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 .
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 1-8, 15-17, 19, 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Osterbauer et al, US 2022/0054259 A1.
Regarding claim 1, Osterbauer discloses a tissue anchor (any of the anchor embodiments 210 or 2000, as shown in Figs. 11A-B, 12A-D, 13A-B, 14A, 20, paras [0046]-[0047]; [0076]) comprising: a frame (1100 or 2000) comprising at least a first pointed end (1162a/1162b, or 1171a and 1171b, Fig. 11A, para [0052]; 2008a/b, Fig. 20); and a membrane (para [0075]; anchors 210 or 2000 may have layer of fabric or mesh, which is equivalent to a membrane) extending across an opening of the frame; wherein the frame is configured to bend such that the first pointed end extends at least partially over the membrane (para [0048], frame can be stretched, compressed and is therefore bendable, and also paras [0051]-[0052]; Fig. 12A, ends 1171a/b can be rolled toward one another and over the membrane; see also para [0076]).
Regarding claim 2, Osterbauer discloses the tissue anchor of claim 1, wherein the frame and membrane are diamond shaped (para [0050] and para [0075]).
Regarding claim 3, Osterbauer discloses the tissue anchor of claim 1, wherein the frame and membrane are oval-shaped (see embodiment in Fig. 20).
Regarding claim 4, Osterbauer discloses the tissue anchor of claim 1, wherein the frame and membrane are droplet shaped (see embodiment in Fig. 20).
Regarding claim 5, Osterbauer discloses the tissue anchor of claim 1, wherein the first pointed end is configured to puncture a valve leaflet of a heart (paras [0057]; [0065]; anchor 210 has sharp leading end (tip end 1162a) that is intended to pierce the ventricular wall).
Regarding claim 6, Osterbauer discloses the tissue anchor of claim 1, wherein the first pointed end comprises an eyelet (1150, 1152, Fig. 11B; eyelet is attached to pointed end by way of frame structure) configured to receive a tethering suture (226, para [0051]).
Regarding claim 7, Osterbauer discloses the tissue anchor of claim 1, wherein the membrane is configured to attach to a tethering suture (para [0075]; layers of mesh attach to frame, and frame has a suture attached).
Regarding claim 8, Osterbauer discloses the tissue anchor of claim 1, wherein the frame is configured to bend such that the frame assumes a heart-shaped form (see Figs. 12A; rolled edges form a heart shape, paras [0054] to [0055]).
Regarding claim 15, Osterbauer discloses a tissue anchoring system (any of the anchor embodiments 210 or 2000, as shown in Figs. 11A-B, 12A-D, 13A-B, 14A, 20, paras [0046]-[0047]; [0076]; see also second suture anchor at 1602, Fig. 16, [0071]) comprising: a first tissue anchor (210) configured for delivery via a lumen of a delivery shaft to a valve leaflet of a heart (Figs. 15A-D, delivery tube and introducer 230/295, para [0065]), the first tissue anchor comprising: a frame (1100 or 2000) comprising at least a first pointed end (1162a/1162b, or 1171a and 1171b, Fig. 11A, para [0052]; 2008a/b, Fig. 20); a membrane (para [0075]; anchors 210 or 2000 may have layer of fabric or mesh, which is equivalent to a membrane) extending across an opening of the frame, wherein the frame is configured to bend such that the first pointed end extends at least partially over the membrane (para [0048], frame can be stretched, compressed and is therefore bendable, and also paras [0051]-[0052]; Fig. 12A, ends 1171a/b can be rolled toward one another and over the membrane; see also para [0076]); and a first suture (226) tethered to the first tissue anchor and configured to anchor to a ventricle wall (para [0051], Figs. 15A-D, paras [0066]-[0068]).
Regarding claim 16, Osterbauer discloses the tissue anchoring system of claim 15, wherein the frame comprises an eyelet (1150, 1152, Fig. 11B), and wherein the first suture is configured to form a knot through the eyelet (226, para [0059]).
