Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26709 Page 1 of 50
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`EXHIBIT A
`TO DASHE DECLARATION
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`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26710 Page 2 of 50
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`PROVISIONAL APPLICATION FOR PATENT COVER SHEET
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`Express Mail Label No. ER 310993525 US
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`C1)
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`—11:3
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`Given Name (first and middle [if any])
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`INVENTOR(S)
`Family Name or Surname
`
`MattHEW
`
`Curran
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`Residence
`(City and either State or Foreign Cosntry)
`e- co
`San Diego, California
`a_
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`Additional inventors are being named on the
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`separately numbered sheets attached hereto
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`.
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`SYSTEM AND METHODS FOR SPINAL FUSION
`Direct all correspondence to:
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`TITLE OF THE INVENTION (500 characters max)
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`30328
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`TYPED or PRINTED NA•
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`Jonathan D.
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`angler
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`.029
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`[Page 1 of 2]
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`Date March 29, 2004
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`NUVA_ATEC0020805
`
`EXHIBIT A
`PAGE 5
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`yr-
`q
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`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26711 Page 3 of 50
`ER310993525US)
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`1 hereby certify that this parer or fee is being d osited with the United States Postal Service "Express Mail Post
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`310993525 US ) under 37 CFR 1.10 on _March 29, 2604_ and is
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`pplication, Commissioner for Patents, P.O. Box 1450, Alexandria, VA
`22313.1450.
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`Jonathan D. Spangler
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`PROVISIONAL APPLICATION
`
`FOR UNITED STATES LETTERS PATENT
`
`5
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`SYSTEMS AND METHODS FOR SPINAL FUSION
`
`10
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`15
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`By Inventor:
`
`MATTHEW CURRAN
`
`a citizen of the United States
`Carlsbad, California
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`Filed:
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`March 29, 2004
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`NUVA_ATEC0020806
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`EXHIBIT A
`PAGE 6
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`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26712 Page 4 of 50
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`SYSTEMS AND METHODS FOR SPINAL FUSION
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`BACKGROUND OF THE INVENTION
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`I. Field of the Invention
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`5
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`The present
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`invention relates generally to spinal surgery and, more
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`particularly, to a system and method for spinal fusion comprising a spinal fusion
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`implant of non-bone construction releasably coupled to an insertion instrument
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`dimensioned to introduce the spinal fusion implant into any of a variety of spinal
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`target sites.
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`10
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`II. Discussion of the Prior Art
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`Currently there are nearly 500,000 spine lumbar and cervical fusion
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`procedures performed each year in the United States. Such procedures are
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`commonly performed to correct problems, such as chronic back or neck pain, which
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`15
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`result from degenerated intervertebral discs or trauma. Generally, spinal fusion
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`procedures involve removing some or all of the diseased or damaged disc, and
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`inserting one or more intervertebral implants into the resulting disc space.
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`Introducing the intervertebral implant serves to restore the height between adjacent
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`vertebrae ("disc height"), which reduces if not eliminates neural impingement
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`20
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`commonly associated with a damaged or diseased disc.
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`2
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`NUVA_ATEC0020807
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`EXHIBIT A
`PAGE 7
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`Autologous bone grafts are widely used intervertebral implant for lumbar
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`fusion. Autologous bone grafts are obtained by harvesting a section of bone from the
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`iliac crest of the patient and thereafter implanting the article of autologous bone graft
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`to effect fusion. While generally effective, the use of autologous bone grafts suffers
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`5
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`certain drawbacks. A primary drawback is the morbidity associated with harvesting
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`the autologous graft from the patient's iliac crest. Another related drawback is the
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`added surgical time required to perform the bone-harvesting.
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`Allograft bone grafts have been employed with increased regularity in an
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`10
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`effort to overcome the drawbacks of autologous bone grafts. Allograft bone grafts
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`are harvested from cadaveric specimens, machined, and sterilized for implantation.
