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 .
Drawings
The drawings have been received on 08/22/2023 & 10/13/2023 and these drawings have been objected to under 37 CFR 1.84 for the following reasons: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. Additionally, solid black shading should only be used to represent bar graphs or color – MPEP 608.02(v), however, the current drawings employ black shading as part of the structure of the apparatus shown in the figures. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of the reasons stated above. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites the following anatomical locations: “an anterior annulus”, “the septal annulus”, and “the posterior annulus”. While a tricuspid valve inherently has a known anterior/septal/posterior annulus, the recitations of “septal” and “posterior” should be preceded by the term “a” instead of the term “the” to correspond to the use in from of the term “anterior” as well as to indicate that it is the first instance that the term is being recited. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the claim recites “the cardiac cycle”. While this is an inherent characteristic of a heart, the term would be in better form by reciting it as “a cardiac cycle”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the claim appears to be missing an article such as “a” preceding the phrase “cone needle tip stylet”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the coaptive edge" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the coaptive edge" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the central portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the direction of the right ventricle" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the position of the coaptive edges" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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”).
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 (see Fig. 57A) having a first anchoring portion (504), a second anchoring portion (526), and a central portion (502) (see Figs. 57A-D and [0257]-[0262]) (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 advacnement 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. 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) 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”).
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.
Conclusion
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