Ex. 1002B
`
`Materials Considered
`
`Amgen’s Opening Claim Construction Brief in case no. 2:17-cv-01235-MRH, United States
`Court for the Western District of Pennsylvania, June 1, 2018
`
`Amgen’s Reply Claim Construction Brief in case no. 2:17-cv-01235-MRH, United States Court
`for the Western District of Pennsylvania, July 20, 2018
`
`Ashnagar, F. et al., “Optimizing Primary Recovery and Refolding of Human Interferon-B from
`Escherichia coli Inclusion bodies,” Iran J Biotech. 12(4):26-34 (December 2014)
`
`Bollag, D. et al., Protein Methods, (John Wiley & Sons, 2nd ed. 1996)
`
`Creighton, T., Encyclopedia of Molecular Biology (John Wiley & Sons, vols. 1-4, 1999)
`
`Cutler, P., Protein Purification Protocols (Humana Press, 2nd ed., 2004)
`
`Deutscher, M. Methods in Enzymology: Volume 182 Guide to Protein Purification (Academic
`Press, 1999)
`
`De Bernardez Clark, E. et al., “Oxidative Renaturation of Hen Egg-White Lysozyme. Folding vs
`Aggregation,” Biotechnology Progress 14(1):47-54 (1998)
`
`De Bernardez Clark, E., “Refolding of recombinant proteins,” Current Opinion in Biotechnology
`9:157-163 (1998)
`
`De Bernardez Clark, E., “Protein refolding for industrial processes,” Current Opinion in
`Biotechnology 12(2):202-207 (April 2001)
`
`Fahey, E. et al., “Refolding and purification of a urokinase plasminogen activator fragment by
`chromatography,” Journal of Chromatography B 737:225-235 (2000)
`
`Fan, X. et al., “Refolding and purification of rhNTA protein by chromatography,” Biomedical
`Chromatology 23:257-266 (2009)
`
`Fischer B. et al., “Isolation, Renaturation, and Formation of Disulfide Bonds of Eukaryotic
`Proteins Expressed in Escherichia coli as Inclusion Bodies,” Biotechnology and Bioengineering
`41(1):3-13 (January 1993)
`
`Georgiou, G. & Valax, P., “Isolating Inclusion Bodies from Bacteria,” Methods in Enzymology
`309:48-58 (1999)
`
`GE Healthcare, Purifying Challenging Proteins: Principles and Methods (General Electric
`Company, 2007)
`
`1 of 4
`
`Fresenius Kabi
`Exhibit 1002B
`
`
`
`Materials Considered
`
`Amgen’s Opening Claim Construction Brief in case no. 2:17-cv-01235-MRH, United States
`Court for the Western District of Pennsylvania, June 1, 2018
`
`Amgen’s Reply Claim Construction Brief in case no. 2:17-cv-01235-MRH, United States Court
`for the Western District of Pennsylvania, July 20, 2018
`
`Ashnagar, F. et al., “Optimizing Primary Recovery and Refolding of Human Interferon-B from
`Escherichia coli Inclusion bodies,” Iran J Biotech. 12(4):26-34 (December 2014)
`
`Bollag, D. et al., Protein Methods, (John Wiley & Sons, 2nd ed. 1996)
`
`Creighton, T., Encyclopedia of Molecular Biology (John Wiley & Sons, vols. 1-4, 1999)
`
`Cutler, P., Protein Purification Protocols (Humana Press, 2nd ed., 2004)
`
`Deutscher, M. Methods in Enzymology: Volume 182 Guide to Protein Purification (Academic
`Press, 1999)
`
`De Bernardez Clark, E. et al., “Oxidative Renaturation of Hen Egg-White Lysozyme. Folding vs
`Aggregation,” Biotechnology Progress 14(1):47-54 (1998)
`
`De Bernardez Clark, E., “Refolding of recombinant proteins,” Current Opinion in Biotechnology
`9:157-163 (1998)
`
`De Bernardez Clark, E., “Protein refolding for industrial processes,” Current Opinion in
`Biotechnology 12(2):202-207 (April 2001)
`
`Fahey, E. et al., “Refolding and purification of a urokinase plasminogen activator fragment by
`chromatography,” Journal of Chromatography B 737:225-235 (2000)
`
`Fan, X. et al., “Refolding and purification of rhNTA protein by chromatography,” Biomedical
`Chromatology 23:257-266 (2009)
`
`Fischer B. et al., “Isolation, Renaturation, and Formation of Disulfide Bonds of Eukaryotic
`Proteins Expressed in Escherichia coli as Inclusion Bodies,” Biotechnology and Bioengineering
`41(1):3-13 (January 1993)
`
`Georgiou, G. & Valax, P., “Isolating Inclusion Bodies from Bacteria,” Methods in Enzymology
`309:48-58 (1999)
`
`GE Healthcare, Purifying Challenging Proteins: Principles and Methods (General Electric
`Company, 2007)
`
`1 of 4
`
`Fresenius Kabi
`Exhibit 1002B
`
`
`
`Ex. 1002B
`
`GE Healthcare, Recombinant Protein Purification Handbook: Principles and Methods (General
`Electric Company, 2000)
`
`Glocker, M. et al., “Disulfide linkages in the in vitro refolded intermediates of recombinant
`human macrophage-colony-stimulating factor: Analysis of the sulfhydryl alkylation of free
`cysteine residues by fast-atom bombardment mass spectrometry,” Proc. Natl. Acad. Sci. USA,
`91:5868-5872 (June 1994)
`
`Horton, R. et al., Principles of Biochemistry (Pearson Prentice Hall, 4th ed. 2006)
`
