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    IN THE UNITED STATES DISTRICT COURT

    FOR THE DISTRICT OF DELAWARE

    CUBIST PHARMACEUTICALS, INC.,

    Plaintiff,

    v.

    HOSPIRA, INC.,

    Defendant.

    )

    )

    )

    ))

    )

    )

    ))

    C.A. No. 12-367 (GMS)

    (CONSOLIDATED)

    JOINT CLAIM CONSTRUCTION CHARTS FOR THE PATENTS BEING

    ASSERTED BY CUBIST PHARMACEUTICALS, INC.

    The parties have met and conferred, and present the following Joint Claim Construction

    Charts for the patents being asserted by Cubist Pharmaceuticals, Inc.

    I. Stipulated Constructions. During the meet and confer process, the parties

    agreed to the claim construction for twelve claim terms from U.S. Patent Nos. 6,468,967,

    6,852,689, RE39,071, 8,129,342, and 8,058,238 as set forth in Exhibit A. The parties jointly and

    respectfully submit that, if the Court deems it appropriate, the Court include these agreed-upon

    claim constructions in the ultimate claim construction order. In the alternative, the parties agree

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    MORRIS,NICHOLS,ARSHT &TUNNELL LLP

    /s/ Maryellen NoreikaJack B. Blumenfeld (#1014)Maryellen Noreika (#3208)

    1201 North Market Street

    P.O. Box 1347Wilmington, DE 19899

    (302) 658-9200

    [email protected]@mnat.com

    PHILLIPS, GOLDMAN & SPENCE, P.A.

    /s/ John C. Phillips, Jr.John C. Phillips, Jr. (No. 110)

    Megan C. Haney (No. 5016)

    1200 North Broom StreetWilmington, DE 19806

    Tel. (302) 655-4200

    Fax (302) [email protected]

    [email protected]

    OF COUNSEL:

    William F. Lee

    Lisa J. PirozzoloEmily Whelan

    WILMER

    CUTLER

    PICKERING

    HALE

    AND DORRLLP60 State Street

    Boston, MA 02109

    (617) 526-6000

    Attorneys for Plaintiff Cubist Pharmaceuticals,

    Inc.

    OF COUNSEL:

    James F. HurstWINSTON & STRAWN LLP35 W. Wacker DriveChicago, Illinois 60601

    (312) 558-5600E-mail: [email protected]

    Gail J. StandishPeter E. PerkowskiWINSTON & STRAWN LLP333 S. Grand Avenue, Suite 3800

    Los Angeles, California 90071

    (213) 615-1700E-mail:[email protected]

    E-mail: [email protected]

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    1

    Exhibit A

    List of Agreed Upon Claim Term Constructions for U.S. Patent Nos. 6,468,967, 6,852,689, RE39,071, 8,129,342, and 8,058,238

    Claim Term Agreed-Upon Construction

    U.S. Patent Nos. 8,058,238 and 8,129,342

    daptomycin that is substantially free of [another compound]

    (Claims 3-5, 7-9, 50, 55, 56, 58, 61, 62, 64, 87, 88, 90, 165-175 ofthe 238 patent)

    (Claims 10, 11, 16 of the 342 patent)

    the other compound is present in an amount that is no more than1% of the amount of the daptomycin preparation

    daptomycin that is essentially free of [another compound]

    (Claims 4-5, 9, 50, 56, 59, 62, 65, 88, 91, 165-175, 190 of the 238

    patent)

    (Claims 3, 32, 42 of the 342patent)

    the other compound is present in an amount that is no more than0.5% of the amount of the daptomycin preparation

    anhydro-daptomycin

    (Claims 3-5, 7, 50, 55, 56, 61, 62, 87, 88, 165-175, 190 of the 238patent)

    (Claims 1, 3-16, 18, 21-23, 32, 33, 41, 42, 53 of the 342 patent)

    The daptomycin derivative in which the -aspartyl group ofdaptomycin is transpeptidated to an anhydro-succinimido group,

    i.e.,

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    2

    Claim Term Agreed-Upon Construction

    -isomer of daptomycin

    (Claims 3-5, 7, 50, 55, 56, 61, 62, 87, 88, 165-175 of the 238patent)

    (Claims 1, 3-16, 21-23, 32, 33, 41, 42, 53 of the 342 patent)

    The daptomycin derivative that contains a -aspartyl group

    instead of an -aspartyl group, i.e.,

    micelle / daptomycin micelle

    (Claims 21-35, 37-40, 42-45, 99, 104, 106, 107, 108, 131, 138,143, 145, 146, 147, 165-174, 176-180, 184, 185 of the 238 patent)

