Petition for Inter Partes Review
`US Patent 9,186,224
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`WATERS TECHNOLOGIES CORPORATION
`Petitioner
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`v.
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`BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES
`Patent Owner
`____________
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`Case No. IPR2018-00498
`US Patent 9,186,224
`____________
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`PETITION FOR INTER PARTES REVIEW OF US PATENT NO. 9,186,224
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II. CLAIMED PRIORITY DATE AND PRIOR ART ..................................... 2
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`III. RELIEF REQUESTED .................................................................................. 3
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`IV. GROUNDS FOR STANDING ....................................................................... 3
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`V. OVERVIEW OF THE ‘224 PATENT .......................................................... 4
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`A.
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`B.
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`The challenged patent ............................................................................ 4
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`The prosecution history of the ‘224 Patent ........................................... 6
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`VI. CLAIM CONSTRUCTION ......................................................................... 10
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`A.
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`B.
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`“accelerated” ....................................................................................... 11
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`“excess volume area” .......................................................................... 13
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`VII. THE SCOPE AND THE CONTENT OF THE PRIOR ART .................. 16
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`A.
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`B.
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`It was known to use compliance chambers in accelerated test
`systems ................................................................................................ 16
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`Pickard describes the claimed method—and is not limited to
`any specific bpm value or range .......................................................... 19
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`C. Woodward evidences normal physiological heart rates of up to
`270 beats per minute............................................................................ 22
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`D.
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`St. Jude describes methods of operating an accelerated cyclic
`test system with a compliance chamber or fluid reservoir
`located downstream of a heart valve. .................................................. 23
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`VIII. THE PERSON OF ORDINARY SKILL IN THE ART ........................... 26
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`IX. DETAILED EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY .................................................................................. 27
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`A. Ground 1a: All Claims are Rendered Obvious by Pickard in
`light of Woodward............................................................................... 27
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`B.
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`Ground 1b: All Claims are Rendered Obvious by Pickard in
`light of Woodward and St. Jude .......................................................... 46
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`C.
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`Ground 2a: St. Jude Anticipates Claims 1-4 ...................................... 50
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`D. Ground 2b: Claims 3-7 are Rendered Obvious by St. Jude in
`light of Pickard .................................................................................... 61
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`E.
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`Ground 2c: Claims 6 and 7 are Rendered Obvious by St. Jude
`in light of Iwasaki. ............................................................................... 66
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`X. CONCLUSION ............................................................................................. 70
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`XI. MANDATORY NOTICES ........................................................................... 71
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`Notice of Real Party-In-Interest .................................................................... 71
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`Notice of Related Matters .............................................................................. 71
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`Notice of Lead and Backup Counsel and Service Information ..................... 72
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`XII. PAYMENT OF FEES ................................................................................... 73
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`TABLE OF AUTHORITIES
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`CASES
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`Page(s)
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`Biomedical Device Consultants & Laboratories of Colorado, LLC v. TA
`Instruments – Waters LLC, 0:17-cv-03403-DWF-SER (D.Minn.) .....................71
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`DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
`F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006) ................................49
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`In re Smith Int’l, Inc., No. 2016-2303, slip op. at 12 (Fed. Cir. Sept. 26, 2017 ......10
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`KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 417 (2007) ...............63
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`Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015) ...........10
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`STATUTES AND RULES
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`35 USC 102 ..........................................................................................................3, 57
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`35 USC 103 ..........................................................................................................3, 38
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`37 CFR § 42.100(b) .................................................................................................10
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`37 CFR § 42.15(a) ....................................................................................................73
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`MPEP 2143(G) .........................................................................................................49
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`US Patent 9,186,224
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`LIST OF EXHIBITS
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`Exhibit No.
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`Short Name
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`Description
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`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`‘224 Patent US Patent No. 9,186,224 to McCloskey et al.
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`Original
`Application
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`USSN 14/523,104, filed on October 24, 2014
`
`Billiar
`
`Declaration of Prof. Billiar
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`
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`Curriculum Vitae of Prof. Billiar
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`Office Action Office Action mailed March 20, 2015
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`Interview
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`Interview Summary mailed May 14, 2015
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`Response
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`Amendment & Response Mailed June 17, 2015
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`Allowance
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`Notice of Allowance mailed September 17, 2015
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`Inventor
`Declaration
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`Inventor Declaration dated May 10, 2013 (and
`filed with Response Mailed June 15, 2015)
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`Pickard
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`US Patent No. 4,682,491 to Pickard
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`St. Jude
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`US Patent No. 5,916,800 to Elizondo et al. and
`assigned to St. Jude [sic] Medical, Inc.
