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 § 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) 21-22, 25, and 30-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Norton et al. (US 2012/0059417) in view of Rushdy et al. (US 2012/0265219).
Regarding claim 21, Norton discloses a method of securing soft tissue to bone (see figs. 23-33b), comprising: delivering a distal end of an access cannula (120) to a treatment site through a skin layer of a patient (fig. 23); anchoring an adjustable suture construct (see [0078] – suture construction may be as shown in figs. 1a or 1b, which appears to be a typographical error that should read figures 2a or 2b, as there is only a fig. 1) at the treatment site, the adjustable suture construct including a first suture with a first free end (either end 146) that extends longitudinally through a first longitudinal passage (148, which appears to correspond to 28/30 in figs. 2a, 2b) in the first suture to form a first self-locking adjustable loop (46), the first free end pullable for reducing a size of the first self-locking adjustable loop, the adjustable suture construct further including a first flexible tail (104/122/124/150; fig. 21, noting reference number changes to 150 in figs. 30-33b) that is coupled to the first self-locking adjustable loop, wherein said anchoring leaves the pullable first free end of the first suture and a first tail end of the first flexible tail extending through the access cannula to a location outside the patient (figs. 24-28; [0075]), the first tail end additionally passing through a soft tissue (126) positioned over a bone at the treatment site (fig. 24; see also fig. 29, noting access cannula 120 is not shown in fig. 29, but tail remains outside of cannula similar to configuration shown in figs. 27, 28 in order to pull 104/122/124/150 through soft tissue from its configuration in fig. 29 to its configuration in fig. 30 as understood by one of ordinary skill in the art).
Norton makes obvious repeating the procedure above with multiple suture constructs disposed within the bone and soft tissue in order to connect the soft tissue to the bone at multiple locations ([0096]), thus strengthening the securement between the soft tissue and the bone. However, Norton does not expressly disclose the additional steps of threading, after said anchoring, the first tail end through a first piece of a flat material outside the patient; and advancing the first piece of the flat material through the access cannula to the treatment site along the first flexible tail.
Rushdy discloses another method of securing soft tissue to bone, and further discloses the step of threading a first end of suture through a first piece of a flat material (4) (see fig. 7, 11-13) and advancing the first piece of flat material through an access cannula (noting 106 in fig. 6 represents an arthroscopic access port or cannula; [0053]) to a treatment site along the first end of the suture, such that the flat piece of material is secured between the soft tissue (20) and a portion of the suture that has been passed through the flat piece of material. Rushdy discloses that such a step facilitates load sharing between the suture assembly and the first piece of flat material by allowing the flat material to absorb the load applied across the soft tissue ([0065]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Norton to thread a free end portion of the suture assembly through a first piece of flat material outside the patient and advance the first piece of flat material through the access cannula to the treatment site along the portion of the suture assembly as taught by Rushdy in order to facilitate load sharing between the suture assembly and the flat material. In order to allow the piece of flat material to be placed over the soft tissue on a side opposite the bone as taught by Rushdy, one skilled in the art would have found it obvious to thread the first tail end (end of 104/122/124/150) of Norton through the first piece of flat material as this represents the easily accessible free end of the portion of the suture construct that is positioned over the soft tissue opposite the bone (see fig. 30; noting free end of 104/122/124 extends outside of cannula 102 as better shown in figs. 26-28) and will result in the piece of flat material being positioned between the soft tissue and the portion of suture secured over the soft tissue opposite the bone (secured by collapsed tail 124/150; see fig. 31 of Norton) as taught by Rushdy.
Regarding claim 22, said anchoring includes anchoring the adjustable suture construct with an anchoring member (102) positioned at least partly inside a bone hole at the treatment site (see fig. 28,29 of Norton).
Regarding claim 25, the anchoring leaves at least part of the adjustable suture construct inside a bone hole at the treatment site (see fig. 29 of Norton).
Regarding claim 30, the first piece of the flat material taught by Rushdy comprises a strip of material (noting that the flat material disclosed by Rushdy is considered a long, thin piece of material).
Regarding claim 31, the first piece of the flat material comprises a braided material ([0052] of Rushdy).
Regarding claim 32, the method further comprising pulling on the first free end of the first suture as the first free end is extending through the access cannula to reduce a size of the first self-locking adjustable loop (figs. 30-31 of Norton; [0079]).
