`
`John B. Sganga, Jr. (SBN 116,211)
`john.sganga@knobbe.com
`Craig S. Summers (SBN 108,688)
`craig.summers@knobbe.com
`Christy G. Lea (SBN 212,060)
`christy.lea@knobbe.com
`Joshua J. Stowell (SBN 246,916)
`joshua.stowell@knobbe.com
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Telephone: 949-760-0404
`Facsimile: 949-760-9502
`
`Brian C. Horne (SBN 205,621)
`Brian.horne@knobbe.com
`1925 Century Park East, Suite 600
`Los Angeles, CA 90067
`Telephone: 310-551-3450
`
`Attorneys for Defendant,
`EDWARDS LIFESCIENCES CORPORATION
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE CENTRAL DISTRICT OF CALIFORNIA
`
`SOUTHERN DIVISION
`
`
`Case No.: 8:16-CV-00730-CJC-GJS
`
`
`EDWARDS’ SUPPLEMENTAL
`RESPONSE TO BSC’S
`INTERROGATORY NO. 8
`
`
`
`
`))))))))))))))
`
`
`BOSTON SCIENTIFIC
`CORPORATION and
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`
`
`Plaintiff,
`
`
`v.
`
`EDWARDS LIFESCIENCES
`CORPORATION, a California
`corporation,
`
`
`
`
`
`Defendant.
`
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`EDWARDS LIFESCIENCES EX. 1129
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00444
`
`

`

`
`
`Pursuant to the Federal Rules of Civil Procedure 26 and 33, Defendant
`Edwards Lifesciences Corporation (“Edwards”) hereby supplements its response
`to Interrogatory No. 8 of Plaintiffs Boston Scientific Corporation and Boston
`Scientific Scimed, Inc. (collectively, “BSC”).
`PRELIMINARY STATEMENT
`Edwards hereby incorporates, in full, the Preliminary Statement set forth
`in its Responses to BSC’s First Set of Interrogatories served on August 26,
`2016.
`
`GENERAL OBJECTIONS
`Edwards hereby incorporates, in full, the General Objections set forth in
`its Responses to BSC’s First Set of Interrogatories served on August 26, 2016.
`INTERROGATORY NO. 8:
`
`For each Patent-in-Suit, state all factual and legal bases for any contention
`that non-infringing alternatives regarding any Accused Product were or are
`available and acceptable, including an identification of all persons who have
`knowledge of such contention and all documents related to such contention.
`RESPONSE TO INTERROGATORY NO. 8:
`
`Subject to its General and Specific Objections, Edwards responds as
`follows:
`Edwards responds that acceptable non-infringing alternatives to the
`Accused Products exist. For example, at least some customers would choose to
`purchase
`the following
`transcatheter heart valve systems for use
`in
`transcathether aortic valve replacement or implantation if they could not
`purchase products from Edwards: CoreValve Evolut R System, CoreValve
`Evolut System, CoreValve ReValving System, Medtronic CoreValve System,
`Medtronic Engager System, St. Jude Medical Portico Transcatheter Aortic
`Valve Replacement System, Symetis Acurate neo System, Symetis Acurate neo
`System, Symetis Acurate TF System, Symetis Acurate TA System, Direct Flow
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`
`Medical Transcatheter Aortic Valve System, and JenaValve System. Edwards
`is unaware of any allegations by BSC that any of the transcatheter heart valve
`systems sold by these companies infringe any of the patents-in-suit. Because
`Edwards’ investigation of this matter is ongoing, Edwards reserves the right to
`supplement or amend this response, and to rely on additional documents,
`witnesses, or other evidence.
`The above response is subject to Edwards’ General Objections, each
`of which is fully incorporated herein, as well as the following Specific
`Objections: Edwards objects to this Interrogatory as premature, because fact
`discovery is ongoing and Edwards’ investigation of this matter continues.
