Case 3:18-cv-00347-CAB-MDD Document 253-17 Filed 01/18/20 PageID.22777 Page 1 of
` 33
`
`
`
`
`
`
`EXHIBIT 17
`
`
`TO THE DECLARATION OF BRIAN J. NISBET
`IN SUPPORT OF DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY ADJUDICATION
`
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-17 Filed 01/18/20 PageID.22778 Page 2 of
` 33
`
`US008753270B2
`
`(12) United States Patent
`Miles et al.
`
`(io) Patent No.:
`(45) Date of Patent:
`
`US 8,753,270 B2
`*Jun. 17, 2014
`
`(54) SURGICAL ACCESS SYSTEM AND RELATED
`METHODS
`
`(71) Applicant: NuVasive, Inc., San Diego, CA (US)
`
`(72)
`
`Inventors: Patrick Miles, San Diego, CA (US);
`Scot Martinelli, Mountain Top, PA
`(US); Eric Finley, Poway, CA (US)
`
`(73) Assignee: NuVasive, Inc., San Diego, CA (US)
`
`(52) u.s. ci.
`CPC .................................... A61B 17/0218 (2013.01)
`USPC ............................................... 600/215; 600/235
`(58) Field of Classification Search
`CPC ....................................................... A61B 17/0218
`USPC ............................................. 600/213, 215, 235
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`This patent is subject to a terminal dis­
`claimer.
`
`208,227 A
`972,983 A
`1,003,232 A
`1,044,348 A
`
`9/1878 Don-
`10/1910 Arthur
`10/1910 Cerbo
`6/1912 Cerbo
`(Continued)
`
`(21) Appl. No.: 13/955,950
`
`(22) Filed:
`
`Jul. 31, 2013
`
`(65)
`
`Prior Publication Data
`US 2013/0317311 Al Nov. 28, 2013
`
`Related U.S. Application Data
`(63) Continuation of application No. 13/466,531, filed on
`May 8, 2012, now Pat. No. 8,523,768, which is a
`continuation of application No. 13/417,499, filed on
`Mar. 12, 2012, now Pat. No. 8,343,046, which is a
`continuation of application No. 12/650,301, filed on
`Dec. 30, 2009, now Pat. No. 8,133,173, which is a
`continuation of application No. 12/636,860, filed on
`Dec. 14, 2009, now Pat. No. 8,403,841, which is a
`continuation of application No. 10/759,811, filed on
`Jan. 16, 2004, now Pat. No. 7,691,057.
`
`(51) Int. Cl.
`A61B1/32
`A61B17/02
`
`(2006.01)
`(2006.01)
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`
`7/1999
`299 08 259
`4/2002
`100 48 790
`(Continued)
`OTHER PUBLICATIONS
`Anatomy of the Lumbar Spine in MED TM MicroEndoscopic
`Discectomy (1997 Ludann Grand Rapids MI), 14 pgs.
`(Continued)
`
`Primary Examiner — Ellen C Hammond
`(74) Attorney, Agent, or Firm — Fish & Richardson PC.
`
`ABSTRACT
`(57)
`A surgical access system including a tissue distraction assem­
`bly and a tissue refraction assembly, both of which may be
`equipped with one or more electrodes for use in detecting the
`existence of (and optionally the distance and/or direction to)
`neural structures before, during, and after the establishment
`of an operative corridor to a surgical target site.
`
`12 Claims, 18 Drawing Sheets
`
`ATEC LLIF000848888
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-17 Filed 01/18/20 PageID.22779 Page 3 of
` 33
`
`US 8,753,270 B2
`Page 2
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`1,328.624 A
`1,548,184 A
`2,594,086 A
`2,704,064 A
`2,736,002 A
`2,808,826 A
`3,364,929 A
`3,664,329 A
`3,682,162 A
`3,785,368 A
`3,803,716 A
`3,830,226 A
`3,957,036 A
`D245,789 S
`4,099,519 A
`4,164,214 A
`4,207,897 A
`4,224,949 A
`4,226.228 A
`4,226,288 A
`4,235,242 A
`4,285,347 A
`4,291,705 A
`4,449,532 A
`4,461,300 A
`4,512.351 A
`4,515,168 A
`4,519,403 A
`4,545,374 A
`4,561,445 A
`4,562,832 A
`4,573,448 A
`4,592.369 A
`4,595,013 A
`4,595,018 A
`4,611,597 A
`4,633,889 A
`4,658,835 A
`0295,445 S
`4,744.371 A
`4,753,223 A
`4,759,377 A
`4,784,150 A
`4,807,642 A
`D30Q,561 S
`4,892,105 A
`4,913.134 A
`4,917,274 A
`4,926,865 A
`4,950,257 A
`4,962,766 A
`4,964,411 A
`5,007,902 A
`5,045.054 A
`5,052,373 A
`5,058,602 A
`5,081,990 A
`5,092,344 A
`5,127,403 A
`5,161,533 A
`5,171.279 A
`5,195,541 A
`5,196,015 A
`5,215,100 A
`RE34.390 E
`D340.521 S
`5,255,691 A
`5,282.468 A
`5,284,153 A
`5,284,154 A
`5,295,994 A
`5,299,563 A
`5,312,417 A
`5,313,956 A
`5,313,962 A
`
`1/1920 Graham
`8/1925 Cameron
`4/1952 Smith
`6/1955 Fizzell et al.
`2/1956 Oriel
`10/1957 Reiner et al.
`1/1968 Ide et al.
`5/1972 Naylor
`8/1972 Colyer
`1/1974 McCarthy et al.
`4/1974 Gamier
`8/1974 Staub et al.
`5/1976 Normann
`9/1977 Shea et al.
`7/1978 Warren
`8/1979 Stark et al.
`6/1980 Lloyd et al.
