Becton, Dickinson and Company vs Sage Products, LLC et al.

Sage Products, LLC's Notice of Appeal

Jointly Submitted Redacted Final Written Decision - Corrected

EXPUNGED

JUDGMENT Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a) Granting Patent Owner’s Motion for Entry of Protective Order and to Seal 37 C.F.R. §§ 42.14, 42.54

Other: Hearing transcript

Patent Owner's Updated Exhibit List

Petitioner's Updated Exhibit List

Patent Owner Oral Argument Demonstratives

Petitioner Oral Argument Demonstratives

ORDER TRIAL HEARING

Patent Owner's Sur-Reply

Transcript of the Deposition of Dr. Sean Sheridan, dated August 29, 2022

Transcript of the Deposition of Simon Noble-Clarke, dated August 22, 2022

Transcript of the Deposition of Christopher McGinley, dated August 23, 2022 (Confidential)

Transcript of the Deposition of Christopher McGinley, dated August 23, 2022 (Redacted Version)

Patent Owner's Motion to Seal Portions of Exhibit 2045

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Argument

Patent Owner's Notice of Deposition of Simon Noble-Clarke

Patent Owner's Notice of Deposition of Christopher McGinley

Patent Owner's Notice of Deposition of Dr. Sean Sheridan

Patent Owner's Objections to Petitioner's Exhibits Submitted with Its Reply

Petitioner's Reply to Patentee's Response

Exhibit 1037

Exhibit 1038 Under Seal

Exhibit 1038 Redacted

Exhibit 1041

Exhibit 1042

Exhibit 1043

Exhibit 1044

Exhibit 1045

Exhibit 1046

Exhibit 1047 Under Seal

Exhibit 1047 Public

1048

Exhibit 1049

Exhibit 1050 Public

Exhibit 1051 Public

Exhibit 1050 Sealed.

Exhibit 1051 Sealed

Exhibit 1039 Public

Exhibit 1039 Under Seal

Exhibit 1040

Corrected Exhibit 1050 Under Seal

Notice of Deposition of Dr. Rutala

Petitioner���s Objections To Evidence Pursuant To 37 C.F.R. �� 42.64(b)(1)

Patent Owner's Response (Confidential)

Declaration of Dr. William Rutala (Confidential)

Transcript of the Deposition of Dr. Roger Dabbah, dated April 6, 2022

BD Press Release for FDA Approval for Fully Sterile Chlorhexidine Gluconate Antiseptic

Spreadsheet BDSageDNJ_0182166 (Confidential)

Spreadsheet BDSageDNJ_0271058 (Confidential)

Spreadsheet BDSageDNJ_0270958 (Confidential)

Spreadsheet BDSageDNJ_0182169 (Confidential)

Spreadsheet BDSageDNJ_0270915 (Confidential)

BD presentation BDSageDNJ_0270922 (Confidential)

Meeting minutes summary BDSageDNJ_0044200 (Confidential)

Degala File History Appeal Brief

Degala File History McGinley Declaration

Degala File History PTAB Decision (Ex Parte Degala)

Additional excerpts from Transcript of Deposition of Ralph Tarantino, September 17, 2021

British Standards Institution Screenprint British Standards and the Law

BSI Screenprint Standards and Regulations

MHRA Guide to Medicinal Products

Degala File History - USP Chapter 55

Additional excerpts BD���s Invalidity Contentions and Noninfringement Contentions (Redacted)

Redacted version of the Declaration of Dr. William Rutala (Ex. 2023)

Patent Owner's Response - Redacted

Patent Owner's Motion to Seal and Unopposed Motion for Entry of the Default Protective Order

Other: ORDER Conduct of Proceeding 37 C.F.R. § 42.5; 37 C.F.R. § 42.51

Patent Owner's Amended Notice of Deposition of Dr. Roger Dabbah

Joint Summary of Disputed Documents

Email From Deborah Laughton To Conn, Paula; Bob Surrette Sandra Frantzen Ben J. Mahon Jenna E. Saunders [email protected] [email protected] Sage-BDIPR Cc: Trials Subject: RE IPR2021-01201 and IPR2021-01202 Conference Request Date Tuesday, February 15, 2022

