`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`Waters Technologies Corporation
`Petitioner
`
`v.
`
`Biomedical Device Consultants & Laboratories
`Patent Owner
`
`
`
`
`
`Case IPR2018-00498
`Patent 9,186,224
`
`
`
`
`
`PATENT OWNERS’ PRELIMINARY RESPONSE
`
`

`

`
`
`TABLE OF CONTENTS
`Introduction .......................................................................................................... 1
`
`I.
`
`II. Background .......................................................................................................... 4
`
`III. The ’224 Patent ................................................................................................. 8
`
`A. Overview .......................................................................................................... 9
`
`B. Prosecution History ........................................................................................14
`
`1. ’708 Patent ...................................................................................................14
`
`2. ’224 Patent ...................................................................................................15
`
`IV. Person of Ordinary Skill in the Art ................................................................17
`
`V. Claim Construction ............................................................................................17
`
`A. “accelerated cyclic test system” (claim 1)...................................................18
`
`1. Preamble is limiting .....................................................................................19
`
`2. Specification ................................................................................................19
`
`3. Prosecution History .....................................................................................21
`
`4. Extrinsic evidence .......................................................................................26
`
`B. “driving a test system fluid cyclically above the normal physiological rate”
`(claim 1) ................................................................................................................30
`
`C. “excess volume area” (claims 1-4) .................................................................30
`
`VI. Petitioner’s Asserted References ....................................................................32
`
`A. Pickard ............................................................................................................32
`
`B. Elizondo (St. Jude) .........................................................................................35
`
`VII. PETITIONER FAILS TO DEMONSTRATE A REASONABLE
`LIKELIKHOOD OF PREVAILING ON ANY OF ITS FIVE ASSERTED
`GROUNDS ..............................................................................................................37
`
`A. GROUND 1a: Claims 1-7 in view of Pickard and Woodward ......................37
`
`1. Claim 4 ........................................................................................................42
`
`B. GROUND 1b: Claims 1-7 in view of Pickard, Woodward, and Elizondo ....42
`
`1. Claim 4 ........................................................................................................46
`
`C. GROUND 2a: Claims 1-4 in view of Elizondo ..............................................46
`
`1. Claim 2 ........................................................................................................47
`
`
`
`i
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`

`

`
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`2. Claim 4 ........................................................................................................48
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`D. GROUND 2b: Claims 3-7 in view of Elizondo and Pickard .........................48
`
`E. GROUND 2c: Claims 6 and 7 in view of Elizondo and Iwasaki ...................49
`
`VIII. CONCLUSION ..............................................................................................50
`
`
`
`
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`
`
`
`
`ii
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`

`

`
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) ............................................................................ 19
`
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002) .................................................................... 18, 25
`
`Free-Flow Packaging Int’l, Inc. v. Automated Packaging Sys.,
`IPR2016-00350, Paper 7 (June 27, 2016) ........................................................... 49
`
`Helmsderfer v. Bobrick Washroom Equip., Inc.,
`527 F.3d 1379 (Fed. Cir. 2008) .......................................................................... 18
`
`InTouch Techs., Inc. v. VGO Commc’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .......................................................................... 49
`
`Metabolite Labs., Inc. v. Corp. of Am. Holdings,
`370 F.3d 1354 (Fed. Cir. 2004) .......................................................................... 19
`
`Nautilus Hyosung Inc. v. Diebold, Inc.,
`IPR2016-00633, Paper 9 (Aug. 22, 2016) .......................................................... 45
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 17
`
`In re Ratti,
`270 F.2d 810 (CCPA 1959) .......................................................................... 44, 45
`
`In re Suitco Surface, Inc.,
`603 F.3d 1255 (Fed. Cir. 2010) .......................................................................... 17
`
`Thorner v. Sony Comp. Entmt. Amer. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .......................................................................... 25
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................ 18
`
`
`
`iii
`
`

`

`
`
`Other Authorities
`
`37 C.F.R. §42.107(a) .................................................................................................. 1
`
`MPEP § 2111.01 ...................................................................................................... 18
`
`
`
`iv
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`