`9/1980 Scott et al.
`10/1980 Shin et al.
`10/1980 Collins, Jr.
`11/1980 Howson et al.
`8/1981 Hess
`9/1981 Severinghaus et al.
`5/1984 Storz
`7/1984 Christensen
`4/1985 Pohndorf
`5/1985 Chester et al.
`5/1985 Dickhudt
`10/1985 Jacobson
`12/1985 Berke et al.
`1/1986 Wilder et al.
`3/1986 Kambin
`6/1986 Davis et al.
`6/1986 Jones et al.
`6/1986 Rantala
`9/1986 Kraus
`1/1987 Talalla
`4/1987 Pohndorf
`4/1988 Freeman
`5/1988 Harris
`6/1988 Bremer
`7/1988 Dykstra
`11/1988 Voorhies et al.
`2/1989 Brown
`4/1989 Asa et al.
`1/1990 Prass
`4/1990 Luque
`4/1990 Asa et al.
`5/1990 Oman
`8/1990 Hibbs et al.
`10/1990 Herzon
`10/1990 Johnson et al.
`4/1991 Witt
`9/1991 Flood et al.
`10/1991 Michelson
`10/1991 Brody
`1/1992 Deletis
`3/1992 Lee
`7/1992 Brownlee
`11/1992 Prass et al.
`12/1992 Mathews
`3/1993 Obenchain
`3/1993 Neubardt
`6/1993 Spitz et al.
`9/1993 Culver
`10/1993 Heinzelman et al.
`10/1993 Often
`2/1994 Klepinski
`2/1994 Raymond et al.
`2/1994 Raymond et al.
`3/1994 Bonutti
`4/1994 Seton
`5/1994 Wilk
`5/1994 Knutsson et al.
`5/1994 Obenchain
`
`5,327,902 A
`5.331,975 A
`5,333,618 A
`5,342,384 A
`5.357,983 A
`5,375,067 A
`5,375,594 A
`5,383,876 A
`5.395,317 A
`5,450,845 A
`5,474,057 A
`5.474,558 A
`5,480,440 A
`5,482,038 A
`5,484,437 A
`5.487,739 A
`5,509,893 A
`5,514,153 A
`5.540,235 A
`5,549,656 A
`5,560,372 A
`5,566,678 A
`5.571,149 A
`5,579,781 A
`5,593,429 A
`5.599,279 A
`5,630,813 A
`5,667,508 A
`5,671,752 A
`5,681,265 A
`5,688,223 A
`5,707,359 A
`5.711,307 A
`5,728,046 A
`5,741,253 A
`5,759,159 A
`5.762,629 A
`5,772,661 A
`5,775,331 A
`5,776,144 A
`5,779,642 A
`5,785,658 A
`5,792,044 A
`5,797,854 A
`5,797,909 A
`5,814,073 A
`5,830,151 A
`5.851,191 A
`5,853,373 A
`5,860,973 A
`5.862,314 A
`5,872,314 A
`5,885,210 A
`5,885,219 A
`5.888,196 A
`5,891,147 A
`5,902,231 A
`5.928,139 A
`5,928,158 A
`5,931,777 A
`5,935,131 A
`5.938,688 A
`5,944,658 A
`5,976,094 A
`6.004,262 A
`6,004,312 A
`6,007,487 A
`6,010,520 A
`6,024,696 A
`6,024,697 A
`6,027,456 A
`6,038,469 A
`6,038,477 A
`6,050,992 A
`6,074,343 A
`6,083,154 A
`6,095,987 A
`6,104,957 A
`6,104,960 A
`
`7/1994 Lemmen
`7/1994 Bonutti
`8/1994 Lekhtman et al.
`8/1994 Sugarbaker
`10/1994 Mathews
`12/1994 Berchin
`12/1994 Cueva
`1/1995 Nardella
`3/1995 Kambin
`9/1995 Axelgaard
`12/1995 Makower et al.
`12/1995 Neubardt
`1/1996 Kambin
`1/1996 Ruff
`1/1996 Michelson
`1/1996 Aebischer et al.
`4/1996 Pracas
`5/1996 Bonutti
`7/1996 Wilson
`8/1996 Reiss
`10/1996 Cory
`10/1996 Cadwell
`11/1996 Liss et al.
`12/1996 Cooke
`1/1997 Ruff
`2/1997 Slotman et al.
`5/1997 Kieturakis
`9/1997 Errico et al.
`9/1997 Sinderby et al.
`10/1997 Maeda et al.
`11/1997 Rosendahl
`1/1998 Bufalini
`1/1998 Smits
`3/1998 Mayer et al.
`4/1998 Michelson
`6/1998 Masreliez
`6/1998 Kambin
`6/1998 Michelson
`7/1998 Raymond et al.
`7/1998 Leysieffer et al.
`7/1998 Nightengale
`7/1998 Benaron
`8/1998 Foley et al.
`8/1998 Hedgecock
`8/1998 Michelson
`9/1998 Bonutti
`11/1998 Hadzic et al.
`12/1998 Gozani
`12/1998 Griffith et al.
`1/1999 Michelson
`1/1999 Jeddeloh
`2/1999 Clinton
`3/1999 Cox
`3/1999 Nightengale
`3/1999 Bonutti
`4/1999 Moskovitz et al.
`5/1999 Foley et al.
`7/1999 Koros et al.
`7/1999 Aristides
`8/1999 Sava
`8/1999 Bonutti
`8/1999 Schiff
`8/1999 Koros et al.
`11/1999 Gozani et al.
`12/1999 Putz et al.
`12/1999 Finneran
`12/1999 Foley et al.
`1/2000 Pattison
`2/2000 Hoftman et al.
`2/2000 Pisarik
`2/2000 Feler et al.
`3/2000 Karlsson et al.
