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 .
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 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.
Response to Amendment
The Response filed March 6, 2026 has been entered. Claims 1-5, 9, 11, and 16-17 are pending in the application. The previous objections to the claims are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Terminal Disclaimer
The terminal disclaimer filed on March 29, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 17887475 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb et al. (U.S. Patent Application Publication No. 20150223793; hereinafter “Goldfarb”) in view of Foerster et al. (U.S. Patent Application Publication No. 20040098050; hereinafter “Foerster”).
Regarding claim 1, Goldfarb discloses a system for edge-to-edge repair of a mitral valve comprising:
an integrated therapy catheter (500; Figs. 42-51) configured to engage a first leaflet and a second leaflet of a mitral valve having:
a puncture device (520) configured to:
puncture a first hole in the first leaflet (Fig. 46; para. [0133]); and
puncture a second hole in the second leaflet (Fig. 46; para. [0133]);
a delivery device (including push rods; para. [0134]) configured to:
deliver a first leaflet anchor (522; Fig. 48) through the first hole, the first leaflet anchor having a first tether (524) with distal end configured to engage the distal side of the first leaflet (para. [0134]);
deliver a second leaflet anchor (522; Fig. 48) through the second hole, the second leaflet anchor having a second tether (524) with distal end configured to engage the distal side of the second leaflet (para. [0134]);
a "knot replacement" tool (530) configured to tension the first and second tethers to bring the first and the second leaflet edges together and lock the first and second tethers together (Figs. 50-51; para. [0135]).
Goldfarb further discloses the delivery device configured to deliver a first pledget coupled to the first tether to the first hole and deliver a second pledget coupled to the second tether to the second hole because Goldfarb discloses the delivery device being designed to deliver a first part (370) of an anchor against a distal side of a leaflet and deliver a second part (372) of the anchor against a proximal side of the leaflet (Figs. 26A-26B; para. [0111]).
Alternatively, should Goldfarb be found to not anticipate claim 1, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device to be configured to deliver a first pledget coupled to the first tether to the first hole and deliver a second pledget coupled to the second tether to the second hole, in view of Goldfarb, to facilitate anchoring the tethers to respective leaflets to position the leaflets for treatment of the patient’s valve.
The device of Goldfarb discloses the invention substantially as claimed, except for the “knot replacement” tool including a locking cap and a locking screw.
Foerster, a reference in the surgery field of endeavor, teaches configuring a “knot replacement” tool to include
a locking cap (60) having first and second tether locking cap holes (Figs. 2-3),
a locking screw (50) having first and second tether locking screw holes (Figs. 2-3),
wherein the locking screw is configured to be screwed into the locking cap (e.g., for “threaded fitting;” para. [0068]), with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions (para. [0068])
to lock a suture in place (para. [0068]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the "knot replacement" tool to include:
a locking cap having first and second tether locking cap holes,
a locking screw having first and second tether locking screw holes,
wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions
in view of Foerster, in order to prevent the tethers from slipping and moving the leaflets to an undesired position that could impede proper functioning of the valve.
Regarding claim 2, Foerster discloses wherein locking the first and second tethers with the “knot replacement” tool includes:
the first and second tethers being inserted through the first and second locking cap holes (Figs. 2-3); and
the first and second tethers being inserted through the first and second locking screw holes (Figs. 2-3); and
the locking screw is screwed into the locking cap, with the first so that the first tether and second tether are twisted around each other and are locked in place (para. [0068]).
Regarding claim 3, Foerster discloses wherein the "knot replacement" tool further includes a detachable delivery shaft coupled with the locking screw (Figs. 8-9 para. [0073]).
Regarding claim 4, Goldfarb disclose the system further comprising a cutter device configured to cut the first and second tethers (para. [0135]).
Regarding claim 9, Goldfarb meets the claim limitation “wherein distal ends of the first and second tethers are self-expanding and configured to expand larger than the first and second holes,” because the first and second tethers are merely functionally recited in claim 9 and the delivery device of Goldfarb is capable of delivering first and second anchors having respective tethers with self-expanding ends (i.e., the push rods are capable of delivering an anchor (522) with a first tether (524) having a self-expanding distal end because no structure of the catheter (500) or push rods would prevent delivering such an anchor and tether).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb in view of Foerster, as applied to claim 4 above, and further in view of Findlay, III et al. (U.S. Patent Application Publication No. 20070005081; hereinafter “Findlay”).
Regarding claim 5, the modified device discloses the invention substantially as claimed, except for the cutter device including an outer body and an inner body.
