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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-16 and 22- 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 refers to “ the delivery device handle” which lacks antecedence.
Claim 11 refers to “the delivery device” and “the locking mechanism” which also lack antecedence.
Claims 22, 24, 25, 26, and 28 recites the limitation "the button" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 22, 23, 27, and 29 recites the limitation "the slider component" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the intermediate member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the cap" in line 1, and “the rotating assembly” in line 1. There is insufficient antecedent basis for this limitation in the claim.
For examination purposes, claims 22, 23, 27, 28, 29, and 30 will be read as if dependent on claim 21; claims 24, and 25 will be read as if dependent on claim 23; and claim 26 will be read as if dependent on claim 24.
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.
Claims 1-7, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Seguin (US 2004/0236354), and further in view of Graham et al. (US 2011/0077621).
Regarding claim 1, Seguin discloses a delivery system for an implantable valve leaflet fixation device (see Figs. 4, and 5 illustrating the delivery system and fixation assembly), but fails to disclose comprising: a delivery catheter handle having an integrated fastening system disposed at a distal end thereof and moveable between a locked configuration and an unlocked configuration; and a delivery catheter shaft extending into the delivery catheter handle through the distal end thereof, wherein, when the fastening system is in the locked configuration, the fastening system operatively engages the delivery catheter shaft to arrest relative movement between the delivery catheter shaft and the delivery handle, and when in the unlocked configuration, the fastening system releases the delivery catheter shaft so that the delivery catheter handle is translatable relative to the delivery catheter shaft.
Graham et al. also discloses a handle assembly (16) (see [0034]) that includes a housing (44) (see [0035]), a locking mechanism (50) (see [0036]), an actuator (see [0036]), and an elongate member (40) (see [0036]). Graham et al. teaches the handle assembly (16) includes a locking mechanism (50) thereby functioning as an integrated fastening system (see [0036] disclosing the handle assembly and locking mechanism); the actuator (52) which moves the system from a first position allowing the elongate member (40) to move freely in an unlocked configuration, and a second position that locks it from movement relative to the handle (see [0041] disclosing the locking mechanism and handle assembly configurations); the elongate member (40) extends through the lumen (28) to the handle assembly (16), thereby using the elongate member as a catheter shaft that extends into the handle (see [0034] disclosing the handle assembly); and the mechanical interaction where the locked configuration arrests movement and the unlocked configuration permits movement translation, is accomplished in the first (unlocked) and second (locked) positions (see [0044] disclosing the functional operation of arresting vs. releasing of the handle). 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 provided Seguin’s valve leaflet delivery system, modified with the integrated handle locking/fastening system, as taught by Graham et al. Doing so would provide a means for one-handed operation and precise positioning during the delivery of the fixation device.
Regarding claim 2, Seguin/Graham et al., discloses the system of claim 1.
Seguin fails to disclose wherein: the fastening system includes a threaded ring threadedly engaged to the distal end of the delivery catheter handle and rotatable in a first direction which advances the fastening system into the locked configuration and an opposite second direction which advances the fastening system into the unlocked configuration.
Graham et al. also discloses a locking mechanism (50) (see [0036]), a threaded male connector (36) (see [0033], a female luer lock connector (34) (see [0033]), and a bore (60) (see [0042]). Graham et al. teaches the locking mechanism (50) utilizes the threaded connection between the handle housing (44) with a bore (60), and an actuator (52) engages with the handle assembly (16) (see [0035]); the threaded male connector (36) at the handles (16) distant end, and the female luer connector (34) is the corresponding threaded component that engages this distal end (see [0033] disclosing the threaded engagement to the distal handle), thereby requiring rotating the luer connector (34) in a tightening position (first direction) in order to advance it onto the threads to create a secure, locked connection that prevents relative movement between the handle and the elongate member (40) that functions as the shaft of the handle, while rotating it in the opposite second direction (loosening) releases that engagement. 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 provided Seguin’s valve leaflet delivery system, wherein a female luer lock connector (34) is rotatable and, through its threaded engagement, moves axially to create a secure fit relationship between the handle and shaft components, as taught by Graham et al. Doing so would provide a means for fine-tuned, incremental adjustment of the clamping force on the catheter shaft.
Regarding claims 3, and 4, Seguin/Graham et al., discloses the system of claim 2.
Seguin fails to disclose wherein: the fastening system includes a compression ring disposed over the delivery catheter shaft and between at least a portion of the threaded ring and the delivery catheter shaft, the compression ring being configured to frictionally engage the delivery catheter shaft and arrest movement thereof upon rotation of the threaded ring in the first direction; and wherein: the compression ring is made from a compressible elastomeric or polymeric material.
