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 .
Response to Arguments
Applicant argues in the response filed 12/17/2025 that the claim amendments would overcome the claim objections and 112 rejections. The objections and 112 rejections have been withdrawn. Of Note: the amendments to the independent claims have changed the scope of the claims and therefore interpretation. The scope/interpretation of claim 20 has been amended/changed, see interpretation below.
The applicant argues prior art Zajac and Stone do not disclose the new amendments with respect to a portion of the hollow braid wraps arounds (or encircles) a portion of the outer wall of the suture anchor, where the shuttle is capable of being positioned within and move a portion of the second suture into the portion of the hollow braid that wraps (encircles) the outer wall of the suture anchor. The applicant further argues teaching references Marchand, Sengun, and Rodriguez as cited do not remedy the deficiencies of Zajac and Stone. However, the examiner maintains that Rodriguez does teach embodiments of a suture wrapping around or encircling a portion of the suture anchor in at least figures 7, 8, 18b,d.
New rejections with respect to Stone in view of Rodriguez (and Zajac) have been made below. Further amendments with respect to the different configurations of the device with respect to when/how/what configuration the device will be in when the shuttle pulls the second suture through the hollow braid of the first suture which is wrapped around suture anchor as it is delivered/deployed/anchored are recommended by the examiner.
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.
Claims 1, 2, 5-13, 15, 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0144338 to Stone in view of U.S. Patent Publication 2013/0096612 to Zajac and U.S. Patent Publication 2015/0173739 to Rodriguez.
As to claim 1, Stone discloses a device for securing soft tissue to bone (paragraph 6), comprising: a suture anchor (30, figure 2) capable of being positioned within a bone hole, the suture anchor including a first end (figure 1a,c), a second end (figure 1a,c), an outer wall (figure 1a,c) extending along a length between the first end and the second end (figure 1a,c), and a hollow interior (paragraph 48, the inner lumen of the tube) extending along at least a portion of the length; a first suture (12) including a first end portion (figure 1a,c), a second end portion (figure 1a,c), and a hollow braid (paragraph 46, the entire suture can be hollow), the first suture passing through the outer wall of the suture anchor at least once (figure 1a,c), wherein at least a portion of the first suture is positioned within at least a portion of the hollow interior of the suture anchor (figure 1a,c); a second suture (14) including a first end portion (50) and a second end portion (52), one of the first or second end portions of the second suture coupled to the first suture (figure 1a, 4), but is silent about at least a portion of the hollow braid wraps around at least a portion of the outer wall of the suture anchor, a shuttle and a suture-engaging structure, the shuttle capable of being positioned within at least a portion of the hollow braid of the first suture wrapping around the at least a portion of the outer wall suture anchor, the other of the first or second end portions of the second suture capable of being coupled to the suture-engaging structure, wherein the shuttle is capable of being actuated to move the other of the first or second end portions of the second suture into the hollow braid of the first suture wrapping around at least a portion of the outer wall of the suture anchor. However, the second suture is shuttled into the first suture as seen in figure 1a.
Rodriguez teaches a similar device (tissue repair, abstract) having a portion of the first suture wrapping around at least a portion of an outer wall of a suture anchor (figure 7, 8, 18b,d, paragraph 72, 73, 87, 90) for the purpose of aiding in the expansion of the anchor when deployed to help secure the anchor into bone. Rodriguez teaches that the suture can snake, extend circumferentially across, and/or create a loop around the anchor which can control how the anchor will expand when deployed into bone. The first suture of Stone can similarly wrap around the suture anchor. Since the first suture is hollow, a portion of the hollow braid will therefore wrap around at least a portion of the outer wall of the suture anchor. It would have been obvious to one of ordinary skill in the art before the effective filing date to have at least a portion of the hollow braid of the first suture of Stone wrap around at least a portion of the outer wall of the suture anchor as taught by Rodriguez in order for helping to transform and secure the anchor into bone as desired.
Zajac teaches a similar device (repair systems, abstract) having a shuttle (4) and a suture-engaging structure (4a), the shuttle capable of being positioned within at least a portion of the hollow braid of the first suture, which will be wrapped around at least portion of the outer wall of the suture anchor (as taught by Rodriguez), the other of the first or second end portions of the second suture capable of being coupled to the suture engaging structure (figure 5,6), wherein the shuttle is capable of being actuated to move the other of the first or second end portions of the second suture into the at least a portion of the hollow braid of the first suture (figure 5,6, paragraph 29, 33) which will be wrapped around at least portion of the outer wall of the suture anchor (as taught by Rodriguez) for the purpose of helping to passing a first suture through a second suture. Rodriquez also teaches a shuttle and a suture-engaging structure (90, figure 8) can be positioned within the first suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the shuttle of Zajac with the device of Stone in order for aiding in passing a second suture through a first suture.