`

`
`
`
`
`EXHIBITS
`EXHIBITS
`
`
`Ex. 2001 Declaration of Michael Girard
`EX.
`Declaration of Michael Girard
`2001
`
`Ex. 2002 Declaration of Craig Weinberg in Support of Motion for Preliminary
`EX.
`2002
`Declaration of Craig Weinberg in Support of Motion for Preliminary
`
`Injunction
`Injunction
`
`Ex. 2003
`EX.
`2003
`
`ISO 5840-3 2013
`ISO 5840-3 2013
`
`Ex. 2004
`EX.
`2004
`
`‘210 Patent
`‘210 Patent
`
`Ex. 2005 Gabbay Ed
`EX.
`2005
`Gabbay Ed
`
`Ex. 2006
`EX.
`2006
`
`‘708 Patent
`‘708 Patent
`
`Ex. 2007 Response to Office Action 5.10-13
`EX.
`2007
`Response to Office Action 5.10-13
`
`Ex. 2008 Notice of Allowance
`EX.
`2008
`Notice of Allowance
`
`
`
`v
`
`
`
`

`

`I.
`
`Introduction
`
`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
`
`
`
`Pursuant to 37 C.F.R. §42.107(a), Biomedical Device Consultants &
`
`Laboratories of Colorado, LLC (“Patent Owner”) submit this Preliminary
`
`Response to the Petition for Inter Partes Review (“IPR”) of U.S. Patent No.
`
`9,186,224 (“the ’224 patent”) filed by Waters Technologies Corporation
`
`(“Petitioner”).
`
`Institution must be denied because Petitioner fails to meet its burden of
`
`showing a reasonable likelihood that it would prevail with respect to claims
`
`challenged in the Petition. Petitioner’s arguments largely mimic those of the
`
`Examiner during prosecution. Indeed, Petitioner’s primary reference, Pickard, was
`
`considered at length during prosecution. The Examiner’s rejections were
`
`overcome by amending the claims to make clear that the claimed invention is to an
`
`accelerated testing system. The Examiner was convinced that it is not obvious to
`
`combine pieces and parts from an accelerated durability testing system with those
`
`of a physiological ‘real-time’ hydrodynamic testing system. The two systems are
`
`fundamentally different and serve fundamentally different purposes. Driving a
`
`hydrodynamic testing system at accelerated rates would frustrate its purpose of
`
`
`
`1
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`

`

`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
`
`
`
`mimicking the human circulatory system. Yet, Petitioner argues for just that
`
`combination.
`
`Specifically, the Petition is deficient in the following ways:
`
`Pickard in combination with Woodward does not disclose an “accelerated
`
`cyclic test system,” “driving a test system fluid cyclically above the normal
`
`physiological rate,” nor “driving a test system fluid . . . at an accelerated pulsed
`
`rate of greater than 200 beats per minute.” While Woodward does disclose that
`
`hearts rates in young adults may reach 270 bpm, it does not disclose driving its or
`
`any hydrodynamic system at such rates. It specifically limits its system to rates
`
`below 200 bpm. Likewise, the ISO 5840 also limits its test rates to below
`
`200 bpm.
`
`In addition, Petitioner admits that 270 bpm is a “normal physiological rate.”
`
`So, even if one were motivated to drive Pickard’s system at 270 bpm, such a
`
`combination would still not satisfy the limitation of “driving a test system fluid
`
`cyclically above the normal physiological rate,” and consequently not satisfy the
`
`limitation of “accelerated cyclic test system.”
`
`With respect to Elizondo, that reference does not disclose an “excess volume
`
`area” for storing fluid added during the compression stroke which alleviates some
`
`
`
`2
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`

`

`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
`
`
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`of the pressure in the channel. Petitioner contends that Elizondo discloses the use
`
`of compliance in an accelerated durability system (which is unusual).1 Even
`
`assuming that to be true, Elizondo does not disclose using the type of compliance
`
`provided in claim 1—an “excess volume area.” Any compliance in Elizondo
`
`mitigates pressure through material deformation (i.e., expanding a graft or bag). It
`
`does not store excess fluid being introduced into the channel as required by
`
`claim 1.
`
`Petitioner fails to provide any reasonable rationale for combining Pickard
`
`and Elizondo, or Elizondo with Iwasaki. Instead, Petitioner makes generalized
`
`statements that the systems are similar and the substitution would be simple. Such
`
`conclusory statements are insufficient to prove motivation for combining
`
`references.
`
`Accordingly, the Board should conclude that the information presented in
`
`the Petition and accompanying evidence do not establish a reasonable likelihood
`
`that Petitioner will prevail. Thus, the Board should deny institution of all grounds
`
`asserted in the Petition.
`
`
`1 The disclosure of how vascular grafts of bags provide compliance is not entirely
`clear in Elizondo. So, for the purposes of this Preliminary Response, Patent Owner
`will largely adopt Petitioner’s expert’s explanation of Elizondo.
`
`
`
`3
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`

