throbber

`
`
`EXHIBIT 31
`
`REDACTED IN ITS ENTIRETY
`
`REDACTED IN ITS ENTIRETY
`
`EXHIBIT 31
`
`

`

`
`
`
`EXHIBIT 32
`
`REDACTED IN ITS ENTIRETY
`
`REDACTED IN ITS ENTIRETY
`
`EXHIBIT 32
`
`

`

`
`
`
`EXHIBIT 33
`
`REDACTED IN ITS ENTIRETY
`
`REDACTED IN ITS ENTIRETY
`
`EXHIBIT 33
`
`

`

`
`
`
`EXHIBIT 34
`
`REDACTED IN ITS ENTIRETY
`
`REDACTED IN ITS ENTIRETY
`
`EXHIBIT 34
`
`

`

`
`
`
`EXHIBIT 35
`
`REDACTED IN ITS ENTIRETY
`
`REDACTED IN ITS ENTIRETY
`
`EXHIBIT 35
`
`

`

`EXHIBIT 36
`
`

`

`lllllllllllllllllllllllllllllllllllllllllll||||||||l|1||1||
`USOO8309087B2
`
`(121 United States Patent
`Hellmann
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,309,087 B2
`Nov. 13, 2012
`
`(S4) TREATMENT \VlTH ANTI-ERBBZ
`AN “BODIES
`
`(75)
`
`Inventor.
`
`SusanD.llellmann.S:111Carlux,CA
`(US)
`
`(73) Assignee: Generitecli, lnc., Soulh San Francisco.
`CA(US)
`
`( ‘ 1 Notice:
`
`Subject to any disclaimer. the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(1)) by 0 clays.
`
`(21) Appl.No.: 13/103399
`
`(22)
`
`Filed:
`
`May 9. 201]
`
`(65)
`
`Prior Publication Data
`US 2011/0250194 A1
`Oct. 13, 2011
`
`Related LLS. Appllcntlon Data
`
`(60) Continuation 111'npplicalion No. 11/969,465. filed on
`Jan. 4. 2008,11011/ abandoned. which is a continuation
`of application No. 10/406325. filed on Apr 4. 2003.
`now abandoned, which is a division of application No.
`09/209023. filed on Dec. 10. 1998. now abandoned.
`
`(60) Provisional application No. 60/069,346. filed on Dec.
`12.1997.
`
`(511
`
`lm.(‘l.
`.161K39/395
`(52) us. (:1.
`
`(2006.01)
`424/1434; 424/1301: 424/133 1;
`424/] 34.1; 424/1351; 424/1361: 424/138J;
`424/141.l;424/'155.l;424/174.1
`Field ofClnIslficatinn Search ............... 424/130 1,
`424/1111,1341.135.1,136.1,1381,14l1,
`424/1411, 143.1, 155.1, 174.1
`Sec application file for complete search history.
`
`(58)
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`4/1977 Davies
`(1- 1988 Frankel et a1.
`6/1990 Bargmann ct a1.
`7/1990 Mendel 501m at 11.
`1 1/1990 Slainon «:1 nl.
`12/1990 Senter ct al.
`21/1991 Armour Ct 81
`12/1992 Frankel et al
`2/1993 Kraus er a1
`3 1994 “new
`111 1994 ( :ipun e1 :11
`I
`l 1994
`\krntllcli cl :11
`.1 1'19."
`1 znncy :1 .11
`ll [9'19
`li1ccnc 1:1 111
`1 I006 Kl'illlfi c1 :11
`< 1000 linens.
`I I 10110 Wcls 1.1111
`l
`l 1906 l ippmnn ml
`I.‘ 19011 King et :11
`'7
`. 199'
`( rirncy c1 .11
`(1 [9‘17 Vilndlcn e1 :11
`‘./' l‘N" (Elven/c e1 :11
`It] 1097 lluil'nnl; k" :11
`I
`[003 tirccnc
`
`2>>>>2>>2>>>>>>>>>>>>>>>
`
`.'11
`
`4.017.471
`4.755.894
`4.935.341
`4.947.533
`4.968.603
`4.975.278
`4.994.558
`5.169.774
`1181.884
`5 288,177
`5 35.9.1146
`5 3107.061)
`5 401.6le
`i 401.7.”
`5.118113%?1
`5.511.151
`3 571.891
`5 “MAXI
`S “(7.4%:
`§ (101. 107
`\'. (1'11 .869
`< (10}. 1'14
`5 (177.171
`< 70711:?
`
`5.720.937
`5.720.954
`5 725,856
`5.726.023
`5.728.687
`5.747.261
`5.770.195
`5.772.097
`5.776.427
`5.783.186
`S 783,404
`S.80l,005
`5.804.396
`5.821.337
`5.824.311
`5 1134.220
`5 837,523
`5 840.525
`5346.5.“
`5.846.749
`5.856.089
`5 856,110
`5.859.106
`5 1169.445
`5.876.712
`5 27mm
`5 «10mm
`
`>>>>>>>>>>>>>>>>>>>>>>>>>>>
`
`2/1')98 Hndziakctnl
`3/1998 Hudziakctal.
`3/1998 Hudziakct .11
`3/1998 (Zliccvcr c1111.
`3/1998 Bisscry
`5-1998 Kingel :11.
`6.1993 Hudzinketal.
`6/1998 lludziaketnl.
`7/1998 Thorpe et n1
`7/1993 Araknvsn et at.
`7/1998 Koslti
`9/1998 Chewcr ct a].
`9/1998 Plowman
`10/1998 Carteretal.
`10-1998 Greene e1 n1.
`11/1998 Vandlen 21:11
`1 1/1998 Greene cl ul
`11/1998 Vandlcn e1 at
`1111998 Chewer et at
`11/1998 Slzmon e! at
`1/1999 Wang er a1
`1/1999 Vandlcn or at
`1/1999 Vandl- e1 .11.
`1/1999 (Iheever et a1.
`3/1999 CIIGWCI’ et al
`L’l999 Huston at al
`1’ 1 99‘) Kisser)!
`(Continuedl
`
`111’
`
`FOREIGN PATENT DOCUMENTS
`(1 599 274 A1
`6/1994
`
`(Continued)
`OTHER PUBLICATIONS
`
`Busclgn. .1. e1 31 . Journal ofClinical Oncology. 14(3): 737-744. Mar
`1996 ‘
`11117111“: A U cf :11 , Cancer 7‘7: 25071-2513. Jun 1996 ‘
`Buzdar. .\.U et 31., J. Clinical Oncology 14: 2000-2011. Jul. [996 "
`Klijn. J. Steroid Biochern. Melee. Biol. 43(1-3): 211-221. 1992.‘
`Witwis. L.M.. ct al. Breast Cancer Research and 't‘retltmrnt. 42: 1-5.
`1997.‘
`"An adjuvnnl Herceptin trials using the wrong drugs?" Scrip
`2493: 21 (1999).
`[ablets" Physicians' Desk Reference
`"Arimidex (mash-0201c)
`(website version ofpmduct information) pp. 1-14. (2003).
`"Aromnsin (excmcsluc ublctn)" Physicim' Desk Reference
`(website version ofpioiluct infatuation) pp 1-9. (2003).
`Anna a 111.. "Clinical Activity in a PM“: lTrinl of HER-Z-Tnmod
`rluMAb 2C4 (pcrtu‘lmnnh) in Patients with Advanced Solid Malig-
`nancics MST)" Proceedings ofllm American Associuion for Cancer
`Research lAhsu'act No. 771). 22:192.(2003).
`
`(Continued)
`Primary Examiner ,- Alana Harris Dent
`Assistant Examiner — Anne Hollertm
`(74) Altar/rev. Age/ii. or 1'1‘1'111—-Diune Marschang: Ginger
`R. Dug/n: Amnld & Porter 1.1.1)
`(57)
`Alls'l‘RAF'l‘
`1111: present
`invcntmn concerns the "eminent 111 disorders
`clulnrclcrixed I?) the mercxpressiun ul‘l-Irhll2. More syn-cili-
`cnlly. the invention ammunis 1111- Iruntnu‘nl 11111111111111 ptlllt‘llN
`suscqilihlc to ur diagnosed wilh cunccr owruxprussing
`11117112 with .1 cumlriuuliun 111';111.11111-l'111|12untihudyslud .1
`clicmnlhempculic 113,011! other 111:111
`1111 zinlhnrcyclinc. cg
`dummhicin 111 epinihicin. 'l he invention further provides 11
`mullmd 111' trailing cancer in :1
`|111111:111 pulicnl comprising
`administering ell'eclivu amounts 111 .111 nuti-l-Zrlilll’ 111111111111)-
`;md .- mnlinpnrlcclunl tn the patient
`)1 ('laims. I Drawing Slit-ct
`
`AMGKAN02977625
`
`

