throbber
DocCode — SEQ.TXT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 14091888
`
`Document Date: 11/27/2013
`
`The presence of this form in the IFW record indicates that the following document type was received
`in electronic format on the date identified above. This content is stored in the SCORE database.
`
`Since this was an electronic submission, there is no physical artifact folder, no artifact folder is
`recorded in PALM, and no paper documents or physical media exist. The TIFF images in the IFW
`record were created from the original documents that are stored in SCORE.
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`Sequence Listing
`
`At the time of document entry (noted above):
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`. External customers may access SCORE content via PAIR using the Supplemental Content
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`_
`.
`.
`Form Revnslon Date. August 26, 2013
`
`AMGEN INC.
`Exhibit 1043
`
`EX. 1043 - Page 1 of 469
`
`Ex. 1043 - Page 1 of 469
`
`AMGEN INC.
`Exhibit 1043
`
`

`

`Doc Code: PA..
`Document Description: Power ofAttorney
`
`PTO/AlA/82B (07-12)
`Approved for use through 1 1/30/2014. OMB 0651-0035
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`TRANSMITTAL FOR POWER OF ATTORNEY TO ONE OR MORE
`REGISTERED PRACTITIONERS
`
`NOTE: This form is to be submitted with the Power of Attorney by Applicant form (PTO/AlA/8ZB or equivalent) to identify the
`application to which the Power of Attorney is directed, in accordance with 37 CFR 1.5. If the Power of Attorney by Applicant form
`is not accompanied by this transmittal form or an equivalent, the Power of Attorney will not be recognized in the application.
`
`
`
`Application Number Not Yet Assigned
`
`Filing Date
`
`Concurrently Herewith
`
`First Named Inventor
`
`Hans-Juergen Krause
`
`Title
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA
`ASSOCIATED DISORDERS
`
`
`
`Art Unit Not Yet Assigned
`
`
`
`Examiner Name
`
`Not Yet Assigned
`
`Attorney Docket Number
`
`110222-0005-305
`
`/BRIAN M. GUMMOW/
`
`Si - nature
`
`Name
`
`.
`.
`Reistration Number
`
`63,933
`
`- November 27, 2013
`
`Date
`
`Teleohone
`
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`
`*Total of
`
`1
`
`forms are submitted.
`
`EX. 1043 - Page 2 of 469
`
`Ex. 1043 - Page 2 of 469
`
`

`

`Pmmwsc {07.12;
`Apnmved 1:3! mm lhmugh 11/313121)“. OMB 065141935
`v.5. F'aEen! and Trademark 05%: 2.1.5 DEPARHENY 0F COMMERCE
`Unaar the Papa-musk Raéucficn Act of 1895. no parse-r15 are required to 135mm) 10 a mflmian c-f infamaiicn unless it éifipiays 21 1:31:91 OMB centre! number.
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`A: atmmafis) car 2191311113) 10 rep-resent the: undersigtzeé beiara 11w Unéteai 813m; Pawn! and Trademark Office: (USPTO) In mnneménn with
`any and an paaent appiicafions asstgnad 031g to tha undamignad accordirsg to the USPTO assigfimena «rewards ur assignments dccumanis
`; assachad 10 inks {mm 591 accordance with 3‘? CFR 3.73m.
`
`Reese change the corrasanendenca address for the angiication identified in the macaw summer-11 under ‘35? CFR 3.73m.) 10:
`
`The adérass associated with Customer Number:
`
`I; “g 82?fi
`
`shamans: Name
`
`Acdiass
`
`City
`
`Country
`
`I
`
`5
`
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`
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`
`3
`
`Assignee Name and Addtess: Abbvge Bictemnaiagy Lid
`Ciarendan House, 2 Church Street
`Hamiiton. 1111111. Sermuda
`
`fix mpg; 01 this: farm, tagaihar wiéh as siafietatem mania? :17 CFR 3.73M (Fem! PTGIAENEES as“ aquivaient} is rename! 1&- be:
`flied in 133:?! appiisaficsz in which fihés fem; is used, “PM statement under 3? CFR 3130:} may be templates} by we cf
`1m aracfitémem apszcémeté in mass 16m, am: muse identify the: 333911931103 in which 11115 Power of Mammy 13 1:) 136 11196.
`
`SiGbéA‘FURE of Asségaas cf Retard
`The individual! whose signafiure £11111 Weas suppiied he:c-va is 312111931233 to act or: behalf :31 the: assignee
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`by the USMC to process) an app:“.icatioa Confluaniiafiw'as gowmw by‘é5.1}5{2.122 and 3? cm 1.11 2111451 .15 This coBociicn is estimated 10 1311:: 3 minutes
`to oompiete. winding gathering. preparing, and submitting; the wmpiexed apnacatim 1cm so me USPTO. Time wili vary nemmuing upon 1:11:- indiwduaf case. Any
`com-ants on the amouni oi iéme yw 1mm!» 1:) compiete Ems toms and/oz mgasfinw is: ”musing 111:5 burden. shock! be 581“ is the Chief infmuan Officer,
`us. 931m! and 'Trademasm 011k». US. Demmm cf Commerce. 9.0. Sex 1450. Naznnéria, VP. 223134650. EX) N1)? SEND FEES CR COMPLET‘EG
`FDRMS TO TEES ADQRESS. SEND TO: Cammlsslane: for P3101111, RE). Sax 1456, Mexanaria. Wk 22313-1659.
`
`if you neat! assistance in mmpiafing m9 ierm, can 1~EOG~PYOv91§9 and 39199: omisn 2.
`
`Ex. 1043 - Page 3 of 469
`
`Ex. 1043 - Page 3 of 469
`
`

