US00825 1997B2
`
`(12) United States Patent
`Michelson
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,251,997 B2
`Aug. 28, 2012
`
`(54) METHOD FOR INSERTING AN ARTIFICIAL
`MPLANT BETWEEN TWO ADJACENT
`VERTEBRAE ALONG ACORONAL PLANE
`
`(75) Inventor: Gary Karlin Michelson, Venice, CA
`(US)
`
`(73) Assignee: Warsaw Orthopedic, Inc., Warsaw, IN
`US)
`(
`-
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(*) Notice:
`
`(21) Appl. No.: 13/306,583
`
`(22) Filed:
`
`Nov. 29, 2011
`
`(65)
`
`Prior Publication Data
`US 2012/OO71984 A1
`Mar. 22, 2012
`
`Related U.S. Application Data
`(60) Continuation of application No. 10/371,757, filed on
`Feb. 21, 2003, now Pat. No. 8,066,705, which is a
`continuation of application No. 08/480,461, filed on
`Jun. 7, 1995, now Pat. No. 7,491,205, which is a
`division of application No. 08/394,836, filed on Feb.
`27, 1995, now Pat. No. 5,772,661.
`
`2,065,659 A 12, 1936 Cullen
`3. 2. 2. A 1 . 3. Stant
`Ocea
`2,514,665 A
`7/1950 Myller
`2,537,070 A
`1/1951 Longfell
`2,543,780 A
`3, 1951 E.
`2,677,369 A
`5, 1954 Knowles
`2,774,350 A 12/1956 Cleveland
`2,789,558 A
`4, 1957 Rush
`2,832,343 A
`4, 1958 Mose
`2,842,131 A
`7, 1958 Smith
`2,878,809 A
`3/1959 Treace
`2.919,692 A
`1/1960 Ackermann .................. 600/S67
`3,128,768 A
`4, 1964 Geistauts
`3.298,372 A
`1/1967 Feinberg
`3,426,364. A
`2f1969 Lumb
`3,486,505 A 12/1969 Morrison
`3,604.487. A
`9/1971 Gilbert
`3,605,123 A
`9, 1971 Hahn
`3,618,611 A 1 1/1971 Urban
`3,709,219 A
`1/1973 Halloran
`(Continued)
`
`DE
`
`FOREIGN PATENT DOCUMENTS
`1961. 531
`7, 1970
`(Continued)
`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 08/219,626, filed Mar. 1994, Michelson.
`(Continued)
`
`(51) Int. Cl.
`"Rs. 606/60: 606/246
`(52)
`t; 7/56
`(58) Field of Classification Search .................... ...,
`606/60, 86 A 246-250, 61; 623/16, 17
`See application file for complete search history.
`
`Oa -
`
`- - -
`
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
`
`s
`
`s
`
`74). Att
`
`Agent, or Firm — Martin & F
`
`Primary Examiner — Michael A. Brown
`(74) Attorney, Agent, or Firm
`Martin & Ferraro,
`(57)
`ABSTRACT
`
`LLP
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`350,420 A 10, 1886 Dillon
`1,137,585 A
`4/1915 Craig
`
`A method for inserting an artificial implant between two
`adjacent vertebrae along a coronal plane.
`
`30 Claims, 14 Drawing Sheets
`
`
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1021, p. 1 of 37
`
`

`

`US 8,251,997 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`3,719,186 A
`3/1973 Merig, Jr.
`3,720.959 A
`3/1973 Hahn
`3,750,652 A
`8/1973. Sherwin
`3,848,601 A * 11/1974 Maet al. ..................... 606/86. A
`3,855,638 A 12/1974 Pilliar
`3,867,728. A
`2, 1975 Stubstad et al.
`3,867,932 A
`2, 1975 Huene
`3,867,950 A
`2, 1975 Fischell
`3.3% A
`E. Ei
`3.893.23. A
`7, 1975 NES
`3905,047 A
`9, 1975
`t
`- W -
`Ong
`3,915, 151 A 10/1975 Kraus
`3,916,907 A 11/1975 Peterson
`3,918.440 A
`1 1/1975 Kraus
`3,941,127 A
`3/1976 Froning
`3,942,535 A
`3/1976 Schulman
`3,948,262 A
`4, 1976 Zaffaroni
`3,952,334. A
`4, 1976 Bokros et al.
`3,987.499 A 10, 1976 Scharbach et al.
`4,016,651 A
`4, 1977 Kawahara et al.
`4,027,392 A
`6/1977 Sawyer et al.
`P.S.
`887 St.
`W - J.
`ce
`4,059,115 A 11, 1977 Jumashev et al.
`4,070,514 A
`1/1978 Entherly et al.
`4,082,097 A
`4, 1978 Mann et al.
`4,086,701 A
`5/1978 Kawahara et al.
`4,124,026 A 1 1/1978 Berner et al.
`4,142,517 A
`3/1979 Stavropoulos et al.
`4,168,326 A
`9, 1979 Broemer et al.
`4,175,555 A 1 1/1979 Herbert
`4,177,524. A 12/1979 Grell et al.
`4,181,457. A
`1/1980 Holmes
`4,197,850 A
`4, 1980 Schulman et al.
`4,206,516 A
`6/1980 Pilliar
`4,222,128 A
`9/1980 Tomonaga et al.
`D257,511 S
`11/1980 Zahn
`4,232,679 A 1 1/1980 Schulman
`4,237,948 A 12/1980 Jones et al.
`4,258,716 A
`3/1981 Sutherland
`4,259,072 A
`3/1981 Hirabayashi et al.
`4,262,369 A
`4, 1981 Roux
`4,271,832 A
`6/1981 Evans et al.
