NeoGenomics Laboratories, Inc. vs Natera, Inc.

Director Discretionary Decision: Deny

Email Correspondence

EX2075 - Reinert T., Henriksen T., Christensen E., et al., Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer, JAMA Oncol. 2019;5(8):1124–1131

EX2076 - Pray, L., DNA Replication and Causes of Mutation, Nature Education 1(1):214 (2008)

EX2077 - Excerpt of Natera’s Fifth Suppl. ROs to Neo’s Second Set of Interrogatories (Nos. 6-15) (April 4, 2025)

EX2079 - Excerpt of Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 24-1324, Non-Confidential Joint Appendix Vol. III of IV (Mar. 18, 2024)

EX2080 - May 14, 2025 Declaration of Sayem Osman

Patent Owner's Preliminary Response

EX1107 - Transcript March 11, 2025 Natera v. NeoGenomics

EX1108 - Neo's Rule 28(j) Letter

EX1109 - Natera Response to Neo's 28(j) Letter

EX1110 - NeoGenomics FQ4 2024 Earnings Call

Petitioner’s Opposition to Patent Owner’s Request for Discretionary Denial Under 35 U.S.C. § 314(a)

Notice: Extending Deadline for Discretion Briefing

EX2001 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Text Order (Feb. 12, 2025)

EX2002 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant’s Amended Final Invalidity Contentions (Mar. 14, 2025)

EX2003 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit 1-A – Final Invalidity Claim Chart for U.S. Patent No. 11,319,596 (Mar. 14, 2025)

EX2004 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit 1-B – Final Invalidity Claim Chart for U.S. Patent No. 11,319,596 (Mar. 14, 2025)

EX2005 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit 1-C – Final Invalidity Claim Chart for U.S. Patent No. 11,319,596 (Mar. 14, 2025)

EX2006 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit 2-A – Final Invalidity Claim Chart for U.S. Patent No. 11,530,454 (Mar. 14, 2025)

EX2007 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit 2-B – Final Invalidity Claim Chart for U.S. Patent No. 11,530,454 (Mar. 14, 2025)

EX2008 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit 2-C – Final Invalidity Claim Chart for U.S. Patent No. 11,530,454 (Mar. 14, 2025)

EX2009 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit 2-D – Final Invalidity Claim Chart for U.S. Patent No. 11,530,454 (Mar. 14, 2025)

EX2010 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant’s Final Invalidity Contentions (Redacted) (M.D.N.C. July 11, 2024)

EX2011 - Compilation of Exhibits to Defendant’s July 11, 2024 Final Invalidity Contentions in Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629

EX2012 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Complaint for Patent Infringement, Dkt. No. 1 (M.D.N.C. July 28, 2023)

EX2013 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera’s Motion for a Preliminary Injunction, Dkt. No. 5 (M.D.N.C. July 31, 2023)

EX2014 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera’s Memorandum of Law in Support of Its Motion for a Preliminary Injunction Pursuant to Federal Rule of Civil Procedure 65(a) and 35 U.S.C. § 283, Dkt. No. 6 (M.D.N.C. July 31, 2023)

EX2015 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s Answer, Affirmative Defenses, and Counterclaims to Plaintiff Natera, Inc.’s Complaint for Patent Infringement, Dkt. No. 58 (M.D.N.C. Sept. 11, 2023)

EX2016 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s First Amended Answer, Affirmative Defenses, and Counterclaims to Plaintiff Natera, Inc.’s Complaint for Patent Infringement, Dkt. No. 81 (M.D.N.C. Oct. 6, 2023)

EX2017 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s Opposition to Plaintiff Natera’s Motion for a Preliminary Injunction, Dkt. No. 89 (M.D.N.C. Oct. 19, 2023)

EX2018 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera’s Reply in Support of Its Motion for a Preliminary Injunction Pursuant to Federal Rule of Civil Procedure 65(a) and 35 U.S.C. § 283, Dkt. No. 139 (M.D.N.C. Nov. 6, 2023)

EX2019 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Minute Entry, Dkt. No. 159 (M.D.N.C. Nov. 27, 2023)

EX2020 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Order, Dkt. No. 169 (M.D.N.C. Dec. 27, 2023)

EX2021 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant’s Notice of Appeal, Dkt. No. 173 (M.D.N.C. Dec. 27, 2023)

EX2022 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Joint Claim Construction Statement, Dkt. No. 249 (M.D.N.C. Mar. 15, 2024)