`

`II. Background
`
`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
`
`
`
`Heart disease remains the leading cause of death in the U.S., killing more
`
`than 600,000 Americans each year. More than five million Americans are
`
`diagnosed with heart valve disease each year. While heart valve disease can occur
`
`in any of the four heart valves, most commonly the aortic and mitral valves are
`
`diseased. Without a valve replacement, as many as 50 percent of patients with
`
`severe aortic stenosis will not survive more than an average of two years. An
`
`estimated 80,000-85,000 aortic valves are replaced each year in the U.S.2
`
`To obtain regulatory approval for a prosthetic heart valve, a variety of tests
`
`need to be carried out and satisfactory results shown. In this regard, the
`
`International Organization for Standardization establishes verification testing and
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`reporting guidelines for prosthetic heart valves in ISO 58403. Ex. 1015. ISO 5840
`
`
`2 https://www.johnmuirhealth.com/services/cardiovascular-
`services/intervention/transcatheter-aortic-valve-replacement/facts-and-
`figures.html.
`
`3 The Fourth edition of ISO 5840 was released in 2005 and was in effect in 2009
`(the priority date of the ’224 Patent). ISO 5840 was updated in 2013, the
`significance of which will be later addressed. References to ISO 5840 throughout
`this brief are to the 2005, Fourth edition. Ex. 1015. References to ISO 5840: 2013
`are to the Fifth edition released in 2013. Ex. 2003.
`
`
`
`4
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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`sets forth two types of in vitro verification tests for prosthetic heart valves.
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`Ex. 2003 at 21 (Section 7.2 In vitro assessment).
`
`One type is hydrodynamic performance assessment. Id. at 22 (Section
`
`7.2.3). Hydrodynamic testing is performed to provide information on the fluid
`
`mechanical performance of the heart valve and indicators of its performance in
`
`terms of load to the heart and potential for damage to blood cells. Id. It is akin to
`
`a wind tunnel but with water or similar fluid. In other words, hydrodynamic
`
`testing is concerned with how the prosthetic valve will operate in vivo from a fluid
`
`dynamics perspective. The valve must satisfy certain minimum performance
`
`requirements—delivering a minimum output of fluid while operating at 70 bpm
`
`and a mean pressure of 100 mm Hg (i.e., a normal aortic blood pressure). Id. at 22.
`
`Guidelines for hydrodynamic testing are provided in Annex L. Id. at 68-73. The
`
`guidelines include running tests at pressures of 80-160 mm Hg and cycle rates of
`
`45-120 bpm. Id. at 66-67 (Section L.4.3). Because the goal of hydrodynamic
`
`testing is to gauge the performance of the prosthetic valve in vivo, the tester would
`
`like to mimic the heart and circulatory system to the extent possible within
`
`confines of the testing apparatus. Id. at 66 (Section L.4.2) Also, hydrodynamic
`
`testing is carried out at normal heart rates (referred to as “real-time testing”),
`
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`5
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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`usually around 70 bpm, even though as reflected in Table 1 it is known that normal
`
`heart rates in adults may reach 200 bpm for short periods of time. Id.
`
`The second type of testing set forth in ISO 5840 is structural performance
`
`assessment (also referred to as durability testing). Id. at 23 (Section 7.2.4).
`
`Durability testing is performed to assess continued function over a reasonable
`
`lifetime, that is, to ensure the prosthetic valve will last for a reasonable period of
`
`time (defined as 200 million cycles for a flexible heart valve and 400 million
`
`cycles for a rigid one). Id. Durability testing is performed at fluid pressures
`
`“consistent with normotensive conditions [i.e., normal blood pressure] specified in
`
`Table 1.” Id. While ISO 5840 allows for durability testing in real-time (i.e., at
`
`normal heart rates), doing so would take years. (At 70 bpm, it would take about
`
`five years to achieve 200 million cycles). Thus, the standard allows for
`
`“accelerated and quasi-real time durability testing,” although justification should
`
`be demonstrated and consideration should be given to the behavior of the tested
`
`materials. Id. Durability testing guidelines are set forth in Annex M. Id. at 74-75.
`
`Quasi-real time testing may be performed “under conditions that fall within
`
`the range of those specified in Table 1.” Id. at 74 (Section M.3). Thus, the test
`
`cycle rate would need to be in the normal physiological rates of Table 1 (30-200
`
`
`
`6
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`

