throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner v.
`
`ICOS CORPORATION,
`Patent Owner
`
`U.S. Patent No. 6,943,166 B1
`Inter Partes Review No. IPR2017-01762
`
`DECLARATION OF DR. JACKIE CORBIN, PH.D.
`
`-1-
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`ARGENTUM EX1038
`
`Page 1
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`

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`I, Jackie Corbin, do declare as follows:
`
`1.
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`I am over the age of eighteen (18) and otherwise competent to make this
`
`declaration.
`
`2.
`
`My name is Jackie Corbin. I am currently a Professor Emeritus of
`
`Molecular Physiology and Biophysics at the Vanderbilt University Medical Center’s
`
`Ingram Cancer Center. I understand that my declaration is being submitted in
`
`connection with a Petition for Inter Partes Review of U.S. Patent No. 6,943,166 (the
`
`“’166 patent”) (Ex. 1001).
`
`3.
`
`I received a B.S. in Biology from Tennessee Polytechnic Institute in
`
`Cookeville, Tennessee in 1963 and a Ph.D. in Physiology from Vanderbilt University
`
`in Nashville, Tennessee in 1968. I completed my postdoctoral training at the
`
`University of California, Davis in 1971.
`
`4.
`
`I have extensive experience in the field of pharmacology, physiology,
`
`and enzymology, including the uses of cyclic nucleotides, phosphodiesterases, and
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`phosphodiesterase inhibitors.
`
`5.
`
`A more complete recitation of my professional experience including a
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`list of my journal publications, patents, conference proceedings, book authorship, and
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`committee memberships may be found in my Curriculum Vitae and Publication List,
`
`which are attached to my declaration as Appendix A.
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`6.
`
`I have been retained in this matter by Argentum Pharmaceuticals LLC
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`(“Petitioner”) as a technical expert to provide analysis and opinions regarding the
`
`’166 patent. I am being compensated for my work in this matter at my usual and
`
`customary rate of $650 per hour. I have no personal or financial stake or interest in
`
`the outcome of the Petition for Inter Partes Review or any related action. My
`
`compensation in no way depends upon my testimony or the outcome of the Petition
`
`for Inter Partes Review.
`
`7.
`
`I have been advised that Laurence & Phillips IP Law LLP represents
`
`Argentum Pharmaceuticals LLC (collectively, “Argentum” or “Petitioner”) in this
`
`matter and that ICOS Corporation (“Patent Owner”) owns the ’166 patent. I have no
`
`personal or financial stake or interest in Argentum, ICOS Corporation, or the ’166
`
`patent.
`
`8.
`
`I understand that the ’166 patent is currently subject to a previous IPR,
`
`Mylan Pharmaceuticals Inc. v. ICOS Corporation, IPR2017-00323 (“Mylan IPR”).
`
`I understand that the Mylan IPR has been instituted as of June 12, 2017 and that
`
`Petitioner Argentum seeks to become a party to the Mylan IPR.
`
`9.
`
`In the context of my retention, I have reviewed the Declarations of Dr.
`
`George Grass, Pharm.D., Ph.D. and Dr. Muta M. Issa, M.D., M.B.A. IPR2017-00323,
`
`Exs. 1002, 1004. Upon careful review and analysis of the two declarations, I agree
`
`
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`Page 3
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`with their findings and conclusions in full and hereby incorporate those findings and
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`\
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`conclusions.
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`10.
`
`I hereby declare that all statements made herein of my own knowledge
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`are true and that all statements made on information and belief are, to the best of my
`
`knowledge, believed to be true; and further that these statements are made with the
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`knowledge that willful false statements and the like so made are punishable by fine
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`or imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
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`
`
`Dated: July 12, 2017
`
`Dr. Jackie Corbin, Ph.D.