`

`US 8,309,087 B2
` Page 2
`
`424/1301
`
`U.S. PATENT DOCUMFNI‘S
`5.910.486 A
`6/1999 ('uriel cl :1]
`5,922,845 A
`7/1999 Dec 61 :11.
`5.925.519 A
`7/1999 Jensen elul,
`5.939.531 A
`8/1999 Welsetul.
`5.977.322 A
`11/1999 Marks «:1 a].
`5.985.553 A
`11/1999 Kingdul.
`5.994.071 A
`11/1999 Russel :11.
`6.015.567 A
`[/2000 11111121111; 1:1 :0.
`6.028.059 A
`2/2000 Cm‘ieldal.
`6.054.297 A
`4/2000 Canct ctnl.
`6.054.561 A
`4/2000 Ring
`6.123.939 A
`9/2000 Slnwver ct nl.
`6.165.464 A
`12/2000 [[udzink 6111.1.
`6.214.388 131
`4/2001 Benzelal.
`6.214.863 Bl
`4/2001 Dissery
`6267.958 13]
`7/200] Andyaclal.
`6.270.765 Bl
`8/2001 Dco c111,
`6.316.462 Bl
`11/2001 Dishopct a1.
`6.333.348 Bl
`12/2001 Vogcl er 31.
`6.339.142 Bl
`1/2002 aneyel :11.
`6.387.371 Bl
`5/2002 Hudziak 01 :11.
`6.395.712 B1
`5/2002 Hung at 11.
`6.399.063 Bl
`6/2002 11ndzink at .11.
`6.407.213 Bl
`6’2002 Caner at :11.
`6.458.356 Bl
`10’2002 Amknwnetnl.
`6.512.097 Bl
`1/2003 Marks :1 n1.
`6.627.196 Bl
`9/2003 Bmlghman e1 :11.
`6.639.055 31
`10/2003 Carter :1 :11.
`6.685.940 B2
`1120041 Audya ct 31
`6.719.971 Bl
`4/2004 Camera n1.
`6.8m.738 Bl
`10/2004 Caner et :11.
`6.821.515 Bl
`11/2004 ("Island 2191.
`7.041.292 131
`5/2006 Sliwkowflii
`7.000.268 152
`6/2006 Andya el :11.
`7.097.840
`2
`8/2006 Erickson etal.
`20000014326 A1
`8/2001 Andy» ctal
`Kill/0001587 AI
`1/2002 Erick/um et :11
`NIH/0076408 A1
`6/2002 Buchahaum
`2m2’0155527 A1
`10/2002. Sman elal.
`2m3'0103973 A1
`6/2003 Rockwell c131.
`20030108545 A1
`6/2003 Rockwell clal.
`2103101471184 A1
`11/2003 Patch 6 :11.
`2003/0170234 A1
`9/2003 Hclhnnnn
`200350202972 A1
`10/2003 Andya c1 81.
`211140013660 A1
`1/2004 Bissery
`200410037823 A9
`2/2004 Paton et :11.
`2004-0037824 A1
`2/2004 Baugmun et :1.
`200410106161 A1
`6/2004 Busscnmaicrctal.
`200410236078 A1
`11/2004 Curler et 31.
`200410258685 A1
`12/2004 Blunclla cl a1,
`200510002928 Al
`1/2005 Hellmann
`zoos/0203043 A1
`9/2005 Adams at a].
`20050238640 A1
`10/2005 Sliwkowski
`2005'0244417 A1
`11/2005 Ashkeuazi 01 n1,
`20000013819 A1
`“3006 dey
`20060018899 A1
`"2006 Kw d al-
`200610034840 Al
`2/3006 Agus
`2°00 003““ N ”41°“ Adm“ °‘ “'-
`_.
`-
`-
`,-
`zoos/00.3143 A1
`4/2006 Adams at al.
`2006 0083/39 A1
`4/2006 Sllwkowsh
`2006001111523 A1
`4/2006 Andya c. 111.
`20050099201 Al
`5/2006 may“ c. “I,
`20060121044 A1
`6/2006 ““1" ct n1.
`2m6'0165703 ,\|
`7'2006 Allison cl ”1,
`21X16 01988-13 Al
`‘) .7006 Adams :1 n1
`21116 0.101505 Al
`'1 2011(- Sliwkuwski cl :Il
`200“ "3105“ A'
`I) 3006 11""E)‘"“"‘ “‘1 “1
`30"“ 0359/45 "‘1
`'0 300‘! ““53
`70000205395. “I
`l’! 3,0116 Blynm
`21X") 03.75.1116 AI
`13 2001‘ Andy: 1'1 :11
`1007 00.20261 AI
`1 3007 Mitt-10mm 1-1 :11
`7110701))MKlI AI
`.2 .2007
`\sllkcmzi N "I
`2007 00173.18 AI
`3 2007 Mum-1‘s u ,-.|
`sum olx-mss Al
`:4 .mo‘: sniwtuwm
`.)[x;7[)_vu.g<|(. AI
`5 300“ Mass
`3(x17()_'_.‘4_u)1 ,\|
`U 2001 l-ricss cl :11
`.3007 01694.“)
`.-'\I
`1
`“U117 Rely.) c1 nl
`1
`2007 0192419 ,\I
`12 .1007
`llcllmunn
`
`1-3?
