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 .
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.
Election/Restrictions
Applicant’s election of Group I, claims 1-15, in the reply filed on 2/18/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 16-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claim(s) 1-4, 7, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross (20110166649).
With regards to claim 1, Gross discloses an annuloplasty apparatus (100) configured to be implanted into the body of a subject ([0238]), the annuloplasty apparatus (100) comprising: a contractile bridging element (110); a bar member (200/461) connected to the contractible bridging element (FIG 3), the bar member (200/461) being provided with a rotatable connection mechanism (463/1200, FIG 11, [0261], connected to bar member 200/461 by anchor mount 341); and a tissue anchor (360, [0260]) configured to secure the bar member to the annulus tissue by the rotatable connection mechanism ([0260], FIG 4), and comprising: a head portion (380); and a helical tissue coupling element (370), the proximal end of which is fixed to the head portion (FIG 4), wherein the helical tissue coupling element (370) is configured to be driven into the annulus tissue by rotation ([0262]), wherein the rotatable connection mechanism (463/1200, FIG 11) is at least partially configured to be rotatable relative to the bar member ([0261]), thereby allowing the tissue anchor (360) to rotate further relative to the bar member (200/461) when the proximal end of the helical tissue coupling element (370) is in contact with the rotatable connection mechanism ([0261]).
With regards to claim 2, Gross discloses the annuloplasty apparatus according to claim 1, wherein, the rotatable connection mechanism (463/1200, FIG 4) comprises: a fixed portion (463) that is fixedly provided with respect to the bar member (200/461), and a rotatable portion (1200) through which the tissue anchor (360) is capable of fixing the bar member to the annulus tissue ([0262]), wherein one of the rotatable portion (1200) and the fixed portion (463) is provided with an annular circumferential groove (see annotated FIG 11 below), and the other is received in the annular circumferential groove in a rotatable manner with respect to the one (FIG 4).
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With regards to claim 3, Gross discloses the annuloplasty apparatus according to claim 2, wherein the bar member (200/461) includes a first surface (FIG 3), a second surface opposite to the first surface (FIG 3) and a circular through hole extending from the first surface to the second surface (340), and wherein the rotatable portion (1200) comprises: a tubular body (FIG 11) having a proximal end (FIG 11) and a distal end (FIG 11), a top ring (Proximal end of 1200 is ringed shaped), and a bottom ring (distal end of 1200 is ring shaped), the top ring and the bottom ring being disposed at the proximal end and the distal end of the tubular body (FIG 11), respectively, thereby defining the annular circumferential groove extending along outer circumference of the tubular body (see annotated FIG 11 above); wherein the fixed portion (463) is a portion of the bar member (200/461) defining the circular through hole (340), and the portion is received in the annular circumferential groove (FIG 4).
With regards to claim 4, Gross discloses the annuloplasty apparatus according to claim 3, wherein the rotatable portion (1200) further includes a connection portion (longitudinal bar [0304]) disposed at one of the top ring, the tubular body, and the bottom ring (longitudinal bar placed between slits 1230 and 1240, FIG 11, [0304]), with the tissue anchor securing the bar member to the annulus tissue by the connection portion ([0305]). Note that the prior art does not need to disclose the connection portion disposed at the top ring and tubular body to meet the claimed invention since the claim recites the limitations in the alternative only using the phrase “disposed at one of”.
With regards to claim 7, Gross discloses the annuloplasty apparatus according to claim 4, wherein the connection portion is a crossbar (longitudinal bar [0304]) radially fixed to an inner peripheral wall of the bottom ring or a proximal end face or a distal end face of the bottom ring ([0304], FIG 11), the distal end face of the tubular body is provided with two notches (1230, 1240) that are opposed radially and are configured to receive the crossbar (FIG 11).
With regards to claim 10, Gross discloses the annuloplasty apparatus according to claim 3, wherein one of the top ring and the bottom ring is integrally formed with the tubular body (FIG 11).
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.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (20110166649) as applied to claim 1 above, and further in view of Lyon (20130123841).
With regards to claim 5, Gross discloses the annuloplasty apparatus according to claim 4, wherein the connection portion is a crossbar (longitudinal bar [0304]) radially fixed to an inner peripheral wall of the top ring, or a proximal end face, or a distal end face of the top ring longitudinal bar placed between slits 1230 and 1240, FIG 11, [0304]), but fails to disclose that the proximal end face of the tubular body is provided with two notches that are opposed radially and are configured to receive the crossbar (1230, 1240). Note that the prior art does not need to disclose the limitation “radially fixed to a proximal end face or a distal end face of the top ring” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”.
