Prehirnary Amendment Dated: 2/28/2022
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`This listing of claims will replace all prior versions, andlistings, of claims in the application:
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`Listing of Clams:
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`1.
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`(Original) A decorticating screwdevice, comprising:
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`a substantially cylindrical body, the body having a distal threaded section,
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`a proximal threaded section, a central ring having one or more decorticating elements.
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`2.
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`(Original} The device of claim 1, wherein the screwdevice further
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`coniprises a lumen running between a proximal opening and a distal opening.
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`3.
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`(Original) Phe device of claim 2, wherein the screw device further
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`comprises a cap having a threaded lumen sizedto fit over the proximal threaded section of the
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`body and a proximal lip having a diameter greater than a diameter of the cap.
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`4.
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`(Original) The device of claim 3, wherein the central ring is
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`independently rotatable from the threaded distal section.
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`5.
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`(Original) The device of claim 4, wherein the screw device further
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`comprises one or more lateral openings fluidly connected to the lumen.
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`6.
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`(Original) The device of claim 1, wherein the screwdevice comprises one
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`or more cutting flutes at a distal end.
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`7.
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`(Original) The device of claim 1, wherein the screw device comprises one
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`or more pointed tips at a distal end.
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`3.
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`(Original) Phe device of claim 1, wherein the proximal threaded section
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`comprises a threading selected from the group consisting of: knuckle threads, trapezoidal
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`threads, square threads, and buttress threads.
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`Prehirnary Amendment Dated: 2/28/2022
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`9.
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`(Original) Phe device of claim 1, wherein the proximal threaded section
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`comprises a rounded or tapered proximal end.
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`10.
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`(Currently Amended) The device of claim 1, wherein the central ring is
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`attached to the proximal threaded section, such that the central ring and proximal threaded
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`section are independently rotatable from the threaded distal threaded section.
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`ll.
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`(Original) The device of claim 1, wherein the central ring is movable in
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`proximal and distal directions to increase the reach of the one or more decorticating elements.
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`12.
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`(Original) The device of claim 1, wherein the screw device comprises two
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`or more external slots formed between the distal threaded section, the central ring, and the one or
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`more decorticating elements, such that cach external slot is sized to receive a pin of a screw
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`driving device.
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`13.
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`(Original} The device of claim 1, wherein the one or more decorticating
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`elements each comprise one or more surface voids configured to accept graft material ortissue
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`ingrowth.
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`14.
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`(Currently Amended) The device of claim [[11]3, wherein the cap
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`comprises one or more surface voids configured to accept graft material or tissue ingrowth.
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`13.
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`(Currently Amended) The device of claim [[1]]3, wherein the cap
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`comprises a thread-locking insert positioned at a proximal end of the threaded himen.
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`16.
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`(Currently Amended} The device of claim [[1]]3, wherein the cap lip
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`comprises a distal-facing surface having a rounded convex shape.
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`17,
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`(Currently Amended) The device of claim [711]3, wherein the cap
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`comprises a locking nut in alignment with the threaded lumen ofthe cap, the locking nut being
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`connected to the cap by one or more connecting bridges configured to break with an application
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`of a torque on the locking nut.
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`Prehirnary Amendment Dated: 2/28/2022
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`18.
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`(Original) The device of claim 1, wherein the one or more decorticating
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`elements are moveable between a closed position and an open position.
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`19.
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`(Currently Amended) The device of claim 18, wherein the closed position
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`positions the decorticating elements adjacent to the central ring such that they have a diameter
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`substantially equal to a diameter of the distalthreaded distal-section, and wherein the open
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`position positions the decorticating elements away from the central ring such that the
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`decorticating elements extend beyond the diameter of the distal threaded distal-section.
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`20.
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`(Original) The device of claim 18, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is in parallel with a long
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`axis of the body and are laterally swung from the closed position to the open position.
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`24.
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`(Original} The device of claim 18, wherein the one or more decorticating
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`elements are hingedly connected to the central nog along an axis that is perpendicular to a long
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`axis of the body and splay outwards from the closed pasition to the open position.
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`22.
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`(Original) The device of claim 18, wherein the one or more decorticating
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`elements are flexible wire blades retracted into the central ring in a closed position and are
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`pushable outwards from the central ring to the open position.
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`23.
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`(Original} The device of claim 18, wherein the one or more decorticating
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`elements are sheathed within the central ring in a closed position and are slideable outwards from
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`the closed position to the open position.
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`24.
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`(Original) The device of claim 18, wherein the one or more decorticating
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`elements are at least partially phable and are bendable from a closed position to an open pasition.
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`25,
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` (Qnginal) The device of claim 18, wherein the one or more decorticating
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`elements comprises at least one serration.
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`(Currently Amended) The device of claim 1, wherein the proximal
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`threaded prommateal-section has adiameter that is less than a diameter of the distal threaded distal
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`26.
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`section.
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`Prehirnary Amendment Dated: 2/28/2022
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`27,
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`(Currently Amended) The device of claim [[1]]3. wherein the diameter of
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`the cap is substantially equal to a diameter of the threaded distal section.
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`28.
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`(Currently Amended) The device of claim [[1]]Z, further comprising a
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`lock screwhaving a diarneter larger than a diameter of the screwdevice lumen, the lock screw
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`being drivable into the proximal opening ofthe screw device to expand a proximal end ofthe
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`screwdevice.
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`29.
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`(Original) The device of claim 1, wherein the screw device has a length
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`between about 10 mm and about 150 mm.
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`30.
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`(Original) The device of claim 1, wherein the screw device has an outer
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`diameter between about 5 mm and about 50 mm.