`3/2000 Kayyali
`4/2000 Nichols
`6/2000 Nathanson et al.
`7/2000 Liu et al.
`8/2000 Schmulewitz
`8/2000 Alo et al.
`8/2000 Duysens et al.
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-17 Filed 01/18/20 PageID.22780 Page 4 of
` 33
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`US 8,753,270 B2
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`6,120.503 A
`6,126,660 A
`6,132,386 A
`6,132,387 A
`6,135,965 A
`6,139,493 A
`6,146,335 A
`6,152,871 A
`6,159,179 A
`6,161,047 A
`6,174,311 B1
`6,181,961 B1
`6,196,969 B1
`6,206,826 B1
`6,217,509 B1
`6,224,549 B1
`6,245,082 B1
`6,259,945 B1
`6,264.651 B1
`6,266,558 B1
`6,273,905 B1
`6,292,701 B1
`6,306,100 B1
`6,308,712 B1
`6,312,392 B1
`6,325.764 B1
`6,334,068 B1
`6,348,058 B1
`6,360,750 B1
`6,371,968 B1
`6,395,007 B1
`6,425,859 B1
`6,425.887 B1
`6,425,901 B1
`6,450,952 B1
`6,451,015 B1
`6,466,817 B1
`6,468,205 B1
`6,468,207 B1
`6,500.116 B1
`6,500,128 B2
`6,520,907 B1
`6,524,320 B2
`6,535,759 B1
`6,564,078 B1
`6,579,244 B2
`6,599.294 B2
`6,620,157 B1
`6,645,194 B2
`6,679,833 B2
`6,719,692 B2
`6,760,616 B2
`6,770,074 B2
`6,796.985 B2
`6,810,281 B2
`6,819,956 B2
`6,829,508 B2
`6,847,849 B2
`6,849,047 B2
`6,855,105 B2
`6,869.398 B2
`6,871,099 B1
`6,902,569 B2
`6,916,330 B2
`6,926,728 B2
`6,929,606 B2
`6,945,933 B2
`6,951.538 B2
`7,047,082 B1
`7,050,848 B2
`7,079,883 B2
`7,089,059 B1
`7,177,677 B2
`7,198,598 B2
`7,207,949 B2
`
`9/2000 Michelson
`10/2000 Dietz
`10/2000 Gozani et al.
`10/2000 Gozani et al.
`10/2000 Turner et al.
`10/2000 Koros et al.
`11/2000 Gozani
`11/2000 Foley et al.
`12/2000 Simonson
`12/2000 King et al.
`1/2001 Branch et al.
`1/2001 Prass
`3/2001 Bester et al.
`3/2001 Mathews et al.
`4/2001 Foley et al.
`5/2001 Drongelen
`6/2001 Gellman et al.
`7/2001 Epstein et al.
`7/2001 Underwood et al.
`7/2001 Gozani et al.
`8/2001 Streeter
`9/2001 Prass et al.
`10/2001 Prass
`10/2001 Shaw
`11/2001 Herzon
`12/2001 Griffith et al.
`12/2001 Hacker
`2/2002 Melkent et al.
`3/2002 Gerber et al.
`4/2002 Kogasaka et al.
`5/2002 Bhatnagar et al.
`7/2002 Foley et al.
`7/2002 McGuckin et al.
`7/2002 Zhu et al.
`9/2002 Rioux et al.
`9/2002 Rittman, III et al.
`10/2002 Kaula et al.
`10/2002 Mollenauer et al.
`10/2002 Fowler, Jr.
`12/2002 Knapp
`12/2002 Marino
`2/2003 Foley et al.
`2/2003 DiPoto
`3/2003 Epstein et al.
`5/2003 Marino et al.
`6/2003 Goodwin
`7/2003 Fuss et al.
`9/2003 Dabney et al.
`11/2003 Briscoe et al.
`1/2004 Smith et al.
`4/2004 Kleffner et al.
`7/2004 IToey et al.
`8/2004 Michelson
`9/2004 Bolger et al.
`10/2004 Brock et al.
`11/2004 DiLorenzo
`12/2004 Schulman et al.
`1/2005 Mamo et al.
`2/2005 Goodwin
`2/2005 Jackson, III et al.
`3/2005 Obenchain
`3/2005 Whitehurst et al.
`6/2005 Parmer et al.
`7/2005 Simonson
`8/2005 Zucherman et al.
`8/2005 Ritland
`9/2005 Branch
`10/2005 Ritland
`5/2006 Schrom et al.
`5/2006 Hoey et al.
`7/2006 Marino et al.
`8/2006 Pless
`2/2007 Kaula et al.
`4/2007 Smith et al.
`4/2007 Miles et al.
`
`7,226,451 B2
`7,261,688 B2
`7,470,236 B1
`7,473,222 B2
`7,481,766 B2
`7,522,953 B2
`7,556,601 B2
`7,582,058 B1
`7,643,884 B2
`7,691,057 B2
`7,693,562 B2
`7,717,959 B2
`7.819,801 B2
`7.935,051 B2
`8.000,782 B2
`8.005,535 B2
`8,021,430 B2
`8,133,173 B2
`8,192,356 B2
`8,251,997 B2
`8,343,046 B2
`2001/0039949 Al
`2001/0056280 Al
`2002/0007129 Al
`2002/0010392 Al
`2002/0072686 Al
`2002/0077632 Al
`2002/0123744 Al
`2002/0123780 Al
`2002/0161415 Al
`2002/0193843 Al
`2003/0032966 Al
`2003/0070682 Al
`2003/0083688 Al
`2003/0105503 Al
`2003/0139648 Al
`2003/0149341 Al
`2003/0225405 Al
`2003/0236544 Al
`2004/0199084 Al
`2004/0225228 Al
`2005/0004593 Al
`2005/0004623 Al
`2005/0033380 Al
`2005/0075578 Al
`2005/0080320 Al
`2005/0149035 Al
`2005/0182454 Al
`2005/0192575 Al
`2006/0025703 Al
`2006/0052828 Al
`2006/0069315 Al
`2006/0224078 Al
`2007/0016097 Al
`2007/0198062 Al
`2007/0293782 Al
`2008/0058606 Al
`2008/0058838 Al
`2008/0064976 Al
`2008/0064977 Al
`2008/0065178 Al
`2008/0071191 Al
`2008/0097164 Al
`2008/0300465 Al
`2009/0124860 Al
`2009/0138050 Al
`2009/0192403 Al
`2009/0204016 Al
`2010/0069783 Al
`2010/0130827 Al
`2010/0152603 Al
`2010/0160738 Al
`2010/0174146 Al*
`
`6/2007 Shluzas et al.