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`
`
`APPENDIX A
`
`
`CURRICULUM VITAE
`
`Jackie D. Corbin
`
`Personal Data
`
`Birthdate: February 8, 1941
`Citizenship Status: United States of America
`Office Address: Department of Molecular Physiology and Biophysics
` 766 Medical Research Building
` Vanderbilt University School of Medicine
` Nashville, TN 37232-0615 USA
` (615) 322-4384
`
`Educational Background
`
`1963 B.S. Tennessee Polytechnic Institute, Cookeville, Tennessee
`1968 Ph.D. Vanderbilt University, Nashville, TN (Advisor: Dr. C.R. Park)
`1971 Postdoctoral University of California, Davis, CA (Advisor: Dr. E.G. Krebs)
`
`Professional Experience and Positions Held
`
`2012-present Professor Emeritus, Dept. of Molecular Physiology & Biophysics,
`Vanderbilt University School of Medicine, Nashville, TN
`
`Professor, Dept. of Molecular Physiology & Biophysics,
`1980-2012
`Vanderbilt University School of Medicine, Nashville, TN
`
`1975-1980
`
`1971-1975
`
`Associate Professor, Dept of Molecular Physiology & Biophysics, Vanderbilt
`University School of Medicine, Nashville, TN
`
`Assistant Professor, Dept. of Molecular Physiology & Biophysics, Vanderbilt
`University School of Medicine, Nashville, TN
`
`Jan-Jul 1978 Visiting Scientist, Department of Clinical Biochemistry,
`University of Otago, Dunedin, New Zealand. Studies of insulin action on
`phosphodiesterase in collaboration with Drs. Loten and J.G.T. Sneyd.
`
`July 1972-
`Sept. 1989
`
`Investigator, Howard Hughes Medical Institute,
`Dept. of Physiology, Vanderbilt University, Nashville, TN
`
`USPHS Predoctoral Trainee and ADA Research Awardee, Department of
`Biological Chemistry, University of California
`
`Sept. 1963-
`Oct. 1968
`
`Ph.D. Thesis Research, Department of Physiology,
`Vanderbilt University, Nashville, TN
`
`
`
`-5-
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`
`
`A.
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`B.
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`C.
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`1968-1971
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`Board Memberships
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`Page 5
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`Editorial Board, Molecular and Cellular
`
`Editorial Board, The Journal of Biological
`
`June 1977-Jan. 1983
`Chemistry
`Jan. 1979-Dec. 1983
`Endocrinology
`June 1984-June 1990 Editorial Board, Journal of Cyclic Nucleotide and
`Phosphoprotein Research
`1989-1995
`
`Editorial Advisory Board, Biochemistry
`1991-1996
`
`Editorial Board, The Journal of Biological
`Chemistry
`
`
`
`
`
`
`
`
`
`
`
`National Service
`
`
`
`
`
`
`
`
`1984 Chairman, Gordon Research Conference on Cyclic Nucleotides
`1991 Chairman, FASEB Summer Research Conference "Protein Kinases"
`1987 Organizer, HHMI Workshop on cGMP Action
`1989 Organizer, HHMI Workshop on cAMP-Dependent Protein Kinase
`1995 Chairman, Ninth International Conference on Second Messengers and
`
`Phosphoproteins
`1998 Chairman, Gordon Research Conference on Cyclic Nucleotide
`Phosphodiesterases
`
`
`Service on Study Sections and Site Visitations
`
`
`
`
`
`
`
`
`
`D.
`
`March 1974
`
`Tennessee Heart Association Study Section (3 years)
`American Cancer Society Study Section (ad hoc)
`NIH Study Section, Metabolism (ad hoc)
`NIH Study Section, Biochemistry (ad hoc)
`NIH Intramural Site Visit
`Howard Hughes Medical Institute Graduate Student Evaluation Panel
`
`Honors or Awards
`
`
`May 1972-present
`
`
`July 1971-July 1972
`
`
`October 1968-July 1971
`
`
`1994
`
`1971-1976
`
`2002
`
`
`
`Diabetes-Endocrinology Center Grant Awardee, Department of
`Physiology, Vanderbilt University, Nashville, TN.
`
`NIH Research Grant Awardee, Department of Physiology, Vanderbilt
`University, Nashville, TN.
`
`American Diabetes Association Research and Development Awardee,
`Department of Physiology, Vanderbilt University, Nashville, TN.
