Spectrum Solutions LLC et al. vs Longhorn Vaccines & Diagnostics, LLC

Fed. Cir. Order Dismissing Appeal

Director Review Decision Modifying Entered Sanctions on Unopposed Remand and Sua Sponte Reconsideration

Federal Circuit Limited Remand Order

Petitioner’s Spectrum's Notice of Cross-Appeal

PO's Amended Notice of Appeal

Ex. A

Ex. B

Ex. C

Ex. 3107

Decision Granting Director Review and Affirming FWD

Director Review Decision

Director Review Decision Email

PO’s Responsive Brief Regarding Sua Sponte Director Review of Board’s Sanctions Orders

Petitioner’s Responsive Brief to USPTO Director

Brief of Amicus Curiae – Naples Roundtable

EXPUNGED

Brief of Amicus Curiae – Unified Patents

PO's Opening Brief Regarding Sua Sponte Director Review of Board's Sanctions Orders

Petitioner’s Brief for USPTO Director

Brief of Amicus Curiae – Richard Neifeld

Brief of Amicus Curiae - Josh Malone

Schoenhard Declaration

Order: Conduct of the Proceeding

Ex. 3105

UNOPPOSED MOTION FOR PRO HAC VICE ADMISSION OF PAUL M. SCHOENHARD

EXPUNGED

Ex. 3104 CAFC Order

Ex. 3103 PO Notice of Appeal

EXPUNGED

Pro Hac Motion Paul M. Schoenhard

Ex. 3101

Motion to Substitute

Updated Mandatory Notice

Power of Attorney

Order Granting Sua Sponte Director Review

Preliminary Guidance Patent Owner's Motion to Amend - REDACTED

Opposition to Motion to Seal - REDACTED

Opposition to Motion to Exclude - REDACTED

Sur-Reply to Motion to Amend - REDACTED

Unopposed Supplemental Motion to Seal - REDACTED

Hearing Transcript 2022.08.16 - REDACTED

Hearing Transcript 2022.08.19 - REDACTED

Ex. 1096 - REDACTED

Ex. 2031 - REDACTED

Petitioners Demonstratives for Oral Argument - REDACTED

Unopposed Supplemental Motion to Seal

Order Granting Petitioner Motions for Sanctions 37 C.F.R. §§ 42.5, 42.11, and 42.12 PUBLIC VERSION (Originally enter May 3, 2023)

Final Written Decision PUBLIC VERSION (Originally enter May 3, 2023)

Granting Petitioner Motions for Sanctions 37 C.F.R. §§ 42.5, 42.11, and 42.12

Final Written Decision

Ex. 3009

Order Extending One Year Pendency for Good Cause

Order: GRANT OF GOOD CAUSE EXTENSION

Other: Hearing transcript

Corrected Patent Owner's Response

Corrected Patent Owner's Sur-Reply

Patent Owner's Updated Exhibit List

Declaration of Elliott J. Williams re PO's Corrected Citations to Petition

Other: Hearing transcript

Petitioner Updated Exhibit List

Petitioner Demonstratives for 8-19-2022 Hearing

Patent Owner's Updated Exhibit List

Patent Owner's Demonstratives

ORDER Granting Patent Owners Motions for Pro Hac Vice Admission of Bradley Tellam 37 C.F.R. sec 42.10

From Ben Anger To: Trials; Williams, Elliott J. Cc: [email protected]; [email protected]; [email protected]; Brunette, Nathan; BoxSpectrum; 2cpw Subject: RE: IPR2021-00847, -00850, -00854, -00857, -00860 Pre-hearing Conference [SR-ACTIVE.FID5179199] Date August 15, 2022

Petitioner Sur-Reply to Patent Owner's Motion to Amend

Petitioner Updated Exhibit List

2022-08-10 Condensed Deposition Transcript of Dr. Louis DeFilippi [FUS]

Patent Owner's Reply in Support of Motion to Exclude

Patent Owner's Updated Exhibit List

Birkebak Declaration (Supplemental Evidence Previously Served But Not Filed)

Tolli Declaration (Supplemental Evidence Previously Served But Not Filed)

2022.04.22 Service Email

[REDACTED] Petitioner Reply to Motion for Sanctions

Declaration of Bradley Tellam in Support of Patent Owner's Motion for Pro Hac Vice

Updated Mandatory Notices

Patent Owner's Motion for Pro Hac Vice Admission of Bradley Tellam

Other: Setting Oral Argument

Patent Owner's Motion to Exclude Evidence [REDACTED]