    (Claims 22-23, 30-49 of the 342 patent)

    aggregates of amphipathic molecules / aggregates comprisingdaptomycin

    aggregate / daptomycin aggregate

    (Claims 3-5, 7-9, 49-52, 55, 56, 58, 59, 61, 62, 64, 65, 85, 87, 88,

    90-109, 113-123, 125-148, 151-161, 164-175, 179, 183-187, 189,190 of the 238 patent)

    (Claims 1, 3-23, 25-29, 50-54 of the 342 patent)

    associated molecules including but not limited to micelles /

    associated molecules comprising daptomycin including but notlimited to daptomycin micelles

    conditions effective to form daptomycin [micelles/aggregates]

    (Claims 3-5, 7-9, 37-40, 42-43, 93-107, 125-146, 166-174,

    conditions that result in the formation of daptomycinmicelles/aggregates, including but not limited to one or more of the

    daptomycin concentration, temperature, salt concentration, and/or

    pH of a daptomycin solution

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    3

    Claim Term Agreed-Upon Construction

    176-179 of the 238 patent)

    (Claims 5-6 of the 342 patent)

    daptomycin purified by a process comprising the steps of:

    (Claims 3-5, 7, 166-174 of the 238 patent)

    (Claims 30-39, 50-54 of the 342 patent)

    daptomycin that has been purified by a process including, but notlimited to, the following steps

    daptomycin that is free of [another compound]

    (Claims 50, 165-175 of the 238 patent)

    the other compound is present in an amount that is no more than

    0.1% of the amount of the daptomycin preparation

    essentially pure daptomycin

    (Claims 50, 165-175 of the 238 patent)

    at least 98% of a sample is daptomycin

    purified daptomycin

    (Claims 8-9, 49-52, 55, 56, 58, 59, 61, 62, 64, 65, 85, 87,88, 90-109, 113-123, 125-148, 151-161, 164-180, 183-

    187, 189, 190 of the 238 patent)

    daptomycin that is substantially pure, essentially pure, or

    substantially free, essentially free, or free of another compound

    U.S. Patent No. RE 39,071

    a combination of a compound of formula 1, a compound offormula 2, and a compound of formula 3

    (Claims 18, 19, 26, 28 of the 071 patent)

    a compound of formula 1, a compound of formula 2, and acompound of formula 3, present together and totaling 100% by

    weight of the combination

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    1

    Exhibit B

    Summary of Proposed Claim Constructions for U.S. Patent Nos. 6,468,967, 6,852,689, 8,129,342, 8,058,238, and RE39,071

    Term To Be Construed Cubists Proposed Construction Hospiras Proposed Construction

    U.S. Patent Nos. 6,468,967, 6,852,689, 8,129,342, and 8,058,238

    daptomycin

    (Claims 3-5, 16-17, 27-28, 34-35,

    42-45 of the 967 patent)

    (Claims 48-52 of the 689 patent)

    (Claims 3-5, 7-9, 21-35, 37-40, 42-45,

    49-52, 55, 56, 58, 59, 61, 62, 64, 65,85, 87, 88, 90-109, 113-123, 125-148,

    151-161, 164-180, 183-187, 189, 190of the 238 patent)

    (Claims 1, 3-23, 25-54 of the 342

    patent)

    The cyclic lipopeptide antibiotic derived fromthe fermentation of Streptomyces roseosporus,

    comprised of a decanoyl side chain linked to the

    N-terminal tryptophan of a cyclic 13-amino acidpeptide, i.e.,

    (LY146032) or a pharmaceutically acceptablesalt thereof.

    The compound described in the Baltzarticle at Fig. 1a (Biotechnology of

    Antibiotics, 2nd

    Ed., ed. by Strohl,

    415-435 (1997)) and in the Tally articleat Fig. 1 (Exp. Opin. Invest. Drugs,

    8:1223-1238 (1999)), (i.e., having the

    L-Asn configuration)

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    Term To Be Construed Cubists Proposed Construction Hospiras Proposed Construction

    U.S. Patent No. RE39,071

    formula 3 compound / compound offormula 3

    (Claims 18, 26, 28 of the 071 patent)

    An A21978C cyclic peptide of

    wherein RN

    is n-decanoyl (i.e., LY 146032).

