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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-20 and Figs. 1, 2A-2L in the reply filed on 04/16/2026 is acknowledged. Thus, claims 1-20 are presently pending in this application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-7, 10-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Lee et al. (2003/0199974) “Lee”.
Regarding claim 1, Lee discloses a method of repairing a mitral valve of a heart of a subject (abstract), the method comprising: positioning an elongate support of an implant 202 (par. 0068 and Fig. 8A) at the heart such that the support is aligned with a coronary sinus of the heart (par. 0018 discloses the implant is placed on the posterior portion of the valve annulus; Fig. 10A shows the implant at a posterior portion of the valve leaflet which is adjacent and aligned with the coronary sinus), the support having a first end and a second end (implant 202 has two ends which each end having washers 224); anchoring a first anchor 224/204b of the implant to a first location on an anterior side of the valve (the combination of Figs. 9 and 10B disclose washer and coil anchor 224/204b anchored on an anterior side AA of the valve; par. 0068 discloses anchors in the form of claps 204), such that a first tether-segment of the implant spans across the valve between the first anchor and the first end of the support and anchoring a second anchor of the implant to a second location on the anterior side of the valve, such that a second tether-segment of the implant spans across the valve between the second anchor and the second end of the support (Fig. 8A discloses the structure of the two anchors 224/204b on each end of implant 202; Fig. 9 discloses the anchor 224/204b and a tether 204a; Fig. 10B, discloses the anchor 204, which is similar to anchor 224/204b and tether 204a, is anchored across the valve body from the posterior side to the anterior side of the valve).
Regarding claim 2, Lee discloses wherein anchoring the first anchor to the first location and anchoring the second anchor to the second location comprises anchoring the first and second anchors to their respective locations such that the support distributes forces therebetween (as shown in Figs. 8A and 10, the centrally located support 202 distributes forces to each anchors on its sides).
Regarding claim 3, Lee discloses wherein the method further comprises, for each of the first anchor and the second anchor, prior to anchoring the anchor to the respective location, transluminally sliding the anchor over and along the respective tether-segment to the heart (pars. 0077-0078 discloses the washer 224 slides along the tether 204a and compresses coil 204b which also slides along tether 204a).
Regarding claim 5, Lee discloses wherein the support 202 is a flexible support (par. 0069 discloses the support 202 is a flexible wire capable of folding to form loops 212), and wherein positioning the support at the heart comprises positioning the flexible support at the heart (as shown in Fig. 10A).
Regarding claim 6, Lee discloses wherein anchoring the second anchor to the second location comprises anchoring the second anchor to the second location such that the support maintains the first end and the second end at a fixed distance from one another (Figs. 8A and 10B disclose the anchor 204 keeping the support 202 at a fixed distance).
Regarding claim 7, Lee discloses wherein: the first location is proximate to a first commissure of the valve, the second location is proximate to a second commissure of the valve, anchoring the first anchor to the first location comprises anchoring the first anchor to the first location that is proximate to the first commissure of the valve, and anchoring the second anchor to the second location comprises anchoring the second anchor to the second location that is proximate to the second commissure of the valve (as shown in Fig. 10B, the anchors 204 are proximate the commissures of the valve).
Regarding claim 10, Lee discloses wherein the valve has an annulus circumscribing the valve, the first location is on the annulus, the second location is on the annulus, anchoring the first anchor to the first location comprises anchoring the first anchor to the first location on the annulus, and anchoring the second anchor to the second location comprises anchoring the second anchor to the second location on the annulus (as shown in Fig. 10B, anchors 204 are anchored on the annulus border of the valve).
Regarding claim 11, Lee discloses wherein the method further comprises reshaping the valve by modifying tension of at least one tether-segment selected from the group consisting of the first tether-segment and the second tether-segment (par. 0082 and abstract).
Regarding claim 12, Lee discloses wherein modifying tension of the selected tether-segment comprises pulling on the selected tether-segment (par. 0082 discloses the implant wire being drawn together which involves a pulling force).
Regarding claim 13, Lee discloses wherein the selected tether-segment is a suture (par. 0084 discloses the use of sutures), and wherein modifying tension in the selected tether-segment comprises applying tension to the selected tether-segment (combination of pars. 0082 and 0084).
Regarding claim 14, Lee discloses wherein reshaping the valve comprises reducing a circumference of an annulus of the valve (par 0082 discloses reduction in annulus size).
