DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s remarks filed 23 June 2025 are acknowledged. Claims 1-14 and 22-24 are pending.
Response to Arguments
Applicant’s arguments, see pages 9-13, filed 23 June 2025, with respect to claims 1, 2, 5, 8, 9, and 12 have been fully considered and are persuasive. The nonstatutory double patenting rejection of claims 1, 2, 5, 8, 9, and 12 has been withdrawn.
Applicant's arguments filed 23 June 2025 have been fully considered but they are not persuasive. With respect to Applicant’s arguments regarding the 102 rejection of claims 1-14 and 22-24, see pages 14-17, that the reference Wei fails to teach “wherein the coupler is configured to move freely” do not overcome the rejection. Wei teaches that the stud 74 “is joinable with an actuator rod which extends through the shaft 12 and is axially extendable and retractable to move the stud 74 and therefore the legs 68” [0050]. Further, Wei teaches that “immobilization of the stud 74 holds the legs 68 in place” [0050]. Therefore, movement of the stud along with the shaft 12 is required for the opening and closing of the legs of the device, similar to the coupler 610 which moves with the shaft 609 of Applicant’s invention. Wei further teaches that “further advancement of [the] actuator rod relative to shaft 12, and thus stud 74 relative to coupling member 19, the distal elements 18 are further rotated” [0056] and “further advancement of the stud 74 further rotates the distal elements 18” [0057]. Therefore, stud 74 meets the limitations set forth by the claim wherein it “move[s] freely” to open and close the paddles (Wei’s distal elements 18).
Regarding Applicant’s arguments that Wei fails to teach movement of the device “during the cardiac cycle” (pg. 17 of remarks), Fig. 4 of Wei depicts the fixation device 14 in its desired orientation in relation to the leaflets [0041]. Wei further teaches that “during diastole…fixation device 14 hold the leaflets in position between elements 16, 18” [0041], therefore exhibiting that intention for the cardiac implant to adapt to the movement of the leaflets during the cardiac cycle.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 and 22-24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wei et al. (US 2016/0174979 A1), “Wei”.
Regarding claim 1, Wei teaches
A valve repair device (Fig. 5, interventional tool 10) for repairing a native heart valve of a patient, the valve repair device comprising: a pair of clasps (Fig. 5, proximal elements 16); a pair of paddles (Fig. 5, distal elements 18), wherein the clasps and paddles are configured to attach to native valve leaflets (Fig. 3A-C, proximal elements 16 and distal elements 18 attach to leaflets LF) of the heart valve;
A coupler (Fig. 5, stud 74) mechanically connected to the paddles (Fig. 5, stud 74 is connected to distal elements 18), wherein the coupler is configured to move the paddles between a partially open position (Fig. 7B depicts an open position) and a closed position (Fig. 6B depicts a closed position);
and wherein the coupler is configured to move freely (Fig. 5, stud 74 moves freely along shaft 12) such that ends of the pair of paddles move away from one another when the native valve leaflets open during a diastolic phase of a cardiac cycle (Fig. 7B, distal elements are away from one another when in open position),
and wherein the ends of the pair of paddles move toward one another when the native valve leaflets close during a ventricular systole of the cardiac cycle (Fig. 6B, distal elements 18 move towards one another when device closes).
Regarding claim 2, Wei teaches
a shaft (Fig. 5, shaft 12), wherein the coupler (Fig. 5, stud 74) is configured to move along the shaft such that movement of the coupler along the shaft causes the pair of paddles to move between the partially open position and the closed position (Fig. 5, movement of shaft 12 causes opening and closing of interventional tool 10 [0053]).
Regarding claim 3, Wei teaches
wherein the ends of the paddles (Fig. 5, distal elements 18) are angled away from one another when the paddles are in the partially open position (Fig. 7B depicts an open position where distal elements 18 are angled away from each other).
Regarding claim 4, Wei teaches
wherein the coupler (Fig. 5, stud 74) is connected to the paddles (Fig. 5, distal elements 68) by a linkage that pivots (Fig. 7B, joints 80 (or Fig. 5, ref 78, unnamed joint)) when the coupler moves the pair of paddles between the partially open position and the closed position (Figs. 7A-B, joints 80 rotate when paddles are adjusted from open to closed position).
Regarding claim 5, Wei teaches
wherein the clasps (Fig. 5, proximal elements 16) are connected to a base assembly (Fig. 7A, proximal element lines 90) such that the clasps are movable with the base assembly to adjust a width of an opening between the clasps and the paddles (Figs. 7A, proximal element lines 90 cause movement of proximal elements 16 [0054]).
Regarding claim 6, Wei teaches
a coaption element (Fig. 5, actuator rod (not shown)) connected to the pair of paddles (Fig. 5, distal elements 18 are moved by actuator rod [0050]),
wherein the movement of the paddles causes the native valve leaflets (Figs. 3A-C, leaflets LF) to coapt against the coaption element when the native valve closes (Figs. 3A-C, actuator rod (not shown) causes movement to closed position of distal elements 18 [0050]) and causes the native valve leaflets to separate from the coaption element when the native valve opens (Figs. 3A-C, actuator rod (not shown) causes movement to open position of distal elements 18 [0050]).
Regarding claim 7, Wei teaches
wherein the native valve leaflets (Figs. 3A-C, leaflets LF) are leaflets of one of a mitral valve or a tricuspid valve (leaflets LF are of the mitral valve MV [0037]).
