`
`20070918
`
`US 8536134
`US 20080009436
`US 8211855
`US 20080070834
`US 20120270805
`PRIORITY APPLN.
`INFO.:
`
`32
`A1
`32
`A1
`A1
`
`20130917
`20080110
`20120703
`20080320
`20121025
`
`20071115
`US 2007—940652
`20120628
`US 2012—13536479
`A2 20050713
`US 2005—181178
`A2 20050713
`US 2005—181187
`A2 20050713
`US 2005—181409
`A2 20050713
`US 2005—181428
`A2 20050713
`US 2005—181509
`A3 20051019
`US 2005—255821
`A1 20070918
`US 2007—857223
`ASSIGNMENT HISTORY FOR US PATENT AVAILARLE IN LSUS DISPLAY FORMAT
`
`A3
`
`A composition is disclosed herein comprising from about 0.001% to about 0.4%
`cyclosporin A, castor oil, and a surfactant selected from the group
`consisting of alc. ethoxylated, alcs., alkyl glycosides, alkyl
`po’yg’ycosides, alkylphenol ethoxylates, amine oxides, block polymers,
`carboxylated alc. or a’ky’phenol ethoxylates, carboxylic adds/fatty acids,
`ce’lu’ose derivs., ethoxylated alcs., ethoxylated alkylphenols,
`ethoxylated aryl phenols, ethoxylated fatty acids, ethoxylated fatty
`acids, ethoxylated fatty esters and oils,
`fatty alcs., fatty esters,
`glycol esters,
`lanolin—based derivs.,
`lecithin and lecithin derivs.,
`lignin and lignin derivs., Me esters, monoglycerides and derivs.,
`phospholipids, polyacrylic acids, polyethylene glycols, polyethylene
`oxide—polypropylene oxide copolymers, polyethylene oxides, polymeric
`surfactants, polypropylene oxides, propoxylated alcs., propoxylated alkyl
`phenols, propoxylated fatty acids, protein—based surfactants, sarcosine
`derivs., silicone—based surfactants, sorbitan derivs., stearates, sucrose
`and glucose esters and derivs., and combinations thereof.
`For example,
`emulsion was prepared containing cyclosporin A 0.1%, castor oil 1%, clove
`oil 0. %, Polysorbate—80 1%, diglycerol 0.7%, glycerin 2%,
`CM—cellulose 0.5%,
`sodium hydroxide to adjust OH (7.2) and wa:er as
`needed.
`OS.CITING REF COUNT:
`
`R«b«R«NC« COUNI:
`
`89
`
`1
`
`_{«R« ARE 1 CAPLJS RECORDS l{Al CIIE l{IS RECORD
`(2 CITINGS)
`.{«R« AR« 89 CIl«D R«b«R«NC«S AVAILAR.? FOR THIS
`RECORD. AEL CITATIONS AVAILARLE IN lifi Rn bORMAl
`
`ANSWER 5 OF 5
`L1
`ACCESSION NU RER:
`DOCJ ENI NUME«R:
`
`COPYRIGIT 2013 ACS on STN
`CAPLUS
`2007:58577
`CAPEUS
`146:149007
`
`lI_.«:
`INVEN_OR(S):
`PA_EN_ ASSIGN««(S):
`SOURCE:
`
`DOCJ ENI TYPE:
`
`Comoosi:io1 comorising cyclosporin A
`Chang,
`James N.; Olejnik, Orest; Firestone, Bruce A.
`Allergan,
`Inc., USA
`PCT Int. AOpl., 32 pp.
`CODEN: PIXXD2
`Patent
`
`LANGJAGE'
`FAMIEY ACC. NUM. COUNT:
`PATENT INFOR.ATION:
`
`English
`3
`
`PATENT No.
`
`KIND DATE
`
`APPLICATION No.