EX2024 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera, Inc.’s Opening Claim Construction Brief, Dkt. No. 262 (M.D.N.C. Apr. 8, 2024)

EX2025 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Declaration of Dr. Michael L. Metzker in Support of Plaintiff Natera, Inc.’s Opening Claim Construction Brief, Dkt. No. 263 (M.D.N.C. Apr. 8, 2024)

EX2026 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant’s Initial Invalidity Contentions, Dkt. No. 263-5 (M.D.N.C. Apr. 8, 2024)

EX2027 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics, Inc.’s Opening Claim Construction Brief, Dkt. No. 264 (M.D.N.C. Apr. 8, 2024)

EX2028 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Declaration of David I. Smith, Ph.D. on Claim Construction, Dkt. No. 264-5 (M.D.N.C. Apr. 8, 2024)

EX2029 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s Responsive Claim Construction Brief, Dkt. No. 271 (M.D.N.C. Apr. 22, 2024)

EX2030 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera, Inc.’s Responsive Claim Construction Brief, Dkt. No. 272 (M.D.N.C. Apr. 22, 2024)

EX2031 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Claim Construction Order, Dkt. No. 280 (M.D.N.C. May 17, 2024)

EX2032 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, USCA Opinion Affirmed, Dkt. No. 293 (M.D.N.C. July 12, 2024)

EX2033 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Mandate of the USCA, Dkt. No. 316 (M.D.N.C. Aug. 19, 2024)

EX2034 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Joint Motion for Temporary Stay of Case Deadlines, Dkt. No. 318 (M.D.N.C. Aug. 21, 2024)

EX2035 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Stipulated Order and Permanent Injunction, Dkt. No. 329 (M.D.N.C. Sept. 23, 2024)

EX2036 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera’s Motion for Leave to File First Amended Complaint, Dkt. No. 336 (M.D.N.C. Nov. 4, 2024)

EX2037 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s Opposition and Conditional Consent to Natera’s Motion for Leave to File First Amended Complaint, Dkt. No. 340 (M.D.N.C. Nov. 15, 2024)

EX2038 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff’s Reply in Support of Motion for Leave to File First Amended Complaint, Dkt. No. 342 (M.D.N.C. Nov. 29, 2024)

EX2039 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff’s Natera, Inc.’s Disclosure of Asserted Claims and Preliminary Infringement Contentions (redacted), Dkt. No. 342-2 (M.D.N.C. Nov. 29, 2024)

EX2040 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Order Granting Motion to Amend and Adding Deadlines, Dkt. No. 345 (M.D.N.C. Dec. 6, 2024)

EX2041 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, First Amended Complaint for Patent Infringement, Dkt. No. 353 (M.D.N.C. Dec. 10, 2024)

EX2042 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s Answer to Plaintiff Natera, Inc.’s First Amended Complaint for Patent Infringement, Dkt. No. 357 (M.D.N.C. Dec. 20, 2024)

EX2043 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, NeoGenomics’ Reply in Support of Its Motion for Issuance of Letters of Request for Production of Documents and To Examine Persons Pursuant to Hague Evidence Convention, Dkt. No. 358 (M.D.N.C. Dec. 20, 2024)

EX2044 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera, Inc.’s Opening Claim Construction Brief Regarding U.S. Patent No. 11,319,596, Dkt. No. 372 (M.D.N.C. Jan. 21, 2025)

EX2045 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s Opening Claim Construction Brief, Dkt. No. 373 (M.D.N.C. Jan. 21, 2025)

EX2046 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Declaration of Niall Lennon, Ph.D., on Claim Construction, Dkt. No. 374 (M.D.N.C. Jan. 21, 2025)

EX2047 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Declaration of Dr. Michael L. Metzker in Support of Plaintiff Natera, Inc.’s Responsive Claim Construction Brief, Dkt. No. 379 (M.D.N.C. Feb. 3, 2025)

EX2048 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Declaration of Niall Lennon, Ph.D., in Support of Defendant NeoGenomics Laboratories, Inc.’s Responsive Claim Construction Brief Regarding U.S. Patent No. 11,319,596, Dkt. No. 381 (M.D.N.C. Feb. 3, 2025)

EX2049 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Transcript of Deposition of Dr. Niall Lennon, Dkt. No. 381-1 (M.D.N.C. Feb. 3, 2025)

EX2050 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Parties’ Joint Interim Status Report, Dkt. No. 382 (M.D.N.C. Feb. 7, 2025)

