For the Patent Owner
`Backup counsel: Robert W. Hahl, Reg. No. 33,893
`Backup counsel: Robert Mihail, Reg. No. 66,021
`Neifeld IP Law, PC
`
`
`
`Paper No. __
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`Coalition For Affordable Drugs V LLC
`Petitioner
`v.
`
`Biogen MA Inc.
`Patent Owner
`____________
`
`Case IPR2015-01136
`Patent 8,399,514
`Title: TREATMENT FOR MULTIPLE SCLEROSIS
`____________
`
`
`
`
`PETITIONER’S EXHIBIT LIST OF 5/27/2015
`
`
`
`
`
`
`
`1
`
`
`Backup counsel: Robert W. Hahl, Reg. No. 33,893
`Backup counsel: Robert Mihail, Reg. No. 66,021
`Neifeld IP Law, PC
`
`
`
`Paper No. __
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`Coalition For Affordable Drugs V LLC
`Petitioner
`v.
`
`Biogen MA Inc.
`Patent Owner
`____________
`
`Case IPR2015-01136
`Patent 8,399,514
`Title: TREATMENT FOR MULTIPLE SCLEROSIS
`____________
`
`
`
`
`PETITIONER’S EXHIBIT LIST OF 5/27/2015
`
`
`
`
`
`
`
`1
`
`
`
`37 CFR 42.63(e) states that:
`
`(e) Exhibit list. Each party must maintain an exhibit list with the exhibit
`
`number and a brief description of each exhibit. If the exhibit is not filed,
`
`the exhibit list should note that fact. A current exhibit list must be
`
`served whenever evidence is served and the current exhibit list must be
`
`filed when filing exhibits.
`
`
`
`Description of Marks in the Date Served, and Date Filed columns:
`
`A date in the "Date Served" column indicates the exhibit has been served on
`
`the specified date.
`
`A date in the "Date Filed" column indicates the exhibit has been filed on the
`
`Date Filed
`Date Served
`
`5/1/2015
`
`5/1/2015
`
`
`
`specified date.
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1001 US Patent No. 8,399,514, titled “Treatment for Multiple
`
`Sclerosis” to Lukashev et al. (‘514 patent)
`
`1002 Unassigned
`
`
`
`2
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1003 Kappos et al., “A randomised, placebo-controlled phase
`
`II trial of a novel oral single-agent fumarate therapy,
`
`BG00012, in patients with relapsing-remitting multiple
`
`sclerosis”, 2005, J Neurol (2005) 252 [Suppl 2]: II/95–
`
`II/170, pII/148, P574.
`
`1004
`
`International Conference on Harmonization of
`
`Technical Requirements for Registration of
`
`Pharmaceuticals for Human Use, ICH Harmonized
`
`Tripartite Guideline, Dose-Response Information to
`
`Support Drug Registration E4, Current Step 4 version,
`
`dated 10 March 1994.
`
`1005 Declaration of Dr. Steven E. Linberg.
`
`
`
`1006 Unassigned
`
`
`
`3
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1007
`
`“Preliminary Amendment Under 37 C.F.R. § 1.115, In
`
`re application of: LUKASHEV et al.”, Application No.
`
`13/372,426 that issued into US Patent 8,399,514.
`
`1008
`
`“Amendment and Reply Under 37 C.F.R. § 1.111, In re
`
`application of: LUKASHEV et al., Appl. No.
`
`13/372,426” that issued into US Patent 8,399,514.
`
`1009 Office Action with mail date of 05/03/2012 for
`
`Application No. 13/372,426 that issued into US Patent
`
`8,399,514.
`
`1010 Unassigned
`
`1011
`
`PCT Application No. PCT/US2008/001602
`
`
`
`1012
`
`Certified copy of US Provisional Application No.
`
`601888,921
`
`1013 Assignment Record for US Patent No. 8,399,514 from
`
`USPTO’s Assignments on the Web.
`
`
`
`4
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1014
`
`IFW of PCT/US2008/001602.
`
`
`
`1015
`
`Certified Copy of US Provisional 60/888,921 as
`
`received by the International Bureau on March 26,
`
`2008.
