`INTUITIVE SURGICAL, INC., INTUITIVE
`SURGICAL OPERATIONS, INC., and
`INTUITIVE SURGICAL HOLDINGS, LLC
`
`
`Defendants.
`
`v.
`
`
`
`
`
`
`
`)
`)
`)
`) C.A. No. 1-17-cv-871 (LPS) (CJB)
`)
`) JURY TRIAL DEMANDED
`)
`)
`)
`)
`)
`)
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`ETHICON LLC,
`ETHICON ENDO-SURGERY, INC., and
`ETHICON US, LLC.
`
`
`Plaintiffs,
`
`ETHICON’S TECHNOLOGY TUTORIAL DESK REFERENCE BOOK
`
`Plaintiffs Ethicon LLC, Ethicon Endo-Surgery, Inc., and Ethicon US, LLC (“Ethicon”)
`
`submit this desk reference book to accompany the interactive technology tutorial that is being
`
`submitted concurrently. The images, text, and slide numbers in this desk reference book
`
`correspond to the presentation in the interactive technology tutorial.
`
`MORRIS, NICHOLS, ARSHT &
`TUNNELL LLP
`/s/ Jack B. Blumenfeld
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347 Wilmington, DE 19899
`(302) 658-9200 jblumenfeld@mnat.com
`began@mnat.com
`Attorneys for Ethicon LLC, Ethicon Endo-
`Surgery, Inc. and Ethicon US, LLC
`
`
`
`
`
`
`
`
`
`
`
`OF COUNSEL:
`Elizabeth S. Weiswasser
`Anish R. Desai
`WEIL GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`(212) 310-8000
`
`
`
`1
`
`Ethicon Exhibit 2003.001
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`
`Diane P. Sullivan
`WEIL GOTSHAL & MANGES, LLP
`17 Hulfish Street Suite 201
`Princeton, NJ 08542
`(609) 986-1120
`
`Christopher T. Marando
`Christopher M. Pepe
`Matthew D. Sieger
`WEIL GOTSHAL & MANGES, LLP
`2001 M Street, N.W.
`Suite 600
`Washington, D.C. 20005
`(202) 682-7000
`
`June 28, 2018
`
`
`
`
`
`
`2
`
`Ethicon Exhibit 2003.002
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 1
`This tutorial is accompanied with a narrative audio track. Please make sure that the
`speakers on your computer are turned ON and your volume is turned UP appropriately.
`You may advance to the next slide at any time by pressing the next arrow (or the right
`arrow key). You may go to a previous slide at any time by pressing the back arrow (or
`the left arrow key). You may jump to any slide by entering the slide number in the field
`and pressing the enter key. You may jump to any section in the tutorial by using the
`chapter menu. When it is time to advance the slide, you will be prompted by a blinking
`next arrow.
`
`6/28/2018
`
`Ethicon Exhibit 2003.003
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 2
`This is Ethicon’s technology tutorial in the matter of Ethicon LLC et al. v. Intuitive Sur-
`gical, Inc. et al., Civil Action No. 1:17-cv-871-LPS-CJB. There are seven patents asser-
`ted in this case. Each patent concerns surgical tools for use in laparoscopic surgical
`procedures. My name is Elizabeth Weiswasser, and I am an attorney representing
`Ethicon. I will be addressing some background concepts to provide context for the
`patented technology. My colleague Anish Desai will then discuss the asserted patents
`in more detail.
`
`6/28/2018
`
`Ethicon Exhibit 2003.004
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 3
`The first topic we will discuss is the difference between open surgery and laparoscopic
`surgery.
`
`6/28/2018
`
`Ethicon Exhibit 2003.005
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 4
`Traditional surgery is commonly referred to as open surgery. In open surgery, incisions
`are made that are large enough to allow the surgeon to view the surgical site. Because
`the surgeon has direct access to the surgical site, the surgeon can use tools of varying
`sizes and geometries. The benefit of direct access to the surgical site comes at the
`cost of a relatively long recovery time and increased pain for the patient.
`
`6/28/2018
`
`Ethicon Exhibit 2003.006
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 5
`Laparoscopic surgery is an alternative to open surgery. Laparoscopic surgery replaces
`one large incision with several smaller incisions. The terms “laparoscopic” and “mini-
`mally invasive” are commonly used interchangeably. We’ll use the term laparoscopic
`for convenience. In a laparoscopic procedure, a small camera is inserted through one
`of the incisions, and the surgical site is displayed on a monitor. Devices called trocars
`are inserted through the incisions, and surgical tools are inserted through the trocars.
`The smaller incisions in laparoscopic surgery offer the potential benefits of reduced
`recovery time and pain, but they come at the cost of reduced access to the surgical
`site.
`
`6/28/2018
`
`Ethicon Exhibit 2003.007
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 6
`We will next describe some background concepts concerning surgical stapling.
