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 Objections
Claim 15 is objected to because of the following informalities: In order to avoid any antecedent issues, lines 11-12 should be amended to read “..to the area of the heart valve”. Appropriate correction is required.
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 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.
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.
Claims 1-3, 7-9, 11, 14-16, 18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0331971 to Keranen in view of U.S. Patent Publication 2007/0255396 to Douk.
As to claim 1, Keranen discloses a device for assisting the functioning of a heart valve (paragraph 54) comprising a ventricular winding (300) having in an unconstrained condition a generally spiral shape (figure 9, 15), and a grasping element (center of 300, as seen as 304 in figure 15, the “connection interface”, paragraph 191) connected to a center of the ventricular winding and extending from the center of the ventricular winding (figure 9, 15), wherein the generally spiral shape comprises at least a first turn (figure 9, 15) and a second turn (figure 9, 15), wherein in a radial direction from the center of the ventricular winding the second turn is farther away from the center of the ventricular winding than the first turn (figure 9, 15), and wherein at least the first turn is a full turn extending 360 degrees around the center of the ventricular winding (figure 9, 15), wherein the device is adapted to be advanced to an area of the heart valve using a delivery system (11) with the ventricular winding held within the delivery system in a constrained condition in which the ventricular winding has a relatively straitened shape (paragraph 237, the device can be delivered by a catheter and therefore will have a constrained straitened shape to fit within the catheter), wherein the ventricular winding is adapted to be released from the delivery system (paragraph 186) thereby allowing the ventricular winding to assume its unconstrained condition in which it has the general spiral shape (paragraph 27, figure 9), wherein the ventricular winding in its unconstrained condition is adapted to be positioned on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular windings within a general spiral path defined by the general spirally shape of the ventricular winding (figure 15, 16, 17), wherein the grasping element has an axis (figure 9, 15), and wherein the ventricular winding in its unconstrained condition is adapted to be turned by using the delivery system to turn the grasping element (paragraph 10, 191-193) whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element (paragraph 210, 212) such that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought toward the center of the ventricular winding (figure 8a,b, 14, 15, 16, 17), thereby causing the first leaflet and the second leaflet of the heart to be drawn together (figure 8a,b, 14, 15, 16, 17, paragraph 191-193), wherein the grasping element is adapted to be releasably held by the delivery system during maneuvering of the device (paragraph 214), wherein the device is adapted to be left in a desired location after release of the device from the delivery system and withdrawal of the delivery system (figure 17, paragraph 197), wherein the device is free of any atrial stabilizing section (figure 17, the device can be located on the ventricle side without any structural that can be designated as an atrial stabilizing section). Keranen discloses multiple embodiments where a spiral winding is delivered to a ventricular side of a heart valve. Keranen discloses that the device can have multiple of different turns, and loops, and have a grasping element that is attached to a medical device, where the medical device can turn the proximal end to help deliver the winding (at least paragraph 186, 187, 191, figure 6a, 9). Further the device can be delivered by multiple approaches and by a catheter (paragraph 174-181, 237). If it would not be known that Keranen would be able to disclose in one embodiment the winding with a generally spiral shape with at least first turn extending 360 degrees and the second turn, and a grasping element adapted to be turned by a delivery system and released, it would have been obvious in order to reshape the heart as desired.
If it would not be known that the winding would have a relatively straitened shape in the constrained condition within the delivery system, Douk teaches a similar device (heart valve treatment, abstract) comprising a winding (120, figure 1) have a relatively straitened shape in the constrained condition within the delivery system (figure 1, paragraph 36, 37, 45) for the purpose of helping to easily delivery the device to the heart. If it would not be known that the winding of Keranen would be delivered such that there were no atrial stabilizing sections, Douk also teaches a similar winding free of any atrial stabilizing sections engaging chords of the first and second leaflets (figure 11-18, paragraph 45) for the purpose of alternative mechanisms that are configure to engage chords to reshape the heart. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device of Keranen be free of atrial stabilizing sections and have a relatively straitened shape in the constrained condition within the delivery system in order for reshaping the heart as desired.
As to claim 2, with the device of Keranen and Douk above, Douk teaches the ventricular winding is substantially flat (figure 14). The winding of Keranen can be deployed as taught by Douk such that it is substantially flat.
As to claim 3, with the device of Keranen and Douk above, Keranen discloses the ventricular winding is substantially conical (figure 15). Douk further teaches the ventricular winding is substantially conical (figure 3).
As to claim 7-9, 11, with the device of Keranen and Douk above, Keranen discloses the device is comprised at least in part of a metallic material, shape member metal material, nitinol, and/or a composite (paragraph 198, 209). Douk can further teach and/or provide evidence on the material (paragraph 37). It would have been obvious to one of ordinary skill in the art before the effective filing date to select a known material for the desired characteristics of the device.
As to claim 14, with the device Keranen and Douk above, Keranen discloses the ventricular winding has an end portion that is angled downwardly (figure 8a).
