`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC
`Petitioner
`
`v.
`
`
`NPS PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case No. To Be Assigned
`Patent No. 7,056,886
`_____________________
`
`
`
`APPENDIX OF EXHIBITS
`
`
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`FILED
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`Declaration of Dr. Anthony Palmieri III, Ph.D., R.Ph.
`
`CV of Dr. Palmieri
`
`U.S. Patent No. 7,056,886 to Isaacs
`
`U.S. Patent Application Ser. No. 09/750,022
`
`U.S. Patent No.5,496,801 to Holthuis et al.
`
`U.S. Patent No.6,120,761 to Yamazaki et al.
`
`1007 March 8, 2002 Non Final Office Action
`
`1008
`
`1009
`
`1010
`
`1011
`
`June 10, 2002 Amendment and Reply
`
`February 5, 2003 Non Final Office Action
`
`July 9, 2003 Amendment and Reply
`
`September 16, 2003 Non Final Office Action
`
`1012 March 16, 2004 Amendment and Reply
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`June 8, 2004 Final Office Action
`
`September 7, 2004 Amendment and Reply
`
`October 4, 2004 Non Final Office Action
`
`January 4, 2005 Amendment and Reply
`
`April 4, 2005 Notice of Allowance and Fee(s) Due
`
`Kieffer & Habener, The Glucagon-Like Peptides, Endocrine
`Reviews 20(6): 876-913 (1999)
`
`Lomize et al., Thermodynamic Model of Secondary Structure
`for α-Helical Peptides and Proteins, Bioploymers 42:239
`(1997)
`
`
`
`2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1020
`
`1021
`
`Dacambra et al., Structural Determinants for Activity of
`Glucagon-like Peptide-2. Biochemistry 39:8888-8894 (July
`2000)
`
`Drucker et al., Regulation of the biological activity of
`glucagon-like peptide 2 in vivo by dipeptidyl peptidase IV,
`Nat. Biotechnol. 15(7):673-7. (July 1997)
`
`1022 Munroe et al.,Prototypic G-protein coupled receptor for the
`intestinotrophic factor glucagon –like peptide 2, Proc. Nat’l
`Acad. Sci. 96:1569 (1999)
`
`1023
`
`1024
`
`Drucker et al., Human [Gly2]GLP-2 reduces the severity of
`colonic injury in a murine model of experimental colitis, Am J.
`Physiology 276:G79 (1999)
`
`Cleland et al., Formulation and Delivery of Proteins and
`Peptides, American Chemical Society, Washington D.C.,
`Chapter 1 (1994)
`
`1025 WO 99/043361 to Knudsen
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`
`
`
`
`
`
`U.S. Patent No. 4,985,244 to Makino
`
`U.S. Patent No. 5,652,216 to Kornfelt et al.
`
`PCT Publication WO98/03547
`
`U.S. Patent No. 5,789,379 to Drucker et al.
`
`Osterberg et al., Physical state of L-histidine after freeze-
`drying and long-term storage, EP. J. of Pharm. Sci. 1999 Aug.,
`8:301-308.
`Remington, The Science and Practice of Pharmacy Vol.II, 19th
`edition, Mack Publishing Co., Easton, PA. 1995 at p 1545.
`
`3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`