`8/2007 Smith et al.
`12/2008 Kelleher et al.
`1/2009 Dewey et al.
`1/2009 Lee et al.
`4/2009 Kaula et al.
`7/2009 Branch et al.
`9/2009 Miles et al.
`1/2010 Pond et al.
`4/2010 Miles et al.
`4/2010 Marino et al.
`5/2010 William et al.
`10/2010 Miles et al.
`5/2011 Miles et al.
`8/2011 Gharib et al.
`8/2011 Gharib et al.
`9/2011 Michelson
`3/2012 Miles et al.
`6/2012 Miles et al.
`8/2012 Michelson
`1/2013 Miles et al.
`11/2001 Loubser
`12/2001 Underwood et al.
`1/2002 Marino
`1/2002 Desai
`6/2002 Hoey et al.
`6/2002 Tsou
`9/2002 Reynard
`9/2002 Grill et al.
`10/2002 Cohen et al.
`12/2002 Hill et al.
`2/2003 Foley et al.
`4/2003 Wilson et al.
`5/2003 Simonson
`6/2003 Marino
`7/2003 Foley et al.
`8/2003 Clifton
`12/2003 Weiner
`12/2003 Lunsford et al.
`10/2004 Kelleher et al.
`11/2004 Ferree
`1/2005 Simonson
`1/2005 Miles et al.
`2/2005 Tanner et al.
`4/2005 Gharib et al.
`4/2005 Lee et al.
`7/2005 Pimenta et al.
`8/2005 Gharib et al.
`9/2005 Pacheco
`2/2006 Miles et al.
`3/2006 Kim et al.
`3/2006 Miles et al.
`10/2006 Hoey et al.
`1/2007 Farquhar et al.
`8/2007 Miles et al.
`12/2007 Marino
`3/2008 Miles et al.
`3/2008 Steinberg
`3/2008 Kelleher et al.
`3/2008 Kelleher et al.
`3/2008 Kelleher et al.
`3/2008 Kelleher et al.
`4/2008 Miles et al.
`12/2008 Feigenwinter et al.
`5/2009 Miles et al.
`5/2009 Ferree
`7/2009 Gharib et al.
`8/2009 Gharib et al.
`3/2010 Miles et al.
`5/2010 Pimenta et al.
`6/2010 Miles et al.
`6/2010 Miles et al.
`7/2010 Miles et al.............
`
`600/202
`
`ATEC LLIF000848890
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-17 Filed 01/18/20 PageID.22781 Page 5 of
` 33
`
`US 8,753,270 B2
`Page 4
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2010/0174148 A1 7/2010 Miles etal.
`2012/0238822 A1 *
`9/2012 Miles et al....................... 600/202
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`EP
`FR
`JP
`JP
`KR
`WO
`WO
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`
`9/1989
`0 334 116
`10/1993
`0 567 424
`1/2000
`0 972 538
`5/2000
`1 002 500
`1/2001
`2 795 624
`5/1990
`793186
`3/1996
`10-14928
`11/1999
`3019990007098
`12/1994
`94/28824
`1/1997
`97/00702
`6/1998
`98/23324
`10/1999
`99/52446
`5/2000
`00/27291
`7/2000
`00/38574
`8/2000
`00/044288
`11/2000
`00/66217
`11/2000
`00/67645
`2/2001
`01/08563
`5/2001
`01/37728
`8/2001
`01/60263
`7/2002
`02/054960
`8/2002
`02/058780
`9/2002
`02/071953
`11/2002
`02/087678
`1/2003
`03/005887
`4/2003
`03/026482
`5/2003
`03/037170
`2/2005
`2005/013805
`4/2005
`2005/030318
`4/2006
`2006/042241
`6/2006
`2006/066217
`OTHER PUBLICATIONS
`
`Dirksmeier et al., “Microendoscopic and Open Laminotomy and
`Discectomy in Lumbar Disc Disease” Seminars in Spine Surgery,
`1999, 11(2): 138-146.
`METRx Delivered Order Form, 1999, 13 pages.
`Medtronic Sofamor Danek “METRx™ MicroDi sectomy System,”
`Medtronic Sofamor Danek USA, 2000, 21 pgs.
`Medtronic Sofamor Danek “METRx System Surgical Technique,”
`2004, 22 pages.
`“MetRx System Micro Endoscopic Discectomy: An Evolution in
`Minimally Invasive Spine Surgery,” Sofamor Danek, 1999, 6 pages.
`Smith and Foley “MetRx System Micro Endoscopic Discectomy:
`Surgical Technique” Medtronic Sofamor Danek, 2000, 24 pages.
`“Sofamor Danek MED Microendoscopic Discectomy System Bro­
`chure” including Rapp “New endoscopic lumbar technique improves
`access preserves tissue” Reprinted with permission from: Orthope­
`dics Today, 1998, 18(1): 2 pages.
