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 .
Claim Objections
Claim 1 is objected to because of the following informalities: lines 6- 7- “the shuttle tail exists the body from an exit splice location” should be amended to - - the shuttle tail exists the body from an exit splice location - - the shuttle tail exits the body from an exit splice location - - to correct an apparent typographical error. Appropriate correction is required.
Claims 2- 13 are objected to because they depend off claim 1.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodriguez et al. (US Pub. No, 2015/0173739 A1).
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Regarding claim 1, Rodriguez discloses a system for securing an amount of tissue to a bone, comprising:
a suture construct formed by a fixation limb having a body (10) (Figs. 1- 6) with a first end (12) (Figs. 1- 6) and a second end (14) (Figs. 1- 6), a loop (L) (See Annotated Fig. 3) formed at the first end (12) of the body (10), and a tail (T) (See Annotated Fig. 3) extending from the loop (L) through the body (32) (Figs. 2- 6); and
a suture shuttle (30) (Fig. 2) having a shuttle loop (SL) (See Annotated Fig. 2) and a shuttle tail (ST) (See Annotated Fig. 2) extending into and through the body of the fixation limb (32) so that the shuttle loop (30) is positioned proximately to the loop and the shuttle tail (ST) exists the body (32) from an exit splice location (ESL) (See Annotated Fig. 2) (P. [0065] - - The first suture end 12, which has been passed or looped around the tissue, is placed within snare 30, so that the snare may draw the first suture end between the suture braids and into the lumen of the length of suture. The first suture end 12 may be drawn along the suture lumen in a direction away from the second suture end 14 before exiting the suture lumen a short distance later. As will be described further herein, the region 32 along the suture length creates a binding interface, suture cradle, or first friction lock region when actuated; it is noted that as the first suture end 12 is drawn into and out of region 32, the snare 30 exits the region 32 from an exit splice location (ESL) as shown in Annotated Fig. 2).
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(s) 2- 3 and 8- 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al. (US Pub. No. 2015/0173739 A1).
Regarding claim 2, Rodriguez discloses the system of claim 1, Rodriguez further disclosing that the embodiment in Figs. 1- 6 illustrates the formation of suture locking regions and, for ease of understanding, an anchoring implant is not shown in Figs. 1- 6 (P. [0061]). Rodriguez further discloses that it is to be understood that the anchoring assemblies may vary greatly and use alternate textiles and materials such as the hard anchor assembly 300 in combination with suture lock mechanism(s) described in Figs. 1- 6, along at least one of the sidewalls of the anchor (P. [0106]), Rodriguez teaching
(claim 2) further comprising a hard body anchor (300) (Fig. 21) coupled to the suture construct (302, 304) (Fig. 21) (Ps. [0106], [0107] - - FIG. 21, for example, shows a hard anchor assembly 300 in combination with suture lock mechanism(s) along at least one of the sidewalls of the anchor. One or more sutures 302 may be deployed about the anchor 300 in a path as shown in FIG. 21. Threading the suture along the path may be carried out with snares as described herein and as shown and described in FIGS. 1-6, for example; A wide variety of anchor shapes may be used in combination with the suture-locking mechanisms described herein. For example, as shown in FIG. 21, the anchor may include barbs or other bone locking features 308 to hold the anchor securely in the bone. Additionally, the suture may be looped around or threaded about protrusions, eyelets or other features 312, 314 present in the anchor to control the suture path, and bolster the desired tissue approximation. Suture ends 322, 324 may be pulled to approximate tissue 320 after the anchor is deployed in the bone tunnel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the suture-locking system of claim 1 to include a hard body anchor as taught by the embodiment of Fig. 21 because Rodriguez contemplated the suture-locking mechanism of claim 1 being used with a hard body anchor in order to approximate tissue to bone to be securely held in place using the hard body anchor (Ps. [0061], [0106], [0107]).
Regarding claim 3, Rodriguez discloses the system of claim 2, Rodriguez further disclosing where the hard body anchor (300) is coupled to the suture construct (302, 304) by the loop and an eyelet (312, 314) (Fig. 21) of the hard body anchor (300) (See Fig. 21 - - showing loops disposed in eyelets 312, 314) (P. [0107] - - A wide variety of anchor shapes may be used in combination with the suture-locking mechanisms described herein … the suture may be looped around or threaded about protrusions, eyelets or other features 312, 314 present in the anchor to control the suture path, and bolster the desired tissue approximation).