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`34.
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`(Orginal) A method of fusing a jount between a first bone and a second
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`bone, comprising the steps of:
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`providing a decorticating screw having a threaded distal section, a
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`threaded proximal section, a rotatable central ring having one or more decorticating elements, a
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`lumen running between a proximal opening and a distal opening, and one or more lateral
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`openings fluidly connected to the lumen;
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`inserting the screwinto a joint in need of fixation, such that the distal
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`section is positioned in a first bone, the proximal section is positioned in a second bone, and the
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`central ring is positioned in a joint space between the first bone and the second bone;
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`rotating the certtral ring, such that the one or more decorticating elements
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`decorticate the joint space between the first bone and the second bone;
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`packing at least one graft material into the proximal opening ofthe screw,
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`such that the at least one graft material enters the hamen and exits the one or morelateral
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`openings of the screw;
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`placing a cap onto the proximal section of the screw; and
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`screwing a lock screwinto the proximal opening of the screw.
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`Prehirnary Amendment Dated: 2/28/2022
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`32.
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`(Original) The method of claim 31, wherein the graft material is selected
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`from the group consisting of: autclogous bone grafts, allogeneic bore grafts, xenogeneic bone
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`grafts, hydroxyapatite, calcium phosphate, calcium sulphate, bioactive glass, polymers, cements,
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`and combinations thereof,
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`33
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`(New) The device of claim 5, wherein the screw device comprises one or
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`more cutting flutes at a distal end.
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`34,
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`(New) The device of claim 5, wherein the screwdevice comprises one or
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`more pointed tips at a distal end.
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`35.
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`(New} The device of claim 5, wherein the proximal threaded section
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`comprises a threading selected from the group consisting of knuckle threads, trapezoidal
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`threads, square threads, and buttress threads.
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`36.
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`(New) The device of claim 5, wherein the proximal threaded section
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`comprises a rounded or tapered proximal end.
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`37.
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`(New) The device of claim 5, wherein the central ring is attached to the
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`proximal threaded section, such that the central ring and proximal threaded section are
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`independently rotatable from the distal threaded section.
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`38.
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`(New} The device of claim 5, wherein the central mng is movable in
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`proximal and distal directions to increase the reach of the one or more decorticating elements.
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`39.
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`(New) The device of claim 5, wherein the screw device comprises two or
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`more external slots formed between the distal threadedsection, the certtral ring, and the one or
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`more decorticating elements, such that each external slot is sized to receive a pin of a screw
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`driving device.
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`40.
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`(New) The device of claim 5, wherein the one or more decorticating
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`elements each comprise one or more surface voids configured to accept graft material or tissue
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`ingrowth.
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`Prehirnary Amendment Dated: 2/28/2022
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`At.
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`(New} The device of claim 5, wherein the cap comprises one or more
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`surface voids configured to accept graft material or tissue ingrowth.
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`42.
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`(New) The device of claim 5, wherein the cap comprises a thread-locking
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`insert positioned at a proximal end of the threaded lumen.
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`43.
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`(New) The device of claim 5, wherein the cap lip comprises a distal-
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`facing surface having a rounded convex shape.
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`44.
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`(New} The device of claim 5, wherein the cap comprises a locking nut in
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`alignment with the threaded lumen of the cap, the locking nut being connected to the cap by one
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`or more connecting bridges configured to break with an application of a torque on the locking
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`nut.
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`45.
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`(New) The device of claim 5, wherein the one or more decorticating
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`elements are moveable between a closed position and an open position.
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`46.
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`(New) The device of claim 45, wherein the closed position positions the
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`decorticating elements adjacent to the certtral ring such that they have a diameter substantially
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`equal to a diameter ofthe distal threaded section, and wherein the open position positions the
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`decorticating elements away from the central ring such that the decorticating clements extend
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`beyond the diameter of the distal threaded section.
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`A?
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`(New} The device of claim 45, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is in parallel with a long
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`axis of the body and are laterally swung from the closed position to the open position.
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`AB.
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`(New} The device of claim 45, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is perpendicular to a long
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`axis of the body and splay outwards from the closed position to the open position.
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`Prehirnary Amendment Dated: 2/28/2022
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`49,
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`(New) The device of claim 45, wherein the one or more decorticating
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`elements are flexible wire blades retracted into the central ring in a closed position andare
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`pushable outwards from the central ring to the open position.
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`30.
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` (New} The device of claim 45, wherein the one or more decorticating
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`elements are sheathed within the central ring in a closed position andare slideable outwards from
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`the closed position to the open position.
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`St.
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`{New} The device of claim 45, wherein the one or more decorticating
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`elements are at least partially pliable and are bendable from a closed position to an open pasition.
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`52.
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`(New) The device of claim 45, wherein the one or more decorticating
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`elements comprises at least one serration.
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`53.
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`(New} The device of claim 5, wherein the proximal threaded section has a
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`diameter that is less than a diameter of the distal threaded section.
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`$4,
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`(New) The device of claim 5, wherein the diameter of the cap is
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`substantially equal to a diameterof the distal threaded section.
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`55,
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`(New} The device of claim 5, further comprising a lock screw having a
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`diameter larger than a diameter of the screwdevice lumen, the lock screwbemg drivable inte the
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`proximal opening of the screw device to expand a proximal end ofthe screw device.
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`56.
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` (New} The device of claim 5, wherein the screw device has a length
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`between about 10 mm and about 150 mim.
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`87,
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`(New} The device of claim 5, wherein the screw device has an outer
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`diameter bebween about 5 mm and about 50 mm.
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