Trial No. IPR2013-00187
`Docket No.: 0100678-00140
`
`Filed on behalf of Atrium Medical Corporation
`By: David L. Cavanaugh, Reg. No. 36,476
`
`Larissa Park, Reg. No. 59,051
`
`Wilmer Cutler Pickering Hale and Dorr LLP
`
`1875 Pennsylvania Ave., NW
`
`Washington, DC 20006
`Tel: (202) 663-6025
`Email: David.Cavanaugh@wilmerhale.com
`Larissa.Park@wilmerhale.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`ATRIUM MEDICAL CORPORATION
`
`Petitioner
`
`v.
`
`DAVOL, INC.
`
`Patent Owner of U.S. Patent No. 7,785,334 to Ford et al.
`
`IPR Trial No. IPR2013-00187
`
`DECLARATION OF THEODORE KARWOSKI
`
`- 1 -
`
`Atrium v. Davol
`IPR2013-00187
`ATRIUM 1129
`
`
`Docket No.: 0100678-00140
`
`Filed on behalf of Atrium Medical Corporation
`By: David L. Cavanaugh, Reg. No. 36,476
`
`Larissa Park, Reg. No. 59,051
`
`Wilmer Cutler Pickering Hale and Dorr LLP
`
`1875 Pennsylvania Ave., NW
`
`Washington, DC 20006
`Tel: (202) 663-6025
`Email: David.Cavanaugh@wilmerhale.com
`Larissa.Park@wilmerhale.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`ATRIUM MEDICAL CORPORATION
`
`Petitioner
`
`v.
`
`DAVOL, INC.
`
`Patent Owner of U.S. Patent No. 7,785,334 to Ford et al.
`
`IPR Trial No. IPR2013-00187
`
`DECLARATION OF THEODORE KARWOSKI
`
`- 1 -
`
`Atrium v. Davol
`IPR2013-00187
`ATRIUM 1129
`
`
`
`Declaration of Theodore Karwoski
`
`
`
`I, Theodore Karwoski, declare as follows:
`
`1.
`
`2.
`
`My name is Theodore Karwoski.
`
`From 1982 through 2013, I worked at Atrium Medical Corporation
`
`(“Atrium”), serving variously as Chief Operating Officer, Chief Development
`
`Officer, and Senior Vice President of Research and Operations. I am now a
`
`consultant to Atrium.
`
`3.
`
`Atrium is in the business of making and selling medical devices,
`
`including hernia repair devices such as plugs and patches. In the late 1990s,
`
`Atrium introduced its Self-Forming Plug, a hernia repair device with three layers
`
`of polypropylene mesh including a tissue barrier layer and a center rectangular tab
`
`for placement, control of insertion, positioning and attachment. Patented by
`
`Atrium in 2000, the Self-Forming Plug was designed to expand into and conform
`
`to the shape and space of a hernia defect. Atrium still sells it today.
`
`4.
`
`In 2006, Atrium received FDA clearance for, and began to market, its
`
`C-QURTM Mesh, a hernia repair device consisting of Atrium’s polypropylene mesh
`
`coated with Omega-3 fatty acid (“O3FA”). The C-QURTM Mesh was designed to
`
`be a tissue separating layer for open and laparoscopic hernia repair. Atrium still
`
`sells it today.
`
`- 2 -
`
`
`
`Declaration of Theodore Karwoski
`
`5.
`
`In late 2005, Atrium began development of the C-QUR V-PatchTM
`
`(“V-PatchTM”). In 2008, Atrium received FDA clearance for, and began to market,
`
`the device. Atrium’s V-PatchTM is designed to repair small hernias and other
`
`abdominal wall defects. It has an O3FA bioabsorbable coating and is constructed
`
`out of two layers of polypropylene mesh that are sewn with, and include, a mesh
`
`stabilizing ring. The O3FA bioabsorbable coating is integral to the polypropylene
`
`mesh. Building off the success of Atrium’s Self-Forming Plug’s prior art tabs, it
`
`also has two extended mesh fixation straps to allow the doctor to position, fixate,
`
`and handle the patch.
