Palette Life Sciences, Inc. et al. vs Incept LLC et al.

Other: Fed Circuit mandate

Other: other court decision

Patent Owner's Amended Notice of Appeal

Patent Owner's Amended Notice of Appeal

Order Denying Request for Director Review

Petitioner's Mandatory Change-of-Information Notices

Ex. 3100 Director Review Request

Patent Owner's Request for Review by the Director

Patent Owner's Notice of Appeal

Patent Owner's Updated Mandatory Notice

Patent Owner's Power of Attorney

DECISION Granting Patent Owner's Motion for Pro Hac Vice Admission of Timothy E. Grimsrud

DECISION Granting Patent Owner's Motion to Withdraw and Substitute Counsel

Patent Owner Updated Exhibit List

Ex. 2035 - Declaration of Timothy E. Grimsrud in Support of Motion for Pro Hac Vice Admission

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Timothy E. Grimsrud

Patent Owner's Motion for Withdrawal and Substitution of Counsel

EXPUNGED

Petitioner's Mandatory Change-of-Information Notices

Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. sec. 318(a)

IPR2020-00004 Notice of Transcript Corrections

Patent Owner's Updated Power of Attorney

Granting Patent Owner's Motions for Withdrawal and Substitution of Counsel 37 C.F.R. sec. 42.10

Hearing Transcript

Patent Owner's Updated Mandatory Notices

Patent Owner Motion for Withdrawal and Substitution of Counsel

Patent Owner Updated Exhibit List

Ex. 2034 - Patent Owner Demonstratives

Petitioner's Updated Exhibit List

EX1156 - Petitioner's Demonstratives

Reply to Opposition to Motion to Exclude

Patent Owner Opposition to Motion to Exclude Evidence

Order - Setting Oral Argument - 37 CFR 42.70

Petitioner's Motion to Exclude Evidence

Patent Owner Sur-Reply

Ex. 2029 McDuff Trump University Report

Ex. 2032 Dicker Transcript

Ex. 2028 McDuff Transcript

Ex. 2030 Order excluding McDuff Testimony

Ex. 2031 Chen 2018

Ex. 2033 McDuff Transcript IPR2017-01621

Conference Hearing Transcript Taken November 30, 2020

Petitioner's Updated Exhibit List

Petitioner's Updated Exhibit List

Patent Owner Request for Oral Argument

Petitioner's Request for Oral Argument

Notice of Deposition of Zhibin Guan

Notice of Deposition of Adam Dicker, M.D., Ph.D.

Patent Owner's Objections to Reply Evidence

Notice of Deposition of DeForest McDuff

EX1077 - Boston Scientific - Form 10-K 2019

EX1084 - FDAnews Augmenix's Space0AR Prostate Treatment Receives FDA Clearance (2015)

EX1087 - Fox Factory v. SRAM, 944 F.3d 1366 (Fed. Cir. 2019)

EX1092 - HHS Process and Information Required to Apply or Additional Device Categories (2019)

EX1093 - Deposition Transcript of Jessica Ray October 15, 2020

EX1096 - OncoLink Endorectal Balloons for Prostate Radiation Therapy

EX1099 - QLRAD Homepage

EX1100 - S.J. Im (2007)

EX1106 - Deposition Transcript of Timothy Showalter October 22, 2020

EX1107 - USPTO - Patent Assignment Cover Sheet

EX1108 - Declaration of DeForest McDuff

EX1075 - Annunziata (2002)

EX1076 - Bloomberg Markets - Incept LLC

EX1078 - SpaceOAR Hydrogel Brochure

EX1079 - Chao (2019)

EX1080 - Anushree Datta Master¿¿¿s Thesis (2007)

EX1081 - Dexur - MEDRAD PRO-TEKT Endorectal Balloon

EX1082 - Digital Impulse - Augmenix

EX1083 - ECRI SpaceOAR System (Augmenix, Inc.) Hydrogel Spacer for Reducing Exposure during Prostate Cancer Radiation Therapy (2017)

EX1085 - FDA Establishment Registration & Device Listing Search for Rectal Balloon

EX1086 - FDA Product Classification for Rectal Balloon for Prostate Immobilization

EX1088 - Hamdy (2016)

EX1089 - Prostate Cancer - Treat or Wait (2015)

EX1090 - BioProtect Spacer

EX1091 - HHS Medicare Program - Changes to Hospital Outpatients Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (2018)

EX1094 - Lin (2008)

EX1095 - Mok (2014)

EX1097 - Palette Life Sciences website ¿¿¿About¿¿¿ section

EX1098 - Pinkawa (2015)

EX1101 - Santos (2014)

EX1102 - Trifiletti (2016)

EX1103 - B.D. Smith (2010)

EX1104 - How Does SpaceOAR Hydrogel Work

EX1105 - Tae (2001)

EX1109 - Expert Declaration of Dr. Adam Dicker

EX1110 - Expert Declaration of Dr. Zhibin Guan

EX1114 - Datla (2014)