Graham et al. also discloses a flexible tubular member (54) (see [0042]). Graham et al. teaches the flexible tubular member (54), functions as the compression ring that is positioned in the second portion of the bore (60) within the handle housing (44) (see [0038] disclosing the positioning of the flexible member); and the flexible tubular member (54) can be made of silicone or other flexible materials, can also have a threaded interface, exerting a force to compress the member (54) against the elongate member, functioning as the shaft, thereby giving it the ability to frictionally grip the elongate member (40) (see [0039] disclosing the flexible member and its material composition). 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 provided Seguin’s valve leaflet delivery system, wherein an internal locking assembly involves the use of a flexible tubular member (54) between the threaded ring of the female luer lock connector (34), as taught by Graham et al. Doing so would provide a means for non-marring, infinitely adjustable locking of the catheter shaft.
Regarding claim 5, Seguin/Graham et al., discloses the system of claim 3.
Seguin fails to disclose wherein: the distal end of the delivery catheter handle defines a space between the distal end and the delivery catheter shaft, and at least a portion of the compression ring is disposed within the space.
Graham et al. also discloses the handle housing (44) (see [0040]) includes a bore (60) (see [0040]), and a flexible tubular member (54) (see [0040]). Graham et al. teaches the bore (60) extending through the housing (44) includes a second cylindrical portion (64) having a second diameter which is larger than the diameter of the adjacent portions, with the enlarged second portion (64) defining the physical space between the distal end of the handle assembly (16) and the elongate member (40), which functions as the catheter shaft (see [0035] disclosing the distal space); and the structural relationship between the distal, the internal space, and the tubular member (54) (see Figs, 2 and 5 illustrating the enlarged bore (64) space located near the distal end of the handle housing (44), with the flexible tubular member (54) residing entirely within that space and surrounding the elongate member (40)). 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 provided Seguin’s valve leaflet delivery system, modified with a specific internal bore geometry, as taught by Graham et al. Doing so would provide a means for protected, internal housing of the locking components to ensure smooth mechanical operation.
Regarding claim 6, Seguin/Graham et al., discloses the system of claim 5.
Seguin fails to disclose wherein: the threaded ring is internally threaded, the distal end of the delivery catheter handle is externally threaded and includes an inner tapered surface, the compression ring defines an outwardly bulging profile, and rotating the threaded ring in the first direction drives the outwardly bulging profile of the compression ring into engagement with the inner tapered surface of the distal end.
Graham et al. also discloses the proximal end (32) (see [0033]) of the push catheter (14) (see [0033]), may include a female luer lock connector (34) (see [0033]) that is threadably coupled to a threaded male connector (36) (see [0033]) of the handle assembly (16) (see [0033]). Graham et al. teaches where a female connector (34), with an inherent inner tapered surface to facilitate a wedge like fit, engages a male connector (36) on the handle housing (44) (see [0033]); when the flexible tubular member (54) is axially or radially compressed within the housing (44), it naturally assumes an outwardly bulging profile as it is squeezed against the inner walls of the housing and the outer surface of the elongate member (40), functioning as the shaft (see [0043] disclosing the states of the tubular member); and the functional result of rotating the threaded component to drive the flexible tubular member (54) into the housing (44) internal geometry (see [0050]; [0051] disclosing the functional result of rotating the female connector (34) relative to the housing (144) causes the connector (34) to move axially, thereby exerting a compressive force that drives the tubular member into the housing). 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 provided Seguin’s valve leaflet delivery system, wherein a handle assembly (16) uses a female luer lock connector (34) threadably coupled to a threaded male connector (36), as taught by Graham et al. Doing so would provide a means for a self-centering, high-torque frictional lock through wedge-action.
Regarding claim 7, Seguin/Graham et al., discloses the system of claim 1.
Seguin fails to disclose wherein: the fastening system includes a locking arm hingedly secured to the distal end of the delivery catheter handle and being configured to pivot between the locked and unlocked configurations, the locking arm having a base portion and a protrusion extending from the base portion, the protrusion engaging the delivery catheter shaft when the locking arm is in the locked configuration and disengaging the delivery catheter shaft when the locking arm is in the unlocked configuration.
Graham et al. also discloses an actuator (52) that is pivotably attached to the housing (44) (see [0037]). Graham et al. teaches the actuator (52) attached to the housing (44), functions as a locking arm that rotates between configurations (see [0037] disclosing the pivotable movement in a first and second position); the specific geometry of the actuator (52) is shaped to facilitate the locking action along with an eccentric or cam portion (70) which has an eccentric or cam surface (72), with the cam portion (70) functioning as the base, so as the actuator (52) pivots, this eccentric profile protrudes toward the elongate member (40) to apply force in order to directly control whether the elongate member is engaged or free to move (see [0045] disclosing the components of the actuator; Fig. 4 illustrating the actuator (52) with its eccentric portion (70) and the pivot pin (58) allowing for pivotal movement; Fig. 5 illustrating the actuator (52) functioning as the arm in a disengaged position). 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 provided Seguin’s valve leaflet delivery system, modified with a pivotable cam-lock actuator (52), as taught by Graham et al. Doing so would provide a means for rapid, binary, and one-handed “toggle” locking of the delivery system.