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`Woodward
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`US Patent No. 3,208,448 to Woodward
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`Iwasaki
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`
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`Iwasaki et al., Implications for the Establishment
`of Accelerated Fatigue Test Protocols for
`Prosthetic Heart Valves, Artificial Organs Vol. 26
`No. 5:420-429 (2002).
`
`Reul et al., Durability/Wear Testing of Heart
`Valve Substitutes, J Heart Valve Dis Vol. 7, No. 2:
`151-157 (March 1998).
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`1014
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`Reul
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`Exhibit No.
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`Short Name
`
`Description
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`1015
`
`ISO 5840
`
`1016
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`
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`1017
`
`Girard
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`International Standard ISO 5840, Cardiovascular
`implants – Cardiac valve prostheses, Fourth
`Edition, (March 2005).
`
`Certificate of Service for Complaint in
`Biomedical Device Consultants & Laboratories of
`Colorado, LLC v. TA Instruments – Waters LLC,
`Civil No. 0:17-cv-03403 DWF-SER (D. Minn)
`
`Declaration of Michael Girard In Support of
`Motion for Preliminary Injunction in Civil No.
`0:17-cv-03403
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`1018
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`‘224 Claims Claims of US Patent No. 9,186,224
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`I.
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`INTRODUCTION
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`US Patent No. 9,186,224 (the ‘224 Patent) is directed to a method for
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`operating an “accelerated” test system for evaluating a valved prosthetic device.
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`Both the Patent Owner and the Patent Office in its Notice of Allowance point to
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`the incorporation of an “excess volume area” in an “accelerated” system as the
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`point of novelty. But, as Patent Owner admitted in the underlying prosecution,
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`there is nothing new about incorporating an “excess volume area” into a system for
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`testing replacement heart valves. And, contrary to Patent Owner’s statements to
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`the Patent Office, doing so in an “accelerated” system had been well known for at
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`least 10 years prior to the earliest claimed priority date of the ‘224 Patent.
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`II. CLAIMED PRIORITY DATE AND PRIOR ART
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`The earliest claimed priority date of the ‘224 Patent is March 6, 2009.
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`(Ex1001[‘224 Patent] cover page). Each reference pre-dates this date by more than
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`one year and qualifies as 102(b)-type prior art:
`
`Reference
`US Patent No. 4,682,491 to
`Pickard
`US Patent No. 3,208,448 to
`Woodward
`US Patent No. 5,916,800 to
`Elizondo et al. and assigned to
`St. Ju[d]e Medical, Inc.
`Iwasaki et al., Implications for
`the Establishment of
`Accelerated Fatigue Test
`Protocols for Prosthetic Heart
`Valves, Artificial Organs Vol.
`26 No. 5:420-429 (2002).
`Reul et al., Durability/Wear
`Testing of Heart Valve
`Substitutes, J Heart Valve Dis
`Vol. 7, No. 2: 151-157 (March
`1998).
`International Standard ISO
`5840, Cardiovascular implants
`– Cardiac valve prostheses,
`Fourth Edition, (March 2005).
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`Short Name Publication Date
`Pickard
`July 28, 1987
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`Woodward
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`February 2, 1962
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`St. Jude
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`June 29, 1999
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`Iwasaki
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`May 2002
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`Reul
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`March 1998
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`ISO 5840
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`March 2005
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`US Patent 9,186,224
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`III. RELIEF REQUESTED
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`Petitioners request inter partes review of all claims (i.e., claims 1-7), on the
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`following grounds, as explained below and in the Declaration of Professor Kristen
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`Billiar. Woodward, St. Jude and Iwasaki have not been considered by the Patent
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`Office. And the combination of Pickard and Woodward and/or St. Jude is new.
