UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`
`
`RTI SURGICAL, INC.,
`
`Petitioner
`
`
`
`v.
`
`LIFENET HEALTH,
`
`Patent Owner
`
`____________________
`
`IPR2019-00570
`U.S. Patent No. 8,182,532
`____________________
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`
`
`RTI SURGICAL, INC.,
`
`Petitioner
`
`
`
`v.
`
`LIFENET HEALTH,
`
`Patent Owner
`
`____________________
`
`IPR2019-00570
`U.S. Patent No. 8,182,532
`____________________
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`Exhibit
`
`Description
`
`2001
`
`Declaration of Mark E. Shaffrey, M.D.
`
`2002
`
`Declaration of David L. Kaplan, Ph.D.
`
`2003 Wang et al., “Bone grafts and biomaterials substitutes for bone defect
`repair,” Bioactive Materials 2:224-247 (2017).
`
`2004
`
`2005
`
`Khan et al., “The Biology of Bone Grafting,” J Am Acad Orthop
`Surg 13:77-86 (2005).
`
`Kim et al., “Prospective study of iliac crest bone graft harvest site
`pain and morbidity,” The Spine Journal 9:886-892 (2009).
`
`2006 Marchesi, “Spine fusions: bone and bone substitutes,” Eur Spine J
`9:372-378 (2000).
`
`2007
`
`Robinson et al., “Techniques of exposfure and fusion of the cervical
`spine,” Clinical Orthopaedics and Related Research, No. 109, 78-84
`(June 1975)
`
`2008
`
`Russel et al., “Surgical harvesting of bone graft from the ilium: point
`of view,” Medical Hypotheses 55(6):474-479 (2000).
`
`2009
`
`2010
`
`Schwartz et al., “Prospective evaluation of chronic pain associated
`with posterior autologous iliac crest bone graft harvest and its effect
`on postoperative outcome,” Health and Quality of Life Outcomes
`7:49 (2009)
`
`Sen et al., “Autologous iliac crest bone graft: should it still be the
`gold standard for treating nonunions?,” Int J Care Injured 38S1:S75-
`S80 (2007).
`
`1
`
`
`
`Exhibit
`
`Description
`
`2011
`
`Trumees et al., “Alternatives to autologous bone harvest in spine
`surgery,” U Penn Ortho J 12:77-88 (1999).
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`Goulet et al., “Autogenous iliac crest bone graft: complications and
`functional assessment,” Clinical Orthopaedics and Related Research
`No. 339, 76-81 (1997).
`
`Bryan Fox et al., “Radiographic Fusion Rates for Anterior Cervical
`Discectomy and Fusion Using Frozen Laminated Composite
`Allograft and Plating,” 19th Annual Meeting of the North American
`Spine Society (2004).
`
`Heneghan et al., “Use of autologous bone graft in anterior cervical
`decompression: morbidity & quality of life analysis,” BMC
`Musculoskeletal Disorders 10:158 (2009).
`
`Eriksen et al., “Bone Remodeling and Bone Structure” Handbook of
`Experimental Pharmacology, Vol. 107, Chapter 2, pages 67-109,
`Springer-Verlag Berlin Heidelberg (1993).
`
`Bandyopadhyay-Ghosh, “Bone as a Collagen-hydroxyapatite
`composite and its repair,” Trends Biomater. Artif. Organs 22(2):116-
`124 (2008).
`
`2017 Wakamatsu, “The cancellous bone of the iliac crest,” Calc. Tiss. Res.
`4:147-161 (1969).
`
`2018
`
`Seeman et al., “Bone quality: the material and structural basis of
`bones strength and fragility,” New Engl. J Med. 354:2250-61 (2006).
`
`2019
`
`Dr. David Kaplan curriculum vitae
`
`2
`
`
`
`Exhibit
`
`Description
`
`2020
`
`Dr. Mark Shaffrey curriculum vitae
`
`2021
`
`2022
`
`Excerpt from the prosecution history of U.S. Application No.
`10/953,881 (now U.S. Patent No. 8,182,532): response to Office
`Action of October 12, 2010.
`
`Excerpt from the prosecution history of U.S. Application No.
`10/953,881 (now U.S. Patent No. 8,182,532): response to Office
`Action of June 21, 2011.
`
`2023
`
`Reserved
`
`2024
`
`2025
`
`Willems et al., “The microstructural and biomechanical development
`of the conylar bone: a review,” Eur J Orthodontics 36:479-485
`(2014).
`
`Representative Reports using Vertigraft® and I/C Graft Chamber®,
`ttps://www.lifenethealth.org/sites/default/files/files/68-20-
`165%281%29.pdf.
