DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2020/0367871 (Van Hoven et al.).
Van Hoven discloses an implant delivery device comprising a delivery assembly (300 for delivering fixation device 104; Fig 2; [0041]), a first flexible catheter (inner guide catheter 1020) and a second flexible catheter (outer guide catheter 1000), wherein at least a part of the delivery assembly is movably inserted in the first flexible catheter along an axial direction thereof ([0042]), each of the first flexible catheter (1020) and the delivery assembly (324) movably inserted in the second flexible catheter (1000) along an axial direction thereof and configured to protrude out from a distal end of the second flexible catheter (see Fig. 3) [0042].
The first and second flexible catheters (1000 and 1020) are configured to bend independently (see first catheter 1020 bending in Figures 5A-C; [0044] and second catheter 1000 bending in Figures 4A-C; [0043]), and wherein an extension direction of the delivery assembly (300) changes when bent shapes of the first and second flexible catheters vary [0044-0046]. Van Hoven teaches that the combination of the first inner steerable catheter and the second outer steerable catheter provides the operator with the capability of controlling the curvature of the delivery catheter (300) (and thus placement of the implant) in two planes [0014].
Regarding claim 2, Cooper discloses the delivery device has a forward-backward driving unit (elongate catheters 302 and/or rod 64 [0041]). The loading unit is considered to be the distal end portion (324) to which the implant (102) is attached [0041], and protrudes out from a distal end of the first catheter (1020) (Fig. 3).
Regarding claim 10, Van Hoven further discloses the implant delivery system further comprises a driving device (see handle with controls in Figure 3 at the proximal end of the catheters) coupled to a proximal end of the delivery device, wherein the driving device is configured to drive the first and second flexible catheters to bend, respectively [0057-0058].
Regarding claim 11, Cooper discloses the delivery device has a forward-backward driving unit (elongate catheters 302 and/or rod 64 [0041]). The loading unit is considered to be the distal end portion (324) to which the implant (102) is attached [0041], and protrudes out from a distal end of the first catheter (1020) (Fig. 3).
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.
Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over 10,350,066 (Cooper et al.) in view of USPAP 2020/0367871 (Van Hoven et al.)
Regarding claims 1 and 10: Cooper discloses an implant delivery device comprising a delivery assembly (27) (see implant 70 loaded over delivery assembly 27 in Fig. 2B), but fails to disclose a first flexible catheter and a second flexible catheter in which the delivery assembly (27) is movably inserted, wherein the first and second flexible catheters are configured to bend independently.
Van Hoven discloses an implant delivery assembly comprising a first and second flexible, independently steerable catheters (1000 and 1020) through which an implant delivery assembly (300) is guided to an implantation site (see Fig. 2-3; [0013]). Van Hoven teaches that the combination of the first inner steerable catheter and the second outer steerable catheter provides the operator with the capability of controlling the curvature of the delivery catheter (300) (and thus placement of the implant) in two planes [0014]. This is analogous to Cooper, as Cooper teaches that it is desirable to steer the delivery system through complex areas of the heart in order to deliver a prosthetic valve (col 26, lines 30-40). Cooper also teaches it is obvious to configure a delivery device for different types of medical implants (column 10, line 46 to column 11, line 5).
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the first and second steerable catheters taught by Van Hoven with the heart valve delivery assembly disclosed by Cooper, as this modification merely involves a combination of known catheter devices according to known methods that obtains a predictable result of steering a guide catheter in two planes to optimize the placement of an implant device within a patient’s heart. Additionally, the modification merely involves a substitution of the fixation device delivery assembly (300) in the Van Hoven system with the heart valve delivery device of Cooper, wherein the heart valve delivery device of Cooper is inserted through the first flexible catheter (1020) taught by Van Hoven.
Further regarding claim 10, Van Hoven further discloses the implant delivery system further comprises a driving device (see handle with controls in Figure 3 at the proximal end of the catheters) coupled to a proximal end of the delivery device, wherein the driving device is configured to drive the first and second flexible catheters to bend, respectively [0057-0058].
