Paper No. ___
`Filed: May 3, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`PROTIVA BIOTHERAPEUTICS, INC.,
`Patent Owner.
`_____________________________
`
`Case IPR2018-00739
`Patent No. 9,364,435
`_____________________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
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`Filed: May 3, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`PROTIVA BIOTHERAPEUTICS, INC.,
`Patent Owner.
`_____________________________
`
`Case IPR2018-00739
`Patent No. 9,364,435
`_____________________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
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`
`
`LIST OF EXHIBITS
`
`EXHIBIT NO.
`
`DESCRIPTION
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`2001
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`2002
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`2003
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`2004
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`2005
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`2006
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`2007
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`2008
`
`2009
`
`2010
`
`2011
`
`Declaration of Edward R. Reines in Support of Patent Owner’s
`Motion for Pro Hac Vice Admission
`
`In re Reines, No. 14-MA004 (14-4) (Fed. Cir. Nov. 5, 2014)
`
`Personal Statement of Edward R. Reines
`
`Tam P. et al., Stabilized Plasmid-Lipid Particles for Systemic
`Gene Therapy 7 GENE THERAPY 1867-1874 (2000)
`
`Huang L. et al., Liposomal Gene Delivery: A Complex Package
`15 NATURE BIOTECHNOLOGY 620-621 (1997)
`
`Pak C.C., Erukulla R.K., Ahl, P.L., Janoff, A.S. and Meers, P.,
`Elastase-Activated Liposomal Delivery to Nucleated Cells. 1419
`BIOCHIM. BIOPHY. ACTA 111-126 (1999)
`
`U.S. Patent No. 7,491,409
`
`Transcript of October 2, 2018 Conference Call
`
`Declaration of David H. Thompson, Ph.D.
`
`Curriculum Vitae of David H. Thompson, Ph.D.
`
`Charles W. Schmidt, Therapeutic Interference: Small RNA
`Molecules Act as Blockers of Disease Metabolism AM. CHEM.
`SOC’Y 37 (2003)
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`
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`1
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`
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`2012
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`2013
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`2014
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`2015
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`2016
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`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`C. Russell Middaugh & Joshua D. Ramsey, Analysis of
`Cationic-Lipid-Plasmid-DNA Complexes, ANALYTICAL
`CHEMISTRY 7240 (2007)
`
`Liposome Drug Products: Chemistry, Manufacturing, and
`Controls; Human Pharmacokinetics and Bioavailability; and
`Labeling Documentation, Guidance for Industry, FOOD AND
`DRUG ADMINISTRATION (2018)
`
`Erika Check, RNA to the Rescue? 425 NATURE 10 (2003)
`
`Dirk Hausseker, The Business of RNAi Therapeutics in 2012, 2
`AM. SOC’Y OF GENE & CELL THERAPY (2012)
`
`Luke Timmerman, Merck’s Alan Sachs, on RNAi’s Big
`Challenge: Delivery, Delivery, Delivery, XCONOMY (Jan. 21,
`2010), https://xconomy.com/national/2010/01/21/mercks-alan-
`sachs-on-rnais-big-challenge-delivery-delivery-delivery/
`
`U.S. Patent No. 8,236,943
`
`U.S. Publication No. 2013/0116307
`
`U.S. Publication No 2017/0307608
`
`Combined Declaration for Patent Application and Power of
`Attorney in U.S. Patent Application No. 90/914,615.
`
`Sean C. Semple, et al., Rational Design of Cationic Lipids for
`siRNA Delivery, 28 NATURE BIOTECH. 172 (2010)
`
`Supplementary Figures to Sean C. Semple, et al., Rational Design
`of Cationic Lipids for siRNA Delivery, 28 NATURE BIOTECH. 172
`(2010)
`
`Heidi Ledford, Gene-Silencing Drug Approved: US Government
`Okays First RNA-Interference Drug — After a 20-Year Wait 560
`NATURE 291 (2018)
`
`
`
`2
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`
`
`2024
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`2025
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`2026
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`2027
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`2028
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`2029
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`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`FDA Approves First-of-its Kind Targeted RNA-based Therapy to
`Treat a Rare Disease, FOOD AND DRUG ADMIN. (2018), https://
`www.fda.gov/newsevents/newsroom/pressannouncements
`/ucm616518.htm
`
`New Medicine for Hereditary Rare Disease, EUROPEAN MED.