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`Ground ‘224
`Claims
`1-7
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`1a
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`1-7
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`1-4
`3-7
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`6-7
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`1b
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`2a
`2b
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`2c
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`Basis
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`35 USC 103: Obvious in view of Pickard and
`Woodward
`35 USC 103: Obvious in view of Pickard,
`Woodward, and St. Jude
`35 USC 102: Anticipated by St. Jude
`35 USC 103: Obvious in view of St. Jude and
`Pickard
`35 USC 103: Obvious in view of St. Jude and
`Iwasaki
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`IV. GROUNDS FOR STANDING
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`Petitioner certifies that the ‘224 Patent is available for IPR. This Petition is
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`being filed within one year of service of a complaint against Petitioners. (Ex1016).
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`Petitioner is not barred or estopped.
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`US Patent 9,186,224
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`V. OVERVIEW OF THE ‘224 PATENT
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`A. The challenged patent
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`The ‘224 Patent describes a testing system for evaluating prosthetic vascular
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`devices and heart valves. (Ex1001[‘224 Patent] 1:21-25). And claims a method of
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`operating such a test system. (Id. 18:1-32). The prosthetic devices are placed in a
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`test chamber and then subjected to physiologically appropriate conditions that may
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`include: pressure, temperature, flowrate and cycle times. (Id. 2:4-13).
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` Figure 3 of the ‘224 Patent illustrates an exemplary testing system
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`containing two heart valves 130:
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`(FIG. 3, annotated.)
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`To create the testing conditions within the test chamber 106, piston 114 is driven
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`by a motor up and down and attached flexible diaphragm 115 cyclically increases
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`and decreases the pressure. (Id. 6:31-50; 11:51-55). Fluid flow 110 is indicated by
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`the dashed lines traveling from the plenum 118 to the sample holders 129 to exit
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`through the return conduit 168 and into the center conduit 124. (Id. 11:66-12:3).
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`Fluid is blocked by a one-way valve 127 on the upstroke to create directional flow.
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`(Id. 12:3-6).
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`“The combination of the compliance chambers 135 and the throttle valves
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`132 help control undesirable pressure loading or pressure spikes within the sample
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`holder 129 and consequent adverse effects on the test samples 130 when the piston
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`114 moves in a decompression stroke.” (Id. 12:18-22). “Compliance chambers
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`and throttle valves associated with each of the sample holders regulate the gradient
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`and back pressure across the prosthetic devices being tested.” (Id. Abstract). “The
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`compliance chambers 135 provide excess volume area for fluid to move into when
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`the piston 114 performs a compression stroke. As the pressure of the gas in the
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`compliance chamber 135 increases, the volume occupied by the gas decreases to
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`provide additional volume for displacement of the liquid working fluid within the
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`test chamber 106.” (Id. 12:10-15).
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`Issued Claim 1 of the ‘224 Patent is quoted below with the step added during
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`prosecution underlined:
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`Claim 1. A method for operating an accelerated cyclic test system for
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`evaluating a valved prosthetic device comprising
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`[a] driving a test system fluid cyclically above a normal physiological
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`rate, at an accelerated pulsed rate of greater than 200 beats per
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`minute within the test system;
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`[b] storing a volume of test system fluid in an excess volume area
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`during a system driving stroke that opens the valved prosthetic
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`device; and
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`[c] releasing the stored volume of test system fluid during a return
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`stroke that closes the valved prosthetic device.
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` A
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` copy of the claims is provided in a separate exhibit for the convenience of
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`the PTAB. (Ex1018). Originally, claim 1 only recited steps [b] and [c]. Step [a]
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`was introduced in during prosecution of the ‘224 Patent. (Ex1007[Response] 2).
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`B.
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`The prosecution history of the ‘224 Patent
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`During the prosecution of the ‘224 Patent, the Patent Office concluded that
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`the originally-filed claims were anticipated. Specifically, the Patent Office found
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`that Pickard “teaches a method for operating an accelerated cyclic test system for
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`evaluating a valved prosthetic device ... comprising [b] storing volume of test
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`system fluid in an excess volume area ... and [c] releasing the stored volume of test
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`system fluid during a return stroke that closes the valved prosthetic device ...”
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`(Ex1005[Office Action] 31). In short, the Patent Office concluded that Pickard
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`anticipated claim 1, prior to the addition of the driving step [a]. (Ex1003[Billiar]
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`¶25). The Patent Owner did disagree. (Ex1007[Response] 5-6). Patent Owner’s
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`only argument for novelty of the original claims—identical except for the added
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`step [a]—was that Pickard’s test system was not an “accelerated” test system. (Id.
