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`EXHIBIT 1
`
`TO THE DECLARATION OF
`BRIAN J. NISBET IN SUPPORT OF
`DEFENDANTS’ MOTION FOR
`SUMMARY JUDGMENT
`
`
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27862 Page 2 of 50
`
`PTO/SB/16 (01-04)
`Approved for use through 07/31/2006. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid 0MB control number.
`PROVISIONAL APPLICATION FOR PATENT COVER SHEET
`This is a re uest for filin a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53 c.
`
`Ex ress Mail Label No. ER 310993525 US
`
`c::
`er.,
`-0
`--4
`C)
`
`Given Name (first and middle [if any])
`
`INVENTOR(S)
`Family Name or Surname
`
`Residence
`(Citv and either State or Foreion Countrvl
`
`Matt~G'.W
`
`Curran
`
`San Diego, California
`
`separately numbered sheets attached hereto
`Additional inventors are being named on the
`TITLE OF THE INVENTION (500 characters max)
`SYSTEM AND METHODS FOR SPINAL FUSION
`CORRESPONDENCE ADDRESS
`Direct all correspondence to:
`
`0
`
`OR
`
`Customer Number:
`
`I
`
`□ Firm or
`
`Individual Name
`Address
`
`Address
`
`City
`
`Country
`
`30328
`
`I
`
`State
`
`Telephone
`
`Zip
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`Fax
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`ENCLOSED APPLICATION PARTS (check all that apply)
`0 Specification Number of Pages 27
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`D Application Data Sheet. See 37 CFR 1.76
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`□ CD(s), Number
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`Other {specify) Postcard
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`17
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`~ Q_~i
`-~,
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`0
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`u~~}
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`co-
`L{) -
`r--.CD
`.,....
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`METHOD OF PAYMENT OF FILING FEES FOR THIS PROVISIONAL APPLICATION FOR PATENT
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`0 Applicant claims small entity status. See 37 CFR 1.27.
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`fees or credit any overpayment to Deposit Account Number:
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`The invention was made by an agency of the United States Government or under a contract with an agency of the
`United States Government.
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`D Yes. the name of the U.S. ~n t agency a~ Government contract number are:
`Respectfully subm4
`TYPED" PRINTET"""' D. ~"'''"
`
`>c [Page 1 of 2)
`
`SIGNATURE
`
`Date March 29, 2004
`
`REGISTRATION NO. 40,182
`(if appropriate)
`Docket Number: "109PRlf
`
`I ()q_ I' I< ll
`
`TELEPHONE (858) 24
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`029
`"""--- USE OfJJiY FOR FILING A PROVISIONAL APPLICATION FOR PATENT
`This collection of information is requireu uy ,,, vFR 1.51. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO
`to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 8 hours lo complete, including
`gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the
`amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS. SEND TO: Mail Stop Provisional Application, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
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`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`NUVA_ATEC0020805
`
`EXHIBIT 1 - PAGE 1
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`
`
`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27863 Page 3 of 50
`ER310993525US;
`
`I hereby certify that this
`Office to Addressee" servi
`directed to: Mail. Stop: Pr
`
`sited with the United States Postal Service "Express Mail Post
`10993525 US under 37 CFR I.IO on _March 29, 2004~ and is
`ion, Commissioner for Patents, P.O; Box 1450, Alexandria, VA
`22313-1450.
`
`Jonathan D. S an ler
`
`PROVISIONAL APPLICATION
`
`FOR UNITED STATES LETTERS PATENT
`
`5
`
`SYSTEMS AND METHODS FOR SPINAL FUSION
`
`10
`
`15
`
`By Inventor:
`
`MATTHEW CURRAN
`
`a citizen of the United States
`Carlsbad, California
`
`Filed:
`
`March 29, 2004
`
`NUVA_ATEC0020806
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`EXHIBIT 1 - PAGE 2
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27864 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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`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.
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`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
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`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 1 - PAGE 3
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27865 Page 5 of 50
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`Autologous bone grafts are widely used iritervertebral 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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`I
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`•
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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 surgicai 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 1 - PAGE 4
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27866 Page 6 of 50
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`. SUMMARY OF THE INVENTION
`
`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-~ther-ether-ketone (PEEK) and/or poly:.ether-ketone-ketone
`
`(PEKK)), ceramic, metal or any combination of these materials.