Regarding claims 15-16, Lee discloses wherein the valve has an anterior leaflet and a posterior leaflet, and an annulus circumscribing the anterior leaflet and the posterior leaflet, and wherein reshaping the valve comprises drawing the posterior leaflet towards the anterior leaflet (par. 0082 and Fig. 10B) and wherein drawing the posterior leaflet towards the anterior leaflet comprises drawing the posterior leaflet towards the anterior leaflet by pulling on the selected tether-segment (par. 0082 discloses drawing the leaflets together by using forces to pull the implant wire).
Regarding claims 17 and 19, Lee whether the method further comprises locking the tension in the selected tether-segment 204a, following the reshaping of the valve and wherein locking the tension in the selected tether-segment comprises locking the tension adjacent at least one of the first anchor and the second anchor (par. 0078 discloses the washer 224 and mechanism 208 compress the coil anchor 204b which results in the coil anchor 204b maintaining its locked configuration).
Regarding claim 20, Lee discloses wherein modifying the tension in the selected tether-segment comprises modifying the tension in both the first tether-segment and the second tether-segment by, for each tether-segment, subsequently locking the tension in the tether-segment by applying a lock adjacent the respective anchor of the tether-segment (par. 0078 discloses both anchors are applied the locking mechanism as discussed above under claims 17 and 19).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2003/0199974) “Lee” in view of Webler et al. (7981152) “Webler” further in view of Douk (2007/0027533).
Lee discloses the claimed invention of claim 1; except for wherein the method further comprises, prior to positioning the support at the heart, transluminally advancing the support into the coronary sinus via a femoral artery and an aorta of the subject. However, Webler teaches a similar method comprising transluminally advancing a support 320 (Fig. 4) into the coronary sinus (abstract and Fig. 5). Furthermore, Douk teaches a similar method comprising transluminally advancing a support 100 (Fig. 3) via a femoral artery and an aorta of the subject (par. 0034). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Lee to include prior to positioning the support at the heart, transluminally advancing the support into the coronary sinus via a femoral artery and an aorta of the subject, as taught and suggested by Webler and Douk, for using a minimally invasive method that reduces the risks associated with open heart surgery.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2003/0199974) “Lee” in view of Douk (2007/0027533).
Lee discloses the claimed invention of claim 1 including wherein: the implant comprises a tether (wire 202; par. 0069; Fig. 8A) that defines the first tether-segment 204 a (left side of support 202; Figs. 8A-9), the second tether-segment 204a (right side of support 202; Figs. 8A-(, and a middle tether-segment between the first tether-segment and the second tether-segment (wire 202; par. 0069), and anchoring the second anchor to the second location comprises anchoring the second anchor to the second location such that the tether extends: as the first tether-segment, from the first location across the valve to the first end of the support and as the second tether-segment, from the second end of the support back across the valve to the second location (Fig. 8A discloses the structure of the two anchors 224/204b on each end of implant 202; Fig. 9 discloses the anchor 224/204b and a tether 204a; Fig. 10B, discloses two anchors 204, which are similar to anchors 224/204b and tether 204a, are anchored across the valve body from the posterior side to the anterior side of the valve); except for the tether extends as a middle tether-segment extending along the support; the support is a tube, and positioning the support at the heart comprises positioning the tube at the heart while the middle tether-segment extends within the tube.
However, Douk teaches a similar method of repairing a mitral valve comprising an implant 100 (Fig. 3) having a tether 110 that extends as a middle tether-segment extending along a support 102 (as shown in Fig. 4 and discussed in par. 0028 where the tether extends within hollow tube 102); the support is a tube (hollow tube; par. 0028), and positioning the support at the heart comprises positioning the tube at the heart while the middle tether-segment extends within the tube (as shown in Figs. 4 and 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Lee to include the tether extends as a middle tether-segment extending along the support; the support is a tube, and positioning the support at the heart comprises positioning the tube at the heart while the middle tether-segment extends within the tube, as taught and suggested by Douk, for using the tether ends to reduce the gap within the mitral valve using a flexible member (pars. 0026 and 0028).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2003/0199974) “Lee” in view of Groothuis et al. (10702274) “Groothuis”.
Lee discloses the claimed invention of claims 1, 11 and 17; except for wherein the method further comprises, subsequently to locking the tension in the selected tether-segment, cutting excess tether from the selected tether-segment. However, Groothuis teaches a similar method comprising subsequently to locking the tension in the selected tether-segment, cutting excess tether from the selected tether-segment (col. 11, lin. 53-56 disclose using lockers and then cutting the excess tether). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Lee to include subsequently to locking the tension in the selected tether-segment, cutting excess tether from the selected tether-segment, as taught and suggested by Groothuis, for eliminating excess unnecessary tether at the implantation site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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