Regarding claim 17, Seguin/Graham et al., discloses a delivery system for a valve leaflet fixation device.
Seguin fails to disclose comprising: a delivery catheter shaft; and a delivery catheter handle defining an opening at a distal end thereof and having a fastening system disposed at the distal end, the opening slidably receiving the delivery catheter shaft, and the fastening system being selectively moveable in a first direction to operatively engage the delivery catheter shaft and arrest movement of the delivery catheter handle relative to the delivery catheter shaft and a second direction to release the delivery catheter shaft and permit translation of the delivery catheter handle along the delivery catheter shaft.
Graham et al. also discloses a handle assembly (16) (see [0035]), a housing (44) (see [0035]), a bore (60) (see [0035]), an elongate member (40) (see [0034]), a flexible tubular member (54) (see [0038]), and an actuator (52) (see [0036]). Graham et al. teaches the elongate member (40) which functions as the shaft, is positioned within the bore (60) and is longitudinally movable (slidably received) with respect to the housing (44) (see [0006]) disclosing the handle assembly designed to receive the elongate member); the flexible tubular member (54) functions as part of the fastening system with the bore (60) of the housing (44) (see [0038] disclosing the fastening system), with an actuator (52) that is movably attached to the housing, which acts as the control interface for the fastening system (see [0008] disclosing the positioning of the actuator); and the actuator (52) can be moved into a first and second position in order to restrain (arresting movement) the elongate member (40) from longitudinal movement (see [0008] disclosing the second position), or allow (permitting translation) the elongate member to be longitudinally moveable (see [0008] disclosing the first position). 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 provided Seguin’s valve leaflet delivery system, modified with a fastening system in order to temporarily “lock” the handle assembly (16) longitudinal position, as taught by Graham et al. Doing so would provide a means to stabilize and maintain the longitudinal position of a valve repair tool relative to the patient’s vasculature during the delicate process of leaflet capture.
Regarding claim 18, Seguin/Graham et al., discloses the system of claim 17.
Seguin fails to disclose wherein: the fastening system includes a threaded ring threadedly engaged to the distal end of the delivery catheter handle and extending about the delivery catheter shaft.
Graham et al. also discloses a proximal end (32) of a push catheter (14) (see [0033]), a female luer lock connector (34) threadably coupled to a threaded male connector (36) of the handle assembly (16) (see [0033]), and an elongate member (40) (see [0034]). Graham et al. teaches a handle assembly (16) where the distal end is specifically designed to threadably engage an external component that extends about the elongate member (40) which functions as the shaft (see Figs. 3, 4, and 5 illustrating the threaded male connector (36) as a set of external threads integrated into the distal-most tip of the housing (44)); the female luer lock connector (34) functions as the threaded ring that screws onto the distal end of the handle (see Figs. 2, and 5 illustrating the threaded engagement); and the threaded interface (34, 36) surrounds the internal moving parts of the catheter (see Fig. 5 illustrating the threaded interface extending about the longitudinal axis Y of the delivery catheter shaft). 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 provided Seguin’s valve leaflet delivery system, modified with a modular threaded fastening system at the distal end of a handle assembly (16), as taught by Graham et al. Doing so would provide a means to removably and securely couple an external delivery sheath to a control handle, ensuring the axial alignment of leaflet-capturing tools.
Regarding claim 19, Seguin/Graham et al., discloses the system of claim 18.
Seguin fails to disclose wherein: the fastening system further includes a compression ring at least partially disposed within the threaded ring and configured to frictionally engage the delivery catheter shaft when the threaded ring is rotated in the first direction.
Graham et al. also discloses a flexible tubular member (54) (see [0038]), a female luer lock connector (34) (see [0033]), and an elongate member (see [0034]). Graham et al. teaches the flexible tubular member (54) functions as the compression ring and is partially disposed within the axial space defined by the threaded connection between the female luer lock connector (34) and the handle distal tip (see [0033] disclosing the threaded interface; Fig. 5 illustrating the flexible tubular member (54) within the threaded interface); and a force is exerted against the flexible tubular member (54), causing it to compress against the elongate member (40) which functions as the delivery catheter shaft, to which the female luer lock connector (34) inherently functions by rotating the threaded collar (first direction) to tighten the seal, therefore this rotation drives the mechanical compression that results in the frictional engagement required to arrest the movement of the elongate member (40) (see [0043] disclosing the frictional engagement). 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 provided Seguin’s valve leaflet delivery system, modified with a threaded compression fitting, as taught by Graham et al. Doing so would provide a means to infinitely adjust and then securely lock the longitudinal position of the leaflet-capture tolls with a variable-tension frictional interface.
