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.
Claim Objections
Claim 25 objected to because of the following informalities: “wherein the bridle point comprise a bridle know” should read “wherein the bridle point comprises a bridle knot”. Appropriate correction is required.
Claim 26 objected to because of the following informalities: “fixed know” should read “fixed knot”. Appropriate correction is required.
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) 1-2, 4-8, 13-14, 20, 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (WO2011148374A2).
With regards to claim 1, Miller discloses a soft tissue anchor system for implantation in soft body tissue (132; 22), comprising: a plurality of anchor members (172a-d; 69a-c); and a bridle arrangement (168; 66) comprising a plurality of bridle lines (168a-d; 66a-c) and a common bridle point (166, 164; 64); wherein each bridle line is associated with a respective anchor member and is connected to the common bridle point (FIG 5; FIG 4); wherein the bridle point (166, 164; 64) is configured to place each bridle line (168a-d; 66a-c) under tension when the soft tissue anchor system is implanted in the soft body tissue and the bridle point itself is under tension, such that each anchor member is motivated towards an axis intersecting the bridle point and a direction in which the tensile force is being applied to the bridle point (FIG 5; FIG 4).
With regards to claim 2, Miller discloses the soft tissue anchor system as claimed in claim 1, comprising an artificial line (162, 160); wherein the artificial line is connected to the bridle point (166, 164) and is configured to apply a tension force to the bridle point (FIG 5).
With regards to claim 4, Miller discloses the soft tissue anchor system as claimed in claim 1, wherein the bridle point (166, 164) is arranged to provide each of the bridle lines (168a-d) on a first side of the bridle point (FIG 5), and a line (162, 160) applying tension to the bridle point on a second side of the bridle point opposite the first side (FIG 5).
With regards to claim 5, Miller discloses the soft tissue anchor system as claimed in claim 1, wherein the bridle lines (168a-d) consist of two bridle lines and the bridle arrangement comprises a Y-shaped configuration (FIG 5).
With regards to claim 6, Miller discloses the soft tissue anchor system as claimed claim 1, wherein the bridle lines (66a-c) consist of three bridle lines and the bridle arrangement comprises a trident-shaped configuration (FIG 4).
With regards to claim 7, Miller discloses the soft tissue anchor system as claimed in claim 1, wherein the bridle point (64) is a slidable bridle point such that the bridle lines can move relative to the bridle point at the connection (64 can be a bead, which is understood to be slidable. pg 18 line 10).
With regards to claim 8, Miller discloses the soft tissue anchor system as claimed in claim 1, wherein the bridle point (164, 166) is a fixed bridle point such that the bridle lines cannot move relative to the bridle point at the connection (164, 166 can be a knot, which is understood to not be able to move pg 25 line 5).
With regards to claim 13, Miller discloses the soft tissue anchor system as claimed in claim 1, wherein the soft body tissue anchor system (132) is a leaflet anchor system (14) and the soft body tissue is a leaflet heart valve (8).
With regards to claim 14, Miller discloses a catheter device for implanting a soft tissue anchor system in heart tissue (300), the catheter device (300) comprising: a housing section (42), wherein the housing section extends from a distal end of the catheter device along the length of the catheter device toward a proximal end of the catheter device (FIG 2); and a soft tissue anchor system as claimed in claim 1 located within the housing section (FIG 2).
With regards to claim 20, Miller discloses the catheter device as claimed in claim 14, comprising: a leaflet anchor for placement in a leaflet of a heart valve (132), wherein the leaflet anchor is the soft tissue anchor system (FIG 5), wherein the leaflet anchor is arranged to be coupled to the artificial line (FIG 5); and a leaflet anchor deployment mechanism for deploying the leaflet anchor to attach it to the leaflet of the heart (“Implant may be implanted using a delivery tool 300”. Pg 20 line 2).
With regards to claim 23, Miller discloses a method of implanting a soft tissue anchor system as claimed in claim 1 in soft body tissue, the method comprising: implanting each of the anchor members in the soft body tissue (given the disclosed structure of the anchor members, there must be a genetic method of implanting them); and applying a tensile force to each of the bridle lines by application of a tensile force to the common bridle point (FIG 5).
With regards to claim 24, Miller discloses a method of manufacturing a soft tissue anchor system as claimed in claim 1, the method comprising: connecting each bridle line to a respective anchor member; and connecting each bridle line to a common bridle point (given that Miller discloses each of these components, there must be a generic method of manufacturing them).
With regards to claim 25, Miller discloses the soft tissue anchor system as claimed in claim 7, wherein the bridle point comprises a bridle knot (64 can be a knot. pg 18 line 10).
With regards to claim 26, Miller discloses the soft tissue anchor system as claimed in claim 8, wherein the bridle point comprises a fixed knot (164, 166 can be a knot, which is understood to not be able to move. pg 25 line 5). Note that the prior art does not need to disclose the limitation “an eye plate” to meet the claimed invention since the claim recites the limitations in the alternative only using the terms “one of” and “or”.
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.
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO2011148374A2) in view of Cabiri (20200113685).
With regards to claim 3, Miller discloses the soft tissue anchor system as claimed in claim 2, wherein the bridle point (166, 164) is located along the artificial line (162, 160) (FIG 5); and wherein the bridle lines are joined to the artificial line at the bridle point (FIG 5). Miller fails to disclose wherein the artificial line forms one of the bridle lines.