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`5-9).
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`During the prosecution of the ‘224 Patent, the Patent Office also concluded
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`that claims 2, 3, 6 and 7 were anticipated by Pickard as well. (Ex1005[Office
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`Action] 3-4). Patent Owner also did not challenge these conclusions.
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`(Ex1007[Response] 9).
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`Although it tried, Patent Owner was unable to convince the Patent Office
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`that the inclusion of the word “accelerated” distinguished the claimed method over
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`Pickard. (Ex1006[Interview]; Ex1007[Response] 5-6).
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`To overcome the rejection in view of Pickard, Patent Owner amended claim
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`1 to include new language. Patent Owner amended claim 1 to require “driving a
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`1 Page 3 refers to the page numbers provided in the original document (i.e.,
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`USPTO page numbers). This page can be found at page 4 of 17 of Exhibit 1005.
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`test system fluid ... at an accelerated pulsed rate of greater than 200 beats per
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`minute.” (Ex1007[Response] 2). But the ‘224 Patent disclosed nothing about 200
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`beats per minute for its tests. (Ex.1003[Billiar] ¶29). The specification of the ‘224
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`Patent does not have the term “beats per minute” anywhere in it.
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`Where did “greater than 200 beats per minute” come from? Patent Owner
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`relied on Table 1 of ISO 5840. (Ex1007[Response] 7). ISO 5840 is not
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`referenced anywhere in the ‘224 Patent. And its contents are not incorporated by
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`reference. ISO 5840 is an International Standard that imposes minimum
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`performance specifications for heart valve prosthetics. (Ex1015[ISO 5840] 1.4).
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`According to relied upon Table 1 of ISO 5840, operational specifications
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`for cardiac prostheses include minimal operational rates between 30 and 200 beats
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`per minute in accordance with normal and pathological patient conditions. (Id.
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`6.2.1). Patent Owner used that information in ISO 5840 to persuade the Patent
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`Office that “accelerated” means greater than “normal” or “greater than 200 beats
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`per minute.” (Ex1007[Response] 6-7; Ex1003[Billiar] ¶33). It is noted that ISO
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`5840 does not define “accelerated” testing as testing at greater than 200 beats per
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`minute. (Ex1003[Billiar] ¶¶32, 44).
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`Patent Owner also argued that this new claim language distinguished its
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`amended claim from Pickard. (Ex1007[Response] 5, 8). Patent Owner suggested
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`that Pickard discloses a “real time” system, and that a “real time” system would
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`have been operated at 72 beats per minute. (Id.; Ex1003[Billiar] ¶31). But Patent
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`Owner could not cite to any limiting disclosure of Pickard, because none exists;
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`Pickard does not disclose any particular number of beats per minute for testing.
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`(Ex1003[Billiar] ¶52).
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`And while Patent Owner admitted that both accelerated testing and the use
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`of an “excess volume area” were well known in heart valve test systems, it
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`asserted the combination was new:
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`Thus, while the concept of using a compliance chamber to store
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`excess volume of test fluid in real-time, physiologically accurate,
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`cardiac valve test system is well known…a method in an accelerated
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`cyclic test system that uses an excess volume area is entirely new.
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`(Ex1007[Response] 8).
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`The Patent Office was unaware that—contrary to Patent Owners
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`assertions—the use of compliance chambers in accelerating testing devices was
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`also well known. (Ex1003[Billiar] ¶¶45-47). For example, over 5 years prior,
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`Iwasaki disclosed that a compliance chamber to store excess volume was added to
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`an accelerated testing device. (Ex1013[Iwasaki] 422 (“the tester was modified to
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`incorporate an air compliance chamber as shown in Fig. 5.”); Ex1013[Billiar] ¶45).
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`In the opinion of Dr. Billiar “Patent Owner obtained allowance based on the
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`incorrect assertion that the use of compliance chambers in accelerated tests systems
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`was new.” (Ex1003[Biliar] ¶47).
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`It is also noted that while Patent Owner argued, and the inventor opined at
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`length, about the inadequacies of, for example, piston pumps and metal bellows in
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`accelerated testing systems, no particular equipment is claimed. (Compare
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`Ex1007[Response] 9; Ex1009[Inventor Declaration] ¶¶5-9 to Ex1018[‘224
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`Claims]).
