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
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.
Claims 1-4, 6-7, 9-10, 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marsot et al. (US 20170100250 A1).
Regarding claim 1, Marsot discloses a system 14 for delivering an implant to a vascular system, comprising: an implant 18 having a first member 53 moveable between a first position and a second position (i.e., as shown in Figs. 19 and 20) and a lock actuatable between a locked configuration in which the lock restricts movement of the first member and an unlocked configuration in which the lock permits movement of the first member (i.e., see para. [0099] which discloses a locking mechanism that locks the mechanism in a position that permits movement of the first member); and a delivery device having a delivery catheter (i.e., as disclosed in paras. [0014], [0067]; i.e., also 302), a delivery handle (i.e., as disclosed in para. [0014] and [0187]), and a lock line 92, the delivery catheter having a first end releasably coupled to the implant and a second end coupled to the delivery handle (i.e., see para. [0014, [0067]]), the delivery handle having a lock line handle (i.e., handle as disclosed by para. [0012], also handle cap 319 as disclosed by para. [0173]) releasably coupled to the delivery handle and being rotatable relative thereto between a locked position and an unlocked position (para. [0173]), and the lock line being coupled to the lock line handle and being configured such that actuation of the lock line by rotation of the lock line handle between the locked position and the unlocked position respectively actuates the lock between the locked configuration and the unlocked configuration (para. [0173]).
Regarding claim 2, Marsot discloses the system of claim 1. Marsot also discloses wherein the implant is a fixation device having a second member (i.e., opposite arm 53) disposed opposite the first member, the second member being moveable relative to the first member to capture tissue disposed therebetween (para. [0059]).
Regarding claim 3, Marsot discloses the system of claim 2. Marsot also discloses wherein: the fixation device includes a third member and a fourth member (i.e., opposing gripping members 16), the third member being moveable between a first position and a second position (Figs. 27-28), the fourth member being disposed opposite the third member and moveable relative thereto to capture tissue disposed therebetween (para. [0058], [0060]), and the lock is configured to restrict movement of the third member when the lock is in the locked configuration and to permit movement of the third member when the lock is in the unlocked configuration (para. [0094], [0100]).
Regarding claim 4, Marsot discloses the system of claim 2. Marsot also discloses wherein: the implant includes an actuation mechanism (i.e., as disclosed in para. [0099]) having a stud 74 configured to move in an axial direction upon actuation of the actuation mechanism (para. [0103]), the first member is an arm (Fig. 28) operably coupled to the actuation mechanism such that movement of the stud in an axial direction moves the arm between the first and second positions, and the lock, when in the locked configuration, is configured to engage the stud to restrict movement thereof in the axial direction, and when in the unlocked configuration, the lock is configured to disengage from the stud so as to permit movement of the stud in the axial direction (paras. [0102]-[0105]).
Regarding claim 6, Marsot discloses the system of claim 1. Marsot also discloses wherein: the implant includes an actuation mechanism operably connected to the first member, the actuation mechanism including a coupling member 19 and a base 69, the coupling member being releasably coupled to the first end of the delivery catheter (para. [0114]), the base being axially moveable relative to the coupling member upon actuation of the actuation mechanism (para. [0099]), and the lock being disposed at least partially between the coupling member and the base and being configured to restrict axial movement of the base when in the locked configuration and to permit axial movement of the base relative to the coupling member when in the unlocked configuration (see Fig. 33), and the delivery device includes an actuator rod 64 extending from the delivery handle and from the first end of the delivery catheter, the actuator rod being releasably coupled to the actuation mechanism and being configured to actuate the actuation mechanism upon axial movement thereof (para. [0099]).
Regarding claim 7, Marsot discloses the system of claim 1. Marsot also discloses wherein: the delivery handle includes a first end, a second end connected to the delivery catheter (para. [0187]), and a longitudinal axis extending between the first and second ends thereof (i.e., through the device), and the lock line handle defines an axis of rotation about which the lock line handle is rotated between the first and second positions thereof, the axis of rotation extending in a direction transverse to the longitudinal axis of the delivery handle (para. [0173]).
Regarding claim 9, Marsot discloses the system of claim 8. Marsot also discloses wherein the lock line includes a first end portion fixedly secured to the lock line handle and a second end portion releasably coupled to the lock line handle such that, upon release and withdrawing of the lock line handle from the delivery handle, the second end portion of the lock line is withdrawn from the delivery device and the lock line is released from the implant (paras. [0177]-[0178]).
Regarding claim 10, Marsot discloses the system of claim 1. Marsot also discloses wherein the delivery handle includes a locking assembly 106 moveably coupled to a main body of the delivery handle and configured to selectively secure the delivery handle in the locked and unlocked positions (paras. [0102]-[0106]).
Regarding claim 14, Marsot discloses a system 14 for delivering an implant to a vascular system, comprising: an implant 18 having a first member 53 moveable between a first position and a second position (i.e., as shown in Figs. 19 and 20) and a lock actuatable between a locked configuration in which the lock restricts movement of the first member and an unlocked configuration in which the lock permits movement of the first member (i.e., see para. [0099] which discloses a locking mechanism that locks the mechanism in a position that permits movement of the first member); and a delivery device having a delivery catheter (i.e., as disclosed in paras. [0014], [0067]; i.e., also 302), a delivery handle (i.e., as disclosed in para. [0014] and [0187]), and a lock line 92, the delivery catheter having a first end releasably coupled to the implant and a second end coupled to the delivery handle (i.e., see para. [0014, [0067]]), the delivery handle having a lock line handle (i.e., handle as disclosed by para. [0012], also handle cap 319 as disclosed by para. [0173]) rotatably coupled thereto such that the lock line handle is rotatable between a locked position and an unlocked position (para. [0173]), and the lock line being coupled to the lock line handle and being configured such that actuation of the lock line by rotation of the lock line handle between the locked position and the unlocked position respectively actuates the lock between the locked configuration and the unlocked configuration (para. [0173]).