`Edwards objects to this Interrogatory as overly broad and not proportional to the
`needs of this case to the extent that it seeks information about Edwards’ non-
`accused products or for products that BSC has identified as infringing but for
`which it has not provided sufficiently (or any) particularized and detailed
`infringement contentions. Edwards objects to this Interrogatory because it
`presumes that the Accused Products infringe the Patents-in-Suit, which they
`do not. Therefore, Edwards does not need to identify any non-infringing
`alternatives to the Accused Products. Edwards objects to this Interrogatory
`to the extent it seeks expert testimony or Edwards’ contentions at trial.
`Edwards will disclose any expert opinions or trial contentions as required by
`the Federal Rules of Civil Procedure, the Local Rules, and the Court’s
`Scheduling Order. Edwards objects to this Interrogatory as premature and
`calling for legal conclusions to the extent it seeks information concerning
`the meaning of claim terms that have yet to be construed. Edwards objects
`to this Interrogatory as overly broad, unduly burdensome, and not
`proportional to the needs of this case to the extent it seeks “all factual and
`legal bases” for any such contention. Edwards objects to this Interrogatory
`to the extent it seeks information that is publicly available, and therefore, of
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`no greater burden for BSC to obtain than Edwards. Edwards objects to this
`Interrogatory as seeking information protected from disclosure by a
`privilege or immunity, including without limitation, the attorney-client
`privilege, the work-product doctrine, and the common interest privilege.
`SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 8:
`Edwards hereby incorporates, in full, its response, including Specific
`Objections, set forth in its Response to Interrogatory No. 8 served on August 26,
`2016. Subject to its General and Specific Objections, Edwards responds that, in
`addition to the products identified in its original response, Edwards had
`noninfringing designs that were available and acceptable alternatives to the
`following accused products:
`NovaFlex family and Commander: For the asserted claims of the ’543,
`’548, ’962, ’827, ’234, and ’062 patents, Edwards had several acceptable non-
`infringing alternative designs that do not use the balloon insert in the NovaFlex
`or the coil in the Commander, which Boston accuses of satisfying the
`“mounting body” and other similar claim limitations. These designs would have
`provided adequate retention force on the valve.
`One option, which Edwards considered in June 2008, was to instruct
`doctors to add a small amount of fluid to the inflation balloon after the valve is
`aligned over the inflation balloon. By this time, doctors had commonly added a
`small amount of fluid to balloon-expandable catheters before deploying the
`balloon, and doctors had commonly done so with Edwards’ Retroflex delivery
`systems. Edwards tested this solution in June 2008, and determined that it
`provided a 7.3 lb. retention force, which was greater than the approximately
`4.78 lb. force provided by the balloon insert. See EWL 00373671-72; EWL
`00397057; May 24, 2017 Deposition Transcript of Tri Tran at 164-172. It
`would have taken Edwards no additional time to develop this solution, and it
`would not have cost any more to manufacture than the commercial NovaFlex
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`
` Edwards could have
`that Edwards sold.
`and Commander products
`commercialized this alternative by the same time that it commercialized its
`accused NovaFlex and Commander products.
`A second option, which Edwards considered by September 2008, was to
`add unidirectional stoppers. This option would have prevented the valve from
`moving after the valve alignment step and before the valve deployment step. See
`EWL 00350069; June 2, 2017 Deposition Transcript of Ronaldo Cayabyab at
`88-91, 96-97; May 24, 2017 Deposition Transcript of Tri Tran at 164-172. It
`would have taken Edwards approximately 10-12 weeks and less than $25,000 to
`develop this design. Edwards could have manufactured this alternative for the
`same cost as the accused NovaFlex and Commander products. Edwards could
`have commercialized this alternative by the same time that it commercialized its
`accused NovaFlex and Commander products.
`A third option would have been to redesign the tip of the flex catheter so
`that it could expand and break away during inflation. This design would allow
`the flex tip to support the proximal end of the valve as the valve crossed the
`native annulus and during initial inflation. It would have taken Edwards
`approximately 10-12 weeks and less than $25,000 to develop this design.
`Edwards could have manufactured this alternative for the same cost as the
`accused NovaFlex and Commander products.
` Edwards could have
`commercialized this alternative by the same time that it commercialized its
`accused NovaFlex and Commander products.