`
`Postdoctoral Fellow of the NIH (Advisor: Dr. E.G. Krebs) and American
`Diabetes Association Research and Development Awardee, Department of
`Biological Chemistry, University of California, Davis, CA.
`
`Wellcome Visiting Professor (Univ. of North Dakota)
`
`Glaxo Cardiovascular Discovery Grant Awardee
`
`John H. Exton Award for Outstanding Contribution to Research
`
`
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`-6-
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`Page 6
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`2009
`
`Teaching
`
`Alumnus of the Year (Arts and Sciences)
`
`
`
`Tennessee Tech University
`
`
`E.
`
` i. Graduate Students Supervised
`1986
` Charles Cobb, Ph.D.
`1988
` Lynn Wolfe, Ph.D.
`1989
` Melissa Thomas, Ph.D.
`1992
` Hang Jiang, Ph.D.
`1994
` Linda McAllister, Ph.D.
`1996
` Celeste Poteet, Ph.D.
`1996
` Jeff Smith, Ph.D.
`1996
` Robin Reed, Ph.D.
`1994
` Der-Ming Chu
`1994
` Michelle Fosler
`1994
` Tamara Haik
`1995
` Rene Combs
`2003
` Robin Richey-Janetta
`2002
` Jenny Busch
`1997
` Wendall Lu
` Mitsi Blount 2006
` Emmanuel Bessay 2006
` James Weeks 2007
` ii. Postdoctoral Fellows Supervised
` S. Keely
` P. Sugden
` D. Flockhart
` T. Lincoln
` S. Rannels
` A. Robinson-Steiner
` V. Sheorain
` S. Beebe
` T. Gettys
` S. Cordle
` T. Woodford
` A. Robichon
` J. Shabb
` J. Atkinson
` R. Sekhar
` F. Burns
` T. Wyatt
` L. Turko
` V. Gopal
` R. Zoraghi
` G. Morris
`
` iii. Graduate Thesis Committees
` Served on ~ 30 committees
`
`Two medical students are mentored in this lab each year in the Research Component of the first-year
`curriculum (two days per week for three months). At least one medical student is mentored for three
`
`
`-7-
`
`1972-75
`1973-75
`1976-79
`1976-79
`1978-83
`1981-83
`1985-86
`1982-87
`1985-87
`1986-88
`1986-89
`1987-89
`1988-92
`1989-93
`1990-95
`1992-94
`1992-95
`1994-99
`1999-2000
`2002-05
`
`2005-08
`
`
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`Page 7
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`# Hours Topic
`
`6 per year
`1 per year
`1 per year
`1 per year
`2 per year
`
`
`1 per year
`2 per year
`
`
`1 per year
`
`
`
`Cardiac Physiology (Medical Physiology)
`Exercise Physiology (Medical Physiology)
`Cell Signaling (Medical Physiology)
`Altitude/diving (Medical Physiology)
`Molecular Endocrinology (protein phosphorylation,
`phosphodieterases)
`Insulin Secretion and Action, Diabetes
`Signal Transduction (Meharry Graduate
`Biochemistry)
`Vascular Biology
`
`summer months (five days per week).
`
` iv. Lectures
`
` Year
`
`1972-2004
`1985-2004
`
`
`1985-1995
`
`1986-1987
`1988-1990
`
`1995-present
`
` v. Visiting Professorships or Participation in Special Courses
`
`Otago University, Department of Clinical Biochemistry (New Zealand)
`February-July 1978
`May-June 1986 University of Bergen-Anatomy Institute (Norway)
`
`
`Publications
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`
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`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`Corbin JD. The role of adenosine 3',5'-monophosphate in adipose tissue metabolism. Ph.D.
`Thesis, Vanderbilt University, 1968
`
`Sneyd JGT, Corbin JD, and Park CR. The role of cyclic AMP in the actions of insulin.
`Presented at the International Symposium on the Pharmacology of Hormonal Polypeptides and
`Proteins, Milan. In: Pharmacology of Hormonal Polypeptides and Proteins 367-376, 1968
`
`Corbin JD and Krebs EG. A cyclic AMP-stimulated protein kinase in adipose tissue.