As to claim 15, Keranen discloses a method of repairing a heart valve (paragraph 54) comprising delivering a heart valve repair device to an area of the by the use of a delivery system (catheter paragraph 37 and mechanism that turns the connection interface, paragraph 191, figure 5a), the heart valve repair device comprising a ventricular winding (300) having in an unconstrained condition a generally spiral shape (figure 9, 15,), and a grasping element (center of 300, as seen as 304 in figure 15, the “connection interface”, paragraph 191) connected to a center of the ventricular winding and that extends from the center of the ventricular winding (figure 9, 15), wherein the grasping element has an axis (figure 9, 15), wherein the generally spiral shape comprises at least a first turn (figure 9, 15) and a second turn (figure 9, 15), wherein in a radial direction from the center of the ventricular winding the second turn is farther away from the center of the ventricular winding than the first turn (figure 9, 15), and wherein at least the first turn is a full turn extending 360 degrees around the center of the ventricular winding (figure 9, 15), using the delivery system to advance the heart valve repair device to an area of the heart valve (paragraph 237, 174-182) with the ventricular winding held within the delivery system (paragraph 237, 197) in a constrained condition in which the ventricular winding has a relatively straightened shape (paragraph 237, the device can be delivered by a catheter and therefore will have a constrained straitened shape to fit within the catheter), and then to release the ventricular winding from the delivery system (paragraph 186, 197), thereby allowing the ventricular winding to assume its unconstrained condition in which it has the general spiral shape (paragraph 27, figure 9), using the delivery system to position the ventricular winding on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular windings within a general spiral path defined by the general spirally shape of the ventricular winding (figure 15, 16, 17, paragraph 69, 75, 76, 81), whereby positioning the ventricular winding comprises turning the grasping element while grasping element is releasably held by the delivery system (paragraph 191-193), whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element such that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought toward the center of the ventricular winding thereby causing the first leaflet and the second leaflet of the heart to be drawn together (figure 8a,b, 14, 15, 16, 17, paragraph 192, 210,212), releasing the heart valve repair from the delivery system (paragraph 186, 208, 197), withdrawing the delivery system while leaving the heart valve repair device at a desired location (figure 15-17, paragraph 197), wherein the device is free of any atrial stabilizing section (figure 17, the device can be located on the ventricle side without any structural that can be designated as an atrial stabilizing section). Keranen discloses multiple embodiments where a spiral winding is delivered to a ventricular side of a heart valve. Keranen discloses that the device can have multiple of different turns, and loops, and have a grasping element that is attached to a medical device, where the medical device can turn the proximal end to help deliver the winding (at least paragraph 186, 187, 191, figure 6a, 9). Further the device can be delivered by multiple approaches and by a catheter (paragraph 174-181, 197, 237). If it would not be known that Keranen would be able to disclose in one embodiment the winding with a generally spiral shape with at least first turn extending 360 degrees and the second turn, and a grasping element turned by a delivery system and released, it would have been obvious in order to reshape the heart using the shaped device as desired.
If it would not be known that the winding would have a relatively straitened shape in the constrained condition within the delivery system, Douk teaches a similar device and method (heart valve treatment, abstract) comprising a winding (120, figure 1) have a relatively straitened shape in the constrained condition within the delivery system (figure 1, paragraph 36, 37, 45) for the purpose of helping to easily delivery the device to the heart. If it would not be known that the winding of Keranen would be delivered such that there were no atrial stabilizing sections, Douk also teaches a similar winding free of any atrial stabilizing sections engaging chords of the first and second leaflets (figure 11-18, paragraph 45) for the purpose of alternative mechanisms that are configure to engage chords to reshape the heart. St Goar also teaches a similar device and method (endovascular repair of cardiac valves, abstract) having a winding (60, figure 32a, col. 25 ll. 40-60) with a linear constrained shape and a spiral unconstrained shape, where the winding is delivered via an approach such that the device engages chords of the heart valve on the ventricular side (figure 32a, 33, 34a). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device of Keranen be free of atrial stabilizing sections and have a relatively straitened shape in the constrained condition within the delivery system in order for reshaping the heart as desired.
As to claim 16, with the method of Keranen and Douk, Keranen discloses the step of positioning the ventricular winding comprises turning the ventricular winding in the first direction, such that the chords move closer to the center of the ventricular winding (paragraph 191). Douk also teaches or provides evidence on the chords moving closer to the center (paragraph 50, figure 15).
As to claim 18, with the device of Keranen and Douk above, Keranen discloses after turning the ventricular winding in a first direction, turning the ventricular winding in a second direction such that the chords move further from the center of the ventricular windings, to adjust the position of the chords in the heart valve repair device (paragraph 233, 243). The up/down rotation can be the first and second directions.
Claims 20-28 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0331971 to Keranen in view of U.S. Patent Publication 2007/0255396 to Douk and/or in view of and/or as evidenced by U.S. Patent Publication 2010/0010514 to Ishioka.