`EP
`1P
`JP
`JP
`JP
`JP
`11’
`JP
`JP
`11’
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`WU
`W0
`W0
`W0
`W0
`WO
`\Vf)
`W0
`W0
`W0
`\VO
`W0
`W0
`W0
`W0
`W0
`W0
`
`FOREIGN PATENT DOCUMENTS
`0616 812 Bl
`9/1994
`0 711 565
`8/1998
`3-240-198
`10/1991
`5-117165
`5/1993
`5-170667
`7/1993
`5-213775
`8/1993
`53517084
`12/1993
`95006982 1'32
`1/1995
`7-59588
`3/1995
`2761543 132
`6/1998
`2895105 112
`5/1999
`WO 87107646 A2
`12/1987
`W0 89/06692
`7/1989
`W0 89/10412 A1
`11/1989
`WO 91/02062 A2
`2/1991
`W0 91/05264 A1
`4/1991
`W0 92.10573
`6/1992
`WO 93303741 A1
`3/1993
`W0 93.712220 A1
`6/1993
`W0 93/161115 AZ
`8/1993
`W0 93121232 A1
`10/1993
`W0 93121319 A1
`10/1993
`WO 94100136 A1
`1/1994
`W0 94/223478 A1
`10/1994
`WOW/28127
`12/1994
`WO 95116051
`6/1995
`WO 95/17507
`6/1995
`WO 95528485
`101995
`W0 96-07321 Al
`3/ 1996
`W0 9616673 A1
`6/1996
`W0 96'18409
`6/1996
`W0 96340789 A1
`12/1996
`\VO 97/011271 Al
`1/1997
`W0 97/208515 A1
`6/1997
`W0 97/278118
`8/1997
`WO 97138731 A1
`10/1997
`wn 98/0246] AI
`1/1998
`\VO 9K’l7797 Al
`4/1998
`W0 98/111489 A1
`5/1998
`W0 98513914 Al
`8/1998
`W0 08.115479 A1
`10/1998
`WO 99/24401
`5/1999
`W09W25320
`5/1999
`W0 99.31140 AI
`6/1999
`W0 00.61145 A1
`10/2000
`W0 00/694110 A1
`11/2000
`W0 01/117334 A1
`11/2001
`WO 02055106 A2
`7/2002
`\VO 20075145862 A2
`12/2007
`‘
`_
`__
`,_
`OTHER PUBULAI IONS
`Albancll at al., "Tarzan-numb. nhumnnizcd anti-HERB monoclonal
`antibody.
`for the trcntment 01' breast cancer" Drugs of Today
`35(12);93|-946.(1999).
`Allmncll. 1. :1 111.. New Tleuk in Cancer for the 2131 Century. ed
`1.10mbarr-Bosch. KluwcrAcademjc,200.1.pp.253-268
`Argiris
`and DiGiovanna.
`“Synergistic
`interactions between
`tamoxifen and HERCBPI'IN 1M" Proceedings of the Amaicnn
`aaocwtlon for Cancer Rcscarch (Ahmad #4565) 41.718. (2000).
`A
`.
`~
`.
`,
`,-
`,-
`_:
`.
`.
`.
`.
`,
`.
`.
`Arleaga er a1... p185; abs Slymlmg filflmuu‘prlalm-mrlugul
`Cytotoxic-w 111 Human Breast Carcmomn (.clls: Association
`Betwecnnn ()ncogcnic Roceplor'l'yrosine Kinase and Drug-induced
`DNA kqanir'Cnncchcscnrch 54(14):.17511-3765.11994)
`Ilncuscl“1.,"1)111'clcnlizllimml‘Cllllurcd“unumlhcuxl('anccfl'rlls
`(>\11-5(\5:Im1M(‘15-T) \ssocimcxl Will! 1 ossul'('c11.’~1url§wc“FR-2:
`Ilul Ami-,-
`1“ Molecular (';l|cilmgulc.\m 1161350662 1 Iwm.
`11660501311”"1.1110001111110110” Monuclonnl.~'\nlilxx|iuslolhc 11111-
`.7 \lcu Recuplur Innlncu Iiill'crcnlinlinn "1' Human Ilrmst 1 nnccn
`( c11<"("lm:ur ch1rch‘i‘('1)"75‘10-‘ ‘N'J ( '90,)
`.
`.
`H ‘1'
`.
`'_
`I
`\4 .
`'1'. "' .'. ‘j, ‘
`“
`f
`was pl .Im . mu whn. Ruqxlm 111011.111; Wnlh Monucloml
`\nlihmlics As Anti-('nncu 'l'hcmpy” I‘lnrnmc '1 1Ic1.. 6-1 127~1 54.
`”994'-
`_
`”51501:;1L1111..".\1111111‘I1(2111111ullll/L‘l1.\1l'lll.'\.'10115|1(\lll11h111)'1.\1‘\1)1
`\lnnc am! in ( nmhmminn with ('hcnnlhcmpy Agninul Human
`“was” ‘zuvinnnul chugulfls" l’r-‘vculingsul 1M '1)
`1.1111 \mmul
`\‘1wling1‘1mllxwl "55,-. |).'Ill:ls. ’IX 13:6} (ll/94).
`
`AMGKAN02977626
`
`