Regarding claim 20, Seguin/Graham et al., discloses the system of claim 19.
Seguin fails to disclose wherein: the threaded ring is internally threaded, the distal end of the delivery catheter handle is externally threaded, and the threaded ring and distal end of the delivery catheter define complementary stop-forming surfaces that limit translation of the threaded ring relative to the distal end of the delivery catheter handle.
Graham et al. also discloses a proximal end (32) of the push catheter (14) (see [0033]), and a female luer lock (34) and threaded male connector (36) (see [0033]). Graham et al. teaches a male-to-female threaded coupling at the distal end of the handle assembly (16) (see Fig. 5 illustrating the external threads on the distal neck of the housing (44) and the corresponding internal threads of the female connector (34)); and the threaded engagement (34, 36) reaches a definitive mechanical limit to ensure a secure fit (see Fig. 5 illustrating the male threaded connector (36) on the housing (44) and the leading edge/internal shoulder of the female connector (34) functions as complementary stop-forming surfaces). 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 provided Seguin’s valve leaflet delivery system, modified with internally threaded rings and external handle threads with defined stop-forming surfaces, as taught by Graham et al. Doing so would provide a means to establish a rigid and over-tightening-protected union between the delivery handle and the catheter sheath.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Seguin (US 2004/0236354), as applied to claim 7 above, in view of Graham et al. (US 2011/0077621), and further in view of Gharibadeh et al. (US 5458613).
Regarding claim 8, Seguin/Graham et al., discloses the system of claim 7, but fails to disclose wherein: the fastening system includes a resilient element comprised of an insert and a spring element each disposed within the delivery catheter handle at a side thereof opposite from the locking arm, the resilient element engaging the delivery catheter shaft.
Gharibadeh et al. also discloses an insert (37) (see Col. 7, line 2), a flexible arm (41) (see Col. 7, line 2), and a guiding element (25) (see Col. 7, line 1). Gharibadeh et al. teaches the insert (37) fits into the interior of the adapter (32) (see Col. 7, lines 1-3 disclosing the insert); the flexible arm (41) made of a superelastic alloy provides resilient properties, along with a guidewire guiding element (25), and a tubular base (42), functions as the spring element (see Col. 7, lines 26-51 disclosing the spring element function and material composition of the arm); and the flexible arm (41) extends from the same side as the guidewire port to the opposite side thereto to engage and guide the shaft/guidewire (see Col. 2, lines 62-67; Col. 3, lines 1-8 disclosing the positioning and engagement of the arm). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al., with a resilient spring/insert assembly, as taught by Gharibadeh et al. Doing so would provide a means for a self-adjusting tensioning mechanism, while ensuring the locking arm maintains a firm, non-destructive grip on the catheter shaft by accommodating manufacturing variations in shaft diameter through the biasing force of the resilient element.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Seguin (US 2004/0236354), as applied to claim 1 above, in view of Graham et al. (US 2011/0077621), and further in view of Ellis (US 5334160).
Regarding claim 9, Seguin/Graham et al., discloses the system of claim 1, but fails to disclose wherein: the fastening system includes a screw having a cap and a threaded shaft extending from the cap, the threaded shaft extending into the delivery catheter handle in a direction transverse to a longitudinal axis of the delivery catheter handle, the threaded shaft being configured to engage the delivery catheter shaft when the screw is rotated in a first direction to the locked configuration and to disengage the delivery catheter shaft when the screw is rotated in a second direction to the unlocked configuration.
Ellis also discloses a hemostatic seal valve (60) which includes a valve body (62) with a thread portion on the outer side, a Y-adaptor port (54), and an O-ring (70) (see Col. 4, lines 26-37 disclosing these components). Ellis teaches the valve includes a handle portion (66) which is used to rotate the body, and the valve body (62) is fitted within the port (54) and extends into the assembly to compress internal components (see Col.4, lines 26-37 disclosing the system components and its orientation); the Y-adaptor port (54) is axially aligned with the guide catheter lumen, providing an axis rotation, which results in an occurring locking action when the O-ring (70) bulges axially inward to reduce the opening and clamp down, thereby creating a transverse engagement and longitudinal axis of the shaft (see Col. 4, lines 18-48 disclosing the transverse engagement and longitudinal axis of the shaft); and the valve body (62) can have a locked configuration where the body is rotated clockwise to compress the O-ring (70) in order to clamp down the guide catheter (40), and an inherent unlocked configuration where the O-ring must naturally be rotated in the second direction (loosened) to allow the catheter and sleeve to be moved or withdrawn (see Col. 4, lines 38-52 disclosing the rotational locking and unlocking configuration). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al., with a threaded rotational fastening system, as taught by Ellis. Doing so would provide a means for an infinitely adjustable clamping, while minimizing blood loss and allowing unimpeded shaft movement during delicate positioning.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Seguin (US 2004/0236354), as applied to claim 1 above, in view of Graham et al. (US 2011/0077621), and further in view of Martin et al. (US 2004/0044350).