EX2051 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Order, Dkt. No. 385 (M.D.N.C. Feb. 19, 2025)

EX2052 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Transcript of Deposition of Dr. Michael Metzker, Dkt. No. 388-1 (M.D.N.C. Feb. 27, 2025)

EX2053 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Joint Stipulation and Order Regarding Deposition Limits, Dkt. No. 391 (M.D.N.C. Mar. 6, 2025)

EX2054 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Exhibit and Witness List, Dkt. No. 393 (M.D.N.C. Mar. 11, 2025)

EX2055 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Claim Construction Order, Dkt. No. 394 (M.D.N.C. Mar. 17, 2025)

EX2056 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Joint Stipulation and Order Regarding Taking of One Fact Witness Deposition After Close of Fact Discovery, Dkt. No. 399 (M.D.N.C. Mar. 27, 2025)

EX2057 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Natera’s Sixth Set of Interrogatories (Nos. 25-29), (M.D.N.C. June 18, 2024)

EX2058 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, NeoGenomics Laboratories, Inc.’s Third Set of Interrogatories (Nos. 16-25) (Redacted), (M.D.N.C. June 18, 2024)

EX2059 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, NeoGenomics Laboratories, Inc.’s First Set of Requests for Admission (Nos. 1-24), (M.D.N.C. June 18, 2024)

EX2060 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, NeoGenomics Laboratories, Inc.’s Third Requests for Production (Nos. 105-123), (M.D.N.C. Mar. 4, 2025)

EX2061 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Natera’s Eighth Set of Requests for Production (Nos. 114-122), (M.D.N.C. Mar. 4, 2025)

EX2062 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 24-1324, General Docket (Fed. Cir. 2024)

EX2063 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 24-1324, NeoGenomics Laboratories, Inc.’s Corrected Opening Brief, Dkt. No. 24 (Fed. Cir. Feb. 13, 2024)

EX2064 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 24-1324, Response Brief for Appellee Natera, Inc., Dkt. No. 36 (Fed. Cir. Mar. 11, 2024)

EX2065 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 24-1324, NeoGenomics Laboratories, Inc.’s Reply Brief, Dkt. No. 39 (Fed. Cir. Mar. 18, 2024)

EX2066 - Explanation of Selected Terms, United States District Courts National Judicial Caseload Profile

EX2067 - United States District Courts National Judicial Caseload Profile for 12-Month Periods Ending in September 30 (2019-2024)

EX2068 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Joint Stipulation and Order Regarding Briefing and Discovery Schedule, Dkt. No. 46 (M.D.N.C. Aug. 23, 2023)

EX2069 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGenomics Laboratories, Inc.’s Second Amended Answer, Affirmative Defenses, and Counterclaims to Plaintiff Natera, Inc.’s Complaint for Patent Infringement, Dkt. No. 128 (Oct. 20, 2023)

EX2070 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Preliminary Injunction, Dkt. No. 171 (Dec. 27, 2023)

EX2071 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Declaration of Dr. Michael L. Metzker in Support of Plaintiff Natera, Inc.’s Responsive Claim Construction Brief, Dkt. No. 273 (Apr. 22, 2024)

EX2072 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Plaintiff Natera, Inc.’s Responsive Claim Construction Brief Regarding U.S. Patent No. 11,319,596, Dkt. No. 378 (Feb. 3, 2025)

EX2073 - Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, Defendant NeoGeonimcs Laboratories, Inc.’s Responsive Claim Construction Brief Regarding U.S. Patent No. 11,319,596, Dkt. No. 380 (Feb. 3, 2025)

EX2074 - Declaration of Sayem Osman

Patent Owner's Brief in Support of Discretionary Denial

Patent Owner Updated Mandatory Notice

Patent Owner Updated POA

Petitioner's Updated Mandatory Notices

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

Notice: Mandatory Notice

Notice: Power of Attorney

Notice: Power of Attorney

EX1001- USP11,319,596

EX1002 - Demonstrative of Priority Chain 596

EX1005 – Lennon CV

EX1055 - Swaminathan (2006)

EX1056 - Schwarzenbach (2011)

EX1006 – Diaz

EX1007 - Kinde 2013

EX1057 – Elmore (2007)

EX1059 - Kidess (2013)

EX1062 – Perkel (Apr. 11, 2014)

EX1063 - Kumar (2010)

EX1064 – U.S. Publication No. 2004/0126760

EX1065 - Markoulatos (2002)

