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`EXHIBIT 2
`(PART 1)
`
`TO THE DECLARATION OF
`BRIAN J. NISBET IN SUPPORT OF
`DEFENDANTS’ MOTION FOR
`SUMMARY JUDGMENT
`
`
`
`

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`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27912 Page 2 of 94
`
`FISH & RICHARDSON P.C.
`
`Frederick P. Fish
`1855-1930
`
`WK. Richardson
`1859-1951
`
`April 6, 2012
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`Street Address
`3200 RBC P1AZA
`60 SOUTH SIXTH STREET
`MINNEAPOLIS, MINNESOTA
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`TWIN CITIES
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`WASHINGTON, DC
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`Attorney Docket No.: 13958-0099003/104US4
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-14 5 0
`
`Presented for filing is a new continuation patent application of:
`
`Applicant: MATTHEW CURRAN AND MARK PETERSON
`
`Title:
`
`SYSTEMS AND METHODS FOR SPINAL FUSION
`
`Assignee:
`
`Enclosed are the following papers, including those required to receive a filing date
`under 37 C.F.R. § 1.53(b):
`
`Specification
`Claims
`Abstract
`Declaration
`Drawing(s)
`
`Enclosures:
`
`Pages
`25
`10
`1
`3
`20
`
`- Application Data Sheet, 5 pages.
`New disclosure information, including:
`Information disclosure statement, 1 page.
`PTO-1449, 11 pages.
`References, 0 items.
`Statement under rule 3.73, 9 pages.
`
`This application is continuation of United States Patent Application Serial Number
`13/440,062 filed April 5, 2012, which is a continuation of United States Patent
`Application Serial Number 13/079,645 filed April 4, 2011, which is continuation of
`United States Patent Application Serial Number 11/093,409 filed March 29, 2005
`(now U.S. Patent No. 7,918,891), which claims the benefit of the filing date under 35
`USC 119(e) of United States Provisional Application entitled "Systems and Methods
`for Spinal Fusion," serial No. 60/557,536 filed March 29, 2004.
`
`NUVA_ATEC0022785
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`EXHIBIT 2 - PAGE 50
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`

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`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27913 Page 3 of 94
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`FISH & RICHARDSON P.C.
`
`Commissioner for Patents
`April 6, 2012
`Page 2
`
`Basic Filing Fee
`Search Fee
`Examination Fee
`over 20
`Total Claims 46
`over 3
`Independent Claims 2
`Fee for Multiple Dependent claims
`Application size fee for each 50 pages over 100
`No ( 25 +20)* .75) - 100)/50 = No0 x
`Total Filing fee
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`26 X $60
`0 X $250
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`$380
`$620
`$250
`$1560
`$0
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`The filing fee in the amount of $2810 is being paid concurrently herewith on the
`Electronic Filing System (EFS) by way of Deposit Account authorization. Please
`apply all charges or credits to Deposit Account No. 06-1050, referencing Attorney
`Docket No. 13958-0099003.
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`If this application is found to be incomplete, or if a telephone conference would
`otherwise be helpful, please call the undersigned at (612) 335-5070.
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`Please direct all correspondence to the following:
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`26191
`PTO Customer Number
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`Respectfully submitted,
`
`/Michael T. Hawkins/
`
`Michael T. Hawkins
`Reg. No. 57,867
`Enclosures
`MTH/kmo
`60763337.doc
`
`NUVA_ATEC0022786
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`EXHIBIT 2 - PAGE 51
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`

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`PTO/SB/14 (11-08)
`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27914 Page 4 of 94
`Approved for use through 0913012010. 0MB 0651-0032
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
`
`13958-0099003
`
`Application Number
`
`Title of Invention
`
`Systems and Methods for Spinal Fusion
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
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`r
`t I f
`f
`A ,oo 1can
`n orma 10n:
`Aoolicant 1
`Applicant Authority @Inventor I QLegal Representative under 35 U.S.C. 117
`Prefix Given Name
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`Matthew
`Curran
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`Carlsbad
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`us
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`3218 Rancho Quartillo
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`92009
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`Annlicant 2
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`I CA
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`Mark
`Peterson
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`I Country of Residence i I us
`City Medford
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`I CA
`us
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`Mailing Address of Applicant:
`Address 1
`840 Royal Avenue Suite #1
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`I Medford
`Postal Code
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`97504
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`NUVA_ATEC0022787
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`EXHIBIT 2 - PAGE 52
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`

