DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 07/30/2026.
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 .
Drawings
The drawings were received on 07/30/2026. These drawings are acceptable.
Claim Objections
The objection to claim(s) 1, 9, and 15 in the previous Office Action for informalities is hereby withdrawn in view of Applicant’s Amendment.
Claim Rejections - 35 USC § 112
The rejection of claim(s) 6-9 in the previous Office Action under this section, 2nd paragraph (pre-AIA ) or subsection (b) (AIA ), for being indefinite is hereby withdrawn in view of Applicant’s Amendment.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-13 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0214270 A1 to Subramanian et al. (hereinafter “Subramanian”) in view of US 2016/0235533 A1 to Gilmore et al. (hereinafter “Gilmore”) (both references previously of record).
Regarding claim 1, Subramanian discloses (see abstract; Figs. 57A-112A; and [0257]-[0412]) a method (see [0361]-[0369]) for treating a tricuspid valve (see [0002]/[0018]/[0389]), the method comprising: anchoring a first anchor (1012) to a first location of an annulus (see Figs. 99-100 and [0361]-[0362]); anchoring a second anchor (1012) to a second location of an annulus (see Figs. 99-100 and [0361]-[0362]); positioning a transvalvular bridge (500) comprising an elongate body (560) (see Fig. 57E) having a first anchoring portion (509) at a first end of the transvalvular bridge (see Figs. 57E-G), a second anchoring portion (at diagonally opposed end of 560 to #509 indicated in Figs. 57E/G which would also be represented as #509) at a second end of the transvalvular bridge, and a central portion (518 + 522) having a central opening (see Figs. 57E-G, the curved structure of the device as shown in Fig. 57G shows a central opening defined by central portion 518 + 522), wherein a width of the transvalvular bridge at the central portion is greater than a width of the transvalvular bridge at the first end and the second end (see Figs. 57E-G, the width at 518 is defined by the intersection of struts 516 crossing each other as per [0263], which would be wider than the rings 509 at the ends since the rings would be less than twice the width of the struts), wherein the central opening is capable of allowing blood to flow therethrough (blood is fully capable of flowing around the skeleton layer 560 even when embedded within dacron mesh shown in Fig. 57D) (see Figs. 57A-G and [0257]-[0264]) (see [0364]); and anchoring the transvalvular bridge to the first anchor and the second anchor (see [0364]-[0369]).
Subramanian further discloses (claim 2) wherein positioning the transvalvular bridge comprises sliding the transvalvular bridge relative to a tether (1014) attached to the first anchor (see [0361]-[0369]); (claim 3) wherein positioning the transvalvular bridge comprises sliding the transvalvular bridge relative to a tether (1014) attached to the second anchor (see [0361]-[0369]); (claim 4) sliding a locking clip (1016) relative to a tether (1014) attached to the first anchor (see [0364]-[0368]); (claim 5) sliding a locking clip (1016) relative to a tether (1014) attached to the second anchor (see [0364]-[0368]); (claim 6) wherein anchoring the transvalvular bridge comprises anchoring the transvalvular bridge to span the coaptive edge between the leaflets (see [0147]/[0177]-[0181]); (claim 7) wherein positioning a transvalvular bridge comprises positioning the transvalvular bridge to extend transversely across the coaptive edge formed by the closure of the anterior leaflet during systole (see [0147]); (claim 8) wherein positioning a transvalvular bridge comprises positioning the central portion convex in the direction of the right ventricle (see [0258]); (claim 9) further comprising elevating the position of the coaptive edges during valve closure to thereby cause early coaption relative to the cardiac cycle (see [0171]); (claim 10) wherein anchoring the transvalvular bridge does not affect the size and shape of the annulus (see [0428]); (claim 11) further comprising advancing an anchor driver (1006) relative to a clip driver (advancement of 1006 prior to advancement of 1008 for deployment of 1016) (see Figs. 104-105 and [0358]/[0364]); (claim 12) further comprising loading the first anchor, the second anchor, the transvalvular bridge, a first locking clip, and a second locking clip into a steerable catheter (1002) (see [0358]/[0364]); (claim 13) further comprising providing a sheath (1006) disposed between a tether (1014) attached to the first anchor (1016) and a steerable catheter (1004) (see Figs. 99-100 and [0360]); (claim 16) further comprising a steering catheter (800) comprising a stabilizing tip (806) (see Figs. 68A-B and [0315]); (claims 17-18) further comprising applying and releasing tension to a tether attached to the first anchor to engage an anchor driver (408) (see [0251]-[0252]); (claim 19) further comprising abutting a hard stop (cross-bar of "t-tag" anchor, see [0203]) to prevent advancement of the first anchor; (claim 20) further comprising adjusting the travel distance of the first anchor relative to a steering catheter (deployment location selection; see Figs. 104-105 and [0368]
