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Case No. IPR2016-00254
`Paper 29
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`J KYLE BASS and ERICH SPANGENBERG,
`
`
`
`Petitioners
`
`
`
`v.
`
`
`
`FRESENIUS KABI USA, LLC
`
`
`
`Patent Owner
`
`
`
`Case No. IPR2016-00254
`U.S. Patent No. 8,476,010
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`

`

`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner submits the following
`
`Case No. IPR2016-00254
`Patent Owner’s Updated Exhibit List
`
`
`exhibit list.
`
`Exhibit No.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`Description
`Routes of Administration and Dosage Forms:
`Pharmacology Introduction, MERCK VETERINARY MANUAL
`(March 7, 2016), available at:
`http://www.merckvetmanual.com/mvm/pharmacology/phar
`macology_introduction/routes_of_administration_and_dosa
`ge_forms.htm
`
`George H. Hopkins, Elastomeric Closures for
`Pharmaceutical Packaging, T.J., Vol. 54, No. 1, 138-143
`(1965)
`
`Steven L. Shafer, et al., Intravenous Anesthesia: Techniques
`and New Drugs (1990)
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Information Disclosure Statement dated Nov.
`10, 2011 (including International Search Report and Written
`Opinion of the International Search Authority concerning
`PCT/US2004/020923)
`
`David F. Capes, et al., The Effect on Syringe Performance of
`Fluid Storage and Repeated Use: Implications for Syringe
`Pumps, PDA J. Pharm. Sci. and Tech. 1996, 50, 40-50
`(1996)
`
`D. Lomax, Propofol Injection Pain, Anaesthesia and
`Intensive Care, Vol. 22, No. 4 (Aug. 4, 1994)
`
`Eric L. Cermin, et al., Any Propofol Compatibility Study
`Must Include an Emulsion Stability Analysis, Anesth.
`Analg., 91, 1306-13 (2000)
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Examiner-Initialed Copy of Information
`Disclosure Statement (considered July 20, 2006)
`
`
`
`1
`
`

`

`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`Case No. IPR2016-00254
`Patent Owner’s Updated Exhibit List
`
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Information Disclosure Statement (including EP
`390,244 A1)
`
`U.S. Patent No. 6,576,245
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Office Action dated Aug. 23, 2006
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Reply to Office Action dated Nov. 16, 2006
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Office Action dated Mar. 22, 2010
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Response to Office Action dated Dec. 16, 2010
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Office Action dated Nov. 29, 2011
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Reasons for Pre-Appeal Brief Request for
`Review dated Mar. 29, 2012
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Notice of Panel Decision from Pre-Appeal Brief
`Review dated Apr. 20, 2012
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Applicant-Initiated Interview Summary dated
`Nov. 16, 2012
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Notice of Allowability dated Apr. 30, 2013
`
`Joseph Walker, et al., New Hedge Fund Strategy: Dispute
`the Patent, Short the Stock, WALL STREET JOURNAL, Apr. 7,
`2015, available at: www.wsj.com/articles/hedge-fund-
`manager-kyle-bass-challenges-jazz-pharmaceuticals-patent-
`1428417408
`
`
`
`2
`
`

`

`Case No. IPR2016-00254
`Patent Owner’s Updated Exhibit List
`
`
`Zachary Silbersher, Why Are Bass and Spangenberg Filing
`IPR Petitions By Themselves?, Markman Advisors, Nov. 30,
`2015, available at:
`http://www.markmanadvisors.com/blog/2015/11/30/why-
`are-bass-and-spangenberg-filing-ipr-petitions-by-
`themselves/
`
`Lisa Schuchman, The Saga Continues: Kyle Bass and
`Partner File Personal, ‘Altruistic’ Challenges to Drug
`Patents, CORPORATE COUNSEL, Dec. 1, 2015, available at:
`http://www.corpcounsel.com/id=1202743748187/The-Saga-
`Continues-Kyle-Bass-and-Partner-File-Personal-Altruistic-
`Challenges-to-Drug-Patents
`
`Michael Loney, Kyle Bass’s Success at the PTAB – An
`Update, MANAGING INTELLECTUAL PROPERTY, Dec. 22,
`2015, available at:
`http://www.managingip.com/Blog/3516275/Kyle-Basss-
`success-rate-at-the-PTAB-an-update.html
`
`U.S. Patent No. 5,163,919
`
`Diazepam, IARC Monograph, Vol. 66
`
`Max T. Baker, et al., Propofol – The Challenges of
`Formulation, Anesthesiology, Vol. 103, No. 4 (Oct. 2005)
`
`Intentionally Left Blank
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Office Action dated Jul. 6, 2009
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Office Action dated Jan. 28, 2011
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Reply to Office Action dated Nov. 5, 2009
`
`Excerpt from file history of U.S. Pat. App. Serial. No.
`10/616,709, Response to Office Action dated Jul. 28, 2011
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`
`
`3
`
`