    The FORMULA 3 compound asrecited in claims 18 and 26 thatre-issued on April 18, 2006 (i.e.,

    having the L-Asn configuration)

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    1

    Exhibit C

    Joint Claim Chart for U.S. Patent Nos. 6,468,967, 6,852,689, 8,129,342, and 8,058,238

    Proposed Construction of Disputed Claim Term with Citations to Supporting Evidence

    Term To Be

    Construed

    Cubists Proposed

    Construction

    Intrinsic Evidence

    Supporting Cubists

    Construction

    Hospiras Proposed

    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    Daptomycin

    (Claims 3-5,

    16-17, 27-28,34-35, 42-45 of

    the 967 patent)

    (Claims 48-52 of

    the 689 patent)

    (Claims 3-5, 7-9,

    21-35, 37-40,42-45, 49-52, 55,

    56, 58, 59, 61, 62,64, 65, 85, 87, 88,

    90-109, 113-123,125-148,151-161, 164-180,

    183-187, 189, 190

    of the 238 patent)

    (Claims 1, 3-23,

    25-54 of the 342

    The cyclic lipopeptide

    antibiotic derived from thefermentation of Streptomyces

    roseosporus, comprised of adecanoyl side chain linked to

    the N-terminal tryptophan of acyclic 13-amino acid peptide,i.e.,

    (LY146032) or apharmaceutically acceptable

    salt thereof.

    967 Patent Specification

    Col. 1, lns. 10-13

    Col. 1, lns. 18-51

    Col. 1, ln. 63Col. 2, ln.

    43

    Col. 3, lns. 14-28

    Col. 3, lns. 36-41

    Col. 3, ln. 45Col. 4, ln.48

    Col. 4, ln. 64Col. 5, l.13

    Col. 5, lns. 41-56

    Col. 5, l. 65Col. 6, ln. 1

    Col. 6, lns. 9-12

    The compound describedin the Baltz article at Fig.

    1a (Biotechnology ofAntibiotics, 2nd Ed., ed. by

    Strohl, 415-435 (1997))

    and in the Tally article atFig. 1 (Exp. Opin. Invest.

    Drugs, 8:1223- 1238(1999)), (i.e., having the

    L-Asn configuration)

    967 Patent and FileHistory

    Abstract

    Col. 1, ln. 2Col. 3,ln. 12

    Col. 14, lns. 38-48

    Baltz et al.,Biotechnology of

    Antibiotics, 2nd

    Ed., ed.by Strohl, 415-435

    (1997) (cited at Col. 1,lns. 40-51)

    Tally et al., Exp. Opin.

    Invest. Drugs,

    8:1223-1238 (1999)(cited at Col. 1, lns.

    20-38)

    9/11/00 Declaration of

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    patent) Col. 6, lns. 17-38

    Col. 7, ln. 17Col. 8, ln.

    2

    Col. 8, lns. 8-12

    Col. 8, lns. 15-17

    Col. 8, lns. 21-46

    Col. 9, ln. 25Col. 12,ln. 30 (Examples 1, 2)

    Col. 12, ln. 62Col. 14,

    ln. 27 (Examples 4, 5)

    Col. 14, ln. 50Col. 15,ln. 2 (Claims 1-7)

    Col. 15, ln. 27Col. 16,

    ln. 29 (Claims 12-28)

    Col. 16, lns. 33-62(Claims 32-45)

    Figures 1-3

    967 Patent Abstract

    Francis Tally at 5-6

    238 Patent and File

    History

    Abstract

    Col. 1, ln. 21Col. 3,ln. 46

    Col. 7, lns. 2-27

    Col. 37, lns. 30-40

    Claims 49, 50, 66, and

    191

    Baltz et al.,Biotechnology of

    Antibiotics, 2nd

    Ed., ed.by Strohl, 415-435

    (1997) (cited at Col. 1,

    lns. 58-66)

    Tally et al., Exp. Opin.

    Invest. Drugs,

    8:1223-1238 (1999)(cited at Col. 1, lns.

    39-57)

    U.S. Patent No. RE

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    967 Patent File History

    9/11/2000 Amendment

    and Response to OfficeAction at pp. 6-21

    (CUBH 000794-809)

    9/11/2000 Declaration of

    Francis P. Tally Under 37C.F.R. 1.132 at pp. 3-8

    (CUBH 000812-17)

    06/02/2000 InformationDisclosure Statement at p.

    2 (CUBH 000845)

    01/07/2002 AmendmentUnder 37 C.F.R. 1.312

    at p. 2 (CUBH 000934)

    References Cited in the

    Specification or FileHistory of the 967 Patent

    U.S. Patent No.

    RE32,310

    Col. 2, ln. 51Col. 11,ln. 62

    32,333 to Hamill (cited

    at Col. 2, lns. 13-19)

    U.S. Patent No. RE32,455 to Hamill (cited

    at Col. 2, lns. 13-19)

    U.S. Patent No. RE

    32,310 to Debono(cited at Col. 2, lns.