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`VI. CLAIM CONSTRUCTION
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`A claim in an unexpired patent subject to IPR receives its “broadest
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`reasonable interpretation [(“BRI”)] in light of the specification of the patent in
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`which it appears.” 37 CFR § 42.100(b). The BRI does not mean that claim terms
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`are construed so broadly as to be “unreasonable under general claim construction
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`principles.” In re Smith Int’l, Inc., No. 2016-2303, slip op. at 12 (Fed. Cir. Sept.
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`26, 2017) (quoting Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed.
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`Cir. 2015) (emphasis in original). Neither can the BRI give “claims a legally
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`incorrect interpretation” “divorced from the specification and the record evidence.”
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`Id. (citations and internal quotations omitted).
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`Petitioner proposes constructions of the following terms under the BRI. All
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`remaining terms should be given their plain meaning.
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`A.
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`“accelerated”
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`The term “accelerated” is not defined in the specification. (Ex1013[Billiar]
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`¶34). It was defined by amendment to the claims during prosecution to allegedly
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`distinguish the claimed subject matter from Pickard. (Ex1003[Billiar] ¶¶35, 36,
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`and 51; Ex1007[Response] 5-9; Ex1008[Allowance] 32). The claims are directed
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`to a method of operating a system. The word “accelerated” is used twice in the
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`claims. It originally appeared only in the preamble, i.e., “a method of operating an
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`accelerated cyclic test system.” But the “Examiner expressed concern that the term
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`‘accelerated’ … was insufficient to differentiate the types of test systems disclosed
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`in the cited prior art…” (Ex1007[Response] 5; see also Ex1006[Interview]). In
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`order to alleviate the Examiner’s concerns, Patent Owner made an amendment to
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`recite the term in the claims. Specifically, the claims were amended to recite “an
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`accelerated pulsed rate of greater than 200 beats per minute within the test
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`system.” (Ex1007[Response] 2, 5-6; Ex1003[Billiar] ¶35).
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`2 Page 3 refers to the page numbers provided in the original document (i.e.,
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`USPTO page numbers). This page can be found at page 7 of 21 of Exhibit 1008.
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`US Patent 9,186,224
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`The term “accelerated” in the preamble should be accorded no patentable
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`weight, consistent with the examination of these claims. But to the extent that the
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`term in the preamble is afforded any patentable weight, it should bear the
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`definition ascribed to it by Patent Owner to obtain allowance and imported into its
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`added step [a]. Patent Owner asserted that a person of ordinary skill in the art
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`recognizes that the term “accelerated” means a system that cycles faster than 200
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`beats per minute:
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`Applicant noted that…the industry (i.e., a person of ordinary skill in
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`the art) recognizes an “accelerated” valve test system to mean a
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`system that cycles faster than a normal physiological rate. It was
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`discussed that the typical upper end of a normal physiological rate is
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`above 200 beats per minute. The Examiner agreed that a limitation
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`describing the system environment as being greater than 200 beats per
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`minute would be sufficient to address this concern with the claim.
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`(Ex1007[Response] 6).
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`The Examiner explicitly relied on this definition and tied “accelerated” in
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`the preamble to the “above 200 bpm” limitation in his reasons for allowance:
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`The specific limitation of an accelerated cyclic test system for
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`evaluating a valved prosthetic device with a pulsed rate of greater
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`than 200 beats per minute in independent claim 1 when combined
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`with the limitations of an excess volume area (which is a term of art,
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`see remarks of 06/17/2015 p. 8, final ¶) and its location also in
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`independent claim 1 distinguish the present invention from the
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`US Patent 9,186,224
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`combined prior art.
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`(Ex1008[Allowance] 3 (emphasis added)).
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`
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`In short, the term “accelerated” was defined in the claim by Patent
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`Owner to mean “cycling above 200 beats per minute.” (Ex1003[Billiar]
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`¶¶34-36).
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`B.