`Each alternative to using a balloon insert would have retained the valve as
`effectively as the balloon insert. Thus, the alternative would have been equally
`acceptable to doctors using the delivery system. These options could have fit
`into the same size sheath as the accused products, and therefore could have
`served the same patient population.
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`Edwards could have also sold its RetroFlex 2 for XT delivery system.
`Edwards developed this system before the end of 2007, but did not
`commercialize it. See EWL 00019543-020043, EWL 00022112-22145.
`Because Edwards developed this system before it developed the balloon insert
`for the NovaFlex, Edwards could have commercialized this product by the same
`time it commercialized the NovaFlex and Commander products. This catheter
`was an “on-balloon” catheter much like the RetroFlex catheters used to delivery
`Edwards’ Sapien valve. Like the RetroFlex catheters that delivered the Sapien,
`this catheter did not have a balloon insert. Instead, it had a tri-fold balloon that
`provided adequate retention force on the valve. The product would have been
`acceptable for a segment of the patient population that could have accepted a
`21-22 fr sheath. The product would not have cost more than the NovaFlex or
`Commander products to manufacture.
`Edwards could have also marketed and sold its corresponding transapical
`products (Ascendra+ and Certitude), as well its Retroflex 3 delivery system (for
`Sapien).
`Edwards identifies Sean Chow and Larry Wood as the persons most
`knowledgeable about these alternatives.
`Certitude: For the asserted claims of the ’767 patent, Edwards had
`multiple acceptable non-infringing alternatives.
`One option was to use its Ascendra+ with its Sapien 3 valve. The
`Certitude was Edwards’ next-generation
`transapical catheter after
`the
`Ascendra+. The Certitude was designed for easier manufacturability, so the
`Ascendra+ would have been equally acceptable to physicians. The Ascendra+
`cost approximately $50 per unit more to manufacture than the Certitude.
`Because the Ascendra+ was developed and commercialized before work began
`on the Certitude, Edwards could have commercialized the Ascendra+ for the
`Sapien 3 valve by the same time it commercialized the Certitude. As a second
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`option, Edwards could have manufactured the Certitude differently. Edwards
`could have changed the manufacturing process so that the balloon is bonded to
`the catheter prior to the process of pleating and folding. This is different than
`the claimed process, which requires that the balloon be folded before it is
`welded. All other TAVR catheters that Edwards has sold have used a balloon
`that is welded before it is folded. The existing Certitude assembly machinery
`can be used to laser bond the Certitude balloon prior to the process of pleating
`and folding without modifying the equipment. The only change required is
`reordering the steps in the existing delivery system manufacturing procedure for
`the
`Edwards Certitude
`to
`have
`SOP6923.12/SOP7492.12
`and
`SOP6923.15/SOP7492.15 performed prior to SOP6923.09/SOP7492.09. See
`EWL 00006628; EWL 00006631; EWL 00006633; EWL 00748341; EWL
`0078353; EWL 00748312; May 30, 2017 Deposition Transcript of Antonio
`Vidal at 230-247.
`This second option would have been acceptable to doctors because the
`order of folding and welding has no effect on catheter performance, and doctors
`are unaware of this manufacturing method. There would have been little, if any
`cost to Edwards to make such a change, and the change would have taken
`Edwards little, if any time to implement. Edwards could have commercialized
`this alternative at the same time as it commercialized its accused product. This
`alternative would not have cost Edwards any more per unit to manufacture than
`its accused product.
`Another alternative would have been to market and sell its corresponding
`transfemoral Commander product.
`Edwards identifies Larry Wood, Walter Lee, and Antonio Vidal as the
`persons most knowledgeable about these alternatives.
`
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`Crimper: For the asserted claims of U.S. Patent No. ’560, at least one
`acceptable non-infringing alternative, which would have applied to foreign
`sales, was to manufacture the accused crimper, and package it into a kit, in a
`foreign country. Edwards manufactured the accused crimper in Israel until late
`2006 and had a kitting facility available in Switzerland at the time. It would
`have taken Edwards the same amount of time to validate a sterilization process
`for the crimper in Israel as it did in the United States, which was about 2-3
`months, and it would have cost Edwards approximately $50,000 to do so. This
`alternative would have cost Edwards approximately $2-3 per unit more to
`manufacture and assemble into a kit. Edwards could have commercialized this
`alternative by the same time it commercialized its accused product.
