Becton, Dickinson and Company et al. vs B. Braun Melsungen AG

FINAL WRITTEN DECISION 35 U.S.C. ¿¿ 318(a) and 37 C.F.R. ¿¿ 42.73 ORDER ADDRESSING MOTION TO AMEND 37 C.F.R. ¿¿ 42.121 (PUBLIC VERSION)

Notice of Appeal

Notice of Confidential Information in Written Decision

Redacted Final Written Decision

Termination Decision Document

Conduct of the Proceeding

Order Denying Two Motions to Exclude and One Motion to Strike

Order Granting Three Motions to Seal

Hearing Transcript

Patent Owner's Updated Demonstratives for Oral Argument

Petitioner's Revised Demonstratives

PETITIONER'S DEMONSTRATIVES FOR ORAL ARGUMENT

Patent Owner's Demonstratives for Oral Argument

PETITIONER'S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE EVIDENCE

Patent Owner's Reply in Support of its Motion to Exclude

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

Order - Trial Hearing

Order - Conduct of the Proceeding

Petitioner's Motion to Strike

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

Petitioner's Motion to Seal

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

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

Joint Request for Oral Argument

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

Transcript of Deposition of Richard Meyst on August 13, 2018

Screenshot from Exhibit 2044, Part 1 at 0:50, provided as Exhibit A in the August 13, 2018 Deposition of Richard Meyst

Annotated version of U.S. Patent No. 8,460,247, provided as Exhibit D in the August 13, 2018 Deposition of Richard Meyst

Screenshot from Exhibit 2044, Part 2 at 0:05, provided as Exhibit B in the August 13, 2018 Deposition of Richard Meyst

Annotated version of Figure 3 from the '247 patent, provided as Exhibit C in the August 13, 2018 Deposition of Richard Meyst

Petitioner's Objections to Evidence

Patent Owner's Motion to Exclude

Petitioner's Motion to Exclude Evidence

Patent Owner's Motion to Exclude

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

Joint Stipulation Regarding Due Date 4

Petitioner's Response to Patent Owner's Sur-Reply Regarding New Arguments

Petitioner's Notice of Deposition of Richard P. Meyst

Joint Motion to Seal

Redacted July 12, 2018 Deposition Transcript of J. Griffis III

Patent Owner's Sur-Reply Regarding New Arguments Presented by Petitioner's Reply

PETITIONER'S OBJECTIONS TO EVIDENCE

Patent Owner's Reply in Support of its Contingent Motion to Amend

Supplemental Declaration of Richard Meyst

July 12, 2018 Deposition Transcript of Jack Griffis, III

Certified Translation of Japanese Patent Application No. 2001-68570 to Nakajima

July 12, 2018 Deposition Transcript of Jack Griffis, III

Patent Owner's Notice of Deposition of Jack Griffis, III

Patent Owner's Evidentiary Objections

Declaration of Richard Meyst in Support of Patent Owner's Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 9,370,641

Michael Pham and Steven M. Neustein, A Needlestick Injury With the Introcan Safety Needle, 108 Anesthesia & Analgesia 669 (2009) ("Needlestick Article")

Meeting Agenda/Minutes" dated May 4, 2009, starting at Bates Number BBDE0245616

Blood Control Technology Competitive Update dated June 22, 2012, starting at Bates Number BBDE0299865

Lynn Dianne Phillips, Manual of IV Therapeutics 290-95 (3rd ed. 2001

Declaration of Richard Meyst in Support of Patent Owner's Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 8,460,247

International Standard, ISO 9626, Stainless steel needle tubing for the manufacture of medical devices - Amendment 1 (2001 version) ("ISO 9626")

B.Braun starting at Bates Number BBDE0176652

VOC Sao Paulo Brazil dated October 1, 2007, starting at Bates Number BBDE0177428

Septum performance comparison (IAG-BC vs Medikit) starting at Bates Number BBDE0255539

VOC Chicago IL dated October 5, 2007, starting at Bates Number BBDE0267666

Project Boulder - Development Phase - Interim Review dated June 3, 2010, starting at Bates Number BBDE0318033

