1100 meets the broad requirement of a synchronous conveying device of the proximal conveyance subsystem).
Morrissey fails to disclose that each of the conveyance sub-systems comprises a ratchet device fixed to the synchronous conveying device, the ratchet device configured to enable safe self-locking, transmission and guidance of the outer or inner tube through the synchronous conveying device.
Longo discloses another deployment handle that has an actuator for controlling axial movement of a catheter shaft. Longo teaches another type of conveyance subsystem comprising a ratchet device having a ratchet wheel (118/218) and a ratchet slider (311). Similar to Morrissey, the actuation mechanism taught by Longo functions to drive the catheter tube (34) upon rotation of the handwheel (18) [0050]. Longo additionally teaches the actuator is self-locking, as the ratchet slider functions as a wheel lock (311) [0051]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute each of the proximal and distal conveyance sub-systems of Morrisey with the handwheel actuated conveyance subsystem taught by Longs, as the modification merely involves a substitution of one known type of catheter actuator for another that obtains the predictable result of controlling axial movement of catheter components with the added benefit of a locking mechanism.
In regard to claim 2, Longs discloses a rotatable handwheel (18) coupled with the synchronous conveying device (handle) and a retention mechanism in the form of a catheter holder (see link 74 connected to proximal end of outer sheath in Figured 8 [0064]) that enables the handwheel (18) to drive the outer or inner tube to which it is operably coupled.
Regarding claim 3, the ratchet device taught by Longo comprises a ratchet wheel (318), a ratchet slider (319), a slider pin (tab 315) and a slider base (327), the slider base (327) configured to accommodate the ratchet slider (319); the ratchet slider (319) having one end resiliently secured to the slider base (327) (see description of living hinge at [0051]) and a further end disposed near the ratchet wheel (318), the ratchet slider (319) configured to control whether the ratchet wheel is rotated and a direction of rotation of the ratchet wheel; the ratchet wheel (318) fixed to the synchronous conveying device and configured to cooperate with the ratchet slider (319) to control whether the outer or inner tube to move axially and a direction of axial movement of the outer or inner tube, the slider pin (315) coupled to the one end of the ratchet slider (319) and configured to drive the ratchet slider to move.
IN regards to claim 4, the synchronous conveying device comprises a driving pulley (66), a driven pulley (idler pulley 82) and a synchronous conveying belt (70), the synchronous conveying belt (70) provided on both the driving pulley and the driven pulley, the driving pulley (66) disposed coaxially with the handwheel (18) so as to rotate therewith, the driving pulley configured to drive the driven pulley to rotate in a direction in which the driving pulley rotates and cause the synchronous conveying belt to move in an axial direction of the outer tube [0064].
In regard to claim 5, the ratchet wheel (66) is disposed coaxially with the handwheel (118) and is located between the driving pulley (70) and the handwheel (118) [0050], wherein the ratchet wheel has a toothed face facing toward the handwheel (the teeth facing radially outwardly towards the handwheel 118 outer perimeter), and wherein the further end of the ratchet slider (319) is located in one of grooves defined by the toothed face (see Fig. 8).
In regard to claim 6, the further end of the ratchet slider (319) defines a beveled surface (see esp. fig. 8) wherein the toothed face defines chamfered surfaces between the grooves and teeth on opposite sides thereof, and wherein the ratchet slider is configured to control whether the ratchet wheel is rotated and the direction of rotation of the ratchet wheel through altering an angle of the beveled surface with respect to the chamfered surfaces [0051]; [0053].
In regard to claim 7, wherein the beveled surface of the ratchet slider (319) is parallel to one of the chamfered surfaces so that the ratchet wheel is rotatable in one direction, or wherein the beveled surface is not parallel to any of the chamfered surfaces so that the ratchet wheel is not rotatable.
Regarding claim 9, the catheter assembly of modified Morrissey comprises an outer tube (1022) and an inner tube (1026), which are arranged one sleeved over the other from the outside inwards respectively, wherein the implant delivery handle drives the outer and inner tubes to move axially (see col 9-11 of Morrisey).
Regarding claim 10, modified Morrissey comprises an outer tube (1024), an inner tube (1026), a tapered tip (1014) and a retainer (1025), the retainer disposed at a distal end of the inner tube (1026) (see Fig. 3A), the tapered tip disposed at a distal end of the outer tube, the outer tube configured for an implant to be compressed within a distal portion of the outer tube and located between the tapered tip and the retainer, wherein the implant delivery handle drives the outer and inner tubes to move axially to enable loading, delivery and release of the implant.
In regards to claim 11, modified Morrisey comprises a method of using comprising the steps of pivoting a slider pin (315 of Longo) so that a beveled surface of a ratchet slider (319 of Longo) is not parallel to a chamfered surface of a toothed face (teeth of 66 of Longo) and the ratchet slider is restricted in a groove where the ratchet slider is located (see Fig. 8 of Longo), and allowing safe self-locking of the inner or outer tube by the synchronous conveying device; and pivoting the slider pin (315) so that the beveled surface is parallel to the chamfered surface, making the ratchet wheel rotatable only in a first direction or a second direction opposite to the first direction, and allowing transmission and guidance for the inner or outer tube by the synchronous conveying device, wherein the proximal one of the conveyance sub-systems is coupled to the inner tube, and the distal one of the conveyance sub-systems is coupled to the outer tube.
Claim(s) 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 10,898,324 (Morrissey et al.) in view of USPAP 2021/0361453 (Longo et al.), as applied to claim 3 above, and further in view of US 9,149,379 (Keady et al.)./
The retention mechanism taught by Longo comprises a catheter holder (74) sleeved over a proximal end of the outer or inner tube (34) (see Fig. 8 and [0066] of Longo). Longo fails to disclose the synchronous conveying belt is clamped between a clamp plate and a clamp plate holder of the catheter holder, but Longo does disclose the catheter holder (74) comprises teeth that engage the belt (70) [0072-0074]. Keady discloses another actuation mechanism for retracting a tube of an implant delivery device having a pulley and belt mechanism. Keady teaches a proximal end of a tube (1200) having a retention mechanism (Figure 7) with a catheter holder (1207), a clamp plate holder (1202) and a clamp plate (1218), the catheter holder (1207) sleeved over the proximal end of the tube (1200), a clamp plate (1218) retained on the clamp plate holder (1202), and the belt (1209) clamped between the clamp plate (1218) and the clamp plate holder (1202) (col 4, lines 19-27). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the connection of the retention mechanism of modified Morrissey according to the Keady’s disclosure, in order to arrive at a secure connection between the belt and the retention mechanism to ensure reliable control of axial movement of the catheter tube.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11,185,411, USPAP 2020/0246144, and USPAP 2015/0306358 generally disclose handles with actuators for both inner and outer shafts of a catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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