`Biochem Biophys Res Comm 36, 328-336 1969
`
`Krebs EG, Walsh DH, Reimann EM, Brostrom MA, Corbin JD, Hickenbottom JP, and
`Soderling TR. Cyclic AMP as a regulatory agent in carbohydrate and lipid metabolism. In:
`Fogarty International Proceedings 4, 127-136, 1969
`
`Park CR, Sneyd JGT, Corbin JD, Jefferson LA, and Exton JH. Role of cyclic adenylate in the
`actions of insulin. In: Proceedings of the Sixth Congress of the International Diabetes
`Federation. Stockholm: Excerpta Medica Foundation, Diabetes 5-15, 1969
`
`Corbin JD, Reimann EM, Walsh DA, and Krebs EG. Activation of adipose tissue lipase by
`skeletal muscle cyclic adenosine 3',5'- monophosphate-stimulated protein kinase. J Biol Chem
`245, 4849- 4851, 1970
`
`Walsh DA, Krebs EG, Reimann E, Brostrom M, Corbin JD, Hickenbottom JP, Soderling TR,
`and Perkins JP. The receptor protein for cyclic AMP in the control of glycogenolysis. In: Role
`of cyclic AMP in cell functions: Eds. P. Greengard and E. Costa. Advances in Biochemical
`Psychopharmacology 3, 265-285, 1970
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`8. Brostrom CO, Corbin JD, King CA, and Krebs EG. Interaction of the subunits of
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`adenosine 3',5'-monophosphate-dependent protein kinase of muscle. Proc Natl Acad Sci USA 68,
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`2444-2447, 1971
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`9.
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`10.
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`11.
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`12.
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`13.
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`14.
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`15.
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`16
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`17.
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`18.
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`19.
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`20.
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`21.
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`Reimann EM, Brostrom CO, Corbin JD, King CA, and Krebs EG. Separation of regulatory and
`catalytic subunits of the cyclic 3',5'-adenosine monophosphate-dependent protein kinase(s) of
`rabbit skeletal muscle. Biochem Biophys Res Comm 42, 187-194, 1971
`
`Corbin JD, Brostrom CO, Alexander RL, and Krebs EG. Adenosine 3',5'-monophosphate-
`dependent protein kinase from adipose tissue. J Biol Chem 247, 3736-3743, 1972
`
`Corbin JD, Brostrom CO, King CA, and Krebs EG. Studies on the adenosine, 3',5'-
`monophosphate-dependent protein kinases of rabbit skeletal muscle. J Biol Chem 247, 7790-
`7798, 1972
`
`Corbin JD, Soderling TR, and Park CR. Regulation of adenosine 3',5'-monophosphate-
`dependent protein kinase (I). J Biol Chem 248, 1813-1821, 1972
`
`Exton JH, Friedmann N, Wong EH, Brineaux JP, Corbin JD, and Park CR. Interaction of
`glucocorticoids with glucagon and epinephrine in the control of gluconeogenesis and
`glycogenolysis in liver and of lipolysis in adipose tissue. J Biol Chem 247, 3579-3588, 1972
`
`Soderling TR, Corbin JD, and Park CR. Regulation of adenosine 3',5'-monophosphate-
`dependent protein kinase (II). J Biol Chem 248, 1822-1829, 1972
`
`Walsh DA, Brostrom MA, Brostrom L, Chen L, Corbin JD, Reimann E, Soderling TR, and
`Krebs G. Cyclic AMP-dependent protein kinases from skeletal muscle and liver. Adv Cyclic
`Nucleotide Res 1, 33-45, 1972
`
`Corbin JD and Reimann ER. Assay of cyclic AMP-dependent protein kinases. Methods
`Enzymol 38, 287-290, 1974
`
`Means AR, MacDougall E, Soderling T, and Corbin JD. Testicular adenosine 3',5'-
`monophosphate-dependent protein kinase. J Biol Chem 249, 1231-1238, 1974
`
`Soderling TR, Corbin JD, and Park CR. Techniques for the study of protein kinase activation
`in intact cells. Methods Enzymol 38, 358-367, 1974
`
`Corbin JD, Keely SL, and Park CR. Distribution and dissociation of adenosine 3',5'-
`monophosphate-dependent protein kinases in adipose cardiac and other tissues. J Biol Chem
`250, 218-225, 1975
`
`Corbin JD, Keely SR, Soderling TR, and Park CR. Hormonal regulation of adenosine 3',5'-
`monophosphate-dependent protein kinase. Adv in Cyclic Nucleotide Res 5, 265-279, 1975
`
`Keely SL, Corbin JD, and Park CR. Regulation of adenosine 3',5'-monophosphate-dependent
`protein kinase: Regulation of the heart enzyme by epinephrine, glucagon, insulin and 1-
`methyl-3-isobutylxathine. J Biol Chem 250, 4832-4840, 1975
`
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`22.