`
`DATE
`
`WO 2006—US26881
`
`20070118
`A2
`WO 2007008894
`20070628
`A3
`WO 2007008894
`W:
`AE, AG, Al, AM, AT, AJ, A7, EA, 2%, EC, 2%, EN, RY, 27, CA, CH,
`CN, CO, CR, CU, CZ, DE, DK, DM, 37,
`«C,
`«E,
`«G, as, bI, G3, GD,
`GE, GH, G , HN, HR, HJ,
`ID,
`IL,
`IN,
`Is, JP, <E,
`<G,
`<M, KN, KP,
`KR, K7, LA, LC, LK, L2, Ls,
`.T,
`.J,
`.v,
`.Y,
`A,
`D,
`G, M<, MN,
`MW, MX, MZ, NA, NG, NI, NO, Nz, o , PG, P4, Pl, PT, RO, RS, RU,
`sC,
`sD,
`sE, SG,
`sK, sl,
`SM, sy,
`IJ,
`1M,
`IN, 1?, 1.,
`lZ, UA, UG,
`US, UZ, VC, VN, ZA, ZM,
`zw
`
`20060712
`
`TEVA - EXHIBIT 1025 (PART 2 OF 4)
`
`0202
`
`TEVA - EXHIBIT 1025 (PART 2 OF 4)
`
`
`
`IE,
`{U,
`RW: AT, 3E, 3G, Ci, CY, CZ, DE, D<, ««, «S, FI, FR, G3, GR,
`IS,
`IT, ET, LJ, LV, MC, N., P., PT, RO, SE, SI, S<, TR, 3F, 3J,
`CF, CG, CI, C , GA, GN, GQ, GW,
`E,
`R, NE, SN, TD, TG,
`3W, Gi,
`GM, <E,
`.S, MW, MZ, NA, SD, SE, SZ, TZ, UG, ZM, ZW, AM, AZ, BY,
`KG, <Z, MD, RJ, TJ, TM, AP,
`«A, «P, OA
`JS 200700_5690
`A1
`20070118
`JS 2005—181178
`JS 7297679
`32
`20071120
`JS 200700_5710
`A1
`20070118
`JS 7276476
`32
`20071002
`JS 200700_5691
`A1
`20070118
`JS 200700_5692
`A1
`20070118
`JS 7202209
`32
`20070410
`200507_3
`JS 2005—181509
`JS 200700_5693
`A1
`20070118
`200607_2
`AU 2006—268264
`AU 2006268264
`A1
`20070118
`200607_2
`CA 2006-2602452
`CA 2602452
`A1
`20070118
`200607_2
`EP 2006—786892
`EP 190171_
`A2
`20080326
`R: A_, 3«, 3G, CH, CY, CZ, DE, DK, ««, «S, FI, FR, G3, GR, HU,
`IE,
`IS,
`IT, EI, LT, LU, LV, MC, NL, PE, PT, RO, SE, SI, SK, TR
`JP 200950_228
`T
`20090115
`JP 2008—521528
`200607_2
`3R 2006013533
`A2
`20110118
`3R 2006-13533
`200607_2
`JS 20070149447
`A1
`20070628
`-8 2007—679934
`20070228
`JS 8536134
`32
`20130917
`JS 20080070834
`A1
`20080320
`JS 20080207494
`A1
`20080828
`JS 8288348
`32
`20121016
`PRIORITY APPLN.
`
`200507_3
`
`JS 2005—181187
`
`200507_3
`
`JS 2005—181409
`JS 2005—181428
`
`200507_3
`200507_3
`
`CS 2007—940652
`-8 2007—917448
`
`200711_5
`200712_3
`
`200507_3
`200507_3
`20050713
`200507_3
`200507_3
`200607_2
`
`INFO.:
`
`-S 2005—l8ll78
`-8 2005—181187
`US 2005—181409
`-8 2005—181428
`-8 2005—181509
`WO 2006—JS26881
`ASSIGNMENT {ISTORY FOR US PAlEN_ AVAILA3LE IN LSUS DISPLAY FORMAT
`
`A
`A
`A
`A
`A
`
`A3
`
`Cyclosoorih A comphs. are disclosed qereih comorisihg an oil and a
`Thus,
`surfac:aht.
`These are useful
`in tie treatment of dry eye disease.
`composition was prepared coh:aihihg cyclosporin A 0.1, castor oil 1, clove oil
`0.7, polysorbate—80 1, diglycerol 0.7, glycerin 2, CM—ce'lu’ose 0.5
`and wa:er as needed.
`OS.CITING REF COUNT:
`
`6
`
`_H«R« AR« 6 CAPLUS RECORDS lHA_ CIlE lHIS RECORD
`(6 CITINGS)
`
`=> d his
`
`(bI.« 'HOM«' «Nl«R«D Al 23:44:39 ON 01 OCT 2013)
`
`L1
`
`«N_«R«D A1 23:44:57 ON 01 OCT 2013
`«M3AS«, 3IOSIS'
`FI.? 'CAPLJS, M«DLIN«,
`5 CYCLOSPORIN AND CASTOR AND POLYSOR3ATE AND P«MUL«N AND (GLYCERI
`
`=> logoff h
`COST IN U.S. DOLLARS
`
`bU.L «S_IMA_«D COS1
`
`SINC« bIL«
`ENTRY
`37.83
`
`TOTAL
`SESSION
`38.07
`
`INJTES
`SESSION WIL. 3« H«.D FOR 120
`SIV INlLRNA_IONAL SESSION SUSP«ND«D Al 23:48:15 ON 01 OCT 2013
`
`0203
`
`0203
`
`
`
`Application/Control No.
`
`Search NOTES
`
`13967163
`
`Applicant(s)/Patent Under
`Reexamination
`
`ACHEAMPONG ET AL.
`
`Art Unit
`Examiner
`
`
`MARCELA M CORDERO GARCIA
`
`CPC- SEARCHED
`
`SEARCH NOTES
`
`Search Notes 2
`
`STN Search (attached)
`EAST updated (attached)
`also ran PALM Inventor search
`
`INTERFERENCE SEARCH
`
`US Classl
`
`CPC S mbol
`
`US Subclass / CPC Group
`
`—
`
`US. Patent and Trademark Office
`
`Part of Paper No.
`
`: 2013CWO4
`
`0204
`
`
`
`gggggggigatez 09/12/2013
`Doc description: Information Disclosure Statement (IDS) Filed
`
`13957153 ~ GAE}: 1658
`
`'NF°RMAT'°N °'S°"°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`
`
`Amt
`
`ALL REFERENCES CONSEDERED EXCEPT WHERE LENED THROUGH.
`
`/’i"i'l.l\!l.C.G./
`
`U.S.PATENTS
`
`Examiner Cite
`.
`.
