Substitute Disclosure Form
`
`Information Disclosure Statement
`by Applicant
`(Use several sheets if necessary)
`
`(37 CFR §1.98(b))
`
`U.S. Department of Commerce Attorney Docket No.
`Patent and Trademark Office
`43612-0002015
`Applicant
`Teva Pharmaceuticals International GmbH
`I Group Art Unit
`Filing Date
`May 5, 2017
`1647
`
`Sheet _l_ of _3_
`I Application No.
`15/588,490
`
`Examiner
`Initial
`
`Desig.
`ID
`
`Document
`Number
`
`U.S. Patent Documents
`Publication
`Date
`
`Patentee
`
`Class Subclass
`
`Filing Date
`If Appropriate
`
`Examiner
`Initial
`
`Foreign Patent Documents or Published Foreign Patent Applications
`Translation
`Desig.
`Publication
`Country or
`ID
`Date
`Patent Office Class Subclass
`Yes
`No
`12/15/2011 WIPO
`1.
`
`Document Number
`WO 2011/156324 Al
`
`Examiner
`Initial
`
`Other Documents (include Author, Title, Date, and Place of Publication)
`Desig.
`ID
`
`Document
`Ashina, "Calcitonin Gene-Related Peptide in Tension-Type Headache," The Scientific World
`2:1527-1531, 2002
`Boyce and Hill, "Substance P (NK.l) Receptor Antagonists - Analgesics or Not?" Handbook of
`Experimental Pharmacology Stress, Immunology and Behaviour
`Brown and Morice, "Clinical Pharmacology of Vasodilator Peptides," Jornal of Cardiovascular
`Pharmacology lO(Suppl. 12):S82-S87, 1987
`Cumberbatch et al., "Dural vasodilation causes a sensitization of rat caudal trigeminal neurones in
`vivo that is blocked by a 5-HTlB/lD agonist," British Journal of Pharmacology 126:1478-1486,
`1999
`Declaration of Dr. Stephen D. Silberstein (with Annex A)
`Dennis et al., "Structure-Activity Profile of Calcitonin Gene-Related Peptide in Peripheral and Brain
`Tissues. Evidence for Receptor Multiplicity," The Journal of Pharmacology and Experimental
`Therapeutics 251(2):718-725, 1989
`Di Angelantonio et al., "A Novel Class of Peptides with Facilitating Action on Neuronal Nicotinic
`Receptors of Rat Chromaffin Cells in Vitro: Functional and Molecular Dynamic Studies," Molecular
`Pharmacology 61(1):43-54, 2002
`Edvinsson et al. "Characterisation of the effects of a non-peptide CGRP receptor antagonist in SK-
`N-MC cells and isolated human cerebral arteries," European Journal of Pharmacology 415:39-44,
`2001
`Ferro et al., "A comparison of the contractile effects of 5-hydroxytryptamine, sumatriptan and MK-
`462 on human coronarv artery in vitro," Br J Clin Pharmacol 40:245-251, 1995
`Gardiner et al., "Haemodynamic effects of human a-calcitonin gene-related peptide following
`administration of endothelin-1- or NG-nitro-L-arginine methyl ester in conscious rats," Br J
`Pharmacol 103:1256-1262, 1991
`Gardiner et al., "Regional haemodynamic effects of human a- and ~-calcitonin gene-related peptide
`in conscious Wistarrats," Br JPharmacol 98:1225-1232, 1989
`Gardiner et al., "Regional hemodynamic effects of calcitonin gene-related peptide," Am J Physiol
`256(25):R332-R338, 1989
`Hay et al., "CGRP modulation by RAMPS," Pharmacology and Therapeutics 109:173-197, 2006
`
`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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`8.
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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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`Examiner Signature
`
`Date Considered
`
`EXAMINER: Initials citation considered. Draw line through citation if not in conformance and not considered. Include copy of this form with
`next communication to applicant.
`
`Substitute Disclosure Form
`
`

