UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`
`NIPRO CORPORATION,
`Petitioner,
`
`v.
`
`NXSTAGE MEDICAL, INC.,
`Patent Owner.
`___________________
`
`Case IPR2016-00744
`Patent No. 8,092,414
`___________________
`
`
`NXSTAGE MEDICAL, INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
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`
`
`
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`
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`9538992
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`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`
`
`NIPRO CORPORATION,
`Petitioner,
`
`v.
`
`NXSTAGE MEDICAL, INC.,
`Patent Owner.
`___________________
`
`Case IPR2016-00744
`Patent No. 8,092,414
`___________________
`
`
`NXSTAGE MEDICAL, INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
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`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`TABLE OF CONTENTS
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`Case IPR2016-00744
`Patent No. 8,092,414
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`Page
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`I.
`
`II.
`
`INTRODUCTION ........................................................................................ 7
`
`BACKGROUND .......................................................................................... 7
`
`III. CLAIM CONSTRUCTION ....................................................................... 10
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`“integrally attached to the chamber” (Claim 1), “integral with
`said pod” (Claims 13/23) .................................................................. 11
`
`“pressure sensing pod” (Claim 1)..................................................... 18
`
`“said diaphragm being moveable between first and second
`positions . . .” (Claim 1) ................................................................... 23
`
`“dome shaped” (Claim 12), “having a dome shape” (Claims
`13/23) ................................................................................................ 26
`
`“said dome shaped diaphragm being capable of bowing
`outwardly to form said dome shape in either of two opposed
`directions” (Claims 12/22/23) .......................................................... 33
`
`F.
`
`“is inside of said diaphragm” (Claim 1) ........................................... 37
`
`IV. RESPONSE TO GROUNDS OF CHALLENGE ...................................... 39
`
`A. Ground 1: Claims 1, 2 and 7 Are Not Anticipated by Minami ........ 39
`
`1. Minami does not teach the claimed “first position” and
`“second position” ................................................................... 39
`
`2. Minami does not disclose a “pressure sensing pod” .............. 46
`
`3. Minami does not teach “integrally attached” pressure
`tubing...................................................................................... 47
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`4. Minami does not anticipate claims 2 and 7 ............................ 50
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`Page
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`B.
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`Grounds 2-5 ...................................................................................... 52
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`1.
`
`2.
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`3.
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`4.
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`Ground 2: Claims 3 and 9 are not obvious over
`Minami in view of Kirita ....................................................... 53
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`Ground 3: Claim 4 is not obvious over Minami in view
`of Kirita/Isou .......................................................................... 56
`
`Ground 4: Claims 5 and 6 are not obvious over
`Minami in view of Tamari ..................................................... 57
`
`Ground 5: Claim 8 is not obvious over Minami in view
`of Brugger .............................................................................. 58
`
`C.
`
`Ground 6: Claims 12, 13, 16, 19, 22, 23, and 26 are not
`obvious over Minami in view of He, further in view of
`Gangemi, Onishi, Kersten, Calzia, and Kell (“the GOKCK
`references”) ...................................................................................... 59
`
`1.
`
`2.
`
`3.
`
`4.
`
`He does not disclose the claimed flexible and easily
`distortable dome ..................................................................... 60
`
`The GOKCK references do not disclose the claimed
`dome shape ............................................................................. 62
`
`Nipro has not met its burden to show a reason to
`combine Minami, He and the GOKCK references ................ 69
`
`The combined references further fail to teach the
`“flipping” limitations of claims 12, 22 and 23 ...................... 72
`
`D. Grounds 7, 8, 9, and 10 .................................................................... 74
`
`V.