Regarding claim 8, Rodriguez discloses the system of claim 1, Rodriguez further disclosing that the embodiment in Figs. 1- 6 illustrates the formation of suture locking regions and, for ease of understanding, an anchoring implant is not shown in Figs. 1- 6 (P. [0061]). Rodriguez further discloses that it is to be understood that the anchoring assemblies may vary greatly and use alternate textiles and materials (P. [0106]), moreover, Rodriguez discloses that the embodiment of FIGS. 7-14 illustrates a soft anchoring implant, and formation of a plurality of suture locking regions along a length of suture for knotless reattachment of tissue to bone (P. [0069])
(claim 8) further comprising an all suture anchor (70) (Figs. 7- 17) coupled to the suture construct (82, 84) (Figs. 7- 17) (Ps. [0060], [0073], [0083] - - A suture anchoring implant for securing soft tissue to bone, or tissue to tissue is described herein. In embodiments, the anchor is a soft all suture implant; With reference again to FIG. 7, and prior to inserting the anchoring implant 70 into the bone tunnel, a length of suture is threaded through the anchoring implant, using a snare as mentioned herein; FIGS. 15-17 show approximation of the tissue 102 to the bone 112. The surgeon may pull on the first suture end 82 to further reduce the loop 104 to a smaller loop 104', and yet smaller loop 104'' corresponding to FIGS. 16 and 17 respectively. The surgeon may further pull on the first suture end 82 until a desired tension force T1 of the tissue 102 to the anchoring implant and bone is created).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the suture-locking system of claim 1 to include an all suture anchor as taught by the embodiment of Figs. 7- 17 because Rodriguez contemplated the suture-locking mechanism of claim 1 being used with anchoring assemblies that may vary greatly and use alternate textiles and materials, including an all suture anchor to approximate tissue to bone and create sufficient tension to the anchoring implant and bone (Ps. [0060], [0083], [0106]).
Regarding claim 9, Rodriguez discloses the system of claim 8, Rodriguez further disclosing wherein the all suture anchor (70) includes a suture body that is configured to be compacted from an extended configuration (Fig. 13) to a compressed configuration (Figs. 14, 15) (P. [0081], [0082] - - FIG. 13 shows inserting the loaded implant 70 into a hole 110 within a bone 112; FIG. 14 shows deploying the anchor by pulling first and second suture ends 82, 84 with force (F2) … As shown, the anchor implant expands to a second deployed configuration 70' underneath the cortical layer of the bone, creating a bone lock).
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Regarding claim 10, Rodriguez discloses the system of claim 9, Rodriguez further disclosing wherein the suture construct (82, 84) and the suture shuttle (90, 94) (Figs. 8- 11) is woven through the suture body (86, 96) (Figs. 8- 12) of the all suture anchor (70) (P. [0076] - - FIG. 8 shows a first snare 90 extending (or drawn) through the lumen of the suture locking region 86 of suture that is interwoven within the implant wall) so that the loop (L1) (See Annotated Fig. 11) of the suture construct (82, 84) is positioned at a first end of the suture body (E1) (See Annotated Fig. 11 - - above the dashed line) and the tail of the suture construct (T1) (See Annotated Fig. 11) is positioned at a second end of the suture body (E2) (See Annotated Fig. 11 - - below the dashed line).
Regarding claim 11, Rodriguez discloses the system of claim 10, Rodriguez further disclosing wherein the shuttle tail (ST1) (See Annotated Fig. 11) extends through the loop of the suture construct (L1) (See Annotated Fig. 11).
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Regarding claim 12, Rodriguez discloses the system of claim 11, Rodriguez further disclosing wherein the tail of the suture construct (T1) and the shuttle tail (ST1) extend through the loop of the suture construct (L1) (See Annotated Fig. 10 and Annotated Fig. 12; it is noted that during the formation of the suture-locking mechanisms, there is a configuration wherein each of the tail of the suture construct (T1) and the shuttle tail (ST1) extend through the loop of the suture construct (L1) as shown in the annotated figures).
Regarding claim 13, Rodriguez discloses the system of claim 12, Rodriguez further disclosing wherein all of the tail of the suture construct (T1), the shuttle loop (SL1), and the shuttle tail (ST1) extend through the loop of the suture construct (L1) (See Annotated Fig. 10 and Annotated Fig. 12; it is noted that since the loop portion indicated with the reference number 90 in Fig. 10 wraps around the suture construct portion indicated with reference number 82 in Fig. 10, some of loop portion 90 lies within the inside perimeter of the loop of the suture construct (L1) as shown in Annotated Fig. 10; additionally, as noted in the rejection of claim 12 above, during the formation of the suture-locking mechanisms, there is a configuration wherein each of the tail of the suture construct (T1) and the shuttle tail (ST1) extend through the loop of the suture construct (L1) as shown in the annotated figures).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al. (US Pub. No, 2015/0173739 A1) in view of Widmer (US Pub. No. 2016/0331366 A1).