`
`1016 D. Werdenberg, et al., “Presystemic Metabolism and
`
`Intestinal Absorption of Antipsoriatic Fumaric Acid
`
`Esters”, 2003, BIOPHARMACEUTICS & DRUG
`
`DISPOSITION, Biopharm. Drug Dispos. 24: 259–273
`
`(2003), Published online in Wiley InterScience
`
`(www.interscience.wiley.com). DOI: 10.1002/bdd.364.
`
`1017
`
`CV of Dr. Steven E. Linberg
`
`
`
`1018 US Application 13/372,426, as filed on February 13,
`
`2012
`
`
`
`5
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1019 Nieboer et al., “Fumaric Acid Therapy in Psoriasis: A
`
`Double-Blind Comparison between Fumaric Acid
`
`Compound Therapy and Monotherapy with
`
`Dimethylfumaric Acid Ester” Dermatologica 1990;
`
`181:33- 37
`
`1020 Declaration of Scott Bennett
`
`
`
`1021
`
`“BG 12 BG 00012, BG 12/Oral Fumarate, FAG-201,
`
`Second-Generation Fumarate Derivative – Fumapharm/
`
`Biogen Idec”, 2005, Drugs R D 2005; 6 (4): 229-230.
`
`1022
`
`“View of NCT00168701 on 2005_09_14”, from URL
`
`https://clinicaltrials.gov/archive/NCT00168701/2005_0
`
`9_14
`
`
`
`6
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`5/1/2015
`5/1/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1023
`
`“Galenic development”, Fumapharm AG archival page
`
`located at
`
`http://web.archive.org/web/20050803080203/http://ww
`
`w.fumapharm.ch/EN/Research/Galenical_Development/
`
`index.php
`
`1024 Declaration of Robert Mihail
`
`
`
`1025 Declaration of Christopher Butler
`
`
`
`1026
`
`Talalay et al., “Identification of a common chemical
`
`signal regulating the induction of enzymes that protect
`
`against chemical carcinogenesis”, November 1998,
`
`Proc. Nati. Acad. Sci. USA, Vol. 85, pp. 8261-8265,
`
`Medical Sciences.
`
`
`
`7
`
`
`
`Date Filed
`Date Served
`
`5/1/2015
`5/1/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1027
`
`Begleiter et al., “Dietary induction of NQO1 increases
`
`the antitumour activity of mitomycin C in human colon
`
`tumours in vivo”, 2004, British Journal of Cancer, 1624
`
`– 1631.
`
`1001A US Patent No. 8,399,514, titled “Treatment for Multiple
`
`Sclerosis” to Lukashev et al. (‘514 patent)
`
`
`
`1003A Kappos et al., “A randomised, placebo-controlled phase
`
`II trial of a novel oral single-agent fumarate therapy,
`
`BG00012, in patients with relapsing-remitting multiple
`
`sclerosis”, 2005, J Neurol (2005) 252 [Suppl 2]: II/95–
`
`II/170, pII/148, P574
`
`
`
`8
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1004A International Conference on Harmonization of
`
`Technical Requirements for Registration of
`
`Pharmaceuticals for Human Use, ICH Harmonized
`
`Tripartite Guideline, Dose-Response Information to
`
`Support Drug Registration E4, Current Step 4 version,
`
`dated 10 March 1994
`
`
`
`1005A Declaration of Dr. Steven E. Linberg
`
`
`
`
`
`9
`
`
`
`1007A “Preliminary Amendment Under 37 C.F.R. § 1.115, In
`
`5/27/2015
`
`5/27/2015
`
`re application of: LUKASHEV et al.”, Application No.