`
`The spinal fusion implant of the present invention may be provided in any
`
`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
`
`present invention. For lumbar fusion, the spinal fusion implant of the present
`
`invention may be dimensioned, by way of example only, having a length ranging
`
`20
`
`between 9 and 18 mm, a height ranging between 8 and 16 mm, and a width ranging
`
`between 25 and 45 mm. For cervical fusion, the spinal fusion implant of the present
`
`4
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`NUVA_ATEC0020809
`
`EXHIBIT 1 - PAGE 5
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27867 Page 7 of 50
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`invention may be dimensioned, by way of example only, having a length .about 11
`
`mm, a height'ranging between 5 and 12 mm, and a width about 14 mm.
`
`The spinal fusion implant of the present invention may be provided with any
`
`5
`
`number of additional features for promoting fusion, such as apertures extending
`
`between the upper and lower vertebral bodies which allow a honey 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-
`' .
`resorbable polymers, including but not limited to any of a variety of poly (D,L(cid:173)
`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.
`
`10
`
`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
`
`s
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`NUVA_ATEC0020810
`
`EXHIBIT 1 - PAGE 6
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27868 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 a;ea between the spinal fusion implant of the present
`
`invention and the adjacent vertebrae, which prnmotes overall bone fusion rates.
`
`5
`
`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
`
`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
`
`of the present invention into the intervertebral space. According to one embodiment,
`
`10
`
`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
`'
`
`.
`
`present invention. According to another embodiment, the insertion instrument
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`includes an elongate fork member and a generally tubular lock member.
`
`15
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Many advantages of the present invention will be apparent to those skilled in
`
`the art with a reading of this specification in conjunction with the attached drawings,
`
`wherein like reference numerals are applied to like elements and wherein:
`
`6
`
`NUVA_ATEC0020811
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`EXHIBIT 1 - PAGE 7
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27869 Page 9 of 50
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`Figure l 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
`
`instrument according to one embodiment of the present invention;
`
`5
`
`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
`
`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;
`
`' .
`
`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;
`
`15
`
`Figure 4 is a side view of the lumbar fusion implant of FIG. 1, illustrating
`
`(among other things) the visualization apertures, the anti-migration feature, and a
`
`receiving aperture for releasably engaging the insertion instrument of FIG. .i
`
`according to one embodiment of the present invention;
`
`20
`
`Figure 5 is an end view of the lumbar fusion implant of FIG. 1, illustrating
`
`_ (among other things) the receiving aperture formed in the proximal end, the anti~
`
`7
`
`NUVA_ATEC0020812
`
`EXHIBIT 1 - PAGE 8
`
`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27870 Page 10 of
`50
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`migration features, and the visualization apertures according to one embodiment of
`
`the present invention;
`
`Figure 6 is an enlarged side view of the lumbar fusion implant of FIG. 1
`
`5
`
`releasably coupled to the distal end of the insertion instrument of FIG. 1 according to
`
`one embodiment of the present invention;
`
`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;
`
`Figure 8 is an enl,arged perspective view of the distal region of the insertion
`
`instrument of FIG. 1 according to one embodiment of the present·invention;
`
`Figure 9 is a perspective exploded view of the insertion instrument of FIG. 1,
`
`15
`
`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
`
`20
`
`insertion instrument according to one embodiment of the present invention;
`
`8
`
`NUVA_ATEC0020813
`
`EXHIBIT 1 - PAGE 9
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27871 Page 11 of
`50
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`Figure 11 is a perspective view of the proximal side of the cervical.fusion
`
`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(cid:173)
`
`migration features;
`
`10
`
`I
`
`•
`
`Figure 13 is a top view of the cervical fusion implant of flG. 10, illustrating
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`(among other things) the fusion apertures and anti-migration features according to
`
`one embodiment of the present invention;
`
`15
`
`Figure 14 is a side view of the cervical fusion implant ofFIG. 10, illustrating
`
`(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;
`
`20
`
`9
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`NUVA_ATEC0020814
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`EXHIBIT 1 - PAGE 10
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27872 Page 12 of
`50
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`Figure 15 is a perspective view of the cervical fusion implant of the present
`
`invention just prior to attachment to. the cervical insertion device according to one
`
`embodiment of the present invention;
`
`5
`
`Figure 16 is a perspective view of the insertion instrument of FIG. 10 in a
`
`fully assembled form according to one embodiment of the present invention;
`
`Figure 17 is a perspective exploded vfow of the insertion instrument of FIG.
`
`10, illustrating the component part_s of the insertion instrument according to one
`
`10
`
`embodiment of the present invention. .
`
`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
`
`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
`
`business-related constraints, which will vary from one implementation to another.
