IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`FRESENIUS KABI USA LLC
`
`Petitioner,
`
`
`
`v.
`
`
`
`CUBIST PHARMACEUTICALS, INC.
`
`Patent Owner.
`
`
`
`Case: IPR2015-01571
`Patent No. 8,058,238
`
`
`FRESENIUS KABI USA LLC’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`FRESENIUS KABI USA LLC
`
`Petitioner,
`
`
`
`v.
`
`
`
`CUBIST PHARMACEUTICALS, INC.
`
`Patent Owner.
`
`
`
`Case: IPR2015-01571
`Patent No. 8,058,238
`
`
`FRESENIUS KABI USA LLC’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Exhibit
`No.
`
`Reference
`
`1001 High Purity Lipopeptides, U.S. Patent No. 8,058,238 (filed Apr. 24,
`2007) (issued Nov. 15, 2011).
`
`1002 High Purity Lipopeptides, U.S. Patent No. 8,129,342 (filed Sept. 22,
`2010) (issued Mar. 6, 2012).
`
`1003
`
`1004
`
`1005
`
`1006
`
`File History U.S. Patent No. 8,058,238
`
`File History U.S. Patent No. 8,129,342
`
`Expert Declaration of Ralph Tarantino, Ph.D. Relating to U.S. Patent
`No. 8,052,238
`
`Expert Declaration of Ralph Tarantino, Ph.D. Relating to U.S. Patent
`No. 8,129,342
`
`1007 Chromatographic Purification Process, U.S. Patent No. 4,874,843 (filed
`Dec. 3, 1987) (issued Oct. 17, 1989).
`
`1008 Richard H. Baltz, Lipopeptide Antibiotics Produced by Streptomyces
`roseosporus and Streptomyces fradiae, in BIOTECHNOLOGY OF
`ANTIBIOTICS (W.R. Strohl ed., 1997). (“Baltz”)
`
`1009
`
`Peptide Antibiotics, U.S. Patent No. 4,331,594 (filed Nov. 14, 1980)
`(issued May 25, 1982).
`
`1010 Anhydro- and Isomer-A-21978C Cyclic Peptides, U.S. Patent No.
`5,912,226 (filed Dec. 16, 1991) (issued Jun. 15, 1999).
`
`1011
`
`1012
`
`F.M. Huber et al., The formation of daptomycin by supplying decanoic
`acid to Streptomyces roseosporus cultures producing the antibiotic
`complex A21978C, J. BIOTECHNOL. 7:283-92 (1988).
`
`F.M. Huber et al., Dispersal of insoluble fatty acid precursors in stirred
`reactors as a mechanism to control antibiotic factor distribution, in
`BIOTECHNOLOGY PROCESSES (Ho and Oldshue eds., 1987).
`
`1
`
`
`
`
`
`Exhibit
`No.
`
`Reference
`
`1013 Catherine N. Mulligan & Bernard F. Gibbs, Recovery of Biosurfactants
`by Ultrafiltration, J. CHEM. TECHNOL. BIOTECHNOL. 47:23-9
`(1990). (“Mulligan”)
`
`1014
`
`1015
`
`Sung-Chyr Lin and Horng-Jyh Jiang, Recovery and Purification of the
`Lipopeptide Biosurfactant Bacillus subtilis by Ultrafiltration,
`BIOTECHNOLOGY TECHNIQUES, 11:413-16 (1997). (“Lin I”)
`
`Sung-Chyr Lin et al., General Approach for the Development of High-
`Performance Liquid Chromatography Methods for Biosurfactant
`Analysis and Purification, JOURNAL OF CHROMATOGRAPHY,
`825:145-49 (1998). (“Lin II”)
`
`1016 Method of Producing Surfactin with the Use of Mutant of Bacillus
`Subtilis, U.S. Patent No. 5,227,294 (filed June 20, 1991) (issued Jul. 13,
`1993).
`
`1017 Mohamad Osman et al., Tuning micelles of a bioactive heptapeptide
`biosurfactant via extrinsically induced conformational transition of
`surfactin assembly, J. PEPTIDE SCI., 4:449-58 (1998). (“Osman”)
`
`1018
`
`F.P. Tally et al., Daptomycin: A Novel Agent for Gram-positive
`Infections, EXPERT OPIN. INVEST. DRUGS 8:1223-38 (1999).
`(“Tally”)
`
`1019 BIOSURFACTANTS: RESEARCH TRENDS & APPLICATIONS
`(Catherine N. Mulligan ed., 2014).
`
`1020
`
`Sung-Chyr Lin, Biosurfactant: Recent Advances, J. CHEM. TECH.
`BIOTECHNOL. 66:109-20 (1996).
`
`1021 Kei Arima et al., Surfactin, a crystalline peptide lipid surfactant
`produced by Bacillus subtilis: Isolation, characterization and its
`inhibition of fibrin clot formation, BIOCHEM. BIOPHYS. RES.