`

`US 8,309,087 BZ
`Page 3
`
`Baselgn ct ill . "Antitutnor activity 01‘ paclttaxcl ill combination with
`nnti-growtli Dictor receptor monoclonal antibodies in breast cancer
`xenogmfts" Proceedings of the American Association for Cancer
`Research (Abstract No. 2262) 35380 (Mar. 1994).
`Basclga ct al., “HER2 ()vcrcxprossion and Pnclitmtcl Sensitivity in
`Breast Cancer: therapeutic Implications" Uncology (Supplement
`No.2). 11(3):43—48. (1997).
`8:13er cl al.. “Monmlottal Antibodies Directed Against Growth
`Factor Receptor: Enhance the Efficacy of Chemotherapeutic
`Agents." Annals ot‘Oncology (abstract #010) 5(Suppl. 5) (1994).
`anclga. ct a1, "Antitutnor efiectsofdoxorubicin in combination with
`anti-epidermal growth factor receptor monoclonal antibodies". Jour-
`nal of the National Cancer Instittne 85(16): 1327-1333. (1993).
`Peg-am et al.. "Phase 11 Study of Intravenous Recombinant Human-
`ized Ami-p135 HER-2 Monoclonal AntibodytrhuMAb HER-2) Plus
`(iisplatin in Patients with HER-Z:NF.U ()vcrexpressing Metastatic
`Breast C:iacer” Proceedings of
`the ASCt)—--‘3 [at Annual
`Mccting.(Abstractt1124) [4:106 (1995).
`Vitsltoglou-Numiltos cl 311.. “Clinical predictive value of the in film
`cell line, human xenogriii't. and mouse nllogmtt preclinical cancer
`models" Clinical Cancer Research 90 t):4227-423. (2003).
`Basclga ct 111.. “llERZ Ovct’cxprcssion and Paclitaxcl Sensitivity in
`Breast Cancer: Therapeutic ltrtplications" Oncology (Supplement
`No.2) 11(3): 4348.1Mar. I997).
`Baselgn or 111.. "Monoclonal Antibodies Directed Against Growth
`Factor Rcccplois Enhance the Emcncy ot‘ Cliciitulhcrapcutic
`Agents." Annnls nt‘Oncnlogy (abstract 11010) 5(Suppl .5) (1994).
`Baselga et :11. “Phase 11 Study ofWeekly Intravenous Recombinant
`Human izcrl Anti-p185HER' Monoclonal Antibody in Patients \Vtth
`HERL’ncii-OverexprcssingMetnsuitic Breast Cancer“ .1. CI in. Oncol.
`14(1): 737-744 (Mar 19%)
`l-ltnrvtninrl Anti-1117.112 Amihody
`Hanelgn et al.. “Recombinant
`(llerccptin) l-‘nclwtcc: the Antilumot Activity of Paclitaxcl and
`Doxontbicin against HE Rlltrcu Overcxpessing Human Breast Can-
`cerXenograflt" Cancer Reticuch 58: 2825-1831 (1998).
`Benz ct 111.. “Estrogen-dependent, tamoxifen-resistant unnorigcnic
`growth of MCF-7 cells trusfected with liER2/tteu" Breast Cancer
`Research & Tmtment 24(2):85-95 (1992)
`Brodowi cz ct al., "Sinetc-agent gemcitabinc as second- and third-tine
`treatment in metastatic breast cancer" The Breast 9: 338-3112, (2000).
`Bmcggcmcicr. R.. “Arornatnac. nmmntasc inhibitors. and brcaat can-
`cer” American Journal of Therapeutics 8(5): 333-)“. (Sop-Oct.
`2001).
`Brutsky et al.. “Phase 11 study ofgernc itrrhine((‘rem) and trustuzumah
`(T) combinmion therapy in first. line metastatic breast cancer (MISC)
`patients (pts) with HERZ overexpression" Joumal ol'Clinical Oncol-
`ogy (Abstract No. 10591) 24(188‘) (Jun. 20. 2006).
`Bunnetal.,“13xprossion of l tor-22mm in human lung canccrccll lines
`by inunrtnohistochemislry and fluorescence in siltr hybridization ltlltl
`its relationship to in vitro cytotoxicity by irastuzumab and chemo-
`therapeutic agents” Clinical Cancer Research 7( 10):.121‘3-1250 (Oct
`20011.
`Brian etnl.. "HER2!nett expression and effects ol'HERCEPTIN alone
`and in combination with cytotoxic agents in lung cancer" Proceed-
`ittgs of the Amer ican Association for Cancer Research (Abstract No.
`45711-11: 719. (Mar. 2000).
`Burris er al , "Phase II trial ol‘docctaxel and Herceptirr(R) as first- or
`second-line chemotherapy for women with metastatic breast cancer
`whom.-
`lurnoiirs m-‘crcxptcas: lllflll” European Journal of ('nncct‘
`(Altsltttct No. 12'”) 35(4); H.122 (Sop 1999).
`litmliu c1 .11.. “.r\it:i.\lirr/rrlc. :1 )mtcrtl :ttul scluliw :iioinntasc ittltibi-
`tut.
`\L‘lbll:
`ritc'gcsttul
`.‘tcclirlt:
`itt
`txrsttttcrturviusrtl wriittcti with
`rulvn ncul lllt‘fls‘l utncct: lk'hlllh irl'uvcn row analysie ol‘lwri plats: III
`trials" Journal 011 linical ( Incology 111(7). 2000-3011 (Jul 1900)
`llrr/tlnr cl
`:rl.. “t-‘zirtrrmrlc Ill 1
`(t ‘( 18-10910.“ \ circuit irregcsttul
`itcclzilc trcntiitcrn of Imstiircrinixirisnl paticritx wrth irictiixlulic Itiensl
`carcinoma: results orlwo truirlotitr/cil tlotiblc lilinrl coritr‘rillcrl ntrrlti
`institutional lii;i|ir”(':tiiccr 717(12): 251).1-25|3.(ltiit. 15. 1096).
`(‘rrrririrhacl ct