Regarding claim 10, Seguin/Graham et al., discloses the system of claim 1, but fails to disclose wherein: the delivery device handle further includes controls for manipulating the implantable valve leaflet fixation device, the controls extend from the delivery catheter handle and through the delivery catheter shaft to the implantable valve leaflet fixation device.
Martin et al. also discloses a handle (20) (see Fig. 3) located at the proximal end of the sheath (10) (see Fig. 3), comprising a shaft (11) (see [0039]), and actuators (22, 24, and 26) (see [0059]). Martin et al. teaches the proximal portion of the delivery device serves as the control interface, with the actuators (22, 24, and 26) on the handle (20) can create curves in the distal portion when manipulated (see [0064] disclosing the actuators); pullwires (80) extend through the central lumen of the shaft (11) from the handle (20) to manipulate the distal articulating members (18) (see [0062] disclosing the controls extending through the shaft); and manipulation of the valve leaflets (see [0066] disclosing the handle controls allow for movement of the distal tip (15) to direct the device towards an opening (60) between the valve leaflets). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al., with a handle (20) with actuators that are operatively coupled to pullwires (80) that extend through the catheter shaft (11), as taught by Martin et al. Doing so would provide a means to ergonomically centralize complex distal mechanical actuation within a stabilized, lockable handle housing.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Seguin (US 2004/0236354), as applied to claim 1 above, in view of Graham et al. (US 2011/0077621), and further in view of Raschdorf, Jr. et al. (US 2009/0163934).
Regarding claim 11, Seguin/Graham et al., discloses the system of claim 1, but fails to disclose wherein: the delivery device includes a main body, a slider, a crimping cam, an actuator rod, and a locking component, the slider being at least partially disposed within the main body and being translatable relative to the main body, the actuator rod being secured to the crimping cam and extending through the delivery catheter shaft to the implantable valve leaflet fixation device, and the crimping cam being releasably connected to the slider via the locking mechanism such that, when the crimping cam is connected to the slider via the locking mechanism, relative rotation of the crimping cam and the slider is prevented.
Raschdorf, Jr. et al. also discloses a base (69) of an actuation mechanism (58) (see Col. 20, lines 51-55), a coupling mechanism (19) (see Col. 20, lines 16-18), an actuator rod (64) (see Col. 18, line 4), and a locking mechanism (106) (see Col. 24, lines 49-50). Raschdorf, Jr. et al. teaches the base (69) can function as the slider of the actuation mechanism (58), and is situated within the proximal portion of the device (main body/handle) and moves relative to it to facilitate mechanical work (see Col. 16, lines 39-49 disclosing the operation of the actuation mechanism on the distal elements (18) of the fixation device; Fig. 10B illustrating the proximal location of the base (69)); the actuator rod (64) is secured to the coupling mechanism (19) which functions as a crimping cam, passes through the shaft (12) to reach the fixation device (14) (see Col. 24, lines 54-59 disclosing the interface between the handle and the distal fixation tool); and the engagement of the locking mechanism (106) disposed between the coupling mechanism (19) and the base (69), results in precise distal movement of the fixation device, while preventing relative rotation (see Col. 20, lines 13-25 disclosing the functional connection required to ensure the actuator rod does not twist during linear movement). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al., with a handle-based linear actuator (base (69)) that is releasably locked to a distal drive component (coupling mechanism (19)) to prevent rotation, as taught by Raschdorf, Jr. et al. Doing so would provide a means to mechanically isolate linear deployment forces from rotational instability within a stabilized delivery platform.
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Seguin (US 2004/0236354), as applied to claim 11 above, in view of Graham et al. (US 2011/0077621), in view of Raschdorf, Jr. et al. (US 2009/0163934), and further in view of Seddon et al. (US 2013/0197484)
Regarding claim 12, Seguin/Graham et al./Raschdorf, Jr. et al., discloses the system of claim 11, but fails to disclose wherein: the slider and the crimping cam each include a channel extending therethrough, and the locking mechanism includes a handle and a deployment pin, the locking mechanism having a locked configuration in which the deployment pin extends through the channels of the slider and the crimping cam and an unlocked configuration in which the deployment pin is removed from each channel.