As to claim 20, Keranen discloses a delivery system for implanting a heart valve repaid device for repairing a heart valve (paragraph 54) comprising an applicator tube (catheter, paragraph 237) and an internal rod (attachment mechanism that engages with the connection interface, paragraph 191,105 the element that applies to rotation which will be within the catheter within the applicator tube) wherein the delivery system is adapted to advance the heart valve repair device to an area of the heart valve (figure 15, paragraph 175, 197, 237) with a ventricular winding (300) of the heart valve repair device held within the delivery system in a constrained condition in which the ventricular winding has a relatively straightened shape (paragraph 237, the device can be delivered by a catheter and therefore will have a constrained straitened shape to fit within the catheter)) and then to release the ventricular winding from the delivery system, thereby allowing the ventricular winding to assume an unconstrained condition in which the ventricular winding has a generally spiral shape (figure 9, 15), wherein the delivery system is adapted to position the ventricular winding on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular winding within a generally spiral path defined by the generally spiral shape of the ventricular winding (figure 9, 15, 16, 17), wherein the delivery system is adapted to turn the ventricular winding that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought to toward the center of the ventricular winding, thereby causing the first leaflet and the second leaflet of the heart valve to be drawn together (figure 15, paragraph 192-193) having in an unconstrained condition a generally spiral shape (figure 9, 15), and a grasping element (center of 300, as seen as 304 in figure 15, the “connection interface”, paragraph 191, and/or the catheter wire in paragraph 197) connected to a center of a the ventricular winding and extending from the center of the ventricular winding (figure 9, 15, paragraph 191), wherein the internal rod is adapted to releasably hold the heart valve repair device during maneuvering of the heart valve repair device (paragraph 191,237) wherein the delivery system is adapted to release the heart valve repair device from the internal rod by advancement of the internal rod to the applicator tube after positioning the heart valve repair device in a desired location (paragraph 186, 191), and wherein the delivery system is adapted to be withdrawn while leaving the heart valve repair device at the desired location (figure 17, paragraph 197). Keranen discloses multiple embodiments where a spiral winding is delivered, released, and deployed to a ventricular side of a heart valve. Keranen discloses that the device can have multiple of different turns, and loops, and have a grasping element that is attached to a medical device, where the medical device can turn the proximal end to help deliver the winding (at least paragraph 186, 187, 191, figure 6a, 9). Further the device can be delivered by multiple approaches and by a catheter (paragraph 174-181, 237).
If it would not be known that the winding would have a relatively straitened shape in the constrained condition within the delivery system, Douk teaches a similar system (heart valve treatment, abstract) comprising a winding (120, figure 1) have a relatively straitened shape in the constrained condition within the delivery system (figure 1, paragraph 36, 37, 45) for the purpose of helping to easily delivery the device to the heart. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device of Keranen have a relatively straitened shape in the constrained condition within the delivery system in order for reshaping the heart as desired.
If it would not be known that an internal rod can be within an applicator tube, where the internal rod is adapted to releasably hold the heart valve repair device during maneuverability and release the heart valve repair device, Ishioka teaches a similar system (tissue fastening, abstract) having an applicator tube (54) and an internal rod (53) where the internal rod adapted to releasably hold the heart valve repair device during maneuverability and release the heart valve repair device (figure 13a-d, 14-20, 29a,b, 31-35, 38a,b, 39a,b) for the purpose of controlling movement of the winding based on the internal rod (paragraph 60). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the system of Keranen have applicator tube and internal rod which releasably holds the heart valve repair device in order for controlling movement of the winding based on the internal rod.
As to claim 21, with the system of Keranen, Douk, and Ishioka above, Keranen discloses the delivery system is adapted to be withdrawn from a patient while leaving the heart valve repair device implanted in the patient (figure 17, paragraph 197).