Petitioner Opposition to Motion to Exclude Evidence

Petitioner Updated Exhibit List

Declaration of Christopher M. Beausoleil

Curriculum Vitae of Christopher M. Beausoleil, CCRP

Order: ORDER

Petitioner Reply to Motion for Sanctions

Petitioner Notice of Deposition of Dr. Louis DeFilippi

Patent Owner's Updated Exhibit List

Counsel's May 2022 Email Exchange re BioScience Depositions

Patent Owner's Motion to Exclude Evidence

Petitioner Objections to Evidence in Patent Owner Response

Exhibit 2043 Taylor Deposition Transcript

Patent Owner's Updated Exhibit List

Exhibit 2044

Exhibit 2045

Petitioner Opposition to Revised Motion to Amend [REDACTED]

Taylor Declaration [REDACTED]

Patent Owner's Opposition to Motion for Sanctions

Patent Owner's Opposition to Motion for Sanctions [REDACTED]

Patent Owner's Reply in Support of Revised Motion to Amend

Louis DeFilippi Declaration

EXPUNGED

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Argument

Patent Owner's Updated Exhibit List

EXPUNGED

3/24/2022 Email

3/25/2022 Email

US10619187

Williams Declaration

SDCA-3-21-cv-00516 ECF 92

SDCA-3-21-cv-00516 ECF 119

MPEP 201.07

MPEP 905.03

Patent Owner's Evidentiary Objections

Petitioner Updated Exhibit List

Declaration of Richard F. Taylor, Ph.D. dated July 11, 2022

Lozano, et al., ���A simple nucleic acid amplification assay for the rapi detection of Junin virus in whole blood samples,��� Virus Research, 27:37-53 (1993)

Marmur, ���A Procedure for the Isolation of Deoxyribonucleic Acid from Micro-organisms,��� J. Mol. Biol., 3:208-218 (1961)

U.S. Publication No. 2004/0151629 A1 to Pease, et al.

Kravchenko, et al., ���Preservation of Nucleic Acid Integrity in Guanidine Thiocyanate Lysates of Whole Blood,��� Russian Journal of Bioorganic Chemistry, 32(6): 547-551 (2006)

Aygan, ���Nucleic Acid Extraction from Clinical Specimens for PCR Applications,��� Turk J Biol, 30:107-120 (2006)

Hill, ���Molecular diagnostic testing for infectious diseases using TMA technology,��� Expert Rev. Mol. Diagn. 1(4): 445-455 (2001)

Finan, ���From molecular diagnostics to personalized testing,��� Pharmacogenomics, 8(1): 85-99 (2007)

Gen-Probe Incorporated Annual Report (2003)

Jungkind, ���Molecular Testing for Infectious Disease,��� Science, 294: 1553-55 (2001)

Bilitewski, et al., ���Biochemical analysis with microfluidic systems,��� Anal Bioanal Chem, 377:556-569 (2003)

Cammack, Oxford Dictionary of Biochemistry and Molecular Biology (Revised Edition), Oxford University Press (2006)

Hyde, ���The Extraction and Purification of DNA and RNA from In Vitro Cultures of the Malaria Parasite Plasmodium falciparum,��� Methods in Molecular Biology, 21:133-143 (1993)

Petitioner Opposition to Patent Owner's Revised Motion to Amend

Patent Owner's Notice of Deposition of Richard Taylor

Patent Owner's Updated Exhibit List

Amended Supplemental Expert Report of Dr. Louis DeFilippi

Patent Owner's Declaration of Elliott Williams

Amended Patent Owner's Response

Patent Owner's Reply In Support of Motion to Seal

Ex. 3007

Order: Granting Patent Owner's Motion to Amend Patent Owner Response and Supplemental DeFilippi Declaration

Spectrum Motion for Sanctions [Redacted]

2022-06-13 Condensed Hearing Transcript re Motion for Sanctions [PUBLIC]

Petitioner's Objection to the Admissibility of Evidence

Other: Revised Scheduling Order

Spectrum Motion for Sanctions

Spectrum Updated Exhibit List

Email Exchange re ABL Witness Depositions

06-13-2022 Condensed Hearing Transcript

Patent Owner's Updated Exhibit List

Richard Taylor Deposition Transcript June 9-10, 2022

Christopher Beausoleil Deposition Transcript June 1-2, 2022

Patent Owner's Sur-Reply

Revised Patent Owner's Contingent Motion to Amend

Patent Owner's Motion for Leave to Amend

Petitioner Updated Exhibit List

06-03-2022 Telephonic Hearing Transcript re Patent Owner's Request for Authorization to File a Motion to Strike [Filed Under Seal]

06-03-2022 Telephonic Hearing Transcript re Patent Owner's Request for Authorization to File a Motion to Strike [Redacted]

to Patent Owner's Motion to Seal

Notice: PRELIMINARY GUIDANCE PATENT OWNERS MOTION TO AMEND

Petitioner���s Update of Mandatory Notice of Counsel Information

Patent Owner's Notice of Deposition of Christopher M. Beausoleil

Patent Owner's Notice of Second Deposition of Richard Taylor

Petitioner Opposition to Patent Owner Motion to Amend (IPR2021-00860) REDACTED

Petitioner Reply in Support of Petition for Inter Partes Review (IPR2021-00860) REDACTED