    20-27)

    U.S. Patent No. RE32,311 to Debono

    (cited at Col. 2, lns.20-27)

    U.S. Patent No.

    4,537,717 to Abbott

    (cited at Col. 2, lns.20-27)

    U.S. Patent No.

    4,482,487 to Abbott(cited at Col. 2, lns.

    20-27)

    U.S. Patent No.4,524,135 to Abbott

    (cited at Col. 2, lns.

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    Col. 15, ln.45Col. 23,

    ln. 62

    U.S. Patent No.RE32,311

    Abstract

    Col. 1, ln. 9Col. 12, ln.

    17

    Col. 17, ln. 65Col. 43,ln. 17

    U.S. Patent No.

    4,537,717

    Abstract

    Col. 1, ln. 13Col. 7, ln.68

    Col. 15, ln. 10Col. 32,ln. 68

    U.S. Patent No.

    4,482,487

    Abstract

    Col. 1, ln. 11Col. 6, ln.

    20-27)

    U.S. Patent No.

    5,912,226 to Baker(cited at Col. 2, ln. 65

    Col. 3, ln. 46)

    Miao et al.,

    DaptomycinBiosynthesis in

    Streptomyces

    roseosporus: Cloningand Analysis of theGene Cluster and

    Revision of Peptide

    Stereochemistry,Microbiology, 151:

    1507-23 (2005)

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    61

    Col. 8, ln. 53Col. 13,

    ln. 42

    Col. 22, ln. 32Col. 33,ln. 15

    U.S. Patent No.

    4,524,135

    Abstract

    Col. 1, ln. 13Col. 6, ln.56

    Col. 8, ln. 47Col. 13,

    ln. 40

    Col. 21, ln. 60Col. 32,ln. 30

    U.S. Patent No.RE32,333

    Col. 1, ln. 40Col. 2, ln.

    16

    Col 19, ln. 62Col. 25,

    ln. 58

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    U.S. Patent No.

    RE32,455

    Col. 1, ln. 51Col. 2, ln.25

    Col. 20, ln. 4Col. 25,

    ln. 65

    U.S. Patent No.4,800,157

    Col. 1, lns. 1-64

    Col. 8, ln. 40Col. 10,

    ln. 29

    U.S. Patent No.4,874,843

    Col. 1, ln. 1Col. 5, ln.

    16

    U.S. Patent No.4,885,243

    Col. 1, ln. 1Col. 8, ln. 7

    U.S. Patent N. 4,208,403

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    Abstract

    Col. 1, ln. 1Col. 25, ln.

    19

    Baltz,LipopeptideAntibiotics Produced by

    Streptomyces

    roseosporus andStreptomyces fradiae,

    BIOTECHNOLOGY OF

    ANTIBIOTICS, 2d ed.415-435 (1997) at pp.415-16, 419-20, 423-26,

    430

    (HOSP_CUB0004829-30HOSP_CUB0004833-34,

    HOSP_CUB0004837-40,HOSP_CUB0004844)

    Tally et al.,Daptomycin:

    A Novel Agent forGram-Positive Infections,EXP.OPIN.INVEST.

    DRUGS 8:1223-1238(1999) at 1223, -24,

    1229-35

    (HOSP_CUB0005043-44HOSP_CUB0005049-55)

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    Oleson et al., Once-Daily

    Dosing in DogsOptimizes Daptomycin

    Safety, ANTIMICROBIAL

    AGENTS AND

    CHEMOTHERAPY, 44:

    2948-2953 (2000) at pp.2948, 2951-53 (CUB

    00487949, CUB

    00487952-54)

    Lee et al.,Daptomycinversus Conventional

    Therapy in the Treatmentof Endocarditis and

    Bacteremia, ABSTRACTS

    OF THE INTERSCIENCECONFERENCE ON

    ANTIMICROBIAL AGENTSAND CHEMOTHERAPY,

    A885, 1991

    Sexton et al., The Use ofDaptomycin, a

    Lipopeptide Antibiotic, in

    the Treatment of GramPositive Infections in

    Man, ABSTRACTS OF THEINTERSCIENCE

    CONFERENCE ON

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    ANTIMICROBIAL AGENTS

    AND CHEMOTHERAPY,A932, 1988

    689 Patent Specification

    Col. 1, lns. 13-16

    Col. 1, lns. 21-53

    Col.1, ln. 65Col. 2, ln.

    45

    Col. 3, lns. 17-30

    Col. 3, lns. 38-43

    Col. 3, ln. 48Col. 4, ln.50

    Col. 4, ln. 66Col. 5, ln.

