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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-8 and 19 (corresponding to Species I) in the reply filed on 09/14/2026 is acknowledged. Claims 9-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. A complete action on the merits of pending claims 1-8 and 19 appears below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figure 5, reference number (210).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
The following phrase of Line 3 of the abstract should be amended to the following to be grammatically correct and coherent, “an elongate shaft axially slidable within the lumen”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The following phrase on Page 9, line 14, should be amended to the following to be grammatically correct and coherent, “may be used to deliver any medical device”.
The following phrase on Page 9, line 17, should be amended to the following to be grammatically correct and coherent, “an elongate shaft 120 axially slidable within the lumen 115”.
Appropriate correction is required.
Claim Objections
Claims 1, 5, and 19 are objected to because of the following informalities:
Claim 1 should be amended to the following, “A delivery system for deploying a medical implant, comprising:
a delivery catheter having a lumen extending therethrough;
an elongate shaft axially slidable within the lumen of the delivery catheter;
a housing configured to be removably attached to the elongate shaft, the housing having a first lumen configured to receive the elongate shaft; and
an actuation element disposed within the housing and configured to axially advance and retract the elongate shaft.” Examiner notes, Applicant uses the proposed terminology in claim 19.
Claim 5 should be amended to the following, “The delivery system of claim 1, wherein the delivery catheter includes a hub adjacent a proximal end thereof, wherein the housing is configured to be removably attached to a proximal portion of the hub.”
Claim 19 should be amended to the following, “A medical system comprising:
a left atrial appendage closure device including a self-expandable framework and a proximal hub;
a delivery catheter having a lumen extending therethrough sized to receive the left atrial appendage closure device in a collapsed configuration;
an elongate shaft axially slidable within the lumen of the delivery catheter, a distal end of the elongate shaft configured to releasably couple with the proximal hub of the left atrial appendage closure device;
a housing configured to be removably attached to the elongate shaft adjacent a proximal end of the elongate shaft, the housing having a first lumen configured to receive the elongate shaft, and a second lumen extending transverse to and intersecting the first lumen; and
an actuation shaft disposed within the second lumen and is in direct contact with the elongate shaft, wherein rotation of the actuation shaft axially advances or retracts the elongate shaft.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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) 1 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landey (US 2021/0045822 A1), in view of Winston (US 6,752,800 B1).
Regarding claim 1, Landey discloses, axial motion drive devices for robotic medical systems. Landey teaches, a drive device (Figures 21-24E, drive device (300) comprising housing (302) with upper portion (304) and lower portion (306); Paragraphs [0155], [0159]-[0160], and [0168]-[0173]) comprising:
an elongate shaft (Figure 21 and 24D-24E, elongate shaft (220) of medical instrument (210)) that is axially movable (Paragraphs [0155]-[0160] and [0173]);
a housing (Figure 23, housing (302) with upper portion (304) and lower portion (306); Paragraph [0171]) configured to receive (removably attached) the elongate shaft (Figures 21-24A and 24D-24E; Paragraphs [0160], [0171]-[0173], and [0184]; Where channel (310) formed in the upper surface (308) of the housing is configured to receive a portion of a shaft of a medical instrument, where the shaft can be top-loaded or loaded laterally into the open channel), the housing having a first lumen (Figures 21-23, channel (310)) configured to receive the elongate shaft (Paragraphs [0160] and [0171]-[0173]); and
an actuation element (Figures 21-22, 24A-24B, and 24D-24E, opposing rollers (312); Paragraphs [0159], [0173], and [0183]-[0189]) disposed within the housing (Figure 24A-24B and 24D-24E; Paragraphs [0159], [0173], and [0184]-[0185]; rollers (312) positioned within the housing (302) on opposite sides of the channel (310)) and configured to axially advance and retract the elongate shaft (Paragraphs [0159], [0173], [0184]-[0185], and [210]; As the rollers (312) rotate, the shaft is pulled, pushed, or otherwise driven axially through the drive device; rotating the rollers in a first direction causes insertion/advancement of the shaft and rotating in a second opposite direction causes retraction of the shaft).