2022-03-30 & 04-26 Condensed Deposition Transcripts of Joshua Birkebak Ph.D. (REDACTED)

Taylor Declaration ('256 Patent)(REDACTED)

-2022-03-30 & 04-26 Condensed Deposition Transcripts of Anna Tolli (REDACTED)

2022-03-31 & 04-27 Condensed Deposition Transcripts of David Grant (REDACTED)

LH_AB_IPR_0000086 (qPCR Data) (REDACTED)

Patent Owner's Objection to Evidence filed with Reply

Spectrum's Reply to Patent Owner's Response to IPR Petition (IPR2021-00860) [AEO]

Spectrum's Opposition to Patent Owner's Motion to Amend (IPR2021-00860) [AEO]

Spectrum Updated Exhibit List- 9,683,256 (IPR2021-00860)

U.S. Provisional Application No. 60976,728

Tuttle, Preservation of Nucleic Acids for Polymerase Chain Reaction (1998)

Casas, New Method for the Extraction of Viral RNA and DNA (1995)

Zinkevich, 2000 Isolation of I33 Intact High Molegulat Weight Chromosomal DNA (2000)

Donofrio, Detection of Influenza A and B in Respiratory Secretions (1992)

Donofrio, Diagnosis of Equine Influenza by the Polymerase Chain Reaction (1994)

Fontan, Global Transcriptional Profile of Mycobacterium (2008)

Laulier, An Easy Method for Preserving Nucleic Acids in Field Samples (1995)

2022-04-12 & 13 Condensed Deposition Transcripts of Dr. Louis DeFilippi

QiaAmp Viral RNA Mino Handbook

MagMax Viral RNA Isolation Kit

Rafer - PRIMESTORE Insert Tuberculosis

2022-05-05 - BioScience Labs Final Report

U.S. Patent No. 8,293, 467 (Fisher)

Dr. Taylor's List of Materials Considered

RNase A from bovine pancreas _ Sigma-Aldrich

Chirgwin PubMed Citations Final

Birkebak Exhibit 1201 [REDACTED]

Birkebak Exhibit 1205

Grant - Exhibit 1208

2022-03-30 & 04-26 Condensed Deposition Transcripts of Joshua Birkebak, Ph.D. [AEO]

2022-05-06 Taylor Declaration - LP6 ('860) [AEO]

2022-03-30 & 04-26 Condensed Deposition Transcripts of Anna Tolli [AEO]

2022-03-31 & 04-27 Condensed Deposition Transcripts of David Grant [AEO]

Birkebak Exhibit 1201 [AEO]

Birkebak Exhibit 1202 [AEO]

Birkebak Exhibit 1203 [AEO]

Birkebak Exhibit 1204 [AEO]

Birkebak Exhibit 1206 [AEO]

Grant - Exhibit 1207 [AEO]

DNase Validation [AEO]

Product Testing Data Sheet (LH_AB_IPR_0000027) [AEO]

Data Analysis (qPCR) (LH_AB_IPR_0000086) [AEO]

Patent Owner's Motion to Seal

Patent Owner's Unopposed Motion for Entry of Protective Order

Redline Copy of Proposed Protective Order

Updated Patent Owner's Exhibit List

Clean Copy of Proposed Protective Order

Petitioner Update of Mandatory Notice of Counsel Information

EXPUNGED

Exhibit 300

Exhibit 300

Exhibit 3004

Order: Conduct of Proceeding

Patent Owner's Updated Exhibit List

Rough Draft Deposition Transcript of Joshua Birkebak, Ph.D.

Rough Draft Deposition Transcript of David Grant

Rough Draft Deposition Transcript of Anna Tolli

Redline of Confidential Patent Owner Brief on Work Product

Confidential Patent Owner���s Brief on Work Product

EXPUNGED

Petitioner���s Authorized Brief Regarding Patent Owner���s Work Product Objections

Spectrum Updated Exhibit List- 9,683,256

2022-03-30 ROUGH Deposition Transcript of Joshua Birkebak, Ph.D.

