Page 51 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`— Process Flow and Final
`
`Packaging T "
`
`if
`
`,
`,1! '1 '
`
`TV
`
`nusdaiuunyun VALVE noun.
`. -'
`'
`
`at
`
`Highly Confidential
`
`EDWARDS 01933891
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 52 of 100
`
`
`
`Page 53 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`
`
`Highly Corindentnal
`
`51
`
`EDWARDS 01933893
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 54 of 100
`
`
`
`Test Results
`
`
`
`I WIRAII‘I‘HITII NIAIT VALVI PIO‘IAI
`
`Highly Confidential
`
`EDWARDS 01933894
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 55 of 100
`
`
`
`Frame structural nerformance - Oval
`
`
`
`9 '
`
`.
`
`1 .5."
`
`Ila-smutnuuun VAL" noon-
`3
`'
`
`'
`
`‘4-
`
`L?
`
`T.‘ '
`
`‘5
`
`.
`
`. .-
`
`v
`9L,"
`
`Highly Confidential
`
`EDWARDS 01933895
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 55 of 100
`
`
`
`
`
`Highly Corindentnal
`
`53
`
`EDWARDS 01933896
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 57 of 100
`
`
`
`Frame structural performance —
`Over Expansion
`
`- 2"
`
`7'
`
`l).-
`
`’I
`
`
`
`I WIIA-Icumfllfl "HIV VALVE P'O‘IA'
`
`Highly Confidential
`
`EDWARDS 01933897
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 53 of 100
`
`
`
`
`
`Highly Corindentnal
`
`54
`
`EDWARDS 01933898
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 59 of 100
`
`
`
`Crim- orofile evaluations - Latest Iterations
`
`Crim
`
`rofile:
`
`More features:
`
`
`
`
`- 2"
`
`7'
`
`l).-
`
`’I
`
`I WIIA-Icumfllfl "HIV VALVE P'O‘IA'
`
`Highly Confidential
`
`EDWARDS 01933899
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page so of 100
`
`
`
`Crime orofile evaluations - Latest Iterations '4».
`
`IMun-smug:nunVAL" noun:
`
`.
`
`Highly Confidential
`
`EDWARDS 01933900
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 51 of 100
`
`
`
`Crim .
`
`- Possible improvements:
`
`. rofile evaluations - Current status
` ." 7 7
`
`I HVYIAIICI'HITII "MIT VALVI PIO'IAI
`
`-‘
`
`’
`
`Highly Confidential
`
`EDWARDS 0‘933901
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 52 of 100
`
`
`
`Page 63 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`
`
`Highly Corindentnal
`
`58
`
`EDWARDS 01933903
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 64 of 100
`
`
`
`S3 Valve Build Ian for 2010 - 2011
`
`[DWAIDS YIANS(AYHEYIR HEAIY VALVE PROGRAM
`
`
`
`Highly Confidential
`
`EDWARDS 01933904
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 55 of 100
`
`
`
`Page 66 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`
`
`Highly Corindentnal
`
`60
`
`EDWARDS 01933906
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 67 of 100
`
`
`
` F.
`
`.
`
`u‘, “1
`
`Highly Confidential
`
`EDWARDS 01933907
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 53 of 100
`
`.
`
`1
`
`q _¢ 4 q
`
`I£MTIAIMI‘EIR {sun VALVI nonu-
`
`
`
`Animal Study GLP Study- Plan
`
`[DWAIDS YIANS(AYHEYIR HEAIT VALVE PROGRAM
`
`Highly Confidentlal
`
`EDWARDS 01933908
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 59 of 100
`
`
`
`Page 70 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`SAPIEN 3 — Model 9500TFX
`
`Final Packaaina Confiauration
`
`
`‘ :1.“
`TIA-mall INIAIY VALVI PIO'III
`
`
`Highly Confidential
`
`EDWARDS 01933910
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 71 of 100
`
`
`
`SAPIEN 3 - Model 9500TFX Final Packao in .
`
` ‘ Li
`
`‘5,
`
`'
`
`‘IIAIMI‘I’II—IIIIAIY VALVI PIO'IAI
`
`Highly Confidential
`
`EDWARDS 01933911
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 72 of 100
`
`
`
`Page 73 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`Regulatory Strategy - Assumptions
`
`
`
`- ' 3
`II! ‘
`- 3,.
`.
`I ngVnnmninn nun VALVI nos-All
`
`K n.
`
`‘ _
`
`I
`
`Highly Confidential
`
`EDWARDS 01933913
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 74 of 100
`
`
`
`-Overview
`
`Re-ulato Strate-
`
` Tmtuuélg a
`
`:'T .
`l.
`o ‘
`'31:“ nu" VALVE nouns
`'
`
`,
`
`u 0"
`
`_
`
`Highly Confidential
`
`EDWARDS 01933914
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 75 of 100
`
`
`
`ulato Review Periods
`
`Notification
`
`PMA Supplement
`
`Dossier Change
`
`' Based on historical product registration approval timeframes
`
`IDWAIDS YIANS(AYHEYIR HEAIY VALVE PROGRAM
`
`Highly Confidential
`
`EDWARDS 01933915
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 75 of 100
`
`
`
`Page 77 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`Risk management plan
`
`RMP HVOO7
`
`The Risk Management Plan covers only the valve design control
`
`stage.
