UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`AGILA SPECIALTIES INC. AND
`MYLAN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`CUBIST PHARMACEUTICALS, INC.,
`Patent Owner
`
`Patent No. 8,058,238
`________________________
`
`Case IPR2015-00144
`________________________
`
`PETITIONER AGILA SPECIALTIES INC.’S [REVISED] EXHIBIT LIST
`UNDER 37 C.F.R. §42.63
`
`

`

`1
`
`EXHIBIT LIST
`
`Exhibit No.
`
`Reference
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`High Purity Lipopeptides, U.S. Patent No. 8,058,238 (filed Apr. 24,
`2007) (issued Nov. 15, 2011).
`
`High Purity Lipopeptides, U.S. Patent No. 8,129,342 (filed Sept. 22,
`2010) (issued Mar. 6, 2012).
`
`File History U.S. Patent No. 8,058,238
`
`File History U.S. Patent No. 8,129,342
`
`Declaration of Catherine N. Mulligan re U.S. Patent No. 8,052,238
`
`Declaration of Catherine N. Mulligan re U.S. Patent No. 8,129,342
`
`Chromatographic Purification Process, U.S. Patent No. 4,874,843
`(filed Dec. 3, 1987) (issued Oct. 17, 1989).
`
`Richard H. Baltz, Lipopeptide Antibiotics Produced by Streptomyces
`roseosporus and Streptomyces fradiae, in BIOTECHNOLOGY OF
`ANTIBIOTICS (W.R. Strohl ed.,1997). (“Baltz”)
`
`Peptide Antibiotics, U.S. Patent No. 4,331,594 (filed Nov. 14, 1980)
`(issued May 25, 1982).
`
`Anhydro- and Isomer-A-21978C Cyclic Peptides, U.S. Patent No.
`5,912,226 (filed Dec. 16, 1991) (issued Jun. 15, 1999).
`
`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).
`
`

`

`Exhibit No.
`
`2
`
`Reference
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`Catherine N. Mulligan & Bernard F. Gibbs, Recovery of
`Biosurfactants by Ultrafiltration, J. CHEM. TECHNOL. BIOTECHNOL.
`47:23-9 (1990).
`
`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”)
`
`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).
`
`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”)
`
`F.P. Tally et al., Daptomycin: A Novel Agent for Gram-positive
`Infections, EXPERT OPIN. INVEST. DRUGS 8:1223-38 (1999).
`
`BIOSURFACTANTS: RESEARCH TRENDS & APPLICATIONS (Catherine
`N. Mulligan ed., 2014).
`
`Sung-Chyr Lin, Biosurfactant: Recent Advances, J. CHEM. TECH.
`BIOTECHNOL. 66:109-20 (1996).
`
`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).
`
`

`

`Exhibit No.
`
`3
`
`Reference
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`A.W. Bernheimer et al., Nature and properties of a cytolytic agent
`produced by Bacillus subtilis, J. GEN. MICROBIOL. 61:361-69 (1970).
`
`David G. Cooper, Biosurfactants, MICROBIOL. SCI. 3:145-47 (1986).
`
`Dirk Vollenbroich et al., Antimycoplasma properties and application
`on cell surface of surfactin, a lipopeptide antibiotic from Bacillus
`subtilis, APPL. ENVIRON. MICROBIOL. 63:44-69 (1997).
`
`Catherine N. Mulligan et al., Selection of microbes producing
`biosurfactants in media without hydrocarbons, J. FERMENT.
`TECHNOL. 62:311-14 (1984).
`
`Catherine N. Mulligan & Bernard F. Gibbs, Correlation of nitrogen
`metabolism with biosurfactant production, APPL. ENVIRON.
`MICROBIOL. 55:3016-69 (1989).
`
`Catherine N. Mulligan et al., Enhanced biosurfactant production by
`a mutant Bacillus subtilis strain, APPL. MICROBIOL.31:486-69
`(1989).
`
`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).
`
`H.E. Reiling et al., Pilot plant production of rhamnolipid
`biosurfactant by Pseudomonas aeruoginosa, APPL. ENVIRON.
`MICROBIOL., 51:985-89 (1986).
`
`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).
`
`