`

`November 27, 2013
`Substitute for form 1449A/B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`Attorney Docket Number
`
`(Use as many sheets as necessary)
`
`—NotYetAssigned
`Examiner Name
`Not Yet Assigned
`110222-0005-3 05
`
`_
`
`_
`
`u 'ca 'on
`
`a e
`
`ame o
`
`a en ee or
`
`Pages, Columns, Lines, Where
`
`U.S. PATENT DOCUMENTS
`
`-_—
`-_—
`-- 5945098
`08-31-1999
`-_—
`-- 6090382
`07-18-2000
`-_—
`-_—
`-_—
`-_—
`-- 6509015
`01-21-2003
`
`6737405
`05-18-2004 Roemisch et al.
`
`6818613
`11-16-2004
`Sharma et al.
`
`6875432
`04-05-2005 Liu et al.
`
`7070775
`07-04-2006
`Le et al.
`
`7220409
`05-22-2007 Norman et al.
`
`7223394
`05-29-2007
`Salfeld et al.
`
`7250165
`07-31-2007 Heavner et al.
`
`7276239
`10-02-2007
`Le et al.
`
`7318931
`01-15-2008 Okumu et al.
`
`7541031
`06-02-2009
`Salfeld et al.
`
`7588761
`09-15-2009
`Salfeld et al.
`
`7863426
`04-01-2011 Wan et al.
`
`7919264
`05-05-2011 Maksymowych et a1.
`
`20030012786
`01-16-2003 Teoh et a1.
`
`20030049725
`03-13-2003 Heavner et a1.
`
`20030138417
`07-24-2003 Kaisheva et a1.
`
`20030161828
`08-20-2003 Abdelghany et a1.
`
`20030180287
`09-25-2003 Gombotz et a1.
`
`20030190316
`10-09-2003 Kakuta et a1.
`
`20030206898
`11-06-2003
`Fischkoff et a1.
`
`20030219438
`11-27-2003
`Salfeld et a1.
`
`20030235585
`12-25-2003
`Fischkoff et a1.
`
`20040009172
`01-15-2004
`Flshchkoff et a1.
`
`20040033228
`02-19-2004 Krause et a1.
`
`20040038878
`02-26-2004 Tanikawa et a1.
`
`
`
`
`
`Examiner
`Signature
`
`Date
`Considered
`
`EX. 1043 - Page 4 of 469
`
`Ex. 1043 - Page 4 of 469
`
`