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`While allograft bone grafts eliminate the morbidity associated with iliac crest bone
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`harvesting, as well as decrease the overall surgical time, they still suffer certain
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`drawbacks. A primary drawback is supply constraint, in that the tissue banks that
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`15
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`process and produce allograft bone implants find it difficult to forecast allograft
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`given the inherent challenges in forecasting the receipt of cadavers. Another related
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`drawback is that it is difficult to manufacture the allograft with consistent shape and
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`strength characteristics given the variation from cadaver to cadaver.
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`20
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`The present invention is directed at overcoming, or at least improving upon,
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`the disadvantages of the prior art.
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`3
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`NUVA_ATEC0020808
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`EXHIBIT A
`PAGE 8
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`SUMMARY OF THE INVENTION
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`The present invention overcomes the drawbacks of the prior art by providing
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`5
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`a spinal fusion system and related methods involving the use of a spinal fusion
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`implant of non-bone construction. The non-bone construction of the spinal fusion
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`implant of the present invention overcomes the drawbacks of the prior art in that it is
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`not supply limited (as with allograft) and does not require harvesting bone from the
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`patient (as with autograft). The spinal fusion implant of the present invention may
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`10
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`comprise of any suitable non-bone composition, including but not limited to polymer
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`compositions (e.g. poly-ether-ether-ketone (PEEK) and/or poly-ether-ketone-ketone
`
`(PEKK)), ceramic, metal or any combination of these materials.
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`The spinal fusion implant of the present invention may be provided in any
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`15
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`number of suitable shapes and sizes depending upon the particular surgical procedure
`
`or need. The spinal fusion implant of the present invention may be dimensioned for
`
`use in the cervical and/or lumbar spine without departing from the scope of the
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`present invention. For lumbar fusion, the spinal fusion implant of the present
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`invention may be dimensioned, by way of example only, having a length ranging
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`20
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`between 9 and 18 mm, a height ranging between 8 and 16 mm, and a width ranging
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`between 25 and 45 mm. For cervical fusion, the spinal fusion implant of the present
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`4
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`NUVA_ATEC0020809
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`EXHIBIT A
`PAGE 9
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`invention may be dimensioned, by way of example only, having a length about 11
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`mm, a height ranging between 5 and 12 mm, and a width about 14 mm.
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`The spinal fusion implant of the present invention may be provided with any
`
`5
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`number of additional features for promoting fusion, such as apertures extending
`
`between the upper and lower vertebral bodies which allow a boney bridge to form
`
`through the spinal fusion implant of the present invention. Such fusion-promoting'
`
`apertures may be dimensioned to receive any number of suitable osteoinductive
`
`agents, including but not limited to bone morphogenic protein (BMP) and bio-
`
`10
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`resorbable polymers, including but not limited to any of a variety of poly (D,t.-
`
`lactide-co-glycolide) based polymers, such as disclosed in U.S. Patent No. 6,013,853.
`
`The spinal fusion implant of the present invention is preferably equipped with one or
`
`more lateral openings which aid it provides in visualization at the time of
`
`implantation and at subsequent clinical evaluations.
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`15
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`The spinal fusion implant of the present invention may be provided with any
`
`number of suitable anti-migration features to prevent spinal fusion implant from
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`migrating or moving from the disc space after implantation. Suitable anti-migration
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`features may include, but are not necessarily limited to, angled teeth formed along
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`20
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`the upper and/or lower surfaces of the spinal fusion implant and/or spike elements
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`disposed partially within and partially outside the upper and/or lower surfaces of the
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`5
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`NUVA_ATEC0020810
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`EXHIBIT A
`PAGE 10
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`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26716 Page 8 of 50
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`spinal fusion implant. Such anti-migration features provide the additional benefit of
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`increasing, the overall surface area between the spinal fusion implant of the present
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`invention and the adjacent vertebrae, which promotes overall bone fusion rates.
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`5
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`The spinal implant of the present invention may be introduced into a spinal
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`target site through the use of any of a variety of suitable instruments having the
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`capability to releasably engage the spinal implant. In a preferred embodiment, The
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`insertion instrument permits quick, direct, accurate placement of the spinal implant
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`of the present invention into the intervertebral space. According to one embodiment,
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`10
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`the insertion instrument includes a threaded engagement element dimensioned to
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`threadably engage into a receiving aperture formed in the spinal fusion implant of the
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`present invention. According -to another embodiment, the insertion instrument
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`includes an elongate fork member and a generally tubular lock member.