    16

    Col. 5, lns. 43-58

    Col. 5, ln. 67Col. 6, ln.3

    Col. 6, lns. 11-14

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    Col. 6, lns. 19-40

    Col. 7, ln. 38Col. 8, ln.

    4

    Col. 8, lns. 10-14

    Col. 8, lns. 17-19

    Col. 8, lns. 23-48

    Col. 9, ln. 29Col. 12,ln. 30 (Examples 1, 2)

    Col. 12, ln. 63Col. 14,

    ln. 25 (Examples 4, 5)

    Col. 14, lns. 48-62(Claims 1-5)

    Col. 15, ln. 21Col. 16,

    ln. 65 (Claims 10-57)

    Figures 1-3

    689 Patent Abstract

    689 Patent File History

    02/20/2002 InformationDisclosure Statement at p.

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    2 (CUBH 001680)

    11/20/2002 Amendment

    at pp. 6-17 (CUBH001530-41)

    References Cited in the

    Specification or File

    History of the 689 Patent

    U.S. Patent No.

    RE32,310

    Col. 2, ln. 51Col. 11,

    ln. 62

    Col. 15, ln.45Col. 23,ln. 62

    U.S. Patent No.

    RE32,311

    Abstract

    Col. 1, ln. 9Col. 12, ln.

    17

    Col. 17, ln. 65Col. 43,

    ln. 17

    U.S. Patent No.

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    4,537,717

    Abstract

    Col. 1, ln. 13Col. 7, ln.

    68

    Col. 15, ln. 10Col. 32,ln. 68

    U.S. Patent No.

    4,482,487

    Abstract

    Col. 1, ln. 11Col. 6, ln.61

    Col. 8, ln. 53Col. 13,

    ln. 42

    Col. 22, ln. 32Col. 33,

    ln. 15

    U.S. Patent No.

    4,524,135

    Abstract

    Col. 1, ln. 13Col. 6, ln.

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    56

    Col. 8, ln. 47Col. 13,

    ln. 40

    Col. 21, ln. 60Col. 32,ln. 30

    U.S. Patent No.

    RE32,333

    Col. 1, ln. 40Col. 2,ln. 16

    Col 19, ln. 62Col. 25,

    ln. 58

    U.S. Patent No.RE32,455

    Col. 1, ln. 51Col. 2, ln.

    25

    Col. 20, ln. 4Col. 25,ln. 65

    U.S. Patent No.4,800,157

    Col. 1, lns. 1-64

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    Col. 8, ln. 40Col. 10,

    ln. 29

    U.S. Patent No.4,874,843

    Col. 1, ln. 1Col. 5, ln.

    16

    U.S. Patent No.4,885,243

    Col. 1, ln. 1Col. 8, ln. 7

    U.S. Patent N. 4,208,403

    Abstract

    Col. 1, ln. 1Col. 25, ln.

    19

    Baltz,Lipopeptide

    Antibiotics Produced byStreptomyces

    roseosporus andStreptomyces fradiae,

    BIOTECHNOLOGY OFANTIBIOTICS, 2d ed.

    415-435 (1997) at pp.

    415-16, 419-20, 423-26,

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    Construction

    430

    (HOSP_CUB0004829-30,

    HOSP_CUB0004833-34,

    HOSP_CUB0004837-40,HOSP_CUB0004844)

    Tally et al.,Daptomycin:

    A Novel Agent forGram-Positive Infections,

    EXP.OPIN.INVEST.

    DRUGS 8:1223-1238(1999) at 1223, -24,

    1229-35(HOSP_CUB0005043-44

    HOSP_CUB0005049-55)

    Oleson et al., Once-Daily

    Dosing in DogsOptimizes Daptomycin

    Safety, ANTIMICROBIAL

    AGENTS ANDCHEMOTHERAPY, 44:2948-2953 (2000) at pp.

    2948, 2951-53 (CUB

    00487949, CUB00487952-54)

    Lee et al.,Daptomycin

    versus Conventional

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    16

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    Construction

    Therapy in the Treatment

    of Endocarditis andBacteremia, ABSTRACTS

    OF THE INTERSCIENCE

    CONFERENCE ON

    ANTIMICROBIAL AGENTS

    AND CHEMOTHERAPY,A885, 1991

    Sexton et al., The Use of

    Daptomycin, a

    Lipopeptide Antibiotic, inthe Treatment of Gram

    Positive Infections inMan, ABSTRACTS OF THE

    INTERSCIENCE

    CONFERENCE ONANTIMICROBIAL AGENTS

    AND CHEMOTHERAPY,A932, 1988

    238 Patent Specification:

    Fig. 1.