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`PTO/SB/14 (11-08)
`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27915 Page 5 of 94
`Approved for use through 0913012010. 0MB 0651-0032
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`13958-0099003
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`Application Number
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`Title of Invention
`
`Systems and Methods for Spinal Fusion
`
`Customer Number
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`26191
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`Application Information:
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`Title of the Invention
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`Attorney Docket Number 13958-0099003
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`Application Type
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`Nonprovisional
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`Systems and Methods for Spinal Fusion
`I Small Entity Status Claimed □
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`Subject Matter
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`Utility
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`Suggested Class (if any)
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`an application filed in another country, or under a multilateral international agreement, that requires publication at
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`I O US Patent Practitioner 10 Limited Recognition (37 CFR 11.9)
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`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate National Stage
`entry from a PCT application. Providing this information in the application data sheet constitutes the specific reference required by
`35 U S.C 119(e) or 120, and 37 CFR 1.78(a)(2) or CFR 1 78(a)(4), and need not otherwise be made part of the specification
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`13/440,062
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`EFS Web 2.2.2
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`NUVA_ATEC0022788
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`EXHIBIT 2 - PAGE 53
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`

`

`PTO/SB/14 (11-08)
`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27916 Page 6 of 94
`Approved for use through 0913012010. 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 contains a valid 0MB control number.
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`13958-0099003
`
`Application Number
`
`Title of Invention
`
`Systems and Methods for Spinal Fusion
`
`Prior Application Status
`
`Application Number
`
`Continuity Type
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`Prior Application Number
`
`13079645
`
`Continuation of
`
`11093409
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`Prior Application Status
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`Application Number
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`Continuity Type
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`Prior Application Number
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`11093409
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`non provisional of
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`60557536
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`If the Assignee is an Organization check here.
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`Organization Name
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`I NuVasive, Inc.
`Mailing Address Information:
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`7475 Lusk Boulevard
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`San Diego
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`Address 1
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`Address 2
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`Phone Number
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`92121
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`Signature
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`/Michael T. Hawkins/
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`First Name Michael T.
`
`I Last Name
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`I Hawkins
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`Date (YYYY-MM-DD) 2012-04-06
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`57867
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`NUVA_ATEC0022789
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`EXHIBIT 2 - PAGE 54
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`