`International Publication No. WO 2004/001056
`
`International Publication No. WO 2006/097944
`
`Ion Exchange Chromatography & Chromatofocusing: Principles and Methods (Amersham
`Biosciences, ed. AA, 2004)
`
`Jebasingh, T. et al., “Expression, purification and molecular modeling of the Nla protease of
`Cardamon mosaic virus,” Journal of Biomolecular Structure and Dynamics 31(6):602-611
`(2013)
`
`Jungbauer, A. & Kaar, W., “Current status of technical protein refolding,” Journal of
`Biotechnology 128:587-596 (2007)
`
`Kattamuri, C. et al., “Expression and purification of recombinant protein related to DAN and
`Cerberus (PRDC),” Protein Expression and Purification 82:389-395 (2012)
`
`McCartney, J. et al., “Biosynthetic Antibody Binding Sites: Development of a Single-Chain Fv
`Model Based on Antidinitrophenol IgA Myeloma MOPC 315,” Journal of Protein Chemistry
`10(6):669-683 (1991)
`
`Neubauer, P. et al., “Protein Inclusion Bodies in Recombinant Bacteria,” in Inclusions in
`Prokaryotes, ed. J.M. Shively, pp. 237-292 (Springer-Verlag Berlin Heidelberg 2006)
`
`Opinion in Amgen Inc. v. Sandoz Inc., Appeal from the United States District Court for the
`Northern District of California in No. 3:14-cv-04741-RS, United States Court of Appeals for the
`Federal Circuit, May 8, 2019
`
`Oxford Dictionary of Biochemistry and Molecular Biology, Revised Edition, ed. R. Cammack
`(Oxford University Press, 2nd ed, 2006)
`
`Patent Owners’ Preliminary Response in IPR2016-01542, Patent No. 8,952,138, November 23,
`2016
`
`2 of 4
`
`Fresenius Kabi
`Exhibit 1002B
`
`
`
`Ex. 1002B
`
`Patra, A. et al., “Optimization of Inclusion Body Solubilization and Renaturation of
`Recombinant Human Growth Hormone from Escheria coli,” Protein Expression and Purification
`18:182-192 (2000)
`
`Panda, A., “Bioprocessing of Therapeutic Proteins from the Inclusion Bodies of Escherichia
`coli,” Adv Biochem Engin/Biotechnol 85:43-93 (2003)
`
`Pavlinkova, G. et al., “Charge-Modified Single Chain Antibody Constructs of Monoclonal
`Antibody CC49: Generation, Characterization, Pharmacokinetics, and Biodistribution Analysis,”
`Nuclear Medicine & Biology 26:27-34 (1999)
`
`Profacgen, “Inclusion body purification & protein refolding,” accessed at
`https://www.profacgen.com/inclusion-body-purification-protein-refolding.htm
`
`Protein Purification - Handbook (Amersham Biosciences, 2001)
`
`Remington: The Science and Practice of Pharmacy, ed. Troy, D. (Lippincott Williams &
`Wilkins, 21st ed., 2006)
`
`Rönnmark, J. et al., “Construction and characterization of affibody-Fc chimeras produced in
`Escherichia coli,” Journal of Immunological Methods 261:199-211 (2002)
`
`Singh, S. & Panda, A., “Solubilization and Refolding of Bacterial Inclusion Body Proteins,”
`Journal of Bioscience and Bioengineering, 99(4):303-310 (2005)
`
`Stirling, P. et al., “Getting a grip on non-native proteins,” European Molecular Biology
`Organization 4(6):565-570 (2003)
`
`United States Patent Application Publication No. 2004/0024186
`
`United States Patent Application Publication No. 2006/0172384
`
`United States Patent Application Publication No. 2007/0238860
`
`United States Patent Application Publication No. 2008/0125580
`
`United States Patent Application Publication No. 2008/0171857
`
`United States Patent Application Publication No. 2008/0260684
`
`United States Patent No. 4,929,700
`
`United States Patent No. 5,663,304
`
`United States Patent No. 5,714,371
`
`United States Patent No. 5,912,327
`
`3 of 4
`
`Fresenius Kabi
`Exhibit 1002B
`
`
`
`Ex. 1002B
`
`United States Patent No. 6,207,806
`
`United States Patent No. 6,632,425
`
`United States Patent No. 7,138,370
`
`United States Patent No. 7,306,931
`
`United States Patent No. 8,952,138
`
`United States Patent No. 9,643,997
`
`United States Patent No. 9,643,997 File History
`
`Vallejo, L. & Rinas, U., “Strategies for the recovery of active proteins through refolding of
`bacterial inclusion body proteins,” Microbial Cell Factories 3:11 (2004)
`
`Wang, C. et al., “Solubilization and Refolding with Simultaneous Purification of Recombinant
`Human Stem Cell Factor,” Appl Biochem Biotechnol (2008) 144:181-189 (2008)
`
`Wang, X. et al., “Perturbation of the antigen-binding site and staphylococcal Protein A-binding
`site of IgG before significant changes in global conformation during denaturation: an equilibrium
`study,” Biochem. J. 325:707-710 (1997)
`
`Whitford, D., Proteins: Structure and Function (John Wiley & Sons 2005)
`
`
`
`4 of 4
`
`Fresenius Kabi
`Exhibit 1002B
`
`
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