`*
`Initial
`No
`
`Patent Number
`
`Kind
`Code1
`
`Issue Date
`
`Name of Patentee or Applicant PageS’CO|UmnS’LmeS Where
`.
`Relevant Passages or Relevant
`of cited Document
`.
`Figures Appear
`
`3278447
`
`4388229
`
`4388307
`
`1966-10 11
`
`Thomas McNicho|as
`
`1983-06 14
`
`Cherng-Chyi Fu
`
`1983-06 14
`
`Thomas Cavanak
`
`Delevalleeetal
`
`I I
`I I
`I I
`II
`I I
`
`4649047
`
`4764503
`
`I I
`
`4814323
`
`0205
`
`0205
`
`
`
`eceépi date: 09/12/201313967163
`
`13967163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`I 1
`
`ALL REFERENCES CONSEDERED EXCEPT WHERE LENED THROUGH.
`
`/’W\!’i.C.G./
`
`990-11-13
`
`David Horrobin
`
`5053000 I 1991-10-01
`
`Boothetal
`
`Nussenblattetal
`
`0206
`
`0206
`
`
`
`ecetpt date: 09/12/201313967163
`
`$957163 ~ GAE}: 1658
`
`Amt
`
`ALL REFEEENCES CONSEDEEED EXCEPT WHERE LENED THROUGH.
`
`/i’\/i.l\/i.C.(3./
`
` I I II
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`AnthonyDziabo
`Chartrainetal
`
`-
`
`
`
`5540931
`
`-IIIIII
`
`1995 12 12
`
`Ding et al
`
`Application No. OE?/243,379 and
`its entire prosecution history
`
`0207
`
`
`
`eceépi date: 09/12/201313967163
`
`13967163 ~ GAE}: 1658
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CON-SEDERED EXCEPT WHERE LINED THROUGH,
`
`,’I‘v’i.:’\fi.C.G./'
`
`1997-06-17
`
`Thomas Cavanak
`
`1997-07 29
`
`Cavanak et al
`
`1998-02 17
`
`Morley et al
`
`1998-0414
`
`1998-05-19
`
`Dalton et al
`
`5766629 I
`
`1998-06-16
`
`Cho et al
`
`1998 08-25
`
`Bernard Sherman
`
`YoshitakaYamamura
`
`5834017 I
`
`0208
`
`0208
`
`
`
`eceépi date: 09/12/201313967163
`
`13967163 ~ GAE}: 1558
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CONSEDERED EXCEPT WHERE LINED THROUGH.
`
`/’M.:‘VLC.G./’
`
`I BernardSherman
` Bhalanietal
` Haueretal
` etal
`
` -1999-0629
` -
`
`1999 07 27
`
`Hamied et al
`
`5929030
`
`1999-09 14
`
`Kawashima et al
`
`1999-10-05
`1999-10-05
`
`1999-10-05
`
`Cho et al
`
`I I I I
`
`5951971
`
`5962014
`
`5962017
`
`5962019
`
`0209
`
`
`
`eceépi date: 09/12/201313967163
`
`13967163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`
`
`ALL REFERENCES CONSEDERED EXCEPT WHERE LENED THROUGH.
`
`/M.M.C.G./
`
`II I
`
`1999-11-02
`
`Thomas Cavanak
`
`5977066
`
`5981479
`
`5981607
`
`:1:1:::::::m:::224and
` BernardSherman
`
`IIII
`IIII
`
`6046163
`
`0210
`
`
`
`eceépi date: 09/12/201313967163
`
`13967163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`Attorney Docket Number
`
`17618-US-BCON6-AP
`
`ALL REFERENCES CONSHFERED EXCEPT WHERE LENED THROUGH.
`
`/:VLM.C.G..:’
`
` NirmalMulye
`2000-12-12
`BernardSherman
`
`a 2
`
`II
`
`Bernard Sherman
`
`001-03-06
`
`0211
`
`“I
`“I
`
`II
`
`ThomasCavanak
`
`I I
`
`2002-02-12
`
`Singh et al
`
`6323204
`
`6346511
`
`0211
`
`
`
`eceépi date: 09/12/201313967163
`
`$957163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`
`
`Attorney Docket Number
`
`17618-US-BCON6-AP
`
`ALL REFEEENCES CONSEDERED EXCEPT WHERE LENED THROUGH.
`
`/'Fv’LI‘v’i,C.C3./’
`
`6475519
`
`Cavanak et al
`
`2002 10 22
`
`-
`2002-11 05
`
` 6486124 I
`
`2002 11 26
`
`Olbrich et al
`
`ToshihikoMatsuo
`
`6582718 I
`
`YoichiKawashima
`
`0212
`
`0212
`
`
`
`eceipt date: 09/12/201313967163
`
`$957163 ~ GAE}: 1658
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CONSEDERED EXCEPT WHERE LENED THROUGH.
`
`/lvl.l\.'i,C.(3./’
`
`I. Ni
`atat
`atat
`
`I
`I
`I
`I
`
`8288348
`
`I
`I
`I
`I
`
`mt
`mt
`em
`
`If you wish to add additional U.S. Patent citation information please click the Add button.