As to claim 2, Stone as modified by Rodriguez and Zajac discloses when the shuttle is positioned within at least the portion of the hollow braid of the first suture, the portion of the hollow braid of the first suture is positioned outside of the hollow interior of the suture anchor. The portion of the hollow braid that wraps around the suture anchor, as taught by Rodriguez (figure 7, 8, 18b,d) and that can have a shuttle placed therethrough, is positioned outside of the hollow interior of the suture anchor.
As to claim 5, with the device of Stone, Rodriguez, and Zajac above, Stone discloses the one of the first or second end portions of the second suture is coupled to one of the first or second end portions of the first suture by an opposing end to end tuck splice (figure 1a). The specification does not have a definition of an “end-to-end tuck splice”. Therefore the coupling will be interpreted broadly. The end suture second is coupled to the first suture, the second suture does have a splice, as well as an end of the suture that is tucked. There are two ends that are coupled. Therefore the coupling and structure of the first and second sutures as seen in figure 1a of Stone will be able to read on the “end-to-end tuck splice”.
As to claim 6, with the device of Stone, Rodriguez, and Zajac above, Stone discloses the one of the first or second end portions of the second suture is coupled to one of the first or second end portions of the first suture by opposing finger trap structures (figure 1a). The structure of 22/28 as well as 56 can seem to read on a finger trap and they are opposing sides of the suture. Therefore Stone will be able to read on the opposing finger trap coupling structure.
As to claim 7, Stone as modified by Rodriguez and discloses at least portions of the first suture are positioned outside of the hollow interior of the suture anchor (figure 1a of Stone), and the shuttle is positioned within the at least two portions of the first suture outside of the hollow interior of the suture anchor (figure 1a and figures 7, 8, 18b,d of Rodriguez), wherein the shuttle is capable of being actuated to move the other of the first or second end portions of the secure suture into the hollow braid of the least two portions of the first suture positioned outside of the hollow interior of the suture anchor (figure 1a). The shuttle as taught by Zajac will move the portions of the second suture within the first suture outside of the anchor as taught by Rodriguez.
As to claim 8, with the device of Stone, Rodriguez, and Zajac above, Stone discloses none of the second suture is positioned within the hollow interior of the suture anchor (figure 1a). In the configuration as seen in figure 1a, none of the second suture is positioned within the hollow interior of the suture anchor.
As to claim 9, with the device of Stone, Rodriguez and Zajac above, Stone discloses the one the first or second end portions of the secured suture is coupled to the first suture without passing through the hollow braid of the first suture (figure 4). The portion 50 is coupled to the first suture without passing through the first suture.
As to claim 10, Stone discloses a device for securing soft tissue to bone (paragraph 6), comprising: a suture anchor (30, figure 2) capable of being positioned within a bone hole, the suture anchor including a first end (figure 1a,c), a second end (figure 1a,c), an outer wall (figure 1a,c) extending along a length between the first end and the second end (figure 1a,c), and a hollow interior (paragraph 48, the inner lumen of the tube) extending along at least a portion of the length; a first suture (12) including a first end portion (figure 1a,c), a second end portion (figure 1a,c), and a hollow braid (paragraph 46, the suture can be hollow), the first suture passing through the outer wall of the suture anchor at least once (figure 1a,c), wherein at least a portion of the first suture is positioned within at least a portion of the hollow interior of the suture anchor (figure 1a,c); a second suture (14) including a first end portion (50) and a second end portion (52), one of the first or second end portions of the second suture coupled to the first suture (figure 1a, 4), but is silent about another portion of the first suture encircling the suture anchor circumferentially around the outer wall at least one half of a complete rotation and a shuttle and a suture-engaging structure, the shuttle capable of being positioned within at least a portion of the hollow braid of the first suture the other of the first or second end portions of the second suture capable of being coupled to the suture engaging structure, wherein the shuttle is capable of being actuated to move the other of the first or second end portions of the second suture into the hollow braid of the first suture. However, the second suture is shuttled into the first suture as seen in figure 1a.