Landey further teaches, the rollers can be moved between an engaged position (pressing against opposite sides of the shaft) and a spaced-apart/loading position, and that a cover can selectively open or close the channel to facilitate loading or retention of the shaft (Paragraphs [0160], [0184]-[0185], and [0201]-[0205]).
Landey fails to teach, a delivery catheter having a lumen extending therethrough in which the elongate shaft is axially slidable for the purpose of deploying a medical implant.
Winston discloses, a catheter handle for controlling the advancement of a guide wire through a catheter. Winston teaches, a catheter (Figure 1, catheter (102); Col. 3, line 34-44) having a lumen (Col. 3, line 45-52; central lumen extending therethrough (not shown)) that accommodates an elongate member (Col. 3, line 34-44; guide wire); the handle is couples to the catheter via luer-lock elements (Figures 1-3, male luer lock element (134) and female luer lock (132); Col. 3, line 63-67);
an elongate member (guide wire) that is advanced through the catheter (Col. 3, line 34-44);
a housing (Figures 1-3, housing (124) of handle (100); Col. 3, line 53-59) that receives the elongate member (the guide wire is introduced at the proximal end of the handle, passed through the handle, and into the catheter (Col. 3, line 37-40); a continuous path including hypodermic tubing portion and guiding channel (188) receives the guide wire (Col. 4, line 58-61)); and
an actuation element (Figure 2, advancement mechanism (172) including friction wheel (180) coupled to geared drive wheel (182); Col. 4, line 30-47) disposed within the housing and configured to axially advance the elongate member (the guide wire makes contact with the friction wheel (Col. 4, line 58-61); “clicking” the control knob rotates the friction wheel via a ratchet/spring assembly to advance the guide wire in precisely controlled incremental steps, and the mechanism can also free the wire for movement in either direction, including retraction (Col. 4, line 32-Col. 6, line 32)).
Winston further teaches, the handle can be coupled to a variety of commercial catheters via the luer-lock interface and can be reused after a disposable catheter is removed (Col. 7 line 21-28).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Landey’s drive device to incorporate a delivery catheter having a lumen in which an elongate shaft is axially slidable for deploying a medical implant, as taught by the catheter-coupling principles of Winston, as both references and the claimed invention are directed to devices that provide controlled axial movement of an elongate member. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, to obtain the advantages of precise, incremental axial control (including the ability to advance and retract), which reduce the risk of damage or misplacement during implant deployment (Col. 6, line – Col. 7, line 20 of Winston).
Regarding claim 5, Landey teaches, the housing (housing (302)).
Landey fails to teach, wherein the delivery catheter includes a hub adjacent a proximal end thereof, wherein the housing is configured to be removably attached to a proximal portion of the hub.
Winston teaches, the delivery catheter (catheter (102)) includes a hub (Figures 1-3, male luer lock element (134)) adjacent a proximal end thereof (Figures 1-3), and that the housing (housing (124) of handle (100)) is configured to be removably attached to a proximal portion of the hub (female luer lock element (132) on the handle mates with the male luer lock of the catheter (Col. 3, line 63-67); the handle can be detached and reattached to different catheters (Col. 7, line 21-28)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to provide Landey’s drive-device housing with a removable attachment to a proximal of a delivery catheter, as taught by Winston, as both references and the claimed invention are directed to devices that provide controlled axial movement of an elongate member. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, in order to allow the same housing/actuation unit to be used with different catheters or to be attached only when precise axial control is needed (Col. 7, line 21-28 of Winston).
Claim(s) 2-4 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landey, in view of Winston, and further in view of Ferry (US 2006/0041245 A1).
Regarding claim 2, Landey teaches, the actuation element (opposing rollers (312)) disposed within the housing (housing (302)) that engages opposite sides of the elongate shaft (elongated shaft (220)), wherein rotation of the rollers causes axial advancement and retraction of the elongate shaft (Paragraphs [0159], [0173], and [0184]-[0185]).
Landey fails to teach, wherein the housing includes a second lumen extending transverse to and intersecting the first lumen, wherein the actuation element includes an actuation shaft extending through the second lumen, the actuation shaft engaging the elongate shaft, wherein rotation of the actuation shaft causes axial movement of the elongate shaft.
Winston teaches, aspects of the delivery system according to claim 1 (See above rejection of claim 1).