EX1067 - Definition Polymerase Chain Reaction (PCR)

EX1068 - Shendure (2008)

EX1009 - Rabinowitz

EX1010 Fleischhacker

EX1070 - Table of Sequencing Costs (May 2022)

EX1012 – U.S. Provisional App. 61/982,245

EX1013– U.S. Provisional App. 61/987,407

EX1072 - Diehl

EX1014 – U.S. Provisional App. 61/994,791__Part 1

EX1073 – Joint Claim Construction Statement

EX1014 – U.S. Provisional App. 61/994,791__Part 2

EX1074 – Joint Claim Construction Statement - Exhibit A

EX1075 – Mullins CV

EX1015 – U.S. Provisional App. 62/066,514

EX1076 – Bettegowda A-1

EX1016 – U.S. Provisional App. 62/146,188

EX1077 - Bettegowda A-2

EX1017 – U.S. Provisional App. 62/147,377

EX1078 - Bettegowda A-3

EX1018– U.S. Provisional App. 62/148,173

EX1079 - Bettegowda A-4

EX1080 - Bettegowda A-5

EX1081 - American Association for Advancement of Science A-6

EX1082 - National Library of Medicine A- 7

EX1019 – U.S. Application 14/692,703

EX1083 - Google Scholar A-8

EX1084 – Cunnea A-9

EX1020 – USPTO Memo

EX1021 – U.S. District Court National Judicial Caseload Profile

EX1023 – Order Granting Motion to Amend and Adding Deadlines

EX1024 – Order Granting Preliminary Injunction

EX1025 – Decision on Institution in IPR2024-00346

EX1026 – Termination Decision in IPR2024-00812

EX1027 – U.S. Publication No. 2019/0194758

EX1028 – USP 11,530,454

EX1029 – USP 11,519,035

EX1030 - Diehn

EX1031 – U.S. Publication No. 2016/0032396

EX1087 – Kinde B-3

EX1088 – Kinde B-4

EX1033 - Nguyen-Dumont

EX1034 - Wang

EX1089 – Kinde B-5

EX1035 - Talasaz

EX1090 – WorldCat B-6

EX1036 - Kennedy

EX1091 – Bedard B-7

EX1037 - Leary

EX1038 - van Dijk

EX1093 – Email from Wisconsin TechSearch C-2

EX1094 – Diaz C-3

EX1095 – Diaz C-4

EX1096 – Journal of Clinical Oncology C-5

EX1097 – Georgia Southern University Library OPAC C-6

EX1098 - Alix-Panabières C-7

EX1099 – Fleischhacker D 1

EX1100 - Fleischhacker D 2

EX1101 – WorldCat D 3

EX1102 - Linda Hall Library Catalog D-4

EX1103 – Natera’s Opp to NeoGenomics Motion for Issuance of Letters Request

EX1104 - Mardis (2008)

EX1105 - Meyerson (2010)

EX1040 – U.S Publication No. 2012/0171687

EX1041 - Publication No. WO2013/045432

EX1042 - O’Rawe

EX1045 – Diamandis (2014)

EX1046 - Natera Publication

EX1047 – Navin (2014)

EX1049 – Kinde 2011

EX1052 - Image of Nucleotide

EX1053 – Alberts (2003)

EX1022 – Order on Motions and Setting Schedule in Natera, Inc. v. NeoGenomi

EX1051 – Horlitz (2011)

EX1054 – Jackson (2006)

EX1003 – Excerpted File Wrapper 596__Part 1

EX1003 – Excerpted File Wrapper 596__Part 3

EX1003 – Excerpted File Wrapper 596__Part 2

EX1003 – Excerpted File Wrapper 596__Part 4

EX1066 - Schochetman (1988)

EX1043 – Forster (2012)

EX1044 – Kisch

EX1048 - De Vlaminck (2014)

EX1050 – Tie ASCO Abstract (2013)

EX1058 - Bischoff (2005)

EX1061 - Domínguez (2002)

EX1069 - DNA Sequencing Costs: Data (May 16, 2023)

EX1086 – Kinde B-2

EX1060 - Dawson (2013)

EX1008 - Bettegowda

EX1071 - Narayan (2012)

EX1085 – Kinde B-1

EX1092 – Diaz C-1

EX1106 - Labrousse

EX1004 – Lennon Declaration

EX1011 – Mullins Declaration

EX1039 - Couraud

EX1032 - Mertes

Petition: as filed