Rodriguez teaches a similar device (tissue repair, abstract) having a portion of the first suture encircling the suture anchor circumferentially around the outer wall at least one half of a complete rotation (figure 7, 8, 18b,d, paragraph 72, 73, 87, 90) for the purpose of aiding in the expansion of the anchor when deployed to help secure the anchor into bone. Rodriguez teaches that the suture can snake, extend circumferentially across, and/or create a loop around the anchor which can control how the anchor will expand when deployed into bone. This configuration can read on encircling the suture anchor at least one half of a rotation. The first suture of Stone can similarly encircle around the suture anchor. Since the first suture is hollow, a portion of the hollow braid will therefore encircle around at least a portion of the outer wall of the suture anchor. It would have been obvious to one of ordinary skill in the art before the effective filing date to have another portion of the first suture of Stone encircle the suture anchor circumferentially around the outer wall at least one half of a complete rotation as taught by Rodriguez in order for helping to transform and secure the anchor into bone as desired.
Zajac teaches a similar device (repair systems, abstract) having a shuttle (4) and a suture-engaging structure (4a), the shuttle capable of being positioned within at least a portion of the hollow braid encircling the suture anchor (as taught by Rodriguez) and, the other of the first or second end portions of the second suture capable of being coupled to the suture engaging structure (figure 5,6), wherein the shuttle is capable of being actuated to move the other of the first or second end portions of the second suture into the at least a portion hollow braid of the first suture (figure 5,6, paragraph 29, 33) which will be encircling the suture anchor (as taught by Rodriguez) for the purpose of helping to passing a first suture through a second suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the shuttle of Zajac with the device of Stone and Rodriguez in order for aiding in passing a first suture through a second suture.
As to claim 11, with the device of Stone, Rodriguez, and Zajac above, Rodriguez further teaches a first portion of the first suture and a second portion of the first suture extend from an end portion of the first suture, the first portion encircling the suture anchor circumferentially around the outer wall at least one half of a complete rotation and the second portion passing through the outer wall of the suture anchor at least twice (figure 7, 18b,d).
As to claim 12, with the device of Stone, Rodriguez, and Zajac above, Rodriguez further teaches the end portion of the first suture is partially disposed within the hollow interior of the suture anchor (figure 7, 18b,d).
As to claim 13, with the device of Stone, Rodriguez, and Zajac above, Rodriguez further teaches the end portion of the first suture includes a loop (figure 7, 18b,d). Each of the end portions have a loop formation. The loop may not be a closed loop, but there is a curvature of the suture which can read on a loop.
As to claim 15, with the device of Stone, Rodriguez, and Zajac above, Rodriguez further teaches the first portion of the first suture passes in between the second portion of the first suture and the outer wall of the suture anchor at least once (figure 7, 18b,d).
As to claim 16, with the device of Stone, Rodriguez, and Zajac above, Rodriguez further teaches at least two portions of the second portion of the first suture are positioned outside of the hollow interior of the suture anchor, and a second shuttle (94, figure 9), includes a length and a second suture-engaging structure (the loop of 94), is positioned within the at least two portions of the second portions of the first suture positioned outside of the hollow interior of the suture anchor (figure 9), wherein the second shuttle is capable of being actuated to move the other of the first or second end portions of the second suture, capable of being coupled to the suture engaging structure, into the hollow braid of the first suture positioned outside of the hollow interior of the suture anchor (figure 9) for the purpose of using a second snare that can help connect to the suture and anchor portions of the device. Rodriguez does disclose a first and second shuttle 90,94. The second shuttle will be capable, or structured to engage portions of the second suture as claimed. The shuttle is used to shuttle one suture into another suture. Therefore, second shuttle can be actuated and moved any suture portion into any hollow braid of another suture portions and therefore be able to read on the claim limitation. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the second shuttle of Rodriguez in the device of Stone, Rodriguez in order for using a second snare that can help connect to the suture and anchor portions of the device.
Claims 3, 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0144338 to Stone in view of U.S. Patent Publication 2013/0096612 to Zajac and U.S. Patent Publication 2015/0173739 to Rodriguez as applied to claims 1, 2, 5-13, 15, 16 above, and further in view of U.S. Patent Publication 2013/0131722 to Marchand.
As to claim 3, 17, Stone as modified by Rodriguez and Zajac discloses the device above but is silent about the first suture is a cylindrical length of suture and the second suture is a flat length of suture.
Marchand teaches a similar device (fixation device, abstract) where a suture can be a cylindrical length of suture and the second suture is a flat length of suture (paragraph 42) for the purpose of using constructing the suture by known means. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the first suture of Stone, Rodriguez, and Zajac be a cylindrical length of suture and the second suture of Stone, Rodriguez, and Zajac be a flat length of suture in order for using constructing the suture by known means.