`
`U.S.PATENT APPLICATION PUBLICATIONS
`
`l;:i'nilf§';$2222.E2'nLlélffigizs
`l;:i'nilf§';$2222.E2'nLlélffigls’
`iLtJs-Se-n’EEep|riJ(r:tsi:Eu'tJiEn1h1i§:$§*21
`
`t’gZ'nfilf§';$Z2:2tE2'nLtétffigi‘8a““
`t’gi'nfitf§l$22:2.E2'nLt:?§§3?3
`iltjs-Se-n’:IPep|{i)$:tSi::u'tJigI-'11h1i;?(1IQ:48
`
`Publication
`
`Number
`
`Cod
`
`e1 Date
`
`Publication
`
`NameofPatenteeorApplicant PageS’CO|UmnS’LineSWhere
`
`Relevant Passages or Relevant
`.
`Figures Appear
`
`of cited Document
`
`0213
`
`0213
`
`
`
`eceépi date: 09/12/201313967163
`
`$957163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`
`
`Attorney Docket Number
`
`17618-US-BCON6-AP
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`./[\fi.:‘VLC.G./’
`
`20020016290 I2002-02-07
`
`F|0c'hetal
`
`YoichiKawashima
`Petszulatetal
`Meinzeretal
`
`0214
`
`0214
`
`
`
`eceépi date: 09/12/201313967163
`
`$957163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`
`
`Attorney Docket Number
`
`17618-US-BCON6-AP
`
`ALL REFEQENCES CONSEDERED EX! EFT WHERE LENED THRQUGH.
`
`/F\/l.i\/‘a.C.(3./
`
`2003 03 20
`
`-
`
`Stergiopoulos et al
`
`20030059470
`
`2003-03 27
`
`Rainer Muller
`
`20030060402 I
`
`2003 03 27
`
`Cavanak et al
`
`20030109426 I
`
`0215
`
`0215
`
`
`
`eceipt date: 09/12/201313967163
`
`$957163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`
`
`Attorney Docket Number
`
`17618-US-BCON6-AP
`
`ALL REFERENCES CONSHFERED EXCEPT WHERE LENED THROUGH.
`
`/VLtv‘!.C.G../
`
`2003 09 04
`
`-
`
`Fricker et al
`
`20050014691
`
`zmsmzo
`
`Bflmeml
`
`20050059583 I
`
`2005 03 17
`
`Andrew Acheampong
`
`iLt’S'Se'r$fef"ri)‘;:tSi::U';'ig}]$353357 and
`
`20O7_01_18
`
`James Chang
`
`Application No 11_/181,*A;09 and
`its entire prosecution history
`
`2007-02-01
`200704-19
`
`20O7_06_28
`
`Chang et al
`
`Application No 11/679,334 and
`its entire prosecution history
`
`eta:
`
`t’gi'nfi}f§';$2222.E2'n‘h‘ié?§$l”
`
`0216
`
`0216
`
`
`
`eceipt date: O9/t2/201313967163
`
`13887183 - GAE}: 1858
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`
`
`ALL REFERENCES CONSEDERED EXCEPT WHERE LENED THEOUGH,
`
`/F\Il.lvl.C.G./
`
`20080039378
`
`2008-02-14
`
`Graham et ai
`
`.U'S' A."""°a“°“ N.°' 11/781 ‘E195 and
`its entire prosecution history
`
`20080070834
`
`2008-03-20
`
`chang et ai
`
`.U'S' A."p'i°a“°“ N.°' 11/94°’fi52 and
`its entire prosecution history
`
`20080146497
`
`2008-06-19
`
`Graham et ai
`
`.U'S' A."""°a“°“ N.°' 11.’858fi°° and
`its entire prosecution history
`
`20080207495
`
`2008-08-28
`
`Graham et ai
`
`.U'S' A."""°a“°“ N.°' 12.’°35’fi98 and
`its entire prosecution history
`
`20090131307
`
`2009-05-21
`
`Tien et ai
`
`.U'S' A.pp'i°a“°“ N.°' 12/361fi35 and
`its entire prosecution history
`
`34
`
`35
`
`36
`
`37
`
`38
`
`20100279951
`
`20110009339
`
`I I
`I I
`I I
`I I
`I I
`
`20110294744
`
`20120270805
`
`20130059796
`
`2010-11-04
`
`Morgan et ai
`
`.U'S' A."p'i°a“°“ N.°' 12/771’fZ52 and
`its entire prosecution history
`
`2011-01-13
`
`Rhett Schiffman
`
`.U'S' A."""°a“°“ N.°' 12/759fi31 and
`its entire prosecution history
`
`2011-12-01
`
`Morgan et ai
`
`.U'S' A."p'i°a“°“ N.°' 1371153364 and
`its entire prosecution history
`
`2012-10-25
`
`chang et ai
`
`.U'S' A."p'i°a“°“ N.°' 13/536359 and
`its entire prosecution history
`
`2013_03_07
`
`Chang et al
`
`Application No. 13/649,387 and
`its entire prosecution history
`
`If you wish to add additional U.S. Published Application citation information please click the Add button.
`
`FOREIGN PATENT DOCUMENTS
`
`0217
`
`0217
`
`
`
`eceipt date: 09/12/201313967163
`
`13967163 ~ GAE}: 1658
`
`INFORMATION DISCLOSURE
`STATEMENTBY ’“"’”°’*“T
`
`(Not for submission under 37 CFR 1.99)
`
`ACHEAMPONQANDREW
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LENED THROUGH.