`Japanese Patent Office JP Patent Application No. 2006-528306
`Office Action with English Translation, Jun. 10, 2009, 4 pages.
`Plaintiffs’ Preliminary Invalidity Contentions re US Patents
`7207949; 7470236 and 7582058, Sep. 18, 2009, 19 pages.
`Plaintiffs’ Preliminary Invalidity Contentions-Appendices, Sep. 18,
`2009, 191 pages.
`Plaintiffs’ Supplemental Preliminary Invalidity Contentions re US
`Patents 7207949, 7470236, and 7582058, Sep. 29, 2009, 21 pages.
`Plaintiffs’ Supplemental Preliminary Invalidity Contentions-Appen­
`dices, Sep. 29, 2009, 294 pages.
`Axon 501(k) Notification: Epoch 2000 Neurological Workstation,
`Dec. 3, 1997, 464 pages.
`Foley and Smith, “Microendoscopic Discectomy,” Techniques in
`Neurosurgery, 1997, 3(4):301-307.
`Medtronic Sofamor Danek “Union™ / Union-L™ Anterior & Lateral
`Impacted Fusion Devices: Clear choice of stabilization,” Medtronic
`Sofamor Danek, 2000, 4 pages.
`
`NuVasive Vector™ Cannulae, 2000, 1 page.
`NuVasive Triad™ Tri-Columnar Spinal EndoArthrodesis™ via
`Minimally Invasive Guidance, 2000,1 page, (prior to Sep. 25, 2003).
`NuVasive Triad™ Cortical Bone Allograft, 2000, 1 page (prior to
`Sep. 25,2003).
`NuVasive Vertebral Body Access System, 2000, 1 page.
`Marina, “New Technology for Guided Navigation with Real Time
`Nerve Surveillance for Minimally Invasive Spine Discectomy &
`Arthrodesis,” Spineline, 2000, p. 39.
`NuVasive “INS-I Screw Test,” 2001, 10 pages.
`NuVasive letter re 510k Neuro Vision JJB System, Oct. 16, 2001, 5
`pages.
`NuVasive letter re 510k Guided Arthroscopy System, Oct. 5, 1999, 6
`pages.
`NuVasive letter re 510k INS-1 Intraoperative Nerve Surveillance
`System, Nov. 13, 2000, 7 pages.
`“NuVasiveTM Receives Clearance to Market Two Key Elem Mini­
`mally Invasive Spine Surgery System,” Nov. 27, 2001, 20 pages.
`Schick et al., “Microendoscopic lumbar discectomy versus open
`surgery: an intraoperative EMG study,” fMr Spine J, 2002, 11: 20-26.
`NuVasive letter re: 510(k) for Neurovision JJB System (Summary),
`Sep. 25, 2001, 28 pages.
`NuVasive letter re: Special 510(k) Premarket Notification: Neurovi­
`sion JJB System (Device Description), Jul. 3, 2003, 18 pages.
`NuVasive letter re: Special 510(k) Premarket Notification: Neurovi­
`sion JJB System (Device Description), Mar. 1, 2004, 16 pages.
`NuVasive letter re: Special 510(k) Premarket Notification: Neurovi­
`sion JJB System (Device Description), May 26, 2005, 17 pages.
`NuVasive letter re: 510(k) Premarket Notification: Neurovision JJB
`System (Device Description), Jun. 24, 2005, 16 pages.
`NuVasive letter re: Special 510(k) Premarket Notification: Neurovi­
`sion JJB System (Device Description), Sep. 14, 2006, 17 pages.
`NuVasive 510(k) Premarket Notification: Neurovision JJB System
`(Device Description), Aug. 20, 2007, 8 pages.
`NuVasive letter re: 510(k) Premarket Notification: Guided Spinal
`Arthroscopy System (Device Description), Feb. 1, 1999, 40 pages.
`NuVasive 510(k) Premarket Notification: Spinal System (Summary),
`Apr. 12, 2004, 10 pages.
`NuVasive 510(k) Summary NIM Monitor, Sep. 4, 1998, 4 pages.
`NuVasive correspondence re 510(k) Premarket Notification INS-1
`Intraoperative Nerve Surveillance System: Section IV Device
`Description, pp. 12-51 (prior to Sep. 25 2003).
`Isley et al., “Recent Advances in Intraoperative Neuromonitoring of
`Spinal Cord Function: Pedicle Screw Stimulation Techniques,”
`American Journal of Electroneurodagnostic Technology, Jun. 1997,
`37(2): 93-126.
`Mathews et al., “Laparoscopic Discectomy with Anterior Lumbar
`Interbody Fusion,” Spine, 1995, 20(16): 1797-1802
`Rose et al., “Persistently Electrified Pedicle Stimulation Instruments
`in Spinal Instrumentation: Techniques and Protocol Development,”
`Spine, 1997, 22(3): 334-343.
`“Electromyography System,” International Search report from Inter­
`national Application No. PCT/US00/32329, Apr. 27, 2001, 9 pages.
`“Nerve Proximity and Status Detection System and Method,” Inter­
`national Search Report from International Application No. PCT/
`US01/18606, Oct. 18, 2001, 6 pages.
`“Relative Nerve Movement and Status Detection System and
`Method,” International Search Report from International Application
`No. PCT/US01/18579, Jan. 15, 2002, 6 pages.
`“System and Method for Determining Nerve Proximity Direction
`and Pathology During Surgery,” International Search Report from
`International Application No. PCT/US02/22247, Mar. 27, 2003, 4
`pages.
`“System and Methods for Determining Nerve Direction to a Surgical
`Instrument,” International Search Report from International Appli­
`cation No. PCT/US03/02056, Aug. 12, 2003, 5 pages.
`“Systems and Methods for Performing Percutaneous Pedicle Integ­
`rity Assessments,” International Search Report from International
`Application No. PCT/US02/35047, Aug. 11, 2003, 5 pages.