`
`CONCLUSION ........................................................................................... 74
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`TABLE OF AUTHORITIES
`
`
`Cases
`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) .............................................................. 52
`
`Anderson Corp. v. Fiber Composites, LLC,
`474 F.3d 1361 (Fed. Cir. 2007) .............................................................. 19
`
`Atofina v. Great Lakes Chem. Corp.,
`441 F.3d 991 (Fed. Cir. 2006) ................................................................ 43
`
`Bettcher Indus. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) ................................................................ 43
`
`Chef Am., Inc. v. Lamb-Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004) ........................................................ 18, 23
`
`Ex parte Wada,
`No. 2007-3733, 2008 WL 142652 (B.P.A.I. Jan. 14, 2008) .................. 52
`
`Greenberg v. Ethicon Endo-Surgery, Inc.,
`91 F.3d 1580 (Fed. Cir. 1996) .......................................................... 55, 56
`
`Hill-Rom Servs., Inc. v. Stryker Corp.,
`755 F.3d 1367 (Fed. Cir.), cert. denied, 135 S. Ct. 719, 190 L. Ed.
`2d 463 (2014) .......................................................................................... 32
`
`Hockerson-Halberstadt, Inc. v. Avia Group Int’l,
`222 F.3d 951 (Fed. Cir. 2000) ................................................................ 44
`
`Illumina, Inc. v. The Trustee of Columbia University,
`IPR2012-00006, 2013 WL 2023631 (PTAB, March 12, 2013) ............. 10
`
`In re Am. Acad. of Sci. Tech Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) .............................................................. 10
`
`Kinetic Technologies, Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00529, Paper 8 (Sept. 23, 2014) ........................................ 53, 57
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`Page
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`Lighting World, Inc. v. Birchwood Lighting, Inc.,
`382 F.3d 1354 (Fed. Cir. 2004) .............................................................. 55
`
`Microsoft Corp. v. Proxyconn,
`789 F.3d 1292 (Fed. Circ., 2015) ........................................................... 23
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .............................................................. 71
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .............................................................. 39
`
`Straight Path IP Grp., Inc. v. Sipnet EU S.R.O.,
`806 F.3d 1356 (Fed. Cir. 2015) .............................................................. 32
`
`Thorner v. Sony Computer Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .............................................................. 29
`
`Toshiba v. Intellectual Ventures II LLC,
`IPR2014-00201, Paper 11 (May 21, 2014) ............................................ 54
`
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 628 (Fed. Cir. 1987) ................................................................ 39
`
`W.L. Gore & Associates, Inc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) .............................................................. 71
`
`Zimmer Holdings, Inc. v. Bonutti Skeletal Innovations LLC,
`IPR2014-01078, Paper 17 (Oct. 30, 2014) ............................................. 54
`
`Statutes
`
`35 U.S.C. § 102 ........................................................................................... 39, 43
`
`37 C.F.R. § 42.100 ............................................................................................ 10
`
`37 C.F.R. § 42.23 ................................................................................................ 6
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`TABLE OF EXHIBITS
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`
`
`NxStage Ex 2001 Definition of “dome” and “bow,” The American Heritage
`Dictionary of the English Language, Fourth Edition
`
`NxStage Ex 2002 Amendment Accompanying Request for Continued
`Examination filed June 6, 2011 in U.S. Application
`No. 11/270,080
`
`NxStage Ex 2003 U.S. Patent No. 4,666,598, “Apparatus for Use with Fluid
`Flow Transfer Device,” issued to Gary B. Heath et al.,
`May 19, 1987
`
`NxStage Ex 2004 U.S. Patent No. 6,440,080, “Automatic Oscillometric
`Apparatus and Method for Measuring Blood Pressure, “
`issued to John W. Booth et al., August 27, 2002
`
`NxStage Ex 2005 Curriculum Vitae of Gary Heath
`
`NxStage Ex 2006 Declaration of Gary Heath
`
`NxStage Ex 2007 Smith, P., Clinical Evidence, When compared to
`conventional blood tubing, Streamline® reduced dialysate
`flow and conserved fresh water while improving average
`Kt/V, Medisystems, ©2015
`
`NxStage Ex 2008 Cooke JD, Moran J., Compared to conventional
`bloodlines, Streamline® provided significantly lower
`costs per treatment and reductions in heparin usage and
`medical waste, Medisystems, ©2016
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`STATEMENT OF MATERIAL FACTS IN DISPUTE
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`Nipro did not submit a statement of material facts in its Petition.
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`Accordingly, no response is due pursuant to 37 C.F.R. § 42.23(a), and no facts are
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`admitted.