`
`/M.l\¢l.C.G./’
`
`|nitial*
`
`No
`
`Examiner ForeignDocument
`l
`
`1
`
`19810655
`
`'
`
`Publication
`
`Date
`
`1999-09-16
`
`1993-01-07
`
`Applicant of Cited
`Document
`
`Universitat Tubingen
`Universitatskl
`
`' U
`
`Pages,Columns,Lines
`
`Passages or Relevant
`.
`Figures Appear
`
`1
`
`NameofPatenteeor whereRelevant
`Eberhard—Karis-
`lam
`LLTInstituteCo.,Ltd.
`
`I 20O0_01_06
`2001-05-10
`I 2001-06-14
`I 2002-02-07
`20020627
`
`\|Z\:((jJnJinBiopharmaCo.,
`CiplaLimited
`Transneuronix,Inc.
`PharmasolGMBH
`|C_:(:r|e'lfil:§-ehold&Health
`
`0218
`
`0218
`
`
`
`eceipt date: 09/12/201313967163
`
`13987183 ~ GAE}: 1658
`
`INFORMATION DISCLOSURE
`STATEMENTBY ’“"’”°’*“T
`
`(Not for submission under 37 CFR 1.99)
`
`ACHEAMPONQANDREW
`
`
`
`Attorney Docket Number
`
`17618-US-BCON6-AP
`
`ALL REFERENCES CONSIDERED EXCEET WHERE LENED THROUGH.
`
`/l\/i.i\/l.(.‘;.G./"
`
`I 11
`I 12
`
`2003-030834 I2003-04-17
`2003-053405 I2003-07-03
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number( ),
`publisher, city and/or country where published.
`
`01
`
`ABDULRAZIK, M. ET AL, Ocular Delivery of Cyclosporin A II. Effect of Submicron Emu|sion's Surface Charge on
`Ocular Distribution of Topical Cyclosporin A, S.T.P. Pharma Sciences, Dec. 2001, 427-432, 11(6)
`
`ACHEAMPONG, ANDREW ET AL, Cyclosporine Distribution into the Conjunctiva, Cornea, Lacrimal Gland and
`Systemic Blood Following Topical Dosing of Cyclosporine to Rabbit, Dog and Human eyes, 1996, 179
`
`ACHEAMPONG, ANDREW ET AL, Cyclosporine Distribution Into The Conjunctiva, Cornea, Lacrimal Gland, and
`Systemic Blood Following Topical Dosing of Cyclosporine to Rabbit, Dog, and Human Eyes, Adv. Exp. Med. Biol.,
`1998, 1001-1004, 438
`
`ACHEAMPONG, ANDREW ET AL, Distribution of Cyclosporin A in Ocular Tissues After Topical Administration to
`Albino Rabbits and Beagle Dogs, Current Eye Research, 1999, 91-103, 18(2)
`
`AKPEK, ESEN KARAMURSEL ET AL, A Randomized Trial of Topical Cyclosporin 0.05% in Topical Steroid-Resistant
`Atopic Keratoconjunctivitis, Ophthalmology, 2004, 476-482, 111
`
`ANGELOV, O. ET AL, Preclinical Safety Studies of Cyclosporine Ophthalmic Emulsion, Adv Exp Med Biol, 1998,
`991-995, 438
`
`ANGELOV, O. ET AL, Safety Assessment of Cyclosporine Ophthalmic Emulsion in Rabbits and Dogs, Xlth Congress
`of the European Society of Ophthalmology, 1997, 25-28, 1-5, Soc. Ophthalmol Eur., HU
`
`0219
`
`II I I I I I
`
`I I
`
`Examiner Cite
`|nitials*
`No
`
`0219
`
`
`
`eceipt date: 09/12/201313967163
`
`139571 53 ~ GAE}: 1658
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH,
`
`/'i\/LI‘v‘i.C.G,/
`
`ARDIZZONE, SANDRO ET AL, A Practical Guide to the Management of Distal Ulcerative Colitis, Drugs, 1998,
`519-542, 55(4)
`
`BANIC, MARKO ET AL, Effect of Cyclosporine in a Murine Model of Experimental Colitis, Digestive Diseases and
`Sciences, June 2002, 1362-1368, 47(6)
`
`BONINI, S. ET AL, Vernal Keratoconjunctivitis, Eye, 2004, 345-351, 18
`
`BREWSTER, MARCUS ET AL, Enhanced Delivery of Ganciclovir to the Brain Through the Use of Redox Targeting,
`Antimicrobial Agents and Chemotherapy, Apr 1994, 817-823, 38(4)
`
`BREWSTER, MARCUS ET AL, Intravenous and Oral Pharmacokinetic Evaluation of a 2-Hydroxypropy|-r5-cyc|odextrin-
`Based Formulation of Carbamazepine in the Dog: Comparison with Commercially Available Tablets and Suspensions,
`Journal of Pharmaceutical Sciences, March 1997, 335-339, 86(3)
`
`BREWSTER, MARCUS ET AL, Preparation, Characterization, and Anesthetic Properties of 2-Hydroxypropy|-f5-
`cyclodextrin Complexes of Pregnanolone and Pregnenolone in Rat and Mouse, Journal of Pharmaceutical Sciences,
`October 1995, 1154-1159, 84(10)
`
`BRINKMEIER, THOMAS ET AL, Pyodermatitis-Pyostomatitis Vegetans: A Clinical Course of Two Decades with
`Response to Cyclosporine and Low—Dose Prednisolone, Acta Derm Venereol, 2001, 134-136, 81
`
`CASTILLO, JOSE M. BENITEZ DEL ET AL, Influence of Topical Cyclosporine A and Dissolvent on Corneal Epithelium
`Permeability of Fluorescein, Documenta Ophthalmologica, 1995, 49-55, 91
`
`CHEEKS, LISA ET AL, Influence of Vehicle and Anterior Chamber Protein Concentration on Cyclosporine Penetration
`Through the Isolated Rabbit Cornea, Current Eye Research, 1992, 641-649, 11(7)
`
`Database WPI Week 200044, Derwent Pub. Ltd., London, GB; An 2000-492678 & JP2000/143542, 2000, 2 Pages
`
`DING, SHULIN ET AL, Cyclosporine Ophthalmic O/W emulsion: Formulation and Emulsion Characterization, Pharm
`Res, 1997, 1 page, 14 (11)
`
`0220
`
`A Q
`
`A A
`
`1
`
`I I I I
`
`A
`
`A
`
`A CD
`
`A N
`
`I
`
`00
`
`0220
`
`
`
`eceipt date: 09/12/201313967163
`
`139571 53 ~ GAE}: 1658
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CONSEERED EXCEPT WHERE LENED THROUGH.