As to claim 22, Keranen discloses a delivery system for repairing a heart valve (paragraph 54) comprising a heart valve repair device comprising a ventricular winding (300) that in an unconstrained condition has a generally spiral shape (figure 9), the heart valve repair device first comprising a grasping element (center of 300, as seen as 304 in figure 15, the “connection interface”, paragraph 191) connected to a center of the ventricular winding and extending from the center of the ventricular winding, a delivery system comprising an applicator tube (“catheter”, paragraph 237) and an internal rod (mechanism that engines the connection interface in paragraph 191, and/or the catheter wire in paragraph 197) within the applicator tube to deliver the heart valve repair device to an area of the heart valve (paragraph 237), wherein the heart valve repair device is adapted to be releasably held by the internal rod and advanced to the area of the heart valve with the ventricular winding held within the applicator tube of the delivery system in a constrained condition in which the ventricular winding has a relatively straightened shape (paragraph 237, the device can be delivered by the catheter and therefore will have a constrained straightened shape to fit within the catheter), wherein the ventricular winding is adapted to be released from the applicator tube by advancement the internal rod relative to the applicator tube or withdrawal of the applicator tube relative to the internal rod, thereby allowing the ventricular winding to assume its unconstrained condition in which it has the generally spiral shape (paragraph 237, 191, the winding can be delivered through the catheter, so there will be movement relative to the “internal rod” and “applicator tube” to deliver the winding out of the catheter), wherein ventricular winding is further adapted to be positioned on a ventricular side of the heart valve and turned in a first direction such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular winding within one generally spiral path defined by the generally spiral shape of the ventricular winding (figure 9, 15, 16, 17), wherein by turning the ventricular winding in the first direction, the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought to toward the center of the ventricular winding, thereby causing the first leaflet and the second leaflet of the heart valve to be drawn together (figure 15) wherein the grasping element has an axis, and wherein the ventricular winding is adapted to be turned by using the delivery system to turn the grasping element (paragraph 191), whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element (figure 9, 15, paragraph 191), wherein the heart valve repair device is adapted to be released from the delivery system (paragraph 191, 237, 197), wherein the delivery system is adapted to be withdrawn while leaving the heart valve repair device at the desired location (figure 17), and wherein the heart valve repair device is free of any atrial stabilizing section (figure 17, the device can be situated in the ventricle side and not have any structure that is a atrial stabilizing section). Keranen discloses multiple embodiments where a spiral winding is delivered, released, and deployed to a ventricular side of a heart valve. Keranen discloses that the device can have multiple of different turns, and loops, and have a grasping element that is attached to a medical device, where the medical device can turn the proximal end to help deliver the winding (at least paragraph 186, 187, 191, figure 6a, 9). Further the device can be delivered by multiple approaches and by a catheter (paragraph 174-181, 237).
If it would not be known that the winding would have a relatively straightened shape in the constrained condition within the delivery system, Douk teaches a similar system (heart valve treatment, abstract) comprising a winding (120, figure 1) have a relatively straightened shape in the constrained condition within the delivery system (figure 1, paragraph 36, 37, 45) for the purpose of helping to easily delivery the device to the heart. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device of Keranen have a relatively straightened shape in the constrained condition within the delivery system in order for reshaping the heart as desired.
If it would not be known that an internal rod can be within an applicator tube, where movement of the interregnal rod relative to the applicator tube will release the winding from the applicator tube, Ishioka teaches a similar system (tissue fastening, abstract) having an applicator tube (54) and an internal rod (53) within the applicator tube, where the internal rod releasable holds the winding and is movable relative to the applicator tube to release the winding (figure 13a-d, 14-20, 29a,b, 31-35, 38a,b, 39a,b) for the purpose of controlling movement of the winding based on the internal rod (paragraph 60). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the system of Keranen have applicator tube and internal rod releasably holds the heart valve repair device, releases the winding from the applicator tube by advancement the internal rod relative to the applicator tube or withdrawal of the applicator tube relative to the internal rod in order for controlling movement of the winding based on the internal rod.
As to claim 23, with the system of Keranen, Douk, and Ishioka above, Keranen discloses in the unconstrained condition of the ventricular winding, the generally spiral shape moves increasingly further away from the center of the ventricular winding as it winds around the center of the ventricular winding (figure 9, 15).
As to claim 24, with the system of Keranen, Douk, and Ishioka above, Keranen discloses the generally spiral shape comprises at least a first turn (figure 9, 15) and a second turn (figure 9, 15), wherein in a radial direction from the center of the ventricular winding the second turn is farther away from the center of the ventricular winding than the first turn (figure 9, 15), and wherein at least the first turn is a full turn extending 360 degrees around the center of the ventricular winding (figure 9, 15).
As to claim 25, with the system of Keranen, Douk, and Ishioka above, Keranen discloses the heart valve repair is adapted such that after release from the delivery system, the heart valve repair device does not have any part that extends into an atrial side of the valve (figure 17, paragraph 122, no part of the device seems to be deployed in the atrial side, and the device can be deployed from the ventricular side so the “grasping element” would still be in the ventricular side). Douk further teaches and/or provides evidence that a heart valve repair is adapted such that after release from the delivery system, the heart valve repair device does not have any part that extends into an atrial side of the valve (figure 14, 15, 16).
As to claim 26, with the system of Keranen, Douk, and Ishioka above, Keranen discloses an overall diameter of the ventricular winding is adapted to be smaller than a diameter of an annulus of the heart valve (figure 17, paragraph 82). Douk further teaches/provides evidence that an overall diameter of the ventricular winding is adapted to be smaller than a diameter of an annulus of the heart valve (figure 14, 15, 16). If it would not be known that Keranen would be able to read on the claimed diameter, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the overall diameter of the ventricular winding is adapted to be smaller than a diameter of an annulus of the heart valve in order to modify the heart valve as desired.