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`I.
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`INTRODUCTION
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`Case IPR2016-00744
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`Patent Owner NxStage Medical, Inc. (“NxStage”) was awarded U.S. Patent
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`No. 8,092,414 (“’414 patent”) for its innovations in the extracorporeal blood
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`handling field. Petitioner Nipro Corporation (“Nipro”) seeks an inter partes review
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`(“IPR”) of Claims 1, 2 and 7 of the ’414 patent as anticipated by Japanese Patent
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`Publication No. 1986-143069 (“Minami”); similarly, Petitioner seeks an IPR of
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`Claims 3-6, 8-9, 12-16, 19, 20-26, and 28 as obvious over Minami in view of
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`various other references.
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`Petitioner has not demonstrated a “reasonable likelihood of prevailing” as to
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`any of its proposed grounds of unpatentability. Its arguments are based on
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`unsupported claim constructions that are divorced from the patent claims and
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`specification. Under any reasonable reading of the claims, Minami fails to disclose
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`multiple key elements. Moreover, the additional references cited in Petitioner’s
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`proposed obviousness combinations do not cure the deficiencies in Minami.
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`Accordingly, the Board should deny Nipro’s Petition in its entirety.
`
`II. BACKGROUND
`NxStage is a leading manufacturer of innovative dialysis products, which
`
`strives to dramatically improve renal care with innovative yet simple therapeutic
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`solutions. The technology of the subject patent, including its “pods,” is
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`incorporated into several NxStage products, including NxStage’s Medisystems
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`Streamline bloodlines, NxStage System One Home Dialysis disposables, and
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`NxStage System One Critical Care Dialysis disposables. Conventional bloodline
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`drip chambers rely on an air/blood interface for pressure monitoring during
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`dialysis. The revolutionary technology disclosed in the ’414 patent allows for,
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`among other things, the elimination of the air/blood interface.
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`More specifically, the technology disclosed in the ’414 patent uses an
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`“airless pressure chamber (called a ‘pod’) which contains a diaphragm” that is “not
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`connected to the pressure port on the face of a dialysis machine, but is spaced
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`therefrom.” Ex. 1001 at 2:12-17. To allow for remote placement, the pod chamber
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`is integrally attached to the pressure tubing, creating an air-tight seal between the
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`air in the pod chamber and the air in the tubing. The ’414 patent also discloses the
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`novel use of a diaphragm that is flexible and can take a first position to
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`substantially maximize blood volume in the pod chamber, and a second position to
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`substantially minimize but not eliminate the blood volume in the pod chamber.
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`Specifically, and contrary to the conventional wisdom in the art at the time, the
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`’414 patent discloses the use of a dome-shaped diaphragm, which has two stable
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`positions at manufacture and during shipping, prior
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`to actual pressure
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`measurement. The initial position of the dome optimizes the amount of air in the
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`monitoring side needed for either measuring positive or negative pressures.
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`The diaphragm shape and remotely positioned, airless pressure chamber of
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`the ’414 patent have a number of important clinical and economic advantages.
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`Indeed, the patent notes that with the disclosed pod, (1) it is “unnecessary to set a
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`liquid level as in many prior art chambers, and a blood-air interface can be
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`completely avoided,” (2) the chamber “may be significantly smaller than the drip
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`chambers of the prior art, and thus may have a reduced priming volume,” (3) the
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`“volume of the chamber can be temporarily further reduced by manipulation of the
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`diaphragm . . . to reduce the amount of solution needed in the rinse back process.”
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`Ex. 1001 at 2:12-67. Thus, clinicians using NxStage’s products can now increase
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`blood flow rates, resulting in improved dialysis adequacy or Kt/V. Ex. 2007.