`.11.. "Atlvancwl litcnsl cancer: :1 phase II trial with
`(:r‘uicilnhinr'" Journal an Iitticiil t inn-Inlay I 1(1 ll:’7‘il-.‘. i Mi (Nov
`tout.
`
`Carmichael ct :il.. “Advancul breast cancer: itivcstigatiunal role 01'
`gerncitabine" European Journal of CanCor .13(Siippl. ”$17-$30
`(Jan 1997)
`Carter et al.. "Humanizntion of an Anti-p185HbR2 Antibody for
`Human Cancer Therapy" Proc Natl. Acad. Sci. USA 89(10):-l285-
`4289 (May 1992).
`(‘hristodoulou ct 111.. “Combination ol'tntslucuinab and neiircitubinc
`as salvage treatment in metastatic breast cancer: The experience of
`the Hellenic Cooperative Oncology Group (lleCOG)” (Poster pre-
`sented at the 39th Annual ASCO Meeting held in Chicago. lllinois;
`May Ill-hut. 3. 9.003)
`Christodoulou ct 111.. "Gcmcitabinc and trastuzumab combination a:
`salvage treatment in patients with HER 2-posilive metastatic breast
`cancer" Proc Am Soc (flin nncnl (Abstract No. 166) 72:42 (2003).
`Clemons et
`.11.. "Review of recent
`trials of chemotherapy for
`advanced breast cancer: studies excluding taxrules" European Journal
`ol'Cnncer 33(13):2l7l-2 182 (Nov. 1997).
`"A concerted attack on cancer" Scrip Magazine 2617(Rcvicw issue
`2000):68-70 (Feb 14. 2001).
`D'Souza and Taylor-Papadimitrioti.. "Ovcrexpression of I-ZRBB) in
`Hurmn Mammary Epithelial (‘ells Signals inhibition of 'lrnmcrip-
`tion of the E-Cadherin Gene” Proc. Natl. Acad. Sci. USA
`9 l(lS):7202-7206. (1994).
`Dati ct al.. “Inhibition ofc—crbB-2 oncogene e‘tprcssion by estrogen:
`in human breast cancer cells” Oncogene 5(7):]001-1006(Jul. 1990‘).
`Davidson. N . “Single-agent pnclitaxel at first relapse following adju-
`vnnt chemotherapy for brunt cancer“ Seminars in Oncology 2205
`Suppl 14):2-0 (Dec. 1995)
`De Santes et al.._ “Radiolabeletl Antibody'largeting ol'tlie HER-Zlneu
`Oncoprolcin” Cancer Research 52: 1916-1923(1992).
`Di Flore at 1.1.. “crb13-2 ls aPotcnt Oncogene When Overcxprcssed in
`NIH-8T3 Celia" Science 237(481 1): 178-182. tJul. 10. 1987).
`Dickman. Sn “Antibodies stage :1 comeback in cancer treatment”
`Science 1806367): I ISM-11277. (199$).
`Drebin et al., “Down-Modulation of an Oncogene Protein Product
`and Reversion of the Transformed Phenotype by Monoclonal Anti-
`bodies” Cc]141(3l: 695-706. (1985).
`Drebin et .1. “Inhibition of Tumor Growth by a Monoclonal Anti-
`body Reactive thh an Oncogene-Encoded Tumor Antigen" Proc.
`Natl. Acad. Sci. 83: 9119-9133. (1986).
`Drebin et at, “Monoclonal Antibodies Reactive With Distinct
`Domains of the neu Oncogene-Enema p185 Molecde Exert Syn-
`ergistic Anti-Tm Efi‘ccts In V'rvo" Oncogene 2:273-2‘17. ( I988).
`Drebinetal.. ‘MonoclonalAntibodies Specific for thencu Oncogene
`Product Directly Mediate Anti-tumor BIIects In Vivo“ Oncogene
`2(4):.387-394 (1988).
`"equivocal" The American Heritage- Dictionary of the English Lan-
`guage (Definition found on http:.’.-’www.crerloreferencecom/enlry.‘
`4085073) (20031).
`"roman (lctmzolc tablets)" Physicians' Desk Rcfcrcncc (website
`version of product information) pp. 1-13. (2003).
`Fondly. BM. et al.. “Characterization of Murine Monoclonal Anti-
`bodies Reactive to Either the Human Epidermal Growth Factor
`Receptor or HEKL'neu Gene Predict" Cancer Resezuch 50: 1550-
`1558, ([990).
`Fleiss, JL Statistical Methods for Rates and Proportions. 2"”cdition.
`Nev/York. VY: Wiley pp. 13-17. (1981).
`Fornier el al. "Tntstuzuimb in combination with chemotherapy for
`the-treatment ofmelnstittic brcnxt cancer“ Seminars in Oncology 27(6
`Suppl ll)'RX-'15(l)cc 200(1)
`.‘i‘lkly oflrcrtwiinliMc'
`(iztlzctuciur cl
`:tl.. “A mruloirtiscrl phnsc ll
`cisplirlitt iilortc and “uh Ilcrccptiii in paliciits with Ill-.Rl-positiw
`tiorr-stiuill cell lung cancer (NS('1.(')" Il’oalct Io lit: irresctitcrl .‘rI tlrc
`21101 |i( '( 0 Howling).
`I‘DR". (300(1).
`('rcrtvsii'rpmrr‘italtiric llt'l ). "l’iortrict lnliiiitcition
`(innit-11 ct itl. "( linicirl activity 01' pctltmiinith (rhuMitll _’| 4) in
`irrlvrrrtccrl. rcl‘t'nctory or tccuircnl owiriitn cancer ((11 'I. and tho rule I“
`llliR.) activation Minus" .luirnal ol' ('lintcril Oncology [Abstract
`35051 r10“) Ihr: list
`\ttnttal Mcclinii ol' \S(‘(l) ZitlfiS'). «107$.
`(2005 r.
`111.. “('ruttmrisrm rtl' ntrlinrrgiopmic activities using
`cl
`(imnt
`pitclilitxcl ('Inxollantl thwctiixcl ('Itrxotcrc)“ Intuitalir-riiil .ltllllllill (if
`('zinccr “Ht 1 )' I? 1-13'). (2003)
`
`AMGKAN0297762'7
`
`