Ferry discloses a drive unit/advancer for axially moving an elongate medical device (catheter and/or guide wire). Ferry teaches, a housing (Figures 1-3, base (42)) having a first lumen (Figures 2-3, longitudinal slot (54) extending from the front to the back of the base for receiving a portion of the elongate medical device) (Paragraphs [0047] and [0048]);
opposed wheels (Figure 3, driven wheel (62) and idler wheel (64)) that protrude into the first lumen/slot (54) from opposite sides so as to drivingly engage the elongate medical device disposed therein (Paragraphs [0048] and [0054]);
each wheel mounted on its own shaft (Figures 3-4, driven wheel (62) mounted on shaft (68); idler wheel (64) mounted on shaft (92)) (Paragraphs [0049] and [0051]);
the shafts being oriented transversely (the shafts are “rotatably mounted about an axis generally perpendicular to the bottom,” i.e., perpendicular to the longitudinal direction of slot (54)) (Paragraph [0049]);
the shafts being supported in openings/sockets that intersect the first lumen (shaft (68) is mounted between a socket (50) in the base and a socket (52) in the bottom; shaft (92) is received in a slot in the floor of the base and its upper end is received in a groove in the cover; the side walls of slot (54) contain openings through which portions of the wheels protrude into the slot so the wheels can contact the device) (see Paragraphs [0049], [0051], and the structure illustrated in Figure 3); and
rotation of the shaft (and therefore of the wheel it carries) causes axial advancement or retraction of the elongate medical device within the first lumen (when the motor drives the rigid drive shaft, the worm turns the worm gear on shaft (68), rotating the driven wheel and thereby advancing or retracting the device through slot (54)) (Paragraphs [0049] and [0054]).
Under the broadest reasonable interpretation of the claim language consistent with the specification, Ferry’s transverse shafts (68, 92) that are supported in openings/sockets that intersect the longitudinal slot (54), and that carry the wheels which protrude into and engage the elongate device, constitute “an actuation shaft extending through [a] second lumen” (the supporting sockets/openings) that is transverse to and intersects the first lumen, wherein rotation of the actuation shaft causes axial movement of the elongate shaft.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the roller or friction-wheel actuation element already taught by Landey to the transverse-shaft-and-wheel arrangement of Ferry, as all the references and the claimed invention are directed to systems for controlled axial advancement and retraction of an elongate medical member (catheter, guide wire, or implant shaft) through a housing or catheter. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, because both configurations achieve the identical functional result: rotational input is converted into precise axial advancement and retraction of an elongate medical member by frictional side engagement inside a housing that receives the member. Substituting Ferry’s transverse shafts (supported in intersecting openings so that the wheels can protrude into the first lumen) for the roller axes of Landey would have been a simple and predictable substitution of one known side-engagement drive geometry for another, yielding the same controlled axial movement while providing a compact packaging arrangement useful for catheter and guide-wire advancement.
Regarding claim 3, modified Landey teaches, wherein an outer surface of the actuation shaft is textured (Ferry further teaches that the outer surface of the wheels (the engagement surface carried by the actuation shaft) may be fabricated with small teeth or, alternatively, of a soft material such as rubber, or provided with a coating of rubber, plastic (e.g., urethane) or silicone “to resiliently engage a medical device” and “grip but not damage” it (Paragraphs [0048], [0055], and [0056]). Landey likewise teaches that the engagement surfaces of its rollers may comprise a deformable material such as silicone rubber that provides grip, friction, traction or pressure (Paragraph [0159]). Under the broadest reasonable interpretation, providing teeth or a soft/resilient coating on the outer surface of the wheel (or on the actuation shaft itself) constitutes a “textured” outer surface. It would have been obvious to a person of ordinary skill in the art to texture the outer surface of the actuation shaft (or the wheel it carries) exactly as taught by Ferry (teeth or soft coating) or Landey (silicone rubber) in order to increase friction and prevent slippage during rotational-to-axial conversion. The modification is a routine and predictable surface treatment that improves the reliability of the axial drive already disclosed by the combination).