`AGENCY (2018), https://www.ema.europa.eu/en/news
`/new-medicine-hereditary-rare-disease
`
`Arbutus’ LNP Licensee Alnylam Announces FDA Approval of
`ONPATTRO™ (patisiran), for the Treatment of ATTR
`Amyloidosis, ARBUTUS BIOPHARMA (2018), https://investor.
`arbutusbio.com/news-releases/news-release-details/arbutus-lnp-l
`icensee-alnylam-announces-fda-approval-onpattrotm
`
`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations, Patent and Exclusivity for: N210922,
`FOOD AND DRUG ADMIN. available at https://www.accessdata.
`fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&
`Appl_No=210922&Appl_type=N (last visited Dec. 19, 2018)
`
`Deposition Transcript of Andrew S. Janoff, December 4, 2018
`
`U.S. Patent No. 9,404,127
`
`Intentionally Left Blank
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`Intentionally Left Blank
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`Ian MacLachlan & Pieter Cullis, Diffusible-PEG-Lipid Stabilized
`Pasmid Lipid Particles, 53 ADVANCES IN GENETICS 157 (2005)
`
`Sean C. Semple et al., Immunogenicity and Rapid Blood
`Clearance of Liposomes Containing Polyethylene Glycol-Lipid
`Conjugates and Nucleic Acid, 312 THE JOURNAL OF
`PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS 1020
`(2005)
`
`Doxil Label – FDA (Revised May, 2007), https://www.
`accessdata.fda.gov/drugsatfda_docs/label/2007/
`050718s029lbl.pdf
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`3
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`2035-2039
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`Intentionally Left Blank
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`2040
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`2041
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`2042
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`2043
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`2044
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`2045
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`2046
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`2047
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`2048
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`Declaration of David H. Thompson, Ph.D. in Support of Patent
`Owner’s Contingent Motion to Amend
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`U.S. Provisional Patent Application Number 61/045,228
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`U.S. Patent Application Number 12/424,367
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`U.S. Patent Application Number 13/253,917
`U.S. Patent Application Number 13/928,309
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`U.S. Patent Application Number 14/462,441
`
`Listing of Example Formulations Falling Within the Scope of the
`’435 Patent Claims
`
`International Publication No. WO 2010/088537
`
`Maja Sedic et al., Safety Evaluation of Lipid
`Nanoparticle-Formulated Modified mRNA in the
`Sprague-Dawley Rat and Cynomolgus Monkey, VETERINARY
`PATHOLOGY (2017)
`
`2049
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`International Publication No. WO 2013/090648
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`2050
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`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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`2056
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`Kapil Bahl et al., Preclinical and Clinical Demonstration of
`Immunogenicity by mRNA Vaccines against H10N8 and H7N9
`Influenza Viruses, MOLECULAR THERAPY (2017)
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`International Publication No. WO 2017/223135
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`International Publication No. WO 2018/232357
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`Intentionally Left Blank
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`Intentionally Left Blank
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`Deposition Transcript of Andrew S. Janoff, April 15, 2019
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`April 2, 2019 Email from Trials
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`4
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`2057
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`Transcript of April 30, 2019 Conference Call
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`5
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`CERTIFICATE OF SERVICE
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`
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`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Patent Owner’s Updated Exhibit List and Exhibit 2057, on this 3rd day of
`
`May, 2019, on the Petitioner at the correspondence address of the Petitioner as
`
`follows:
`
`Michael Fleming
`C. Maclain Wells
`IRELL & MANELLA LLP
`mfleming@irell.com
`mwells@irell.com
`ModernaIPR@irell.com
`
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`
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`Date: May 3, 2019
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`Respectfully submitted,
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
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`6
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