`

`November 27, 2013
`WWfom 1449mm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(“WWW“)
`
`II
`
`Nl l
`
`lw
`
`Nl
`
`-- 20040038878
`0040126372
`0040126373
`0040131614
`0040136989
`0040136990
`0040136991
`0040151722
`0040156835
`0040166111
`0040170623
`0040219142
`0050118163
`0050214278
`0060009385
`0060083741
`0060153846
`
`02-26-2004
`07-01-2004 Baner'ee et a1.
`07-10-2004 Baner'ee et a1.
`07-08-2004 Baner'ee et a1.
`07-15-2004 Baner'ee et a1.
`07-15-2004 Baner'ee et a1.
`07-08-2004 Baner'ee et a1.
`08-05-2004 Baner'ee et a1.
`08-12-2004
`lmoto et a1.
`08-26-2004 Ka makcalan et a1.
`09-02-2004 Arvinte et a1.
`11-04-2004 Baner'ee et a1.
`06-02-2005 Mizushima et a1.
`09-29-2005 Kakuta et a1.
`01-12-2006 Hoffman et a1.
`04-20-2006 Hoffman et a1.
`07-13-2006 Krause et a1.
`
`0060182740
`0060246073
`0070041905
`0070053906
`0070071747
`0070081996
`0070172897
`0070202104
`0070292442
`0080118496
`0080131374
`0080166348
`
`08-17-2006 Yan et a1.
`11-02-2006 Kniht et a1.
`02-22-2007 Hoffman et a1.
`03-08-2007
`Samaritani et a1.
`03-29-2007 Hoffman et a1.
`04-12-2007 Hoffman et a1.
`07-26-2007 Maks mow ch et a1.
`08-30-2007 Baner'ee et a1.
`12-20-2007 Wan et a1.
`05-22-2008 Medich et a1.
`06-05-2008 Medich et a1.
`07-10-2008 Ku. .er et a1.
`
`llw
`
`0080193466
`0080227136
`0080286280
`0080311043
`0090017472
`0090028794
`0090068172
`0090110679
`
`0090123378
`0090148513
`
`N
`
`08-14-2008 Baneree et a1.
`09-18-2008
`Pia et a1.
`11-20-2008 Kallme er et a1.
`12-18-2008 Hoffman et a1.
`01-15-2009
`Stuhlmuller et a1.
`01-29-2009 Medich et a1.
`03-12-2009 Ka makcalan et a1.
`04-30-2009 Li et a1.
`
`05-14-2009 Won et a1.
`0 O‘\ H H N O H 0
`Fraunhofer et a1.
`
`Examiner
`Signature
`
`Date
`Considered
`
`Ex. 1043 - Page 5 of 469
`
`
`
`Ex. 1043 - Page 5 of 469
`
`

`

`November 27, 2013
`Substitute for form l449A/B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`-- 20090155205
`
`06-18-2009
`
`Salfeld et al.
`
`-_—
`-_—
`-__
`-_
`-_
`-- 20090304682
`12— 10—2009
`-_—
`-_—
`-_—
`-__
`-_—
`-_—
`-_—
`-_—
`-__
`-_—
`--__
`-- 20110171227
`06-01-2011
`
`_OREIGNPATENT DOCUMENTS
`
`Publication
`Name of Patentee or
`Pages Columns Lines
`SEE“
`13:6
`Country Code-Nurnber-and Code5 (fknown)
`MM.]%I:IYYY
`Applicant 0fCited Document
`W;:f:v§::::dl::f:;§:ror
`
`
`EP- 0417191
`10-02- 1993 Centocor Inc
`
`EP- 0486526
`05-27- 1992 Peptide Technology Ltd
`
`EP- 0531539
`06-03- 1998 Mitsui Toatsu Chemicals Inc
`
`EP- 1174148
`01 2-3-2002 Yarnanouchi Pharrna Co Ltd
`
`EP- 1254666
`Chugai Pharmaceutical Co
`
`11-06-2002 Ltd
`WO- 1986000530
`Woelm Pharma GMBH &
`
`01-30- 1986 C0
`
` -_—
`
`
`
`
`
`
`
`
`
`WO- 1989011298
`WO- 1993008837
`
`11-30- 1989 Centocor Inc
`The Wellness Foundation
`05- 13-1993 Ltd
`
`_-
`
`-—
`WO-1997029131
`08-14-1007 Bast Aktiengesellschaft
`Date
`Considered
`
`Examiner
`Signature
`
`Ex. 1043 - Page 6 of 469
`
`Ex. 1043 - Page 6 of 469
`
`