`

`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`bpm). Id. at 17 (Table 1). Testing at 200 bpm instead of 70 bpm would still
`
`require almost two years to achieve 200 million cycles. However, the ISO
`
`standard only requires 80 million cycles of quasi-real time testing be carried out
`
`(id. at 74), thus, the testing could be completed in about nine months using the
`
`highest heart rate shown in Table 1 (i.e., 200 bpm).
`
`Accelerated durability testing is also allowed (id. at 23) and quasi-real time
`
`testing “may be used to evaluate the validity of any accelerated durability test
`
`results” (id. at 74). While little specific guidance is provided, justification for the
`
`testing conditions is required. Id. at 23, 74. Using accelerated rates, above normal
`
`physiological rates, could shorten testing time considerably. Although, ISO 5840
`
`admonishes the tester to consider the behavior of the materials at higher cycle
`
`rates. Id. at 23.
`
`One known problem with using accelerated testing is that it introduces
`
`pressures and resultant forces that are beyond those found in vitro (sometimes
`
`referred to as a water hammer effect). See e.g., Exs. 1013, 1014. In the Reul
`
`reference, the author compared forces under physiologic, real-time conditions (i.e.,
`
`hydrodynamic testing) with those found above physiological or accelerated rates,
`
`concluding the back-pressures generated “during accelerated testing exceed the
`
`
`
`7
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`

`

`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`
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`real-time loading forces by far.” Ex. 1014 at 1. As noted in the Iwasaki article,
`
`“[a]ccurate estimation of durability in a timely manner [i.e., accelerated] is one of
`
`the most important unresolved issues.” Ex. 1013 at 1. Iwasaki reports that using
`
`accelerated rates notably shortened valve life. Id.
`
`III. The ’224 Patent
`
`Around February 2008, BDC began researching and designing a new
`
`accelerated heart valve durability testing system. Ex. 2002 ¶ 3. One of the
`
`primary problems to be solved was mitigating the excessive forces created by
`
`accelerated cycling (i.e., the water hammer effect). This research resulted in the
`
`issuance of four, directly-related patents (including the ’224 Patent), as well as, the
`
`launch of a commercial product—the VDT-3600i, an accelerated testing system
`
`for prosthetic heart valves. Id. ¶ 5.
`
`Before BDC’s patents and product, commercial products which tested heart
`
`valves at an accelerate rate were unable to adequately control pressure rates. Id.
`
`¶ 6. Consequently, these systems were susceptible to pressure spiking which
`
`prematurely deteriorated the materials used for the prosthetic heart valves being
`
`tested. Id. The VDT-3600i included a compliance chamber, as described in the
`
`’224 Patent, to better manage pressure spikes which provided more accurate testing
`
`
`
`8
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`