`

`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`Case No. IPR2016-00254
`Patent Owner’s Updated Exhibit List
`
`
`Declaration of Samuel E. Sherry in Support of Patent
`Owner’s Motion for Pro Hac Vice Admission of Samuel E.
`Sherry Under 37 C.F.R. § 42.10(c)
`
`Declaration of Daryl L. Wiesen in Support of Patent
`Owner’s Motion for Pro Hac Vice Admission of Daryl L.
`Wiesen Under 37 C.F.R. § 42.10(c)
`
`Declaration of John T. Bennett in Support of Patent Owner’s
`Motion for Pro Hac Vice Admission of John T. Bennett
`Under 37 C.F.R. § 42.10(c)
`
`Deposition Transcript of Thomas N. Feinberg, Ph.D. (Aug.
`11, 2016).
`
`Declaration of Stanley S. Davis Ph.D.
`
`Curriculum Vitae of Stanley S. Davis Ph.D.
`
`Stanley S. Davis et al., Lipid emulsions as drug delivery
`systems, Ann. NY Acad. Sci., 507 (1987).
`
`Duck Hwan Bae, et al., Silicone Nanoemulsion Stabilized
`with Hydrogenated Lecithin, J. Korean Ind. Eng. Chem.,
`Vol. 11, No. 5 (Aug. 2000).
`
`U.S. Patent 4,973,504
`
`Jukka Pekka Mannermaa, et al., Comparison of Different
`Rubber Stoppers; the Effect of Sterilization on the Number
`of Particles Released, J. Parenter. Sci. Technol., Vol. 46 No.
`3 (May, 1992).
`
`U.S. Patent 5,114,794
`
`U.S. Application 2003/0148030
`
`Steven J. Borchert et al., Particulate Matter in Parenteral
`Products: A Review, J Parenter. Sci. Technol., Vol. 40 No. 5
`(Sept. 1986).
`
`
`
`4
`
`

`

`Case No. IPR2016-00254
`Patent Owner’s Updated Exhibit List
`
`
`D. Scott Aldrich et al., Pharmaceutical Trace Analysis, J
`Res. Nat. Buer. Stand., Vol. 93, No. 3 (May, 1988).
`
`USP 23 NF 18, Particulate Matter in Injections, The United
`States Pharmacopeia, The National Formulary, 788 (Jan. 1,
`1995).
`
`British Pharmacopeia Appendix XIII, Particulate
`Contamination, Sub-visible Particles, (Dec. 1, 2002).
`
`USP 29 NF 24, Particulate Matter in Injections, The United
`States Pharmacopeia, The National Formulary, 788 (Jan. 1,
`2006).
`
`Correspondence from Geoffrey M. Levitt, Wyeth
`Pharmaceuticals to Food and Drug Administration (Jan. 20,
`2006).
`
`Lisbeth Illum et al., Blood clearance and organ deposition
`of intravenously administered colloidal particles. The effects
`of particle size, nature and shape, Int. J. Pharm. Vol. 12
`(1982).
`
`Stanley S. Davis et al., Medical and Pharmaceutical
`Applications of Emulsions, Encyclopedia of Emulsion
`Technology, Vol. 2 at 159 (1985).
`
`J. W. L. Puntis et al., Hazards of parental treatment: do
`particles count?, Arch. Dis. Child., Vol. 67 (1992).
`
`Hans-Anton Lehr et al., Particulate Matter Contamination
`of Intravenous Antibiotics Aggravates Loss of Functional
`Capillary Density in Postischemic Striated Muscle, Am. J.
`Respir. Crit. Care Med., Vol. 165 (2002).
`
`C. H. Tan et al., Pain on injection of propofol, Anaesthesia
`Vol. 53 (1998).
`
`Pharmaceutical & Medical Packaging News, Drug Delivery
`(May, 2003).
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
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`2052
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`2053
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`2054
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`2055
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`
`
`5
`
`

`

`2056
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`2057
`
`2058
`
`Case No. IPR2016-00254
`Patent Owner’s Updated Exhibit List
`
`
`PCT Application WO 02/45709
`
`John H. Brewer et al., III Siliconization: Toxicological
`Considerations, Bulletin of the Parental Drug Association,
`Vol. 22, No. 2, 71-75 (Mar., 1968).
`
`Certified English Translation of Exhibit 2039, Duck Hwan
`Bae, et al., Silicone Nanoemulsion Stabilized with
`Hydrogenated Lecithin, J. Korean Ind. Eng. Chem., Vol. 11,
`No. 5 (Aug. 2000).
`
`
`
`
`
`6
`
`
`
`
`
`

`

`Case No. IPR2016-00254
`Patent Owner’s Updated Exhibit List
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing document captioned
`
`
`
`UPDATED LIST OF PATENT OWNER’S EXHIBITS was served electronically
`
`via e-mail on this 31st day of August, 2016, as follows:
`
`Gregory Gonsalves
`gonsalves@gonsalveslawfirm.com
`
`Christopher Casieri
`McNeely, Hare & War LLP
`chris@miplaw.com
`
`
`
`
`
`
` /Eleanor M. Yost/
`
`7
`
`
`Dated: August 31, 2016
`
`
`
`
`
`

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