`

`Exhibit No.
`
`4
`
`Reference
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`1042
`
`1043
`
`Plaintiff’s Complaint, Filed October 9, 2013, ECF No. 1. Cubist
`Pharmaceuticals, Inc. v. Strides, Inc. and Agila Specialties Private
`Ltd., Case No. 13-cv-1679-GMS (D. Del. filed Oct. 9, 2013).
`Proof of Service of Strides, Inc., Filed October 23, 2013, ECF No. 6.
`Cubist Pharmaceuticals, Inc. v. Strides, Inc. and Agila Specialties
`Private Ltd., Case No. 13-cv-1679-GMS (D. Del. filed Oct. 9, 2013).
`Proof of Service of Agila Specialties Private Limited, Filed October
`23, 2013, ECF No. 7. Cubist Pharmaceuticals, Inc. v. Strides, Inc.
`and Agila Specialties Private Ltd., Case No. 13-cv-1679-GMS (D.
`Del. filed Oct. 9, 2013).
`Plaintiff’s Complaint, Filed October 9, 2013 ECF No. 1. Cubist
`Pharmaceuticals, Inc. v. Strides, Inc. and Agila Specialties Private
`Ltd., Case No. 13-cv-06016-NLH, (D. N.J. filed Oct. 9, 2013,
`voluntarily dismissed Oct. 24, 2013).
`Plaintiff’s Notice of Voluntary Dismissal, Filed October 24, 2013,
`ECF No.8. Cubist Pharmaceuticals, Inc. v. Strides, Inc. and Agila
`Specialties Private Ltd., Case No. 13-cv-06016-NLH, (D. N.J. filed
`Oct. 9, 2013, voluntarily dismissed Oct. 24, 2013).
`Proof of Service to Cubist Pharmaceuticals, Inc. dated October 24,
`2014, of IPR2015-00140, -00141, -00142, -00143 and -00144.
`Express Mail receipt stamped with an October 23, 2014 received
`date for filing of Inter Partes Review Petition of U.S. Patent No.
`8,058,238, challenging claims 10-36, 43-47 and 176-192, Exhibits 1-
`37, Motion to Request Acceptance of Mailed Petition and
`accompanying Powers of Attorney forms.
`Payment receipt from USPTO reflecting payment date of October
`23, 2014 re IPR2015-00144
`Electronic filing receipt of October 24, 2014 re IPR2015-00144
`Notice of Filing Date Accorded to Petition and Time for Filing
`Patent Owner Preliminary Response. (Board’s notice according a
`filing date of October 23, 2014). Paper Number 4
`Declaration of Adriana Serrano in Support of Agila’s Motion to
`Correct Accorded Filing Date Under 37 C.F.R. §§1.10, 42.20 and
`42.22
`
`

`

`5
`
`Exhibit No.
`1044
`
`Reference
`Declaration of Lorelei P. Westin in Support of Agila’s Motion to
`Correct Accorded Filing Date Under 37 C.F.R. §§1.10, 42.20 and
`42.22
`
`

`

`6
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), I certify that I caused a true and correct copy
`
`of the foregoing PETITIONER AGILA SPECIALTIES INC.’S [REVISED]
`
`EXHIBIT LIST UNDER 37 C.F.R. §42.63 to be served via electronic mail on the
`
`patent owner for the subject patent as follows:
`
`Lead Counsel
`William DeVaul
`Registration No. 42,483
`William.DeVaul@cubist.com
`
`Backup Counsel
`Henry H. Gu
`Registration No. 55,227
`Henry.Gu@cubist.com
`
`Dated: December 1, 2014
`
`/Lorelei P. Westin/
`Lorelei P. Westin, Ph.D
`Reg. No. 52,353
`
`Wilson Sonsini Goodrich & Rosati PC
`12235 El Camino Real, Suite 200
`San Diego, CA 92130-3002
`Telephone: (858) 350-2225
`Facsimile: (858) 350-2399
`E-mail: lwestin@wsgr.com
`
`