As to claim 27, with the system of Keranen, Douk, and Ishioka above, Keranen discloses the ventricular winding is adapted to capture less than substantially all of the chords associated with the heart valve (paragraph 170, 80-82, 190). The winding can have a blunt end as well as having different chapes and number of loops. The device can be used to circumflex one papillary muscle. Therefore the device can similarly be adapted to capture less than all of the chords associated with the heart valve based on the size of the device, the number of loops, and how/where the device is deployed.
As to claim 28, with the system of Keranen, Douk, and Ishioka above, Keranen discloses the delivery system is adapted to be withdrawn from a patient while leaving the heart valve repair device implanted in the patent (paragraph 197).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 20-24, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,098,738. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to instant application’s claim 1, the reference patent claims a device for assisting the functioning of a heart valve (claim 1, 7) comprising a ventricular winding (claim 1, 7) having in an unconstrained condition a generally spiral shape (claim 1, 7), and a grasping element (claim 1, 7) connected to a center of the ventricular winding and extending from the center of the ventricular winding (claim 1, 7), wherein the generally spiral shape comprises at least a first turn (claim 1, 7) and a second turn (claim 1, 7), wherein in a radial direction from the center of the ventricular winding the second turn is farther away from the center of the ventricular winding than the first turn (claim 1, 7), and wherein at least the first turn is a full turn extending 360 degrees around the center of the ventricular winding (claim 1, 7), wherein the device is adapted to be advanced to an area of the heart valve using a delivery system (claim 1, 7) with the ventricular winding held within the delivery system in a constrained condition (claim 1, 7) in which the ventricular winding has a relatively straightened shape (claim 1, 7), wherein the ventricular winding is adapted to be released from the delivery system (claim 1, 7) thereby allowing the ventricular winding to assume its unconstrained condition in which it has the general spiral shape (claim 1, 7), wherein the ventricular winding in its unconstrained condition is adapted to be positioned on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular windings within a general spiral path defined by the general spirally shape of the ventricular winding (claim 1, 7), wherein the grasping element has an axis (claim 1, 7), and wherein the ventricular winding in its unconstrained condition is adapted to be turned by using the delivery system to turn the grasping element (claim 1, 7) whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element (claim 1, 7) such that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought toward the center of the ventricular winding (claim 1, 7), thereby causing the first leaflet and the second leaflet of the heart to be drawn together (claim 1, 7), wherein the grasping element is adapted to be releasably held by the delivery system during maneuvering of the device (claim 1, 7), wherein the device is adapted to be left in a desired location after release of the device from the delivery system and withdrawal of the delivery system (claim 1, 7, the winding can be separated from the delivery device), wherein the device is free of any atrial stabilizing section (claim 6, 12).
As to the instant application’s claim 20, the reference patent claims a delivery system for implanting a heart valve repaid device for repairing a heart valve (claim 1, 7) comprising an applicator tube (claim 1, 7) and an internal rod (claim 1, 7) wherein the delivery system is adapted to advance the heart valve repair device to an area of the heart valve (claim 1, 7) with a ventricular winding (claim 1, 7) of the heart valve repair device held within the delivery system in a constrained condition in which the ventricular winding has a relatively straightened shape (claim 1, 7) and then to release the ventricular winding from the delivery system, thereby allowing the ventricular winding to assume an unconstrained condition in which the ventricular winding has a generally spiral shape (claim 1, 7), wherein the delivery system is adapted to position the ventricular winding on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular winding within a generally spiral path defined by the generally spiral shape of the ventricular winding (claim 1, 7), wherein the delivery system is adapted to turn the ventricular winding that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought to toward the center of the ventricular winding, thereby causing the first leaflet and the second leaflet of the heart valve to be drawn together (claim 1, 7) having in an unconstrained condition a generally spiral shape (claim 1, 7), and a grasping element (claim 1, 7) connected to a center of a the ventricular winding and extending from the center of the ventricular winding (claim 1, 7), wherein the internal rod is adapted to releasably hold the heart valve repair device during maneuvering of the heart valve repair device (claim 1, 7) wherein the delivery system is adapted to release the heart valve repair device from the internal rod by advancement of the internal rod to the applicator tube after positioning the heart valve repair device in a desired location (claim 1, 7), and wherein the delivery system is adapted to be withdrawn while leaving the heart valve repair device at the desired location (claim 1, 7, the winding can be separated from the delivery system).
As to the instant application’s claim 21, see claims 1, 7. The winding can be separated from the delivery system.