Regarding claim 15, Marsot discloses the system of claim 14. Marsot also discloses wherein the lock line includes a first end portion fixedly coupled to the lock line handle, a second end portion releasably coupled to the lock line handle, and an intermediate portion releasably engaged to the lock of the implant (paras. [0177]-[0178]).
Regarding claim 16, Marsot discloses the system of claim 15. Marsot also discloses wherein the lock line handle is releasably coupled to the delivery handle such that the lock line handle is configured to be removed from the delivery handle whereupon the second end portion of the lock line is withdrawn from the delivery device and the lock line is released from the lock of the implant (paras. [0177]-[0178]).
Regarding claim 17, Marsot discloses the system of claim 14. Marsot also discloses wherein the implant is a fixation device configured to repair a valve within the vascular system (paras. [0058], [0060]) and further comprises a second member (i.e., opposite arm 53), a third member (i.e., opposing gripping members 16), and a fourth member (i.e., opposing gripping members 16), the second member being disposed opposite the first member and being configured to move relative thereto to capture a first leaflet of the valve between the first member and second member (Figs. 27-28), the third member being moveable between a first position and a second position, and the fourth member being disposed opposite the third member and being configured to move relative thereto to capture a second leaflet of the valve between the third member and the fourth member (paras. [0058], [0060]).
Allowable Subject Matter
Claims 5, 8, 11-13, 18-20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 5, Marsot discloses the system of claim 4. Marsot also discloses wherein: the lock includes a binding plate (i.e., as disclosed by para. [0200]) and a release harness 108.
Marsot does not disclose: the binding plate being configured to engage the stud when the lock is in the locked configuration and to disengage the stud when the lock is in the unlocked configuration, the release harness engages the binding plate and is configured to move the binding plate from the locked configuration to the unlocked configuration upon actuation of the release harness, and the lock line releasably engages to the release harness such that tensioning the lock line actuates the lock from the locked configuration to the unlocked configuration. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Regarding claim 8, Marsot discloses the system of claim 7. Marsot does not disclose wherein: the delivery handle includes a spool, the lock line is engaged the lock of the implant and extends about at least a portion of the spool, and the lock line handle includes a shaft releasably coupled to the spool such that the spool rotates with the lock line handle between the locked and unlocked positions and, when the lock line handle is released from the delivery handle, the lock line handle is released from the spool. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Regarding claim 11, Marsot discloses the system of claim 10. Marsot does not disclose wherein the locking assembly includes a latch-detent lock comprising a pin and first and second detents, the first detent corresponding to the locked position, and the second detent corresponding to the unlocked position of the lock line handle. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Regarding claim 12, Marsot discloses the system of claim 11. Marsot does not disclose wherein the lock line handle includes a lock knob defining the first and second detents, and the locking assembly includes a sliding lock slidably coupled to the delivery device and defining the pin of the latch-detent lock. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Regarding claim 13, Marsot discloses the system of claim 10. Marsot does not disclose wherein the delivery handle includes a release assembly coupled to a main body of the delivery handle and comprising a slide and a catch, the slide being slidable relative to the main body, and the catch being selectively engageable with the lock line handle to selectively release the lock line handle from the delivery handle. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Regarding claim 18, Marsot discloses the system of claim 14. Marsot does not disclose wherein the delivery handle includes a spool coupled to the lock line handle such that rotation of the lock line handle correspondingly rotates the spool, and the lock line is engaged to the spool such that rotation of the spool in a first direction tensions the lock line and rotation of the spool in the second direction releases tension on the lock line. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Regarding claim 19, Marsot discloses the system of claim 14. Marsot also discloses wherein: the lock is coupled to the first member via an actuation mechanism (i.e., as disclosed in para. [0099]), the delivery device includes an actuator rod 64 that extends from the delivery handle and from the delivery catheter into releasable engagement with the actuation mechanism such that moving the actuator rod actuates the actuation mechanism and moves the first member between the first and second positions (Figs. 35-37; paras. [0116]-[0119]).
Marsot does not disclose the lock includes a binding lever configured to engage the actuation mechanism when the lock is in the locked configuration and to disengage the actuation mechanism when the lock is in the unlocked configuration, the lock further including a spring biasing the binding lever toward the locked configuration. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Regarding claim 20, Marsot discloses the system of claim 19. Marsot does not disclose wherein the actuation mechanism includes a stud 74 and the lock line handle is configured such that, when the lock line handle is placed in the unlocked position, the bias of the spring is overcome such that the binding lever is disengaged from the stud, and when the lock line handle is placed in the locked position, the bias of the spring biases the binding lever into engagement with the stud to prevent movement of the stud and the first member. The device of Marsot could not be modified to include the above limitations without significantly altering the function of the device or completely re-designing the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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