Allgenesis Biotherapeutics Inc. vs Cloudbreak Therapeutics, LLC

Other: Fed Circuit mandate

Other: other court decision

Petitioner Notice of Appeal

Final Written Decision: original

Other: Hearing transcript

Other: ORDER Oral Hearing 37 C.F.R. § 42.70

Patent Owner's Sur-Reply

Petitioner Request For Oral Argument

Patent Owner's Request for Oral Argument

Exhibit 3002

Joint Stipulation to Modify Due Date 3

Petitioner Reply to Patent Owner Response to Petition

Consultancy Agreement between Allgenesis and Dr. Thomas Hohman, dated February 24, 2016

Deposition of Dr. Thomas Hohman, held August 13, 2021

Second Declaration of Dr. Thomas Malone, dated September 2, 2021

Richard D. Hall, et al., Angiogenesis inhibition as a therapeutic strategy in non-small cell lung cancer (NSCLC), 4(5) Transl. Lung Cancer Res. 515-523 (2015)

Niranjan Awasthi, et al., Antitumour activity of sunitinib in combination with gemcitabine in experimental pancreatic cancer, 13 HPB 597-604 (2011)

Bercin Kutluk Cenik, et al., BIBF 1120 (Nintedanib), a Triple Angiokinase Inhibitor, Induces Hyopxia but not EMT and Blocks Progression of Preclinical Models of Lung and Pancreatic Cancer, 12(6) Molecular Cancer Therapeutics 992-1001 (2013)

Nick Di Girolamo, et al., Pathogenesis of pterygia: role of cytokines, growth factors, and matrix metalloproteinases, 23 Progress in Retinal and Eye Research 195-228 (2004)

Minas T. Coroneo, et al., Chapter 18: Pterygium, Diseases of the Ocular Surface, pp. 125-144 (2013)

Jeanie Chui, et al., The Pathogenesis of Pterygium: Current Concepts and Their Therapeutic Implications, 6(1) The Ocular Surface 24-43 (2008)

JK Lee, et al., Endothelial progenitor cells in pterygium pathogenesis, 21 Eye 1186-1193 (2007)

Ahmed M. Abu El-Asrar, et al., Expression of stem cell factor/c-kit signaling pathway components in diabetic fibrovascular epiretinal membranes, 16 Molecular Vision 1098-1107 (2010)

S. Casey Laizure, et al., The role of human carboxylesterases in drug metabolism: have we overlooked their importance, 33(2) Pharmacotherapy 210-222 (2013)

Xiaodong Liu, et al., The Conduct of Drug Metabolism Studies Considered Good Practice (I): Analytical Systems and In Vivo Studies, 8(8) Curr. Drug Metab. 815-821 (2007)

OFEV�� (Nintedanib), Pharmacology Review(s), Center for Drug Evaluation and Research, FDA, Sept. 22, 2014, available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205832Orig1s000PharmR.pdf

SUTENT�� (Sunitinib), Pharmacology Review(s), Center for Drug Evaluation and Research, FDA, Jan. 20, 2006, available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/ 021938_S000_Sutent_PharmR.pdf

VARGATEF�� (nintedanib) European Medicines Agency (EMA) CHMP Assessment Report, dated Sept. 25, 2014, available at https://www.ema.europa.eu/en/documents/assessmentreport/ vargatef-epar-public-assessment-report_en.pdf

Joint Stipulation to Modify Due Dates 2-3

Petitioner���s Notice of Deposition of Dr. Thomas Hohman

Joint Stipulation to Modify Due Dates 2-3

Granting Petitioner's Motion for Withdrawal of Counsel 37 C.F.R. § 42.10

Petitioner's Unopposed Motion to Withdraw Back-up Counsel

Petitioner's Updated Mandatory Notices

Petitioner Objections to Evidence

Order Modifying Scheduling Order

Ex. 3001

Patent Owner's Response

Declaration of Dr. Thomas Hohman

Cholkar Novel strategies for anterior segment ocular drug delivery

Morrison Advances in ophthalmic drug delivery

Varela-Fernandez Drug Delivery to the Posterior Segment of the Eye

Deposition Transcript of Dr. Thomas Malone

Statutory Disclaimer Filed May 21, 2021

Singh Retina, The Journal of Retinal and Vitreous Diseases

Csaky et al Opthamol.