`

`November 27, 2013
`Swan, WW0
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(MWWWW,
`
`FOREIGN PATENT DOCUMENTS
`
`12—04—1997 Glaxo Giou. Limited
`-- wo—1997045140
`05-28-1998 Genentech, Inc.
`-- WO-1998022136
`12-17-1998 Genentech, Inc.
`-- WO-1998056418
`07—29—1999 AstraAktiebola
`-- wo-1999037329
`11-16-2000 CSL Limited
`-- WO-2000067789
`06-21-2001 Genentech, Inc.
`-- wo—2001043773
`07—05—2001 Chuai Sei aku Kabushiki
`-- wo—2001047554
`
`wo—2002012500
`02—14—2002 CemocOi, Inc.
`
`wo—2002012502
`02—14—2002 CemocOi, Inc.
`
`WO-2002030463
`04-18-2002 Genentech, Inc.
`
`WO-2002100330
`12-19-2002 Abbott Laboratories
`
`
`
`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, page(s), volume—issue number(s), publisher, city and/or
`
`country where published.
`
`Voigt, "Textbook of pharmaceutical technology" VCH, 384, 394, 395 (1987) (in
`
`Adalimumab entry from National Library of Medicine website: WWW.
`n1m.nih. Hov/ci/mesh; I nrinted on 28 Se utember 2009
`Akers et a1., "Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical
`Biotechnology ", Chapter 2: "Formulation Development of Protein Dosage Forms",
`2002,K1uver Academic/Plenum, nub., New York. Vol. 14: 47-127
`Antoni et a1., "Side effects of anti-TNF therapy: Current knowledge," Clin Exp
`Rheumatol;20 su 1. 28 :S-152 -S-157 2002
`
`Barrera et a1., "Effects of treatment with a fully human antitumour necrosis factor alpha
`monoclonal antibody on the local and systemic homeostasis of interleukin 1 and TNFalpha
`
`in I patients with rheumatoid arthritis," Ann Rheum. Dis. 2001, 60(7):660-669
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`
`Cada et a1. "Adalimumab", Hospital Pharmacy (2003) 38,6:568—580
`Carpenter et a1., "Rational Design of Stable Lyophilized Protein Formulations: Some
`Practical Advice" Pharmaceutical Research, Vol 14(8):969-975 (1997)
`Cleland et a1., "A Specific Molar Ratio of Stabilizer to Protein is Required for Storage
`Stability of a Lyophilized Monoclonal Antibody," Journal of Pharmaceutical Sciences,
`2001, Vol. 90 3 :310-321
`den Broeder et a1. 'Long term anti-tumour necrosis factor a monotherapy in rheumatoid
`arthritis: effect on radioloical course and
`nostic value of markers of cartilae turnover
`Date
`Considered
`
`Examiner
`Signature
`
`EX. 1043 - Page 7 of 469
`
`
`
`wo—2004007520
`WO-2006138181
`
`01—22—2004 Medarex, Inc.
`12-28-2006 Amen Inc.
`NON PATENT LITERATURE DOCUMENTS
`
`
`
`
`
`
`Ex. 1043 - Page 7 of 469
`
`