`

`Substitute Disclosure Form
`
`Information Disclosure Statement
`by Applicant
`(Use several sheets if necessary)
`
`(37 CFR §1.98(b))
`
`U.S. Department of Commerce Attorney Docket No.
`Patent and Trademark Office
`43612-0002015
`Applicant
`Teva Pharmaceuticals International GmbH
`I Group Art Unit
`Filing Date
`1647
`May 5, 2017
`
`Sheet _l__ of _3_
`I Application No.
`15/588,490
`
`Other Documents (include Author, Title, Date, and Place of Publication)
`Examiner Desig.
`ID
`Initial
`
`Document
`Hay et al., "International Union of Pharmacology. LXIX. Status of the Calcitonin Gene-Related
`Peptide Subtype 2 Receptor," Pharmacological Reviews 60(2):143-145, 2008
`Haydon and Carmignoto, "Astrocyte Control of Synaptic Transmission and Neurovascular
`Coupling," Physiol Rev 86: 1009-1031, 2006
`Hill, "NK.l (substance P) receptor antagonists - why are they not analgesic in humans?," TiPS
`21:244-246, July 2000
`Hoare, "Mechanisms of peptide and nonpeptide ligand binding to Class B G-protein-coupled
`receptors," Drug Discovery Today 10(6):417-427, March 2005
`Hoelig et al., "A novel CGRP-neutralizing Spiegelmer attenauates neurogenic plasma protein
`extravasation," British Journal of Pharmacology 172:3086-3098, 2015
`Lipton et al., "The role of headache-related disability in migraine management," Neurology 56(Supp
`l):S35-S42, 2001
`Longmore et al., "5-HTlD receptor agonists and human coronary artery reactivity in vitro" crossover
`comparisons of 5-HT and sumatriptan with rizatriptan and L-741,519," Br J Clin Pharmacol 42:431-
`441, 1996
`Longmore et al., "Comparison of the vasoconstrictor effects of the selective 5-HTlD-receptor
`agonist L-775,606 with mixed 5-HTlB/lD-receptor agonist sumatritan and 5-HT in human isolated
`coronary artery," J Clin Pharmacol 49:126-131, 2000
`McCulloch et al., "Calcitonin gene-related peptide: Functional role in cerebrovascular regulation,"
`Proc Natl Acad Sci USA 83:5731-5735, August 1986
`Morara et al., "Calcitonin Gene-Related Peptide Receptor Expression in the Neurons and Glia of
`Developing Rat Cerebellum: An Autoradiographic and Immunohistochemical Analysis,"
`Neuroscience 100(2):381-391, 2000
`O'Connell et al., "On the role of the C-terminus of a-calcitonin-gene-related peptide (aCGRP) The
`Structure of des-phenylalaninamide37-aCGRP and its interaction with the CGRP receptor," Biochem
`J 291:205-210, 1993
`Poyner et al., "Calcitonin gene-related peptide: multiple actions, multiple receptors," Pharmac Ther
`56:23-51, 1992
`Ramadan and Buchanan, "New and future migraine therapy," Pharmacology and Therapeutics
`112:199-212, 2006
`Reuter, "Anti-CGRP antibodies: a new approach to migraine prevention," The Lancet 13(9):857-
`859,September2014
`Sandor, "Nervous control of the cerebrovascular system: doubt and facts," Neurochemistry
`International 35:237-259, 1999
`Schueren et al., "Reproducibility of the capsaicin-induced dermal blood flow response as assessed
`by laser Doppler perfusion imaging," Br J Clin Pharmacol 64(5):580-590, 2007
`Seon et al., "Isolation, Structure, Synthesis, and Activity of a New Member of the Calcitonin Gene-
`related Peptide Family from Frog Skin and Molecular Cloning of Its Precursor," The Journal of
`Biological Chemistry 275(8):5934-5940, 2000
`Shawket et al., "Prolonged effect of CGRP in Raynaud's patients: a double-blind randomised
`comparison with prostacyclin," Br J Clin Pharmac 32:209-213, 1991
`
`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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`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.
`
`Examiner Signature
`
`Date Considered
`
`EXAMINER: Initials citation considered. Draw line through citation if not in conformance and not considered. Include copy of this form with
`next communication to applicant.
`
`Substitute Disclosure Form
`
`

`

`Substitute Disclosure Form
`
`Information Disclosure Statement
`by Applicant
`(Use several sheets if necessary)
`
`(37 CFR §1.98(b))
`
`U.S. Department of Commerce Attorney Docket No.
`Patent and Trademark Office
`43612-0002015
`Applicant
`Teva Pharmaceuticals International GmbH
`I Group Art Unit
`Filing Date
`1647
`May 5, 2017
`
`Sheet _3_ of _3_
`I Application No.
`15/588,490
`
`Other Documents (include Author, Title, Date, and Place of Publication)
`Examiner Desig.
`ID
`Initial
`
`Document
`Shawket et al., "Selective Suprasensitivity to Calcitonin-Gene-Related Peptide in the Hands in
`Raynaud's Phenomenon," The Lancet 1354-1385, December 9, 1989
`Smith et al., "An immunocytochemical investigation of human trigeminal nucleus caudalis: CGRP,
`substance P and 5-HTlD-receptor immunoreactivities are expressed by trigeminal sensory fibres,"
`Cephalalgia 22:242-432, 2002
`Sternini, "Enteric and Visceral Afferent CGRP Neurons, Targets of Innervation and Differential
`Expression Patterns," Annals New York Academy of Sciences 170-185, 1992
`Struthers et al., "Human calcitonin gene related peptide: a potent endogenous vasodilator in man,"
`Clinical Science 70:389-393, 1986
`Swillens, "Interpretation of Binding Curves Obtained with High Receptor Concentrations: Practical
`Aid for Computer Analysis," Molecular Pharmacology 47:1197-1203, 1995
`Troltzsch et al., "The calcitonin gene-related peptide (CGRP) receptor antagonist BIBN4096BS
`reduces neurogenic increases in dural blood flow," European Journal of Pharmacology 562: 103-110,
`2007
`Wimalawansa et al., "Isolation, Purification, and Characterization of Calcitonin Gene-Related
`Peptide Receptor," Peptides 14:691-699, 1993
`Wimalawansa, "Cacitonin Gene-Related Peptide and Its Receptors: Molecular Genetics, Physiology,
`Pathophysiology, and Therapeutic Potentials," Endocrine Reviews 17(5):553-585, October 1996
`Wisskitchen et al., "Bioactive ~-bend structures for the antagonist ha CGRP s-37 at the CGRP1
`receptor of the rat pulmonary artery," British Journal of Pharmacology 129: 1049-1055, 2000
`
`33.
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`34.
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`35.
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`36.
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`37.
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`38.
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`39.
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`40.
`
`41.
`
`Examiner Signature
`
`Date Considered
`
`EXAMINER: Initials citation considered. Draw line through citation if not in conformance and not considered. Include copy of this form with
`next communication to applicant.
`
`Substitute Disclosure Form
`
`