`COMM. 31:488-94 (1968).
`
`1022 Atsushi Kakinuma et al., Confirmation of the structure of surfactin by
`mass spectrometry, AG. BIOL. CHEM. 33:1669-72 (1969).
`
`2
`
`
`
`
`
`Exhibit
`No.
`
`Reference
`
`1023 A.W. Bernheimer et al., Nature and properties of a cytolytic agent
`produced by Bacillus subtilis, J. GEN. MICROBIOL. 61:361-69 (1970).
`
`1024 David G. Cooper, Biosurfactants, MICROBIOL. SCI. 3:145-47 (1986).
`
`1025 Dirk Vollenbroich et al., Antimycoplasmaproperties and application on
`cell surface of surfactin, a lipopeptide antibiotic from Bacillus subtilis,
`APPL. ENVIRON. MICROBIOL. 63:44-69 (1997).
`
`1026 Catherine N. Mulligan et al., Selection of microbes producing
`biosurfactants in media without hydrocarbons, J. FERMENT.
`TECHNOL. 62:311-14 (1984).
`
`1027 Catherine N. Mulligan & Bernard F. Gibbs, Correlation of nitrogen
`metabolism with biosurfactant production, APPL. ENVIRON.
`MICROBIOL. 55:3016-69 (1989).
`
`1028 Catherine N. Mulligan et al., Enhanced biosurfactant production by a
`mutant Bacillus subtilis strain, APPL. MlCROBlOL.31:486-69 (1989).
`
`1029
`
`Enhanced Production of Biosurfactant Through the Use of a Mutated B
`Subtilis Strain, U.S. Patent No. 5,037,758 (filed Jan. 1989) (issued Aug.
`6, 1991).
`
`1030 H.E. Reiling et al., Pilot plant production of rhamnolipid biosurfactant
`by Pseudomonas aeruoginosa, APPL. ENVIRON. MICROBIOL.,
`51:985-89 (1986).
`
`1031
`
`1032
`
`Sung-Chyr Lin et al., Structural and immunological characterization of
`a biosurfactant produced by Bacillus licheniformis JF-2, APPL. ENV.
`MICROBIOL. 60:31-8 (1994).
`
`Jitendra D. Desai and Ibrahim M. Banat, Microbial production of
`surfactants and their commercial potential, MOL. BIOL. REV.
`61:47¬64, 57 (1997).
`
`3
`
`
`
`
`
`Exhibit
`No.
`
`1033
`
`Reference
`
`Lakey and Ptak, Fluorescence Indicates a Calcium-Dependent
`Interaction Between the Lipopeptide Antibiotic LY146032 and
`Phospholipid Membranes, BIOCHEM. 27:4639-4645 (1988).
`
`1034 Anhydro-And Isomer-A-21978C Cyclic Peptides, U.S. Reissued Patent
`No. 39, 071 (filed Apr. 11, 2000) (reissued Apr. 18, 2006).
`
`1035
`
`1036
`
`1037
`
`21 C.F.R. §600(3)(r) (1998)
`
`21 C.F.R. § 610.13 (1998).
`
`Sweadner, K. et al., Filtration Removal of Endotoxin (Pyrogens) in
`Solution in Different States of Aggregation, APPLIED AND
`ENVIRONMENTAL MICROBIOLOGY, 34:382-385 (1997)
`(“Sweadner”)
`
`1038 Kunz, C. et al., Human-milk proteins: analysis of casein and casein
`subunits by anon-exchange chromatography, gel electrophoresis, and
`specific staining methods, Am. J. Clin. Nutr. 1990; 51:37-46 (1990).
`
`1039 Declaration of Daniel P. Margolis in Support of Motion for Pro Hac
`Vice Admission Under 37 C.F.R. § 42.10(c)
`
`1040 Declaration of Robert V. Cerwinski in Support of Motion for Pro Hac
`Vice Admission Under 37 C.F.R. § 42.10(c)
`
`Respectfully submitted,
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland
`Reg. No. 47,657
`Lead Attorney for Petitioner Fresenius Kabi
`USA LLC
`
`
`
`4
`
`
`
`Dated: August 13, 2015
`
`
`
`
`
`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that “FRESENIUS KABI USA LLC.’S
`
`UPDATED EXHIBIT LIST” was served by electronic mail on this 13 day of
`
`August, 2015 on the following:
`
`
`
`
`
`
`
`/Ryan Curiel/
`Ryan Curiel
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`rcuriel@goodwinprocter.com
`
`Emily.whelan@wilmerhale.com
`Andrej.barbic@wilmerhale.com
`Gerard.devlin@merck.com
`Lisa.jakob@merck.com
`
`
`
`Dated: August 13, 2015
`
`
`
`
`5
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