Regarding claim 4, modified Landey teaches, wherein an outer surface of the actuation shaft is tacky (Ferry teaches that the engagement surface may be coated with rubber, plastic (e.g., urethane) or silicone “to resiliently engage” the medical device (Paragraphs [0055] and [0056]). Landey teaches a deformable silicone-rubber surface that provides grip/friction (Paragraph [0159]). A silicone or rubber coating is inherently tacky/sticky when selected for high-friction engagement. Providing an expressly tacky outer surface on the actuation shaft (or on the wheel it carries) is therefore an obvious material selection from the soft/resilient coatings already taught by Ferry and Landey. A person of ordinary skill in the art would have selected a tacky material for the identical purpose of enhancing frictional grip and preventing slip, thereby improving the controlled axial movement already achieved by the combination. The modification is predictable and yields the same anti-slip result).
Regarding claim 7, Landey teaches, the housing (housing (302)) and the elongate shaft (elongate shaft (220)). Landey further teaches that the rollers (the actuation element) remain disposed within the housing while the elongate shaft is loaded into the channel (the rollers are moved apart to the open/loading position but stay inside the housing; the shaft is then placed into the channel and the rollers are closed onto it; Paragraphs [0184]-[0185] and [0201]-[0205]).
Landey fails to teach, wherein the housing is configured to be attached to the elongate shaft with the actuation shaft already disposed within the second lumen.
Winston teaches, aspects of the delivery system according to claim 1 (See above rejection of claim 1).
Ferry teaches, the wheels and their supporting shafts remain mounted in the housing/base while the elongate medical device is loaded into the slot (the sliding cover is opened, the device is laid into the slot between the opposed wheels, and the cover is closed; the shafts and wheels stay in place within the base throughout loading; Paragraphs [0053]-[0054]).
A person of ordinary skill in the art would have found it obvious to retain the transverse actuation shaft of Ferry (or the equivalent roller axes of Landey) already in place inside the housing when the elongate shaft is loaded, because that is precisely how both Landey and Ferry operate. The limitation adds no new structure or unexpected result beyond the loading sequence already disclosed by the combination.
Regarding claim 8, Landey teaches, that axial movement of the elongate shaft is produced by the direct frictional force of the rollers against the shaft (the rollers press into or otherwise engage opposite sides of the shaft; rotation of the rollers drives the shaft axially solely by that frictional engagement; the spring force that presses the rollers against the shaft can be tuned so the rollers slip at a prescribed load; Paragraphs [0159] and [0184]-[0185]).
Furthermore, Ferry teaches that axial movement of the elongate medical device is produced by the direct frictional (or toothed) engagement of the wheels against the device (the wheels protrude into the slot and drivingly engage the device; rotation of the shafts/wheels advances or retracts the device by that contact force; the wheels may be provided with teeth or a soft/resilient coating such as rubber or silicone to grip the device; Paragraphs [0048] and [0054]-[0056]).
Under the broadest reasonable interpretation of the claim language (“based only on force of the actuation shaft against the elongate shaft”), the axial movement in each of Landey and Ferry results from the direct contact force between the engaging surface (roller, wheel, or friction wheel) carried by the actuation shaft and the elongate shaft/member. No intermediate gearing or linkage is required between the contacting surface and the elongate shaft itself.
A person of ordinary skill in the art would have recognized that the rotational-to-axial conversion already taught by the combination operates solely by the force of the actuation element against the elongate shaft. The limitation is therefore met by the same frictional-engagement drive that the combination employs.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landey, in view of Winston, and further in view of Rezac (US 2014/0228800 A1).
Regarding claim 6, Landey teaches, the housing includes a first half connected to a second half (housing (302) with upper portion (304) and lower portion (306)).
Landey does not explicitly teach, the first half and the second half of the housing are connected by a hinge.
Winston teaches, aspects of the delivery system according to claim 1 (See above rejection of claim 1).