`

`US 8,309,087 B2
`Page 4
`
`Green cl u|.. "Preclinical Emlunlion of W'R-151327; Au Orally
`Active Chemotherapy Protector” Cancer Research 54(1):73X-74l
`(Feb. 1, 1994)
`Grem et «1.. “A phase II evaluation of combination chemotherapy
`plus uninoglutcthrmidc in women with metastatic orrccurrcnt breast
`carcinoma. An Eastern Cooperative Oncology Group Pilot Study"
`American Journal ol'Clinical Oncology 1 1(5); 528-534. (Oct. 1988).
`Guy et at, "Expression of the netr Protooncogene in the Mammary
`Epithelium of'l'ransgcnic Mice lntltrces Metastatic Disease.“ Proc.
`Natl. Acad. Sci USA 89(22): 10578-10582. (1992).
`Hamilton rind Piccnn. " I he contribution ofrnolccular markers to the
`prediction of rcrponsc in the treatment of breast cancer: a review of
`the literature on HER-2. p53 and BCL-Z" Annals of Oncology
`I l(6):647-663 (Jun. 2000).
`Hancock et al.. “A Monoclonal Antibody Against the c-erbH-l Pro-
`tein Enhanccs the Cytotoxicity ol' cis—Diammincdichloroplatintun
`Against Human Breast and Ovarian Tumor Cell Lines" Carla?
`Research 51:45754580. (Sep. 1. 1991).
`Hansen. 11.. “(icnrcitubinc
`a review" Armuls Q/‘Orrmlogv (Abstract
`#058 from the 9th NC l—EORTC Symposium on New Dnlgs in
`Cancer Therapy held in Amserdam on Mar. 11-15. 1996).
`Harwerth et al.. “Monoclonal Antibodies Against the Extracellular
`Domain ofthe erbB-2 Receptor Function as Partial Ligand Agonists"
`Journal of Biological Chemistry 267(21): 15160-15167. (Jul. 25.
`I992).
`“Hutu-pun ('1‘rastummab)" Product Information (2000)
`l-lcrzig nndHerrig. “Medical Oncology" (website link. ht‘tp'r'uvww
`guatitysurgical org/'Chnptcr'km'l‘l htrn) pp. 1-1 I, (21116).
`Hirsch et a1 . “Preclinical studies of gemcitabine and trastuzumab in
`breast. and lung cancer cell lines" Clinical Brimsl Cancer (abstract
`only) 3(Suppl I); 12-16 (May 20021.
`Hudziul; a :11, “Increased Expression of the Putative Growth Factor
`Receptor pittSsHR‘ Causes 'l‘mnsl'onmtion and Tutmrigenesis of
`NH 3T} Cells” Prnr. Natl. Arad. SN. USA 34(20): 7159-7163.
`(1987).
`Hudziak at 9.1.. “[11855er Monoclonal Antibody Has Antiproliferative
`Effects In Vitro and Sensitizcs Human Breast Tumor Cells to Tumor
`Necrosis Factor" Molecular & Cellular Biology 9(3). 1165-1172,
`(1989)
`Hymn and Stern. "The BiologyoferbHJ/neiuHER-Z and Its Role in
`Cancer” Uiochlrriica at Biophysics- Ada 1198(2-3): 165-184. (Dec.
`30. I994)
`llgert ct al.. “Characterization ol‘anti-Hl-IRQ antibodies which inhibit
`the growth ot‘brcast tumor cells in vitro" Proceedings ofthe Ameri-
`can Association for Cancer Research (abstract 1/3209) 37:470 (Mar.
`I996).
`Kasprzyk at 1]., "Therapy of an Animal Model of Human Gastric
`Cancer Using a Combination ot'Anti-crbB-Z Monoclonal Antibod-
`ics” Cancer Research 52(10): 2771-2776. (1992).
`KnuI‘rmnn or at, “I’xcmcstano is superior to mega-mo] acctnto alter
`trumxil'en failure irt postmenopausal women with udranuetl brunt
`cancer: Results ofa phase III randomized double-blind trial“ Journal
`ofrTlinir'aI Omvrlogy lRt'7):l30|7-I4I I (Apr 2000).
`Kay: at 511., “Phat: II trials of docetaxcl (‘I'axotcrc) in advanced
`ovarian cancer
`an updated oven'iew" European Journal of Canccr
`33(13): 2167-2170. (Nov. 1997).
`Kim ml at. "Both the qtilolx: specificity and isotypc are important in
`the antituinor etTuct of monoclonal antibodies against Her-2mm
`antigen" lrrlernatimml .hmrrml rifti'rrrrrrr lOZ(4):4ZX-434. (200).)
`Klijn nt .11 . "l‘linical him-st cancer. nc‘w developments in selection
`and endocrine licntnimtl 01' patients" ..’uurnal Lf/ Sltr'uitl [lion/Ir
`
`rrrirlly .Q .lIIr/t'r'II/m' Bin/0'4} ‘13( l-
`: 2| 1-321. (10931.
`Kolltfltyct.rl.. "New ill 1123 It: lirunst cancer therapy; ('tnrcnl position
`and
`l‘trltirc
`[matte-clots"
`(it‘rrru'idtguiai Ir-(itlnrr'lsllr'lllir‘llr'
`Ruth/Witt!!! tlmglisli language :ilrstmct onlyt ‘Tt3t: iii-til (I007)
`Kong-(n): t-t :il . ”'I hourpctttit'
`.‘rtlvnnlngu at chemotherapy drugs in
`combination with llliltt'lzl’l l.\ 'tgzrrnsl human breast cancer calls
`with
`Ill-.R-Ierill
`ttVClIJNPIL'SNIt‘II"
`Ilr'r'rrxl
`('rult'r'r New Ii't'rll
`l.\ltsltatt Vt) 467) 57 IN. t1"‘i‘)).
`KI‘Ii‘l.‘ ct .r|.. “|)illcicrrti:rl (in-“1h Inliilntir-n ol'llilnran ('arcinorm
`('t'lls l vposnl In \vltrnticlnnal In Vilm Antilmtlit‘: Itircduil against
`thc Fx‘lntu‘lltilni Domain \‘|
`tho 11171293171111“? l'rolnunt‘trgonc“