Center For Drug Evaluation and Research Approval Package for SUTENTtm

European Medicines Agency Assessment Report-Nintedanib

Joint Stipulation to Modify Due Dates 1-3

Patent Owner's Updated Notice of Deposition of Dr. Thomas Malone

Patent Owner's Notice of Deposition of Dr. Thomas Malone

Petitioner's Objections to Evidence

Granting Institution of Inter Partes Review 35 U.S.C. sec 314

SCHEDULING ORDER

Proceeding History for US Application No. 16/210,896 Part 1

Proceeding History for US Application No. 16/210,896 Part 2

Patent Owner's Preliminary Response

Hovanesian, et al Surgical Techniques and Adjuvants for the Management of Primary and Recurrent Pterygia

Allgenesis Biotherapeutics Inc. A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia (SURPH)

PCT Publication No. WO2013188283 to Bottger

Declaration of Dr. Thomas Malone, dated August 7, 2020

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney

Notice of Accord Filing Date

U.S. Patent No. 10,149,820

Prosecution history of U.S. Patent No. 10,149,820

U.S. Provisional Patent Application No. 62/186,660, filed on June 30, 2015

U.S. Provisional Patent Application No. 62/172,063, filed on June 6, 2015

U.S. Patent Application Publication No. 2013/0012531 to King et al.

OFEV (nintedanib) FDA label, revised 10/2014, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/ 2014/205832s000lbl.pdf

VARGATEF (nintedanib) European Medicines Agency (EMA) summary of the European public assessment report (EPAR), approved 11/2014, available at https://www.ema.europa.eu/en/documents/overview/ vargatef-epar-summary-public_en.pdf

Prosecution history of U.S. Patent No. 10,154,994 to Nguyen et al., assigned to Allgenesis Biotherapeutics, Inc.

Mindy I. Davis et al., Comprehensive analysis of kinase inhibitor selectivity, 29 Nature Biotechnology 1046-1051 (Nov. 2011)

Request for Continued Examination and Reply to Office Action in Application No. 16/210,896, filed April 10, 2020

P. Gougis et al., Clinical pharmacology of anti-angiogenic drugs in oncology, 119 Critical Reviews in Oncology/Hematology 75-93 (Nov. 2017)

Prosecution history of U.S. Patent No. 9,987,223, assigned to Patent Owner

Declaration of Patrick Gordis, dated August 6, 2020

Amparo listing, Investigative Ophthalmology & Visual Science (January 2013), captured by Internet Archives Wayback Machine on October, 8, 2013, available at https://web.archive.org/web/20131008205602/http: /www.iovs.org/content/54/1.toc

Internet Archive Declaration, dated August 5, 2020

PCT International Publication No. WO 2016/209555 A1 to Nguyen et al. and assigned to Allgenesis Biotherapeutics Inc.

U.S. Provisional Application No. 62/183,180 to Nguyen et al.

Francisco Amparo, et al., Safety and Efficacy of the Multitargeted Receptor Kinase Inhibitor Pazopanib in the Treatment of Corneal Neovascularization, 54 Investigative Ophthalmology & Visual Science 537-544, 2013

PCT International Publication No. WO 2007/038453 A2 to Peyman

Gerald J. Roth et al., Nintedanib: From Discovery to the Clinic, 58 J. Med. Chem. 1053-1063, Dec. 2014

Juan J. Perez-Santonja et al., Inhibition of Corneal Neovascularization by Topical Bevacizumab (Anti-VEGF) and Sunitinib (Anti-VEGF and Anti-PDGF) in an Animal Model, 150 Am. J. Ophthalmology 519-528 (Oct. 2010)

Robert Roskoski Jr., Classification of small molecule protein kinase inhibitors based upon the structures of their drug-enzyme complexes, 103 Pharmacological Research 26-48 (Jan. 2016)

David T. Manallack et al., The significance of acid/base properties in drug discovery, 42 Chemical Society Reviews 485-496 (2013)

April 5, 2018 Memorandum from Deputy Commissioner for Patent Examination Policy to Patent Examining Corps

Inventor Declaration filed during prosecution of U.S. Patent Application Publication No. 2013/0012531 to King et al., dated September 2012

U.S. Patent Application Publication No. 2008/0003219 to Peyman

Ayala Gover-Proaktor et al., Bosutinib, dasatinib, imatinib, nilotinib, and ponatinib differentially affect the vascular molecular pathways and functionality of human endothelial cells, 60 Leukemia & Lymphoma 189-199 (2018)

Nintedanib, Clinical Pharmacology Review, Center for Drug Evaluation and Research, FDA, submitted by Boehringer Ingelheim, Inc. on May 2, 2014, available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/ 205832Orig1s000ClinPharmR.pdf

Internet Archives Standard Affidavit

INTER PARTES REVIEW PETITION

EXPUNGED

Power of Attorney