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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, 10-11, and 13-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-7, 13-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2014/0379074 (Spence et al.) in view of USPAP 2018/0055628 (Patel et al.), and further in view of US 10,080,660 (Keane).
Spence discloses a medical system comprising: a valve clip (dock or anchor 72) comprising a deformable wire [0025] configured to capture valve leaflets of a patient, wherein the deformable wire extends from a first wire portion (100 in Figure 1C) to a second wire portion (see 108 in Fig 1F);
and a catheter (see delivery device 2 and 88 in Figures 1A-F) configured to introduce the valve clip adjacent a native heart valve in a patient (see Figures 1A-F), the catheter comprising:
a handle comprising a plurality of control members (the portions of catheter components 2 and 68 outside the heart in Figures 1A-F are capable of being gripped by an operator);
an elongate body (guide catheter 68) defining a lumen [0107], wherein the elongate body (68) extends from a proximal end mechanically coupled to the handle to a distal portion comprising a distal opening (96).
In an embodiment of Figure 26A, a delivery device (454) passes through catheter component (2) and has a snare (452) to capture and releasably couple to the first wire portion that exits the catheter (68). Spence discloses that the delivery device (454) aids in guiding the first wire portion to the desired position at valve leaflets [0169-0174]. Spence additionally teaches the snare can be pre-attached to the end of the valve clip (450) and/or coupled to the guide catheter [0169]. A similar snare (502) disclosed in Figure 29A-30B comprises jaws (522 and 524) that grip a spherical end (506) of the valve clip (500) [0177-0179].
Although Spence discloses the second wire portion of the valve clip is positioned within the elongate body (68) while the snare (454 or 506) is coupled to the first wire portion of the valve clip, Spence fails to disclose a second delivery device that is coupled to the second wire portion.
Patel discloses another catheter delivery device for a heart valve clip (docking device 1) that comprises a coiled wire configured to capture valve leaflets (see Fig. 6-8). Similar to Spence, Patel discloses the clip is pushed out a lumen of a delivery catheter (1010) [0063]. Patel teaches that a second wire portion held within the elongate body (1010) is coupled to a delivery device (pusher 1165) by a releasable suture (1163) (Fig. 22B-C; [0128]) in order to provide a mechanism for pulling retrieval of the docking device if readjustment is required [0128; 0134].
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the pusher taught by Patel with the Spence delivery assembly in order to aid in both pushing/pulling the valve clip relative to the distal end of the guide catheter in order to facilitate proper positioning and adjustment of the valve clip. This modification results in Spence having both a first delivery device (the snare of Spence) releasably coupled to a the first wire portion and a second delivery device (taught by Patel) that is releasably coupled to the second wire portion.
Spence, as modified by Patel, fails to teach both the first and second delivery devices extend through the lumen of the elongate body (delivery catheter 68 of Spence). Keane discloses another delivery device for positioning a coiled wire implant in a patient’s heart. Keane teaches the concept of having a first delivery device (307) attached to one end of the wire (200) and a second delivery device (306) attached to the other end of the wire (200), wherein the two delivery devices are disposed within a lumen of a catheter (305) (see Fig. 17A-C). The delivery device includes control members on the handle (see Figure 18) for controlling relative movement of the first and second delivery devices (306 and 307) in order to move the implant from an elongated configuration within the catheter (Fig. 17A-B; 18) to an exposed, retracted configuration (Fig. 17C; 22). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure both the first and second delivery devices disclosed by Spence and Patel to be disposed within the same lumen of an elongate body of a catheter, as taught by Keane, as the modification merely involves a combination of known delivery devices according to known methods that obtains a predictable result of containing multiple elongate components withing a lumen of a catheter to simplify insertion in the patient’s body.
Regarding claim 2: Spence discloses the valve clip, when in the extended configuration, is configured to pass through the lumen and the distal opening of the elongate body, and wherein the valve clip, when in the contracted configuration, defines a preformed shape configured to capture the two or more valve leaflets.
Regarding claim 3: Spence discloses the first wire portion is a distal portion of the deformable wire, wherein the second wire portion is a proximal portion of the deformable wire, wherein at least one of the proximal end or the distal end comprises a fixation structure, and wherein at least one of the first or second delivery devices is configured to releasably couple to the fixation structure. A snare (502) disclosed in Figure 29A-30B comprises jaws (522 and 524) that grip a spherical end (506) of the valve clip (500) [0177-0179].