`
`6.
`
`Both patents in these proceedings issued after the V-PatchTM was
`
`approved for clearance in 2008: the ’334 Patent issued on August 31, 2010 and the
`
`’905 Patent issued on October 5, 2010.
`
`7.
`
`Davol, Inc. (“Davol”) competes with Atrium in the hernia repair
`
`device market. Since 2002, Davol or its parent company, C.R. Bard, Inc. (“Bard”),
`
`have marketed and sold the VentralexTM patch.
`
`8.
`
`I understand that, in this proceeding, Davol employee Michael Lee
`
`has testified that Atrium copied Davol’s VentralexTM patch. Specifically, I
`
`understand that Mr. Lee claims that Atrium’s V-PatchTM is a copy of Davol’s
`
`VentralexTM patch.
`
`- 3 -
`
`
`
`Declaration of Theodore Karwoski
`
`9.
`
`Atrium did not copy Davol’s VentralexTM patch, and Atrium’s V-
`
`PatchTM is not a copy of Davol’s VentralexTM patch.
`
`10. As a medical device manufacturer, Atrium naturally wants to develop
`
`and sell superior products to compete in the marketplace. In response to requests
`
`from doctors for a hernia repair device that would perform better than competitors’
`
`products (such as Davol’s VentralexTM patch), Atrium developed the V-PatchTM.
`
`Beginning in the early 1990s, various plugs and patches were developed to
`
`improve repairs made in abdominal wall defects. These implants evolved based
`
`upon surgical use and surgeons’ feedback on improvements in techniques and
`
`design. Initial plugs were found to migrate after insertion due to inadequate
`
`anchoring and abdominal wall defect increases and changes, to harden due to poor
`
`tissue integration, and to have other inadequacies. Atrium’s Self-Forming Plug as
`
`marketed (in 1997) and patented (in 2000) built upon prior art evolution and
`
`improvements. Through surgical use, Surgeons soon recognized that they could
`
`modify the circular plug with tabs of Atrium’s Self-Forming Plug to provide a
`
`patch, or shield, covering a defect through the abdominal wall. Surgeons then
`
`suggested modifications to the Self-Forming Plug’s design, and those suggestions
`
`were part of the variety of product evolutions and designs that led to the V-PatchTM
`
`product.
`
`- 4 -
`
`
`
`Declaration of Theodore Karwoski
`
`11. Atrium’s V-PatchTM and Davol’s VentralexTM patch share certain
`
`features, such as a multiple layer structure, use of polypropylene mesh, use of a
`
`barrier, and straps. All of these features, however, were well-known in the pre-
`
`2002 prior art. None is unique to Atrium or Davol’s products.
`
`12. Unlike Atrium’s V-PatchTM, however, Davol’s VentralexTM patch has
`
`no O3FA coating. The Atrium V-PatchTM’s O3FA coating has been shown to
`
`minimize visceral tissue attachment to the mesh, and was designed in response to
`
`doctors’ demands for a better-performing product.
`
`13. Both Atrium’s V-PatchTM and Davol’s VentralexTM patch come in
`
`identical sizes. That similarity, however, is due not to copying but rather to
`
`doctors’ preferences and the limited range of sizes for the products’ shared purpose
`
`(the repair of small hernia-related defects).
`
`Availability for Cross-Examination
`
`14.
`
`In signing this declaration, I recognize that the declaration will be
`
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office. I also recognize that I may be
`
`subject to cross examination in the case and that cross examination will take place
`
`within the United States. If cross examination is required of me, I will appear for
`
`cross examination within the United States during the time allotted for cross
`
`examination.
`
`- 5 -
`
`
`
`Declaration of Theodore Karwoski
`
`Jurat
`
`15.
`
`I declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and firrther that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
`
`Dated: (63 3 25( f
`
`Theodore Karwoski
`Hollis, New Hampshire
`
`l
`
`
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