    Col. 1, lns. 21-25

    Col. 1, lns. 39-57

    Col. 1, ln. 57Col. 2, ln.

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    Construction

    60

    Col. 3, lns. 33-38

    Col. 4, ln. 21

    Col. 5, lns. 22-36

    Col. 7, lns. 24-27

    Col. 9, lns 9-15

    Col. 9, lns. 16-22

    Col. 14, lns 13-30

    Col. 21, lns. 8-17

    Col. 26, lns. 46-49

    Col. 26, lns. 56-60

    Col. 28, lns. 1-18

    Cols. 30-37

    238 File History

    08/11/2009 Office Action

    at CUBH 001937

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    Supporting Hospiras

    Construction

    3/16/2010 Information

    Disclosure Statement atCUBH 001893

    References Cited in the

    Specification or File

    History of the 238 Patent

    U.S. Patent No.RE32,310

    Col. 2, ln. 51Col. 11,ln. 62

    Col. 15, ln. 45Col. 23,ln. 62

    U.S. Patent No.

    RE32,311

    Abstract

    Col. 1, ln. 9Col. 12, ln.17

    Col. 17, ln. 65Col. 43,

    ln. 17

    U.S. Patent No.4,537,717

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    Construction

    Abstract

    Col. 1, ln. 13Col. 7, ln.

    68

    Col. 15, ln. 10Col. 32,ln. 68

    U.S. Patent No.

    4,482,487

    Abstract

    Col. 1, ln. 11Col. 6, ln.61

    Col. 8, ln. 53Col. 13,

    ln. 42

    Col. 22, ln. 32Col. 33,ln. 15

    U.S. Patent No.4,524,135

    Abstract

    Col. 1, ln. 13Col. 6, ln.56

    Col. 8, ln. 47Col. 13,

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    Supporting Hospiras

    Construction

    ln. 40

    Col. 21, ln. 60Col. 32,

    ln. 30

    U.S. Patent No.RE32,333

    Col. 1, ln. 40Col. 2,

    ln.16

    Col 19, ln. 62Col. 25,ln. 58

    U.S. Patent No.

    RE32,455

    Col. 1, ln. 51Col. 2, ln.25

    Col. 20, ln. 4Col. 25,

    ln. 65

    U.S. Patent No.4,800,157

    Col. 1, lns. 1-64

    Col. 8, ln. 40Col. 10,

    ln. 29

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    Intrinsic Evidence

    Supporting Hospiras

    Construction

    U.S. Patent No.

    4,874,843

    Col. 1, ln. 1Col. 5, ln.16

    U.S. Patent No.

    4,885,243

    Col. 1, ln. 1Col. 8, ln. 7

    U.S. Patent N. 4,208,403

    Abstract

    Col. 1, ln. 1Col. 25, ln.19

    Baltz,Lipopeptide

    Antibiotics Produced byStreptomyces

    roseosporus and

    Streptomyces fradiae,BIOTECHNOLOGY OF

    ANTIBIOTICS, 2d ed.415-435 (1997) at pp.

    415-16, 419-20, 423-26,

    430(HOSP_CUB0004829-30

    HOSP_CUB0004833-34,

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    22

    Term To Be

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    Construction

    Hospiras Proposed

    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    HOSP_CUB0004837-40,

    HOSP_CUB0004844)

    Tally et al.,Daptomycin:A Novel Agent for

    Gram-Positive Infections,

    Exp. Opin. Invest. Drugs8:1223-1238 (1999) at pp.

    1223, -24, 1229-35(HOSP_CUB0005043-44

    HOSP_CUB0005049-55)

    Miao et al.,DaptomycinBiosynthesis in

    Streptomyces

    roseosporus: Cloning andAnalysis of the Gene

    Cluster and Revision of

    Peptide Stereochemistry,

    MICROBIOLOGY 151:

    1507-23 (2005) at pp.

    1507-08, 1512, 1520-21(CUBH 000441-42,CUBH 000446, CUBH

    000454-55)

    342 Patent Specification:

    Fig. 1.

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    Supporting Hospiras

    Construction

    Col. 1, lns. 18-22

    Col. 1, ln. 36 Col. 2, ln.

    57

    Col. 3, lns. 30-36

    Col. 4, ln. 18

    Col. 5, lns. 17-31

    Col. 7, lns. 17-20

    Col. 9, lns. 4-1.