Regarding claim 4: Spence discloses the deformable wire comprises at least one of a biocompatible shape memory alloy [0022]; [0107]; [0112].
Regarding claim 5: Spence discloses the valve clip (72) comprises at least one anchor (194) extending from an exterior surface of the deformable wire and configured to capture the two or more valve leaflets (9A-11C).
Regarding claim 6, Spence discloses the at least one anchor comprises barbs or hooks (9A-11C).
Regarding claim 7, Spence discloses the anchoring barbs or hooks (9A-11C) comprise a shape memory alloy ([0134].
Regarding claim 13, Spence discloses a method comprising:
advancing a catheter (see catheter 302) through vasculature of a patient to a vascular or cardiac selected tissue site (Fig. 17A-18C), wherein the catheter (302) comprises a lumen housing a valve clip (72/330) comprising a deformable wire (72) configured to capture two or more valve leaflets of a patient (Fig. 1F), wherein the deformable wire (72) extends from a first wire portion (distal end exiting catheter first) to a second wire portion (proximal end of wire 72),
and wherein the catheter (302 in Fig. 17-18) further comprises an elongate body defining the lumen, wherein the elongate body extends from a proximal end mechanically coupled to a handle (outside patient’s body) to a distal portion comprising a distal opening.
In an embodiment of Figure 26A-C, Spence teaches a first delivery device (454) that passes through catheter component (2) and has a snare (452) to capture and releasably couple to the first wire portion (460). Spence discloses that the delivery device (454) aids in guiding the first wire portion to the desired position at valve leaflets [0169-0174]. Spence additionally teaches the snare can be pre-attached to the end of the valve clip (450) and/or coupled to the guide catheter [0169]. A similar snare (502) disclosed in Figure 29A-30B comprises jaws (522 and 524) that grip a spherical end (506) of the valve clip (500) [0177-0179].
Spence discloses the second wire portion (proximal end) of the valve clip is positioned within and controlled by a coil guide catheter (see 310 in Figure 17 or 456 in Fig. 26) while the snare (454 or 506) is coupled to the first wire portion (distal end) of the valve clip (see Fig. 26A-C). The first delivery device (or 502 in Fig. 29C is moved relative to the distal end of the guide catheter (2 in Fig. 26A & 29) in order to position the first end of the clip a desired anatomical location [0169-0177] and to move the clip from an elongated configuration (within the catheter) to a contracted configuration (deployed).
Spence fails to disclose a second delivery device that is coupled to the second wire portion (proximal end) within the catheter. Patel discloses another catheter delivery device for a heart valve clip (docking device 1) that comprises a coiled wire configured to capture valve leaflets (see Fig. 6-8). Similar to Spence, Patel discloses the clip is pushed out a lumen of a delivery catheter (1010) [0063]. Patel teaches that a second wire portion held within the elongate body (1010) is coupled to a delivery device (pusher 1165) by a releasable suture (1163) (Fig. 22B-C; [0128]) in order to provide a mechanism for pulling retrieval of the docking device if readjustment is required [0128; 0134].
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the pusher taught by Patel with the Spence delivery assembly in order to aid in both pushing/pulling the valve clip relative to the distal end of the guide catheter in order to facilitate proper positioning and adjustment of the valve clip. This modification results in Spence having both a first delivery device (the snare of Spence) releasably coupled to a the first wire portion (distal end) and a second delivery device (taught by Patel) that is releasably coupled to the second wire portion (proximal end).
Spence and Patel fail to disclose a handle comprising a plurality of control members for moving the first and seconds delivery devices. Keane discloses another delivery device for positioning a coiled wire implant in a patient’s heart. Keane teaches the concept of having a first delivery device (307) attached to one end of the wire (200) and a second delivery device (306) attached to the other end of the wire (200), wherein the two delivery devices are disposed within a lumen of a catheter (305) (see Fig. 17A-C). The delivery device includes control members on the handle (see Figure 18) for controlling relative movement of the first and second delivery devices (306 and 307) in order to move the implant from an elongated configuration within the catheter (Fig. 17A-B; 18) to an exposed, retracted configuration (Fig. 17C; 22). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure both the first and second delivery devices disclosed by Spence and Patel to be disposed within the same lumen of an elongate body of a catheter and to be operatively connected to a control member on a handle, as taught by Keane, as the modification merely involves a combination of known delivery devices according to known methods that obtains a predictable result of delivering and controlling relative movement of two elongate catheter components that obtains a predictable result of delivering a coiled implant.