BD Marketing Documents starting at Bates Number BBDE0391900

Transcript of Deposition of Richard Meyst on May 23, 2018

BD Infusion Therapy Systems Test Protocol 10067, "Boulder Air Vent Aging Effect Evaluation"

BD Infusion Therapy Systems Test Protocol 9142, Boulder Air Vent Performance Evaluation

Comprehensive Safety ¿¿¿ Concept Review dated November 14, 2007, starting at Bates Number BBDE0321416

Project Boulder - Product Design dated October 28, 2010, starting at Bates Number BBDE0334804

Comprehensive Safety - Concept Review dated October 19, 2006, starting at Bates Number BBDE0396050

U.S. Patent No. 8,357,119 to Stout et al

U.S. Patent No. 8,361,020 to Stout

Meeting Agenda/Minutes dated June 3 2009

Presentation entitled "Project Boulder - Envelope Freeze Core Team Check Point and 14/16 ga Strategy Review" dated June 3, 2009

Declaration of Marty Stout in Support of Petitioner's Oppositions to Motions to Amend

Competitive Analysis - Short Peripheral IV Catheter Market (US) starting at Bates Number BBDE0176669

U.S. Patent No. 5,501,675 to Erskine

U.S. Publication No. 2006/0200080 to Abulhaj, published Sep. 7, 2006

U.S. Publication No. 2006/0074384 to Kohler

Uniform, Stedman's Medical Dictionary (27th ed. 2000)

U.S. Patent No. 4,809,679 to Shimonaka et al.

U.S. Patent No. 5,290,246 to Yamamoto et al.

U.S. Patent No. 8,388,583 to Stout et al.

Supplemental Declaration of Jack Griffis, III in Support of Petitioner's Reply and Opposition to Motion to Amend

Supplemental Declaration of Jack Griffis, III in Support of Petitioner's Reply and Opposition to Motion to Amend

Declaration of Marty Stout in Support of Petitioner's Oppositions to Motions to Amend

U.S. Patent Publication No. 2002/0128604 to Nakajima

U.S. Patent No. 5,558,651 to Crawford

U.S. Publication No. 2007/0196414 to Hammarsten et al., published Aug. 23, 2007

U.S. Application No. 13/667,261 Prosecution History Excerpts

U.S. Patent No. 5,032,116 to Peterson et al.

U.S. Patent No. 5,419,766 to Chang et al.

Redacted Opening Expert Report of Jack Griffis III

Claus M. Muth & Erik S. Shank, Gas Embolism, 342 N. England J of Med. 476 (Feb. 17, 2000) ("Muth")

U.S. Patent No. 4,622,964 to Flynn

U.S. Patent No. 6,042,876 to Deem

Excel Spreadsheet entitled, PVD Board AVT Septum Venting

U.S. Patent No. 5,697,907 to Gaba

U.S. Application No. 14/062,081 Prosecution History

Redacted Defendants' Initial Invalidity Contentions, B. Braun Melsungen AG v. Becton, Dickinson and Company Case 16- 411 (D. Del., Feb. 14, 2017)

U.S. Patent No. 5,596,996 to Johanson et al

Excel spreadsheet entitled Vent Leak Pressure

U.S. Patent No. 9,370,641

Motion to Seal

Petitioner's Opposition to Contingent Motion to Amend

Petitioner's Reply to Patent Owner's Response

Petitioner's Reply to Patent Owner's Response

Excel Spreadsheet entitled Boulder BEV

Email from Marty Stout dated Feb. 22, 2010, Re: 1500 Parts

Patent Owner's Contingent Motion to Amend in Inter Partes Review of U.S. Patent No. 9,370,641