`
`
`
`I HVYIAIICITIII‘I'II NIAIY VALVI PIO'IAU
`
`Highly Confidential
`
`EDWARDS 01933917
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 78 of 100
`
`
`
`Page 79 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`Main Design FMEA Risks
`
`.
`
`.
`
`Design L," 'h
`
`.
`
`,
`
`I“
`
`r
`
`.
`.
`* _
`
`I 'HV‘IIAIWI‘NIITII NIAIY VALVE PIO‘III
`
`Highly Confidential
`
`EDWARDS 01933919
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 80 of 100
`
`
`
`Main System Risks
`
`:cgggtnal Failure
`
`Potential Cause System/Process Control “-
`
`
`
`l HAVYIAII‘N'HITII NIAIT VALVI PIOIIAI
`
`Highly Confidentlal
`
`EDWARDS 01933920
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 81 of 100
`
`
`
`Main Pro ect Risks
`Potential Failure mode
`Potential Cause
`
`Systgrgz‘lzgcess m- T‘. I"
`
`,
`
`,'
`
`I
`
`1. 1:1!
`- Nevin-Wu" INIAIY VALVI "on.“
`
`§
`
`i '1 '
`
`Highly Confidential
`
`EDWARDS 01933921
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 82 of 100
`
`
`
`Page 83 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`Document Checklist for CDR:
`
`In compliance to SOP-
`
`Documents Pending signature
`
`IDWAIDS YIANS(AYHEYIR HEAIY VALVE PROGRAM
`
`Highly Confidentlal
`
`EDWARDS 01933923
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 34 of 100
`
`
`
`Page 85 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 86 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`THV3 26mm Frames Manufacturing Material
`
`Flow - 2"
`
`I WIIA-Icumfllfl "HIV VALVE P'O‘IA'
`
`Highly Confidential
`
`EDWARDS 01933926
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 87 of 100
`
`7'
`
`l).-
`
`’I
`
`
`
`Detailed Frame Manufacturing Current Flow
`Chan
`
`
`
`I "VIRAIICITHITII NIAIT VALVI PIO'IAI
`
`Highly Confidential
`
`EDWARDS 01933927
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 88 of 100
`
`
`
`Page 89 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`Animal Trial - -'
`
`' '
`
`.
`
`v .
`: " a
`4'.
`‘ -..-n _I'
`TIA-SWITIIJIIAIT VAL" "own-
`-'7
`'
`
`F
`
`.
`l' ". '
`
`Highly Confidential
`
`EDWARDS 01933929
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 90 of 100
`
`
`
`Animal Trial -
`
`TIA-WIT]. 0|qu VALVI PIO'I‘I
`
`fir
`
`Highly Confidential
`
`EDWARDS 01933930
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 91 of 100
`
`
`
`Page 92 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`SAPIEN 3 Valve develo oment team L," 'h
`
`,
`
`.
`.
`* _
`
`r
`
`I“
`
`I 'HV‘IIAIWI‘NIITII NIAIY VALVE PIO‘III
`
`Highly Confidential
`
`EDWARDS 01933932
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 93 of 100
`
`
`
`Page 94 of 100
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2031 - Part 2
` PROTECTIVE ORDER MATERIAL
`
`
`
`SAPIEN 3
`
`Third Generation Transcatheter Heart Valve
`
`IDWAIDS YIANSCAYHETER HEART VALVE PROGRAM
`
`Highly Confidential
`
`EDWARDS 01933934
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`lPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 95 of 100
`
`
`
`Sapien 3
`Suture Counts and Time per operational sequence
`Without Tooling and at Present Development
`
`“LIICAYHITII NIAIT VALVI 'IOGIAI
`
`2
`
`Highly Confidential
`
`EDWARDS 01933935
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 95 of 100
`
`
`
`‘Sgpien 3
`s‘tfiure Counts and Time per operational sequence
`
`Without Tooling and at Present Development
`
`Highly Confidential
`
`EDWARDS 01933936
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 97 of 100
`
`
`
`Sapien 3
`Suture Counts and Time per operational sequence
`With Scale-up Tooling and Sewing Skill
`
`vnAIICAYHITII NIAIT VALVI PiOGIAI
`
`'
`
`}
`
`Highly Confidential
`
`EDWARDS 01933937
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 98 of 100
`
`
`
`I.
`.Sapien 3
`.n_
`Suture Counts and Time per operational sequence
`with Scale-up Tooling and Sewing Skill
`
`
`
`Highly Confidential
`
`EDWARDS 01933938
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 99 of 100
`
`
`
`:SAPIEN and SAPIEN XT
`Smure Counts and Cost Reference
`
`
`
`Highly Confidential
`
`EDWARDS 01933939
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2031 - Part 2
`PROTECTIVE ORDER MATERIAL
`
`Page 100 of 100
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