`

`November 27, 2013
`WWW... 1449mm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(WWWWWW,
`
`FOREIGN PATENT DOCUMENTS
`
`and endothelial activation," Ann Rheum Dis, 2002;61 :311-318
`Harris et al., "Commercial manufacturing scale formulation and analytical characterization
`of therapeutic recombinant antibodies", Druge Development Research. (2004) Vol. 61 (3):
`
`1 3 7- 1 54.
`
`Hillgren et al., "Protection mechanism of Tween 80 during freeze-thawing of a model
`
`protein," International Journal of Pharmaceutics, 2002, Vol 237: 57-69
`Holt et al., "Domain antibodies: proteins for therapy," Trends in Immunology, 2003 ;21 (11
`: 484-490.
`
`Hovgaard & Frokj aer (eds) "Pharmaceutical Formulation Development of Peptides and
`Proteins", CRC Press 1999
`International Preliminary Examination Report for Application No. PCT/IB03/04502, dated
`Feb. 14,2005
`
`International Search Renort for A .lication No. PCT/IB03/04502 dated Ma 26, 2004.
`Paborij et al., "Chemical and Physical Stability of Chimeric L6, a Mouse-Human
`Monoclonal Antibod ," Pharm. Res. 1994; 11, 5:764-771
`Pennington et al., 'Polyclonal and Monoclonal Antibody Therapy for
`ExperimentalPseudomonas aeruginosa Pneumonia", Infect. lmmun. (1986) Vol. 54, pg.
`239-244
`
`
`
`
`
`Shimazato et al., "Suppression of Tumor Necrosis Factor Alpha Production by a Human
`Immunoglobulin Preparation for Intravenous Use", Infect. lmmun. (1990), Vol. 58, pg.
`
`1 3 84- 1 3 90
`
`Sivasai et al., "Cytomegalovirus immune globulin intravenous (human) administration
`modulates immune response to alloantigens in sensitized renal transplant candidates", Clin.
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`Exp. lmmunol., (2000), Vol. 119, pg. 559-565
`Wang et ai."Antibody Structure, Instability, and Formulation," J Pharmaceutical Sci,
`
`Wang et al. "Instability, Stabilization, and Formulation of Liquid Protein Pharmaceuticals,"
`International Journal 0 Pharmaceutics, 185:129-188 1999
`
`Wang, "Lyophilization and development of solid protein pharmaceuticals," lnt J Pharm
`2000;I 203 -, 1-2:1-60
`Zhao et al., "Recent US. Patents on Protein Drug Formulation: 2000-2007," Recent
`Patents on Dru
`'
`and Formulation, 2008; 2 3 :200—208 9 .
`
`Examiner
`Signature
`
`Date
`Considered
`
`Ex. 1043 - Page 8 of 469
`
`Ex. 1043 - Page 8 of 469
`
`

`

`Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`110222-0005-305
`
`PTO/AIA/424 (03-13)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`”—WInventor:
`Hans-Juer_en Krause
`Number If known I
`k .
`-
`A
`. I - .
`
`Invention:
`
`DISORDERS
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION
`FOR THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1), the prioritized examination fee set forth in 37
`CFR 1.17(c), and if not already paid, the publication fee set forth in 37 CFR 1.18(d) have been
`filed with the request. The basic filing fee, search fee, examination fee, and any required
`excess claims and application size fees are filed with the request or have been already been
`paid.
`
`The application contains or is amended to contain no more than four independent claims and
`no more than thirty total claims, and no multiple dependent claims.
`
`The applicable box is checked below:
`
`Ori
`
`inalA lication Track One -Prioritized Examination under 1.102e 1
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the utility application via EFS-Web.
`___OR___
`
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the plant application in paper.
`The executed inventor's oath or declaration is filed with the application. (37 CFR 1.63 and 1.64)
`CI Reguest for Continued Examination - Prioritized Examination under § 1.102(el(2)
`
`.
`
`A request for continued examination has been filed with, or prior to, this form.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a), or is
`a national stage entry under 35 U.S.C. 371.
`. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`
`No prior request for con(t2inued examination has been granted prioritized examination status
`
`under 37 CFR1. 102(e
`
`ii
`
`'
`
`
`
`/BRIANM. GUMMOW/
`
`Brian M. Gummow
`
`Date
`Si - nature
`Practitioner
`Name
`63933
`Re istration Number
`Print/T oed
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Submit multiple forms if more than one signature is required*.
`
`November 27 2013
`
`*Total of
`
`1
`
`forms are submitted.
`
`Ex. 1043 - Page 9 of 469
`
`Ex. 1043 - Page 9 of 469
`
`