`D260,525 S
`9, 1981 Lassiter
`4,289,123. A
`9/1981 Dunn
`4,293,962 A 10/1981 Fuson
`4,309,777. A
`1/1982 Patil
`4.328,593. A
`5/1982 Sutter et al.
`4.333,469 A
`6/1982 Jeffcoat et al.
`4,341,206 A
`7, 1982 Perrett et al.
`4,349,921. A
`9, 1982 Kuntz
`4,356,572 A 11, 1982 Guillemin et al.
`4,401,112 A
`8, 1983 Rezaian
`4.405,319 A
`9, 1983 Cosentino
`4.414.979 A 11, 1983 Hirshornet al.
`4,423,721 A
`1, 1984 Otte et al.
`2:38: A
`3. St.
`I - W
`SCC
`4.484,570 A 1 1/1984 Sutter et al.
`4,492,226. A
`1/1985 Belykh et al.
`4,497.320 A
`2f1985 Nicholson et al.
`13.
`A SE E. tal
`RE31865 E
`4, 1985 R aa (a.
`4,530.360 A
`7, 1985 SEG
`- - W
`ae
`4,535,374. A
`8, 1985 Anderson et al.
`4,535,485. A
`8/1985 Ashman et al.
`4,542,539 A
`9/1985 Rowe, Jr. et al.
`4,545,374. A 10/1985 Jacobson
`4,547,390 A 10/1985 Ashman et al.
`4,549,547 A 10/1985 Brighton et al.
`4,552,200 A 1 1/1985 Sinha et al.
`4,553,273 A 11, 1985 Wu
`4,554.914 A 11/1985 Kapp et al.
`D281,814 S
`12/1985 Pratt et al.
`4,570,623 A
`2/1986 Ellison et al.
`4,570,624
`2, 1986 Wu
`A
`
`4,573,448 A * 3/1986 Kambin ........................ 606/170
`3.35. A $3. lysis
`4,600,000 A
`7/1986 Edwards
`4,602,638 A
`7/1986 Adams
`4,604,995 A
`8/1986 Stephens
`4,608,052 A
`8/1986 Van Kampen et al.
`4,611,581. A
`9, 1986 Steffee
`4,619.264 A 10/1986 Singh
`4.628921. A 12/1986 Rousso
`4,634,720 A
`1/1987 Dorman et al.
`4,636,217 A
`1/1987 Ogilvie et al.
`4,636,526 A
`1/1987 Dorman et al.
`4,645,503 A
`2f1987 Lin et al.
`4,653,486 A
`3, 1987 Coker
`4,653.509 A
`3, 1987 Oloff et all
`4655,777. A
`4/1987 Dunn
`4,661,536 A
`4, 1987 Dorman et al.
`4,664,567 A
`5, 1987 Edwards
`4,665.920 A
`5/1987 Campbell
`E. A
`57 "
`467797 A
`7, 1987 Tornier
`4,693.721. A
`9/1987 Duchevne
`4,696.290 A
`9, 1987 SE
`4,698,375. A 10/1987 Dorman et al.
`4,710,075 A 12/1987 Davison
`4,713,004 A 12/1987 Linkow etal
`4,714.469 A 12/1987 Kenna
`4,721, 103 A
`1/1988 Freedland
`4,723.540 A
`2f1988 Gilmer, Jr.
`4.736,738 A
`4/1988 Lipovsek et al.
`4,743.256 A
`5/1988 Brantigan
`4743.260 A
`5, 1988 E.
`4,759,766 A
`7/1988 Buettner-Janz et al.
`4,759.769 A
`7/1988 Hedman et all
`4,769,881. A
`9/1988 Pedigo et al.
`4.772.286 A
`9, 1988 Goble
`4.781.59. A 11/1988 Allen
`4790.303 A 12/1988 Steffee
`4,805,602. A
`2/1989 Puno et al.
`4.820.305 A
`4, 1989 Harms etal
`4,830.000 A
`5/1989 Shutt
`4,832,683. A
`5/1989 Idemoto et al.
`4,834,757 A
`5/1989 Brantigan
`4,848,327 A
`7/1989 Perdue
`4.851,008 A
`7/1989 Johnson
`4,863,476 A
`9/1989 Shepperd
`4,863,477 A
`9/1989 Monson
`4865603 A
`9, 1989 Noles
`4,877.020. A
`10/1989 Vich
`4,878,915 A
`1/1989 Brantigan
`4,879.915 A * 1 1/1989 Spencer ..................... T3,864.74
`4.903,882 A
`2/1990 Long
`4,904.260 A
`2/1990 Ray et al.
`4,904.261 A
`2f1990 Dove et all
`4,911,718 A
`3/1990 Lee et al.
`4.913,144 A
`4, 1990 Del Medico
`4,936,848 A
`6, 1990 Bagb
`4943.29 A
`7, 1990 FEy
`4,955,885 A
`9/1990 Meyers
`4,955,908 A
`9/1990 Frey et al.
`4,957.495 A
`9/1990 Kluger
`4,960,420 A 10/1990 Goble et al.
`4.961.740 A 10/1990 Ray et al.
`4,968.316 A 1 1/1990 Hergenroeder
`4.969,888 A 1 1/1990 Scholten et al.
`4,987,904 A
`1, 1991 Wilson
`5,015,247 A
`5/1991 Michelson
`5,015.255. A
`5/1991 Kuslich
`5.026,373 A
`6/1991 Raveral
`S. A.
`E. E."
`5,047,036 A
`9/1991 Koutrouvelis
`5,047,055 A
`9/1991 Bao et al.