`
`6/28/2018
`
`Ethicon Exhibit 2003.008
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 7
`The surgical staplers at issue in this case cut tissue and simultaneously staple the
`tissue on each side of the cut line. This type of surgical stapler can be used to remove
`tissue from the body, such as a tumor, a piece of the intestine, or a piece of the
`stomach. A surgical stapler for use in open surgery is shown here.
`
`6/28/2018
`
`Ethicon Exhibit 2003.009
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 8
`A laparoscopic surgical stapler is also called an endocutter. We will use the terms
`“stapler” and “endocutter” interchangeably in this tutorial to refer to this type of device.
`Unlike an open instrument, an endocutter must be inserted through a trocar. This
`requires a shaft that fits within the trocar and runs from the handle of the endocutter
`to the stapler jaws. The direction pointed toward the stapler jaws is called the “distal”
`direction and the opposite direction is called the “proximal” direction. An Ethicon
`60mm endocutter is shown here. Endocutters are commonly referred to by the length
`of the staple line they produce. For example, it is common for endocutters to be refer-
`red to as 35mm endocutters, 45mm endocutters, or 60mm endocutters. We will next
`describe the basics of surgical stapling in more detail.
`
`6/28/2018
`
`Ethicon Exhibit 2003.010
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 9
`This is a depiction of the shaft and stapler jaws of an endocutter. The stapler has two
`jaws, which can also be referred to as the end effector. Because endocutters are oper-
`ated through trocars and in tight spaces, they typically include controls that allow the
`surgeon to position the stapler jaws without moving the handle. For example, the endo-
`cutters will include controls that spin the shaft and stapler jaws. This is also called
`“roll” motion. The endocutters also include controls to articulate the stapler jaws.
`By articulate, we mean rotating the jaws side to side, which is called “yaw” motion,
`and up and down, which is called “pitch” motion.
`
`6/28/2018
`
`Ethicon Exhibit 2003.011
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 10
`We will now describe how an endocutter clamps, cuts, and staples tissue. Prior to use,
`a stapler reload cartridge is inserted into a pocket in one of the stapler jaws. The sur-
`geon then positions the jaws and clamps them around tissue. The surgeon is now
`ready to cut and staple. This is also referred to as “firing” the endocutter. When the
`surgeon fires, a knife connected to a sled advances forward in the cartridge toward the
`end of the jaws. The knife cuts the tissue, and the sled pushes staples upwardly on
`both sides of the knife into the opposite jaw. This jaw is referred to as the anvil. When
`the staples strike the anvil, the staples are bent inwardly to form a “B” shaped staple
`around the tissue. In this way, tissue on either side of the cut line is stapled.
`
`6/28/2018
`
`Ethicon Exhibit 2003.012
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 11
`We’ll now discuss some example procedures involving surgical stapling.
`
`6/28/2018
`
`Ethicon Exhibit 2003.013
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 12
`Bariatric surgery is an example procedure that involves cutting and stapling tissue in
`the body. Specific types of bariatric surgery include gastric bypass and gastric sleeve
`surgery. In the illustrated gastric bypass procedure, an endocutter is used to simul-
`taneously cut stomach tissue and staple on both sides of the cut line, sealing the
`tissue after the cut.
`
`6/28/2018
`
`Ethicon Exhibit 2003.014
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 13
`In a sleeve gastrectomy procedure illustrated here, portions of stomach tissue are cut
`using an endocutter, resulting in separate sealed sections after stapling on both sides
`of the cut. The narrow portion that is retained is called the gastric sleeve, and the
`remaining section is removed.
`
`6/28/2018
`
`Ethicon Exhibit 2003.015
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 14
`With growing evidence of the positive health outcomes associated with bariatric
`surgeries, the procedure volume has grown substantially over the past 20 plus years.
`The procedures have also gone from being predominantly open procedures in the early
`2000s to nearly entirely laparoscopic procedures as of 2014.
`
`6/28/2018
`
`Ethicon Exhibit 2003.016
`Intuitive v. Ethicon
`IPR2018-00934
`
`
`
`Ethicon Technology Tutorial
`
`Slide 15
`Since the early 1990s, Ethicon has worked to develop numerous endocutters to ad-
`dress changing surgical needs, including surgical needs in bariatric procedures. In
`2011, Ethicon introduced its first motor-powered endocutter — the ECHELON FLEX™
`Powered ENDOPATH® Stapler. Ethicon’s motor-powered endocutters dramatically
`reduce the force required to operate an endocutter, thereby minimizing unwanted
`movement of the device during procedures that could result in increased tissue
`trauma. In 2014, Ethicon introduced its ECHELON FLEX™ Stapler with Gripping Sur-
`face Technology (also known as GST), which greatly reduces tissue slippage while
`firing the stapler.
`
`6/28/2018
`
`Ethicon Exhibit 2003.017
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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