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`23.
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`24.
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`25.
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`26.
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`27.
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`28.
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`29.
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`30.
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`31.
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`32.
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`33.
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`34.
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`35.
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`36.
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`Keely SL, Corbin JD, and Park CR. On the question of trans- location of heart cyclic AMP-
`dependent protein kinase. Proc Natl Acad Sci USA 72, 1501-1504, 1975
`
`Corbin JD, Soderling TR, Sugden PH, Keely SL, and Park CR. Control of metabolic processes
`by cAMP-dependent protein phosphorylation. In: Eukaryotic Cell Function and Growth. Eds.
`Dumont, JE, Brown, B, and Marshall, NJ, pp. 231-247, Plenum Press, London, 1976
`
`Cherrington AD, Assimacopoulos FD, Harper SC, Corbin JD, Park CR, and Exton JH. Studies
`on the alpga-adrenergic activation of hepatic glucose output. Investigation of the roles of
`adenosine 3',5'- monophosphate and adenosine 3',5'-monophosphate-dependent protein kinase
`in the actions of phenylephrine in isolated hepatocytes. J Biol Chem 251, 5209-5218, 1976
`
`Lincoln TM, Hall CL, Park CR, and Corbin JD. Guanosine 3',5'-cyclic monophosphate binding
`proteins in rat tissues. Proc Natl Acad Sci USA 73, 2559-2563, 1976
`
`Sugden PH, Holladay LA, Reimann EM, and Corbin JD. Purification and characterization of
`the catalytic subunit of adenosine 3',5' cyclic monophosphate-dependent protein kinase from
`bovine liver. Biochem J 159, 409-422, 1976
`
`Sugden PH and Corbin JD. Adenosine 3',5'-cyclic monophosphate-binding proteins in bovine
`and rat tissue. Biochem J 159, 423-437, 1976
`
`Corbin J and Keely SL. Characterization and regulation of heart adenosine 3',5'-
`monophosphate-dependent protein kinase isozymes. J Biol Chem 252, 910-918, 1977
`
`Corbin JD, Sugden PH, Lincoln TM, and Keely SL. Compartmentalization of adenosine 3',5'-
`monophosphate-dependent protein kinase in heart tissue. J Biol Chem 252, 3854-3861, 1977
`
`Lincoln TM, Dills WL, and Corbin JD. Purification and subunit composition of guanosine
`3':5'-monophosphate-dependent protein kinase from bovine lung. J Biol Chem 252, 4269-
`4275, 1977
`
`Lincoln T and Corbin JD. Adenosine 3',5'-monophosphate-dependent protein kinases:
`Possible homologous proteins. Proc Natl Acad Sci USA 74, 3239-3243, 1977
`
`Riou JP, Claus TJ, Flockhart DA, Corbin JD, and Pilkis SJ. In vivo and in vitro
`phosphorylation of rat liver fructose 1-6 diphosphatase. Proc Natl Acad Sci USA 74, 4615-
`4619, 1977
`
`Keely SL and Corbin JD. Involvement of cAMP-dependent protein kinase in the regulation of
`heart contractile force. Am J Physiol 233, H269-H275, 1977
`
`Keely SL, Corbin JD, and Lincoln TM. Alpha adrenergic involvement in heart metabolism:
`Effects on adenosine cyclic 3',5'- monosphosphate, adenosine cyclic 3',5'-monophosphate-
`dependent protein kinase, guanosine 3',5'-monophosphate, and glucose transport. Mol Pharm
`13, 965-975, 1977
`
`Corbin JD and Lincoln TM. Comparison of cAMP- and cGMP- dependent protein kinases.