`

`PTO/SB/14 (11-08)
`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27917 Page 7 of 94
`Approved for use through 0913012010. 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 contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
`
`13958-0099003
`
`Application Number
`
`Title of Invention
`
`Systems and Methods for Spinal Fusion
`
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`EXHIBIT 2 - PAGE 55
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`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27918 Page 8 of 94
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`NUVA_ATEC0022791
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`Case 3:18-cv-00347-CAB-MDD Document 304-4 Filed 01/26/21 PageID.27919 Page 9 of 94
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`Attorney Docket No. 13958-0099003/ 104US4
`
`SYSTEMS AND METHODS FOR SPINAL FUSION
`
`CROSS-REFERENCE TO RELATED APPLICATION
`
`5
`
`This application is continuation of United States Patent Application Serial Number
`
`13/440,062 filed April 5, 2012, which is a continuation of United States Patent Application
`
`Serial Number 13/079,645 filed April 4, 2011, which is continuation of United States Patent
`
`Application Serial Number 11/093,409 filed March 29, 2005 (now U.S. Patent No. 7,918,891),
`
`which claims the benefit of the filing date under 35 USC 119(e) of United States Provisional
`
`10 Application entitled "Systems and Methods for Spinal Fusion," serial No. 60/557,536 filed
`
`March 29, 2004, the entire contents of these prior applications are incorporated herein by
`
`reference.
`
`BACKGROUND OF THE INVENTION
`
`15
`
`I. Field of the Invention
`
`The present invention relates generally to spinal surgery and, more particularly, to a
`
`system and method for spinal fusion comprising a spinal fusion implant of non-bone construction
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`releasably coupled to an insertion instrument dimensioned to introduce the spinal fusion implant
`
`into any of a variety of spinal target sites.
`
`20
`
`II. Discussion of the Prior Art
`
`Currently there are nearly 500,000 spine lumbar and cervical fusion procedures
`
`performed each year in the United States. Such procedures are commonly performed to correct
`
`problems, such as chronic back or neck pain, which result from degenerated intervertebral discs
`
`NUVA_ATEC0022792
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`EXHIBIT 2 - PAGE 57
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`Attorney Docket No. 13958-0099003/ 104US4
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`or trauma. Generally, spinal fusion procedures involve removing some or all of the diseased or
`
`damaged disc, and 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 vertebrae
`
`("disc height"), which reduces if not eliminates neural impingement commonly associated with a
`
`5
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`damaged or diseased disc.
`
`Autologous bone grafts are widely used intervertebral implant for lumbar fusion.
`
`Autologous bone grafts are obtained by harvesting a section of bone from the iliac crest of the
`
`patient and thereafter implanting the article of autologous bone graft to effect fusion. While
`
`IO
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`generally effective, the use of autologous bone grafts suffers certain drawbacks. A primary
`
`drawback is the morbidity associated with harvesting the autologous graft from the patient's iliac
`
`crest. Another related drawback is the added surgical time required to perform the bone(cid:173)
`
`harvesting.
`
`15
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`Allograft bone grafts have been employed with increased regularity in an effort to
`
`overcome the drawbacks of autologous bone grafts. Allograft bone grafts are harvested from
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`cadaveric specimens, machined, and sterilized for implantation. While allograft bone grafts
`
`eliminate the morbidity associated with iliac crest bone harvesting, as well as decrease the
`
`overall surgical time, they still suffer certain drawbacks. A primary drawback is supply
`
`20
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`constraint, in that the tissue banks that process and produce allograft bone implants find it
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`difficult to forecast allograft given the inherent challenges in forecasting the receipt of cadavers.
`
`Another related drawback is that it is difficult to manufacture the allograft with consistent shape
`
`and strength characteristics given the variation from cadaver to cadaver.
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`2
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`NUVA_ATEC0022793
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`EXHIBIT 2 - PAGE 58
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`Attorney Docket No. 13958-0099003/ 104US4
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`The present invention is directed at overcoming, or at least improving upon, the
`
`disadvantages of the prior art.
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`5
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`SUMMARY OF THE INVENTION
`
`The present invention overcomes the drawbacks of the prior art by providing a spinal
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`fusion system and related methods involving the use of a spinal fusion implant of non-bone
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`construction. The non-bone construction of the spinal fusion implant of the present invention
`
`overcomes the drawbacks of the prior art in that it is not supply limited (as with allograft) and
`
`10
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`does not require harvesting bone from the patient (as with autograft). The spinal fusion implant
`
`of the present invention may be comprised of any suitable non-bone composition, including but
`
`not limited to polymer compositions ( e.g. poly-ether-ether-ketone (PEEK) and/or poly-ether(cid:173)
`
`ketone-ketone (PEKK)), ceramic, metal or any combination of these materials.
`
`15
`
`The spinal fusion implant of the present invention may be provided in any 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
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`20 width ranging between 9 and 18 mm, a height ranging between 8 and 16 mm, and a length
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`ranging between 25 and 45 mm. For cervical fusion, the spinal fusion implant of the present
`
`invention may be dimensioned, by way of example only, having a width about 11 mm, a height
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`ranging between 5 and 12 mm, and a length about 14 mm.
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`3
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`Attorney Docket No. 13958-0099003/ 104US4
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`The spinal fusion implant of the present invention may be provided with any number of
`
`additional features for promoting fusion, such as apertures extending between the upper and
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`lower vertebral bodies which allow a boney bridge to form through the spinal fusion implant of
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`the present invention. Such fusion-promoting apertures may be dimensioned to receive any
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`number of suitable osteoinductive agents, including but not limited to bone morphogenic protein
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`(BMP) and bio-resorbable polymers, including but not limited to any of a variety of poly (D,L(cid:173)
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`lactide-co-glycolide) based polymers. The spinal fusion implant of the present invention is
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`preferably equipped with one or more lateral openings which aid it provides in visualization at
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`the time of implantation and at subsequent clinical evaluations.
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`The spinal fusion implant of the present invention may be provided with any number of
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`suitable anti-migration features to prevent spinal fusion implant from migrating or moving from
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`the disc space after implantation. Suitable anti-migration features may include, but are not
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`necessarily limited to, angled teeth formed along the upper and/or lower surfaces of the spinal
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`fusion implant and/or spike elements disposed partially within and partially outside the upper
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`and/or lower surfaces of the spinal fusion implant. Such anti-migration features provide the
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`additional benefit of increasing the overall surface area between the spinal fusion implant of the
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`present invention and the adjacent vertebrae, which promotes overall bone fusion rates.
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`The spinal fusion implant of the present invention may be provided with any number of
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`features for enhancing the visualization of the implant during and/or after implantation into a
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`spinal target site. According to one aspect of the present invention, such visualization
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`enhancement features may take the form of the spike elements used for anti-migration, which