`“Systems and Methods for Performing Surgery Procedures and
`Assessments,” International Search Report from International Appli­
`cation No. PCT/US02/30617, Jun. 5, 2003, 4 pages.
`
`ATEC LLIF000848891
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-17 Filed 01/18/20 PageID.22782 Page 6 of
` 33
`
`US 8,753,270 B2
`Page 5
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Lenke et al., “Triggered Electromyographic Threshold for Accuracy
`of Pedicle Screw Placement,” SPINE, 1995, 20(4): 1585-1591.
`“Brackmann II EMG System,” Medical Electronics, 1999, 4 pages.
`“Neurovision SE Nerve Locator/Monitor”, RLN Systems Inc.
`Operators Manual, 1999, 22 pages.
`“The Brackmann II EMG Monitoring System,” Medical Electronics
`Co. Operator’s Manual Version 1.1, 1995, 50 pages.
`“The Nicolet Viking IV,” Nicolet Biomedical Products, 1999, 6
`pages.
`Anderson et al., “Pedicle screws with high electrical resistance: a
`potential source of error with stimulus-evoked EMG,” Spine, Depart­
`ment of Orthopaedic Surgery University of Virginia, Jul. 15, 2002,
`27(14): 1577-1581.
`Bose et al., “Neurophysiologic Monitoring of Spinal Nerve Root
`Function During Instrumented Posterior Lumber Spine Surgery,”
`Spine, 2002, 27(13): 1444-1450.
`Calancie et al., “Stimulus-Evoked EMG Monitoring During
`Transpedicular Lumbosacral Spine Instrumentation” Spine, 1994,
`19(24): 2780-2786.
`Clements et al., “Evoked and Spontaneous Electromyography to
`Evaluate Lumbosacral Pedicle Screw Placement,” Spine, 1996,
`21(5): 600-604.
`Danesh-Clough et al. ,“The Use of Evoked EMG in Detecting Mis­
`placed Thoracolumbar Pedicle Screws,” Spine, Orthopaedic Depart­
`ment Dunedin Hospital, Jun. 15, 2001, 26(12): 1313-1316.
`Darden et al., “A Comparison of Impedance and Electromyogram
`Measurements in Detecting the Presence of Pedicle Wall Break­
`through,” Spine, Charlotte Spine Center North Carolina, Jan. 15,
`1998,23(2): 256-262
`Ebraheim et al., “Anatomic Relations Between the Lumbar Pedicle
`and the Adjacent Neural Structures,” Spine, Department of
`Orthopaedic Surgery Medical College of Ohio, Oct. 15, 1997,
`22(20): 2338-2341.
`Fordetal. “Electrical Characteristics ofPeripheral Nerve Stimulators
`Implications for Nerve Localization,” Regional Anesthesia, 1984, 9:
`73-77.
`Glassman et al., “A Prospective Analysis of Intraoperative
`Electromyographic Monitoring of Pedicle Screw Placement With
`Computed Tomographic Scan Confirmation,” Spine, 1995, 20(12):
`1375-1379.
`Greenblatt et al., “Needle Nerve Stimulator-Locator: Nerve Blocks
`with a New Instrument for Locating Nerves,” Anesthesia& Analge­
`sia, 1962,41(5): 599-602.
`Haig, “Point of view,” Spine, 2002, 27(24): 2819.
`Haig et al., “The Relation Among Spinal Geometry on MR1,
`Paraspinal Electromyographic Abnormalities, and Age in Persons
`Referred for Electrodiagnostic Testing of Low Back Symptoms,”
`Spine, Department of Physical Medicine and Rehabilitation Univer­
`sity of Michigan, Sep. 1, 2002, 27(17): 1918-1925.
`Holland et al., “Higher Electrical Stimulus Intensities are Required to
`Activate Chronically Compressed Nerve Roots: Implications for
`Intraoperative Electromyographic Pedicle Screw Testing,” Spine,
`Department of Neurology, Johns Hopkins University School of
`Medicine, Jan. 15, 1998, 23(2): 224-227.
`Holland, “Intraoperative Electromyography During Thoracolumbar
`Spinal Surgery,” Spine, 1998, 23(17): 1915-1922.
`Journee et al., “System for Intra-Operative Monitoring of the Cortical
`Integrity of the Pedicle During Pedicle Screw Placement in Low-
`Back Surgery: Design and Clinical Results,” Sensory and
`Neuromuscular Diagnostic Instrumentation and Data Analysis I,
`18th Annual International Conference on Engineering in Medicine
`and Biology Society, Amsterdam, 1996, pp. 144-145.
`Maguire et al., “Evaluation of Intrapedicular Screw Position Using
`Intraoperative Evoked Electromyography,” Spine, 1995,20(9): 1068-
`1074.
`Martin et al. “Initiation of Erection and Semen Release by Rectal
`Probe Electro stimulation (RPE),” The Journal of Urology, The Wil­
`liams* Wilkins Co., 1983, 129: 637-642.
`
`Minahan et al., “The Effect of Neuromuscular Blockade on Pedicle
`Screw Stimulation Thresholds” Spine, Department of Neurology,
`Johns Hopkins University School of Medicine, Oct. 1, 2000, 25(19):
`2526-2530.
`Pither et al., “The Use of Peripheral Nerve Stimulators for Regional
`Anesthesia: Review of Experimental Characteristics Technique and
`Clinical Applications,” Regional Anesthesia, 1985, 10:49-58.
`Raj et al., “Infraclavicular Brachial Plexus Block—A New
`Approach” Anesthesia and Analgesia, 1973, (52)6: 897-904.
`Raj et al., “The Use of Peripheral Nerve Stimulators for Regional
`Anesthesia,” Clinical Issues in Regional Anesthesia, 1985, 1(4): 1 -6.