`
`/i\/i.l‘vl.C.G./
`
`LO
`
`DONNENFELD, ERIC D., The Economics Of Using Restasis, Ophthalmology Management, 10/2003, 3 pages, US
`
`DROSOS, A. A. ET AL, Efficacy and Safety of Cyclosporine-A Therapy for Primary Sjogren's Syndrome, Ter. Arkh.,
`1998, 77-80, 60(4)
`
`DROSOS, A.A. ET AL, Cyclosporin A Therapy in Patients with Primary Sjogren's Syndrome: Results at One Year,
`Scand J Rheumatology, 1986, 246-249, 61
`
`EISEN, DRORE ET AL, Topical Cyclosporine for Oral Mucosal Disorders, J Am Acad Dermatol, Dec. 1990,
`1259-1264, 23
`
`EPSTEIN, JOEL ET AL, Topical Cyclosporine in a Bioadhesive for Treatment of Oral Lichenoid Muscosal Reactions,
`Oral Surg Oral Med Oral Pathol Oral, 1996, 532-536, 82
`
`ERDMANN, S. ET AL, Pemphigus Vulgaris Der Mund- Und Kehlkopfschleimhaut Pemphigus Vulgaris of the Oral
`Mucosa and the Larynx, H+G Zeitschrift Fuer Hautkrankheiten, 1997, 283-286, 72(4)
`
`FDA Concludes Restasis (Cyclosporine) Not Effective for Dry Eye (6/18/1999). Accessed online at http://wvvvv.
`dryeyeinfo.org/Restasis_Cyc|osporine.htm on 8/14/09. 1 Page
`
`GAETA, G.M. ET AL, Cyclosporin Bioadhesive Gel in the Topical Treatment of Erosive Oral Lichen Planus,
`International Journal of lmmunopathology and Pharmacology, 1994, 125-132, 7(2)
`
`GIPSON, ILENE ET AL, Character of Ocular Surface Mucins and Their Alteration in Dry Eye Disease, The Ocular
`Surface, April 2004, 131-148, 2(2)
`
`GREMSE, DAVID ET AL, Ulcerative Colitis in Children, Pediatr Drugs, 2002, 807-815, 4(12)
`
`GUNDUZ, KAAN ET AL, Topical Cyclosporin Treatment of Keratoconjunctivitis Sicca in Secondary Sjogren's
`Syndrome, Acta Ophthalmologica, 1994, 438-442, 72
`
`0221
`
`I I
`
`l\) O
`
`[Q A
`
`I I I
`
`l\) \l
`
`l\) 00
`
`l\) LO
`
`0221
`
`
`
`eceimdaterew/2013
`
`'“F°R“"’“'°“°'S°L°S“RE
`“‘““E“"E“”‘Y’“"’L'°’*“T
`(Not for submission under 37 CFR 1.99)
`
`00 O
`
`http://web.archive.org/web/2001030625323/http://wvvvv.surfactant.co.kr/surfactants/pegester.htm|, 2001, 6 Pages,
`retrieved on 7/05/2008
`
`O0 4
`
`00l\)
`
`-PO0O0O0O000O\lU)01-PO0
`
`00 L0
`
`00 O0
`
`HUNTER, P.A. ET AL, Cyclosporin A Applied Topically to the Recipient Eye Inhibits Corneal Graft Rejection, Clin Exp
`Immunol, 1981, 173-177, 45
`
`JUMAA, MUHANNAD ET AL, Physicochemical Properties and Hemolytic Effect of Different Lipid Emulsion
`Formulations Using a Mixture of Emulsifiers, Pharmaceutica Acta Helvetiae, 1999, 293-301, 73
`
`KANAI, A. ET AL, The Effect on the Cornea of Alpha Cyclodextrin Vehicle for Eye Drops, Transplantation Proceedings,
`Febraury 1989, 3150-3152, Vol. 21
`
`KANPOLAT, AYFER ET AL, Penetration of Cyclosporin A into the Rabbit Cornea and Aqueous Humor after Topical
`Drop and Collagen Shield Administration, Cornea/External Disease, April 1994, 119-122, 20(2)
`
`KAUR, RABINDER ET AL, Solid Dispersions of Drugs in Polyocyethylene 40 Stearate: Dissolution Rates and Physico-