`(Abstract "I 7(1) 10(3) 5‘)\(l‘1')ll).
`
`Krona: et al.. “Reguluion of Phosphorylaiion oftlrc c-crbB-.‘11ER2
`Gene Product by a Monoclonal Antibody land Senna Growth Fac-
`tods‘t in Hturutn Mammary Carcinoma Cells" Molecular & Cellular
`Biology 11(2): 979-985, (1991).
`Kunisuc ct nl., "Anti-HERZ antibody enhances the growth inhibitory
`efimt of anti-oestrogen on breast cancer cells expressing both
`oestrogen receptors turd HERZ" British Journal of Cancer 82(1).
`46-51. (2000).
`Icwis et at. “Differential Responses of Human Tumor Cell Lines to
`Anti—p185"ihR' Monoclonal Antibodies" Cancer
`Immunol.
`Immunothcr. .17: 255-26] (1993).
`Lewis et at. "Growth Regulation of Human Breast and Ovarian
`Tumor Cells by Ilercgulin: Evidence for the Requirement ol‘ErbBZ
`as a Critical Component in Mediating Hercgulin Responsiveness"
`('nncchesearch 56-. 1457-1465, (Mar. 15, 1996).
`Llomban ct 31., “Biweekly gemcitabine and paclitaxel in advanccd
`breast cancer. Phase II trial and predictive value of HER: extracel-
`lulardomain(ECD)" European Journal ot'(‘nncer (Abstract No 390)
`36(Suppl 5): $121-$122. (Sop. 2000),
`Lottrisch and Piccan. “an cancer new aspects or adjuvant hor-
`monal therapy" Annals of Oncology lltSunle): tit-2542000),
`Maier et al. "Requirements for the Intemalizntion of a Murine
`Monoclonal Antibody Directed against the HER-2/lcu Gene Product
`c-crbB-Z" Cancer Research 51(19): 5361-5369. (1991).
`Marty ct al.. "kantlomized Phase“ Trial ofthe Efficacy and Saficyof
`Trastummtib Corrbincd with Doceurxet in Patients with Human Epi-
`dermal Grovnh Factor Receptor 2-l’osirivc Metastatic Breast Cancer
`AdministeredAs First-Lino‘lrenuncnt"JoumalofL‘tinical Oncology
`23(19): 4265-4274 (Jul. l, 2005).
`Masai ct 111.. “Growth Inhibition ol'Hurnan Tumor Cells in Athymic
`Mice by Anti-Epidermal Growth Factor Receptor Monoclonal Anti~
`bodies“ Cancer Research 44(3); 1002-1007. (1984).
`Masuka at 31.. "A marine Monoclonal Antibody 'l'hat Recognizes an
`Extracellular Domain of the Human c-crbR-Z Piotooncngcnc Prod-
`uct." Jpn J. Cancer 11:3.80; 10-14, (1989).
`Mch et al., "c-erbB—2 Oncoprotein Expression in Primary Human
`Tumors" Cancer 65(1):88-92. (1990)
`McKenzie ct Il.. “Generation and Characterization of Monoclonal
`Antibodies Specific for the Human ncu Oncogene Product. p185“
`Oncogene 4543-548 ([089)
`Mendelsohn ct IL. “Receptor Blockade and Chemotherapy A New
`Approach to Combination Cancer Therapy." Annals of Oncoloy
`(abstract W0) 7(Suppl. 1): 22. (1996).
`Merlin et al.. “In vino comparative evaluation of Irastuzumalr
`(llciccplinkombined with paclitwtcl (Taxolj or dowlaxel (Tumors)
`in HERZ-arpressing human breast cancer cell
`lines" Annals of
`Oncology 13(11): 1743-17-18 (Nov.2002).
`Miller et al.. "Gemcitabine. paclitaxel. and trastuzumab in metastatic
`breast cancer" Oncology 15 (2 Supp 3): 3840. (Feb. 2001).
`Miller ct a1, “th 11 study of gctncitabinc, paclitmcl and
`uasluzurnab in metastatic breast cancer; a Hoosier Oncology Group
`trial“ (Abstract #437. Presented at
`the 2002 SABCS meeting.)
`(2002).
`Mizukami et 31., “Iifl‘ects ot'tamoxifcn. mcdroxypi ogesterone acetate
`and estradiol on tumor growth and oncogene expression in MCF-7
`breast cancer cell
`line transplanted into nude mice" Anticancer
`Research I
`|(fl_): 1313-1338. (May-Jun. 19911.
`Mosconi at 111.. "Combination therapy with gemcitabirte in non—small
`cell lung cancer" European Journal Mfume-r 13(Suppl
`I): S lot-SI 7,
`(Ian 1007)
`Myers \:l
`.11.. “Biological tent-m ol' Monoclonal Antiiwcplor Anti-
`bodies Reactive “ilh nun (Inn-gum: Product. |Il$5nctl" Mclhtrtls: in
`l.rt'/.yrtro|o)ry tony-7.290 ( I'M l ).
`Nnmmltz cl :tl . "Results ul‘Z open Irrlicl itnrlliccntic plrasc 1| pilot
`studies with llctccptin in corirliiimtion with IlttCL‘Ir'L\C‘ .k platinum
`stills (t'is' or ( .‘trboplaltnt (I('ll) rrs tltcinliy l'or' mluirtcol Inc-mt
`cancer in women \\'l|il1111110”:OVL‘I'CNPICSSIIIgllIG Ill-IR_‘~ricu”l~.ur
`I
`('nnccd Aim (105] ,i7r’Kup (\):SI‘X) (Jlllll)
`Nulrlroltzct nl . “Rumba nl‘lmr uan-lillrcl irnilticcntrt; pilot phase II
`trials “'tlll llcrccptiit in continuation with rl-rcctaxcl and platinum
`salts (('i~< or (':trlrnpl:rlirr) (It'll) .‘IS Ilit'rnpy l‘or minimal lrrcnsl
`t'nnct-r in women in t‘rt‘a’pwssing l I ER)" l'trmsl C it our Rt‘smrt'li r‘ll‘.t1
`lN—‘tllllL‘lll (Abstract ’ .127) M( I t: 82 (2001:)
`
`AMGKAN02977628
`
`

