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 .
Status of Claims
Claims 1-3, 5-30, 33-36 are pending, of which claims 10-30 are withdrawn. Therefore, claims 1-3, 5-9, and 33-36 are examined below
Response to Arguments
The remarks of 05/21/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of amended claims 1 and 34. In particular applicant argues the following claim language:
“the tissue piercing element including a helical piercing element”
Regarding the first bullet point – Figure 2A of Purcell discloses coil 54 which further comprises a sharpened tip 59 as described in paragraph 0052. Paragraph 0053 further discloses that coil 54 is rotated to engage tissue. Therefore, coil 54 of Purcell corresponds to a helical piercing element.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tissue anchor of Frazier with a tissue piercing element including a helical piercing element, as taught by Purcell, in order to stabilize the anchor at the target site (¶0053).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 5-9 and 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0208265 (Frazier) in view of US 2019/0216601 (Purcell) in view of WO 2012/040865 (Vogel)
Regarding claim 1, Frazier discloses a tissue anchor (Fig. 60B, 500) comprising:
a tubular member (Fig. 60B, 516) having a proximal end and a distal end (see annotated Fig. 60B below),
at least one wire (Fig. 60B, 502,504) arranged through the tubular member to form (Fig. 60A, wherein 502, 504 extend through 516):
a plurality of anchors (Fig. 60B, 510, 512) extending from the distal end of the tubular member (see Fig. 60B, wherein 510, 512 extend from distal end of 516), each anchor defining a curve extending in a direction toward the proximal end (see Fig. 60B, wherein anchors 510,512 are curved toward proximal end of 516), and
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an eyelet extending from the proximal end (see annotated Fig. 60B below, see also Fig. 60F-G);
Frazier discloses a plurality of anchors (Fig. 60B, 510, 512) but doesn’t explicitly teach or disclose a tissue piercing element extending from the proximal end of the tissue anchor and arranged adjacent to the plurality of anchors or a biasing member configured to provide tactile feedback to a physician.
Purcell discloses a tissue anchor (Figs. 2A-2B, 50) comprising: a tissue piercing element (Fig. 2A, 62) extending from the proximal end of the tissue anchor (see Fig. 2A, wherein 62 extends from the proximal end of 50) and including a biasing member (¶0055, coil spring 77, show concentrically carried over core wire 62) configured to provide tactile feedback to physician (see Fig. 2A, see also ¶0055, wherein coil spring 71 is configured to provide tactile feedback to the physician because it resists the proximal movement of marker 66 along the core wire 62), the tissue piercing element including a helical piercing element (Fig. 2A, coil 54, see also ¶0052-0053, wherein rotation of 54 engages tissue)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tubular member and plurality of anchors of Frazier with a tissue piercing element extending from the proximal end and including a biasing member configured to provide tactile feedback to a physician, as taught by Purcell, in order to ensure that the anchor is fully embedded in the target tissue (¶0055).
Frazier discloses a tubular member (Fig. 60B, 516) but doesn't explicitly teach or disclose a plurality of lumens extending between the proximal end and the distal end or wherein the lumens are configured to maintain an arrangement of the at least one wire. Purcell doesn't explicitly teach or disclose a plurality of lumens extending between the proximal end and the distal end or wherein the lumens are configured to maintain an arrangement of the at least one wire.
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Vogel discloses a tubular member (Fig. 13a, 75) including a plurality of lumens extending between the proximal end and the distal end (see annotated Fig. 13a, wherein 72 includes a plurality of lumens) and wherein the lumens are configured to maintain an arrangement of the at least one wire (see Page 25, Lines 25-27, wherein the annotated lumens are configured for this intended use because they proximally hold wires 74)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tubular member of Frazier in view of Purcell with a plurality of lumens configured to maintain an arrangement of the at least one wire, as taught by Vogel, in order to securely hold the wires in place while the anchor is being fastened into cardiac tissue.
Regarding claim 2, Frazier further discloses wherein the at least one wire (Fig. 60A, 502, 504) includes at least two wires arranged (Fig. 60C, wherein the 3 hook elements 502,504 corresponds to at least two wires) through the tubular member (Fig. 60A, wherein 502,504 are arranged through 516), and the at least two wires overlap to form the eyelet (See Fig. 60B & 60F, wherein 502, 504 overlap to form eyelet)
Regarding claim 3, Frazier further discloses wherein the at least two wires (Fig. 60A, wherein the hook elements 502, 504 correspond to at least two wires) form the plurality of anchors (Fig. 60C, wherein 510, 512 correspond to the plurality of anchors) and the plurality of anchors includes at least four anchors (Fig. 60C, wherein 8 anchors 510, 512 are shown)
Regarding claim 5, Frazier discloses a tissue anchor comprising plurality of anchors (see rejection of claim 1) but doesn’t explicitly teach or disclose a tissue piercing element which includes a longitudinal portion and a depth indicator.