`5,055,104 A 10, 1991 Ray
`5,059,193 A 10, 1991 Kuslich
`5,062,845. A 11/1991 Kuslich et al.
`5,071.437 A 12/1991 Steffee
`5,084,050 A
`1/1992 Draenert
`5,102414
`4, 1992 Kirsch
`A
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1021, p. 2 of 37
`
`

`

`US 8,251,997 B2
`Page 3
`
`4/1992 Wollschlager et al.
`5,105,819 A
`4, 1992 Green et al.
`5,108,422 A
`5, 1992 Krevolin et al.
`5, 112,336 A
`5, 1992 Cadwell
`5,116,304 A
`6, 1992 Keller
`5, 122,130 A
`6, 1992 Pisharodi
`5,123,926 A
`7/1992 Meyer
`5,131,382 A
`5,171,278 A 12/1992 Pisharodi
`5,171,279 A 12/1992 Mathews
`5, 183,471 A
`2, 1993 Wilk
`5, 192,327 A
`3/1993 Brantigan
`5, 195,541 A
`3, 1993 Obenchain
`5,217,479 A
`6, 1993 Shuler
`5,242,443 A
`9, 1993 Kambin .......................... 606/60
`5,246,458 A
`9, 1993 Graham
`5,258,031 A 11/1993 Salib et al.
`5,263,953. A 1 1/1993 Bagby
`5,269,772 A 12, 1993 Wilk
`5,279,292 A
`1/1994 Baumann et al.
`5,292.252 A
`3, 1994 Nickerson et al.
`5,306,307 A
`4, 1994 Senter et al.
`5,306,309 A
`4/1994 Wagner et al.
`5,314.427 A
`5, 1994 Goble et al.
`5,314,432 A
`5/1994 Paul
`5,324,295 A
`6/1994 Shapiro
`5,352,229 A 10, 1994 Goble et al.
`5,360,430 A 11, 1994 Lin
`5,364,399 A 1 1/1994 Lowery et al.
`5,370,662 A 12/1994 Stone et al.
`5,370,697 A 12/1994 Baumgartner
`5,393,036 A
`2f1995 Sheridan
`RE34,871 E
`3, 1995 McGuire et al.
`5,395,317 A
`3, 1995 Kambin
`5,395,372 A
`3, 1995 Holt etal
`- - -
`Olt et al.
`5,396,880 A
`3/1995 Kagan et al.
`5.397.364 A
`3, 1995 Kozak et al.
`5.425,773 A
`6/1995 Brantigan
`5,435,723 A
`7, 1995 O’Brien
`5,441.527 A
`8, 1995 Erickson et al.
`5,443,514 A
`8, 1995 Steffee
`5,458,638 A 10, 1995 Kuslich et al.
`5,480,440 A
`1/1996 Kambin
`5,484.437 A
`1/1996 Michelson
`5,489,307 A
`2f1996 Kuslich et al.
`5,489,308 A
`2, 1996 Kuslich et al.
`D368,777 S
`4, 1996 Goble et al.
`5,571,109 A 1 1/1996 Bertagnoli
`5,593.409 A
`1/1997 Michelson
`5,609,636 A
`3, 1997 Kohrs et al.
`5,658,337 A
`8, 1997 Kohrs et al.
`5,683.463 A 1 1/1997 Godefroy et al.
`5,766,252 A
`6/1998 Henry et al.
`5,772,661 A
`6, 1998 Michelson
`D397.439 S
`8, 1998 Koros et al.
`5,800,547 A
`9, 1998 Schafer et al.
`5,885,299 A
`3, 1999 Winslow et al.
`6,224,595 B1
`5, 2001 Michelson
`7,207,991 B2
`4, 2007 Michelson
`7,491,205 B1
`2/2009 Michelson
`8.066,705 B2 11/2011 Michelson
`w s. s.
`FOREIGN PATENT DOCUMENTS
`31 O1333 A1 12, 1981
`31. 32.520 A1
`6, 1982
`35 05 567 A1
`6, 1982
`36 08 163 A1
`9, 1987
`O O77 159
`4f1983
`O 162005
`11, 1985
`O 179 695
`4f1986
`O 551 187 A1
`7, 1993
`g 3.
`A.
`E.
`O 627 204 A2 12, 1994
`283,078
`5, 1985
`2581336
`11, 1986
`2703 58O
`10, 1994
`1291470
`10, 1972
`1531487
`11, 1978
`2O76657 A 12/1981
`
`DE
`DE
`DE
`DE
`EP
`EP
`EP
`EP
`E.
`EP
`ES
`FR
`FR
`GB
`GB
`GB
`
`GB
`GB
`JP
`JP
`JP
`JP
`JP
`SE
`SU
`SU
`SU
`SU
`SU
`WO
`WO
`WO
`WO
`WO
`
`3, 1984
`2126,094. A
`3, 1986
`2164277 A
`9, 1985
`60-31706
`10, 1985
`60-43984
`7, 1987
`62-155846
`63 300758 A 12, 1988
`4-88.929 U.
`8, 1992
`106 101
`7, 1939
`1107854
`8, 1984
`1124960
`11, 1984
`1217374
`3, 1986
`1222254
`4f1986
`165O114 A
`5, 1991
`WO 84/O1298
`4f1984
`WO90,00037
`1, 1990
`WO92, 14423
`9, 1992
`WO94,28824
`12/1994
`WO96,22747
`8, 1996
`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 12,655/178, filed Dec. 2009, Michelson
`Adams, et al.; Outline of Orthopaedics, Eleventh Edition; Trunk and
`Spine; 1990; cover page and p. 194.
`Herkowitz, et al., Principles on Bone Fusion; The Spine. Third Edi
`tion; Chapter 44; cover page and p. 1739; 1992.