`A second acceptable non-infringing alternative, which would have
`applied to all sales, would have been to modify the first straight side of the
`crimper dies (i.e. the side that faces the crimping aperture) so that the side is not
`flat. This could be done by making a concave curve in the first side such that
`each die forms a portion of a circular shape in the direction of the circumference
`of the valve to be crimped. This could also be done by making a convex curve
`on the first straight side so that the curve resembles an “hourglass” shape in
`either (1) the direction of the circumference of the valve to be crimped or (2) the
`direction parallel to the longitudinal axis of the valve to be crimped. See EWL
`00749142-159. These alternatives would not infringe because the dies would
`not have an inwardly facing straight side. The change would have taken
`Edwards less than one week to implement, and these crimpers could crimp a
`valve at least as well as Edwards’ accused crimpers. At most, it would have
`cost Edwards $100,000 to implement this change. This alternative would not
`have cost Edwards more to manufacture than its accused crimpers. Edwards
`could have commercialized this alternative by the same time it commercialized
`its accused product.
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`A third acceptable non-infringing alternative, which would have applied
`to all sales, would have been to modify the dies to constitute “fingers” that
`move radially with respect to the longitudinal axis of the valve. The crimper
`would look and operate like the chuck of a drill and apply radial force to the
`crimped valve in the same way a chuck applies force to a drill bit to hold it. This
`change would have taken Edwards less than one week to implement, and this
`design would crimp a valve at least as well as Edwards’ accused crimpers. At
`most, it would have cost Edwards $100,000 to implement this change. Edwards
`may have had to increase the number of blades per crimper to obtain a
`reasonably-round crimp. That may have increased the cost per crimper by up to
`$5. Edwards could have commercialized this alternative by the same time it
`commercialized its accused product.
`Edwards identifies Larry Wood and Yaron Keidar as the persons most
`knowledgeable about these alternatives.
`
`
`
`
`
`Dated: July 24, 2017
`
`
`
`
`
`
`
`
`
`
`
`
` KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`
`
`
`
` By: /s/ Joshua Stowell
`John B. Sganga, Jr.
`Craig S. Summers
`Brian C. Horne
`Christy G. Lea
`Joshua J. Stowell
`
`
`
` Attorneys for Defendant
`EDWARDS LIFESCIENCES CORP.
`
`
`
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`

`
`
`CERTIFICATE OF SERVICE
`I am a citizen of the United States of America and I am employed in
`
`Irvine, California. I am over the age of 18 and not a party to the within action.
`My business address is 2040 Main Street, Fourteenth Floor, Irvine, California.
`On July 24, 2017, I served the foregoing document: EDWARDS’
`SUPPPLEMENTAL RESPONSE TO BSC’S INTERROGATORY NO. 8
`on the parties or their counsel shown below via electronic mail addressed as
`follows:
`Mark A. Cohn
`Edward Han
`John Nilsson
`Matthew M Wolf
`ARNOLD & PORTER KAYE SCHOLER
`601 Massachusetts Ave., NW
`Washington, D.C. 20001
`marc.cohn@apks.com,
`ed.han@apks.com,
`john.nilsson@apks.com,
`matthew.wolf@apks.com
`I declare that I am employed in the office of a member of the bar of this
`Court at whose direction the service was made. I declare under penalty of
`perjury under the laws of the United States of America that the above is true and
`correct.
`
`Executed on July 24, 2017 at Irvine, California.
`
`
`
`Karina Villanueva
`
`24243925
`
`
`
`-1-
`
`Wallace Wu
`Allen Secretov
`Masanori Koresawa
`ARNOLD & PORTER KAYE SCHOLER
`777 South Figueroa Street 44th Floor
`Los Angeles, CA 90017-5844
`marty.koresawa@apks.com,
`allen.secretov@apks.com,
`wallace.wu@apks.com
`
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`