`
`13/372,426 that issued into US Patent 8,399,514
`
`Table of Contents For Ex. 1007A
`
`Amendment -------------------------------- pages 2 - 13
`
`Exhibit 1 (Declaration of Katherine T. Dawson,
`
`M.D. Under 37 C.F.R. § 1.132) --------- pages 14 – 35
`
`Exhibit A (Curriculum Vitae for
`
`Katherine T. Dawson --------------------- pages 38 - 43
`
`Exhibit B (Kappos, L., el al., "Efficacy and safety of
`
`oral fumarate in patients with relapsing-remitting
`
`multiple sclerosis: a multicenter, randomised, double--
`
`blind, placebo--controlled phase IIIb study,"
`
`Lancet 372: 1463-72 (2008) -------------- pages 44 - 54
`
`Exhibit C (Kappos, L., et al., "Efficacy of a novel oral
`
`single-agent fumarate, BG00012, in patients with
`
`relapsing-remitting multiple sclerosis: results of a phase
`
`2 study* 16th Meeting of the European Neurological
`
`Society
`
`(May 30, 2006) (Slide Presentation)) -- pages 56 - 57
`
`
`
`10
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`Exhibit D (Kappos, L., et al., "Efficacy of a novel oral
`
`single-agent Fumarate, BG00012, in patients with
`
`relapsing-remitting multiple sclerosis: results of a phase
`
`II study,"
`
`16th Meeting of the European Neurological
`
`Society (May 30, 2006)
`
`(Abstract to the Presentation) ------------ pages 78 - 79
`
`Exhibit E ("Oral Compound BG-12 Achieves Primary
`
`Endpoint
`
`in Phase II Study of Relapsing-Remitting MS with BG-
`
`12 Led to Statistically Significant Reductions in MRI
`
`Measures,"Biogen Idec News Release (May 30, 2006))
`
`------------------------------------------------ pages 80 - 82
`
`Exhibit 2 (Press Release Details) --------pages 83 - 86
`
`Transmittal letter -------------------------- page 87
`
`
`
`11
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1008A “Amendment and Reply Under 37 C.ER. § 1.111, In re
`
`application of: LUKASHEV et al., Appl. No.
`
`13/372,426” that issued into US Patent 8,399,514
`
`
`
`
`
`12
`
`
`
`5/27/2015
`
`5/27/2
`
`5/27/2015
`
`5/27/2
`
`1009A Office Action with mail date of 05/03/2012 for
`
`Application No. 13/372,426 that issued into US Patent
`
`8,399,514
`
`Table of Contents For Ex. 1009A
`
`Office Action of 05/03/2012 for
`
`Application No. 13/372,426 ------------- pages 2 - 12
`
`First Supplemental Information Disclosure Statement
`
`by Applicant ------------------------------- pages 13 - 42
`
`Information Disclosure Statement
`
`by Application ---------------------------- page 43
`
`Second Supplemental Information Disclosure Statement
`
`by Applicant ------------------------------ pages 44 - 47
`
`First Supplemental Information Disclosure
`
`Statement by Applicant ------------------ pages 48 - 54
`
`Second Supplemental Information Disclosure Statement
`
`by Applicant ------------------------------ pages 55 - 56
`
`Third Supplemental Information Disclosure
`
`Statement by Applicant ------------------ page 57
`
`
`
`1011A PCT Application No. PCTIUS2008/001602
`
`
`
`13
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`Table of Contents For Ex. 1011A
`
`PCT Publication no. 2008/097596 A2
`
`Front page --------------------------- page 2
`
`Specification ------------------------ pages 3 - 36
`
`Claims ------------------------------- pages 37 - 39
`
`Drawings ---------------------------- pages 40 - 43
`
`
`
`
`
`
`
`
`
`
`
`
`
`14
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1012A Certified copy of US Provisional Application No.
`
`601888,921
`
`Table of Contents For Ex. 1012A
`
`Certified Copy of US Provisional 60/888,921
`
`Questel Cover Letter--------------- page 2
`
`Front page --------------------------- page 3
`
`Electronic Acknowledgment
`
`Receipt ------------------------------ page 4 – 6
`
`Provisional Application
`
`Cover Sheet ------------------------- page 7
`
`Specification ------------------------ pages 8 - 43
`
`Claims ------------------------------- pages 44 - 46
`
`Abstract ------------------------------ page 47
`
`Drawings ---------------------------- pages 48 - 49
`
`
`
`
`
`15
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1013A Assignment Record for US Patent No. 8,399,514 from
`
`USPTO’s Assignments on the Web
`
`
`
`
`
`16
`
`
`
`1014A IFW of PCT/US2008/001602
`
`Table of Contents For Ex. 1014A
`
`File Wrapper of PCT Application No.