Regarding claim 14, Spence discloses the valve clip (72), when in the extended configuration, is configured to pass through the lumen of the coil guide catheter (456 in Figure 26A) and the distal opening of the elongate body (2), and wherein the valve clip (72), when in the contracted configuration (Fig. 1F), defines a preformed shape configured to capture the two or more valve leaflets.
Regarding claim 15, Spence discloses the he first wire portion is a distal portion of the deformable wire (see 460 in Fig. 26C), wherein the second wire portion is a proximal portion of the deformable wire, and wherein at least one of the proximal end or the distal end comprises a fixation structure (see spherical end 506 in Figure 30A-B), and the method further comprising coupling at least one of the first or second delivery devices to the fixation structure (see delivery device 502 in Figures 29A-C [0177]).
Regarding claim 16: Spence discloses the deformable wire comprises at least one of a biocompatible shape memory alloy [0022]; [0107]; [0112].
Regarding claim 17: Spence discloses the valve clip (72) comprises at least one anchor (194) extending from an exterior surface of the deformable wire and configured to capture the two or more valve leaflets (9A-11C).
Regarding claim 18, Spence discloses the at least one anchor comprises barbs or hooks (9A-11C). Patel teaches an anchor in the form of a fabric (1180) (Fig. 19).
Regarding claim 20, the two or valve leaflets comprise a mitral valve of a heart (entire disclosure), and wherein advancing the catheter through vasculature of a patient to a vascular or cardiac selected tissue site comprises:
advancing the catheter through the vasculature of the patient to a right atrium (see 210 in Fig 17-C) of the patient; and advancing the catheter through a septum (304) of the heart to the left atrium (46) [0151].
In regards to claim 21, Spence discloses the contracted configuration of the valve clip defines a preformed shape (coil) to which the valve clip recovers in the absence of an applied force (due to shape memory ([0022]; [0107]; [0112]), and wherein, to capture the two or more valve leaflets (38 and 42), the deformable wire is configured to grasp the two or more valve leaflets when the valve clip is in the contracted configuration to clip together the two or more valve leaflets (see Fig. 1A-F).
In regards to claim 22, Spence discloses that the device grasping the proximal end of the clip (see coil guide catheter in Figure 26A) is non-coaxial with the delivery device that engages the opposite end of the clip (see 454 in Figure 26A). These two delivery devices are disposed non-coaxially within the delivery tube (2). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to arrange the first and second delivery devices of above modified Spence to be non-coaxial.
Claim(s) 8, 10, 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2014/0379074 (Spence et al.) in view of USPAP 2018/0055628 (Patel et al.) and US 10,080,660 (Keane), as applied to claim 1 above, and further in view of US Patent No. 6,730,121 (Ortiz et al.).
Regarding claims 8, 10 and 19, Spence discloses the valve clip (72) comprises barbs or hooks (194) extending from an exterior surface of the deformable wire, and Patel discloses a valve clip having a fabric (1180) disposed over the surface (see Fig. 19).
Spence, Patel and Keane fail to disclose a fabric positioned over the plurality of barbs, wherein the barbs are configured to at least partially protrude through the fabric when the valve clip captures the two or more valve leaflets.
Similar to Patel, Ortiz discloses a fabric layer (46) positioned around the wire (see Fig. 5A-B; col 6, lines 3-7). Ortiz teaches the implant may include barbs (44a) extending from the wire and at least partially protrude through the fabric (46) to engage surrounding tissue (Fig. 5A-B; col 6, lines 22-34), and therefore aid in securing the device. One of ordinary skill the art before the effective filing date of the claimed invention would have found it obvious to further modify the Spence valve clip to have barbs extending outward from the clip surface and at least partially through a fabric, as taught by Ortiz, in order to enhance the securement of the implant to surrounding tissue.
Regarding claim 11: Spence discloses the deformable wire comprises at least one of a biocompatible shape memory alloy [0022]; [0107]; [0112].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774