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`15
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`Many advantages of the present invention will be apparent to those skilled in
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`the art with a reading of this specification in conjunction with the attached drawings,
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`wherein like reference numerals are applied to like elements and wherein:
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`6
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`NUVA_ATEC0020811
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`EXHIBIT A
`PAGE 11
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`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26717 Page 9 of 50
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`Figure 1 is a perspective view of a spinal fusion system of the present
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`invention, including a lumbar fusion implant releasably coupled to an insertion
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`instrument according to one embodiment of the present invention;
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`5
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`Figure 2 is a perspective view of the lumbar fusion implant of FIG. 1,
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`illustrating (among other things) fusion apertures extending between top and bottom
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`surfaces, a plurality of visualization apertures extending through the side walls, and a'
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`variety of anti-migration features according to one embodiment of the present
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`invention;
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`10
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`Figure 3 is a top view of the lumbar fusion implant of FIG. 1, illustrating
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`(among other things) the fusion apertures and the anti-migration features according to
`
`one embodiment of the present invention;
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`15
`
`Figure 4 is a side view of the lumbar fusion implant of FIG. 1, illustrating
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`(among other things) the visualization apertures, the anti-migration feature, and a
`
`receiving aperture for releasably engaging the insertion instrument of FIG. 1
`
`according to one embodiment of the present invention;
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`20
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`Figure 5 is an end view of the lumbar fusion implant of FIG. 1, illustrating
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`(among other things) the receiving aperture formed in the proximal end, the anti-
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`7
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`NUVA_ATEC0020812
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`EXHIBIT A
`PAGE 12
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`migration features, and the visualization apertures according to one embodiment of
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`the present, invention;
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`Figure . 6 is an enlarged side view of the lumbar fusion implant of FIG. 1
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`5
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`releasably coupled to the distal end of the insertion instrument of FIG. 1 according to
`
`one embodiment of the present invention;
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`Figure 7 is a perspective view of the insertion instrument of FIG. 1 in a fully
`
`assembled form according to one embodiment of the present invention;
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`10
`
`Figure 8 is an enlarged perspective view of the distal region of the insertion
`
`instrument of FIG. 1 according to one embodiment of the present invention;
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`Figure 9 is a perspective exploded view of the insertion instrument of FIG. 1,
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`15
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`illustrating the component parts of the insertion instrument according to one
`
`embodiment of the present invention;
`
`Figure 10 is a perspective view of a spinal fusion system of the present
`
`invention, including a cervical fusion implant releasably coupled to a cervical
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`20
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`insertion instrument, according to one embodiment of the present invention;
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`8
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`NUVA_ATEC0020813
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`EXHIBIT A
`PAGE 13
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`Figure 11 is a perspective view of the proximal side of the cervical,fusion
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`implant of FIG. 10, illustrating (among other things) fusion apertures extending
`
`between top and bottom surfaces, a plurality of visualization apertures extending
`
`through the lateral walls, a plurality of receiving apertures, and a variety of anti-
`
`5 migration features according to one embodiment of the present invention;
`
`Figure 12 is a perspective view of the distal side cervical fusion implant of
`
`FIG. 10, illustrating (among 'other things) the visualization apertures and anti-
`
`migration features;
`
`10
`
`Figure 13 is a top view of the cervical fusion implant of FIG. 10, illustrating
`
`(among other things) the fusion apertures and anti-migration features according to
`
`one embodiment of the present invention;
`
`15
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`Figure 14 is a side view of the cervical fusion implant of FIG. 10, illustrating
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`(among other things) the visualization apertures, the anti-migration features, and one
`
`of two receiving apertures provided in the proximal end for releasably engaging the
`
`cervical insertion instrument of FIG. 10 according to one embodiment of the present
`
`invention;
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`20
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`9
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`NUVA_ATEC0020814
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`EXHIBIT A
`PAGE 14
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`Figure 15 is a perspective view of the cervical fusion implant of the present
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`invention just prior to attachmeht to the cervical insertion device according to one
`
`embodiment of the present invention;
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`5
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`Figure 16 is a perspective view of the insertion instrument of FIG. 10 in a
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`fully assembled form according to one embodiment of the present invention;
`
`Figure 17 is a perspective exploded view of the insertion instrument of FIG.
