DocCode — SEQ.TXT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 14091661
`
`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.
`
`Sequence Listing
`
`At the time of document entry (noted above):
`. USPTO employees may access SCORE content via eDAN using the Supplemental Content
`tab, or via the SCORE web page.
`. External customers may access SCORE content via PAIR using the Supplemental Content
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`
`Form Revision Date: August 26, 2013
`
`AMGEN INC.
`
`Exhibit 1050
`
`Ex. 1050 - Page 1 of 470
`
`Ex. 1050 - Page 1 of 470
`
`AMGEN INC.
`Exhibit 1050
`
`

`

`Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`110222-0005-303
`
`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. 1050 - Page 2 of 470
`
`Ex. 1050 - Page 2 of 470
`
`

`

`November 27, 2013
`Substitute for form 1449A/B/PTO
`
`INFORMATION DISCLOSURE
`
`Filing Date
`
`Complete ifKnown
`
`Not Yet Assigned
`
`Concurrently HereWith
`
`—NowetAssigned
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`Hans-Juel‘gel’l Krause
`First Named Inventor
`—NotYetAssigned
`
`_
`Exarmner
`Initia1s*
`
`_
`C1te
`No.l
`
`Document Number
`
`Number-Kind Code2 (gamma)
`
`Publication Date
`MM—DD—YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`U.S. PATENT DOCUMENTS
`
`-_—
`-- 5654403
`08-05-1997
`-_—
`-- 6024938
`02-15-2000
`-_—
`-_—
`-_—
`-_—
`-- 6485932
`11-26-2002
`-- 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 al.
`
`20030012786
`01-16-2003 Teoh et a1.
`
`20030049725
`03-13-2003 Heavner et al.
`
`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 al.
`
`2004003 887 8
`02-26-2004 Tanikawa et a1.
`
`
`
`
`
`Examiner
`Signature
`
`Date
`Considered
`
`Ex. 1050 - Page 3 of 470
`
`Ex. 1050 - Page 3 of 470
`
`

`

`November 27, 2013
`WWW 1449mm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(“WWW“)
`
`-- 20040126372
`-- 20040126373
`20040131614
`--
`20040136989
`--
`0040136990
`--
`0040136991
`--
`0040151722
`--
`0040156835
`--
`0040166111
`--
`0040170623
`--
`0040219142
`--
`0050118163
`--
`0050214278
`--
`0060009385
`--
`0060083741
`--
`0060153846
`--
`--
`--
`--
`--
`--
`-- 2
`--
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`--
`--
`--
`--
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`--
`--
`--
`
`N
`
`N
`
`llw
`
`N
`
`llw
`
`07-01-2004
`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
`1moto 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.
`
`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.
`
`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.
`06-11-2010
`Fraunhofer et a1.
`06-18-2009
`Salfeld et a1.
`09-10-2009
`
`
`
`0060182740
`0060246073
`0070041905
`0070053906
`0070071747
`0070081996
`0070172897
`0070202104
`0070292442
`0080118496
`0080131374
`0080166348
`
`0080193466
`0080227136
`0080286280
`0080311043
`0090017472
`0090028794
`0090068172
`0090110679
`
`0090123378
`0090148513
`0090155205
`0090226530
`
`Examiner
`Signature
`
`Date
`Considered
`
`Ex. 1050 - Page 4 of 470
`
`Ex. 1050 - Page 4 of 470
`
`

`

`November 27, 2013
`Substitute for form l449A/B/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`09-24-2009
`--20090239259
`-_
`
`Medich et al.
`
`______________ -
`
`20110054414
`20110171227
`
`03- 03-2011
`06- 01-2011
`
`
`
`
`
`IIIIIII—|.
`
`
`
`Pen; et al.
`William et al.
`Fraunhofer et al.
`Hoffman et al.
`Pollack et al.
`Okun et al.
`Salfeld et al.
`
`Won; et al.
`Borhani et al.
`Salfeld et al.
`Elden et al.
`Julian et al.
`Fraunhofer et al.
`Wan et al.
`
`Shan; et al.
`Okun et al.
`
`_OREIGNPATENT DOCUMENTS
`
`Publication
`Pages, Columns, Lines,
`Name of Patentee or
`Examiner
`Cite
`D t
`Where Relevant Passages or
`MM—D—DYYYY
`Relevant Figures Appear
`a e
`Applicant of Cited Document
`Initia1s*
`No.1
`Country Code -Number-Kind Code5 (ifknown)
`
`10-02- 1993 Centocor Inc.
`EP- 0417191
`
`05-
`EP- 0486526
`27- 1992 Peptide Technology Ltd
`
`06-03- 1998 Mitsui Toatsu Chemicals Inc.
`EP- 0531539
`01 -2-32002 Yamanouchi Pharma Co Ltd
`EP- 1174148
`EP- 1254666
`Chugai Pharmaceutical Co
`06-2002 Ltd
`11-
`WO- 1986000530
`Woelm Pharma GMBH &
`30- 1986 C0.
`01-
`
`11-30- 1989 Centocor Inc.
`WO- 1989011298
`WO- 1993008837
`The Wellness Foundation
`13-1993 Ltd.
`
`05-
`
`--—
`
`_-
`
`_—
`-_
`--—
`--—
`
`_E
`
`xaminer
`Signature
`
`Date
`Considered
`
`Ex. 1050 - Page 5 of 470
`
`Ex. 1050 - Page 5 of 470
`
`