Rezac discloses, catheter actuation handles. Rezac teaches, a housing consisting of two symmetrical and mating exterior shell halves (Figure 1 or 2, exterior shell halves (100A, 100B) or (200A, 200B); Paragraphs [0196]-[0197]) that together form the actuation handle housing, and an interior consisting of two mating interior shell halves (Figures 1 or 2, interior shell halves (101A, 101B) or (201A, 201B); Paragraphs [0196]-[0197]) that nest inside the exterior shell halves; the shell halves are secured to each other after assembly (e.g., by screws (205A-205H) or alternative “snap-fit” systems utilizing pins/projections and matching holes along the mating edges (Paragraphs [0197] and [0202])). Rezac further teaches, the halves can be joined by any suitable connection system that keeps them mated while allowing the housing to be opened and closed for assembly or access (Paragraphs [0225]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to form Landey’s openable housing as a first half connected to a second half by a hinge, as taught by the mateable shell-half construction of Rezac, as all the references and the claimed invention are directed to medical-device housings that must be opened to load or assemble internal components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, providing a hinge between two housing halves is a standard, predictable design choice that keeps the halves connected, facilitates repeated opening and closing, and improves usability of the already-taught openable housing of Landey, while yielding the identical functional result of allowing the housing to be placed around the elongate shaft.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landey, in view of Winston, further in view of Ferry, and even further in view of Van der Burg (US 2012/0065662 A1).
Regarding claim 19, Landey teaches, a drive device (Figures 21-24E, drive device (300) comprising housing (302) with upper portion (304) and lower portion (306); Paragraphs [0155], [0159]-[0160], and [0168]-[0173]) comprising:
an elongate shaft (Figure 21 and 24D-24E, elongate shaft (220) of medical instrument (210)) that is axially movable (Paragraphs [0155]-[0160] and [0173]);
a housing (Figure 23, housing (302) with upper portion (304) and lower portion (306); Paragraph [0171]) configured to receive (removably attached) the elongate shaft (Figures 21-24A and 24D-24E; Paragraphs [0160], [0171]-[0173], and [0184]; Where channel (310) formed in the upper surface (308) of the housing is configured to receive a portion of a shaft of a medical instrument, where the shaft can be top-loaded or loaded laterally into the open channel) adjacent a proximal end of the elongate shaft (Figures 21-22), the housing having a first lumen (Figures 21-23, channel (310)) configured to receive the elongate shaft (Paragraphs [0160] and [0171]-[0173]); and
an actuation element (Figures 21-22, 24A-24B, and 24D-24E, opposing rollers (312); Paragraphs [0159], [0173], and [0183]-[0189]) disposed within the housing (Figure 24A-24B and 24D-24E; Paragraphs [0159], [0173], and [0184]-[0185]; rollers (312) positioned within the housing (302) on opposite sides of the channel (310)) in direct contact with the elongate shaft and configured to axially advance and retract the elongate shaft (Paragraphs [0159], [0173], [0184]-[0185], and [210]; As the rollers (312) rotate, the shaft is pulled, pushed, or otherwise driven axially through the drive device; rotating the rollers in a first direction causes insertion/advancement of the shaft and rotating in a second opposite direction causes retraction of the shaft).
Landey further teaches, the rollers can be moved between an engaged position (pressing against opposite sides of the shaft) and a spaced-apart/loading position, and that a cover can selectively open or close the channel to facilitate loading or retention of the shaft (Paragraphs [0160], [0184]-[0185], and [0201]-[0205]).
Landey fails to teach, a left atrial appendage closure device including a self-expandable framework and a proximal hub; a delivery catheter having a lumen extending therethrough sized to receive the left atrial appendage closure device in a collapsed configuration; the elongate shaft axially slidable within the lumen of the delivery catheter, a distal end of the elongate shaft configured to releasably couple with the proximal hub of the left atrial appendage closure device; the housing having a second lumen extending transverse to and intersecting the first lumen; and the actuation element as an actuation shaft disposed within the second lumen and in direct contact with the elongate shaft, wherein rotation of the actuation shaft axially advances or retracts the elongate shaft.
Winston teaches, a catheter (Figure 1, catheter (102); Col. 3, line 34-44) having a lumen (Col. 3, line 45-52; central lumen extending therethrough (not shown)) that accommodates an elongate member (Col. 3, line 34-44; guide wire); the handle is couples to the catheter via luer-lock elements (Figures 1-3, male luer lock element (134) and female luer lock (132); Col. 3, line 63-67).