As to the instant application’s claim 22, the reference patent claims a delivery system for repairing a heart valve (claim 1, 7) comprising a heart valve repair device comprising a ventricular winding (claim 1, 7) that in an unconstrained condition has a generally spiral shape (claim 1, 7), the heart valve repair device first comprising a grasping element (claim 1, 7) connected to a center of the ventricular winding and extending from the center of the ventricular winding, a delivery system comprising an applicator tube (claim 1, 7) and an internal rod (claim 1, 7) within the applicator tube to deliver the heart valve repair device to an area of the heart valve (claim 1, 7), wherein the heart valve repair device is adapted to be releasably held by the internal rod and advanced to the area of the heart valve with the ventricular winding held within the applicator tube of the delivery system in a constrained condition in which the ventricular winding has a relatively straightened shape (claim 1, 7), wherein the ventricular winding is adapted to be released from the applicator tube by advancement the internal rod relative to the applicator tube or withdrawal of the applicator tube relative to the internal rod, thereby allowing the ventricular winding to assume its unconstrained condition in which it has the generally spiral shape (claim 1, 7), wherein ventricular winding is further adapted to be positioned on a ventricular side of the heart valve and turned in a first direction such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular winding within one generally spiral path defined by the generally spiral shape of the ventricular winding (claim 1, 7), wherein by turning the ventricular winding in the first direction, the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought to toward the center of the ventricular winding, thereby causing the first leaflet and the second leaflet of the heart valve to be drawn together (claim 1, 7) wherein the grasping element has an axis, and wherein the ventricular winding is adapted to be turned by using the delivery system to turn the grasping element (claim 1, 7), whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element (claim 1, 7), wherein the heart valve repair device is adapted to be released from the delivery system (claim 1, 7), wherein the delivery system is adapted to be withdrawn while leaving the heart valve repair device at the desired location (claim 1, 7, the winding can be separated from the system), and wherein the heart valve repair device is free of any atrial stabilizing section (claim 6, 12).
As to the instant application’s claim 23, 24, see reference patent claim 1, 7.
As to the instant application’s claim 28, see reference patent claim 1, 7.
Claims 1-3, 7-9, 11, 14, 20-24, 28 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,864,079. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to instant application’s claim 1, the reference patent claims a device for assisting the functioning of a heart valve (claim 1, 19) comprising a ventricular winding (claim 1, 19) having in an unconstrained condition a generally spiral shape (claim 1, 19), and a grasping element (claim 1, 19) connected to a center of a the ventricular winding and extending from the center of the ventricular winding (claim 1, 19), wherein the generally spiral shape comprises at least a first turn (claim 1, 19) and a second turn (claim 1, 19), wherein in a radial direction from the center of the ventricular winding the second turn is farther away from the center of the ventricular winding than the first turn (claim 1, 19), and wherein at least the first turn is a full turn extending 360 degrees around the center of the ventricular winding (claim 1, 19), wherein the device is adapted to be advanced to an area of the heart valve using a delivery system (claim 1, 19) with the ventricular winding held within the delivery system in a constrained condition (claim 1, 19) in which the ventricular winding has a relatively straightened shape (claim 1, 19), wherein the ventricular winding is adapted to be released from the delivery system (claim 1, 19) thereby allowing the ventricular winding to assume its unconstrained condition in which it has the general spiral shape (claim 1, 19), wherein the ventricular winding in its unconstrained condition is adapted to be positioned on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular windings within a general spiral path defined by the general spirally shape of the ventricular winding (claim 1, 19), wherein the grasping element has an axis (claim 1, 19), and wherein the ventricular winding in its unconstrained condition is adapted to be turned by using the delivery system to turn the grasping element (claim 1, 19) whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element (claim 1, 19) such that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought toward the center of the ventricular winding (claim 1, 19), thereby causing the first leaflet and the second leaflet of the heart to be drawn together (claim 1, 19), wherein the grasping element is adapted to be releasably held by the delivery system during maneuvering of the device (claim 1, 19), wherein the device is adapted to be left in a desired location after release of the device from the delivery system and withdrawal of the delivery system (claim 1, 19), wherein the device is free of any atrial stabilizing section (claim 1, 19).
As to the instant application’s claim 2, see reference patent claim 2.
As to the instant application’s claim 3, see reference patent claim 3.
As to the instant application’s claim 7, see reference patent claim 7.
As to the instant application’s claim 8, see reference patent claim 8.
As to the instant application’s claim 9, see reference patent claim 9.
As to the instant application’s claim 11, see reference patent claim 11.
As to the instant application’s claim 14, see reference patent claim 1.
As to the instant application’s claim 20, the reference patent claims a delivery system for implanting a heart valve repaid device for repairing a heart valve (claim 1) comprising an applicator tube (claim 1) and an internal rod (claim 1) wherein the delivery system is adapted to advance the heart valve repair device to an area of the heart valve (claim 1) with a ventricular winding (claim 1) of the heart valve repair device held within the delivery system in a constrained condition in which the ventricular winding has a relatively straightened shape (claim 1) and then to release the ventricular winding from the delivery system, thereby allowing the ventricular winding to assume an unconstrained condition in which the ventricular winding has a generally spiral shape (claim 1), wherein the delivery system is adapted to position the ventricular winding on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular winding within a generally spiral path defined by the generally spiral shape of the ventricular winding (claim 1), wherein the delivery system is adapted to turn the ventricular winding that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought to toward the center of the ventricular winding, thereby causing the first leaflet and the second leaflet of the heart valve to be drawn together (claim 1) having in an unconstrained condition a generally spiral shape (figure 1), and a grasping element (claim 1) connected to a center of a the ventricular winding and extending from the center of the ventricular winding (claim 1), wherein the internal rod is adapted to releasably hold the heart valve repair device during maneuvering of the heart valve repair device (claim 1) wherein the delivery system is adapted to release the heart valve repair device from the internal rod by advancement of the internal rod to the applicator tube after positioning the heart valve repair device in a desired location (claim 1), and wherein the delivery system is adapted to be withdrawn while leaving the heart valve repair device at the desired location (claim 1).