`Raj et al., “Use of the Nerve Stimulator for Peripheral Blocks,”
`Regional Anesthesia, Apr.-Jun. 1980, pp. 14-21.
`Raymond et al., “The Nerve Seeker: A System for Automated Nerve
`Localization,” Regional Anesthesia, 1992, 17(3): 151-162.
`Shafik, “Cavernous Nerve Simulation through an Extrapelvic
`Subpubic Approach: Role in Penile Erection,” Eur. Urol, 1994, 26:
`98-102.
`Toleikis et al., “The Usefulness of Electrical Stimulation for Assess­
`ing Pedicle Screw Replacements,” Journal ofSpinal Disorder, 2000,
`13(4): 283-289.
`Medtronic Sofamor Danek “Union™/ Union-L™ Anterior & Lateral
`Impacted Fusion Devices: Surgical Technique” Medtronic Sofamor
`Danek, 2001, 20 pages.
`Defendant’s Disclosure of Asserted Claims and Preliminary
`Infringement Contentions Regarding USP 7207949; 7470236 and
`7582058, Aug. 31, 2009, 21 pages.
`Bergey et al., “Endoscopic Lateral Transpsoas Approach to the Lum­
`bar Spine,” Spine, 2004, 29(15): 1681-1688.
`Dezawa et al., “Retroperitoneal Laparoscopic Lateral Approach to
`the Lumbar Spine: A New Approach, Technique, and Clinical Trial,”
`Journal of Spinal Disorders, 2000, 13(2): 138-143.
`Gardocki, “Tubular diskectomy minimizes collateral damage: A logi­
`cal progression moves spine surgery forward,” A AOS Now, 2009, 5
`pages.
`Hovorka et al., “Five years’ experience of retroperitoneal lumbar and
`thoracolumbar surgery,” Eur Spine J., 2000, 9(1): S30-S34.
`Kossmann et al., “The use of a retractor system (SynFrame) for open,
`minimal invasive reconstruction of the anterior column of the tho­
`racic and lumbar spine,” Eur Spine J., 2001, 10: 396-402.
`Mayer, “A New Microsurgical Technique for Minimally Invasive
`Anterior Lumbar Interbody Fusion,” Spine, 1997, 22(6): 691-699.
`Mayer, “TheALIF Concept,” Eur Spine J, 2000, 9(1): S35-S43.
`Mayer and Wiechert, “Microsurgical Anterior Approaches to the
`Lumbar Spine for Interbody Fusion and Total Disc Replacement,”
`Neurosurgery, 2002, 51(2): 159-165.
`McAfee et al., “Minimally Invasive Anterior Retroperitoneal
`Approach to the Lumbar Spine: Emphasis on the Lateral BAK,”
`Spine, 1998, 23(13): 1476-1484.
`Rao, et al. “Dynamic retraction of the psoas muscle to expose the
`lumbar spine using the retroperitoneal approach,” J. Neurosurg
`Spine, 2006, 5: 468-470.
`Wolfla et al., “Retroperitoneal lateral lumbar interbody fusion with
`titanium threaded fusion cages,” J. Neurosurg {Spine 1), 2002, 96:
`50-55.
`Larson and Maiman, “Surgery of the Lumbar Spine,” Thieme Medi­
`cal Publishers, Inc., 1999, pp. 305-319.
`Medtronic XOMED Surgical Products, Inc., NIM-Response Nerve
`Integrity Monitor Intraoperative EMG Monitor User’s Guide, Revi­
`sion B, 2000, 47 pages.
`“NuVasive’s spine surgery system cleared in the US,” Pharm &
`Medical Industry Week, Dec. 10, 2001, 1 page.
`Pimenta, “Initial Clinical Results of Direct Lateral, Minimally
`Invasive Access to the Lumbar Spine for Disc Nucleus Replacement
`Using a Novel Neurophysiological Monitoring System.” The 9th
`IMAST, May 2002, 1 page.
`Pimenta et al., “The Lateral Endoscopic Transpsoas Retroperitoneal
`Approach (Letra) for Implants in the Lumbar- Spine,” World Spine
`II—Second Interdisciplinary Congress on Spine Care, Aug. 2003, 2
`pages.
`Crock, H.V. MD., “Anterior Lumbar Interbody Fusion,” Clinical
`Orthopaedics and Related Research, Number One Hundred Sixty
`Five, 1982, pp. 157-163, 13 pages.
`
`ATEC LLIF000848892
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-17 Filed 01/18/20 PageID.22783 Page 7 of
` 33
`
`US 8,753,270 B2
`Page 6
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Mayer and Brock, “Percutaneous endoscopic discectomy: surgical
`technique and preliminary results compared to microsurgical
`discectomy,” J. Neurosurg, 1993, 78: 216-225.
`Schaffer and Karnbin, “Percutaneous Posterolateral Lumbar
`Discectomy and Decompression with a 6.9-Millimeter Cannula,”
`The Journal of Bone and Joint Surgery, 1991, 73A(6): 822-831.
`Friedman, “Percutaneous discectomy: An alternative to
`chemonucleolysis,” Neurosurgery, 1983, 13(5): 542-547.
`Brau, “Chapter 22: Anterior Retroperitoneal Muscle-Sparing
`approach to L2-S1 of the Lumbar Spine,” Surgical Approaches to the
`Spine. Robert G. Watkins, MD. (ed) 2003. pp. 165-181.
`Kossmann et al., “Minimally Invasive Veitebral Replacement with
`Cages in Thoracic and Lumbar Spine,” European Journal of Trauma,
`2001, 27: 292-300.
`Mayer II. M. (ed.) Minimally Invasive Spine Surgery: A Surgical
`Manual. 2000. 51 pages.