U.S. Patent 9,114,241

Petitioner's Opposition to Contingent Motion to Amend

Petitioner's Updated Mandatory Notices

Petitioner's Updated Power of Attorney

ORDER Motion for Pro Hac Vice Admission of Omar A. Khan

PETITIONER'S MOTION FOR ADMISSION PRO HAC VICE OF OMAR A. KHAN

DECLARATION OF OMAR A. KHAN IN SUPPORT OF MOTION FOR ADMISSION PRO HAC VICE

ORDER Motion for Pro Hac Vice Admission of William G. McElwain

PETITIONER'S AMENDED NOTICE OF DEPOSITION OF RICHARD P. MEYST

Order Conduct of the Proceeding

Petitioner's Motion for Pro Hac Vice of McElwain

McElwain Declaration

Meyst Deposition Notice

Petitioner's Objections to Evidence

U.S. Patent No. 5,228,453

Comparison between the specifications of US8419688 and US8460247

Comparison between the specifications of US8460247 and US8597249

Comparison between the specifications of US8597249 and US8591468

Patent Owner's Response

Supplemental Declaration of Richard Meyst with updated curriculum vitae of Dr. Richard Meyst

Comparison between the specifications of US8308691 and US8419688

Comparison between the specifications of US8591468 and US9370641

Certified copy of German Patent Application No. DE20210394.3 (Original German Version)

Certified English Translation of German Patent Application No. DE20210394.3

IPR2017-01589 ¿¿¿ Decision Instituting Inter Partes Review, Paper No. 8, Issued Jan. 12, 2018

German language comparison between DE20210394 and PCT/EP2003/007073

PTAB Guidance on Motions to Amend in view of Aqua Products, dated November 21, 2017

IPR2017-01588 ¿¿¿ Decision Instituting Inter Partes Review, Paper No. 8, Issued Dec. 21, 2017

File History of U.S. Patent No. 8,308,691

29 C.F.R. 1910.1030 entitled ¿¿¿Bloodborne pathogens¿¿¿

Meyst video showing operation of Introcan Safety¿¿ 3 product- Part 1

File History of U.S. Patent No. 8,460,247

Deposition Transcript of Jack Griffis, III dated March 1, 2018 (Non-Confidential Version)

Deposition Transcript of Jack Griffis, III dated March 2, 2018

Enlargement of paragraph 94 from Griffis Declaration, Ex. 1002, Exhibit B to the March 2, 2018 Deposition Transcript of Jack Griffis, III

Annotated figure 9 of Callaway patent application with markings, Exhibit C to the March 2, 2018 Deposition Transcript of Jack Griffis, III

File History of U.S. Patent No. 9,370,641

B. Braun Introcan Safety¿¿ 3 Closed IV Catheter Video

Meyst video showing operation of Introcan Safety¿¿ 3 product- Part 2

U.S. Patent No. 6,506,181

U.S. Patent No. 5,053,014

File History of U.S. Patent No. 8,597,249

U.S. Patent No. 8,333,375, Ex. A to to the March 2, 2018 Deposition Transcript of Jack Griffis, III

Annotated page 211 from redacted version of Opening Expert Report of Jack Griffis, III, Ex. 2023, Exhibit D to the March 2, 2018 Deposition Transcript of Jack Griffis, III

Annotated figure 7 from Villa patent application, Exhibit E to the March 2, 2018 Deposition Transcript of Jack Griffis, III

U.S. Patent Publication No. 2002/0128604

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

Conduct of the Proceeding 37 C.F.R. sec 42.5

Conduct of the Proceeding Granting Motions to Compel Discovery Granting Motions to Seal Entering Protective Order 37 C.F.R. sec 42.5; 37 C.F.R. sec 42.51(b)

Petitioner's Motion to Seal

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

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

Joint Motion to Seal and For Entry of Stipulated Protective Order

Patent Owner's Motion to Compel Under 37 C.F.R. 42.52

Patent Owner's Updated Exhibit Listing

Patent Owner¿¿¿s Table of Materials for Motion to Compel, contains PROTECTIVE ORDER MATERIAL

Patent Owner¿¿¿s Table of Materials for Motion to Compel

Proposed Protective Order for IPR2017-01589

Redline of Proposed Protective Order in IPR2017-01589

Protective Order in B. Braun Melsungen AG, et al. v. Becton, Dickinson and Company, 16-cv-00411-RGA (D. Del. 10/21/16)