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`NxStage’s revolutionary technology has further resulted in lower cost per
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`treatment with reductions in heparin usage, dialysate and treatment time. Ex. 2008;
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`see also Ex. 1001 at 2:12-67 (noting the clinical advantage of “reducing
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`extracorporeal blood volume (priming volume),” while also reducing material
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`costs by using “less large-bore blood tubing, but more small bore air pressure
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`monitoring tubing” and also allowing for a “reusable pressure monitor line”). In
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`addition, the dome-shape is advantageous because it allows for movement of the
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`diaphragm
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`reflective of pressure changes,
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`resulting
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`in
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`linear pressure
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`measurements. Ex. 2006 ¶ 16. By contrast, a diaphragm with a flat top would
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`prevent measurement of pressure in a linear fashion and instead result in a
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`measurement curve that approaches a flat line when the pressure goes above or
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`below a certain point. Id. Thus, with the dome-shape, the sensed measurement
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`always corresponds to the actual pressure, whereas with a flat shape it does not. Id.
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`The improvements in clinical and economic outcomes as a result of the
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`technology disclosed in the ’414 patent has allowed NxStage to capture substantial
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`market share in the U.S. NxStage’s success has not gone unnoticed by competitors
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`such as Nipro.
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`III. CLAIM CONSTRUCTION
`“During inter partes review, claims are given their broadest reasonable
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`interpretation in view of the specification of which they are part. 37 C.F.R.
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`§ 42.100(b).” Illumina, Inc. v. The Trustee of Columbia University, IPR2012-
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`00006, 2013 WL 2023631, at *3 (PTAB, March 12, 2013). The standard for claim
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`construction at the Patent Office is different from that used during a U.S. District
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`Court litigation. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364, 1369
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`(Fed. Cir. 2004); 37 C.F.R. § 42.100(b). NxStage expressly reserves the right to
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`argue a different claim construction in litigation for any term of the ’414 patent, as
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`appropriate in that proceeding.
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`A.
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`“integrally attached to the chamber” (Claim 1), “integral with
`said pod” (Claims 13/23)
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`NxStage’s Proposal
`“integrally attached” and “integral
`with” each mean “bonded or locked
`together as a sealed unit”
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`Nipro’s Proposal
`“directly attached to the pod”
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`Nipro proposes that the term “integrally” in claim 1 be replaced with the
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`word “directly” and that the term “integral with” in claims 13 and 23 be replaced
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`with “directly attached to.” The Board should reject Nipro’s proposal because it
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`does not comport with the specification or file history; nor is it consistent with
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`Nipro’s own extrinsic evidence. Instead, the evidence shows that “integrally
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`attached” and “integral” require more than a direct attachment—they require that
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`the components be “bonded or locked together as a sealed unit.”
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`Nipro acknowledges that the ordinary meaning of “integral” is “formed as a
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`unit with another part.” Pet. at 16 (citing Ex. 1018 at 607). This ordinary meaning
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`is consistent with the claim language and the specification. For example, the plain
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`language of the claim limits the recited connection to an “integral” attachment—
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`where the components are bonded or locked together as a sealed unit—rather than
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`a mere connection—where the components could be simply directly attached to
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`one another. Ex. 1001 at 14:50-15:2 (reciting that the pressure tubing is
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`“connected” to both the pod chamber and the pressure measuring equipment, but
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`further requiring that the pressure tubing’s connection “at one end”—i.e., the end
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`that connects to the pod chamber—is “integrally attached”).
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`Additionally, the specification supports a meaning of “integral” that requires
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`more than a direct connection, noting in the “Description of the Invention” that
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`“[t]he pressure tubing may be permanently connected to the connection port, the
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`pod, or releasably connected as previously described.” Ex. 1001 at 7:14-17; id. at
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`3:1-30 (noting that tubing can be “permanently attached” or “releasable” by using
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`“an appropriate mating connector” to the pod connector); 3:52-59 (noting that the
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`pressure tubing can be attached to the pod via a “male luer lock” that is
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`“compatible for connection with the sealed port carried on the pod”). Moreover, all
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`of the disclosed embodiments describe the tubing as either “permanently bonded”
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`to the pod chamber or connected via a “sealing and/or locking means” such as a
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`“male luer connector [], having locking sleeve.” Id. at 11:15-24; 12:4-16 (noting
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`that the embodiment in Fig. 1 shows “pressure tubing 42a” that is “permanently
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`bonded to pod 80” whereas Fig. 11 shows pressure tubing that attached via a “male
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`luer connector 106”). Figures 12-17 (as annotated below) show in greater detail
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`how a male luer lock connector can be used to “integrally attach” the pressure
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`tubing by locking it via screw-threading to a female luer lock, tapered fit connector
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`on the chamber connection port to form a sealed unit:
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`While the screw-threading embodiment depicted in Figures 12-17 is just one
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`example of components that are “integrally attached,” any integral attachment must
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`achieve the same result of bonding or locking the two components together as a
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`sealed unit. Id. 11:16-19 (“Pressure sensing pod 80 carries sealed port 116, which
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`may be generally of the design of a female luer lock connector, having lugs or
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`screw threads 118 in conventional manner, or other sealing and/or locking
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`means.”).