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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
`
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`results. Id. ¶¶ 6-7. Essentially, the compliance chamber was a gas-filled space that
`
`excess fluid could be stored through compression of the gas and later released, akin
`
`to a water hammer arrestor. BDC revolutionized the market and within five years
`
`became the industry standard. Id. ¶¶ 8-10. The VDT-3600i currently accounts for
`
`about 80-90% of the worldwide market for heart valve durability testing systems.
`
`Id. at ¶ 11.
`
`Waters launched a competing product, the DuraPulse, which is the subject of
`
`an on-going lawsuit. Id. at ¶ 15. Waters then filed the present IPR challenging the
`
`validity of the ’224 Patent.
`
`A. Overview
`
`The ’224 Patent relates to a method for fatigue or durability testing of
`
`prosthetic devices (such as heart valves). Ex. 1001, 1:21-25. Like most durability
`
`testing systems, it operates at accelerated cycle rates. See e.g., id. at 2:1-3.
`
`As can be appreciated from Figure 3 (reproduced below), the apparatus disclosed
`
`comprises a drive mechanism (in pink) for pumping fluid into the system during
`
`the compression stroke. See e.g., id. at 11:49-65. (For convenience and clarity, the
`
`reference numerals have been removed from Figure 3 and the figure has been
`
`colorized and labelled.)
`
`
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`9
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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`
`Figure 3 of the ’224 Patent
`(colorized and labeled with reference numerals removed)
`
`
`
`As fluid is pumped into an already full channel, it enters distribution channel 126
`
`(in green) and moves up to the left and right of one-way valve 127 in the center.
`
`Id. at 11:66-9. The fluid continues moving up through the two test samples (e.g.,
`
`
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`10
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`

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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
`
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`heart valves) 130 (red) mounted in test chambers 148 (blue section) and then enters
`
`return chamber 136 (in orange). Id. Since the channel (green, blue, and orange
`
`sections combined) is full of fluid at the start, when the drive mechanism (in pink)
`
`pumps more fluid into the system, it increases the pressure in the channel. Id. at
`
`11:49-65. The volume of the excess fluid (i.e., in addition to that already in the
`
`channel) is displaced into compliance chambers 135 (in yellow). Id. at 12:10-15.
`
`Throttle valves 132 are partially closed to restrict the rate of the return flow. Id. at
`
`12:15-17.
`
`On the decompression stroke of the driving mechanism, heart valve 130
`
`closes (heart valves are one-way valves). Id. at 12:31-39. The volume of excess
`
`fluid leaves compliance chambers 135 and flows down return path 128 and
`
`through valve 164. Id. The cycle is then repeated. See also Ex. 2001 ¶¶ 13-16.
`
`Compliance chambers 135 may be filled with a gas the pressure of which
`
`can be adjusted. Ex. 1001 at 12:37-49. Thus, by controlling the pressure in the
`
`compliance chambers and the position of the throttle valves, pressure spikes can be
`
`mitigated. Id. at 12:18-22; 12:58-64. As such the system may be operate at an
`
`accelerated rate while reducing the damage to the heart valve being tested, thus,
`
`mitigating against a premature failure in the same.
`
`
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`11
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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`
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`An alternative embodiment is depicted in Figure 6 (reproduced below
`
`without reference numerals, colorized, and labeled).
`
`Figure 6 of the ’224 Patent
`(colorized and labeled with reference numerals removed)
`
`
`
`
`
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`12
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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`Similar to Figure 3, Figure 6 depicts a drive mechanism (pink), distribution
`
`chamber 226 (green), return chamber 236 (orange), compliance chamber 235
`
`(yellow), and test chamber 236 (blue) which holds test samples 230 (e.g., heart
`
`valves) (red). Id. at 12:65–13:15. On the compression stroke, additional fluid is
`
`introduced into the channel and the fluid flow moves to the left and right of one-
`
`way valve 227 through flow straighteners 271 and into test chamber 248 (blue).
`
`Id. at 13:34-49. Fluid passes through test samples 230. Id. The excess volume
`
`introduced into the channel displaces fluid into compliance chamber 235 (yellow).
`
`Id. at 13:63–14:20. During the decompression stroke, heart valves 230 close and
`
`the excess fluid volume re-enters the channel and flows around throttle valve 232
`
`and returns to distribution chamber 226 (orange). Id. at 13:63–14:2. Thus,
`
`completing one cycle. Id. As with Figure 3, throttle valve 232 may be adjusted to
`
`change the resistance on the fluid returning to the lower chamber (orange) via the
`
`central return conduit, thus, aiding in controlling the differential pressure across
`
`the heart valves. Id. at 14:6-10. As before, the amount of gas inside compliance
`
`chamber 232 may be adjusted to damp the system. Id. at 14:10-14. The
`
`embodiment of Figure 6 additionally includes bypass pathways 269 (purple) which
`
`measure the pressure differential across heart valves 230. Id. at 12:50-62.
`
`
`
`13
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`