`Chemical Interactions, Journal of Pharmacy and Pharmacology, December 1979, 48P
`
`KUWANO, MITSUAKI ET AL, Cyclosporine A Formulation Affects Its Ocular Distribution in Rabbits, Pharmaceutical
`Research, January 2002, 108-111, 19(1)
`
`Lambert Technologies Corp. Material Safety Data Sheet for LUMULSE TM POE-40 MS KP, last revision 8/22/2003. 3
`pages
`
`LEIBOVITZ, Z. ET AL., Our Experience In Processing Maize (Corn) Germ Oil, Journal Of The American Oil Chemists
`Society, 02/1983, 395-399, 80 (2), US
`
`LIXIN, XIE ET AL, Effect Of Cyclosporine A Delivery System in Corneal Transplantation, Chinese Medical Journal,
`2002, 110-113, 115 (1), US
`
`LOPATIN, D.E., Chemical Compositions and Functions of Saliva, 8/24/2001, 31 Pages
`
`0222
`
`0222
`
`
`
`eceipt date: 09/12/201313967163
`
`139571 53 ~ GAE}: 1658
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/VI.Iv‘!.C.G../
`
`LYONS, R.T. ET AL, Influence of Three Emulsion Formulation Parameters on the Ocular Bioavailability of
`Cyclosporine A in Albino Rabbits, Am Assoc Pharm Sci, 2000, 1 Page, 2(4)
`
`PEDERSEN, ANNE MARIE ET AL, Primary Sjogren's Syndrome: Oral Aspects on Pathogenesis, Diagnostic Criteria,
`Clinical Features and Approaches for Therapy, Expert Opin Pharma, 2001, 1415-1436, 2(9)
`
`PHILLIPS, THOMAS ET AL, Cyclosporine Has a Direct Effect on the Differentiation ofa Mucin—Secreting Cell Line,
`Journal of Cellular Physiology, 2000, 400-408, 184
`
`PRESENT, D.H. ET AL, Cyclosporine and Other Immunosuppressive Agents: Current and Future Role in the
`Treatment of Inflammatory Bowel Disease, American Journal of Gastroenterology, 1993, 627-630, 88(5)
`
`Restasis ® Product Information Sheet, Allergan, Inc., 2009, 5 Pages
`
`Restasis® Increasing Tear Production, Retrieved on 08/14/2009, http://wvvvv.restasisprofessional.com/_c|inica|/
`c|inica|_increasing.htm 3 pages
`
`ROBINSON, N.A. ET AL, Desquamative Gingivitis: A Sign of Mucocutaneous Disorders - a Review, Australian Dental
`Journal, 2003, 205-211, 48(4)
`
`RUDINGER, J., Characteristics of the Amino Acids as Components ofa Peptide Hormone Sequence, Peptide
`Hormones, 1976, 1-7
`
`SALL, KENNETH ET AL, Two Multicenter, Randomized Studies of the Efficacy and Safety of Cyclosporine Ophthalmic
`Emulsion in Moderate to Severe Dry Eye Disease, Ophthalmology, 2000, 631-639, 107
`
`SANDBORN, WILLIAM ET AL, A Placebo-Controlled Trial of Cyclosporine Enemas for Mildly to Moderately Active
`Left-Sided Ulcerative Colitis, Gastroenterology, 1994, 1429-1435, 106
`
`SANDBORN, WILLIAM ET AL, Cyclosporine Enemas for Treatment-Resistant, Mildly to Moderately Active, Left-Sided
`Ulcerative Colitis, American Journal of Gastroenterology, 1993, 640-645, 88(5)
`
`-l>
`
`-PI\)
`
`-P O0
`
`-I>-I>
`
`-l>
`
`-P LO
`
`01 O
`
`0‘!