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`A construction of the “integral” element that requires that the components be
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`“bonded or locked together as a sealed unit” is also supported by the file history.
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`Indeed, the “integral” requirement was added to the claims during prosecution.
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`See, e.g., Ex. 2002 at 2, 4, 6. The patentee noted that the pressure tubing of
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`Soussan was “integral” with the processing device, as opposed to “integral” with
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`the pressure pod chamber:
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`As now amended, independent claim 9 additionally
`recites that the pressure tubing is . . . integrally attached
`to the chamber to permit the pod to be positioned
`remotely
`from
`the pressure measuring equipment
`. . . .Soussan’s pressure tubing 93((a)-(d)) is an integral
`part of a processing device . . . . Therefore, contrary to
`Applicants’ invention, Soussan’s pressure tubing [] is
`[not] integrally attached to the pressure pod [] chamber”
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`Id. (underlining in original). This requirement that the pressure tubing is integral
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`with the pod chamber is an important advantage over the prior art. Id. at 10 (noting
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`that integrally attaching (i.e., bonding/locking) the tubing to the pod/chamber as
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`opposed to the pressure measuring equipment allows the pod to “be placed at the
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`most desirable locations on the blood flow set . . . while at the same time
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`inexpensive air pressure monitoring tubing may be used to connect the pod or pods
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`to the machine, to permit the blood flow set to have a minimum length of blood
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`flow tubing”); Ex. 2006 ¶ 24. Indeed, the “integral” attachment that creates a seal
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`between the air in the pressure tubing and the air in the chamber of the pod allows
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`the pressure in the pod to be accurately sensed, even when the pod is positioned
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`“remotely” from the pressure measuring equipment. Id. ¶ 24.
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`Despite the plain meaning of “integral” and extensive support in the intrinsic
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`record for construing the “integral” element consistently with that meaning, Nipro
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`attempts to read out the requirement by proposing a construction that requires
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`merely a direct connection. In support of this argument, Nipro claims “it is
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`nonsensical for a length of tubing and a space to be attached to one another, much
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`less formed as a single unit.” Pet. at 16. But, to the contrary, this is precisely the
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`point of the “integral” requirement—i.e., to seal together the air-mass inside of the
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`tubing and the chamber, via cohesive solvent bonding of the components or
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`locking means. Ex. 2006 ¶ 25. The specification explains that the integral
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`attachment that joins the tube and interior chamber space of the diaphragm creates
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`a seal that results in an integrated unitary air-mass. Ex. 1001 at 9:11-14. Indeed, for
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`the pressure measuring equipment to function properly in the invention, a sealed
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`air-mass must exist. Ex. 2006 ¶ 25. The pressure measuring devices work by
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`sensing the expansion or compression of air within a confined space. Id. This is
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`depicted, for example, in Figure 1, annotated below:
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`As shown, there is a fixed amount of air both in pod chamber 24 and pressure
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`tubing 42 when the diaphragm is in position 26a, for example (note that the blue
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`volume inside the chamber is enlarged for illustration purposes). These two spaces
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`are combined by bonding pressure tubing 42 at connection port 40 to seal together
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`one integrated air-mass in the combined space. This integral attachment is
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`important to the invention because the remotely-positioned pressure measuring
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`devices (41 and 43) require a sealed air-mass to accurately measure pressure in the
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`pod. Ex. 2006 ¶ 26. Positioning the pod remotely from the measuring device as
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`claimed thus requires the “integral attachment” to seal together as a unit the
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`pressure tubing and the pod’s air chamber, sealing together the air-masses inside of
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`them to achieve accurate measurements. Id. ¶ 27.
