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 .
Terminal Disclaimer
The terminal disclaimer filed on 09/06/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 12,059,351 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Considering the approval of the terminal disclaimer filed on 09/06/2026, the previous double patenting rejection over U.S. Patent 12,059,351 has been withdrawn.
Applicant's arguments filed 09/06/2026, pages 5-6, the prior art Ortiz does not disclose a first and second support rings formed from a material into a tubular shape with circumferential walls was persuasive. Therefore, the rejections to Ortiz have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Starksen U.S. Publication 2008/0177380 A1 in view of Keranen et al. 2954826 A1 and Starksen U.S. Publication 2008/0177380 A1 in view of Ortiz et al. U.S. Patent 6,964,684 B2.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 49-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Starksen U.S. Publication 2008/0177380 A1 in view of Keranen et al. 2954826 A1.
Regarding Claim 49, Starksen et al. discloses an annuloplasty device 2600 as seen in Figures 26A-26B (the device is used for mitral valve repair for reducing the distance between the supports and reshaping the mitral valve annulus, see paragraph [0002], [0007]) comprising: first and second support rings 2602, 2604, wherein, the first and second support rings are formed from a material into a tubular shape with circumferential walls (paragraph [0006] and as seen in Figure 26A-26B), and the first and second support rings comprise retention units 2610-2626 (paragraph [0075-0076]), wherein the retention units 2610, 2612, 2614, 2616, 2620, 2622, 2624, 2626 are formed from the material of the circumferential walls (paragraph [0006]). However, Starksen et al. does not expressly disclose the first and second support ring being configured to be arranged as a coil in a first configuration around an axial direction, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, the first support ring is adapted to be arranged on an atrial side of said heart valve and the second support ring is adapted to be arranged on a ventricular side of the heart valve, the first support ring comprises a first posterior bow and the second support ring comprises a second posterior bow, wherein the first and second posterior bows are adapted to conform to a posterior aspect of said heart valve. Keranen et al. teaches an annuloplasty device 10 in the same field of endeavor for treating a mitral valve (page 2, lines 1-25 and page 37, lines 10-25), the device comprises a first and second support 103, 102 (as seen in Figures 6a-7), the first and second support forms a helical element assuming a helical structure with turns and space between each turn and a hollow center (page 31, lines 23-37 and page 32, lines 1-26), the second support 102 is positioned on a first side of the valve tissue, ventricular side and the first support 103 is configured to be positioned on a second opposite side towards an atrium of the valve tissue (page 32, lines 1-11 and as seen in Figure 7 and 12-13) for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus (abstract, page 11, lines 19-30, page 14, lines 4-15) and allow the leaflets to open and close properly (abstract). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Starksen’s first and second support ring to be a coiled structure adapted to be placed in the mitral valve, wherein the first support is positioned on a ventricular side and the second support is arranged on a atrial side as taught by Keranen et al. for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus and allow the valve leaflets to open and close properly.
Regarding Claim 50, Starksen et al. discloses wherein the retention units are flexible (as seen in Figures 24A-26B, the anchors extends outwardly to couple to the tissue 2638, see paragraphs [0076-0077]).
Regarding Claim 51, Starksen et al. discloses wherein the retention units 2610-2626 are transferable from a retracted state, in which the retention units are flush with an outer surface of the first and/or second support rings (as seen in Figures 24A-27 and paragraphs [0072], [0078]), to an expanded state, in which the retention units 2610-2626 protrude from the outer surface of the first and/or second support rings 2603, 2602 (as seen in Figures 26A-26B).
Regarding Claim 52, Starksen et al. discloses wherein the first support ring 2603 comprises first retention units 2620-2626 and the second support ring 2602 comprises second retention units 2610-2616, wherein the first and second retention units 2610-2626 extend from respective first and second support rings to produce a retention force (paragraphs [0072], [0075]). However, Starksen et al. does not expressly disclose the first and second support rings, in use, [are] at both of said opposite sides of said native heart valve leaflets. Keranen et al. teaches an annuloplasty device 10 in the same field of endeavor for treating a mitral valve (page 2, lines 1-25 and page 37, lines 10-25), the device comprises a first and second support 103, 102 (as seen in Figures 6a-7), the first and second support forms a helical element assuming a helical structure with turns and space between each turn and a hollow center (page 31, lines 23-37 and page 32, lines 1-26), the second support 102 is positioned on a first side of the valve tissue, ventricular side and the first support 103 is configured to be positioned on a second opposite side towards an atrium of the valve tissue (page 32, lines 1-11 and as seen in Figure 7 and 12-13) for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus (abstract, page 11, lines 19-30, page 14, lines 4-15) and allow the leaflets to open and close properly (abstract). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Starksen’s first and second support ring to be a coiled structure adapted to be placed in the mitral valve, wherein the first support is positioned on a ventricular side and the second support is arranged on a atrial side as taught by Keranen et al. for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus and allow the valve leaflets to open and close properly.