`
`PCT/US2008/001602
`
`5/27/2015
`
`5/27/2015
`
`Incoming ISA/202 – Notification of Receipt of
`
`Search Copy ------------------------------- page 2
`
`RO/102 – Notification Concerning Payment of
`
`Prescribed Fees and Annex -------------- pages 3 - 4
`
`RO/105 – Notification of the IA Number and of the
`
`International Filing Date ----------------- page 5
`
`RO/101 – Annex
`
`(fee calculation sheet) --------------------- page 6
`
`RO/101 - Request form for new IA
`
`– Conventional ----------------------------- pages 7 – 10
`
`Specification -------------------------------- pages 11 - 44
`
`Claims --------------------------------------- pages 45 – 47
`
`Abstract -------------------------------------- page 48
`
`Drawings ------------------------------------ pages 49 - 52
`
`Miscellaneous Internal Document ------- page 53
`
`PCT Transmittal Letter -------------------- page 54
`
`
`
`17
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`RO/102(b) - Chapter I Fee
`
`Recordation Sheet -------------------------- page 55
`
`Placeholder sheet indicating presence of supplemental
`
`content in SCORE -------------------------- page 56
`
`
`
`18
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1015A Certified Copy of US Provisional 60/888,921 as
`
`received by the International Bureau on March 26, 2008
`
`Table of Contents For Ex. 1015A
`
`Certified Copy of US Provisional 60/888,921 as
`
`received by the International Bureau
`
`WIPO Cover Letter------------------------ page 2
`
`Front page ---------------------------------- page 3
`
`Provisional Application Cover Sheet --- page 4
`
`Specification -------------------------------- pages 5 - 40
`
`Claims --------------------------------------- pages 41 - 43
`
`Abstract -------------------------------------- page 44
`
`Drawings ------------------------------------ pages 45 - 46
`
`Electronic Acknowledgment Receipt --- pages 47 - 49
`
`
`
`
`
`19
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1016A D. Werdenberg, et al., “Presystemic Metabolism and
`
`Intestinal Absorption of Antipsoriatic Fumaric Acid
`
`Esters”, 2003, BIOPHARMACEUTICS & DRUG
`
`DISPOSITION, Biopharm. Drug Dispos. 24: 259–273
`
`(2003), Published online in Wiley InterScience
`
`(www.interscience.wiley.com). DOI: 10.1002/bdd.364
`
`1017A CV of Dr. Steven E. Linberg
`
`
`
`
`
`20
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1018A US Application 13/372,426, as filed on February 13,
`
`2012
`
`Table of Contents For Ex. 1018A
`
`US Application 13/372,426, as filed on February 13,
`
`2012
`
`Face of application ------------------------ page 2
`
`Specification ------------------------------- pages 3 - 36
`
`Claims --------------------------------------- pages 37 - 39
`
`Drawings ------------------------------------ pages 40 - 43
`
`
`
`1019A Nieboer et al., “Fumaric Acid Therapy in Psoriasis: A
`
`Double-Blind Comparison between Fumaric Acid
`
`Compound Therapy and Monotherapy with
`
`Dimethylfumaric Acid Ester” Dermatologica 1990;
`
`181:33- 37
`
`
`
`21
`
`
`
`5/27/2015
`
`5/27/2015
`
`1020A Declaration of Scott Bennett
`
`Table of Contents For Ex. 1020A
`
`
`
`Declaration of Scott Bennett
`
`Declaration of Scott Bennett --------------- pages 1 - 3
`
`Attachment 1: Program cover of the Fifteenth Meeting
`
`of the European Neurological
`
`Society (ENS) -------------------------------- page 4
`
`Attachment 2: ENS Meeting Program
`
`entry for Item 1 ------------------------------- page 5
`
`Attachment 3: Cover of the Journal of Neurology, 22,
`
`Supplement 2 (June 2005) from the University of
`
`Maryland -------------------------------------- page 6
`
`Attachment 4: Item 1 from the Journal of Neurology,
`
`22, Supplement 2
`
`(June 2005), p. II/148 ------------------------ page 7
`
`Attachment 5: Index entry for Item 1 from the Journal
`
`of Neurology, 22, Supplement 2
`
`(June 2005), p. II/164 ------------------------ page 8
`
`Attachment 6: University of Maryland Library catalog
`
`record for the
`
`
`
`22
`
`
`