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`10, illustrating the component parts of the insertion instrument according to one
`
`10
`
`embodiment of the present invention.
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`DESCRIPTION OF THE PREFERRED EMBODIMENTS
`
`Illustrative embodiments of the invention are described below. In the interest
`
`of clarity, not all features of an actual implementation are described in this
`
`15
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`specification. It will of course be appreciated that in the development of any such
`
`actual embodiment, numerous implementation-specific decisions must be made to
`
`achieve the developers' specific goals, such as compliance with system-related and
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`business-related constraints, which will vary from one implementation to another.
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`Moreover, it will be appreciated that such a development effort might be complex
`
`20
`
`and time-consuming, but would nevertheless be a routine undertaking for those of
`
`ordinary skill in the art having the benefit of this disclosure. The system to facilitate
`
`10
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`NUVA_ATEC0020815
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`EXHIBIT A
`PAGE 15
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`

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`bone fusion and related methods disclosed herein boasts a variety of inventive
`
`features and 'components that warrant patent protection, both individually and in
`
`combination.
`
`5
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`FIG. 1 illustrates, by way of example only, a spinal fusion system 5 for
`
`performing spinal fusion between adjacent lumbar vertebrae, including an exemplary
`
`spinal fusion implant 10 and an exemplary insertion instrument 20 provided in'
`
`accordance with the present invention. The spinal fusion implant 10 may comprise
`
`of any suitable non-bone composition having suitable radiolucent characteristics,
`
`10
`
`including but not limited to polymer compositions (e.g. poly-ether-ether-ketone
`
`(PEEK) and/or poly-ether-ketone-ketone (PEKK)) or any combination of PEEK and
`
`PEKK. The spinal fusion implant 10 of the present invention may be dimensioned,
`
`by way of example only, having a length ranging between 9 and 18 mm, a height
`
`ranging between 8 and 16 mm, and a width ranging between 25 and 45 mm.
`
`15
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`As will be described in detail below, the insertion instrument 20 is configured
`
`to releasably maintain the exemplary spinal fusion implant 10 in the proper
`
`orientation during insertion into a lumbar disc space and thereafter released to
`
`deposit the implant 10. The exemplary spinal fusion implant 10, having been
`
`20
`
`deposited in the disc space, facilitates spinal fusion over time by maintaining a
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`restored disc height as natural bone growth occurs through and/or past the implant
`
`II
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`NUVA_ATEC0020816
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`EXHIBIT A
`PAGE 16
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`

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`10, resulting in the formation of a boney bridge extending between the adjacent
`
`vertebral bodies.
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`The spinal fusion implant 10 of the present invention may be provided with
`
`5
`
`any number of additional features for promoting fusion, such as apertures 2
`
`extending between the upper and lower vertebral bodies which allow a boney bridge
`
`to form through the spinal fusion implant 10. According to a still further aspect of
`
`the present invention, this fusion may be facilitated or augmented by introducing or
`
`positioning various osteoinductive materials within the apertures 2 and/or adjacent to
`
`10
`
`the spinal fusion implant 10. Such' osteoinductive materials may be introduced
`
`before, during, or after the insertion of the exemplary spinal fusion implant 10, and
`
`may include (but are not necessarily limited to) autologous bone harvested from the
`
`patient receiving the spinal fusion implant 10, bone allograft, bone xenograft, any
`
`number of non-bone implants (e.g. ceramic, metallic, polymer), bone morphogenic
`
`15
`
`protein, and bio-resorbable compositions, including but not limited to any of a
`
`variety of poly (D,L-lactide-co-glycolide) based polymers, such as disclosed in U.S.