Cabiri discloses a soft tissue anchor system (FIG 22C) with tissue anchors (918), artificial lines (60, 62) and bridle lines (60, 62). Cabiri teaches that the artificial line forms one of the bridle line (FIG 22C). 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 Miller’s soft tissue anchor system to include the artificial line forms one of the bridle lines, as taught by Cabiri, in order to more easily be able to adjust the length of the bridle lines, and therefore how much freedom of motion they have ([0485]).
Claim(s) 9, 10, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO2011148374A2) in view of Stone (20080140092).
With regards to claim 9, Miller discloses the soft tissue anchor system as claimed in claim 1, but fails to disclose a tubular cap member; wherein an end of one of the bridle lines is fixed to the tubular cap member and extends from a central portion thereof such that, in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof; wherein the tubular cap member comprises an opening configured to receive a wire guide member for passing the tubular cap member through the soft body tissue during implantation; wherein the tubular cap member is an anchor member.
Stone discloses a soft tissue anchor system (FIG 18) with anchor members (600) and bridle lines (FIG 18). Stone teaches a tubular cap member (600, [0072]); wherein an end of one of the bridle lines is fixed to the tubular cap member (FIG 18) and extends from a central portion thereof such that (FIG 18), in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof (FIG 27); wherein the tubular cap member comprises an opening (602) configured to receive a wire guide member (650) for passing the tubular cap member through the soft body tissue during implantation (FIG 27); wherein the tubular cap member is an anchor member (600, [0072]). 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 Miller’s soft tissue anchor system to include a tubular cap member; wherein an end of one of the bridle lines is fixed to the tubular cap member and extends from a central portion thereof such that, in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof; wherein the tubular cap member comprises an opening configured to receive a wire guide member for passing the tubular cap member through the soft body tissue during implantation; wherein the tubular cap member is an anchor member, as taught by Stone, in order to facilitate delivery of the soft tissue anchor system ([0005]).
With regards to claim 10, Miller as modified by Stone discloses the soft tissue anchor system as claimed in claim 9, comprising: a plurality of the tubular cap members (FIG 25); wherein an end of each bridle line is fixed to a respective tubular cap member (FIG 25).
With regards to claim 15, Miller discloses the catheter device as claimed in claim 14, but fails to disclose a deployment system configured to simultaneously implant each of the anchor members in the heart tissue; wherein the deployment system comprises a plurality of wire guide members, wherein each wire guide member comprises a guide portion located at a distal end of the wire guide members and configured to engage a respective anchor member; and wherein the deployment system is configured to maintain a coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the anchor members.
Stone discloses a soft tissue anchor system (FIG 18) with anchor members (600), bridle lines (FIG 18), and a catheter deployment system (15A). Stone teaches a deployment system (15A) configured to simultaneously implant each of the anchor members in the heart tissue ([0070]); wherein the deployment system comprises a plurality of wire guide members (106), wherein each wire guide member (106) comprises a guide portion (108) located at a distal end of the wire guide members and configured to engage a respective anchor member (FIG 13); and wherein the deployment system is configured to maintain a coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the anchor members (FIG 13). 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 Miller’s soft tissue anchor system to include a deployment system configured to simultaneously implant each of the anchor members in the heart tissue; wherein the deployment system comprises a plurality of wire guide members, wherein each wire guide member comprises a guide portion located at a distal end of the wire guide members and configured to engage a respective anchor member; and wherein the deployment system is configured to maintain a coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the anchor members, as taught by Stone, in order to effectively secure the anchors during implantation ([0086]).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO2011148374A2) in view of Sugimoto (WO2007005394A1).
With regards to claim 11, Miller discloses the soft tissue anchor system as claimed in claim 1, but fails to disclose a U-shaped fabric body comprising a base portion and at least two arm portions extending from the base portion; wherein each arm portion is configured to collapse in folds towards the base portion such that, in use, the body tissue is sandwiched between the base portion and each of the arm portions; wherein each arm portion is an anchor member.
Sugimoto discloses a soft tissue anchor system (10, FIG 2D) with arm portions (14a-c) and a bridle line (12a). Sugimoto teaches a U-shaped fabric body (FIG 2D, [0010]) comprising a base portion and at least two arm portions extending from the base portion (see annotated FIG 2D); wherein each arm portion is configured to collapse in folds towards the base portion (FIG 2D) such that, in use, the body tissue is sandwiched between the base portion and each of the arm portions (FIG 2E); wherein each arm portion is an anchor member (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 Miller’s soft tissue anchor system to include a U-shaped fabric body comprising a base portion and at least two arm portions extending from the base portion; wherein each arm portion is configured to collapse in folds towards the base portion such that, in use, the body tissue is sandwiched between the base portion and each of the arm portions; wherein each arm portion is an anchor member, as taught by Sugimoto, in order to be able to compress the tissue, as well as adjust to the thickness of the tissue being anchored ([0005]).
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With regards to claim 12, Miller as modified by Sugimoto discloses the soft tissue anchor system as claimed in claim 11, wherein a bridle line (12a) is threaded through the arm portions and the base portion (FIG 1); wherein the bridle line is configured to collapse each arm portion in folds towards the base portion when a tensile force is applied to the bridle line (FIG 2B).
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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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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