    Col. 9, lns 11-17

    Col. 14, lns. 8-12

    Col. 14, lns. 17-26

    Col. 21, lns. 1-11

    Col. 26, lns. 39-42

    Col. 26, lns. 49-53

    Col. 27, ln. 60Col. 28,

    ln. 10

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    Construction

    Cols. 30-37

    342 File History

    07/29/2011 Office Action

    at CUBH 000283

    08/12/2011 InformationDisclosure Statement at

    CUBH 000199

    12/08/2011 InformationDisclosure Statement at

    CUBH 000192

    References Cited in the

    Specification or FileHistory of the 342 Patent

    Cubicin (daptomycin

    for injection) Label 1004September 2003

    Cubicin (daptomycin

    for injection) Label1004-1Revised August

    200

    Cubicin (daptomycin

    for injection) Label

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    25

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    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    1004-2Revised June

    2005

    Cubicin (daptomycinfor injection) Label

    1004-10-1 August 2010

    U.S. Patent No.

    RE32,310

    Col. 2, ln. 51Col. 11,

    ln. 62

    Col. 15, ln.45Col. 23,

    ln. 62

    U.S. Patent No.RE32,311

    Abstract

    Col. 1, ln. 9Col. 12, ln.

    17

    Col. 17, ln. 65Col. 43,

    ln. 17

    U.S. Patent No.

    4,537,717

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    26

    Term To Be

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    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    Abstract

    Col. 1, ln. 13Col. 7, ln.

    68

    Col. 15, ln. 10Col. 32,ln. 68

    U.S. Patent No.

    4,482,487

    Abstract

    Col. 1, ln. 11Col. 6, ln.61

    Col. 8, ln. 53Col. 13,

    ln. 42

    Col. 22, ln. 32Col. 33,ln. 15

    U.S. Patent No.4,524,135

    Abstract

    Col. 1, ln. 13Col. 6, ln.56

    Col. 8, ln. 47Col. 13,

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    Intrinsic Evidence

    Supporting Hospiras

    Construction

    ln. 40

    Col. 21, ln. 60Col. 32,

    ln. 30

    U.S. Patent No.RE32,333

    Col. 1, ln. 40Col. 2, ln.

    16

    Col 19, ln. 62Col. 25,ln. 58

    U.S. Patent No.

    RE32,455

    Col. 1, ln. 51Col. 2, ln.25

    Col. 20, ln. 4Col. 25,

    ln. 65

    U.S. Patent No.4,800,157

    Col. 1, lns. 1-64

    Col. 8, ln. 40Col. 10,

    ln. 29

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    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    U.S. Patent No.

    4,874,843

    Col. 1, ln. 1Col. 5, ln.16

    U.S. Patent No.

    4,885,243

    Col. 1, ln. 1Col. 8, ln. 7

    U.S. Patent N. 4,208,403

    Abstract

    Col. 1, ln. 1Col. 25, ln.19

    Baltz,Lipopeptide

    Antibiotics Produced byStreptomyces

    roseosporus and

    Streptomyces fradiae,BIOTECHNOLOGY OF

    ANTIBIOTICS, 2d ed.415-435 (1997) at pp.

    415-16, 419-20, 423-26,

    430(HOSP_CUB0004829-30

    HOSP_CUB0004833-34,

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    29

    Term To Be

    Construed

    Cubists Proposed

    Construction

    Intrinsic Evidence

    Supporting Cubists

    Construction

    Hospiras Proposed

    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    HOSP_CUB0004837-40,

    HOSP_CUB0004844)

    Tally et al.,Daptomycin:A Novel Agent for

    Gram-Positive Infections,

    Exp. Opin. Invest. Drugs8:1223-1238 (1999) at pp.

    1223, -24, 1229-35(HOSP_CUB0005043-44

    HOSP_CUB0005049-55)

    Miao et al.,DaptomycinBiosynthesis in

    Streptomyces

    roseosporus: Cloning andAnalysis of the Gene

    Cluster and Revision of

    Peptide Stereochemistry,

    MICROBIOLOGY 151:

    1507-23 (2005) at pp.