`
`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
`
`EXHIBIT 1 - PAGE 11
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27873 Page 13 of
`50
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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 iB'
`
`accordance with the present in~ention. The spinal fusion implant 10 may comprise ·
`
`of any suitable non-bone composition having suitable rndiolucent characteristics,
`
`. '
`
`including but not limited to polymer compositions (e.g. poly-ether-ether-ketorie
`
`(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.
`
`10
`
`15
`
`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
`
`restored disc height as natural bone growth occurs through and/or past the implant
`
`l l
`
`NUVA_ATEC0020816
`
`EXHIBIT 1 - PAGE 12
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27874 Page 14 of
`50
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`10, resulting in the formation of a honey br~dge extending between the adjacent
`
`vertebral bodies.
`
`The spinal fusion implant 10 of the present invention may be provided with
`
`5
`
`any number of addi.tional features for promoting fusion, such as apertures 2
`
`extending between the upper and lower vertebral bodies which allow a honey 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
`
`NUVA_ATEC0020817
`
`EXHIBIT 1 - PAGE 13
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27875 Page 15 of
`50
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`the generally radiolucent nature of the implant 10, the lateral openings 4 prov.ide 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.
`
`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.
`
`I
`
`'
`
`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
`
`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.
`
`13
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`NUVA_ATEC0020818
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`EXHIBIT 1 - PAGE 14
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`
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27876 Page 16 of
`50
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`The exemplary spinal fusion implant 10 also preferably includes anti(cid:173)
`
`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 centr,al 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 cen~ral 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
`
`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
`
`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
`
`NUVA_ATEC0020819
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`EXHIBIT 1 - PAGE 15
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27877 Page 17 of
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`The spinal fusion implant 10 has two large fusion apertures 2, separated by a
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`• medial support 50, extending in a vertical fashion through the top surface 31 and
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`bottom surface 33. The fusion apertures 2 function primarily as an avenue for bony
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`fusion between adjacent vertebrae. The fusion apertures 2 may be provided in any of
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`a variety of suitable shapes, including but not limited to the generally rectangular
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`shape best viewed in FIG. 3, or a generally circular, oblong and/or triangular shape or'
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`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
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`10
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`degree of bony fusion un-obscured by the lateral side 14 to facilitate further diagnos{s
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`and treatment. The visualization apertures 4 may be provided in any of a variety of
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`suitable shapes, including but not limited to the generally oblong shape best viewed
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`in FIG. 4, or a generally circular, rectangular and/or triangular shape or any
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`combination thereof.
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`The spinal fusion implant 10 may be provided with any number of suitable
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`features for engaging the insertion instrument 20 without departing from the scope of
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`the present invention. As best viewed in FIGS. 4-6, one engagement mechanism
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`involves providing a threaded receiving aperture 12 in the proximal sidewall 22 of
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`20
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`the spinal fusion implant 10 of the present invention. The threaded receiving
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`aperture 12 is dimensioned to threadably receive a threaded engagement member 24
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`IS
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`NUVA_ATEC0020820
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`EXHIBIT 1 - PAGE 16
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27878 Page 18 of
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`on the insertion instrument 20 (as will be de£cribed in greater detail below). The
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`receiving ;iperture 12 extends inwardly from the proximal side 22 in a generally
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`perpendicular fashion relative to the proximal side 22. Although shown as having a
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`generally circular cross-section, it will be appreciated .that the receiving aperture 12
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`5 may be provided having any number of suitable shapes or cross-sections, including
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`but not limited to rectangular or triangular. In addition to the receiving aperture 12,
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`the spinal fusion implant 10 is preferably equipped with a pair of grooved purchase
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`regions 60, 61 extending generally horizontally from either side of the receiving
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`aperture 12. The grooved purchase regions 60, 61 are dimensioned to receive
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`10
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`corresponding distal head slots 62, 63 on the insertion instrument 20 (as will be
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`described
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`in greater ~etail below), which collectively provide an enhanced
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`engagement between the implant 10 and instrument 20.
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`FIGS. 6-8 detail the exemplary insertion instrument 20 according to one
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`embodiment of the invention. The exemplary insertion instrument 20 includes an
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`elongate tubular element 28 and an inserter shaft 44. The elongate tubular element
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`28 is constructed with a distal head 26 at its distal end, a distal head slot 62 at it s
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`distal end, a thumbwheel housing 38 at its proximal end and a handle 42 at its
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`proximal end. The elongate tubular element 28 is generally cylindrical and of a
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`length sufficient to allow the device to span from the. surgical target site to a location
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`NUVA_ATEC0020821
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`EXHIBIT 1 - PAGE 17
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27879 Page 19 of
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`sufficiently outside the patient's body so the handle 42 and thumbwheel hou~ing 38
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`can be easily accessed by a clinician or a complimentary controlling device.