Ferry teaches, a housing (Figures 1-3, base (42)) having a first lumen (Figures 2-3, longitudinal slot (54) extending from the front to the back of the base for receiving a portion of the elongate medical device) (Paragraphs [0047] and [0048]);
opposed wheels (Figure 3, driven wheel (62) and idler wheel (64)) that protrude into the first lumen/slot (54) from opposite sides so as to drivingly engage the elongate medical device disposed therein (Paragraphs [0048] and [0054]);
each wheel mounted on its own shaft (Figures 3-4, driven wheel (62) mounted on shaft (68); idler wheel (64) mounted on shaft (92)) (Paragraphs [0049] and [0051]);
the shafts being oriented transversely (the shafts are “rotatably mounted about an axis generally perpendicular to the bottom,” i.e., perpendicular to the longitudinal direction of slot (54)) (Paragraph [0049]);
the shafts being supported in openings/sockets that intersect the first lumen (shaft (68) is mounted between a socket (50) in the base and a socket (52) in the bottom; shaft (92) is received in a slot in the floor of the base and its upper end is received in a groove in the cover; the side walls of slot (54) contain openings through which portions of the wheels protrude into the slot so the wheels can contact the device) (see Paragraphs [0049], [0051], and the structure illustrated in Figure 3); and
rotation of the shaft (and therefore of the wheel it carries) causes axial advancement or retraction of the elongate medical device within the first lumen (when the motor drives the rigid drive shaft, the worm turns the worm gear on shaft (68), rotating the driven wheel and thereby advancing or retracting the device through slot (54)) (Paragraphs [0049] and [0054]).
Under the broadest reasonable interpretation of the claim language consistent with the specification, Ferry’s transverse shafts (68, 92) that are supported in openings/sockets that intersect the longitudinal slot (54), and that carry the wheels which protrude into and engage the elongate device, constitute “an actuation shaft extending through [a] second lumen” (the supporting sockets/openings) that is transverse to and intersects the first lumen, wherein rotation of the actuation shaft causes axial movement of the elongate shaft.
Van der Burg discloses devices and methods for left atrial appendage occlusion. Van der Burg teaches, a left atrial appendage closure/occluding device (Figure 1, occluding device (10) or any of the other embodiments disclosed) including a self-expandable framework (Figures 1-2, frame structure (14) made from shape-memory or pseudoelastic alloy such as NiTi that is self-expanding from a constrained configuration; Paragraphs [0045]-[0046] and [0054]-[0055]) and a proximal hub (Figures 1-3, hub (16) located near the center of the occluding member that connects the retention member to the occluding member and allows a constrained configuration for delivery; Paragraphs [0045]-[0046]);
a delivery catheter (Figures 9-12, delivery catheter (85)) having a lumen (Figure 11, inner lumen (98)) extending therethrough and sized to receive the left atrial appendage closure device in a collapsed/constrained configuration (the occluding device is disposed within the delivery catheter in a collapsed state and is forced therefrom by a plunger to deploy; Paragraphs [0053]-[0056]);
an elongate shaft (Figures 9, and 11, plunger (97); Figure 3, tissue-penetrating shaft (25); or equivalent push member) axially slidable within the lumen of the delivery catheter, a distal end of the elongate shaft configured to releasably couple with the proximal hub of the left atrial appendage closure device (the plunger applies axial force to the collapsed occluding member to deploy it; the hub houses a rotational coupling connected to the proximal end of the tissue-penetrating shaft; the device is detachably secured / can be pushed from the catheter and left in place; Paragraphs [0046], [0053]-[0056], and [0059]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the delivery system of Landey, Winston, and Ferry (as previously described in claims 1 and 2 earlier) to incorporate the left atrial appendage closure device (self-expandable framework + proximal hub), the delivery catheter sized to receive that device in a collapsed configuration, and the elongate shaft whose distal end releasably couples to the proximal hub, as taught by Van der Burg, as all the references and the claimed invention are directed to controlled axial movement of an implant or elongate member through a catheter for deployment within the body. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, applying the precise, incremental rotational actuation housing and transverse actuation shaft already taught by Landey, Winston, and Ferry to a conventional LAA occluder delivery catheter and shaft in order to obtain finer control during the final stages of deployment and recapture. The modification is a predictable substitution of one known implant and its dedicated delivery catheter/shaft for the generic elongate medical device already driven by the Landey, Winston, and Ferry housing, and yields the expected advantage of more precise, controlled placement of the LAA closure device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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