`Pimenta et al., “Implante de protese de nucleo pulpost: analise
`inicial,” JournalBrasileiro de Neurocirurgia, 2001, 12(2): 93-96.
`Traynelis, “Spinal Arthroplasty,” Neurological Focus, 2002, 13(2):
`12 pages.
`Zdeblick, Thomas A. (ed.). Anterior Approaches to the Spine. 1999.
`43 pages.
`Kossman et al., “The use of a retractor system (SynFrame) for open,
`minimal invasive reconstruction of the anterior column of the tho­
`racic and lumbar spine,” Eur Spine J, 2001, 10: 396-402.
`de Peretti etal., “New possibilities in L2-L5 lumbar arthrodesis using
`a lateral retroperitoneal approach assisted by laparoscopy: prelimi­
`nary results,” Eur Spine J, 1996, 5: 210-216.
`Litwin et al., “Hand-assisted laparoscopic surgery (FIALS) with the
`handport system,” Annals of Surgery, 2000, 231(5): 715-723.
`Acland’s Video Atlas of Human Anatomy, Section 3.1.7:
`Paravertebral Muscles. Available online: http://aclandanatomy. com/
`abstract/4010463. Accessed Jul. 11, 2012.
`MedlinePlus, a Service oftheU.S. National Library of Medicine and
`National Institutes of Health. Available online: http://www.nlm.nih.
`gov/medlineplus/. Accessed Jul. 11, 2012.
`Amended Complaint for Nu Vasive, Inc. v. Globus Medical, Inc., Case
`No. LlO-cv-0849 (D. Del., Oct. 5, 2010), 28 pages.
`Baulot et al., Adjuvant Anterior Spinal Fusion Via Thorascopy, Lyon
`Chirurgical, 1994, 90(5):347-351 including English Translation and
`Certificate of Translation.
`Leu et al., “Percutaneous Fusion of the Lumbar Spine,” Spine, 1992,
`6(3): 593-604.
`Rosenthal et al., “Removal of a Protruded Thoracic Disc Using
`Microsurgical Endoscopy,” Spine, 1994, 19(9): 1087-1091.
`Counterclaim Defendants’ Corrected Amended Invalidity Conten­
`tions re U.S. Patent Nos. 8,000,782; 8,005,535; 8,016,767;
`8,192,356; 8,187.334; 8,361.156, D652,922; D666,294 re Case No.
`3:12-cv02738-CAB(MDD), dated Aug. 19, 2013, 30 pages.
`Petition for Inter Partes Review IPR2014-00034, filed Oct. 8, 2013,
`65 pages.
`Petition for Inter Partes Review IPR2014-00035, filed Oct. 8, 2013,
`65 pages.
`Declaration of Lee Grant, from IPR2014-00034, Oct. 7, 2013, 36
`pages.
`Declaration of David Hacker from IPR2014-00034, Oct. 4, 2013, 64
`pages.
`Nu Vasive, Inc’s Opening Claim Construction Brief Regarding U.S.
`Patent Nos. 8,000,782; 8,005,535; 8,016,767; 8,192,356; 8,187,334;
`8,361,156; D652,922; and 5,676,146 C2, filed Sep. 3, 2013, in
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 3:12-cv-02738-
`CAB-MDD (S.D. Cal.)., 34 pages.
`Petition for Inter Partes Review IPR2014-00073, filed Oct. 18, 2013,
`65 pages.
`Petition for Inter Partes Review IPR2014-00074, filed Oct. 18, 2013,
`65 pages.
`Petition for Inter Partes Review IPR2014-00075, filed Oct. 21, 2013,
`66 pages.
`Petition for Inter Partes Review IPR2014-00076, filed Oct. 21, 2013,
`65 pages.
`
`Petition for Inter Partes Review IPR2014-00081, filed Oct. 22, 2013,
`64 pages.
`Petition for Inter Partes Review IPR2014-00087, filed Oct. 22, 2013,
`64 pages.
`Declaration of Lee Grant, from IPR2014-00073, Oct. 9, 2013, 36
`pages.
`Declaration of David Hacker, from IPR2014-00073, Oct. 10, 2013,
`64 pages.
`U.S. Appl. No. 60/392,214, filed Jun. 26, 2002, 97 pages.
`Amendment in reply to Feb. 15, 2012 Office Action in U. S. Appl. No.
`12/635,418, dated Mar. 16, 2012, 24 pages.
`Decision on Appeal in Inter Partes Reexamination Control No.
`95/001,247, dated Mar. 18, 2013, 49 pages.
`Declaration of Lee Grant, from 1PR2014-00074, Oct. 9, 2013, 36
`pages.
`Declaration of David Hacker, from IPR2014-00074, Oct. 10, 2013,
`64 pages.
`Declaration of David Hacker, from 1PR2014-00075, Oct. 10, 2013,
`64 pages.
`Amendment in reply to Action of Feb. 7, 2011 and Notice of May 12,
`2011, in U.S. Appl. No. 11/789,284, dated May 17, 2011, 16 pages.
`Notice of Allowance in U.S. Appl. No. 11/789,284, dated Jul. 18,
`2011, 8 pages.
`Office action from U.S. Appl. No. 11/789,284, dated Feb. 7, 2011, 10
`pages.
`Merriam-Webster’s Collegiate Dictionary, p. 65 (10th ed. 1998).
`Declaration of Lee Grant, from 1PR2014-00076, Oct. 9, 2013, 36
`pages.
`Moed et al., “Evaluation of Intraoperative Nerve-Monitoring During
`Insertion of an Iliosacral Implant in an Animal Model, Journal of
`Bone and Joint Surgery J 1999, 81-A(11): 9.
`Declaration of Lee Grant, from IPR2014-0081, Oct. 9, 2013, 36
`pages.
`De