Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 03/03/2026 have been fully considered but they are not persuasive.
The Applicant argues neither Kasher nor Bonutti teach or suggests a lock that is clamped onto a tension member separately to the coupling of the lock to a tissue anchor. However, the specification does not offer any specifics to the scope of the definition of separate. Separate can mean two portions using different mechanisms to accomplish connection or mean two independent pieces of equipment working together to operate as the lock. The lock of Bonutti teaches a upper portion with threads which couples the lock (104) to the anchor (102) and a lower portion with a collet (114) to clamp the lock onto the tension member.
Claim Status
Claims 16-26 have been canceled.
Claims 31-42 are examined below.
Claim Objections
Applicant is advised that should claims 31-36 be found allowable, claims 37-42 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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) 31-34 and 37-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasher (US 2021/0145584 A1) in view of Bonutti (US 2014/0194907 A1).
Regarding claims 31 and 37, Kasher teaches a system for use with a heart (200, system, fig. 5A), the system comprising an implant (210, implant, fig. 5C) that comprises:
a tension member (212, wire, fig. 5C);
a first anchor (220, anchor, fig. 5C, the right most anchor);
a second anchor (220, anchor, fig. 5C, the left most anchor): adapted to receive the lock (246, aperture, fig. 4H, is capable of receiving the lock), and defining a passageway (246, aperture, fig. 4A), through which the tension member is slidably disposed (¶ [0382])
an anchor delivery catheter (252, flexible tube, fig. 5A), adapted to, using a transvascular approach (¶ [0379]), deliver and implant the first anchor and the second anchor within the heart by screwing the first and second anchors into tissue of the heart (¶ [0379]) such that: the tension member extends between the first anchor and the second anchor (fig. 5A) and is slidably disposed through the passageway (¶ [0382]); and applying tension to the tension member draws the first and second anchors towards each other (¶ [0382]);
a lock-delivery catheter (170, adjustment tool, fig. 3A) adapted to, using a transvascular approach (¶ [0346], ¶ [0379]):
advance the lock over and along the tension member towards the first and second anchors within the heart (¶ [0352], fig. 3A).
Kasher fails to teach a lock coupled to the second anchor. However, Bonutti discloses an implantable suture lock system with a tension member (106, elongate member, fig. 16) and anchor (102, base component, fig. 16) that includes
a lock (104, insert component, fig. 16);
couple the lock directly to the second anchor (the aperture of Kasher (246) replaces the shape of the passageway of the base component in fig. 20 of Bonutti, the threads on the lock (104) couple the lock (104) to the second anchor), and separately to the coupling (the coupling is the interaction between the head portion (112) and the base component whereas the clamp is the interaction of the body portion (114) with the base component, two separate coupling mechanisms), clamp the lock onto the tension member in a manner that maintains the tension in the tension member tether (¶ [0164], fig. 16).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to replace the lock system (including the stoper and the eyelet receiving the stoper) as disclosed by Kasher to include the insert component and the passage way of the base component as taught by Bonutti as the two aforementioned lock systems are functional equivalents of each other (each are used for tightening a suture within a minimally invasive implanted device) in order to achieve the desired tension and/or location with respect to the body tissue (¶ [0163], Bonutti) and since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). (Please note in making the aforementioned combination, the lock delivery catheter as disclosed by Kasher would place the lock of Bonutti in the passageway to dispose the lock within the passageway and lock onto the tension member.)
Regarding claims 32 and 38, Kasher fails to teach the lock and the second anchor define threads. However, Bonutti further teaches the lock defines an external thread (¶ [0164], figs. 14 and 16), and wherein the second anchor defines an internal thread (¶ [0164], figs. 16 and 24), and wherein the second anchor is dimensioned to grip the lock via rotation of the external thread with respect to the internal thread (¶ [0164], fig. 16). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Kasher to include the lock and the second anchor define threads as taught by Bonutti in order to achieve the desired tension and/or location with respect to the body tissue (¶ [0163], Bonutti).
Regarding claims 33 and 39, Kasher further teaches each of the first anchor and the second anchor comprise:
an anchor portion (230, tissue engaging element, fig. 4A), and
a drive portion (282, driver portion, fig. 4A) that is configured to reversibly engage with a drive member of the anchor delivery catheter (260, anchor driver, fig. 5A, ¶ [0379]) such that rotation of the drive member drives the anchor portion into tissue of the heart (¶ [0379]).
Regarding claims 34 and 40, Kasher further teaches for each of the first anchor and the second anchor, the anchor portion is helical (¶ [0241], fig. 4A), and configured to be implanted into the tissue by rotation about a longitudinal axis of the tissue anchor (¶ [0241], fig. 5A).
Claim(s) 35-36 and 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasher in view of Bonutti as applied to claims 33 and 39 above, and further in view of Edmiston (US 2020/0222186 A1).
Regarding claims 35 and 41, Kasher in view of Bonutti fails to teach the anchor portion comprises one or more barbs. However, Edmiston teaches an anchor coil (1302, anchor coil, fig. 12A) that includes for each of the first and second anchors, the anchor portion of the tissue anchor comprises one or more barbs (1308, barb, figs. 12A and 12H). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Kasher and Bonutti to include the anchor portion comprises one or more barbs as taught by Edmiston in order to keep the coil from rotating back out of the tissue due to the natural rhythm of the heart (¶ [0052], Edmiston).
Regarding claims 36 and 42, Kasher in view of Bonutti fails to teach each of the barbs comprise a tubular element. However, Edmiston further teaches for each of the first and second anchors, each of the barbs comprises a tubular element (fig. 12A, wrapped around the coil) having an angled end with a tip of the angled end located radially outward (see annotated fig. 12A, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Kasher and Bonutti to include each of the barbs comprise a tubular element as taught by Edmiston in order to keep the coil from rotating back out of the tissue due to the natural rhythm of the heart (¶ [0052], Edmiston).
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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