Purcell discloses a tissue anchor (Fig. 2A, 50) comprising a tissue piercing element (Fig. 2A, 62) which includes a longitudinal portion (see Fig. 2A) and a depth indicator (Fig. 2A, 66) configured to provide tactile feedback to a physician embedding of the plurality of anchors within tissue (see Fig. 2A, see also ¶0055, wherein coil spring 71 is configured to provide tactile feedback to the physician because it resists the proximal movement of marker 66 along the core wire 62)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Frazier with tissue piercing element comprising a longitudinal portion and a depth indicator, as taught by Purcell, in order to ensure that the anchor is fully engaged in the target tissue (Purcell, ¶0055)
Regarding claim 6, Frazier discloses a tissue anchor (see rejection of claim 1) but doesn’t explicitly teach or disclose a depth indicator which includes a spacer and a biasing member.
Purcell discloses wherein the depth indicator includes a spacer (Fig. 2B, 70) and a biasing member (Fig. 2B, 71, ¶0055) arranged about the longitudinal portion of the tissue piercing element (Fig. 2B, ¶0055, wherein 71 is concentrically carried over 62), the spacer is configured to contact tissue and urge the biasing member toward the distal end of the tubular member, the degree of which is configured to indicate the extent to which the plurality of anchors extend within the tissue (see ¶0054, wherein 70 is configured for this intended use because it limits distal travel of 66).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tissue anchor of Frazier with a depth indicator which includes a spacer and a biasing member, as taught by Purcell, in order to provide feedback on how deep the anchor has penetrated the tissue.
Regarding claim 7, Frazier further discloses wherein the tubular member (Fig. 60A, 516) comprises at least one of PEEK and stainless steel (¶0255, where components of distal anchor 500 can be made of stainless steel)
Regarding claim 8, Frazier further discloses a flexible cord (see annotated Fig. 60F, ¶0092, wherein “tether’ corresponds to a flexible cord) arranged through the eyelet (see annotated Fig. 60F below) for coupling the tissue anchor to tissue (¶0092, wherein the “tether” is configured for this intended use)
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Regarding claim 33, Modified Frazier in view of Purcell discloses the tissue anchor of claim 1 (see rejection of claim 1 above).
Purcell further discloses a method for chordae tendineae repair which includes:
arranging a flexible cord through a leaflet (Fig. 6A, wherein 344 is inserted through a leaflet) and anchoring a first end of the flexible cord to the leaflet (Fig. 60A, ¶0077, wherein a first end of 344 is anchored to a leaflet by 340);
coupling a second end of the flexible cord to the tissue anchor (Fig. 12, wherein the second end of 344 is attached to anchor assembly 50); and
anchoring the tissue anchor of claim 1 (see rejection of claim 1 above) to tissue of a heart (¶0050, wherein a tissue anchor is deployed near the apex of the left ventricle – corresponding to tissue of the heart)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to incorporate the tissue anchor of Frazier in view of Purcell, in the method for chordae tendinea repair as further taught by Purcell, in order to more securely anchor the artificial chordae tendineae to the heart.
Regarding claim 34, Frazier discloses a tissue anchor (Fig. 60B, 500) comprising:
a tubular member (Fig. 60B, 516) having a proximal end and a distal end (see annotated Fig. 60B below),
at least one wire (Fig. 60B, 502 & 504) arranged through the tubular member (Fig. 60B, wherein 502 & 504 are arranged through 516) to form:
a plurality of anchors (Fig. 60B, 510,512) extending from the distal end of the tubular member (Fig. 60B, wherein 510,512 extend from the distal end of 516) each anchor defining a curve extending in a direction toward the proximal end (see Fig. 60B, wherein anchors 501,512 are cured toward proximal end of 516), and
an eyelet extending from the proximal end (see annotated Fig. 60B below)
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Frazier discloses a tubular member (Fig. 60B, 516) but doesn't explicitly teach or disclose a tissue piercing element extending from the proximal end of the tissue anchor arranged adjacent to the plurality of anchors, and including a biasing member configured to provide tactile feedback to a physician.