Seddon et al. also discloses a distal (300) and proximal (500) adapter (see [0087]) with recesses (see [0078]), and a securing member (718) (see [0123]). Seddon et al. teaches the distal (300) and proximal (500) adapters include recesses configured to receive an interlocking member, thereby allowing the distal adapter to function as a crimping cam and the proximal adapter to function as a slider/translatable component; the securing member (718) functions as the deployment pin which is a rigid component designed to span the connection portion to a handle or actuator at the proximal end, allowing it to move in a first or second position (see [0138]) disclosing the locking mechanism and deployment); in the second position, the securing member (718) is disposed within the connection portion and extends over the recesses of the 2 adapters (300) and (500), preventing relative rotation, thereby creating a locked configuration (see [0012] disclosing the locked configuration); and in the first position, the securing member (718) is moved away from the connection portion in order to release the distal adapter from the proximal adapter, allowing the sections to separate, thereby creating an unlocked configuration (see [0012] disclosing an unlocked configuration). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al. and Raschdorf, Jr. et al., with the pin-and-channel locking architecture, as taught by Seddon et al. Doing so would provide a means to mechanically secure the deployment sequence of a heart valve implant using a positive physical interlock housed within a stabilized delivery platform.
Regarding claim 13, Seguin/Graham et al./Raschdorf, Jr. et al./Seddon et al., discloses the system of claim 12.
Seguin/Graham et al./Raschdorf, Jr. et al., fail to disclose wherein: the slider has a convexly curved outer surface, and the locking mechanism handle has a concavely curved inner surface complementary to the convexly curved outer surface of the slider, the locking mechanism handle being configured to wrap at least partially around the slider such that the concavely curved inner surface extends along the convexly curved outer surface of the slider.
Furthermore, Seddon et al. also discloses articulation links (400) with distal (300) and proximal (500) adapters (see [0080]), and a securing member (718) (see [0123]). Seddon et al. teaches the proximal (500) adapter can function as the slider, and is a tubular member inserted into the shaft, thereby requiring it to possess a convex exterior (see [0085] disclosing the translatable internal components as having a cylindrical, and therefore convex geometry); the securing member (718) functions as an external cuff, disposed about the connection portion, thereby creating a locking mechanism configured to interface with the convex slider using a complimentary concave profile (see [0012]; [0136] disclosing the locking interface); and the securing member (718) acts as a cover around the proximal portion of the actuator and the distal portion of the elongate member, thereby allowing the handle to wrap around the slider to maintain a secure mechanical interlock (see [0015] disclosing the securing member (718) being disposed on an exterior of the shaft). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al. and Raschdorf, Jr. et al., with a form-fitting, surface-to-surface locking interface that manages the transition between a secured delivery state and an intentional release state, as taught by Seddon et al. Doing so would provide a means to ergonomically nest and stabilize the internal drive components of a heart valve delivery tool using a surface-to-surface mechanical interlock.
Regarding claim 14, Seguin/Graham et al./Raschdorf, Jr. et al./Seddon et al., discloses the system of claim 13.
Seguin/Graham et al./Raschdorf, Jr. et al., fail to disclose the system of claim 13, wherein: the convexly curved outer surface of the slider has a notch, and the concavely curved inner surface of the locking mechanism handle has a protuberance configured to be received within the notch.
Furthermore, Seddon et al. also discloses a distal (300) and proximal (500) adapter (see [0087]) with recesses (see [0078]), and a securing member (718) (see [0123]). Seddon et al. teaches the adapters (300, 500) have a cylindrical (convex) outer surface, with the recess being located on the surface, thereby creating a notch (see [0080] disclosing the convex nature); and the securing member (718) includes a retainer (760) with a recess configured to receive a protrusion (762), thereby functioning as the protuberance that keys into the notch of the internal slider (see [0136] disclosing the protuberance). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al. and Raschdorf, Jr. et al., with a keyed mechanical interlock of a notch-and-protuberance engagement, as taught by Seddon et al. Doing so would provide a means to mechanically “key” the locking mechanism to the internal drive assembly, ensuring precise rotational alignment and tactile confirmation of the locked state.
Regarding claims 15, and 16, Seguin/Graham et al./Raschdorf, Jr. et al./Seddon et al., discloses the system of claim 13.
Seguin/Graham et al./Raschdorf, Jr. et al., fail to disclose wherein: the locking mechanism handle has a first end connected to the deployment pin via a hinge; and wherein: the locking mechanism handle has a second end that includes a groove, the groove configured to receive a pin tip of the deployment pin when the locking mechanism handle is wrapped about the slider.