Regarding claims 2 and 11: Cooper discloses the delivery assembly (10) comprises a forward-backward driving unit and a loading unit, wherein the loading unit (distal end 16 of catheters 20 and 22 shown in Figures 2A-B) is disposed at a distal end of the forward-backward driving unit (elongate catheters 20 and 22). As modified above, the delivery assembly (including the forward-backward driving unit) of Cooper is movably inserted in the first flexible catheter along the axial direction thereof and is configured to protrude out from a distal end of the first flexible catheter (as taught in Fig. 3 of Van Hoven).
Regarding claims 3 and 12, Cooper discloses wherein the forward- backward driving unit (elongate catheter components (20 and 22) comprises a first delivery catheter (20) and a second delivery catheter (22), and wherein the loading unit (distal end portion of catheter shown in Figure 2A-B) comprises a first loading tube (40) and a second loading tube (60), wherein the first delivery catheter (20) is movably inserted in the second delivery catheter (22) along an axial direction thereof, and wherein the second delivery catheter (22) is movably inserted in the first flexible catheter (1020 of Van Hoven) along the axial direction thereof, wherein at least a part of the first loading tube (40) is movably inserted in the second loading tube (60) along an axial direction thereof (see esp. Fig. 2A-B), and wherein the first loading tube (40) is coupled to a distal end of the first delivery catheter (20) (see esp. Fig );
the second loading tube (60) is coupled to a distal end of the second delivery catheter (22) (see Fig. 4);
the first loading tube (40) is configured for engagement with an implant (70) (Fig. 2A) (col 13, lines 22-25);
the second loading tube (60) is configured to restrict a radial expansion of the implant (70) (col 13, line 50 – col 14, line 10);
Since the second loading tube (60) of Cooper has an enlarged diameter relative to the second delivery catheter, it would have been an obvious of design choice to configure the second loading tube (60) to have a radial outer dimension greater than a radial inner dimension of the first flexible catheter (1020 of Van Hoven), as such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claims 4 and 13, the first loading tube (40) of Cooper has an enlarged diameter relative to the first delivery catheter (20) and second delivery catheter (22). It would have been an obvious of design choice to configure the first loading tube (40) to have a radial outer dimension that is greater than an inner radial dimension of the first flexible catheter (1020) but not greater than a radial outer dimension of the first flexible catheter (1020). Such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claims 5 and 14, it would have been an obvious of design choice to configure the first loading tube (40) to have a radial outer dimension that is equal to a radial outer dimension of the first flexible catheter (1020), as such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claims 6 and 15, Cooper discloses the first and second delivery catheters (20 and 22) can be double layered (col 14; lines 11-26 and 60-64), but fails to specify a braided reinforcement between the double layer. Van Hoven teaches that it is known for catheter walls to be constructed of multiple layers and reinforced with braided wires [0051]. It would have therefore been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the delivery catheters of modified Cooper to have a braided wire between double layers, as taught by Van Hoven, as the modification merely involves the application of a well-known type of catheter construction that obtains predictable results.
In regards to claims 7 and 16, it would have been further obvious to construct the loading tubes (40 and 60) of modified Cooper as double-layered tubes, as Van Hoven teaches that it is known for catheter walls to be constructed of multiple layers [0051]. The modification merely involves the application of a well-known type of catheter construction that obtains predictable results.
Regarding claims 8 and 17, Cooper discloses the loading unit further comprises a stent holder (32), wherein the stent holder is fixedly coupled to the loading unit and is used to engage with attachment lugs (tabs 74) of the implant (70) (Fig. 2A; col 13, lines 15-25).
Regarding claims 9 and 18, Cooper further comprises a third delivery catheter (inner shaft 18), wherein the third delivery catheter is movably inserted in the delivery assembly (20 and 22) along the axial direction of the first flexible catheter.
Conclusion
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774