Purcell discloses a tissue anchor (Fig. 2A-2B, 50) comprising a tissue piercing element (Fig. 2A, 59) extending from the proximal end of the tubular member (See Fig. 2A, wherein 59 extends from proximal end of 78) and arranged adjacent to the plurality of anchors (Fig. 2A, wherein 59 is adjacent 61), the tissue piercing element (Fig. 2B, 62) passing through a second lumen (Fig. 2B, wherein 62 passes through 68) of the plurality of lumens (Fig. 2B, wherein 62 and the proximal end of 78 correspond to a plurality of lumens), and including a biasing member (¶0055, coil spring 77, show concentrically carried over core wire 62) configured to provide tactile feedback to physician (see Fig. 2A, see also ¶0055, wherein coil spring 71 is configured to provide tactile feedback to the physician because it resists the proximal movement of marker 66 along the core wire 62)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tubular member of Frazier with a tissue piercing element extending from the proximal end, through a second lumen, adjacent to the plurality of anchors and including a biasing member configured to provide tactile feedback to a physician, as taught by Purcell, in order to reliably pierce tissue upon contact and anchor at the correct depth (Purcell, ¶0053)
Frazier discloses a tubular member (Fig. 60B, 516) and at least one wire (Fig. 60B, 502 & 504) but doesn’t explicitly teach or disclose the tubular member includes a plurality of lumens extending between the proximal end and the distal end, and wherein the at least one wire passes through at least one of the plurality of lumens. Purcell doesn't explicitly teach or disclose the tubular member includes a plurality of lumens extending between the proximal end and the distal end, and wherein the at least one wire passes through at least one of the plurality of lumens.
Vogel discloses a tubular member (Fig. 13a, 75) including a plurality of lumens extending between the proximal end and the distal end (see annotated Fig. 13a, wherein 72 includes a plurality of lumens) and wherein the lumens are configured to maintain an arrangement of the at least one wire (see Page 25, Lines 25-27, wherein the annotated lumens are configured for this intended use because they proximally hold wires 74)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tubular member of Frazier in view of Purcell with a plurality of lumens configured to maintain an arrangement of the at least one wire, as taught by Vogel, in order to securely hold the wires in place while the anchor is being fastened into cardiac tissue.
Regarding claim 35, Frazier discloses a tissue anchor (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the tissue piercing element includes a depth indicator with a longitudinal portion and a spacer, wherein the biasing element is positioned about the longitudinal portion and wherein the spacer is configured to contact tissue and cause the biasing member to compress toward the distal end in response to force applied.
Purcell discloses a tissue anchor (Fig. 2A, 56) comprising a tissue piercing element (Fig 2A, 62) includes a depth indicator (Fig. 2A, 66) with a longitudinal portion (see Fig. 2A, wherein 62 has a longitudinal portion) and a spacer (Fig. 2A, 70), wherein the biasing element is positioned about the longitudinal portion (Fig. 2A, wherein 72 is positioned around the longitudinal portion of 62) and wherein the spacer is configured to contact tissue (¶0054, wherein 70 is configured to contact the target tissue) and cause the biasing member to compress toward the distal end in response to force applied (¶0055, wherein 70 holds 66 distal and causes the spring to compress distally)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tissue anchor of Frazier with a tissue piercing element which includes a depth indicator and a spacer, as taught by Purcell, in order to ensure that the anchor is fully embedded in the target tissue (¶0055).
Regarding claim 36, Frazier doesn't explicitly teach or disclose wherein the helical piercing element extends beyond the biasing member
Purcell discloses wherein the helical piercing element (Fig. 2, 56) extends beyond the biasing member (see Fig. 2A, wherein 56 extends beyond 62)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tissue anchor of Frazier with a helical piercing element that extends beyond the biasing member, as taught by Purcell, in order to ensure that the anchor is fully embedded in the target tissue (¶0055).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0208265 (Frazier) in view of US 2019/0216601 (Purcell) in view of WO 2012/040865 (Vogel), as applied to claims above, and further in view of US 2018/0116800 (Alon)
Regarding claim 9, Frazier discloses a tubular member (see rejection of claim 1) but doesn't explicitly teach or disclose a location feedback mechanism. Purcell doesn't explicitly teach or disclose a location feedback mechanism. Vogel doesn't explicitly teach or disclose a location feedback mechanism.
Alon discloses a tissue anchor (Fig. 4A) comprising a location feedback mechanism (Fig. 4A, protrusion 160) arranged at the distal end of the tubular member (Fig. 5A, wherein 160 is arranged at distal end of 74) and configured to indicate a slope or angle of a tissue wall (¶0056, wherein 160 is configured for this intended use because it can be viewed with fluoroscopic imaging and deflects to indicate the slope or angle of a tissue wall)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tubular member of Frazier in view of Purcell in view of Vogel with a location feedback mechanism, as taught by Alon, in order to give the clinician feedback on the slope of the implantation site.
Conclusion
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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