`
`Patent No. 6,013,853.
`
`The spinal fusion implant 10 of the present invention is preferably equipped
`
`20 with one or more lateral openings 4 which aid it provides in visualization at the time
`
`of implantation and at subsequent clinical evaluations. More specifically, based on
`
`12
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`NUVA_ATEC0020817
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`EXHIBIT A
`PAGE 17
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`

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`the generally radiolucent nature of the implant 10, the lateral openings 4 provide the
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`ability to visualize the interior of the implant 10 during X-ray and/or other suitable
`
`• imaging techniques which are undertaken from the side (or "lateral") perspective of
`
`the implant 10.
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`If fusion has taken place, the lateral openings 4 will provide a
`
`5 method for the surgeon to make follow up assessments as to the degree of fusion
`
`without any visual interference from the spinal fusion implant 10. Further, the lateral
`
`openings 4 will provide an avenue for cellular migration to the exterior of the spinal'
`
`fusion implant 10. Thus the spinal fusion implant 10 will serve as additional
`
`scaffolding for bone fusion on the exterior of the spinal fusion implant 10.
`
`10
`
`FIGS. 2-5 depict various embodiments of the exemplary spinal fusion implant
`
`10. Some common attributes are shared among the various embodiments. More
`
`specifically, each spinal fusion implant 10 has a top surface 31, a bottom surface 33,
`
`lateral sides 14, a proximal side 22, and a distal side 16. In one embodiment, the top
`
`15
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`and bottom surfaces 31, 33 are generally parallel.
`
`It can be appreciated by one
`
`skilled in the art that although the surfaces 31, 33 are generally parallel to one
`
`another, they may be provided in any number of suitable shapes, including but not
`
`limited to concave and/or convex. When provided as convex shapes, the top and
`
`bottom surfaces 31, 33 may better match the natural contours of the vertebral end
`
`20
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`plates.
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`13
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`NUVA_ATEC0020818
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`EXHIBIT A
`PAGE 18
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`The exemplary spinal fusion implant 10 also preferably includes anti-
`
`migration features designed to increase the friction between the spinal fusion implant
`
`10 and the adjacent contacting surfaces of the vertebral bodies so as to prohibit
`
`migration of the spinal fusion implant 10 after implantation. Such as anti-migration
`
`5
`
`features may include ridges 6 provided along the top surface 31 and/or bottom
`
`surface 33. Additional anti-migration features may also include a pair of spike
`
`elements 7 disposed within the proximal region of the implant 10, a pair of spike
`
`elements 8 disposed within the distal region of the implant 10, and a pair of spike
`
`elements 9 disposed within the central region of the implant 10. Spike elements 7, 8,
`
`10
`
`9 may extend from the top surface 31 and/or bottom surface 33 within the respective
`
`proximal, distal and central regions of the implant 10. The spike elements 7, 8, 9
`
`may be manufactured from any of a variety of suitable materials, including but not
`
`limited to a metal, ceramic, and/or polymer material, preferably having radiopaque
`
`characteristics. The spike elements 7, 8, 9 may also take any of a variety of suitable
`
`15
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`shapes, including but not limited to a generally elongated element disposed within
`
`the implant 10 such that the ends thereof extend generally perpendicularly from the
`
`upper and/or lower surfaces 31, 33 of the implant 10. As best appreciated in FIG. 4,
`
`the spike elements 7, 8, 9 may each comprise a unitary element extending through
`
`upper and lower surfaces 31, 33. Alternatively, each spike element 7, 8, 9 may
`
`20
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`comprise a shorter element which only extends through a single surface 31, 33 (that
`
`is, does not extend through the entire height of the implant 10).