`Muschler, et al.: The Biol
`fSpinal Fusion: Spinal Fusion Sci
`usenler, et al.; Ine Biologyo Spinal Fusion; Spinal Fusion Science
`and Technique, Cotler and Cotler (editors); 1990; 2 cover pages and
`pp. 9-21.
`Zindrick, et al., Lumbar Spine Fusion: Different Types and Indica
`tions; The Lumbar Spine, Vol. 1. Second Edition, 2 cover pages and
`pp. 588-593 (1996).
`Gillingham, F.J., et al.: Automatic Patient Monitoring in the Ward;
`Brit. J. Surg. vol.53, No. 10, cover page and pp. 864-866 (Oct. 1966).
`Maloney, A.F.J., et al.; Clinical and Pathological Observations in
`Fatal Head Injuries, Brit. J. Surg., vol. 56, No. 1, cover page and pp.
`23-31 (Jan. 1969).
`Harris, P. et al.; Spinal Deformity After Spinal Cord Injury; Paraple
`gia, vol. 6, No. 4, cover page and p. 232-238 (Feb. 1969).
`Gilli
`F.J. et al.: Head iniuries: P
`di
`fthe 18th World
`illingham, F.J., et al., ead injuries; Proceedings of the
`O
`Congress of the International College of Surgeons, Rome, 2 cover
`pages and pp. 68-71 (May 28-31, 1972).
`Whatmore, W. J.; Sincipitai Encephalomeningoceles; Brit. J. Surg.
`vol. 60, No. 4, cover page and pp. 261-270 (Apr. 1973).
`Whatmore, W. J., et al.; Meningioma Following Trauma; Brit. J.
`Surge., vol. 60, No. 6, cover page and pp. 496-498 (Jun. 1973).
`Bagbv. G
`W.: Wobbler Svindr
`in H
`the Ataxic H
`agby, George W. Wobbler Syndrome in Horses (the Ataxic Horse):
`Spokane County Medical Society Bulletin; Spring 1979; 2 pages.
`Rathke, F.W., et al.; Surgery of the Spine; Atlas of Orthopaedic
`Operations, vol. 1, p. 137, W.B. Saunders Co., Philadelphia (1979).
`Albrektsson, T., et al., Osseointegrated Titanium Implants; Acta.
`Orthop. Scand.; vol. 52:155-170 (1981).
`Raveh, J., et al.; Neue Rekonstruktionsmoglichkeiten des Unterkief
`ers bei knochernen Defekten nach Tumorresektionen; Der Chirurg
`vol. 53.459-467 (1982).
`Crock, H.V.; Practice of Spinal Surgery; Springer-Verlag Wien, New
`York (1983); 14 pages.
`Crock, Henry V.; Practice of Spinal Surgery; Springer-Verlag Wien,
`New York (1983); cover page and pp. 64-92.
`DeBowes, R.M., et al.; Study of Bovine ... Steel Baskets; Transac
`tions of the 29th Annual Meeting; Orthopaedic Research Society, vol.
`8, cover page and p. 407, Mar. 8-10 (1983).
`O'Neill, P. et al.; Spinal Meningoceles in Association with
`Neurofibromatosis; Neurosurgery, vol. 13, No. 1, cover page and pp.
`82-84 (Jul. 1983).
`Brandt, L., et al.; A Dowel Inserter for Anterior Cervical Interbody
`Fusion; J. Neurosurg, 61.793-794 (Oct. 1984).
`Whatmore, W.J., et al.; The Coventry Cervical Spreader and Dowel
`Inserter; ACTA Neurochirurgica, vol. 70, FASC. 1-2; cover page and
`p. 132; (1984).
`Raveh, J., et al.; Use of the Titanium-coated Hollow Screw and
`Reconstruction Plate System in Bridging of Lower Jaw Defects; J.
`Oral Maxillofac Surg. 42:281-294 (1984).
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1021, p. 3 of 37
`
`

`

`US 8,251,997 B2
`Page 4
`
`Otero-Vich, Jose M.; Anterior Cervical linterbody Fusion with
`Threaded Cylindrical Bone; J. NeuroSurg 63: 2 cover pages and pp.
`750-753 (Nov. 1985).
`Morscher, E., et al.; Die vordere Verplattung der Halswirbelsäule mit
`dem Hohlschrauben-Plattensystem aus Titanium, Der Chirurg, vol.
`57, pp. 702-707 (1986) with English Transiation.
`Bagby, G.W.; Basket Implant Facilitates Spinal Fusion; Orthopedics
`Today, vol. 7, No. 10, (Oct. 1987); 3 pages.
`Butts, M. K., et al.; Biomechanical Analysis of a New Method for
`Spinal Interbody Fixation: 1987 Symposium, American Society of
`Mechanical Engineers, "Advances in Bioengineering', Boston, MA
`(Dec. 13, 18, 1987); 7 pages.
`Crawley et al.; A Modified Cloward's Technique for Arthrodesis of
`the Normal Metacarpophalangeal Joint in the Horse; Veterinary Sur
`gery, vol. 17, No. 3, pp. 117-127 (1988).
`Raveh, J., et al.; Surgical Procedures for Reconstruction of the Lower
`Jaw Using the Titanium Coated Hollow Screw Reconstruction Plate
`System: Bridging of Defects; Otolaryngologic Clinics of North
`America; vol. 20, No. 3; pp. 535-558; (Aug. 1987).
`Whatmore, W.J.; Proceedings of the Society of British Neurological
`Surgeons; Journal of Neurology, Neurosurgery, and Psychiatry,
`50: 1093-1 100 (1987).
