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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7th 2026 has been entered.
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.
Claims 1, 4, 12, 13, 15, 16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldfarb et al. (US 2008/0183194).
Regarding claim 1, Goldfarb et al. disclose an interventional system (Figures 52-58) for repairing a heart valve (Abstract), the interventional system comprising: a delivery device (1050) having a shaft (1072); and an implantable repair device (1054) releasably attached to the shaft of the delivery device (¶[0140]; Figure 57), the implantable repair device comprising: a first grasper (one pair of vertically opposing loops 1056/1058) having a first proximal gripping element (1056) and a first distal gripping element (1058), the first proximal and distal gripping elements each having a medial end (where the gripping elements emerge from 1068 or where they attach to 1066) and a lateral end (free end approximately at “1056” and “1058” in Figure 54), wherein the first proximal gripping element is configured to contact an atrial side of a first leaflet of the heart valve and the first distal gripping element is configured to contact a ventricular side of the first leaflet such that the first proximal and distal gripping elements cooperate to grasp the first leaflet therebetween (as shown for the Figures 17A-D embodiments - ¶[0136], [0099]-[0100]), wherein the first proximal and distal gripping elements collectively define a grasping length (length from where the gripping elements emerge from 1068 to their lateral ends) of the first grasper and along which the first proximal and distal gripping elements engage first leaflet of the heart valve (as shown for the Figures 17A-D embodiments - ¶[0136], [0099]-[0100]), and wherein the lateral end of each of the first proximal and distal gripping elements is moveable between a first position and a second position such that the grasping length of the first grasper is greater when the lateral ends of the first proximal and distal gripping elements are in the second position than in the first position (¶[0138]-[0139]; the claim does not require movement from the first position to the second position to cause the grasping length to increase, although two-way movement of the nut 1066 would certainly allow this), and a second grasper (other pair of vertically opposing loops 1056/1058) having a second proximal gripping element (1056) and a second distal gripping element (1058), the second proximal and distal gripping elements each having a medial end and a lateral end, wherein the second proximal gripping element is configured to contact an atrial side of a second leaflet of the heart valve and the second distal gripping element is configured to contact a ventricular side of the second leaflet such that the second proximal and distal gripping elements cooperate to grasp the second leaflet therebetween, wherein the second proximal and distal gripping elements collectively define a grasping length of the second grasper and along which the second proximal and distal gripping elements engage the second leaflet of the heart valve (as shown for the Figures 17A-D embodiments - ¶[0136], [0099]-[0100]).
Regarding claim 4, the medial end of each of the first proximal and distal gripping elements is a fixed end (where the gripping elements attach to 1066) and the lateral end of each of the first proximal and distal gripping elements is a free end (evident from Figure 55), the lateral end being moveable between a first position and a second position relative to the medial end such that the grasping length of the first grasper is greater when the lateral ends of the first proximal and distal gripping elements are in the second position than in the first position (¶[0138]-[0139]; the nut 1066 can be moved vertically upward such that the grasping length increases; the lateral end would move radially outward in an arc relative to the medial end).
Regarding claim 12, Goldfarb et al. disclose an interventional system (Figures 52-58) for repairing a heart valve (Abstract), the interventional system comprising: a delivery device having a shaft (1072); and an implantable repair device (1054) releasably attached to the shaft of the delivery device (¶[0140]; Figure 57), the implantable repair device comprising: a first grasper (one pair of vertically opposing loops 1056/1058) having a first proximal gripping element (1056) and a first distal gripping element (1058), the first proximal and distal gripping elements being positionable on opposite sides of a first leaflet of the heart valve and being moveable relative to each other to grasp the first leaflet therebetween, wherein the first proximal and distal gripping elements collectively define a first grasping interface along which a first leaflet of the heart valve is engaged by the first proximal and distal gripping elements (as shown for the Figures 17A-D embodiments - ¶[0136], [0099]-[0100]), and wherein the first proximal and distal gripping elements each have an adjustable length such that correspondingly adjusting the lengths of the first proximal and distal elements adjusts a length of the first grasping interface (¶[0138]-[0139]), and a second grasper (other pair of vertically opposing loops 1056/1058) having a second proximal gripping element (1056) and a second distal gripping element (1058), the second proximal and distal gripping elements being positionable on opposite sides of a second leaflet of the heart valve and being moveable relative to each other to grasp the second leaflet therebetween, wherein the second proximal and distal gripping elements collectively define a second grasping interface along which second leaflet of the heart valve is engaged by the second proximal and distal gripping elements (as shown for the Figures 17A-D embodiments - ¶[0136], [0099]-[0100]).