`Date Filed
`Date Served
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`Journal of Neurology ------------------------- page 9
`
`Attachment 7: OCLC WorldCat record for the Journal
`
`of Neurology ---------------------------------- page 10
`
`Attachment 8: Web of Science entry for
`
`Item 1 ------------------------------------------- page 11
`
`Attachment 9: SpringerLink entry for
`
`Item 1 download ------------------------------- page 12
`
`
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`1021A “BG 12 BG 00012, BG 12/Oral Fumarate, FAG-201,
`
`Second-Generation Fumarate Derivative – Fumapharm/
`
`Biogen Idec”, 2005, Drugs R D 2005; 6 (4): 229-230
`
`1022A “View of NCT00168701 on 2005_09_14”, from URL
`
`https://clinicaltrials.gov/archive/NCT00168701/2005_0
`
`9_14
`
`
`
`23
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1023A “Galenic development”, Fumapharm AG archival page
`
`located at
`
`http://web.archive.org/web/20050803080203/http://ww
`
`w.fumapharm.ch/EN/Research/Galenical_Development/
`
`index.php
`
`1024A Declaration of Robert Mihail
`
`
`
`1025A Declaration of Christopher Butler
`
`Table of Contents For Ex. 1025A
`
`
`
`Declaration of Christopher Butler
`
`Affidavit of Christopher Butler ----------------- page 2
`
`Exhibit A (Webpage Galenic development) --- page 4
`
`
`
`
`
`24
`
`
`
`Date Filed
`Date Served
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`5/27/2015
`
`Exhibit
`
`Description of
`
`Exhibit Number
`
`1026A Talalay et al., “Identification of a common chemical
`
`signal regulating the induction of enzymes that protect
`
`against chemical carcinogenesis”, November 1998,
`
`Proc. Nati. Acad. Sci. USA, Vol. 85, pp. 8261-8265,
`
`Medical Sciences.
`
`1027A Begleiter et al., “Dietary induction of NQO1 increases
`
`the antitumour activity of mitomycin C in human colon
`
`tumours in vivo”, 2004, British Journal of Cancer, 1624
`
`– 1631
`
`
`
`/RobertHahl#33,893/
`Robert W. Hahl, Reg. No. 33,893
`Lead Counsel for the Petitioner
`Tel: 1-703-415-0012 Ext. 103
`Email: rhahl@neifeld.com
`Backup Counsel for Petitioner
`Robert Mihail, Reg. No. 66,021
`Tel: 1-703-415-0012 Ext. 107
`Email: rmihail@neifeld.com
`Fax for lead and backup counsel for the Petitioner: 1-703-415-0013
`Postal address for lead and backup counsel:
`Neifeld IP Law, PC, 4813-B Eisenhower Avenue, Alexandria, VA 22304
`
`
`
`
`
`25
`
`
`
`42.6(e) CERTIFICATE OF SERVICE
`
`Agreements on Service: “Under 37 C.F.R. § 42.6(e), Patent Owner consents to
`electronic service by email at michael.flibbert@finnegan.com and
`maureen.queler@finnegan.com.” Patent Owner’s Mandatory Notice of 5/22/2015.
`
`
`I certify that this document was served or simultaneously is being served on each
`opposing party with the filing of this document. I certify that the following
`exhibits being filed along with this document, if any, have been or simultaneously
`are being served on each opposing party:
`
`
`Description
`
`Exhibit
`Number
`1001A US Patent No. 8,399,514, titled “Treatment for Multiple Sclerosis” to
`Lukashev et al. (‘514 patent)
`1003A Kappos et al., “A randomised, placebo-controlled phase II trial of a
`novel oral single-agent fumarate therapy, BG00012, in patients with
`relapsing-remitting multiple sclerosis”, 2005, J Neurol (2005) 252
`[Suppl 2]: II/95–II/170, pII/148, P574
`International Conference on Harmonization of Technical
`Requirements for Registration of Pharmaceuticals for Human Use,
`ICH Harmonized Tripartite Guideline, Dose-Response Information to
`Support Drug Registration E4, Current Step 4 version, dated 10 March
`1994
`1005A Declaration of Dr. Steven E. Linberg
`1007A
`“Preliminary Amendment Under 37 C.F.R. § 1.115, In re application
`of: LUKASHEV et al.”, Application No. 13/372,426 that issued into
`US Patent 8,399,514
`“Amendment and Reply Under 37 C.ER. § 1.111, In re application of:
`LUKASHEV et al., Appl. No. 13/372,426” that issued into US Patent
`8,399,514
`1009A Office Action with mail date of 05/03/2012 for Application No.