`Goldthwaite, N., et al.; Toward Percutaneous Spine Fusion; Ch. 45:
`Lumbar Spine Surgery: Techniques and Complications; C.V. Mosby
`Company, 2 cover pages and pp. 512-522 (1987).
`Bagby, G.W.; Arthrodesis by the Distraction-Compression Method
`Using a Stainless Steel Implant; Orthopedics, vol. II, No. 6, pp.
`931-934 (Jun. 1988).
`Itoman, M., et al.; Banked Bone Grafting for Bone Defect Repair—
`Clinical Evaluation of Bone Union and Graft Incorporation; J. Jpn.
`Orthop. Assoc. 62:461–469 (1988).
`Kane, W.J.; Direct Current Electrical Bone Growth Stimulation for
`Spinal Fusion; Spine, vol. 13, No. 3, pp. 363-365 (Mar. 1988).
`The SpF-T Spinal Fusion Stimulator: An Efficacious Adjunct that
`Meets the Diverse Needs of Spine Patients; EBI Medical Systems;
`(Aug. 1991); 4 pages.
`Schmitz et al.; Performance of Alloplastic, Materials and Design of
`an Artificial Disc: The Artificial Disc, Brock, Mayer, Weigel (edi
`tors); cover page and pp. 23-34 (1991).
`The Use of Direct Current for Electrically Induced Osteogenesis; The
`Positive Effect of an Electronegative charge on Bone Growth; EBI
`Medical Systems (Feb. 1993); 4 pages.
`Mylonas, C., et al.; Anterior Cervical Decompression and Fusion
`Using the Coventry Cervical Spreader and Dowel Inserter; British
`Journal of Neurosurgery; 7: cover page and pp. 545-549 (1993).
`Fusion of the Lumbar Spine; Anterior Monosegmental Fusion L5-S1.
`Atlas of Spinal Operations, Thieme, cover page and pp. 270-274
`(1993).
`Spine Basics, Danek Group, Inc., Glossary (1993); 2 pages.
`Lumbar Spine Surgery, Techniques & Complications; 1987, pp.
`11-15, 27, 30, 35-45, and 265-268.
`Cloward, Ralph B.; Surgical Techniques for Lumbar Disc Lesions;
`Codman; Signature Series 3; 1982; 31 pages.
`Cloward, Ralph B.; Ruptured Cervical Intervertebral Discs: Removal
`of Disc & Osteophytes & Anterior Cervical Interbody Fusion (A.C.
`I.F.); Codman; Signature Series 4: 1974; 22 pages.
`Cloward, Ralph B.; Recent Advances in Surgery of the Cervical
`Spine; 2 cover pages and pp. 285-293; German Society for
`Neurosurgery: vol. 2 Cervical Spine Operations; Excerpta Medics;
`1971.
`Hutter, Charles George; Spinal Stenosis and Posterior Lumbar
`Interbody Fusion; 2 cover pages and pp. 103-114; Clinical
`Orthopaedics and Related Research; No. 193; The Association of
`Bone and Joint Surgeons; 1985.
`Lin, Paul M. (editor); Posterior Lumbar Interbody Fusion; 2 cover
`pages and pp. 114-122; Charles C. Thomas; Springfield, Illinois;
`1982.
`Lin, Paul M., et al. (editors); Lumbar Interbody Fusion: Principles
`and Techniques in Spine Surgery; Techniques and Complications; 5
`cover pages and pp. 81, 98, 120, 146, 173, 180-184, 204, 224, 225,
`and 231; Aspen Publishers, Inc.; 1989.
`
`Tan, S.B., et al.; A Modified Technique of Anterior Lumbar Fusion
`with Femoral Cortical Allograft; 2 cover pages and pp. 83-93; The
`Journal of Orthopaedic Surgical Techniques, vol. 5, No. 3, 1990.
`Muller, M.E., et al.: Manual of Internal Fixation: Techniques Rec
`ommended by the AO Group; Second Edition, Expanded and
`Revised; cover page, and pp. V. VI, 3-20), 27-41, 53-58, 71-78, 94.
`311, and 320: Springer-Verlag: 1979.
`Hierholzer, G., et al.; Manual on the AO/ASIF Tubular External
`Fixator; 2 cover pages and pp. 85-91; Springer-Verlag: 1985.
`Heim, Urs, et al.; Small Fragment Set Manual: Technique Recom
`mended by the ASIF-Group; 2 cover pages and pp. 5-7, 10, 20, 21.
`and 30; Springer-Verlag: 1974.
`Harmon, Paul H.; Anterior Excision and Vertebral Body Fusion
`Operation for Intervertebral Disk Syndromes of the Lower Lumbar
`Spine: Three- to Five-Year Results in 244 Cases; pp. 107-127; Clini
`cal Orthopaedics and Related Research, No. 26, J.B. Lippincott Com
`pany, 1963.
`Harmon, Paul H.; A Simplified Surgical Technic for Anterior Lumbar
`Diskectomy and Fusion; Avoidance of Complications; Anatomy of
`the Retropedtoneal Veins; pp. 130-144; Clinical Orthopaedics and
`Related Research, No. 37, J.B. Lippincott Company, 1964.
`Bullough, P. et al.; Atlas of Spinal Diseases; Figure 5.7; J.B. Lip
`pencott Company; 1988; 3 pages.
`Canale, S. Terry; Campbell's Operative Orthopaedics; vol. 3, 9th
`Edition; 2 cover pages and pp. 2191, 2216, and 2459; Mosby, 1998.
`Baulot et al.; "Complementary Anterior Spondylodesis by
`Thoracosopy. Technical note regarding an observation, Technical
`Designs and Experimental Research.” 90(5): 347-351 (1994).