`

`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`
`
`B. Prosecution History
`
`1. ’708 Patent
`
`During the prosecution of the parent patent, U.S. Pat. No. 8,627,708 (’708
`
`Patent), claims to the testing apparatus were rejected over Pickard. Ex. 2006 at 4.
`
`The preambles of all independent claims were amended to indicate that the system
`
`was an “accelerated” cyclical testing system for “valved” prosthetic devices.
`
`Ex. 2007 at 2, 5, 6. Applicant explained that:
`
`Pickard discloses a real time system (e.g., 1 Hz) for testing heart valves
`
`immediately before implantation. Pickard is thus not an accelerated
`
`testing system (e.g., ≥5 Hz) like the presently claimed invention and
`
`trying to cycle the Pickard system faster would frustrate the purpose of
`
`the test it is trying to perform (i.e., characterize valve performance in a
`
`simulated circulatory system under which the valve is to be used) while
`
`not being able to perform the accelerated wear testing of the claimed
`
`invention.
`
`Id. at 7. In other words, Pickard discloses a hydrodynamic testing system designed
`
`to mimic the human circulatory system and to operate at normal heart rates. It is
`
`not an “accelerated” testing system designed to measure durability. In view of the
`
`amendment and argument, the Examiner allowed the claims. Ex. 2008.
`
`
`
`14
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`