ORDER Conduct of the Proceeding

Patent Owner's Notice of Deposition of Jack Griffis, III

Patent Owner's Evidentiary Objections

Trial Instituted Document

Scheduling Order

Exhibit 2002

Exhibit 2004

Exhibit 2006

Exhibit 2009

Exhibit 2010

Exhibit 2011

Exhibit 2012

Patent Owner's Preliminary Response

Exhibit 2001

Exhibit 2003

Exhibit 2005

Exhibit 2007

Exhibit 2008

Exhibit 2016

Exhibit 2017

Exhibit 2018

Exhibit 2013

Exhibit 2014

Exhibit 2015

Exhibit 2020

Exhibit 2021

Exhibit 2022

Exhibit 2019

Notice of Accord Filing Date

Patent Owner's Power of Attorney

Patent Owner's Submission of Mandatory Notice Information

U.S. Patent No. 8,597,249 (issued Dec. 3, 2013) (the 249 Patent)

WO Publication No. 2004/004819 to Woehr, published Jan. 15, 2004 (Woehr)

U.S. Patent Publication No. 2005/0043684 to Basta, published Feb. 24, 2005 (Basta)

Certified Translation of WO Publication No. 2004/004819 to Woehr (Ex. 1003)

U.S. Patent Application No. 13/407,395 Prosecution History, Response of Feb. 7, 2013

U.S. Patent Publication No. 2004/0225260 to Villa et al., published Nov. 11, 2004 (Villa)

U.S. Patent No. 6,709,419 (issued Mar. 23, 2004) (the 419 patent)

U.S. Patent No. 6,616,630 (issued Sept. 9, 2003) (the 630 patent)

U.S. Patent No. 8,382,718 (issued Feb. 26, 2013) (the 718 patent)

U.S. Patent Publication No. 2005/0075609 to Latona, published Apr. 7, 2005

U.S. Patent No. 7,651,476 (issued Jan. 26, 2010) (the 476 patent)

Intravenous Therapy Clinical Principles and Practices 317 (Judy Terry et al. eds., 1995)

U.S. Patent No. 5,858,002 (issued Jan. 12, 1999)

ISO 10555 (1996 version).pdf

U.S. Patent No. 4,850,961 (issued Jul. 25, 1989)

US Publication No. 2001/0053895 to Vaillancourt, published Dec. 20 2001

U.S. Patent No. 5,458,658 (issued Oct. 17, 1995) (Sircom)

U.S. Patent No. 5,215,528 (issued Jun. 1, 1993) (Purdy)

U.S. Patent 6,117,108 (issued Sept. 12, 2000) (Woehr 108)

Hanrahan & Reutter, A critical review of the literature on sharps injuries: epidemiology, management of exposures and prevention, 25 J Adv. Nursing 144-154, 147 (1997)

Plumers Principles & Practice of Intravenous Therapy - 7th

US Publication No. 2002/0169418 to Menzi, published Nov. 14, 2002 (Menzi)

EP 352 928

Powers Article 2002

FDA Guidance Document on Needle Safety Devices

U.S. Patent Publication No. US 2007/0038186 to Sutton et al., published Feb. 15, 2007 (Sutton)

OSHA Bloodborne Pathogens Standard, 56 Fed. Reg. 64004 64114 (Dec. 6, 1991) (OSHA Standard)

Needlestick Safety and Prevention Act, Pub. L. No. 106-430, 114 Stat. 1901, 1902 (2000) (Needlestick Prevention Act)

A.M. Rivera et al., The history of peripheral intravenous catheters: How little plastic tubes revolutionized medicine, 56 Acta Anaesth. Belg. 271, (2005) (Rivera)

US Publication No. 2004/0116856 to Woehr, published Jun. 17, 2004

U.S. Patent Publication No. 2006/0178635 to Callaway, published Aug. 10, 2006 (Callaway)

WO Publication No. 1995/022364 to Rogers et al., published Aug. 24, 1995 (Rogers)

U.S. Patent No. 8,333,735 (issued Dec. 18, 2012) (the 735 patent)

N.Y. STATE, DEPT OF HEALTH, PILOT STUDY OF NEEDLESTICK PREVENTION DEVICES, Report to the New York State Legislature, (March, 1992) (Pilot Study)

Power of Attorney

Fee Authorization

Declaration of Mr. Griffis (Griffis Decl.)

Petition