Findlay, a reference in the surgery field of endeavor, teaches configuring a suture cutter device to include
an outer body (12) with an outer body side opening (38; Fig.2b); and
an inner body (26) with an inner body side opening (34; Fig. 2a) slidably positioned within the outer body (para. [0042]), the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen (Fig. 2a);
wherein the first and second tethers enter a distal end of the center lumen and exit out through the inner body side opening and outer body side opening (Fig. 2c); and
axial movement of the inner body in relation to the outer body side opening closes the opening to the center lumen and scissor cuts the first and second tethers (Figs. 5a-5c; paras. [0051]-[0054])
to facilitate cutting a suture at a remote site within a patient (para. [0008]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the cutter device to include an
outer body with an outer body side opening; and
an inner body with an inner body side opening slidably positioned within the outer body, the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen;
wherein the first and second tethers enter a distal end of the center lumen and exit out through the inner body side opening and outer body side opening; and
axial movement of the inner body in relation to the outer body side opening closes the opening to the center lumen and scissor cuts the first and second tethers,
in view of Findlay, in order to facilitate cutting the tethers near the valve leaflets within the patient.
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb and Foerster.
Regarding claim 11, Goldfarb discloses a system for edge-to-edge repair of a mitral valve comprising:
an integrated therapy catheter (500; Figs. 42-51) configured to engage a first leaflet and a second leaflet of a mitral valve having:
a puncture device (520) configured to puncture a first hole in the first leaflet proximate a first leaflet edge and puncture a second hole in the second leaflet proximate a second leaflet edge (Fig. 46; para. [0133]);
a delivery device (including push rods; para. [0134]) configured to:
deliver a first leaflet anchor (522; Fig. 48) through the first hole to a distal side of the first leaflet, the first leaflet anchor having a first tether (524) with a self-expanding distal end configured to expand larger than the first hole and engage the distal side of the first leaflet (i.e., the push rods are capable of delivering an anchor (522) with a first tether (524) having a self-expanding distal end because no structure of the catheter (500) or push rods would prevent delivering such an anchor and tether);
deliver a second leaflet anchor (522; Fig. 48) through the second hole to a distal side of the second leaflet, the second leaflet anchor having a second tether (524) with a self- expanding distal end configured to expand larger than the first hole and engage the distal side of the second leaflet (i.e., the push rods are capable of delivering an anchor (522) with a first tether (524) having a self-expanding distal end because no structure of the catheter (500) or push rods would prevent delivering such an anchor and tether); and
a "knot replacement" tool (530) configured to couple with the first tether and the second tether and tension the first tether and the second tether to bring first leaflet edge and the second leaflet edge together, and lock the first tether and tether second tether together (Figs. 50-51; para. [0135]).
Goldfarb further discloses the delivery device configured to deliver a first pledget coupled to the first tether to the first hole and deliver a second pledget coupled to the second tether to the second hole because Goldfarb discloses the device being designed to deliver a first part (370) of an anchor against a distal side of a leaflet and deliver a second part (372) of the anchor against a proximal side of the leaflet (Figs. 26A-26B; para. [0111]).
Alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the push rods to be configured to deliver a first pledget coupled to the first tether to the first hole and deliver a second pledget coupled to the second tether to the second hole, in view of Goldfarb, to facilitate anchoring the tethers to respective leaflets to position the leaflets for treatment of the patient’s valve.
The device of Goldfarb discloses the invention substantially as claimed, except for the “knot replacement” tool including a locking cap and a locking screw.
Foerster, a reference in the surgery field of endeavor, teaches configuring a “knot replacement” tool to include
a locking cap (60) having a cylindrical body with an internally threaded portion (for “threaded fitting;” para. [0068]) and a closed distal end having a first tether locking cap hole and a second tether locking cap hole (Figs. 2-3); and
a locking screw (50) having a cylindrical body with an external threaded portion (for “threaded fitting;” para. [0068]) and a closed distal end having first and second tether locking screw holes (Figs. 2-3);
wherein the locking screw is configured to be screwed into the locking cap (e.g., for “threaded fitting;” para. [0068]), with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions so that the first tether and second tether are twisted around each other and are locked in place (para. [0068])
to lock a suture in place (para. [0068]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the "knot replacement" tool to include:
a locking cap having a cylindrical body with an internal threaded portion and a closed distal end having a first tether locking cap hole and a second tether locking cap hole; and
a locking screw having a cylindrical body with an external threaded portion and a closed distal end having first and second tether locking screw holes;
wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions so that the first tether and second tether are twisted around each other and are locked in place,
in view of Foerster, in order to prevent the tethers from slipping and moving the leaflets to an undesired position that could impede proper functioning of the valve.