Regarding claim 8, Wei teaches
A system for repairing a native heart valve of a patient (Fig. 6A), comprising: a catheter (Fig. 6A, catheter 86); a valve repair device (Fig. 6A, intervention tool 10) deliverable through the catheter to the native heart valve (Fig. 6A depicts intervention tool 10 being delivered through catheter 86),
the valve repair device comprising: a pair of clasps (Fig. 5, proximal elements 16) wherein each clasp is configured to attach to native valve leaflets of the heart valve (Fig. 3A-C, proximal elements 16 attach to leaflets LF);
a pair of paddles (Fig. 5, distal elements 18), wherein the clasps and paddles are configured to attach to native valve leaflets of the heart valve (Fig. 3A-C, distal elements 18 attach to leaflets LF);
a coupler (Fig. 5, stud 74) mechanically connected to the paddles (Fig. 5, stud 74 is connected to distal elements 18), wherein the coupler is configured to move the paddles between a partially open position (Fig. 7B, distal elements are away from one another when in open position) and a closed position (Fig. 6B, distal elements 18 move towards one another when device closes);
and wherein the coupler is configured to move freely such that ends of the pair of paddles move away from one another when the native valve leaflets open during a diastolic phase of a cardiac cycle (Fig. 5, stud 74 moves freely to open distal elements 18 [0053]),
and wherein the ends of the pair of paddles move toward one another when the native valve leaflets close during a ventricular systole of the cardiac cycle (Fig. 5, stud 74 moves freely to open distal elements 18).
Regarding claim 9, Wei teaches
a shaft (Fig. 5, shaft 12), wherein the coupler (Fig. 5, stud 74) is configured to move along the shaft such that movement of the coupler along the shaft causes the pair of paddles to move between the partially open position and the closed position (Fig. 5, movement of shaft 12 causes opening and closing of interventional tool 10 [0053]).
Regarding claim 10, Wei teaches
wherein the ends of the paddles (Fig. 5, distal elements 18) are angled away from one another when the paddles are in the partially open position (Fig. 7B depicts an open position where distal elements 18 are angled away from each other).
Regarding claim 11, Wei teaches
wherein the coupler (Fig. 5, stud 74) is connected to the paddles (Fig. 5, distal elements 68) by a linkage that pivots (Fig. 7B, joints 80 (or Fig. 5, ref 78, unnamed joint)) when the coupler moves the pair of paddles between the partially open position and the closed position (Figs. 7A-B, joints 80 rotate when paddles are adjusted from open to closed position).
Regarding claim 12, Wei teaches
wherein the clasps (Fig. 5, proximal elements 16) are connected to a base assembly (Fig. 7A, proximal element lines 90) such that the clasps are movable with the base assembly to adjust a width of an opening between the clasps and the paddles (Figs. 7A, proximal element lines 90 cause movement of proximal elements 16 [0054]).
Regarding claim 13, Wei teaches
further comprising a coaption element (Fig.5, actuator rod (not shown)) connected to the pair of paddles (Fig. 5, distal elements 18 are moved by actuator rod [0050]),
wherein the movement of the paddles causes the native valve leaflets (Figs. 3A-C, leaflets LF) to coapt against the coaption element when the native valve closes (Figs. 3A-C, actuator rod (not shown) causes movement to closed position of distal elements 18 [0050]) and causes the native valve leaflets to separate from the coaption element when the native valve opens (Figs. 3A-C, actuator rod (not shown) causes movement to open position of distal elements 18 [0050]).
Regarding claim 14, Wei teaches
wherein the native valve leaflets (Figs. 3A-C, leaflets LF) are leaflets of one of a mitral valve or a tricuspid valve (leaflets LF are of the mitral valve MV [0037]).
Regarding claim 22, Wei teaches
A valve repair device (Fig. 5, interventional tool 10) for repairing a native heart valve of a patient, the valve repair device comprising: a pair of clasps (Fig. 5, proximal elements 16); a pair of paddles (Fig. 5, distal elements 18),
wherein the clasps and paddles are configured to attach to native valve leaflets of the heart valve (Fig. 3A-C, proximal elements 16 and distal elements 18 attach to leaflets LF);
a coupler (Fig. 5, stud 74) connected to the paddles (Fig. 5, stud 74 is connected to distal elements 18), wherein movement by the coupler changes the position of the paddles (Fig. 5, stud 74 moves freely to open distal elements 18);
and wherein the coupler (Fig. 5, stud 74) is configured to move such that ends of the pair of paddles move away from one another when the native valve leaflets open during a diastolic phase of a cardiac cycle (Fig. 7B, distal elements are away from one another when in open position),
and wherein the ends of the pair of paddles move toward one another when the native valve leaflets close during a ventricular systole of the cardiac cycle (Fig. 6B, distal elements 18 move towards one another when device closes).
Regarding claim 23, Wei teaches
further comprising a shaft (Fig. 5, shaft 12) and wherein the coupler (Fig. 5, stud 74) moves along the shaft (Fig. 5, movement of shaft 12 causes opening and closing of interventional tool 10 [0053]).
Regarding claim 24, Wei teaches
wherein the coupler (Fig. 5, stud 74) moves: in a first direction when the pair of paddles move away from one another when the native valve leaflets open during a diastolic phase of a cardiac cycle (Fig. 7B, distal elements are away from one another when in open position),
and in a second direction when the ends of the pair of paddles move toward one another when the native valve leaflets close during a ventricular systole of the cardiac cycle (Fig. 6B, distal elements 18 move towards one another when device closes).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/G.G.R./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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