Furthermore, Seddon et al. also discloses a securing member (718) and a retainer (760) (see [0136]), a pivot pin (202) (see [0062]), and a protrusion (762) (see [0079]). Seddon et al. teaches the securing member (718) which functions as the locking mechanism handle, is pivotally connected to the handle assembly, to which the retainer (760) can be pivoted or moved relative to the internal drive components (see [0136] disclosing the pivotable mechanical interface; Fig. 3 illustrating a mechanical linkage where a handle is connected to the internal locking hardware via a pivot point/hinge with a pivot pin (202), allowing the operator to toggle the lock between states); when the handle is wrapped about the assembly (second position), the protrusion (762) is received within the recess, in order to ensure the handle stays in the closed position and prevent the pin from backing out of the channels prematurely (see [0136] disclosing the interaction of the securing member with the recess and the protrusion). 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 the valve leaflet delivery system of Seguin, as modified by Graham et al. and Raschdorf, Jr. et al., with the hinge/sliding architecture, as taught by Seddon et al. Doing so would provide a means to mechanically lock a delivery handle’s security latch into a fixed position using a hinged, multi-point detent system.
Claims 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al. (US 2011/0160767), and further in view of Richter et al. (US 2019/0209154).
Regarding claims 21, and 22 (see 112(b) above), Stone et al. discloses a deployment system for a fixation device (see [0062] disclosing a flexible anchor (150)), but fails to disclose the deployment system comprising: a slider component having external threads; an actuator rod control with internal threads mating with the external threads of the slider component for translating the slider component; a rotating assembly arranged within the slider component, the rotating assembly comprising a cap, an intermediate member extending from the cap, and an actuator rod extending from the intermediate member, the actuator rod having a distal end configured to be releasably coupled to a fixation device; and a button having a locked configuration which prevents rotation of the rotating assembly relative to the slider component, and an unlocked configuration which allows rotation of the rotating assembly relative to the slider component, to release the actuator rod from the fixation device; and wherein: the button is located near a proximal end of the slider component.
Richter et al. also discloses a slider (see [0037]), a knob (1230) (see [0389]), a shaft component (see [0035]) and a button (see [0037)]. Richter et al. teaches the knob is configured to mate with the external surface of the slider, and the rotation of the knob causes the linear translation of the slider along the longitudinal axis (see Figs. 110A and 110B illustrating the knobs cross-section, revealing the internal threading designed to drive the slider component); the shaft component includes a proximal handle that functions as a cap, and a body portion that functions as an intermediate member that extends from the handle (see [0035] disclosing the shaft components); an elongate body that functions as the actuator rod that extends from the body portion, with the distal end of the elongate body configured to be coupled to the body (see [0042] disclosing the shaft components connections; Fig. 94 A illustrating the connections); and an actuation feature comprising a button (see [0037] disclosing the button mechanism), which engages the internal assembly to prevent rotation and/or translation of the shaft component relative to the slider and handle, creating a locked configuration, and by depressing or removing the button to a second position creates an unlocked configuration, allowing the rotating assembly to move and release the elongate body from the fixation device (see [0035]; [0037] disclosing the location of the button and the configurations). 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 provided Stone et al.’s deployment system, modified with a threaded slider and locking button assembly, as taught by Richter et al. Doing so would provide a means for high-precision incremental deployment combined with a fail-safe mechanical lock.
Regarding claim 23, Stone et al./Richter et al. discloses the deployment system of claim 1 (see 112(b) above).
Stone et al. fails to disclose wherein: a first recess is defined by the slider component and a second recess is defined within the intermediate member.
Richter et al. also discloses a slider (see [0037]), a top clamp (see [0038]), a shaft component (see [0035]), and a locking groove (see [0040]). Richter et al. teaches the slider is used to control the axial and rotational state of internal components (see [0037]), to which a top clamp (which interfaces with the slider/body) can be received in an indentation formed in the base clamp which functions as the first recess, defined by the slider component to accommodate a mating feature (see [0041] disclosing the clamp and indentation); and the shaft component can include a locking groove that serves as the second recess defined within the shaft component which functions as the intermediate member to secure the shaft to the handle, preventing unintended translation or rotations (see [0040] disclosing the locking groove). 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 provided Stone et al.’s deployment system, modified with an indentation that serves as a first recess in a slider, and a locking groove that serves as a second recess within a shaft component, as taught by Richter et al. Doing so would provide a means to mechanically lock and stabilize the rotational and axial position of an actuator rod relative to its housing during a surgical procedure.
Regarding claims 24, 25, and 26 (see 112(b) above), Stone et al./Richter et al. discloses the deployment system of claim 3.
Stone et al. fails to disclose wherein: in the locked configuration, the button is engaged within the first recess and the second recess; wherein: the second recess corresponds to a shape of the button; and wherein: in the unlocked configuration, the button does not engage the second recess.