EX1111 - Deposition Transcript of Gary Wnek October 29, 2020

EX1112 - Curriculum Vitae of Dr. Zhibin Guan

EX1113 - BrachyFoam

EX1116 - Steinleitner II (1992)

EX1122 - FDA - DuraSeal Spine Sealant System (2009)

EX1123 - PDR Entry for Lantus (2001)

EX1126 - Levy (2019)

EX1127 - U.S. Patent 6,509,031 issued January 21, 2003

EX1128 - U.S. Patent 6,413,742 issued July 2, 2002

EX1130 - U.S. Patent 6,280,772 issued August 28, 2001

EX1131 - U.S. Patent 6,271,278 issued August 7, 2001

EX1132 - U.S. Patent 6,268,405 issued July 31, 2001

EX1133 - U.S. Patent 6,031,148 issued February 29, 2000

EX1136 - U.S. Patent 5,874,500 issued February 23, 1999

EX1137 - U.S. Patent 5,863,984 issued January 26, 1999

EX1138 - U.S. Patent 5,865,367 issued February 2, 1999

EX1139 - U.S. Patent 5,759,583 issued June 2, 1998

EX1140 - U.S. Patent 5,618,563 issued April 8, 1997

EX1144 - U.S. Patent 4,193,813 issued March 18, 1980

EX1148 - Lutolf (2001)

EX1115 - Steinleitner I (1991)

EX1117 - W.R. Noyes Profile (ASTRO)

EX1118 - W.R. Noyes ACRO Ballot Information (2017)

EX1119 - W.R. Noyes About (CCND)

EX1120 - PDR Entry for Furosemide (2000)

EX1121 - PDR Entry for Phenytoin Injection (2001)

EX1124 - Treatment Team Brochure (ASTRO)

EX1125 - Teh (2002)

EX1129 - U.S. Patent 6,388,047 issued May 14, 2002

EX1134 - U.S. Patent 6,110,484 issued August 29, 2000

EX1135 - U.S. Patent 5,932,539 issued August 3, 1999

EX1141 - U.S. Patent 5,599,552 issued February 4, 1997

EX1142 - U.S. Patent 4,970,298 issued November 13, 1990

EX1143 - U.S. Patent 4,703,108 issued October 24, 1987

EX1145 - PCT Publication WO1993017669 published September 16, 1993

EX1146 - U.S. Patent 6,224,893 issued May 1, 2001

EX1147 - Nakayama & Matsuda (1992)

EX1150 - Moon (2017)

EX1149 - U.S. Patent Publication 2020-0009277 published January 9, 2020

EX1151 - Peach (2018)

Petitioner's Reply

Petitioner's Updated Exhibit List

Petitioner's Updated Exhibit List

Transcript of Conference Call w PTAB (October 28, 2020)

MODIFIED SCHEDULING ORDER

Order - Conduct of the Proceeding

EXPUNGED

Petitioner's email to PTAB Trials (October 21, 2020)

Petitioner's Mandatory Change-of-Information Notices

Petitioner's Power of Attorney

Notice of Deposition of Jessica Ray

Notice of Deposition of Timothy Showalter

Notice of Deposition of Gary Wnek

Petitioner's Objections to Evidence Submitted With Corrected Patent Owner Response

Ex. 2026 - Declaration of Jessica Ray

Corrected Patent Owner Response

Ex. 2027 - Supplemental Declaration of Timothy N. Showalter, MD, MPH

PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. ¿¿ 42.5

Petitioner's Objections to Evidence

Patent Owner Response

Ex. 2004 - Zimmerman, In Vivo Measurements of the Viscoelasticity (1980)

Ex. 2006 - Silver and Christiansen, Biomaterials Science and Biocompatibility, Ch. 7 (1999)

Ex. 2008 - Bruskov et al., Heat-induced formation of reactive oxygen species (2002)

Ex. 2009 - Leonov and Elad, Light-induced free radical alkylation (1977)

Ex. 2010 - Mitchell, Alternative starting materials for industrial processes (1992)

Ex. 2011 - Rochette et al, UVA-induced cyclobutane pyrimidine dimers (2003)

Ex. 2017 - Augmenix, Inc. Announces Medicare Administrative Contractor (Press Release 2017)

Ex. 2001 - Declaration of Timothy N. Showalter, M.D., Ph.D.

Ex. 2002 - Declaration of Gary E. Wnek, Ph.D.