`Adv Cyclic Nucleotide Res 9, 159-170, 1978
`
`Corbin JD, Sugden PH, West L, Flockhart DA, Lincoln TM, and McCarthy D. Studies on the
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`37.
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`38.
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`39.
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`40.
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`41.
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`42.
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`43.
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`44.
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`45.
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`46.
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`47.
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`48.
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`49.
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`50.
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`51
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`properties and mode of action of the purified regulatory subunit of bovine heart adenosine
`3',5'-monophosphate-dependent protein kinase. J Biol Chem 253, 3997-4003, 1978
`
`Keely SL, Lincoln TM, and Corbin JD. Interaction of acetylcholine and epinephrine on heart
`cyclic AMP-dependent protein kinase. Am J Physiol 234(4), H432-H438, 1978
`
`Lincoln TM and Corbin, JD. Purified cyclic GMP-dependent protein kinase catalyzes the
`phosphorylation of cardiac tropinin inhibitory subunit (TN-I). J Biol Chem 253, 337-339,
`1978
`
`Lincoln TM and Corbin, JD. On the role of the cAMP- and cGMP-dependent protein kinases
`in cell function. J Cyclic Nucleotide Res 4, 3-14, 1978
`
`Lincoln TM, Flockhart DA, and Corbin JD. Studies on the structure and mechanism of
`activation of cGMP-dependent protein kinase. J Biol Chem 253, 6002-6009, 1978
`
`Dills WL, Goodwin CD, Lincoln TM, Beavo JA, Bechtel PJ, Corbin JD, and Krebs EG.
`Purification of cyclic nucleotide receptor proteins by cyclic nucleotide affinity
`chromatography. Adv Cyclic Nucleotide Res 10, 199-217, 1979
`
`Rannels SR and Corbin JD. Characterization of small cAMP- binding fragments of cAMP-
`dependent protein kinase. J Biol Chem 254, 8605-8610, 1979
`
`Corbin JD and Rannels SR. Studies of functional domains of the regulatory subunit from
`cAMP-dependent protein kinase isozyme I. J of Cyclic Nuc Res 6, 201-215, 1980
`
`Flockhart DA, Watterson DM, and Corbin JD. Studies on functional domains of the regulatory
`subunit of bovine heart adenosine 3',5'-monophosphate-dependent protein kinase. J Biol Chem
`255, 4435-4440, 1980
`
`Francis SH, Lincoln TM, and Corbin JD. Characterization of a novel cGMP binding protein
`from lung. J Biol Chem 255, 620-626, 1980
`
`Loten EG, Francis SH, and Corbin JD. Proteolytic solubilization and modification of hormone-
`sensitive cyclic nucleotide phosphodiesterase. J Biol Chem 255, 7838-7844, 1980
`
`Rannels SR and Corbin, JD. Two different intrachain cAMP binding sites of cAMP-dependent
`protein kinases. J Biol Chem 255, 7085- 7088, 1980
`
`Corbin JD and Rannels SR. Studies on the function of the two intrachain cAMP binding sites
`of protein kinase. J Biol Chem 256, 7871- 7876, 1981
`
`Corbin JD, Rannels SR, Flockhart DA, Robinson AM, and Atkins PD. Cyclic nucleotide-
`binding sites of protein kinases. In Cold Spring Harbor Conferences on Cell Proliferation,
`Vol. 8, Protein Phosphorylation. (Eds. O.M. Rosen and E.G. Krebs) p. 45-53. Cold Spring
`Harbor Laboratory, 1981
`
`Corbin JD and Rannels SR. Perturbation and structural organization of the two intrachain
`cAMP binding sites of cAMP-dependent protein kinase II. J Biol Chem 256, 11671-11676,
`1981
`
`Corbin JD, Rannels SR, Flockhart DA, Robinson-Steiner AM, Tigani MC, Doskeland SO,
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`53.
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`56.
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`59.
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`60.
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`61.
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`62.
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`63.
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