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`The elongate tubular element 28 is dimensioned to receive a spring 46 and the
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`proximal end of the inserter shaft 44 into the inner bore 64 of the elongate tubular
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`element 28. The inserter shaft 44 is dimensioned such that the threaded connector 24
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`at the distal end of the inserter shaft 44 just protrudes past the distal head slots 62, 6:3'
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`to allow engagement with the receiving aperture 12 of the spinal fusion implant 10. ·
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`It should be appreciated by one skilled in the art that such a construction allows the
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`inserter shaft 44 to be able to rotate freely within the elongate tubular element 28
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`10
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`while stabilized by a spring 46 to reduce any slidable play in the insertion instrument
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`20.
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`The handle 42 is generally disposed at the proximal end of the insertion
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`instrument 20. The handle 42 is fixed to the thumbwheel housing 38 allowing easy
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`handling by the clinician. Because the handle 42 is fixed the clinician has easy
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`access to the thumbwheel 34 and can stably tum the thumbwheel 34 relative to the
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`thumbwheel housing 38. Additionally, the relative orientation of the thumbwheel
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`housing 38 to the handle 42 orients the clinician with respect to the distal head 26
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`20
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`and distal head slot 62. By way of example, the thumbwheel housing 38 holds a
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`thumbwheel 34, a set screw 32, and a spacer 36. The inserter shaft 44 is attached to
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`NUVA_ATEC0020822
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`EXHIBIT 1 - PAGE 18
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27880 Page 20 of
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`the thumbwheel 34 and is freely rotatable with low friction due to the spacer 36. One
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`skilled in fhe art can appreciate' myriad methods of assembling a housing similar to
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`the above described.
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`FIG. 6 details the distal head slot of the exemplary insertion instrument 20
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`coupled to the spinal fusion implant 10 through the purchase regions 60, 61. The
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`distal head slots 62, 63 are dimensioned fit slidably into the purchase regions 60, 61
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`with low friction to allow accurate engagement of the threaded connector 24 to the
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`receiving aperture 12 of the spinal f~sion implant 10.
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`In the presented embodiment,
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`10
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`the outer dimension of the threaded connector 24 is smaller than the largest outer
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`dimension of the distal h~ad 26 and elongate tubular element 28. Alternatively, other
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`methods of creating a gripping surface are· contemplated including but not limited to
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`knurling or facets.
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`In order to use the system to perform a spinal fusion procedure, the clinician
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`must first designate the appropriate implant size. After the spinal fusion implant 10
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`is chosen, the distal head slots 62, 63 of the inserter shaft 44 is inserted into the
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`purchase regions 60, 61 of the spinal fusion implant 10. At that time the spinal
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`fusion implant 10 and insertion instrument 20 are slidably engaged with one another.
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`Before the clinician can manipulate the combined spinal fusion implant 10 and
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`insertion instrument 20, they must be releasably secured together. In order to secure
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`NUVA_ATEC0020823
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`EXHIBIT 1 - PAGE 19
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`Case 3:18-cv-00347-CAB-MDD Document 304-3 Filed 01/26/21 PageID.27881 Page 21 of
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`the spinal fusion implant 10 onto the threaded connector 24 of the inserter inst,rument
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`20, the clinician would next employ the thumbwheel 34 to rotate the inserter shaft 44
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`which in tum rotates the threaded connector 24. The rotation of the threaded
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`connector 24 will releasably engage the receiving aperture of the spinal fusion
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`implant 10 and stabilize the insertion instrument 20 relative to the spinal fusion
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`implant 10.
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`A clinician can utilize' the secured system in either an open or minimally
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`invasive spinal fusion procedure:
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`In either type of procedure, a working channel
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`10 would be created in a patient that reaches the targeted spinal level. After the creation
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`of that channel, the intervertebral space would be prepared. After preparation the
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`secured device is used to place · a spinal fusion implant 10 into the prepared
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`intervertebral space. Once the implant 10 is inserted into the prepared space, the
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`implant 10 is released from the insertion instrument 20 by rotating the thumbwheel
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`34 to disengage the threaded connector 24 from the receiving aperture 12. That
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`motion removes the compressive force on the purchase regions 60, 61 between the
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`distal head 26 and the distal head slots 62, 63 of the spinal fusion implant 10 and
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`allows the insertion instrument to be slidably removed from the implant 10. After the
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`threaded connector 24 is disenga