`
`14
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`NUVA_ATEC0020819
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`EXHIBIT A
`PAGE 19
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`

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`The spinal fusion implant 10 has two large fusion apertures 2, separated by a
`
`medial support 50, extending in a vertical fashion through the top surface 31 and
`
`bottom surface 33. The fusion apertures 2 function primarily as an avenue for bony
`
`5
`
`fusion between adjacent vertebrae. The fusion apertures 2 may be provided in any of
`
`a variety of suitable shapes, including but not limited to the generally rectangular
`
`shape best viewed in FIG. 3, or a generally circular, oblong and/or triangular shape or'
`
`any combination thereof. The spinal fusion implant 10 may have a plurality of
`
`visualization apertures 4 which allow a clinician to make visual observations of the
`
`10
`
`degree of bony fusion un-obscured by the lateral side 14 to facilitate further diagnosis
`
`and treatment. The visualization apertures 4 may be provided in any of a variety of
`
`suitable shapes, including but not limited to the generally oblong shape best viewed
`
`in FIG. 4, or a generally circular, rectangular and/or triangular shape or any
`
`combination thereof.
`
`15
`
`The spinal fusion implant 10 may be provided with any number of suitable
`
`features for engaging the insertion instrument 20 without departing from the scope of
`
`the present invention. As best viewed in FIGS. 4-6, one engagement mechanism
`
`involves providing a threaded receiving aperture 12 in the proximal sidewall 22 of
`
`20
`
`the spinal fusion implant 10 of the present invention. The threaded receiving
`
`aperture 12 is dimensioned to threadably receive a threaded engagement member 24
`
`15
`
`NUVA_ATEC0020820
`
`EXHIBIT A
`PAGE 20
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`

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`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26726 Page 18 of
`50
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`on the insertion instrument 20 (as will be described in greater detail below). The
`
`receiving aperture 12 extends inwardly from the proximal side 22 in a generally
`
`perpendicular fashion relative to the proximal side 22. Although shown as having a
`
`generally circular cross-section, it will be appreciated that the receiving aperture 12
`
`5 may be provided having any number of suitable shapes or cross-sections, including
`
`but not limited to rectangular or triangular. In addition to the receiving aperture 12,
`
`the spinal fusion implant 10 is preferably equipped with a pair of grooved purchase
`
`regions 60, 61 extending generally horizontally from either side of the receiving
`
`aperture 12. The grooved purchase regions 60, 61 are dimensioned to receive
`
`10
`
`corresponding distal head slots 62, 63 on the insertion instrument 20 (as will be
`
`described
`
`in greater detail below), which collectively provide an enhanced
`
`engagement between the implant 10 and instrument 20.
`
`FIGS. 6-8 detail the exemplary insertion instrument 20 according to one
`
`15
`
`embodiment of the invention. The exemplary insertion instrument 20 includes an
`
`elongate tubular element 28 and an inserter shaft 44. The elongate tubular element
`
`28 is constructed with a distal head 26 at its distal end, a distal head slot 62 at it s
`
`distal end, a thumbwheel housing 38 at its proximal end and a handle 42 at its
`
`proximal end. The elongate tubular element 28 is generally cylindrical and of a
`
`20
`
`length sufficient to allow the device to span from the surgical target site to a location
`
`16
`
`NUVA_ATEC0020821
`
`EXHIBIT A
`PAGE 21
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`

`

`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26727 Page 19 of
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`sufficiently outside the patient's body so the handle 42 and thumbwheel housing 38
`
`can be easily accessed by a clinician or a complimentary controlling device.
`
`The elongate tubular element 28 is dimensioned to receive a spring 46 and the
`
`5
`
`proximal end of the inserter shaft 44 into the inner bore 64 of the elongate tubular
`
`element 28. The inserter shaft 44 is dimensioned such that the threaded connector 24
`
`at the distal end of the inserter shaft 44 just protrudes past the distal head slots 62, 63'
`
`to allow engagement with the receiving aperture 12 of the spinal fusion implant 10.
`
`It should be appreciated by one skilled in the art that such a construction allows the
`
`10
`
`inserter shaft 44 to be able to rotate freely within the elongate tubular element 28
`
`while stabilized by a spring 46 to reduce any slidable play in the insertion instrument
`
`20.