    1507-08, 1512, 1520-21(CUBH 000441-42,CUBH 000446, CUBH

    000454-55)

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    1

    Exhibit D

    Joint Claim Chart for U.S. Patent Nos. RE39,071

    Proposed Construction of Disputed Claim Term with Citations to Supporting Evidence

    Term To Be

    Construed

    Cubists Proposed

    Construction

    Intrinsic Evidence

    Supporting Cubists

    Construction

    Hospiras Proposed

    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    formula 3

    compound/compound of

    formula 3

    (Claims 18, 26,28 of the 071

    patent)

    An A21978C cyclic

    peptide of

    wherein RN is n-decanoyl

    071 Patent Specification

    Abstract

    Col. 1, lns. 26-35

    Col. 2, lns. 29-31

    Col. 7, ln. 1Col. 8, ln. 25

    Col. 8, lns. 46-67

    Col. 15, ln. 50Col. 17,

    ln. 4 (Claim 18)

    Col. 17, ln. 8Col. 19,

    ln. 30 (Claim 20)

    Col. 20, ln. 26Col. 22,

    ln. 45 (Claim 26)

    Col. 23, ln. 1Col. 26,ln. 6 (Claim 30)

    01/29/2008 Certificate of

    The FORMULA 3compound as recited in

    claims 18 and 26 thatre-issued on April 18, 2006

    (i.e., having the L-Asn

    configuration)

    071 Patent and FileHistory

    Abstract

    Col. 1, lns. 14-35

    Col. 1, ln. 60Col. 2, ln.31

    Col. 6, ln. 56Col. 7, ln.60

    Col. 8, lns. 50-60

    Col. 9, ln. 47Col. 10, ln.

    67

    Claims 1, 2, 18, 20, 26, 30

    as re-issued on April 18,

    2006

    6/10/87 PatentApplication at 11

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    2

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    Intrinsic Evidence

    Supporting Hospiras

    Construction

    (i.e., LY 146032). Correction

    071 Patent File History

    01/29/2008 Certificate of

    Correction (CUBH000436)

    10/18/2007 Request for

    Certificate of Correction atpp. 1-4 (CUBH

    000437-40) andAttachment at pp.1507-08, 1512, 1520-21

    (CUBH 000442-42,CUBH 000446, CUBH

    000454-55)

    References Cited in

    Specification orProsecution History of the

    071 Patent

    U.S. Patent No. 4,885,243

    Col. 2, lns. 9-15

    Col. 2, lns. 20-25

    Col. 2, lns. 33-42

    5/5/88 Office Action at 4

    11/16/88 Amendment at

    5-6

    9/5/89 Amendment at 6

    12/12/89 Office Action at4

    6/28/90 Amendment at

    5-6

    9/14/90 Office Action at2

    8/14/91 Office Action at

    2-4

    11/13/91 Amendment 3,5, 7

    9/1/92 Declaration ofManuel Debono at 2-3

    11/5/92 Office Action at

    3

    3/9/93 Response at 3, 6, 8

    5/27/93 Appeal Brief at 5,

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    3

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    Construction

    Intrinsic Evidence

    Supporting Hospiras

    Construction

    Col. 3, ln. 57Col. 8, ln. 7

    (Examples 1-10)

    U.S. Patent No. 4,537,717

    Col. 2, lns. 54-57

    Col. 17, lns. 20-22

    U.S. Patent No. 4,208,403

    Col. 1, lns. 64-67

    Miao et al.,Daptomycin

    Biosynthesis in

    Streptomycesroseosporus: Cloning and

    Analysis of the Gene

    Cluster and Revision ofPeptide Stereochemistry,

    MICROBIOLOGY 151:1507-23 (2005) at pp.

    1507-08, 1512, 1520-21(CUBH 000441-42,

    CUBH 000446, CUBH

    000454-55)

    11

    12/5/93 Reply Brief at 2

    3/5/98 BPAI Decision at

    6-7, 10

    4/11/00 ReissueApplication at 4-5, claims

    18, 26

    8/22/00 Office Action at6-8

    10/18/07 Certificate of

    Correction Request at 1-2

    1/29/08 Certificate ofCorrection

    U.S. Patent No.

    4,208,403 to Hamill

    (cited at Col. 6, lns.58-64)

    U.S. Patent No.

    4,537,717 to Abbott(cited at Col. 7, lns.

    42-60)

    U.S. Patent No.

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    4

    Term To Be

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    Intrinsic Evidence

    Supporting Hospiras

    Construction

    4,399,067 to Debono

    (cited in 5/5/88 OfficeAction)

    U.S. Patent No. RE

    32,311 to Debono (cited

    in 5/5/88 Office Action)

    U.S. Patent No.5,912,226 to Baker (cited

    in 4/11/00 Reissue

    Application)

    U.S.A.N and the USP

    Dictionary of DrugNames (1989) (cited as

    Exhibit 1 in 6/28/90

    Amendment)

    Miao et al., DaptomycinBiosynthesis in

    Streptomycesroseosporus: Cloning and

    Analysis of the GeneCluster and Revision of

    Peptide Stereochemistry,

    Microbiology, 151:1507-23 (2005)