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`“excess volume area”
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`The claims of the ‘224 Patent require storing a volume of test system
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`fluid in “an excess volume area” during a system driving stroke. The
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`specification of the ‘224 Patent does not provide an explicit definition of this
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`term, and Dr. Billiar is unaware of any special meaning of the term “excess
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`volume area.” (Ex1003[Billiar] ¶¶37, 38). The term is used in the
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`specification to refer to a portion of the compliance chambers taken up by
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`fluid as pressure increases during the compression stroke: “compliance
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`chambers 135 provide excess volume area for fluid to move into when the
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`piston 114 performs a compression stroke.” (Ex1001 12:10-12). The very
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`next sentence of the specification states ‘[a]s the pressure of the gas in the
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`compliance chamber 135 increases, the volume occupied by the gas
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`decreases to provide additional volume for displacement of the liquid
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`working fluid within the test chamber 106.” (Id. 12:12-15).
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`Petition for Inter Partes Review
`US Patent 9,186,224
`
`According to the file history, the Patent Owner appears to have
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`convinced the Patent Office that the term “excess volume area” is a term of
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`art. (Ex1008[Allowance] 3 (“an excess volume area (which is a term of art,
`
`see remarks of 06/17/2015 p.8, final ¶)”; Ex1003[Billiar] ¶37). But nowhere
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`within Patent Owner’s remarks is a definition or a citation to a definition of
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`“excess volume area” given. (Ex1003[Billiar] ¶37). Instead, this section of
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`the remarks contains Patent Owner’s unsupported argument that while
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`compliance chambers were known in so-called “real-time” test systems,
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`their use in “accelerated” systems was allegedly new:
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`Thus, while the concept of using a compliance chamber to store
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`excess volume of test fluid in real-time, physiologically accurate,
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`cardiac valve test system is well known for the purpose of substituting
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`for the arteries of the human circulatory system (in fact, compliance is
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`required by ISO 5840 in Annex L and detailed guidelines for
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`compliant chambers are provided in Annex F) a method in an
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`accelerated cyclic test system that uses an excess volume area is
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`entirely new. As described in the specification of this application,
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`“the compliance chambers 135 assist in minimizing the effects of
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`large and quickly changing pressure gradients (i.e., pressure loading
`
`or pressure spikes) across test samples 130 placed within the test
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`chamber 106.” (See, ¶0061.) In methodologies of prior commercial
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`accelerated test systems, there were no specific design elements or
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`system features to address this phenomenon of pressure spikes, which
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`were therefore viewed as an accepted drawback associated with
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`testing at accelerated rates. As described in the present application,
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`the compliance chamber may also be used to fine-tune the pressure-
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`gradient across the valve sample being tested. The prior art of record
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`fails to teach the claimed method in the context of an accelerated
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`cyclic test system. None of these concerns, goals or solutions
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`addressed and achieved by the claimed method are contemplated or
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`recognized in the prior art of record. Thus, Pickard cannot be held to
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`anticipate the invention of claim 1 because a method performed within
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`an accelerated cyclic test system was not even a consideration in the
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`context of the disclosure of Pickard.
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`(Ex1007[Response] 8-9).
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`Nowhere in Patent Owner’s Remarks, or in the sections of the ISO 5480
`
`referred to therein, is a definition of “excess volume area” provided.
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`(Ex1003[Billiar] ¶¶36-37; Ex1015[ISO 5840], Annex L, Annex F).
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`Petitioner’s expert, Dr. Billiar is unaware of any special meaning of
`
`the term “excess volume area.” (Ex1003[Billiar] ¶38). In other words, the
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`term “excess volume area” is not a term of art. (Id.). After reading the
`
`specification of the ‘224 Patent and its prosecution history, Dr. Billiar
`
`understands this term to indicate a location or a space where fluid displaced
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`by a pulsatile pump can flow into. (Ex1003[Billiar] ¶¶38-39). Consistent
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`with the specification, and by no means contrary to the evidence contained
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`in the prosecution history, the term should be given its ordinary or plain
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`meaning. (Ex1003[Billiar] ¶¶37-39).
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`
`
`VII. THE SCOPE AND THE CONTENT OF THE PRIOR ART
`
`A.
`
`It was known to use compliance chambers in accelerated test
`systems
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`Recall that in order to obtain allowance Patent Owner convinced the Patent
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`Office that “while the concept of using a compliance chamber to store excess
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`volume of test fluid in real-time, physiologically accurate, cardiac valve test
`
`system is well known…a method in an accelerated cyclic test system that uses an
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`excess volume area is entirely new.” (Ex1007[Response] 8; Ex1008[Allowance]
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`3). But the prior art disclosed exactly that many years prior. (Ex1003[Billiar]
`
`¶45). For example Iwasaki et al., published a paper disclosing this combination in
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`2002. (Ex1013[Iwasaki]).