Claims 4, 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0144338 to Stone in view of U.S. Patent Publication 2013/0096612 to Zajac and U.S. Patent Publication 2015/0173739 to Rodriguez as applied to claims 1, 2, 5-13, 15, 16 above, and further in view of U.S. Patent Publication 2006/0259076 to Burkhart.
As to claim 4, 14, Stone as modified by Rodriguez and Zajac discloses the device above but is silent about the of the first or second end portions of the second suture is coupled to one of the first or second end portions of the first suture by a chain-link structure.
Burkhart teaches a similar device (suture application) where a portion of suture are coupled to another portion by a chain link structure (paragraph 7, 48-53, 57 figure 10) for the purpose of using a secure coupling which can increase the footprint of the repair. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the chain link constructure in the device Stone, Rodriguez, and Zajac in order for using a secure coupling which can increase the footprint of the repair.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0144338 to Stone in view of U.S. Patent Publication 2015/0173739 to Rodriguez.
As to claim 18, Stone discloses a device securing soft tissue to bone (paragraph 6) comprising: a suture anchor (30) capable of being positioned within a bone hole (figure 2), the suture anchor including a first end (figure 1a), a second end (figure 1a,c), an outer wall (figure 1a) extending along a length between the first end and the second end, and a hollow interior (paragraph 48, the inner lumen of the tube) extending along at least a portion of the length; a first suture (12, paragraph 46) including a hollow braid, the first suture passing through the outer wall of the suture anchor at least once and the first suture including an internally disposed portion positioned within the hollow interior of the suture anchor (figure 8c); and a second suture (14) having a body extending from a first end portion to a second end portion (figure 1a), at least part of the first end portion being coupled to the first suture and at least part of the body passing internally through the at least a portion of hollow braid of the first suture (figure 1a), the second suture being entirely external to the suture anchor (figure 1a) but is silent about a portion of the hollow braid wraps around at least a portion of the outer wall of the suture anchor and the body of the second suture passing through the at least a portion of the hollow braid wrapping around the at least portion of the outer wall of the suture anchor.
Rodriguez teaches a similar device (tissue repair, abstract) having a portion of the first suture wrapping around at least a portion of an outer wall of a suture anchor (figure 7, 8, 18b,d, paragraph 72, 73, 87, 90) for the purpose of aiding in the expansion of the anchor when deployed to help secure the anchor into bone. Rodriguez teaches that the suture can snake, extend circumferentially across, and/or create a loop around the anchor which can control how the anchor will expand when deployed into bone. The first suture of Stone can similarly wrap around the suture anchor. Since the first suture is hollow, a portion of the hollow braid will therefore wrap around at least a portion of the outer wall of the suture anchor. Rodriguez does teach that a portion of the suture can be passed through the portion of the suture that is wrapped around the suture anchor (figure 8). Therefore the second suture of Stone can be pulled to be placed through the portion of the hollow braid that is wrapped around the outer wall of the suture anchor. It would have been obvious to one of ordinary skill in the art before the effective filing date to have at least a portion of the hollow braid of the first suture of Stone wrap around at least a portion of the outer wall of the suture anchor as taught by Rodriguez, where the body of the second suture can be passed internally through the portion of the hollow braid wrapping around a portion of the outer wall of the suture anchor in order for helping to transform and secure the anchor into bone as desired.
As to claim 19, with the device of Stone and Rodriguez above, Rodriguez further teaches a similar device the hollow braid includes an exteriorly disposed portion that encircles the suture anchor circumferentially around the outer wall at least one half of a complete rotation, the at least part of the body of the second suture (of Stone) passing through internally through the hollow braid of the first suture in the exteriorly disposed portion (figure 7, 8, 18b,d, paragraph 72, 73, 87, 90).
As to claim 20, the device of Stone and Rodriguez discloses the first suture comprises an exteriorly disposed portion and a snail portion on opposite sides of the internally disposed portion, the snail portion having a first sub-portion external to the outer wall and a second sub-portion internal to the outer wall (figure 1 of a of Stone, figure 7, 8, 18b,d of Rodriguez). The claim does not state the specific structure of the snail portion, or the function/structure of the other portions. Further the application does not have a specific definition of a “snail portion”. The first suture of Stone as modified by Rodriguez does seem to extend into, out of, and around the suture anchor with different portions that are exteriorly disposed and internally disposed as necessitated by the amended claim 18 limitation and interpretations. Therefore, the suture can have different portions spaced appropriately to read on the portions of claim 20.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771