`
`The handle 42 is generally disposed at the proximal end of the insertion
`
`15
`
`instrument 20. The handle 42 is fixed to the thumbwheel housing 38 allowing easy
`
`handling by the clinician. Because the handle 42 is fixed the clinician has easy
`
`access to the thumbwheel 34 and can stably turn the thumbwheel 34 relative to the
`
`thumbwheel housing 38. Additionally, the relative orientation of the thumbwheel
`
`housing 38 to the handle 42 orients the clinician with respect to the distal head 26
`
`20
`
`and distal head slot 62. By way of example, the thumbwheel housing 38 holds a
`
`thumbwheel 34, a set screw 32, and a spacer 36. The inserter shaft 44 is attached to
`
`17
`
`NUVA_ATEC0020822
`
`EXHIBIT A
`PAGE 22
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`

`

`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26728 Page 20 of
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`the thumbwheel 34 and is freely rotatable with low friction due to the spacer 36. One
`
`skilled in the art can appreciate' myriad methods of assembling a housing similar to
`
`the above described.
`
`5
`
`FIG. 6 details the distal head slot of the exemplary insertion instrument 20
`
`coupled to the spinal fusion implant 10 through the purchase regions 60, 61. The
`
`distal head slots 62, 63 are dimensioned fit slidably into the purchase regions 60, 61
`
`with low friction to allow accurate engagement of the threaded connector 24 to the
`
`receiving aperture 12 of the spinal fusion implant 10.
`
`In the presented embodiment,
`
`10
`
`the outer dimension of the threaded connector 24 is smaller than the largest outer
`
`dimension of the distal head 26 and elongate tubular element 28. Alternatively, other
`
`methods of creating a gripping surface are contemplated including but not limited to
`
`knurling or facets.
`
`15
`
`In order to use the system to perform a spinal fusion procedure, the clinician
`
`must first designate the appropriate implant size. After the spinal fusion implant 10
`
`is chosen, the distal head slots 62, 63 of the inserter shaft 44 is inserted into the
`
`purchase regions 60, 61 of the spinal fusion implant 10. At that time the spinal
`
`fusion implant 10 and insertion instrument 20 are slidably engaged with one another.
`
`20 Before the clinician can manipulate the combined spinal fusion implant 10 and
`
`insertion instrument 20, they must be releasably secured together. In order to secure
`
`I8
`
`NUVA_ATEC0020823
`
`EXHIBIT A
`PAGE 23
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`

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`Case 3:18-cv-00347-CAB-MDD Document 296-3 Filed 11/25/20 PageID.26729 Page 21 of
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`the spinal fusion implant 10 onto the threaded connector 24 of the inserter instrument
`
`20, the clinician would next employ the thumbwheel 34 to rotate the inserter shaft 44
`
`which in turn rotates the threaded connector 24. The rotation of the threaded
`
`connector 24 will releasably engage the receiving aperture of the spinal fusion
`
`5
`
`implant 10 and stabilize the insertion instrument 20 relative to the spinal fusion
`
`implant 10.
`
`A clinician can utilize the secured system in either an open or minimally
`
`invasive spinal fusion procedure.
`
`In either type of procedure, a working channel
`
`10 would be created in a patient that reaches the targeted spinal level. After the creation
`
`of that channel, the intervertebral space would be prepared. After preparation the
`
`secured device is used to place a spinal fusion implant 10 into the prepared
`
`intervertebral space. Once the implant 10 is inserted into the prepared space, the
`
`implant 10 is released from the insertion instrument 20 by rotating the thumbwheel
`
`15
`
`34 to disengage the threaded connector 24 from the receiving aperture 12. That
`
`motion removes the compressive force on the purchase regions 60, 61 between the
`
`distal head 26 and the distal head slots 62, 63 of the spinal fusion implant 10 and
`
`allows the insertion instrument to be slidably removed from the implant 10. After the
`
`threaded connector 24 is disengaged from the implant 10, the insertion instrument 20
`
`20
`
`is removed from the working channel and the channel is closed. As previously
`
`mentioned, additional materials may be included in the procedure before, during or
`
`19
`
`NUVA_ATEC0020824
`
`EXHIBIT A
`PAGE 24
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`

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`Case