Regarding claim 16, Foerster discloses wherein the "knot replacement" tool further includes a detachable delivery shaft coupled with the locking screw (Figs. 8-9; para. [0073]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb in view of Foerster, as applied to claim 11 above, and further in view of Findlay.
Regarding claim 17, the modified device discloses the invention substantially as claimed, except for the cutter device including an outer body and an inner body.
Findlay, a reference in the surgery field of endeavor, teaches configuring a suture cutter device to include
an outer body (12) that is a cylindrical tube with an outer body side opening (38; Fig.2b); and
an inner body (26) slidably positioned within the outer body (para. [0042]), the inner body is a cylindrical tube with an inner body side opening (34; Fig. 2a) the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen (Fig. 2a);
wherein the first and second tethers enter a distal end of the center lumen and exit out of the center lumen through the inner body side opening and outer body side opening (Fig. 2c); and
axial movement of the inner body scissor cuts the first and second tethers between the edges of the inner body side opening and the outer body side opening (Figs. 5a-5c; paras. [0051]-[0054])
to facilitate cutting a suture at a remote site within a patient (para. [0008]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the cutter device to include an
an outer body that is a cylindrical tube with outer body side opening; and
an inner body slidably positioned within the outer body, the inner body is a cylindrical tube with an inner body side opening, the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen;
wherein the first and second tethers enter the distal end of the center lumen and exit out of the center lumen through the inner body side opening and outer body side opening and
axial movement of the inner body scissor cuts the first and second tethers between the edges of the inner body side opening and outer body side opening,
in view of Findlay, in order to facilitate cutting the tethers near the valve leaflets within the patient.
Response to Arguments
Applicant's arguments filed March 6, 2026 have been fully considered but they are not persuasive.
On pages 11-15 of the Response, Applicant argues that Foerster does not disclose a knot replacement tool as claimed. This argument is not persuasive.
Foerster discloses a suture anchor (46), which constitutes a knot-replacement tool as claimed. The suture anchor (46) replaces a knot to secure suture (34; para. [0068]).
Suture anchor (46) includes a cap (60), which constitutes a locking cap as claimed. Cap (60) has a cylindrical body (Fig. 2) and is internally threaded to have a threaded fitting (para. [0068]) and a closed end with holes allowing passage of suture material (34; Fig. 2; para. [0068]).
Suture anchor (46) also includes a housing (50), which constitutes a locking screw as claimed. Housing (50) has a cylindrical body (Fig. 2) and is externally threaded to have a threaded fitting (para. [0068]) and a closed end with holes allowing passage of suture material (34; Fig. 2; para. [0068]).
Further, Fig. 2 of Foerster shows that the cap holes and housing holes are aligned prior to connection between the cap and the housing. Thus, as cap and housing are rotated to be threadedly fitted together, the cap holes and the housing holes would rotate in opposite directions, thus twisting the suture material (para. [0068]).
Therefore, Foerster teaches
a locking cap (60) having a cylindrical body with an internally threaded portion (for “threaded fitting;” para. [0068]) and a closed distal end having a first tether locking cap hole and a second tether locking cap hole (Figs. 2-3); and
a locking screw (50) having a cylindrical body with an external threaded portion (for “threaded fitting;” para. [0068]) and a closed distal end having first and second tether locking screw holes (Figs. 2-3); and
wherein the locking screw is configured to be screwed into the locking cap (e.g., for “threaded fitting;” para. [0068]), with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions so that the first tether and second tether are twisted around each other and are locked in place (para. [0068])
as recited in the claims.
On pages 12-14, Applicant also argues by comparing the disclosure of Foerster to paragraphs [0059]-[0073] and Figs. 19, 29, and 30 of the Specification. These passages of the Specification include descriptions of a knot replacement tool that is not commensurate with the scope of the claims. As such, these arguments concerning merits of the instant application are not given patentable weight until they are commensurate with the scope of the claims.
On pages 15-16, Applicant argues that claims 5, 16, and 17 are allowable for the same reasons as independent claims 1 and 11. These arguments are not persuasive for the reasons presented above.
For all the reasons above, Examiner maintains that the claimed invention is not patentable over the prior art of record.
Conclusion
Applicant's amendment necessitated any 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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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