Regarding claim 33, Norton makes obvious pulling on the first tail end of the first flexible tail as the first tail end is extending through the access cannula to increase a size of the first self-locking adjustable loop. In particular, the first self-locking adjustable loop expands in size from fig. 29 to fig 30 as the tail is advanced through the soft tissue, and one skilled in the art would have found pulling on the first tail end of the first flexible tail, which extends out the proximal end of the cannula as best shown in fig. 28, to advance the entire first tail through soft tissue 126 from the position shown in fig. 29 to the position shown in fig. 30 obvious.
Regarding claim 34, the method further comprising positioning the first piece of the flat material against the soft tissue at the treatment site as taught by Rushdy (see figs. 9-13 of Rushdy).
Regarding claim 35, the method further comprising pulling on the first free end of the first suture to tension the first piece of the flat material over the soft tissue. In particular, the flat material is placed over the first tail and advanced until it is against the soft tissue as made obvious by Rushdy, and thus pulling on the first free end of the first suture to tension the portion of the first suture that extends over the soft tissue (from figs. 30-31 of Norton) will also tension the first piece of flat material (disposed between 124/150 and the soft tissue) over the soft tissue.
Regarding claim 36, the first piece of the flat material is effective to dissipate a load applied to the soft tissue from said pulling (by load sharing as disclosed by Rushdy; [0052]).
Regarding claims 37 and 38, it would have been obvious to advance the first piece of the flat material along the first flexible tail until the entirety of the first flexible tail has passed through the first piece of flat material and a portion of the first self-locking adjustable loop to which the first flexible tail is coupled passes through the first piece of the flat material in the method of Norton as modified by Rushdy so that, in view of the positioning of the first flexible tail and first self-locking adjustable loop shown in fig. 30, 31 of Norton, the flat material will be placed between the soft tissue and the portion of the suture positioned above the soft tissue to dissipate the load over the soft tissue.
Regarding claim 39, the first flexible tail (104/122/124/150) comprises a hollow core suture (see fig. 21, 31 of Norton; noting suture 103 passes through core of tail).
Regarding claim 40, the first flexible tail being coupled to the first self-locking adjustable loop includes suture (102) of the first self-locking adjustable loop extending longitudinally through an interior of the hollow core suture (see fig. 21 of Norton).
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Norton in view of Rushdy as applied to claim 21 above and further in view of Kaiser et al. (US 2011/0098727). Norton in view of Rushdy discloses the invention substantially except for the anchoring member being a soft, flexible tubular anchor.
Kaiser teaches another suture assembly used to secure soft tissue to bone, wherein the anchoring member (150) placed in a hole in the bone comprises a soft, flexible tubular anchor through which the suture construct of the suture assembly passes (see fig. 5, 11,22). It would have been obvious to one ordinary skill in the art to have further modified the prior art of Norton to replace the anchoring member disclosed by Norton with a soft, flexible tubular anchor as taught by Kaiser as such a modification can be considered a simple substitution of one known anchoring member for anchoring suture within bone for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Norton in view of Rushdy as applied to claim 21 above and further in view of Trenhaile (US 2009/0156997). Norton in view of Rushdy discloses the invention substantially as stated above including advancing the first piece of flat material through the access cannula to the treatment site, but fails to expressly disclose that said advancing includes pushing the first piece of the flat material through the access cannula with a pusher device.
Trenhaile teaches that it is known to use a pusher (knot pusher; [0028]) to push a piece of flat material (graft patch) through an arthroscopic cannula to a treatment site. It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Norton in view of Rushdy to advance the first piece of flat material through the cannula using a pusher device as taught by Trenhaile since the pusher can be easily manipulated from outside the cannula as understood by one of ordinary skill in the art and obviates the need for the surgeon to use his fingers to try to push the flat material through the entire length of the cannula.
Allowable Subject Matter
Claims 26-28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claims 26-28, the closest prior art of Norton in view of Rushdy fails to disclose, or fairly suggest, in combination with the limitations of claim 21, the adjustable suture construct additionally including a second flexible tail coupled thereto, and wherein said anchoring additionally leaves a second tail end of the second flexible tail extending through the access cannula to the location outside the patient.
Conclusion
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KSH 7/16/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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