`Bolesta and Bohlman; Chapter 68: “Surgical Management of Injuries
`to the Thoracic and Lumbosacral Spine;” in “Surgery of the Spine, A
`Combined Orthopaedic and Neurosurgical Approach:” Ed. Findlay
`and Owen, pp. 1115-1129 and cover page; Oxford, Blackwell Sci
`entific Publications (1992).
`Larson et al., “Lateral Extracavitary Approach to Traumatic Lesions
`of the Thoracic and Lumbar Spine;” J. Neurosurg.: 45:628-6387
`(1976).
`Rosenthal et al., “Removal of a Protruded Thoracic Disc Using
`MicroSurgical Endoscopy. A New Technique.” Spine, 19(9): 1087
`1091 (1994).
`Friedman, William; “Percutaneous Discectomy: An Alternative to
`Chemonuleolysis? Neurosurgery, 13(5); cover page, contents page
`and pp. 542-547 (1983).
`Hoppenfeld, Stanley; “Percutaneous Removal of Herniated Lumbar
`Discs.” Clinical Orthopaedics and Related Research, No. 238, 2
`cover pages and pp. 92-97 (1989).
`Leu et al.; “Percutaneous Fusion of the Lumbar Spine: A Promising
`Technique.” Spine, vol. 6, No. 3, 2 cover pages and pp. 593-604
`(1992).
`Verbiest, H.; Chapter 1: “History and Development of Spinal Sur
`gery,” in “Surgery of the Spine, A Combined Orthopaedic and
`Neurosurgical Approach: Ed. Findlay and Owen, 2 cover pages and
`pp. 3-15; Oxford, Blackwell Scientific Publications (1992).
`Willberger, B.R.: “Dowel Intervertebral Fusion as Used in Lumbar
`Disc Surgery.” The Journal of Bone and Joint Surgery, vol. 39A.
`cover page and pp. 234-292, and 331; 1957.
`X-Rays showing Surgeries performed using the Acronex Disc; Sep. 7.
`1989; 7 pages.
`Pictures showing Surgery performed using the Brantigan I/F Cage;
`undated; 11 pages.
`Pictures of Brantigan I/F Cage, undated, 7 pages.
`Brantigan, John W., et al.; presentation titled “Interbody Lumbar
`Fusion Using a Carbon Fiber Cage Implant vs. Allograft Bone—an
`investigational study in the Spanish goat:” undated; 7 pages.
`Pictures showing Surgery performed using the Brantigan Anterior I/F
`Cage, undated; 9 pages.
`X-Rays and pictures showing Surgeries performed on sheep using the
`Brantigan Anterior IF Cage; dated Apr. 30, 1990 through Jul. 4.
`1992; 477 pages.
`X-Rays and picture showing Surgery using the BAK Cage, undated;
`3 pages.
`Drawings and pictures showing Surgery on sheep using the BAK
`Cage, undated; 6 pages.
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1021, p. 4 of 37
`
`

`

`US 8,251,997 B2
`Page 5
`
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.; Defen
`dant Nuvasive, Inc.'s First Amended Answer to Plaintiffs' First
`Amended Complaint for Patent Infringement and Third Amended
`Counterclaims; 24 pages; dated Sep. 4, 2009.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.; Joint
`Claim Construction Chart, Worksheet, and Hearing Statement Pur
`Suant to Patent L.R. 4.2 for U.S. Patent No. 5,772,661 U.S. Patent No.
`5,860,973, and U.S. Patent No. 6,945.933; 5 pages; dated May 27,
`2009; Exhibit A, 22 pages; Exhibit B, 24 pages; Exhibit D, 14 pages;
`Exhibit E, 21 pages.
`Medtronic Sofamor Danek USA, Inc. et al.; v. Nuvasive, Inc.;
`Medtronic's Third Supplemental Disclosure of Asserted Claims and
`Infringement Contentions; 5 pages; dated Nov. 6, 2009; Attachment
`16, 2 pages.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.; Joint
`Claim Construction Chart, Worksheet, and Hearing Statement Pur
`Suant to Patent L.R. 4.2 for U.S. Patent Nos. 6,592,586: 5,860,973;
`6,945.933; 7.582,058; and 7,470.236; 4 pages; dated Nov. 23, 2009;
`Exhibit B, 21 pages; Exhibit G, 17 pages.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Medtronic Sofamor Danek USA, Inc. et al.'s Opening Claim Con
`struction Brief; 70 pages; dated Jan. 11, 2010.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Medtronic's Fourth Supplemental Disclosure of Asserted Claims and
`Infringement Contentions; 8 pages; dated Feb. 12; 2010.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Medtronic Sofamor Danek USA, Inc., et al.'s Preliminary Claim
`Constructions Pursuant to Patent L.R. 4.1; 9 pages; dated Apr. 24.
`2009.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Medtronic Sofamor Danek USA, Inc., et al.'s Preliminary Claim
`Constructions Regarding U.S. Patent Nos. 6,592.586; 5,860,973;
`6,945,933; 7,582,058; 7.207,949; and 7,470,236 Pursuant to Patent
`L.R. 4.1; 11 pages; dated Sep. 30, 2009.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Medtronic Sofamor Danek USA, Inc., et al.'s l Responsive Claim
`Construction Brief; 37 pages; dated Jan. 20, 2010.