Ex. 2003 - Balazs, The Physical Properties of Synovial Fluid (1974)

Ex. 2005 - Umehara et al, Effects of Degeneration on the Elastic Modulus Distribution (1996)

Ex. 2007 - Danehy and Parameswaran, Acidic Dissociation Constants of Thiols (1968)

Ex. 2012 - Boston Scientific Announces Agreement to Acquire Augmenix (press release 2018)

Ex. 2013 - Pieczonka et al, Hydrogel Spacer Application Technique (2016)

Ex. 2014 - De Novo Classification Request for SpaceOAR System, FDA decision (2014)

Ex. 2015 - Mariados et al, Hydrogel Spacer Prospective Multicenter Randomized (2015)

Ex. 2016 - Babayan, Re Aminsharifi et al., Major Complications and Adverse Events (2020)

Ex. 2018 - Augmenix Announces Medicare Reimbursement Rates (Press Release 2017)

Ex. 2019 - Siegel, Cancer Statistics (2019)

Ex. 2020 - Gay, Radiation Therapy for Prostate Cancer (2018)

Ex. 2022 - Prada et al, Transperineal Injection of Hyaluronic Acid in Anterior (2007)

Ex. 2024 - Hepp et al. Case report use of a contrasted hydrogel spacer (2018)

Ex. 2021 - Noyes, Human Collagen Injections to Reduce Rectal Dose (2012)

Ex. 2023 - Rao, A Novel Absorbable Radiopaque Hydrogel Spacer (2017)

Ex. 2025 - Hwang, Stereotactic body radiotherapy with periprostatic hydrogel (2019)

Order - Granting Petitioner's Motions to Submit Supplemental Information - 37 CFR 42.123(a)

Granting Petitioners Unopposed Motions for Pro Hac Vice Admission of Tung-On Kong 37 C.F.R. sec 42.10(c)

Notice of Deposition of Adam Dicker

Joint Notice of Stipulation to Modify Schedule

MODIFIED SCHEDULING ORDER 37 C.F.R. 42.5

Patent Owner Opposition to Motion for Supplemental Information

U.S. Patent No.: 5,410,016, J. Hubbell et al., Issued: April 25, 1995

A.P. Sclafani et al., ¿¿¿Autologous Collagen Dispersion (Autologen) as a Dermal Filler,¿¿¿ Arch. Facial Plast. Surg. 2:48-52 (2000)

Petitioner Palette Life Sciences, Inc. Motion for Supplemental Information

Petitioner's Updated Exhibit List

U.S. Patent No.: 7,247,324, O. Hnojewyj et al., Issued: July 24, 2007

Email from Patent Trial and Appeal Board issued May 8, 2020

Petitioner's Updated Exhibit List

Petitioner's Updated Exhibit List

Patent Owner Objections to Petition Evidence

Petitioner's Motion for Pro Hac Vice Admission

Petitioner's Updated Exhibit List

Declaration of Tung-On Kong

Tung-On Kong WSGR Bio

SCHEDULING ORDER

Trial Instituted Document

Patent Owner Preliminary Response

Patent Owner Mandatory Notices

Patent Owner Power of Attorney

Notice of Accord Filing Date

Petitioner's Power of Attorney

U.S. Patent No.: 8,257,723, W.R. Noyes, Issued: September 4, 2012

Declaration of Dr. Adam Dicker, M.D., Ph.D. in Support of Petition for Inter Partes Review of U.S. Patent No. 7,744,913

File History of U.S. Patent No.: 7,744,913

File History of U.S. Patent No.: 8,257,723

U.S. Provisional Application No.: 60/391,027, W.R. Noyes (filed: June 24, 2002)

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D.C. Damin and A.R. Lazzaron, ¿¿¿Evolving treatment strategies for colorectal cancer: a critical review of current therapeutic options,¿¿¿ World Journal of Gastroenterology 20(4): 877-887 (January 28, 2014)

S.R. Denmeade and J.T. Isaacs, ¿¿¿A history of prostate cancer treatment,¿¿¿ Nature Reviews Cancer 2:389-396 (May 2002)

U.S. Patent No.: 7,744,913, W.R. Noyes, Issued: June 29, 2010

Curriculum Vitae of Dr. Adam Dicker

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U.S. Provisional Application No.: 60/444,143, W.R. Noyes (filed: January 31, 2003)

PCT Publication No.: WO 94/25080, L. Griffith-Cima et al. (published: November 10, 1994)

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L.F. Fajardo, ¿¿¿Morphology of radiation effects on normal tissues,¿¿¿ in PRINCIPLES AND PRACTICE OF RADIATION ONCOLOGY, Chapter 4 (eds. C.A. Perez and L.W. Brady) (Lippincott Company, Philadelphia) (3rd ed. 1998)

R.J. Berry, ¿¿¿Basic concepts in radiobiology: a review,¿¿¿ in THERAPEUTIC RADIOLOGY: NEW DIRECTIONS IN THERAPY, Chapter 1 (ed. C.M. Mansfield) (Medical Examination Publishing Company, New Hyde Park, New York) (1983)

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B.D. Minsky et al., ¿¿¿Carcinoma of the esophagus. Part 1: Primary therapy,¿¿¿ Oncology (Williston Park) 13(9):1225-1236 (September 1999)

E.K. Reddy and C.M. Mansfield, ¿¿¿Carcinoma of the prostate,¿¿¿ in THERAPEUTIC RADIOLOGY: NEW DIRECTIONS IN THERAPY, Chapter 11 (Medical Examination Publishing Company, New Hyde Park, New York) (1983)

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Petition for Inter Partes Review

Petitioner¿¿¿s Explanation of Multiple Petitions Challenging Patent No. 7,744,913 and Ranking of Petitions