`

`November 27, 2013
`WWW... 1449mm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(MWWW,
`
`FOREIGN PATENT DOCUMENTS
`
`-__——l
`-__——I
`-__-_—I
`-__——I
`-__——I
`-__——I
`-__——I
`
`WO-2004007520
`01-22-2004 Medarex, Inc.
`WO-2006138181
`12-28-2006 Am-en Inc.
`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, 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 al., "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
`
`
`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 al., "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 radiological course and prognostic value of markers of cartilage turnover
`and endothelial activation," Ann Rheum Dis, 2002;61 :311-318
`Harris et a1., "Commercial manufacturing scale formulation and analytical characterization
`of therapeutic recombinant antibodies", Druge Development Research. (2004) Vol. 61 (3):
`1 3 7- 1 54.
`
`Examiner
`Signature
`
`Date
`Considered
`
`Ex. 1050 - Page 6 of 470
`
`Ex. 1050 - Page 6 of 470
`
`

`

`November 27, 2013
`WWW... 1449mm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`WWWWWM,
`
`FOREIGN PATENT DOCUMENTS
`
`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.
`
`Exp. lmmunol., (2000), Vol. 119, pg. 559-565
`Wang et ai."Antibody Structure, Instability, and Formulation," J Pharmaceutical Sci,
`
`2007;96 (1): 1-26.
`Wang et al. "Instability, Stabilization, and Formulation of Liquid Protein Pharmaceuticals,"
`
`International Journal ofPlzarmaceutics, 185: 129-188 (1999)
`Wang, "Lyophilization and development of solid protein pharmaceuticals," lnt J Pharm
`
`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. 1050 - Page 7 of 470
`
`Ex. 1050 - Page 7 of 470
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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.
`
`
`
`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
`
`Remove
`
`Legal Name
`
`
`EFS Web 2.2.3
`
`EX. 1050 - Page 8 Of 470
`
`
`
` _
`
`_
`Application Data Sheet 37 CFR 1.76
`
`
`Attorney Docket Number
`110222-0005-303
`
`
`
`Application Number
`
`
`
`Ex. 1050 - Page 8 of 470
`
`

`

`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—303
`
`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
`All
`
`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.
`
`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
`
`110222-0005-303
`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:
`
`EFSWeb 2.2.3
`
`EX. 1050 - Page 9 Of 470
`
`
`
`Ex. 1050 - Page 9 of 470
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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—303
`
`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).
`Either enter Customer Number or complete the Representative Name section below.
`If both sections are completed the customer
`Number will be used for the Representative Information during processing.
`
`
`
`
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`
`
`
`Please Select One:
`@ Customer Number
`0 US Patent Practitioner 0 Limited Recognition (37 CFR 11.9)
`1 18276
`Customer Number
`
`Domestic Benefit/National Stage Information:
`
`
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate
`National Stage entry from a PCT application. Providing this information in the application data sheet constitutes the
`
`specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`
`
`
` Prior Application Status Pending
`
`Application Number
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`Continuity Type
`
`Prior Application Number
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`Continuation of
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`13471820
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`2012-05-15
`
`Prior Application Status
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`Patented
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`W
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`_emove
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`W
`
`
`Prior Application Status
`Expired
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`Application Number Filing Date (YYYY-MM-DD) Continuity Type Prior Application Number
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`
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`a 371 of international PCTIB200300450210525292 2003-08-15
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`
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`
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` Prior Application Status Abandoned
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`Access Code| (if applicable)
`
`
` Filing Date (YYYY-MM-DD)
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`
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` Continuation of
` 2002-08-16
`
`
`
`Application Number Filing Date (YYYY-MM-DD) Continuity Type Prior Application Number
`
`
`
`
`
`PCTIB2003004502
`
`10222140
`
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`by selecting the Add button.
`
`Add
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`Foreign Priority Information:
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`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
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`constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55_(d). When priority is claimed to a foreign application
`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
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`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
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`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).
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`I Filing Date (YYYY-MM-DD)
`I
`Application Number
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`Country I
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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—303
`
`_ 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.
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`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
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`Applications
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`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
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`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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`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
`to have an assignment recorded by the Office.
`
`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—303
`
`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
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`0 Person to whom the inventor is obligated to assign.
`
`O Person who shows sufficient proprietary interest
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`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
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`2 Church Street
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`Clarendon House
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`Email Address
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`D
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`EFSWeb 2.2.3
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`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent
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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
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`Attorney Docket Number
`
`Application Number
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`
`110222-0005—303
`
`
`
`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 1
`
`Address 2
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`City
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`StatelProvince
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`Additional Assrgnee Data may be generated Within this form by selecting the Add button.
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`Signature:
`
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and
`certifications
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`Brian M. Gummowl
`
`Signature First Name
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`Date (YYYY-MM-DD)
`
`2013-11-27
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`Additional Signature may be generated within this form by selecting the Add button.
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`PTOIAIAI'M (0542)
`Appmved fer use ihmugii Gris-1,2014. 0MB 13551—0032
`
`
`DEPARTMENT OF CQMMERCE
`U.S. Pat-ant and Trademark affine; 15
`
`
`Under the Papemnrk Reduciien Act mi 1935! no persons are required to respcnd ie a milecfion or informaticri uniass it dig!) ays a valid OMB contra! number.
`
`‘i 13222—0035333
`
`APPLECATEQN BATA SHEET {3? GFR 1,?83
`
`ECATEGN USENG AN
`
`Tiiis cf
`inventmn
`
`FORMULATSGN or HUMAN Arrrisasiizs FOR mss‘rms i’NF—ALPHA Assocmrsm
`ryasarirarsris
`
`As ihe beiow named irwsrfior, i hereby declare ihasi:
`
`This GSGiaFBiifln W The aiiachaci appiicatian. or
`i‘is direcisci to:
`"""
`
`Limited States apgsiiczaiimi or PCT irriemaiianai appiicaijon number
`
`
`
`
`
`The above—irisntiiied appiicaiicn was;