Lyon discloses a rotatable suture anchor insert (12), plate (14), and crossbar connection portion (30). Lyon teaches that the crossbar (30) is radially fixed to an inner peripheral wall of the top ring (FIG 1), and proximal end face of the tubular body is provided with two notches (28, where the proximal end face of the tubular body is the top ring) that are opposed radially and are configured to receive the crossbar (FIG 1). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gross’ annuloplasty apparatus connection mechanism to include that the connection portion is a crossbar radially fixed to an inner peripheral wall of the top ring, or a proximal end face, or a distal end face of the top ring, and the proximal end face of the tubular body is provided with two notches that are opposed radially and are configured to receive the crossbar, as taught by Lyon, in order to be able to selectively remove the crossbar ([0010]).
Claim(s) 6, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (20110166649) as applied to claim 5, 7 above, and further in view of Turnau (20200072381).
With regards to claim 6, Gross discloses the annuloplasty apparatus according to claim 5, but fail to disclose wherein the distal end face of the tubular body is provided with a plurality of notches configured to receive a plurality of projections, respectively, disposed radially inwardly on the inner peripheral surface of the bottom ring.
Turnau also discloses a tubular body (72) and a bottom ring (70). Turnau teaches that the tubular body (72) is provided with a plurality of notches (99) configured to receive a plurality of projections (83), respectively, disposed radially inwardly on the inner peripheral surface of the bottom ring (FIG 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gross’ annuloplasty apparatus connection mechanism to include that the distal end face of the tubular body is provided with a plurality of notches configured to receive a plurality of projections, respectively, disposed radially inwardly on the inner peripheral surface of the bottom ring, as taught by Turnau, in order to lock the pieces together ([0041]).
With regards to claim 8, Gross discloses the annuloplasty apparatus according to claim 7, but fails to disclose that the proximal end face of the tubular body is provided with a plurality of notches configured to receive a plurality of projections, respectively, disposed radially inwardly on the inner peripheral surface of the top ring.
Turnau also discloses a tubular body (72) and a top ring (70). Turnau teaches that the tubular body (72) is provided with a plurality of notches (99) configured to receive a plurality of projections (83), respectively, disposed radially inwardly on the inner peripheral surface of the top ring (FIG 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gross’ annuloplasty apparatus connection mechanism to include that the distal end face of the tubular body is provided with a plurality of notches configured to receive a plurality of projections, respectively, disposed radially inwardly on the inner peripheral surface of the top ring, as taught by Turnau, in order to lock the pieces together ([0041]).
Claim(s) 12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (20110166649) as applied to claim 2 above, and further in view of Hadden (20170097046).
With regards to claim 12, Gross discloses the annuloplasty apparatus according to claim 2, wherein the bar member (200/461) includes a first surface (FIG 3), a second surface opposite to the first surface (FIG 3) and a through hole extending from the first surface to the second surface (FIG 3), wherein the fixed portion (463) is configured to be fixed within the through hole and defining a circular through hole (340), wherein the annular circumferential groove (see annotated FIG 11) is provided in the inner peripheral surface of the circular through hole in the circumferential direction (FIG 4), and the rotatable portion (1200) includes a circular ring (1250) rotatably received in the annular circumferential groove (FIG 4) of the base, but fails to disclose that the fixed portion includes a split-type fixed base.
Hadden discloses a bearing assembly (FIG 10) with a fixed portion (970) and a rotatable portion (100). Hadden teaches that the fixed portion (970) includes a split-type fixed base (FIG 10, split into 970a, 970b). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gross’ annuloplasty apparatus connection mechanism to include that the fixed portion includes a split-type fixed base, as taught by Hadden, as it is less expensive and easier to replace ([029]).
With regards to claim 15, Gross as modified by Hadden discloses the annuloplasty apparatus according to claim 12, wherein the distal end surface of the split-type fixed base is flush with the second surface of the bar member when secured within the through hole of the bar member (FIG 4, where the distal surface of 1200 is flush with the second surface of bar member 461).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (20110166649) in view of Lyon (20130123841) as applied to claim 5 above, and further in view of Edmiston (20210220138).
With regards to claim 9, Gross as modified by Lyon discloses the annuloplasty apparatus according to claim 5, but fails to disclose wherein a threaded hole is provided in the center of the crossbar, which threaded hole is configured to be detachably engaged with the distal end external thread of a guide for guiding the tissue anchor.