`
`2026
`
`Declaration of Ali H.K. Tehrani in Support of Motion for Pro Hac
`Vice Admission Under 37 C.F.R. § 42.10
`
`2027
`
`Ex. 1003 Annotated by Michael C. Sherman
`
`2028
`
`Second Declaration of Mark E. Shaffrey, M.D.
`
`2029
`
`Second Declaration of David L. Kaplan, Ph.D.
`
`2030
`
`Declaration of Barton D. Gaskins
`
`3
`
`
`
`Exhibit
`
`Description
`
`2031
`
`Deposition Transcript of Jeffrey S. Fischgrund, M.D.
`
`2032
`
`Transcript of Deposition of Michael C. Sherman
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`Robinson, et al., “Techniques of exposfure and fusion of the cervical
`spine,” Clinical Orthopaedics and Related Research, No. 109, 78-84
`(June 1975).
`
`Abla, et al., “Allograft Composite Cortical and Cancellous Bone
`Graft for Anterior Cervical Fusion”, Contemporary Neurosurgery,
`Vol. 27, No. 8 (April 2005).
`
`Boyce, et al., “Allograft Bone, The Influence of Processing on Safety
`and Performance”, Bone grafting and Bone Graft Substitutes, Vol.
`30, No. 4 (October 1999).
`
`Ehrler, et al., “The Use of Allograft Bone in Lumbar Spine Surgery”,
`Clinical Orthopaedics and Related Research, No. 371, pp. 38-44
`(2000).
`
`Fox, et al., “Anterior Cervical Spine Fusion Rates Using a Frozen
`Laminated Composite Allograft and Plating,”, The Internet Journal
`of Spine Surgery, Vol. 2, No. 1 (2004).
`
`2038
`
`Fujita, et al., “Complications of Spinal Fusion in Adult Patients More
`Than 60 Years of Age.”, Spinal Fusion, 0030-5898 (October 1998).
`
`2039
`
`2040
`
`Garbuz, et al., “Biology of Allografting”, Management of Bone Loss
`During Revision Hip or Knee Replacement, Vol. 29, No. 2
`(April 1998).
`
`Gazdag, et al., “Alternatives to Autogenous Bone Graft: Efficacy
`and Indications”, Journal of the American Academy of Orthopaedic
`
`4
`
`
`
`Exhibit
`
`Description
`Surgeons, Vol. 3, No. 1 (1995).
`
`2041
`
`Goldberg, et al., “The Biology of Bone Grafts”, Seminars in
`Arthroplasty, Vol. 4, No. 2, pp. 58-63 (April 1993).
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`Huckell, “Clinical Outcomes After Cervical Spine Fusion”,
`Orthopedic Clinics of North America, Vol. 29, No. 4, pp. 787-799
`(October 1998).
`
`Kim, et al., “Operative Duration as an Independent Risk Factor for
`Postoperative Complications in Single-Level Lumbar Fusion”, Spine,
`Vol. 39, No. 6, pp. 510-20 (2014).
`
`Nazon, et al., “Critical care in orthopedic and spine surgery”, Crit.
`Care Clin. 19, pp. 33-53 (2003).
`
`Goldberg, “Natural History of Autografts and Allografts”, Bone
`Implant Grafting (1992).
`
`Rodway, et al. “Comparison of Fusion Rates between Glycerol-
`Preserved and Frozen Composite Allografts in Cervical Fusion”,
`International Scholarly Research Notices, Vol. 2014, Article ID
`960142 (October 2014).
`
`Sandhu et al., “Biologic Enhancement of Spinal Fusion”, Orthopedic
`Clinics of North America, Vol. 29, No. 4, pp. 621-631 (October
`1998).
`
`2048
`
`Sidhu, et al., “Anterior cervical interbody fusion with rhBMP-2 and
`tantalum in a goat model”, The Spine Journal 1, pp. 331-340 (2001).
`
`2049
`
`Stevenson, “Biology of Bone Grafts”, Bone Grafting and Bone Graft
`Substitutes, Orthopedic Clinics of North America, Vol. 30, No. 4,
`pp. 543-552 (October 1999).
`
`5
`
`
`
`Exhibit
`
`2050
`
`Description
`
`Tomford, et al., “Bone Banking: Update on Methods and Materials”,
`Orthopedic Clinics of North America, Vol. 30, No. 4, pp. 565-570
`(October 1999).
`
`2051
`
`Vaccaro, et al., “Bone grafting alternatives in spinal surgery”, The
`Spine Journal 2, pp. 206-15 (2002).
`
`2052
`
`VG2 Cervical Product Website (https://www.lifenethealth.org/spine).
`
`2053
`
`Excerpt from the prosecution history of U.S. Application No.
`09/782,594, Office Action dated November 4, 2003.
`
`2054
`
`Excerpt from the prosecution history of U.S. Application No.
`09/782,594, Amendment and Response Under 37 C.F.R. § 1.111
`dated May 4, 2004.