Regarding claim 13, first proximal gripping element includes a plurality of frictional elements (1057), the frictional elements at least partially defining the first grasping interface (evident from Figure 53).
Regarding claim 15, the implantable repair device further includes a central portion (1065/1066/1068/1069) defining a longitudinal axis thereof, the delivery device being releasably attached to the central portion (via 1082; ¶[0140]; Figure 57).
Regarding claim 16, the first proximal and distal gripping elements extend from the central portion such that the medial ends thereof are positioned closer to the longitudinal axis of the implantable repair device than the lateral ends thereof (evident from Figure 55), the medial ends being in a fixed position relative to the longitudinal axis of the central portion (they are fixed within 1066 and are radially fixed relative to the longitudinal axis).
Regarding claim 18, Goldfarb et al. disclose an interventional system (Figures 52-58) for repairing a heart valve (Abstract), the interventional system comprising: a delivery device (1050) having a shaft (1072); and an implantable repair device (1054) releasably attached to the shaft of the delivery device (¶[0140]; Figure 57), the implantable repair device comprising: a first grasper (one pair of vertically opposing loops 1056/1058) having a first proximal gripping element (1056) and a first distal gripping element (1058), the first proximal and distal gripping elements being configured to cooperate with each other to grasp a first leaflet of the heart valve therebetween (as shown for the Figures 17A-D embodiments - ¶[0136], [0099]-[0100]) and each having a medial end (where the gripping elements emerge from 1068 or where they attach to 1066), a lateral end (free end approximately at “1056” and “1058” in Figure 54), and an engagement area disposed between the medial end and the lateral end thereof for engagement against the first leaflet, wherein the engagement area of the first proximal gripping element is configured for engagement against a first side of the first leaflet and the engagement area of the first distal gripping element is configured for engagement against a second side of the first leaflet opposite the first side (see Figures 17A-17D; the opposing surfaces of each gripping element grasp a leaflet as claimed to define an engagement area), wherein the lateral end of each of the first proximal and distal gripping elements is moveable relative to the medial end for selective adjustment of the engagement area (¶[0138]-[0139]), and a second grasper (other pair of vertically opposing loops 1056/1058) having a second proximal gripping element (1056) and a second distal gripping element (1058), the second proximal and distal gripping elements being configured to cooperate with each other to grasp a second leaflet of the heart valve therebetween and each having a medial end, a lateral end, and an engagement area disposed between the medial end and the lateral end thereof for engagement against the second leaflet, wherein the engagement area of the second proximal gripping element is configured for engagement against a first side of the second leaflet and the engagement area of the second distal gripping element is configured for engagement against a second side of the second leaflet opposite the first side (as shown for the Figures 17A-D embodiments - ¶[0136], [0099]-[0100]).
Regarding claim 19, the implantable repair device further includes a central portion (1065/1066/1068/1069) defining a longitudinal axis of the implantable repair device, the first proximal gripping element includes a first proximal arm (arm forming either side of the loop) and a second proximal arm (other side of the loop) moveable relative to the first proximal arm (the loops are flexible as evident from Figures 52-58 - they bend into an arch shape from a straight shape), and the first distal gripping element includes a first distal arm (either side of the loop) and a second distal arm (other side of the loop) moveable relative to the first distal arm (the loops are flexible as evident from Figures 52-58).
Allowable Subject Matter
Claims 2, 3, 5-11, 14, 17 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed January 7th 2026 have been fully considered but they are either moot in view of the new grounds of rejection above or are not persuasive. Applicant has argued that the wire-framed elements (1056 and 1058) of Goldfarb et al. move as a unit and this is not an in situ adjustment of the length of the gripping elements. The grasping length or adjustable length as recited in at least claims 1 and 12 can be regarded as only the portion of the gripping elements that has emerged from member 1068. Regarding claim 18, the nut 1066 can be moved vertically upward such that the grasping length increases. The lateral end would move radially outward in an arc relative to the medial end.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771