Regarding claim 4, Rodriguez discloses the system of claim 3, Rodriguez further disclosing suture construct first and second ends (322, 324) being pulled to approximate tissue 320 as shown in Fig. 21. Rodriguez also discloses a knot 98 (Fig. 12) may be placed in order to maintain the suture locking mechanism inside the anchor implant and bone tunnel, but Rodriguez does not explicitly disclose
(claim 4) wherein the loop is formed into a luggage tag knot with the eyelet.
However, Widmer teaches a system for securing an amount of tissue to bone in the same field of endeavor (P. [0025])
(claim 4) wherein the loop (32) (Figs. 1A, 1B) is formed into a luggage tag knot with the eyelet (12) (Figs. 1A- 1C) (P. [0025] - - FIGS. 1A-1C illustrate a typical assembly and method for attaching a target tissue to bone. As shown in FIG. 1A, an anchor 10 is placed into bone surface 20 and a suture line 30 is passed through an eyelet 12 of the anchor 10. The suture line 30 is then passed through the target tissue 40. The resulting configuration consists of a looped portion 32 extending from a first side of the anchor 10 and an outer side 42 of the target tissue 40 and two free ends or tails 34 and 36 extending from a second side of the anchor 10 opposite the target tissue 40. A first tail 34 remains disposed through the eyelet 12 of the anchor 10 while a second tail 36 is free of any engagement with the anchor 10. From this configuration, a surgeon or operator may form a Rogozinski knot or other knot by forming a lark's head (i.e., a pair of adjacent loops) in the loop portion 32 of the suture line 30 and then passing the two tails 34 and 36 through the lark's head, as shown in FIG. 1B, to form the knot and bring the tissue into position against the bone anchor (shown tightened in FIG. 1C; it is noted a lark’s head knot and luggage tag knot are equivalent structures, see P. [0036] of applicant’s Specification - - “a lark head knot (also known as a luggage tag knot)” ).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the suture construct first and second ends (322, 324) being pulled to approximate tissue 320 as shown in Fig. 21 to Rodriguez in order to form a lark’s head in the loop portion and then pass the suture construct first and second ends (322, 324) through the lark's head according to the teachings of Widmer because it would allow an operator to form the knot and bring the tissue into position against the bone anchor in a typical and predictable assembly and method for attaching a target tissue to bone (Widmer - - P. [0025]).
Claim(s) 5- 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al. (US Pub. No, 2015/0173739 A1) in view of Widmer (US Pub. No. 2016/0331366 A1) as applied to claim 4 above, and in further view of Hernandez et al. (US Pub. No. 2018/0042600 A1).
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Regarding claim 5 and claim 7, Rodriguez in view of Widmer disclose the system of claim 4.
(claim 7) Rodriguez further disclosing wherein the exit splice location (ESL2) (See Annotated Fig. 21) is positioned outside of the hard body anchor (300), but Rodriguez in view of Widmer does not disclose
(claim 5, claim 7) wherein the fixation limb of the suture construct extends through a longitudinal bore of the hard body anchor;
(claim 6) wherein the shuttle loop and shuttle tail extend through the longitudinal bore of the hard body anchor.
However, Hernandez discloses an adjustable anchor system provides for securing tissue to bone in the same field of endeavor (Abstract)
(claim 5, claim 7) wherein the fixation limb of the suture construct (204) (Figs. 9- 10, 12- 13C, 14- 15E) extends through a longitudinal bore (218) (Fig. 12) of the hard body anchor (212) (Figs. 10- 13H);
(claim 6) wherein the shuttle loop (234) (12, 13B- 13C ) and shuttle tail (232) (Fig. 12) extend through the longitudinal bore (218) of the hard body anchor (212) (Ps. [0016], [0065] - - In one aspect of the invention the method comprises the step of trapping a first portion of the tissue suture between the suture anchor and the bone. A second portion of the tissue suture, adjacent the first portion of the tissue suture, can be passed through an axial cannulation through the suture anchor prior to implanting the anchor into the bone. This aids in aligning the tissue suture along the suture anchor as it is implanted to better trap the tissue suture; An anchor system 230 comprises the suture anchor 210 with suture 200 rigged as illustrated in FIG. 10 and with a flexible wire suture capture device 232 having a suture capture loop 234 … threaded through the lumen 218 with the suture capture loop 234 distal of the anchor body 212. A separate length of tissue suture 236 is threaded through the loop 204).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the hard body anchor associated with Rodriguez in view of Widmer such that it includes a longitudinal bore of the hard body anchor through which the shuttle loop and shuttle tail extend and outside of which the exit splice location associated with Rodriguez is located according to the teachings of Hernandez because it would aid in aligning the tissue suture along the suture anchor as it is implanted to better trap the tissue suture (Hernandez - - P. [0016]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771