`
`2055
`
`RTI’s Search History
`
`2056
`
`International Patent Publication No. WO 99/09914
`
`2057
`
`International Patent Publication No. WO 00/40177
`
`2058
`
`Excerpt from the prosecution history of U.S. Application No.
`09/782,594, Information Disclosure Statement dated October 9,
`2001.
`
`2059
`
`U.S. Patent No. 6,200,347
`
`2060
`
`Excerpt from the prosecution history of U.S. Application No.
`09/782,594, Patent Application dated February 12, 2001.
`
`6
`
`
`
`Exhibit
`
`2061
`
`Description
`
`Fourth Amendment to First Amended Exclusive Distribution and
`License Agreement between RTI and Medtronic, dated September
`12, 2006.
`
`2062
`
`AlloCraft CA Brochure
`
`2063
`
`AlloQuent Brochure
`
`2064
`
`Capistrano Product Webpage
`
`2065
`
`CeSpace 510(k) dated November 7, 2008.
`
`2066
`
`CeSpace Brochure
`
`2067
`
`Cornerstone Tissue Brochure
`
`2068
`
`Elemax Cortical Cancellous Spacer webpage
`
`2069
`
`2070
`
`Google webpage, http://www.rtix.com/en_us/products/product-
`implant/elemax-cortical-cancellous-spacer - Google Search
`
`Integra Press Release, “Integra LifeSciences Launches an Integrated
`Plate and Cervical Interbody Fixation System”, (August 9, 2011).
`
`2071
`
`LifeNet Vertigraft VG2 Cervical brochure
`
`2072
`
`LifeNet Vertigraft VG2 PLIF brochure
`
`2073
`
`LifeNet VG2 Product Revenues (UNDER SEAL)
`
`7
`
`
`
`Exhibit
`
`Description
`
`2074
`
`Puros-S and Puros-S2 brochure
`
`2075
`
`Puros-S and S-2 Webpage
`
`2076
`
`RTI Biologics, Inc.’s 2008 10-K
`
`2077
`
`RTI Surgical, Inc.’s 2010 10-k
`
`2078
`
`RTI Surgical, Inc.’s 2011 10-k
`
`2079
`
`RTI Biologics, Inc.’s 2012 10-K
`
`2080
`
`RTI Surgical, Inc.’s 2016 10-K
`
`2081
`
`International Patent Publication No. WO 01/78798
`
`2082
`
`U.S. Patent Publication No. 2001/0031254
`
`2083
`
`Ilium Tricortical Strip Webpage
`
`2084
`
`Redline Comparison between continuation-in-part application, filed
`July 16, 2001, and U.S. Patent Application No. 09/905,630, filed
`August 27, 1997.
`
`2085
`
`Nexus Claim Chart LifeNet VG2
`
`2086
`
`Nexus Claim Chart Competitor Products
`
`2087
`
`Excerpt from the prosecution history of U.S. Application No.
`09/782,594, Office Action dated July 23, 2004.
`
`8
`
`
`
`Exhibit
`
`Description
`
`2088 Webster’s Dictionary definition of “distinct”
`
`2089
`
`U.S. Patent No. 2,136,471
`
`2090
`
`2091
`
`2092
`
`Declaration of Jacob Z. Zambrzycki In Support of Motion for Pro
`Hac Vice Admission Under 37 C.F.R. § 42.10
`
`Deposition Transcript of Jeffrey S. Fischgrund, M.D., volume II,
`dated March 16, 2020.
`
`Deposition Transcript of Michael C. Sherman, volume II, dated
`March 19, 2020.
`
`2093
`
`Deposition Transcript of John Bianchi, dated March 26, 2020.
`
`
`
`
`
`
`Date: April 7, 2020
`
`
`Respectfully submitted,
`
`/Michael H. Jacobs/
`Michael H. Jacobs
`Reg. No. 41,870
`Crowell & Moring LLP
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`
`9
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on the date indicated below a copy of the
`
`foregoing PATENT OWNER’S UPDATED EXHIBIT LIST was served
`
`electronically by filing this document through the PTAB e2e System, as well as by
`
`e-mailing a copy to the following counsel of record for Petitioner:
`
`Herbert D. Hart III
`hhart@mcandrews-ip.com
`
`David D. Headrick
`dheadrick@mcandrews-ip.com
`
`Alejandro Menchaca
`amenchaca@mcandrews-ip.com
`
`Gregory C. Schodde
`gschodde@mcandrews-ip.com
`
`Scott P. McBride
`smcbride@mcandrews-ip.com
`
`RTI532IPR@mcandrews-ip.com
`
`
`Respectfully submitted,
`
`/Ali H.K. Tehrani /
`Ali H.K. Tehrani
`Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`
`
`
`
`
`
`Date: April 7, 2020
`
`
`
`
`
`
`
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