`13/372,426 that issued into US Patent 8,399,514
`
`1004A
`
`1008A
`
`1011A
`
`PCT Application No. PCTIUS2008/001602
`
`1012A Certified copy of US Provisional Application No. 601888,921
`26
`
`
`
`
`
`1013A Assignment Record for US Patent No. 8,399,514 from USPTO’s
`Assignments on the Web
`IFW of PCT/US2008/001602
`1014A
`1015A Certified Copy of US Provisional 60/888,921 as received by the
`International Bureau on March 26, 2008
`1016A D. Werdenberg, et al., “Presystemic Metabolism and Intestinal
`Absorption of Antipsoriatic Fumaric Acid Esters”, 2003,
`BIOPHARMACEUTICS & DRUG DISPOSITION, Biopharm. Drug
`Dispos. 24: 259–273 (2003), Published online in Wiley InterScience
`(www.interscience.wiley.com). DOI: 10.1002/bdd.364
`1017A CV of Dr. Steven E. Linberg
`1018A US Application 13/372,426, as filed on February 13, 2012
`
`1023A
`
`1022A
`
`1019A Nieboer et al., “Fumaric Acid Therapy in Psoriasis: A Double-Blind
`Comparison between Fumaric Acid Compound Therapy and
`Monotherapy with Dimethylfumaric Acid Ester” Dermatologica 1990;
`181:33- 37
`1020A Declaration of Scott Bennett
`1021A
`“BG 12 BG 00012, BG 12/Oral Fumarate, FAG-201, Second-
`Generation Fumarate Derivative – Fumapharm/ Biogen Idec”, 2005,
`Drugs R D 2005; 6 (4): 229-230
`“View of NCT00168701 on 2005_09_14”, from URL
`https://clinicaltrials.gov/archive/NCT00168701/2005_09_14
`“Galenic development”, Fumapharm AG archival page located at
`http://web.archive.org/web/20050803080203/http://www.fumapharm.c
`h/EN/Research/Galenical_Development/index.php
`1024A Declaration of Robert Mihail
`1025A Declaration of Christopher Butler
`1026A Talalay et al., “Identification of a common chemical signal regulating
`the induction of enzymes that protect against chemical
`carcinogenesis”, November 1998, Proc. Nati. Acad. Sci. USA, Vol.
`85, pp. 8261-8265, Medical Sciences
`1027A Begleiter et al., “Dietary induction of NQO1 increases the antitumour
`activity of mitomycin C in human colon tumours in vivo”, 2004,
`British Journal of Cancer, 1624 – 1631
`
`27
`
`
`
`
`
`
`
`42.6(e)(4) (iii)(A) The date and manner of service:
`
`Date of Service: 5/27/2015
`
`Manner of service: Email to: michael.flibbert@finnegan.com;
`maureen.queler@finnegan.com
`
`42.6(e)(4)(iii)(B) The name and address of every person served are:
`Lead Counsel for patent owner, telephone and email: Michael J. Flibbert (Reg.
`No. 33,234); Tel: 202.408.4493
`Backup Counsel for patent owner, telephone and email: Maureen D. Queler
`(Reg. No. 61,879); Tel: 202.408.4294
`Postal Address for lead and backup counsel for patent owner: Finnegan,
`Henderson, Farabow, Garrett & Dunner, LLP, 901 New York Avenue, NW,
`Washington, DC 20001.
`Fax Address for lead and backup counsel for patent owner: 202-408-4000
`
`
`/RobertHahl#33,893/
`Robert W. Hahl, Reg. No. 33,893
`Lead Counsel for the Petitioner
`Neifeld IP Law, PC
`4813-B Eisenhower Avenue
`Alexandria, VA 22304
`Tel: 1-703-415-0012 Ext. 103
`Fax: 1-703-415-0013
`Email: rhahl@neifeld.com
`
`
`
`
`
`28
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