`Medtronic Sofamor Danek USA, Inc et al., v. Nuvasive, Inc.; Decla
`ration of Esha Bandyopadhyay in Support of Medtronic's Respon
`sive Claim Construction Brief; 4 pages; dated Jan. 20, 2010; Exhibit
`11, 4 pages; Exhibit 12, 3 pages; Exhibit 13, 2 pages; Exhibit 14, 3
`pages; Exhibit 16, 3 pages; Exhibit 17, 2 pages.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Medtronic Sofamor Danek USA, Inc., et al.'s Responsive Claim
`Constructions Regarding U.S. Patent Nos. 6,592.586; 5,860,973;
`6,945,933; 7,582,058; 7.207,949; and 7,470,236 Pursuant to Patent
`L.R. 4.1; 12 pages; dated Oct. 9, 2009.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Nuvasive, Inc.'s Opening Claim Construction Brief Regarding U.S.
`Patent Nos. 7,470,236; 7,582,058; 5,860,973; 6,592.586; and
`6,945.933; 70 pages; dated Jan. 11, 2010.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Nuvasive, Inc.'s Preliminary Claim Constructions and identification
`of Extrinsic Evidence Pursuant to Patent L.R. 4.1 for U.S. Patent No.
`5,772,661, U.S. Patent No. 5,860,973, and U.S. Patent No.
`6,945.933; 24 pages; dated Apr. 24, 2009.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Nuvasive, Inc.'s Preliminary Claim Constructions and Identification
`of Extrinsic Evidence Pursuant to Patent L.R. 4.1 for U.S. Patent No.
`6,592,586, U.S. Patent No. 5,860,973, U.S. Patent No. 6,945,933;
`U.S. Patent No. 7,207,949, U.S. Patent No. 7,470,236, and U.S.
`Patent No. 7,582,058; 7 pages; dated Sep. 30, 2009.
`Medtronic Sofamor Danek USA, Inc., et al., v. Nuvasive, Inc.;
`Nuvasive, Inc.'s Responsive Claim Constructions Pursuant to Patent
`L.R. 4.1; 15 pages; dated May 8, 2009.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.;
`Nuvasive, Inc.'s Responsive Claim Constructions and Identification
`of Extrinsic Evidence Pursuant to Patent L.R. 4.1 for U.S. Patent No.
`6,592,586, U.S. Patent No. 5,860,973, U.S. Patent No. 6,946,933;
`U.S. Patent No. 7,207,949, U.S. Patent No. 7,470,236, and U.S.
`Patent No. 7,582,058; 18 pages; dated Oct. 9, 2009.
`
`Medtronic Sofamor Danek USA, Inc. et al., v. NuVasive, Inc.;
`NuVasive's Preliminary Identification of Prior Art; 12 pages; dated
`Dec. 24, 2008.
`Medtronic Sofamor Danek USA, Inc. et al., v. NuVasive, Inc.;
`NuVasive Inc.'s Supplemental Response to Plaintiffs' Interrogatory
`No. 6; 26 pages; dated Apr. 17, 2009.
`Medtronic Sofamor Danek USA, Inc. et al., v. Nuvasive, Inc.; Order
`Construing Disputed Claim Terms of United States Patent Nos.
`5,860,973; 6.945.933; 6,592,586; and 7,470,236; pp. 1-22; Case No.
`08cvl 512- MMA(AJB); Apr. 1, 2010.
`Medtronic Sofamor Danek USA, Inc., et al. v. Nuvasive, Inc.; Plaintiff
`Medtronic Sofamor Danek USA, Inc., et al.'s Supplemental Objec
`tions and Responses to NuVasive, Inc.'s Second Set of Interrogato
`ries (No. 16); 13 pages; dated May 10, 2010.
`Medtronic Sofamor Danek, Inc., v. Nuvasive, Inc.; Nuvasive, Inc.'s
`Corrected Final Invalidity Contentions Regarding U.S. Patent Nos.
`5,860,973; 6,592.586; and 6.945.933; 17 pages; dated Jun. 14, 2010;
`Appendix B.1, 63 pages; Appendix B.2, 61 pages; Appendix B.3, 55
`pages; Appendix B.4, 61 pages; Appendix B.5, 51 pages; Appendix
`B.6, 73 pages; Appendix B.7, 61 pages; Appendix B.8, 53 pages;
`Appendix B.9, 43 pages; Appendix B, 10, 60 pages; Amended Appen
`dix B. 11, 78 pages; Appendix B. 14, 27 pages; Appendix B. 15, 50
`pages; Appendix B. 16, 35 pages; Appendix B. 17, 12 pages; Appen
`dix B. 18, 14 pages; Appendix B. 19, 13 pages; Appendix B.20, 12
`pages; Appendix B.21, 13 pages; Appendix 8.22, 13 pages; Appendix
`B.23, 13 pages.
`Medtronic Sofamor Danek, Inc. v. Nuvasive, Inc.; Expert Report of
`Dr. Barton L. Sachs, M.D. M.B.A., CPE Regarding Infringement of
`U.S. Patent Nos. 5,860,973 and 6.945.933 (redacted); 194 pages;
`Dec. 3, 2010.
`Medtronic Sofamor Danek, Inc., v. Nuvasive, Inc.; Expert Rebuttal
`Report of Dr. Barton L. Sachs, M.D., M.B.A., CPE Regarding Valid
`ity of U.S. Patent Nos. 5,860,973 and 6.945.933; 144 pages; Jan. 20,
`2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc.; Medtronic's Opposition
`to Nuvasive iInc.'s Motions for Summary Judgment (Redacted Ver
`sion); 30 pages; Mar. 9, 2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc.; Medtronic's Responses
`to Nuvasive's Statement of Undisputed Facts and Medtronic's State
`ment of Additional Material Facts (Redacted Version); 77 pages; Mar.
`9, 2011.