`

`PTO/AIN14 (03-13)
`Approved for use through 0181/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`
`
`Secrecy Order 37 CFR 5.2
`
`I:I Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`
`Inventor Information:
`
`Inventor
`
`1
`
`Legal Name
`
`
`Hans-Juergen
`
`Prefix Given Name
`
`Middle Name
`Family Name
`
`Residence Information (Select One) 0 US Residency
`(9 Non US Residency 0 Active US Military Service
`City
`Gruenstadt
`Country of Residence i
`I DE
`
`Suffix
`
`
`
`
`
`
`Prefix Given Name
`Middle Name
`Family Name
`Suffix
`Lisa
`Baust
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`
`St. Killian—Strasse 14
`
`City
`Postal Code
`
`Gruenstadt
`
`D-67269
`
`StatelProvince
`DE
`
`Inventor
`
`2
`
`Legal Name
`
`Residence Information (Select One) 0 US Residency @ Non US Residency 0 Active US Military Service
`
`City
`
`Ludwigshafen
`
`Country of Residence i
`
`DE
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`
`Gothestr. 15 a
`
`City
`
`Ludwigshafen
`
`Postal Code
`
`D-67063
`
`Inventor
`
`3
`
`StatelProvince
`
`DE
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`Remove
`
`Legal Name
`
`
`EFS Web 2.2.3
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`_
`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
`110222-0005-305
`
`
`
`Application Number
`
`
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`Ex. 1043 - Page 10 of 469
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`PTO/AIN14 (03-13)
`Approved for use through 0181/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
` Attorney Docket Number
`110222-0005—305
`
`Application Data Sheet 37 CFR 1.76
`_
`_
`
`Application Number
`
`Title of Invention
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`
`
`
`Prefix Given Name Suffix Middle Name Family Name
`
`
`Michael
`Dickes
`
`
`
`Residence Information (Select One) 0 US Residency @ Non US Residency 0 Active US Military Service
`
`City
`
`Rodersheim-Gronau
`
`Country of Residence i
`
`DE
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`
`Schafergasse 58
`
`
`
`118276
`
`City
`Postal Code
`
`Rodersheim-Gronau
`D-67127
`
`StatelProvince
`DE
`
`Inventor Information blocks may be
`Inventors Must Be Listed - Additional
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`generated within this form by selecting the Add button. Add
`
`Correspondence Information:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`|:| An Address is being provided for the correspondence Information of this application.
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`Customer Number
`
`
`
`Email Address | USPatentMail@ropesgray.com
`
`
`
`
`
`Application Information:
`
`Title of the Invention
`Attorney Docket Number
`
`Eggh/IRIELEESION OF HUMAN ANTIBODIES FOR TREATING TNF—ALPHA ASSOCIATED
`
`110222-0005-305
`Small Entity Status Claimed
`|:|
`
`
`Application Type
`Nonprovisional
`
`
`Subject Matter
`Utility
`
`Publication Information:
`
`
`Total Number of Drawing Sheets (if any)
`
`Suggested Figure for Publication (if any)
`
`|:| Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`El
`
`Request Not to Publish. I hereby request that the attached application not be published under
`35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`Representative Information:
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`EFSWeb 2.2.3
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`