Regarding claim 17, Osterbauer discloses the tissue anchoring system of claim 15, wherein the first suture is configured to attach to the membrane (226 is capable of attaching to mesh/fiber layers since suture is attached to frame as a whole, paras [0051] and [0075]).
Regarding claim 19, Osterbauer discloses the tissue anchoring system of claim 15, wherein the first tissue anchor (210) is configured to assume a compressed form within the lumen of the delivery shaft and assume an expanded form following removal from the lumen of the delivery shaft (para [0056]).
Regarding claim 20, Osterbauer discloses the tissue anchoring system of claim 15, wherein the frame and membrane have a diamond shape (para [0050], Figs. 11A-B; and para [0075]).
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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Osterbauer in view of Christianson et al, US 2021/0330459 A1.
Regarding claim 18, Osterbauer discloses the tissue anchoring system of claim 15, further comprising: a second tissue anchor (1602) configured for delivery via the lumen of the delivery shaft to the valve leaflet of the heart (Fig. 16, [0071]); but is silent as to a second suture tethered to the second tissue anchor and configured to anchor to the ventricle wall.
However, Christianson, in the same field of art, namely tissue anchors for use in the heart and around a heart valve implant (para [0182]), teaches first and second tissue anchors (110) each having a first suture and a second suture (paras [0015]; [0016]) tethered to the individual anchors and configured to anchor to the ventricle wall (para [0218]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the system of Osterbauer with a second suture tethered to the second tissue anchor as taught by Christianson in order to provide the stated advantages of anchoring each individual tissue anchor in position and allowing placement at different locations to enhance the seating of the mitral valve while allowing minimally invasive delivery of multiple tissue anchors (Christianson, para [0005]; [0218]). In addition, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that applying the known technique of an additional suture/tether as taught by Christianson to the system of Osterbauer would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of an additional suture to the teaching of Osterbauer would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such sutures/tethers. Further, applying a second suture to Osterbauer, would have been recognized by one of ordinary skill in the art as resulting in an improved system that would allow more efficient tethering and placement of anchors around the heart.
Allowable Subject Matter
Claims 9-14 are allowed. The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 9, Osterbauer discloses a method (Figs. 15A-D, 16, 17, paras [0065]-[0067]) comprising: delivering a needle (introducer 230 that can contain needle 295, see para [0065], top of page 7, para [0066]) carrying two or more tissue anchors (210, 1602, Fig. 16) situated longitudinally within a lumen of the needle (paras [0065]-[0066]), each of the two or more tissue anchors comprising a frame (1100/2000; 1602, Fig. 16) having a pointed end (1162a/1162b, or 1171a and 1171b, Fig. 11A, para [0052]; 2008a/b, Fig. 20; Fig. 16, para [0071]) and a membrane (para [0075]) extending across an opening of the frame (any of the anchor embodiments 210 or 2000, as shown in Figs. 11A-B, 12A-D, 13A-B, 14A, 20, paras [0046]-[0047]; [0076]; [0071]), and each of the two or more tissue anchors tethered to a suture (226, para [0065]); deploying a first tissue anchor (210) of the two or more tissue anchors through a puncture opening in a wall of a heart and beyond a distal end of the needle (para [0067]); positioning the first tissue anchor such that a first membrane of the first tissue anchor covers the puncture opening (para [0067], Fig. 15C).
Osterbaur fails to teach and/or render obvious that each of the two or more tissue anchors tethered to a different suture of two or more sutures and the puncture opening is in a valve leaflet of a heart; and redirecting a first pointed end of the frame of the first tissue anchor such that the pointed end extends at least partially over the first membrane. Since Osterbaur is intended to be anchored in a ventricular wall on the opposite side of the valve (Figs. 15A-D, para [0065]), it would not have been obvious to modify or use in a method of puncturing a heart valve leaflet. In addition, none of the prior art references of record teach or render obvious the step of redirecting a first pointed end of the frame of the first tissue anchor such that the pointed end extends at least partially over the first membrane in combination with the method as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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