Richter et al. also discloses a button (see [0037]), a slider (see [0037]), a top clamp (see [0038]), a locking groove (see [0040]), and a mating tab (see [0041). Richter et al. teaches the slider is used to control the axial and rotational state of internal components (see [0037]), to which a top clamp (which interfaces with the slider/body) can be received in an indentation formed in the base clamp which functions as the first recess, defined by the slider component to accommodate a mating feature (see [0041] disclosing the clamp and indentation); and the shaft component can include a locking groove that serves as the second recess defined within the shaft component which functions as the intermediate member to secure the shaft to the handle, preventing unintended translation or rotations, to which the button is received within the indentation of the slider and the groove of the shaft simultaneously to prevent relative movement (locked configuration) (see [0040] disclosing the locked configuration); the mechanical interface for locking relies on specific mating features such as the mating tab, configured to engage abutment surface, inherently requiring the recess to be shaped to correspond to the button (locking member) for a secure fit; and an unlocked configuration where the button is depressed on the body in order to release the shaft component, the button is moved out of engagement with the internal recess to allow movement (see [0045]) disclosing the unlocked configuration). 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 provided Stone et al.’s deployment system, modified with the specific button-and-recess locking mechanism, as taught by Richter et al. Doing so would provide a means for high-precision, fail-safe operation where the physical engagement of a button allows the user to lock the tool during navigation and unlock it when specific rotation is required to release the device.
Regarding claim 27, (see 112(b) above), Stone et al./Richter et al. discloses the deployment system of claim 1.
Stone et al. fails to disclose wherein: the cap is configured to rotate the rotating assembly relative to the slider component for deployment of the fixation device.
Richter et al. also discloses a shaft component that includes a proximal handle and an elongate body (see [0035]), and a slider (see [0037]). Richter et al. teaches that when the system is in an unlocked configuration, the shaft component via the proximal handle that functions as the cap, is allowed to rotate relative to the handle (slider/body assembly) (see [0038] disclosing the configuration for rotation; Figs. 94A and 93B illustrating the assembly in different states where the proximal handle can be rotated once the locking mechanism is released); and the slider manages the axial position while the proximal handle is configured to be grasped by the user to provide the rotational input (see [0037]; [0040] disclosing the relation to the slider component). 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 provided Stone et al.’s deployment system, modified with a proximal handle that functions as a cap to rotate the internal assembly, as taught by Richter et al. Doing so would provide a means to selectively decouple translational adjustment from rotational deployment using a single-handed interface.
Regarding claim 28, (see 112(b) above), Stone et al./Richter et al. discloses the deployment system of claim 1.
Stone et al. fails to disclose wherein: the button is spring biased.
Richter et al. also discloses a button and release mechanism (see [0045] disclosing the button). Richter et al. teaches in mechanical handle design such buttons are inherently biased (via a spring) to return to their original “locked” or “outward” position once released by the user (see [0045] disclosing the release mechanism). 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 provided Stone et al.’s deployment system, modified with a button that is spring biased, as taught by Richter et al. Doing so would provide a means to automatically return the button to a default locked position.
Regarding claim 29, (see 112(b) above), Stone et al./Richter et al. discloses the deployment system of claim 1.
Stone et al. fails to disclose wherein: at least one pin engages a corresponding groove to prevent rotation of the slider component while allowing translation of the slider component.
Richter et al. also discloses a pin (812) can include a pin head (814) (see [0361]). Richter et al. teaches the mechanical interference of the pin (812) with a groove prevents relative rotation, ensuring the orientation of the distal tip remains fixed while the depth is adjusted, allowing for longitudinal translation of the slider or handle assembly along the axis without spinning (see Figs. 96, and 97 illustrating the pin in groove arrangement). 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 provided Stone et al.’s deployment system, modified with a pin-and-groove interface, as taught by Richter et al. Doing so would provide a means to guide linear travel while preventing unintended rotation.
Regarding claim 30, (see 112(b) above), Stone et al./Richter et al. discloses an implant delivery system comprising: the deployment system of claim 1.
Stone et al. fails to disclose a delivery catheter including a shaft; and a fixation device comprising proximal elements and distal elements configured to move between a closed configuration and an open configuration for capturing tissue therebetween.
Richter et al. also discloses a multi-tool with a shaft component having an elongate body (see [0035]). Richter et al. teaches a multi-tool, that can function as a delivery system or catheter, has a shaft component with an elongate body that defines a central longitudinal axis extending from a proximal handle to a distal tip (see [0035] disclosing the shaft component); a locking handle configured to move the assembly between an open and closed position (see [0038] disclosing an open and closed configuration); an outer and inner shield, with proximal and distal end portions that work in tandem to anchor or shield anatomy (see [0031]; [0032] disclosing the proximal and distal elements); and nerve and tissue shielding that use internal shields which function as proximal/distal elements of the fixation system in order to protect sensitive tissue (see [0195] disclosing tissue shielding). 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 provided Stone et al.’s deployment system, modified with the delivery shaft and moveable locking configurations, as taught by Richter et al. Doing so would provide a means to navigably deliver and secure a surgical implant through a minimally invasive corridor while protecting surrounding anatomy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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