`

`US 8,309,087 Bl
`Page 5
`
`Nagoumcy ct 311.. “Trastuztuturlt ('HERClEl’TlN) enhancement of
`cytotoxic tints activity in human tumor primary cultures". Breast
`Cancer ltcs treat (Abstract No. 47S) 57: Ho, (1999).
`Nallani et a1.. "Difl‘erences in the induction ofeytochrome P450 3A4
`by taxanc anticancer drugs, doeetaxel and pnclitaxol. assessed
`employing primary human hepatocytes" Cancer Cherrrotlrcrapy &
`Pharmacology 54: 219-229. (Sep. 2004).
`Nelson and Fry. "Inhibition of ERBR family receptors bth-lm}
`enhancesthe cytotoXicity ofgemcitabine via modulation ot‘A K'l‘and
`map kinasex" Proceedings 01' the American Association for Cancer
`Research (Alistmct No.
`|$"1_‘l)4 I: 241, (Mar. 3000).
`Nogueraa at a] , “Pilot study ofgernc itahinc (G) plus trastuzurnabd I)
`in metastatic breast cancer patients with orb-2 overexpression previ-
`ously trained with anthracyclincs (A) and taxartes (1)" European
`Journal 01'. Cancer (Abstract No. 416)4(3urp1_t2169(Mai. 2006).
`Norton, L. "Evo ving Concepts in the Systemic Drug Therapy 01'
`Breast Cancer" Seminars in Oncology 24 (4 Suppl 10): 510-3-510-
`10 (Aug. 1997)
`()‘SiuIUgltncssy at at. “Phase 11 Sllltly of lraslomurab plus
`gemcitabinein chemothetnm'pretreated patients with metastatic
`breast cancer" Clinical Breast Cancer 5(2): 142-147, (Jun. 2004).
`U 'Shaugltnessy et at ., "Phase 11 trial of gemeitabine plus trastuztunab
`in metastatic breast cancer patients previously treated with chemo-
`therapy preliminary results" Clinical Breast Cancer (abstract only)
`3(Suppl I): 17-10.t‘_May 2002).
`Peacock et at. “Phase 11 trial 01' gemcitahine plus traslu'lumlb in
`minimally pretreated HERZ overexprcssing metastatic breast can-
`cer" Journal ot'CtinicaI Oncology (Abstract No. 704)23(1(\5 Part] of
`11): 545(Jun 1.2005).
`chram ct 11.. “Effect of erbB-Z (HER-Z’aou) overexprcssion on
`chemotherapeutic drug sensitivity in hum an breast and ovarian can-
`cer cells“ Proceedings of the American Association for Cancer
`Research (Abstract No. 152).“: 26 (Mar. 1993).
`Peyton at at . “Inhibitory effects of combinations of HER-Mien
`antibody and chemotherapeutic agents used for treatment ot’human
`breast cancers" Oncogene 18: 2241-1251. (1999).
`Perez and Hartrmnn, “I‘aclitaxcl and carboplatin for advanced breast
`cancer" Seminars in Oncology 23(5 Suppl 11).41‘15 (Oct. 1996).
`Piccart and Kaufmann. "Introduction“ European Journal of Cancer
`~t7 (Suppl. I): 81—32 (Jan. 2.001)-
`Piccan et al.. "Hutu; a predictive factor ready to use in the daily
`management ot‘breast cancer patients?" European Journal ot'Canoer
`36(14):l755-l761 (Sep. 2000).
`Heart. M, “Closing remarks and treatment guidelines" European
`Jorunal ofCarrcet 37(Suppl. 1)‘ 830-833 (2001).
`Pictras et a1 . “Antibody to HER-yneu Receptor Blocks DNA Repair
`Alter Cisplatin in Human Breast and Ovarian Cancer Cells"
`Oncogene 9: 1829—1838 (1994).
`Pictras ct al.. “HER-2 tyrosine kinnse pathway targets estrogen recep-
`tor" and promotes honnouc-indcpcndent growth in human breast can-
`cer cells" Orwgcnc 10(12): 2435-2446 (1995).
`Pictras er al.. "Hercgutin promotes growth of human breast cancer
`cells with HER-2 (erh Bl) receptors" Proceedings of the American
`Association for Cancer Research (Abstract No. 573) 34: 96 (Mar.
`1993)
`Reefstty et 211.. “Phase 11 Trial ofDocetaxcl and tletceptin as First- or
`Second-Line Chemotherapy for Women with Metastatic Breast (Zan-
`ccr Whose Tumors Ovorexpross 1113112" Proceedings of ASCO
`(Abstract r1523) r 1999)
`ltavdin and t ‘hamncse. "'1 ho c-cth-2 prom-oncogene as .1 prognos-
`tic and predictive marker in tunnel cancer: .1 paradigm for tho tlcvul
`utmtcnt ol't-tltcr trurctontnlcutlar tntttkcts
`:I lL‘t'1c\\" (icut: 159(1):
`19-31(10‘“).
`Itcutl cl :i|.. "lltrrurotrttl rrtotiulntimt ol‘ IIIiR-Z nut pttrtrroncrgulc
`urcs.‘
`Igor ribonucleic (iii and pla‘fi protein corrosion in hunuur
`
`
`lrrrast L'zult‘t'l'ucll lines" t'mccr Research 50( 13 I: 3947-305 1.1 1990).
`Robert ct
`:rl.. “Phase III cornpnratiw study vl ”tutu/numb :mrl
`pitclrlaxcl with and without cttrturplatin in patients with ”lithium
`rmsitnc :ulwrucoil lucasl \ililbk‘l". (Abstract 1/15. Presented at
`the
`.7003 5.41108 rrrcctittg)
`RI‘tlL‘L‘L or
`.11.. “tumult-rims hrlwcuu growth thclot receptors :rml
`t'rlrtt‘spttl‘ltllng monoclonal antibodies in human tumors" .1 t'ulltrlnr
`Hint-horn “14); 315-120. 1 m7)
`
`Safian el '41.. “Herceptin anti getnrilabinc for metastatic pancreatic
`cancers that overexpress HER-yaw” Proc Am Soc. Clin. Oncol.
`(Abstract No. 517) 20:130/\ (2001).
`Santen and Harvey. “Use of aromatase inhibitors in breast carci-
`noma” Endocrine-Related Cancer 6(1): 75-92. (1999).
`bantp et at, "Characterization of an Anti-PISSHHU Monoclonal
`Antibody that Stimulates Receptor Function and lnhibiis'i‘umor Cell
`Growth" Growth Regulation 1: 72-82 (1991).
`Schlotn. .l., "Monoclonal Antibodies

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket