Regeneron Pharmaceuticals, Inc. vs Novartis Vaccines and Diagnostics, Inc. et al.

Termination Decision Document

Joint Motion to Terminate Under 35 U.S.C. 317(a) and 37 C.F.R. 42.72

Ex. 1048

Ex 3001

Power of Attorney - Novartis Vaccines and Diagnostics, Inc.

Updated Power of Attorney - Grifols Worldwide Operations Limited

Patent Owners' Updated Mandatory Notices

Declaration of Kathryn Calame, PhD

688 File History ¿¿¿ 3/29/07 Reexamination Final Rejection

688 File History ¿¿¿ 1/8/08 Examiner's Answer to Appeal Brief

Banerji et al., A Lymphocyte-Specific Cellular Enhancer is Located Downstream of the Joining Region in Immunoglobulin Heavy Chain Genes Cell, Vol 33, 729-740 (1983)

Bebbington, Expression of Antibody Genes in Nonlymphoid Mammalian Cells Methods: A Companion to Methods in Enzymology, Vol. 2., No. 2, 136-145 (Apr. 1991)

Foecking, et al., Powerful and Versatile Enhancer-promoter Unit for Mammalian Expression Vectors Gene, 45, 101-105 (1986)

U.S. Patent No. 5,024,939 (Gorman)

Patent Owner's Preliminary Response

688 File History ¿¿¿ 5/29/07 Applicant Arguments

688 File History ¿¿¿ 7/23/07 Applicant Remarks

688 File History ¿¿¿ 9/7/07 Applicant Remarks

688 File History ¿¿¿ 10/2/07 Decision Dismissing Petition

Claim Construction Opinion and Order dated 8/14/19 (No. 18-cv-2434-DLC (S.D.N.Y.)

Banerji, Expression of a ¿¿-Globin Gene Is Enhanced by Remote SV40 DNA Sequences Cell, Vol. 27, 299-308 (1981)

Dierks, et al., DNA Sequences Preceding the Rabbit ¿¿-Globin Gene are Required for Formation in Mouse L Cells of ¿¿-Globin RNA with the Correct 5¿¿¿ Terminus Proc. Natl. Acad. Sci. USA, Vol. 78, No. 3, 1411-1415 (Mar. 1981)

Grosveld, et al., Sequence Requirements for the Transcription of Rabbit-¿¿-globin Gene In Vivo: The -80 Region Nucleic Acids Research, Vol. 10, No. 16 4951-4971 (1982)

Pierard, et al., Mutant and Chimeric Recombinant Plasminogen Activators Jnl. of Bio. Chem., Vol. 262, No. 24, 11771-11778 (1987)

Reardon, et al., Expression of the Human Apolipoprotein E Gene in Cultured Mammalian Cells Jnl. of Bio. Chem., Vol. 261, No. 21, 9858-9864 (1986)

Rusconi, et al., Transformation of Frog Embryos with Rabbit ¿¿-Globin Gene Proc. Natl. Acad. Sci., Vol. 78, No. 8, 5051-5055 (1981)

U.S. Patent No. 5,168,062 (Stinski)

U.S. Patent No. 5,591,639 (Bebbington)

Villiers, et. al., A Small Segment of Polyoma Virus DNA Enhances the Expression of a Cloned ¿¿-Globin Gene Over a Distance of 1400 Base Pairs Nucleic Acids Research, Vol. 9, No. 23, 6251-6264 (1981)

Wold, et al., Introduction and Expression of a Rabbit ¿¿-Globin Gene in Mouse Fibroblasts, Proc. Natl. Acad. Sci, Vol. 76, NO. 11, 5684-5688 (1979)

Petitioner's Updated Mandatory Notices

Petitioner's Updated Power of Attorney

Patent Owners' Motion for Pro Hac Vice Admission - Rakoczy

Patent Owners' Motion for Pro Hac Vice Admission - Salmen

Power of Attorney - Novartis Vaccines and Diagnostics, Inc.

Power of Attorney - Grifols Worldwide Operations Limited

Patent Owners' Mandatory Notices

Notice of Accord Filing Date

Petition For Inter Partes Review

Power of Attorney

U.S. Patent No. 5,688,688

U.S. Application No. 07/138,894

U.S. Application No. 08/288,336

Lodish et al., Molecular Cell Biology (3d ed. 1995)

'688 File History - 4/24/96 Rejection

'688 Reexamination - 11/2/07 Appeal Brief

U.S. Application No. 08/083,391

U.S. Application No. 07/931,191

Boshart et al., "A Very Strong Enhancer Is Located Upstream of an Immediate Early Gene of Human Cytomegalovirus," Cell 41: 521-530 (1985)

U.S. Patent No. 5,024,939

Deposition Transcript of Dr. Truett, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Opinion and Order on Claim Construction, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Regeneron's Responsive Brief on Claim Construction, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Declaration of Michael Green, M.D., Ph.D.

U.S. Patent No. 5,156,949

'688 File History - Petition for Correction of Inventorship

'688 File History - 3/27/95 Preliminary Amendment

'688 File History - 6/15/95 Non-Final Rejection

'688 File History - 10/25/95 Amendment and Response

'688 File History - 10/24/96 Amendment and Response

'688 File History - Notice of Allowance

'688 Reexamination - Third Party Request

'688 Reexamination -- Grant of Request

'688 Reexamination - 11/21/06 Rejection

'688 Reexamination - 1/22/07 Response

'688 Reexamination - Declaration of Dr. Truett

'688 Reexamination - 3/07/08 Reply Brief

'688 Reexamination - Notice of Intent to Issue

U.S. Application No. 08/107,377

Murakami et al., "Species-Specific in vitro synthesis of DNA containing the polyoma virus origin of replication," PNAS 83: 6347-6351 (1986)

Munholland et al., "Cell specificity of transcription regulation by papovavirus T antigens and DNA replication," EMBO J. 11(1): 177-184 (1992)

Spaete & Mocarski et al., "Regulation of Cytomegalovirus Gene Expression: alpha and beta Promoters Are trans Activated by Viral Functions in Permissive Human Fibroblasts," J. Virol. 56(1): 135-143 (1985)

Chapman et al., "Effect of intron A from human cytomegalovirus (Towne) immediate-early gene on heterologous expression in mammalian cells," Nucleic Acids Research 19(14):3979-3986 (1991)

Novartis's Opening Brief on Claim Construction, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Novartis's Reply Brief on Claim Construction, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Excerpts of Deposition Transcript of Dr. Calame (Claim Construction), Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Webster's Third New International Dictionary (1993)

Oxford English Dictionary (Second Edition 1989)

Webster's II New College Dictionary (1995)

Excerpts of Deposition Transcription Dr. Sodroski, Novartis Vaccines & Diagnostics, Inc. v. Biogen Idec, Inc. and Alexion Pharmaceuticals, Inc., C.A. No. 11-cv-84-SLR-MPT (D. Del.)

Affidavit of Service, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Stipulation and Partial Judgment of Noninfringement, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)

Akrigg et al., "The structure of the major immediate early gene of human cytomegalovirus strain AD169," Virus Res. 2:107-121 (1985)

Stenberg et al., "Structural Analysis of the Major Immediate Early Gene of Human Cytomegalovirus," J. Virol. 49:190-199 (1984)

Thomsen et al., "Promoter-regulatory region of the major immediate early gene of human cytomegalovirus," PNAS 81:659-663 (1984)

U.S. Patent No. 6,096,505

Second Amended Answer and Counterclaims, Novartis Vaccines and Diagnostics, Inc. v. Regeneron Pharmaceuticals, Inc., No. 18-cv-2434-DLC (S.D.N.Y.)