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`
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`1.
`
`Iwasaki
`
`As the title evidences, Iwasaki is directed to “Accelerated Fatigue Test
`
`Protocols for Prosthetic Heart Valves.” (Ex1013[Iwasaki] 420). One of the goals
`
`of Iwasaki’s research “is to establish a reliable methodology for accelerated fatigue
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`tests of prosthetic test valves.” (Ex1013[Iwasaki] Abstract). The test systems of
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`Iwasaki are operated at cycle rates of 400 to 1200 bpm. (Id. 422-423). And
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`Iwasaki discloses use of an “excess volume area” in an accelerated test system.
`
`Specifically, Iwasaki discloses adding a compliance chamber to an accelerated
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`testing device to store excess volume. (Ex1013[Iwasaki] 422 (“the tester was
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`modified to incorporate an air compliance chamber as shown in Fig. 5.”);
`
`Ex1003[Billiar] ¶45). Indeed the motivation to make accelerated testers is the
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`same as that cited by the inventor in his Declaration during prosecution: the
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`accelerated testing requirements of ISO 5840. Compare detailed discussion of ISO
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`5840 in Ex1007[Response] 7-8 and Ex1009[Inventor Declaration] ¶10 to, for
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`example, the very first line of Iwasaki: “Accurate estimation of durability in a
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`timely manner is one of the most important unresolved issues in the basic research
`
`of artificial organs.” (Ex1013[Iwasaki] 420). And motivation to add the
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`compliance chamber was the same as that admitted by the Patent Owner in its
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`response (“for the purpose of substituting for the arteries of the human circulatory
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`system” at Ex1007[Response] 8). Iwasaki cites the use of compliance “to model
`
`the elastic effects of the aorta” and because without it, there was “insufficient
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`opening” of the valve. (Ex1013[Iwasaki] 422). Iwasaki operated its accelerated
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`cyclic test system with its air compliance chamber at 1200 bpm prior to May 2002.
`
`(Id. 423).
`
`2.
`
`Reul
`
`Iwasaki was not alone in publishing on the combination of an accelerated
`
`cyclic test system and excess volume area. In March of 1998, an article entitled
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`“Durability/Wear Testing of Heart Valve Substitutes” by Reul et al., was published
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`in the Journal of Heart Valve Disease. (Ex1014[Reul]). This 1998 article reports
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`on the use of air compliance in accelerated cyclic test systems. Reul teaches
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`testing heart valves in its new design having adjustable compliance at rates of 600
`
`bpm and 1000 bpm. (Id. 154; Ex1003[Billiar] ¶45). In the opening paragraph of
`
`this paper Reul notes that “[f]or all testers, time history of loading and pressure
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`difference across the valve are a function of test frequency, compliance and other
`
`factors.” (Id. 151). Reul discloses an accelerated valve test system designed and
`
`manufactured prior to March 1998 that incorporates “an adjustable compliance
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`chamber … for additional control of loading forces.” (Id. 153; Ex1003[Billiar]
`
`¶¶45-46. Reul explains that “peak loading forces for a …valve have been varied
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`Petition for Inter Partes Review
`US Patent 9,186,224
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`by changing the air compliance at a constant test rate, bypass throttle and stroke
`
`settings.” (Ex1014[Reul] 154). In other words, “compliance chambers were
`
`known to provide excess volume area to avoid pressure spikes.” (Ex1003[Billiar]
`
`¶46).
`
`In short, “Patent Owner obtained allowance based on the incorrect assertion
`
`that the use compliance chambers in accelerated test systems was new.”
`
`(Ex1003[Billiar] ¶47). This combination was known for over ten years. Iwasaki
`
`discloses an accelerated testing system with compliance chambers as of 2002.
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`(Ex1013[Iwasaki] 422; Ex1003[Billiar] ¶45). Reul discloses an accelerated testing
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`system with compliance chambers as of 1998. (Ex1014[Reul] 153;
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`Ex1003[Billiar] ¶45). And, as discussed below, St. Jude disclosed this
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`combination in 1999.
`
`B.
`
`Pickard describes the claimed method—and is not limited to any
`specific bpm value or ran