Subramanian fails to specifically disclose, with respect to claim 1, wherein the first annulus location is an anterior annulus and the second annulus location is between the septal annulus and the posterior annulus, such that the transvalvular bridge is positioned along an anterior-septal-posterior (A-S-P) diameter of the tricuspid valve. Further, with respect to claims 6/10, Subramanian fails to disclose wherein the transvalvular bridge spans the coaptive edge between the anterior leaflet and both posterior and septal leaflets, and that the annulus is a tricuspid annulus. As set forth above, Subramanian discloses that the disclosed method is suitable for treating both a mitral valve and a tricuspid valve (see [0002]/[0018]/[0389]), with the majority of the disclosure only showing the mitral valve embodiment. Further, paragraphs [0360]-[0361] disclose placement of the anchors at a variety of locations around the annulus of the valve (whether mitral or tricuspid).
Gilmore discloses (see abstract; Fig. 3O; Table 1 between [0232] & [0233]; and [0200]-[0235]), in the same field of endeavor, a method of treating a tricuspid valve, wherein a first anchor is placed at an anterior annulus (anchor 42 at location 92 at circumferential middle 121 of anterior leaflet 86, see Fig. 3O and Table 1); wherein a second anchor is placed between the septal annulus and the posterior annulus (anchor 40 at location 90 at septoposterior commissure 117, see Fig. 3O and Table 1) such that the device is positioned along an anterior-septal-posterior (A-S-P) diameter of the tricuspid valve as known annulus locations for traversing a tricuspid valve among a variety of other annulus locations (as per Table 1). Given that Subramanian discloses that the disclosed method is applicable to mitral or tricuspid valves, and that the anchors can be placed at a variety of locations around the annulus, and that Gilmore discloses a suitable location for placing anchors across a tricuspid valve, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of applying a known technique to a known method ready for improvement to yield predictable results (see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395- 97(2007)), to obtain the predictable result of a suitable location that spans the tricuspid valve in order to provide appropriate treatment to address tricuspid valve insufficiency.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Subramanian in view of Gilmore as applied to claim 1 above, and further in view of US 2004/0049211 A1 to Tremulis et al. (hereinafter “Tremulis”) (previously of record).
Regarding claims 14-15, the combination of Subramanian and Gilmore discloses the invention substantially as claimed as discussed above, however, the combination fails to specifically disclose wherein the first anchor comprises an inverted helix coil or a cone needle tip stylet. Rather, Subramanian discloses generic anchors known in the art as being suitable for attaching the transvalvular band to the annulus (see [0176]). Tremulis discloses, in the same field of endeavor of valve repair and tissue anchors (see [0009]-[0010]), a variety of anchor suitable for use in an annulus around a valve (see [0086]/[0103]), wherein the anchor can comprise an inverted helix coil (Fix. 68) or a cone needle tip stylet (Fig. 66, [0113]) for the purpose of providing an anchor that is secured to the heart tissue by torqueing through the tissue with a variable radii (see [0114]-[0115]) or for providing an anchor that has self-tapping threads to engage tissue and advance itself through the tissue (see [0113]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination's method with the anchor types taught by Tremulis, since these are suitable anchors for affixing to an annulus of a heart valve and additionally provide the benefit of providing an anchor that is secured to the heart tissue by torqueing through the tissue with a variable radii or that has self-tapping threads to engage tissue and advance itself through the tissue.
Response to Arguments
Applicant's arguments filed 07/30/2026 with respect to the claims as amended have been fully considered but they are not persuasive.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant does not provide any specific arguments as to the combination of Subramanian and Gilmore other than to generally allege that the amended claim distinguishes from the combination, however, as shown in the rejection above, the combination still reads on the amended claim.
Conclusion
THIS ACTION IS MADE FINAL. 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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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