`

`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
`
`
`
`2. ’224 Patent
`
`During the prosecution the ’224 Patent, the subject of this IPR, the Examiner
`
`rejected the claims over Pickard. Ex. 1005 at 4-6. During an Examiner interview,
`
`the term “accelerated” in the preamble of claim 1 was discussed. Ex. 1006 at 2.
`
`Applicant amended claim 1 adding in the limitation “driving a test system fluid
`
`cyclically above the normal physiological rate, at an accelerated pulsed rate of
`
`greater than 200 beats per minute within the test system.” Ex. 1007 at 2. The
`
`Applicant again explained that Pickard disclosed a real time hydrodynamic testing
`
`system rather than an accelerated durability testing system.
`
`Pickard disclosed a “real-time” test system (e.g., operating at
`
`physiologic rates on the order of 72 beats per minute, or 1.2 Hz) for
`
`hydrodynamic performance testing of heart valves to characterize and
`
`define their anticipated fluid mechanical performance . . . Pickard’s
`
`disclosure is thus not an accelerated durability testing system (e.g.,
`
`operating at rates ≥ 3.5 Hz or 200 beats/cycles per minute) like the
`
`presently claimed invention and trying to cycle the Pickard system faster
`
`would frustrate the purpose of the test it is trying to perform (i.e.,
`
`characterizing valve performance in a simulated circulatory system
`
`under which the valve it to be used while not being able to perform the
`
`accelerated durability wear testing of the claimed invention.
`
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`15
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`Case IPR2018-00498
`Attorney Docket No: P270566.US.01
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`Id. at 5. Applicant noted Examiner’s concern “that the term ‘accelerated’ in the
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`preamble of claim 1 was insufficient to differentiate Pickard.” Id. “While the
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`Applicant disagreed,” it nevertheless amended claim 1. Id.
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`Applicant noted that the ISO 5840 Standard provides guidelines for the
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`accelerated durability testing of heart valves and that the industry (i.e., a
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`person of ordinary skill in the art) recognizes an “accelerated” valve test
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`system to mean a system that cycles faster than a normal physiological
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`rate. It was discussed that the typical upper end of a normal physio-
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`logical rate is above 200 beats per minute.
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`Id. at 6. (emphasis added). The Examiner apparently did not feel the preamble was
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`necessarily limiting, even though it had been successfully used to distinguish the
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`same reference during the examination of the ’708 Patent. To placate the
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`Examiner, the phrase “driving a test system fluid cyclically above a normal
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`physiological rate” was added to claim 1, thus, effectively adding “accelerated
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`cyclic test system” into the body of the claim. The Applicant further added the
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`limitation “an accelerated pulsed rate of greater than 200 beats per minute” which
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`is the typical upper end of a normal heart rate. As will be discussed below, Waters
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`attempts to read “accelerated cyclic test system” in the preamble and “driving a
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`test system fluid cyclically above a normal physiological rate” both to mean “an
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`accelerated pulsed rate of greater than 200 beats per minute,” thus, collapsing three
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`claim limitations into one. BDC will show that while “accelerated cyclic test
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`system” in the preamble means “driving a test system fluid cyclically above a
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`normal physiological rate,” it is not redundant in the sense that the Examiner
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`demanded the limitation be placed in the body of the claim. However, “an
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`accelerated pulsed rate of greater than 200 beats per minute,” is a limitation in
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`addition to the “driving a test system fluid cyclically above a normal physiological
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`rate” limitation.
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`IV. Person of Ordinary Skill in the Art
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`For the purposes of this IPR, Patent Owner agrees to Petitioner’s definition
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`of a person of ordinary skill in the art (Pet. at 26).
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`V. Claim Construction
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`The claims at issue here must be given their broadest reasonable
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`interpretation consistent with the specification as it would be interpreted by one of
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`ordinary skill in the art. Phillips v. AWH Corp., 415 F.3d 1303, 1316, (Fed. Cir.
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`2005) (en banc). Thus the focus of the inquiry regarding the meaning of a claim
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`should be what would be reasonable from the perspective of one of ordinary skill
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`in the art. In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010).
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`There are only two exceptions to this general rule: 1) when a patentee sets
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`out a definition and acts as his own lexicographer, or 2) when the patentee
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`disavows the full scope of a claim term either in the specification or during
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`prosecution. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1580 (Fed. Cir.
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`1996); MPEP § 2111.01. To act as his own lexicographer, a patentee must “clearly
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`set forth a definition of the disputed claim term” other than its plain and ordinary
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`meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir.
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`2002); Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed.
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`Cir. 2008) (the patentee must “clearly express an intent” to redefine the term).
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`As will be discussed below, Petitioner argues that Patent Owner defined the
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`term “accelerated” during prosecution. As will be evident, however, Petitioner
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`fails to show the alleged definition was “clearly set forth,” as required by law.
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`A.
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`“accelerated cyclic test system” (claim 1)
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`The phrase “[a method for operating an] accelerated cyclic test system”
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`means “driving a test system fluid cyclically above the normal physiological.” In
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`the context of the patent and prosecution history, it is clear that the claimed method
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`determines the durability of a prosthetic valve and does so using accelerated cycle
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`rates in excess of normal physiological rates. This system is in contrast to
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`hydrodynamic test systems which are used to measure flow characteristics of a
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`prosthetic valve in real-time (i.e., normal physiological rates).
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`1. Preamble is limiting
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`Petitioner argues that the preamble is not limiting. Pet. 12. However, where
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`the preamble was relied upon, as it was here, to distinguish over the prior art, it is
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`limiting. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808-
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`809 (Fed. Cir. 2002) (“[C]lear reliance on the preamble during prosecution to
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`distinguish the claimed invention from the prior art transforms the preamble into a
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`claim limitation.”); Metabolite Labs., Inc. v. Corp. of Am. Holdings, 370 F.3d
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`1354, 1358-62 (Fed. Cir. 2004). As discussed above, “accelerated” was added
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`during the prosecution of the ’708 Patent to distinguish over Pickard. It was again
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`argued as distinguishing Pickard during the prosecution of the ’224 Patent.
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`Therefore, “accelerated” is a limiting term.
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`2. Specification
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`Petitioner argues that “driving a test system fluid cyclically above the
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`normal physiological rate” means “an accelerated pulsed rate of greater than 200
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`beats per minute within the test system.” Pet. 11. Petitioner ignores the
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`specification (stating only that the “term ‘accelerated’ is not defined in the
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`specification”) which is a legally insufficient reason to simply ignore what can be
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`gleaned from the specification. Id. While the specification does not provide an
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`explicit definition of “accelerated,” it certainly provides context.
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`As stated in the patent title, Abstract, and throughout the specification the
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`invention described is a “fatigue testing system.” The specification refers to the
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`fact that fatigue testing requires a high number of testing cycles which is carried
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`out at accelerated testing speeds. See e.g., Ex. 1001 at 1:21-25 (“technology
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`described herein relates to systems and methods for f