As to the instant application’s claim 21, see claims 1.
As to the instant application’s claim 22, the reference patent claims a delivery system for repairing a heart valve (claim 1) comprising a heart valve repair device comprising a ventricular winding (claim 1) that in an unconstrained condition has a generally spiral shape (claim 1), the heart valve repair device first comprising a grasping element (claim 1) connected to a center of the ventricular winding and extending from the center of the ventricular winding, a delivery system comprising an applicator tube (claim 1) and an internal rod (claim 1) within the applicator tube to deliver the heart valve repair device to an area of the heart valve (claim 1), wherein the heart valve repair device is adapted to be releasably held by the internal rod and advanced to the area of the heart valve with the ventricular winding held within the applicator tube of the delivery system in a constrained condition in which the ventricular winding has a relatively straightened shape (claim 1), wherein the ventricular winding is adapted to be released from the applicator tube by advancement the internal rod relative to the applicator tube or withdrawal of the applicator tube relative to the internal rod, thereby allowing the ventricular winding to assume its unconstrained condition in which it has the generally spiral shape (claim 1), wherein ventricular winding is further adapted to be positioned on a ventricular side of the heart valve and turned in a first direction such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular winding within one generally spiral path defined by the generally spiral shape of the ventricular winding (claim 1), wherein by turning the ventricular winding in the first direction, the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought to toward the center of the ventricular winding, thereby causing the first leaflet and the second leaflet of the heart valve to be drawn together (claim 1) wherein the grasping element has an axis, and wherein the ventricular winding is adapted to be turned by using the delivery system to turn the grasping element (claim 1), whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element (claim 1), wherein the heart valve repair device is adapted to be released from the delivery system (claim 1), wherein the delivery system is adapted to be withdrawn while leaving the heart valve repair device at the desired location (claim 1), and wherein the heart valve repair device is free of any atrial stabilizing section (claim 1).
As to the instant application’s claim 23, 24, see reference patent claims 1.
As to the instant application’s claim 28, see reference patent claims 1.
Claims 2, 3, 7-9, 11, 14, 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,098,738 in view of U.S. Patent Publication 2007/0255396 to Douk.
As to the instant application’s claims 2, 3, 14, the reference patent claims the device above but is silent about the ventricular winding is substantially flat or conical, or has an end portion that is angled downwardly.
Douk teaches a similar device (heart valve repair) having a winding that is substantially flat or conical (figure 3, 14), or as an end portion that is angled downwardly (figure 3,4) for the purpose of shaping the winding to engage the chords as desired (paragraph 38). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent comprise a substantially flat or conical winding or an end portion that is angled downwardly in order for shaping the winding to engage the chords as desired.
As to the instant application’s claims 7-9, 11, the reference patent claims the device above but is silent about the device comprises at least in part a metallic material, shape memory material, nitinol, and/or a composite material.
Douk teaches a similar device (heart valve repair) having a device comprising at least in part a metallic material, shape memory material, nitinol, and/or a composite material (paragraph 37). It would have been obvious to one of ordinary skill in the art before the effective filing since it has been held to be within the general skill of a worker in the art to select a known material based on its intended use.
As to the instant application’s claims 25, 26, the reference patent claims the device above but is silent about the heart valve repair device is adapted such that after release from the delivery system, the heart valve repair device does not have any part that extends into an atrial side of the valve. The reference patent further is silent about an outer diameter of the ventricular winding is adapted to be smaller than a diameter of an annulus of the heart valve.
Douk teaches a similar device (heart valve repair) where the heart valve repair device is adapted such that after release from the delivery system, the heart valve repair device does not have any part that extends into an atrial side of the valve and an outer diameter of the ventricular winding is adapted to be smaller than a diameter of the annulus of the heart valve (figure 12, 15) for the purpose of shaping the winding to engage the chords as desired (paragraph 38). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent comprise a heart valve repair device not extend in the atrial side and have the claimed smaller outer diameter in order for shaping the winding to engage the chords as desired.
As to the instant application’s claim 27, the reference patent claims the device above but is silent the ventricular winding is adapted to capture less than substantially all of the chords associated with heart valve.
Douk teaches a similar device (heart valve repair) where the winding is adapted to capture less than substantially all of the chords associated with the heart valve (paragraph 38) for the purpose of shaping the winding to engage the chords as desired. The winding engage more than one or alternatively all of them. Therefore the winding can be adapted to shape less than substantially all of the cords in the former interpretation. It would have been obvious to one of ordinary skill in the art before the effective filing date to for the winding to be adapted to capture less than substantially all of the chords associated with the heart valve in order to engage the chords as desired.