`Warsaw Orthopedic, Inc., v. Nuvasive, Inc.; Nuvasive's Opposition to
`Warsaw's Motions for Summary judgment (Redacted Version); 31
`pages; Mar. 9, 2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc.; Nuvasive's Response to
`Warsaw's Statement of Undisputed Material Facts (Redacted Ver
`sion); 89 pages; Mar. 10, 2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc.: Medtronic's Responses
`to Nuvasive's Statement of Additional Material Facts (Redacted Ver
`sion); 39 pages; Mar. 16, 2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc., Nuvasive's Reply in
`Support of Motions for Summary Judgment (Redacted Version); 13
`pages Mar. 16, 2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc.; Nuvasive's Reply to
`Warsaw's Statement of Additional Material Facts (Redacted Ver
`sion); 67 pages; Mar. 16, 2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc.; Reply Memorandum in
`Support of Medtronic's Motion for Summary Judgment (Redacted
`Version); 14 pages; Mar. 16, 2011.
`Medtronic Sofamor Danek, Inc. v. Nuvasive, Inc.; Notice and Order
`Providing Tentative Rulings Re: Parties' Cross Motions for Summary
`judgment; 1 page; Mar. 21, 2011.
`Warsaw Orthopedic, Inc. v. Nuvasive, Inc.; Nuvasive, Inc.'s Notice
`Pursuant to 35 U.S.C. S. 282; 11 pages; Jul. 29, 2011.
`Warsaw Orthopedic, Inc., v. Nuvasive, Inc.; Judgment Following
`Jury Verdict; 9 pages; Sep. 20, 2011.
`Barnes, Walter P.; "The Use of Blade-Guides in Intervertebral-Body
`Bone-Grafting.” The Journal of Bone & Joint Surgery, vol. 40-A, No.
`2; Apr. 1958; cover pages and pp. 461-464.
`Brantigan, John W., et al.; "A Carbon Fiber Implant to Aid Interbody
`Lumbar Fusion: 1-year Clinical Results in the First 26 Patients:”
`Lumbar Fusion and Stabilization; cover page and pp. 379-395.
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1021, p. 5 of 37
`
`

`

`US 8,251,997 B2
`Page 6
`
`Brantigan, John W., et al.; "A Carbon Fiber Implant to Aid Interbody
`Lumbar Fusion: Two-Year Clinical Results in the First 26 Patients;”
`SPINE, vol. 18, No. 14; 1993; pp. 2106-2117.
`Brantigan, John W., et al.; "A Carbon Fiber Implant to Aid Interbody
`Lumbar Fusion: Mechanical Testing.” SPINE, Vol. 16, No. 6S; Jun.
`1991; pp. S277-S282.
`Brantigan ALIF Cage, 1993, 121 pages.
`Chang, Benjamin B., et al.; "The Right Retroperitoneal Approach for
`Abdominal Aortic Surgery.” The American Journal of Surgery; vol.
`158; Aug. 1989; cover and pp. A2, A3, and 156-158.
`Freebody, D., et al.; "AnteriorTransperitoneal Lumbar Fusion.” The
`Journal of Bone and Joint Surgery; vol. 53B, No. 4; Nov. 1971; pp.
`617-627.
`Fujimaki, Arihisa, et al.; "The Results of 150 Anterior Lumbar
`interbody Fusion Operations Performed by Two Surgeons in Austra
`lia.” Clinical Orthopaedics and Related Research; No. 165; May
`1982: pp. 164-167.
`Harmon, Paul H.; "Subtotal Anterior Lumbar Disc Excision and
`Vertebral Body Fusion.” American Journal of Surgery; vol. 97; May
`1959: pp. 649-659.
`Hodgson, A.R., et al.; "The Classic Anterior Spinal Fusion.” Clinical
`Orthopaedics and Related Research; No. 300; Mar. 1994; pp. 16-23.
`Hoover, Norman W., et al., “Methods of Lumbar Fusion;' The Jour
`nal of Bone & Joint Surgery; vol. 50-A, No. 1; Jan. 1968; cover page
`and pp. 194-210.
`Mack, Michael J., et al.; “Video-Assisted Thoracic Surgery for the
`Anterior Approach to the Thoracic Spine.” Ann Thorac Surg; No. 59;
`1995; pp. 1100-1106.
`McAfee, Paul C.; "Complications of Anterior Approaches to the
`Thoracolumbar Spine;” Clinical Orthopaedics; vol. 306; Sep.1994;
`pp. 110-119.
`Nissan, M., et al.; "The Cervical and Lumbar Vertebrae—An
`Anthropometric Model:” Engineering in Medicine; vol. 13, No. 3;
`1984; pp. 111-114.
`Panjabi, Manohar M., et al.; "Cervical Human Vertebrae Quantitative
`Three-Dimensional Anatomy of the Middle and Lower Regions;”
`SPINE; vol. 16, No. 8; 1991; pp. 861-869.
`Panjabi, Manohar M., et al.; "Thoracic Human Vertebrae Quantita
`tive Three-Dimensional Anatomy.” SPINE; vol. 16, No. 8; 1991; pp.
`888-901.
`Postacchini, Franco, et al.; “Morphometry of the Lumbar Vertebrae;”
`Clinical Orthopaedics and Related Research; No. 172; Jan.-Feb.
`1983; pp. 296-303.
`Program for Thorascopy and Laparoscopy of the Spine; Feb. 18-19,
`1994; 4 pages.
`Scoles, Peter V., et al.; “Vertebral Body and Posterior Element Mor
`phology: The Normal Spine in Middle Life.” Spine; vol. 13, No. 10;
`Oct. 1988; cover page and pp. 1083-1085.
`Texas Back Institute Research Foundation Neuroscience Conference
`Schedule; First Quarte