`
`0223
`
`0223
`
`
`
`eceipt date: 09/12/201313967163
`
`139571 53 ~ GAE}: 1658
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/M.Iv’I.C.G./'
`
`SCHWAB, MATTHIAS ET AL, Pharmacokinetic Considerations in the Treatment of Inflammatory Bowel Disease, Clin
`Pharm, 2001, 723-751, 60(10)
`
`SECCHI, ANTONIO ET AL, Topical Use of Cyclosporine in the Treatment of Vernal Keratoconjunctivitis, American
`Journal of Ophthalmology, December 1990, 641-645, 110
`
`SMALL, DAVE ET AL, The Ocular Pharmacokinetics of Cyclosporine in Albino Rabbits and Beagle Dogs, Ocular Drug
`Delivery and Metabolism, 1999, 54
`
`SMALL, DAVID ET AL, Blood Concentrations of Cyclosporin A During Long—Term Treatment With Cyclosporin A
`ophthalmic Emulsions in Patients with Moderate to Severe Dry Eye Disease, Journal of Ocular Pharmacology and
`Therapeutics, 2002, 411-418, 18(5)
`
`SMILEK, DAWN ET AL, A Single Amino Acid Change in a Myelin Basic Protein Peptide Confers the Capacity to
`Prevent Rather Than Induce Experimental Autoimmune Encephalomyelitis, Proc. Natl. Acad. Sci., Nov 1991,
`9633-9637, 88
`
`STEPHENSON, MICHELLE, The Latest Uses Of Restasis, Review Of Ophthalmology, 12/30/2005, 7 Pages, US
`
`STEVENSON, DARA ET AL, Efficacy and Safety of Cyclosporin A ophthalmic Emulsion in the Treatment of Moderate-
`to-Severe Dry Eye Disease, Ophthalmology, 2000, 967-974, 107
`
`TESAVIBUL, N. ET AL, Topical Cyclosporine A (CsA) for Ocular Surface Abnormalities in Graft Versus Host Disease
`Patients, Invest Ophthalmol Vis Sci, Feb 1996, S1026, 37(3)
`
`The Online Medical Dictionary, Derivative, Analog, Analogue, Xerostomia, accessed 7/7/2005 and 7/13/2005, 6 Pages
`
`TIBELL, A. ET AL., Cyclosporin A In Fat Emulsion Carriers: Experimental Studies On Pharmacokinetics And Tissue
`Distribution, Pharmacology & Toxicology, 1995, 115-121, 76, US
`
`TSUBOTA, KAZUO ET AL, Use of Topical Cyclosporin A in a Primary Sjogren's Syndrome Mouse Model, Invest
`Ophthalmol Vis Sci, Aug. 1998, 1551-1559, 39(9)
`
`0224
`
`I I I
`
`0‘!l\)
`
`O1 O0
`
`O‘!-P
`
`E I I
`
`CDI\)
`
`CD A
`
`0224
`
`
`
`eceipt date: 09/12/201313967163
`
`139571 53 ~ GAE}: 1658
`
`
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`;’lV.i‘v’l.C.G./
`
`U) 00
`
`VAN DER REIJDEN, WILLY ET AL, Treatment of Oral Dryness Related Complaints (Xerostomia) in Sjogren's
`Syndrome, Ann Rheum Dis, 1999, 465-473, 58
`
`O)-P
`
`WINTER, T.A. ET AL, Cyclosporin A Retention Enemas in Refractory Distal Ulcerative Colitis and 'Pouchitis', Scand J
`Gastroenterol, 1993, 701-704, 28
`
`U)U)\lO‘!
`
`\l O
`
`N A
`
`\ll\)
`
`. Pending Application: 13/967,189 Filed on August 14, 2013
`
`. Pending Application: 13/976,179 Filed on August 14, 2013
`
`. Pending Application: 13/961,818 Filed on August 07, 2013
`
`. Pending Application: 13/961,835 Filed on August 07, 2013
`
`. Pending Application: 13/961,808 Filed on August 07, 2013
`
`. Pending Application: 13/961,828 Filed on August 07, 2013
`
`. Pending Application: 13/967,168 Filed on August 14, 2013
`
`. Re—Examination Application: 90/009,944 Filed on August, 27, 2011
`
`If you wish to add additional non-patent literature document citation information please click the Add button
`
`0225
`
`0225
`
`
`
`eceipt date: 09/12/201313967163
`
`$957163 ~ GAE}: 1658
`
`'“F°R""’“'°“ °'S°L°S”RE
`STATEMENT BY APPLICANT
`-
`-
`(Not for submission under 37 CFR 1.99)
`
`Amt
`
`
`if English language translation is attached.
`
`2 Enter office that issued the document, by the two-letter code (WIPO
`f:_~ij}_‘,5ior MPEP 901.04.
`1 See Kind Codes of USPTO Patent Documents at \.»x-‘xi
`Standard ST.3).
`3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible.
`5 Applicant is to place a check mark here
`
`ALL REFEEENCES CONSEDERED EXCEPT WHERE LENED THROUGH.
`
`/'lv’l.l‘v‘l.C.Cl./
`
`EXAMINER SIGNATURE
`
`Examiner Signature
`
`/Marcela Cardem Garcia/r
`
`Date Considered
`
`G]. 7],,‘
`
`*EXAM|NER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`
`0226
`
`0226
`
`
`
`eceimdaterew/2013
`
`'“F°R“"’“'°“°'S°L°S“RE
`“‘““E“"E“”‘Y’“"’L'°’*“T
`(Not for submission under 37 CFR 1.99)
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`CERTIFICATION STATEMENT
`
`I:I
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97( )(1).
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97( )(2).
`
`El
`
`** Signature indicates consideration of publication and file history. The Examiner has access to these materials through the PTO computer
`systems. If additional copies are desired, please notify the Applicants through their attorneys.
`
`|:| See attached certification statement.
`
`|:| Fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`Q None
`
`SIGNATURE
`
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Name/Print
`
`Date WW-MM-DD>
`Registration Number
`
`68,681
`
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
`1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed
`application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND
`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`0227
`
`0227
`
`
`
`Receipt date: 09/12/2013
`
`$967163 ~ GAL}: 1658
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
`that:
`(1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited
`is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to
`process and/or examine your submission related to a patent application or patent.
`If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether the Freedom of Information Act requires disclosure of these record s.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance from the
`Member with respect to the subject matter of the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`r