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`may be manufactured from any of a variety of suitable materials, including but not limited to a
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`metal, ceramic, and/or polymer material, preferably having radiopaque characteristics. The
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`spike elements may also take any of a variety of suitable shapes, including but not limited to a
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`generally elongated element disposed within the implant such that the ends thereof extend
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`generally perpendicularly from the upper and/or lower surfaces of the implant. The spike
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`elements may each comprise a unitary element extending through upper and lower surfaces or,
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`alternatively, each spike element may comprise a shorter element which only extends through a
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`single surface (that is, does not extend through the entire height of the implant). In any event,
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`IO when the spike elements are provided having radiodense characteristics and the implant is
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`manufactured from a radiolucent material (such as, by way of example only, PEEK and/or
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`PEKK), the spike elements will be readily observable under X-ray or fluoroscopy such that a
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`surgeon may track the progress of the implant during implantation and/or the placement of the
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`implant after implantation.
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`The spinal implant of the present invention may be introduced into a spinal target site
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`through the use of any of a variety of suitable instruments having the capability to releasably
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`engage the spinal implant. In a preferred embodiment, the insertion instrument permits quick,
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`direct, accurate placement of the spinal implant of the present invention into the intervertebral
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`space. According to one embodiment, the insertion instrument includes a threaded engagement
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`element dimensioned to threadably engage into a receiving aperture formed in the spinal fusion
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`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.
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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 the art with
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`a reading of this specification in conjunction with the attached drawings, wherein like reference
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`numerals are applied to like elements and wherein:
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`Figure 1 is a perspective view of a spinal fusion system of the present invention,
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`including a lumbar fusion implant releasably coupled to an insertion instrument according to one
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`embodiment of the present invention;
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`Figure 2 is a perspective view of the lumbar fusion implant of FIG. l, illustrating (among
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`other things) fusion apertures extending between top and bottom surfaces, a plurality of
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`visualization apertures extending through the side walls, and a variety of anti-migration features
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`according to one embodiment of the present invention;
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`Figure 3 is a top view of the lumbar fusion implant of FIG. 1, illustrating (among other
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`things) the fusion apertures and the anti-migration features according to one embodiment of the
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`present invention;
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`Figure 4 is a side view of the lumbar fusion implant of FIG. 1, illustrating (among other
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`things) the visualization apertures, the anti-migration feature, and a receiving aperture for
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`releasably engaging the insertion instrument of FIG. 1 according to one embodiment of the
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`present invention;
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`Figure 5 is an end view of the lumbar fusion implant of FIG. 1, illustrating (among other
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`things) the receiving aperture formed in the proximal end, the anti-migration features, and the
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`visualization apertures according to one embodiment of the present invention;
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`Figure 6 is an enlarged side view of the lumbar fusion implant of FIG. 1 releasably
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`coupled to the distal end of the insertion instrument of FIG. 1 according to one embodiment of
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`the present invention;
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`Figure 7 is a perspective view of the insertion instrument of FIG. 1 in a fully assembled
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`form according to one embodiment of the present invention;
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`Figure 8 is an enlarged perspective view of the distal region of the insertion instrument of
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`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, illustrating
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`the component parts of the insertion instrument according to one embodiment of the present
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`invention;
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`20
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`Figure 10 is a perspective view of a spinal fusion system of the present invention,
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`including a cervical fusion implant releasably coupled to a cervical insertion instrument
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`according to one embodiment of the present invention;
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`Figure 11 is a perspective view of the proximal side of the cervical fusion implant of FIG.
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`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
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`receiving apertures, and a variety of anti-migration features according to one embodiment of the
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`5
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`present invention;
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`Figure 12 is a perspective view of the distal side cervical fusion implant of FIG. 10,
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`illustrating (among other things) the visualization apertures and anti-migration features;
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`10
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`Figure 13 is a top view of the cervical fusion implant of FIG. 10, illustrating (among
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`other things) the fusion apertures and anti-migration features according to one embodiment of
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`the present invention;
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`Figure 14 is a side view of the cervical fusion implant of FIG. 10, illustrating (among
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`15
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`other things) the visualization apertures, the anti-migration features, and one of two receiving
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`apertures provided in the proximal end for releasably engaging the cervical insertion instrument
`
`of FIG. 10 according to one embodiment of the present invention;
`
`Figure 15 is a perspective view of the cervical fusion implant of the present invention just
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`20
`
`prior to attachment to the cervical insertion device according to one embodiment of the present
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`invention;
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`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;
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`Figure 17 is a perspective exploded view of the insertion instrument of FIG. 10,
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`5
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`illustrating the component parts of the insertion instrument according to one embodiment of the
`
`present invention;
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`Figures 18 and 19 are perspective and side views, respectively, illustrating the "enhanced
`
`visualization" feature of the present invention as employed within a lumbar fusion implant
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`10
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`according to one embodiment of the present invention;
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`Figures 20