Edmiston discloses a helical cardiac anchor (100) with a rotatable portion (112), a fixed portion (110), and a connection portion (106). Edmiston teaches that a threaded hole (FIG 2E) is provided in the center of the connection portion (106), which threaded hole is configured to be detachably engaged with the distal end external thread of a guide for guiding the tissue anchor (FIG 2E). Therefore, 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 Gross’ annuloplasty apparatus connection mechanism to include that a threaded hole is provided in the center of the crossbar, which threaded hole is configured to be detachably engaged with the distal end external thread of a guide for guiding the tissue anchor, as taught by Edmiston, in order to connect and guide the anchor assembly ([0034]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (20110166649) as applied to claim 2 above, and further in view of Singh (20190269445).
With regards to claim 11, Gross discloses the annuloplasty apparatus according to claim 2, wherein the bar member (200/461) includes a first surface (FIG 3), a second surface opposite to the first surface (FIG 3) and a circular through hole extending from the first surface to the second surface (340); wherein the fixed portion (463) includes a portion of the bar member (200/461) defining the circular through hole (340), wherein the annular circumferential groove (see annotated FIG 11 above) is provided in the inner peripheral surface of the circular through hole (FIG 4) of the bar member (200/461); and the rotatable portion (1200) includes a circular ring (1250) rotatably received in the annular circumferential groove (FIG 4), but fails to disclose a top plate having a circular through hole, the top plate being secured to the first surface with its circular through hole substantially concentric with the circular through hole of the bar member. Note that the prior art does not need to disclose the limitation “and/or the top plate in the circumferential direction” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “and/or”.
Singh discloses a plating system (220) with bar member (230), a rotatable portion (271), a circular through hole (240) and a connector (260). Singh teaches a top plate (280) having a circular through hole (FIG 8), the top plate being secured to the first surface ([0101]) with its circular through hole substantially concentric with the circular through hole of the bar member (FIG 8). Therefore, 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 Gross’ annuloplasty apparatus connection mechanism to include a top plate having a circular through hole, the top plate being secured to the first surface with its circular through hole substantially concentric with the circular through hole of the bar member, as taught by Singh, in order to be able to lock the tissue anchor to the plate due to friction between the top plate and anchor ([0103]).
10. Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (20110166649) in view of Singh (20190269445), as applied to claim 11 above, and further in view of Khairkhahan (20240341957).
With regards to claim 13, Gross as modified by Singh discloses the annuloplasty apparatus according to claim 11, but fails to disclose that the circular ring (1250) is provided with a connection portion, and the tissue anchor (360) secures the bar member to the annulus tissue by the connection portion.
Khairkhahan discloses a mitral valve implant (500) with tissue anchor (800) and bar member configured as a circular ring (510). Khairkhahan teaches the circular ring (510) is provided with a connection portion (512), and the tissue anchor (800) secures the bar member (510) to the annulus tissue by the connection portion ([0134]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gross’ annuloplasty apparatus connection mechanism to include that the rotatable portion further includes a connection portion disposed at one of the top ring, the tubular body, and the bottom ring, as taught by Khairkhahan, in order to allow the anchor to secure the bar member to the tissue ([0134]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (20110166649) in view of Singh (20190269445) and Khairkhahan (20240341957), as applied to claim 13 above, and further in view of Edmiston (20210220138).
With regards to claim 14, Gross as modified by Singh and Khairkhahan discloses the annuloplasty apparatus according to claim 13, wherein the connection portion is a crossbar (Khairkhahan 512) radially fixed to an inner peripheral wall of the circular ring or a proximal end face or a distal end face of the circular ring (Khairkhahan FIG 8I). Note that the prior art does not need to disclose the limitation “radially fixed to an inner peripheral wall of the top ring or a distal end face of the top ring” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”. Gross as modified by Singh and Khairkhahan fails to disclose that a threaded hole is provided in the center of the crossbar, which threaded hole is configured to be detachably engaged with the distal end external thread of a guide for guiding the tissue anchor.
Edmiston discloses a helical cardiac anchor (100) with a rotatable portion (112), a fixed portion (110), and a connection portion (106). Edmiston teaches that a threaded hole (FIG 2E) is provided in the center of the connection portion (106), which threaded hole is configured to be detachably engaged with the distal end external thread of a guide for guiding the tissue anchor (FIG 2E). Therefore, 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 Gross’ annuloplasty apparatus connection mechanism to include that a threaded hole is provided in the center of the crossbar, which threaded hole is configured to be detachably engaged with the distal end external thread of a guide for guiding the tissue anchor, as taught by Edmiston, in order to connect and guide the anchor assembly ([0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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