2022-03-31 ROUGH Deposition Transcript of David Grant

2022-03-30 ROUGH Deposition Transcript of Anna Tolli

Petitioner���s Notice of Deposition of Dr. Louis DeFilippi

Petitioner���s Notice of Deposition of Dr. Joshua Birkebak

Petitioner���s Notice of Deposition of Mr. David Grant

Petitioner���s Notice of Deposition of Ms. Anna Tolli

Biological Specimen Collection and Transport System

Petitioner's Objections to Evidence in Patent Owner's Response

Patent Owner's Updated Exhibit List

Supplemental Declaration of Dr. Louis DeFilippi

FDA Emergency Use Authorization for Spectrum's "SDNA-1000"

U.S. Department of Transportation Safety Advisory Notice for the Transportation of COVID-19 Diagnostic Samples

Excerpt of Prosecution History of US8084443

AssuredBio Test Report

Deposition Transcript (two days) of Dr. Richard Taylor

EXPUNGED

Patent Owner's Contingent Motion to Amend Under 37 C.F.R. �� 42.121

Patent Owner's Response Pursuant to 37 C.F.R. �� 42.120

Notice of Deposition of Richard Taylor

ORDER Granting Patent Owners Motion for Pro Hac Vice Admission of Nathan C. Brunette 37 C.F.R. sec 42.10

Patent Owner's Motion for Pro Hac Vice Admission of Nathan C. Brunette Under 37 C.F.R. 42.10(c)

Declaration of Nathan C. Brunette in Support of Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10(c)

Patent Owner's 37 C.F.R. Sec. 42.64 Evidentiary Objections

Petitioner's Objections to the Admissibility of Evidence Submitted Before Trial Institution

SCHEDULING ORDER

Institution Decision: Granting Institution of Inter Partes Review

Exhibit 3003

Exhibit 3002

Patent Owner's Exhibit List

Spectrum's Answer and Counterclaim to Second Amended Complaint

EXPUNGED

Patent Owner's Sur-Reply to the Petitioner's Reply Opposing Patent Owner's Preliminary Response

Exhibit 3001

Petitioner's Reply to Patent Owner Preliminary Response for U.S. Pat. 9,683,256

Petitioner's Updated Exhibit List - 9,683,256

Lounatmaa, et al., ���Effect of Polymyxin on the Ultrastructure of the Outer Membrane of Wild-Type and Polymyxin-Resistant Strains of Salmonella,��� J. of Bacteriology, 127:3 (1976)

McDaniel et al., ���A Putative ABC Transporter Permease is Necessary for Resistance to Acidified Nitrite and EDTA

Office Action dated August 11, 2011 in Application No. 12/243,949 (U.S. Patent No. 8,084,443)

IPR 2021-00860 Patent Owner's Preliminary Response

Expert Report of Louis DeFilippi on '256 Patent

On the Mechanism of Action of Ribonuclease A

Guideline for Disinfection and Sterilization

Study of the Frequency of Clostridium Difficile

Effectiveness of Alcohol-based Hand Rubs

Screening of SDS-degrading Bacteria

Effects of Treatment with Sodium Dodecyl Sulfate

Effect of Ethylenediaminetetraacetic acid (EDTA)

EDTA Medium

Declaration of Elliott J. Williams

Notice of Accord Filing Date

Patent Owner's Mandatory Notices Pursuant to 37 C.F.R. Sec. 42.8

Power of Attorney for Longhorn Vaccines & Diagnostics, LLC

Petition for Inter Partes Review of U.S. Patent No.9,683,256

Spectrum's Power of Attorney - 9,683,256

Fischer, U.S. Pat. 9,683,256

Taylor Declaration

Birnboim, U.S. Pub. 2004-0038269 A1

Maniatis, Isolation of mRNA from Mammalian Cells (1982)

Cox, The Use of Guanidinium Chloride in the Isolation of Nucleic Acids (1968)

Sela, The Correlation of Ribonuclease Activity (1957)

Longhorn Vaccines's Amended Complaint

Das, U.S. Pub. 2005-0123928 A1

Goldrick, U.S. Pat. 5,422,241

Chomczynski, WO 97-05248 A2 (Original 20201218053237)

Mori, WO 2005-111210 A1

Moon, U.S. Pub. 2004-0101859 A1

Ausubel, Preparation and Analysis of RNA, (2003)

Ausubel, Analysis of Protein Interactions (2003)

Chirgwin, Isolation of Biologically Active Ribonucleic Acid (1979)

Koller, WO 1991-002740 A1

Reed, WO 2000-77235 A1

Lader, U.S. Pat. 6,204,375

Helftenbein, U.S. Pat. 6,776,959

Monahan, Extraction of RNA from Intracellular Mycobacterium Tuberculosis

Augello, U.S. Pat. 6,617,170

WO 2004/104181 A2

Farrell, Chapters 4 and 5

Excerpts from The American Heritage Dictionary (2000)

Heineman, U.S. Pub. 2005-0079484 A1

Promega 1993-1994 Catalog (1994)

Fisher Catalog 1998-1999 (1999)

Brady 1990 buffers.

Taylor Resume

Taylor's List of Materials Considered