ORDER Conduct of Proceeding 37 C.F.R. sec 42.5 37 C.F.R. sec 42.51

Notice of Stipulation to Modify Due Dates 1, 2 and 3

BD's Miscellaneous Motion 1 (unopposed request for admission of Zachariah Summers, Esq. pro hac vice)

Ex. 1037

Patent Owner's Notice of Deposition of Dr. Roger Dabbah

Petitioner's Opposition to Patent Owner's Motion to Compel

Petitioner's Updated Exhibit List

Ex. 1036

Patent Owner's Motion to Compel Routine Discovery or, in the Alternative, for Additional Discovery

Stipulated Discovery Confidentiality Order

Email Correspondence

Letter Submitted by Patent Owner

Order, 02-23-2022

Patent Owner's Updated Exhibit List

Patent Owner's Updated Exhibit List

Transcript of Proceedings February 17, 2022

Patent Owner Updated Mandatory Notice Information

Patent Owner's Objections to Petitioner's Exhibits to the Petition

Institution Decision: Grant

Order: Scheduling Order

Patent Owner's Preliminary Response

FDA Call for Public Hearing

Pyrek Article (2013)

Rutala Outbreaks Article

2012 NEJM Article (Chang)

FDA Safety Announcement

2015 ChloraPrep FAQ

BD Elevating the Standard Brochure

FDA Website

2013 ChloraPrep Label

Ralph Tarantino, Ph.D. Transcript 09-17-21

Joint Claim Construction and Prehearing Statement

10,188,598 Certified FH Excerpted

BS EN 556-2 (2004)

Interrogatory Responses

Chiang US20140371695A1

BD Invalidity Contentions (Redacted)

NBC News Article

Patent Owner Mandatory Notice Information

Patent Owner Power of Attorney

Notice of Accord Filing Date

U.S. Patent No. 10,688,067

Prosecution History of U.S. Patent No. 10,688,067

Authenticating Affidavit of Duncan Hill from the Internet Archive

Excerpt of Ex. 1004 Authenticated ChloraPrep PAR

ChloraPrep PAR as archived on the MHRA Website

U.S. Patent Pub. No. 2015/0190535 A1 to Degala, et. al. (Degala)

U.S. Patent Application 2006/0051385 (Schlotz)

U.S. Patent Application 2014/0322072 (Margoosian)

U.S. Patent Application 2004/0162533

U.S. Patent Application 2015/0374729

International Standards Organization (ISO), ISO 11135:2014

ISO 17665-1:2006

ISO Technical Specification (ISO/TS) ISO/TS 17665-2:2009

ISO 20857:2010

British Standard (BS) BS EN 556-1:2001

Second Supplement to the United States Pharmacopeia (USP) USP-33-NF 28, Ch. 1211 (2010)

USP-38-NF 33, Ch. 71, 1211 (2015)

https://www.gov.uk/guidance/find-product-information-about-medicines#pars

https://products.mhra.gov.uk/about

http://discovery.nationalarchives.gov.uk/details/r/C1569

http://www.nationalarchives.gov.uk/webarchive/atoz/#m

https://webarchive.nationalarchives.gov.uk/*/http://www.mhra.gov.uk/index.htm

MHRAs archived sites for November 16, 2010

Food and Drug Administration (FDA) Guidance, Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice, (September 2004)

FDA Presentation, Sterility Review of 510(k) Submissions: Common Microbiology Issues Found in 510(k) Submissions

Food and Drug Administration Guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, Guidance for Industry and Food and Drug Administration Staff, (January 21, 2016)

von Woedtke T, Kramer A., The limits of sterility assurance. GMS Krankenhhyg Interdiszip. 2008;3(3):Doc19

Complaint, Sage Products, LLC, v. Becton, Dickinson and Company, No. 2:20-cv-08000-KM-JBC (D.N.J. June 30, 2020)

U.S. Patent No. 10,188,598

USP Monograph, April 1, 2014

U.S. Patent No. 6,536,975

U.S. Patent No. 6,991,394

Power of Attorney

Petition

U.S. Patent Pub. No. 20020115795

Dabbah Declaration

ISO 11137