cbst v hsp 20130201 - cc charts joint
TRANSCRIPT
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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]
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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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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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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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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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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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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Term To Be
Construed
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Construction
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Construction
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Intrinsic Evidence
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Construction
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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Construction
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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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8
Term To Be
Construed
Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
Construction
Intrinsic Evidence
Supporting Hospiras
Construction
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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15
Term To Be
Construed
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Construction
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Construction
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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
Term To Be
Construed
Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
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Construction
Intrinsic Evidence
Supporting Hospiras
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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Intrinsic Evidence
Supporting Hospiras
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
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
25/40
18
Term To Be
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Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
Construction
Intrinsic Evidence
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
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
26/40
19
Term To Be
Construed
Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
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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27/40
20
Term To Be
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Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
Construction
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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21
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Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
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,
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
29/40
22
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)
342 Patent Specification:
Fig. 1.
-
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Construction
Intrinsic Evidence
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Construction
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Construction
Intrinsic Evidence
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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Term To Be
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Construction
Intrinsic Evidence
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Construction
Hospiras Proposed
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Intrinsic Evidence
Supporting Hospiras
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
Term To Be
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Construction
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Construction
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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
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
33/40
26
Term To Be
Construed
Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
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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27
Term To Be
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Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
Construction
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
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
35/40
28
Term To Be
Construed
Cubists Proposed
Construction
Intrinsic Evidence
Supporting Cubists
Construction
Hospiras Proposed
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,
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
36/40
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)
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
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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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Construction
Intrinsic Evidence
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Construction
Hospiras Proposed
Construction
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
Term To Be
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Construction
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Supporting Cubists
Construction
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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.
-
7/30/2019 Cbst v Hsp 20130201 - Cc Charts Joint
40/40
4
Term To Be
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Cubists Proposed
Construction
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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)