`PTO/AIN14 (03-13)
`Approved for use through 0181/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
` _
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`Attorney Docket Number
`110222-0005—305
`
`Appllcatlon Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`
`
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
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`specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`
`
`
` Prior Application Status Pending
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Continuation of
`
`13471820
`
`2012-05-15
`
`Prior Application Status
`
`Patented
`
`W
`
`_emove
`
`W
`
`
`Prior Application Status
`Expired
`
`Application Number Filing Date (YYYY-MM-DD) Continuity Type Prior Application Number
`
`
`
`a 371 of international PCTIB200300450210525292 2003-08-15
`
`
`
`
`
`
`
` Prior Application Status Abandoned
`
`Access Code| (if applicable)
`
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` Filing Date (YYYY-MM-DD)
`
`
`
` Continuation of
` 2002-08-16
`
`
`
`Application Number Filing Date (YYYY-MM-DD) Continuity Type Prior Application Number
`
`
`
`
`
`PCTIB2003004502
`
`10222140
`
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`that is eligible for retrieval under the priority document exchange program (PDX) Ithe information will be used by the Office to
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`automatically attempt retrieval pursuant to 37 CFR 1.55(h)(1) and (2). Under the PBX program, applicant bears the ultimate
`
`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
`
`property office, or a certified copy of the foreign priority application is filed, within the time period specified in 37 CFR 1.55(g)(1).
`
`I Filing Date (YYYY-MM-DD)
`I
`Application Number
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`
`
`Country I
`
`EFS Web 2.2.8
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`

`PTO/AIN14 (03-13)
`Approved for use through 0181/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`_
`_
`Appllcatlon Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`_
`
`110222-0005—305
`
`_ Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add
`Add button.
`
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`
`Applications
`
`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`D 16, 2013.
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
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`16, 2013, will be examined under the first inventor to file provisions of the AIA.
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`Authorization to Permit Access:
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`|:| Authorization to Permit Access to the Instant Application by the Participating Offices
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`If checked, the undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO),
`the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the World Intellectual Property Office (WIPO),
`and any other intellectual property offices in which a foreign application claiming priority to the instant patent application
`is filed access to the instant patent application. See 37 CFR 114(0) and (h). This box should not be checked if the applicant
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`In accordance with 37 CFR 1.14(h)(3), access will be provided to a copy of the instant patent application with respect
`to: 1) the instant patent application—as—filed; 2) any foreign application to which the instant patent application
`claims priority under 35 U.S.C. 119(a)—(d) if a copy of the foreign application that satisfies the certified copy requirement of
`37 CFR 1.55 has been filed in the instant patent application; and 3) any US. application-as-filed from which benefit is
`sought in the instant patent application.
`
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`
`Applicant Information:
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`
`
`
`
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title 37 of CFR
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`
`EFSWeb 2.2.3
`
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`

`

`PTO/AIN14 (03-13)
`Approved for use through 0181/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
` Attorney Docket Number
`110222-0005—305
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`
`
`
`0 Joint Inventor
`
`
`Applicant
`
`1
`
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`The information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`Clear
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`0 Legal Representative under 35 U.S.C. 117
`
`0 Person to whom the inventor is obligated to assign.
`
`O Person who shows sufficient proprietary interest
`
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`Name of the Deceased or Legally lncapacitated Inventor::|
`If the Applicant is an Organization check here.
`
`organ'zam” Name
`
`ABBVIE BIOTECHNOLOGY LTD.
`
`Mailing Address Information:
`
`Address 1
`
`Address 2
`
`2 Church Street
`
`Clarendon House
`
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`
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`
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`Assignee
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`1
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`
`D
`
`EFSWeb 2.2.3
`
`EX. 1043 - Page 14 Of 469
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`
`
`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent
`application publication . An assignee-applicant identified in the "Applicant Information" section will appear on the patent application
`publication as an applicant. For an assignee-applicant, complete this section only if identification as an assignee is also desired on the
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`
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`Ex. 1043 - Page 14 of 469
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`

`

`PTO/AlAl14 (03-13)
`Approved for use through 0181/2014. OMB 0651-0032
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
` Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`Application Number
`
`
`110222-0005—305
`
`
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`Title of Invention
`
`
`
`
`
`
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`
`
`Prefix
`
`Given Name
`
`Middle Name
`
`Family Name
`
`Mailing Address Information:
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`
`Address 2
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`StatelProvince
`
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`
`
`
`Additional Assrgnee Data may be generated Within this form by selecting the Add button.
`
`Signature:
`
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and
`certifications
`
`Brian M. Gummowl
`
`Signature First Name
`
`Date (YYYY-MM-DD)
`
`2013-11-27
`
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`
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`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which
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`COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
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`EFSWeb 2.2.3
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