Regarding Claim 53, Starksen et al. does not expressly disclose wherein: the first and second support rings are separated with a first pitch distance in the axial direction, in a first configuration; the first and second support rings are configured to assume a contracted state having a second pitch distance in the axial direction being shorter than the first pitch distance; and the first and second support rings are configured to be transferable between the first configuration and the contracted state to pinch the heart valve leaflets. Keranen et al. teaches an annuloplasty device 10 in the same field of endeavor for treating a mitral valve (page 2, lines 1-25 and page 37, lines 10-25), the device comprises a first and second support 103, 102 (as seen in Figures 6a-7), the first and second support forms a helical element assuming a helical structure with turns and space between each turn and a hollow center (page 31, lines 23-37 and page 32, lines 1-26), the first support 103 and the second support 102 are separated with a first pitch distance in a first configuration which is larger and a second pitch distance to transfer the first and second support rings from the contracted state to pinch the heart valve leaflets (page 15, lines 3-15 and page 16, lines 3-11 and page 32, lines 12-25 and page 34, lines 1-35 and page 38, lines 16-33) for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus (abstract, page 11, lines 19-30, page 14, lines 4-15) and allow the leaflets to open and close properly (abstract and page 38, lines 25-33). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Starksen’s first and second support ring to be a coiled structure adapted to be placed in the mitral valve, wherein the first support is positioned on a ventricular side and the second support is arranged on a atrial side as taught by Keranen et al. for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus and allow the valve leaflets to open and close properly.
Regarding Claim 54, Starksen et al. discloses wherein the first and second support rings are formed from a continuous piece of material (paragraph [0006]).
Claim(s) 55-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Starksen U.S. Publication 2008/0177380 A1 in view of Ortiz et al. U.S. Patent 6,964,684 B2.
Regarding Claim 55, Starksen et al. discloses a method of repairing a defective heart valve (abstract and paragraph [0030]), said method comprising: positioning a first and second support rings 2604, 2602 of an annuloplasty device in a first configuration in side of the native heart valve leaflets (as seen in Figure 3A-3G, and 21A-21C, the device 10 is used for mitral valve repair for reducing the distance between the supports and reshaping the mitral valve annulus, see paragraph [0002], [0007]), the first and second support rings 2604, 2602 are formed from a material into a tubular shape with circumferential walls (paragraph [0006] and as seen in Figure 26A-26B), the first and second support rings comprise retention units 2610, 2612, 2614, 2616, 2620, 2622, 2624, 2626 formed from the material of the circumferential walls (paragraph [0006]), wherein positioning the first and second support rings comprises: positioning a sheath 2104 and ejecting the first and second support rings from the sheath while retracting the sheath (as seen in Figures 4C and 21A-21C and paragraphs [0008], [0066]) and whereby the retention units are engaged into tissue of the heart valve from the opposite sides when the sheath is retracted (see Figures 3A-3G and 21A-21C and paragraphs [0041], [0050]). However, Starksen et al. does not expressly disclose positioning a sheath to form first and second curves thereof as a coiled shape on the opposite sides of the native heart valve leaflets, such that the annuloplasty device is arranged along the first and second curves on the opposite sides, and positioning first and second support rings of an annuloplasty device in a first configuration as a coil on opposite sides of native heart valve leaflets of the heart valve. Ortiz et al. teaches a method of repairing a defective heart valve (abstract and column 3, lines 13-27), said method comprising: positioning first and second support rings 80 of an annuloplasty device in a first configuration as a coil on opposite sides of native heart valve leaflets of the heart valve (as seen in Figures 10-11), wherein positioning the first and second support rings comprises: positioning a sheath 84 to form first and second curves thereof as a coiled shape on the opposite sides of the native heart valve leaflets (as seen in Figures 10-11) and ejecting the first and second support rings 80 from the sheath 84 while retracting the sheath such that the annuloplasty device is arranged along the first and second curves on the opposite sides (as seen in Figures 1A-2C and 6A-6B and 10-11 and column 6, lines 64-67 and column 7, lines 1-14) for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus (abstract, column 3, lines 13-30) and allow the leaflets to open and close properly (abstract and column 2, lines 46-62). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Starksen’s first and second support ring to be a coiled structure adapted to be placed in the mitral valve, wherein the first support is positioned on a ventricular side and the second support is arranged on a atrial side as taught by Ortiz et al. for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus and allow the valve leaflets to open and close properly.
Regarding Claim 56, Starksen et al. discloses wherein the first and second support rings 2604, 2602 are kept substantially stationary in relation to the heart valve when being ejected from the sheath while simultaneously retracting the sheath (as seen in Figures 3A-3G and Figures 21A-21C).
Regarding Claim 57, Starksen et al. does not disclose wherein the opposite sides of native heart valve leaflets are an atrial side of the heart valve and a ventricular side of the heart valve, wherein the first curve of the sheath is arranged along an annulus of the heart valve on the atrial side, and wherein the second curve of the sheath is arranged around chordae of the heart valve on the ventricular side. Ortiz et al. teaches a method of repairing a defective heart valve (abstract and column 3, lines 13-27), said method comprising: positioning first and second support rings 80 of an annuloplasty device in a first configuration as a coil on opposite sides of native heart valve leaflets of the heart valve (as seen in Figures 10-11), wherein positioning the first and second support rings comprises: positioning a sheath 84 to form first and second curves thereof as a coiled shape on the opposite sides of the native heart valve leaflets (as seen in Figures 10-11) and ejecting the first and second support rings 80 from the sheath 84 while retracting the sheath such that the annuloplasty device is arranged along the first and second curves on the opposite sides (as seen in Figures 1A-2C and 6A-6B and 10-11 and column 6, lines 64-67 and column 7, lines 1-14) for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus (abstract, column 3, lines 13-30) and allow the leaflets to open and close properly (abstract and column 2, lines 46-62). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Starksen’s first and second support ring to be a coiled structure adapted to be placed in the mitral valve and having a sheath having a first and second curve arranged around the atrial and ventricular side of the heart valve as taught by Ortiz et al. for the purpose of forming a loop shaped device that is adapted to change the shape or contour of the heart valve annulus and allow the valve leaflets to open and close properly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