Claims 15, 16, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,700,412 to Yaron in view of U.S. Patent Publication 2007/0255396 to Douk.
As to the instant application’s claim 15, the reference patent claims a method of repairing a heart valve (claim 1) comprising delivering a heart valve repair device to an area of the by the use of a delivery system (claim 1), the heart valve repair device comprising a ventricular winding (claim 1) having in an unconstrained condition a generally spiral shape (claim 1), and a grasping element (claim 1) connected to a center of the ventricular winding and that extends from the center of the ventricular winding (claim 1), wherein the grasping element has an axis (claim 1), wherein the generally spiral shape comprises at least a first turn (claim 1) and a second turn (claim 1), wherein in a radial direction from the center of the ventricular winding the second turn is farther away from the center of the ventricular winding than the first turn (claim 1), and wherein at least the first turn is a full turn extending 360 degrees around the center of the ventricular winding (claim 1), using the delivery system to advance the heart valve repair device to an area of the heart valve (claim 1) with the ventricular winding held within the delivery system (claim 1) in a constrained condition in which the ventricular winding has a relatively straightened shape (claim 1), and then to release the ventricular winding from the delivery system (claim 1), thereby allowing the ventricular winding to assume its unconstrained condition in which it has the general spiral shape (claim 1), using the delivery system to position the ventricular winding on a ventricular side of the heart valve such that chords associated with a first leaflet of the heart valve and chords associated with a second leaflet of the heart valve are captured between adjacent turns of the ventricular windings within a general spiral path defined by the general spirally shape of the ventricular winding (claim 1), whereby positioning the ventricular winding comprises turning the grasping element while grasping element is releasably held by the delivery system (claim 1), whereby turning the grasping element results in turning the ventricular winding generally around the axis of the grasping element such that the captured chords of the first leaflet and the second leaflet within the generally spiral path are brought toward the center of the ventricular winding thereby causing the first leaflet and the second leaflet of the heart to be drawn together (claim 1), releasing the heart valve repair from the delivery system (claim 1), wherein the device is free of any atrial stabilizing section (claim 1) but is silent about withdrawing the delivery system while leaving the heart valve repair device at a desired location.
Douk teaches a similar method (heart valve repair, abstract) including a step withdrawing a delivery system while leaving a heart valve repair device at a desired location (figure 9-18, paragraph 48) in order for allowing the device to engage the chords and be implanted. It would have been obvious to one of ordinary skill in the art before the effective filing date for the reference patent to include the step of withdrawing the delivery system while leaving the heart valve repair device at a desired location in order for allowing the device to engage the chords and be implanted.
As to the instant application’s claim 16, see reference patent claim 1.
As to the instant application’s claim 18, see reference patent claim 10.
Claims 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,864,079 in view of U.S. Patent Publication 2007/0255396 to Douk.
As to the instant application’s claims 25, 26, the reference patent claims the device above but is silent about the heart valve repair device is adapted such that after release from the delivery system, the heart valve repair device does not have any part that extends into an atrial side of the valve. The reference patent further is silent about an outer diameter of the ventricular winding is adapted to be smaller than a diameter of the annulus of the heart valve.
Douk teaches a similar device (heart valve repair) where the heart valve repair device is adapted such that after release from the delivery system, the heart valve repair device does not have any part that extends into an atrial side of the valve and an outer diameter of the ventricular winding is adapted to be smaller than a diameter of the annulus of the heart valve (figure 12, 15) for the purpose of shaping the winding to engage the chords as desired (paragraph 38). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent comprise a heart valve repair device not extend in the atrial side and have the claimed smaller outer diameter in order for shaping the winding to engage the chords as desired.
As to the instant application’s claim 27, the reference patent claims the device above but is silent the ventricular winding is adapted to capture less than substantially all of the chords associated with heart valve.
Douk teaches a similar device (heart valve repair) where the winding is adapted to capture less than substantially all of the chords associated with the heart valve (paragraph 38) for the purpose of shaping the winding to engage the chords as desired. The winding engage more than one or alternatively all of them. Therefore the winding can be adapted to shape less than substantially all of the cords in the former interpretation. It would have been obvious to one of ordinary skill in the art before the effective filing date to for the winding to be adapted to capture less than substantially all of the chords associated with the heart valve in order to engage the chords as desired.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,792,400 to Talja, U.S. Patent 6,629,534 to St Goar, U.S. Patent Publication 2003/0225420 to Wardle, U.S. Patent Publication 2010/0010520 to Takahashi, U.S. Patent Publication 2011/0029055 to Tidemand, U.S. Patent Publication 2012/0277853 to Rothstein, and U.S. Patent Publication 2014/0194975 to Quill all disclose similar devices, systems, and methods capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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