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`Nipro also argues that “it makes little sense for the pressure tubing and the
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`pod to be formed as a single unit, because they are typically made of different
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`materials.” Pet. at 16. But neither Nipro, nor its expert, provides any factual
`
`evidence or support for this conclusory assertion. To the contrary, there is no
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`technical or mechanical reason that would prevent different materials from being
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`solvent bonded or locked together in this context. Ex. 2006 ¶ 28. Indeed, it is
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`common in the medical device disposables industry to bond two components of
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`different materials and/or rigidities together with a solvent agent such a
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`cyclohexanone, which creates a hermetic seal of the bonded components whether
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`they are the same material/rigidity or not, as long as the dissimilar materials being
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`bonded are both affected by the applied solvent bonding material. Id. Similarly, the
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`’414 patent explains that a male luer lock could be used to “integrally attach” the
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`tubing to the pod chamber. A male luer lock attachment could certainly be used to
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`connect components consisting of different materials and/or rigidities. Id.
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`Nipro further argues that dependent claim 16—which requires that the
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`pressure tubing “is capable of disconnection from the connection port of the
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`pod”—precludes the pressure tubing from being permanently attached to the pod.
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`But Nipro has not shown that permanent attachment is required. As noted above,
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`the specification clearly describes various “integral” attachments formed via
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`locking means—such as a luer lock—that are releasable but still result in the pod
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`chamber and pressure tubing being locked together as a sealed unit.
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`The only other support Nipro offers for its proposed construction is a
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`conclusory statement that it is “consistent” with the patent’s figures. But Nipro’s
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`contention is factually inaccurate, as it disregards the descriptions of those figures
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`which—as noted above—indicate that the connection between the pod chamber
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`and the tubing must be more than a mere direct attachment. Indeed, as noted above,
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`the figures show a permanent bond (Figure 1) or a screw-threaded lock
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`(Figures 11-17).
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`B.
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`“pressure sensing pod” (Claim 1)
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`NxStage’s Proposal
`plain meaning
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`Nipro’s Proposal
`“Pressure Transmitting Pod.”
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`Nipro’s proposed construction is plainly wrong, as it asks the Board to
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`rewrite the claim by replacing an element from claim 1—“pressure sensing pod”—
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`with a distinct element recited in claims 13 and 23—“pressure transmitting pod.”
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`Nipro’s attempt to rewrite the claim is a violation of basic claim construction
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`principles. Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1373 (Fed. Cir.
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`2004) (“Courts are not permitted to redraft claims.”). Indeed, it is presumed that
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`different meanings and scope will attach where different words or phrases are used
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`in separate claims. See, e.g., Anderson Corp. v. Fiber Composites, LLC, 474 F.3d
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`1361, 1370 (Fed. Cir. 2007). Nipro fails to present any compelling reason to rebut
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`this presumption.
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`Nipro argues that the term “pressure sensing pod” is “a misnomer” because,
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`according to Nipro, “the pod itself does not sense pressure, but rather only
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`transmits pressure from a blood circuit.” Pet. at 13-14. But there is no “misnomer”
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`in the claim. The plain language of claim 1 unambiguously requires a “pressure
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`sensing pod,” which is different in several key technical respects from the
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`“pressure transmitting pod” of claims 13 and 23 (which do not use this language).
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`The pressure sensing pod as recited in claim 1 is sensing the pressure of
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`flowing blood in a blood circuit. Ex. 2006 ¶ 33. To that end, claim 1 recites the
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`unique feature of “said second position bowing inwardly to substantially minimize
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`but not eliminate the blood volume in said chamber, said diaphragm in use
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`being in contact on one side thereof with flowing blood.” Ex. 1001 at 14:59-63
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`(emphasis added). This limitation specifies that even when the diaphragm is in the
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`inwardly bowed position where blood volume is substantially minimized, the blood
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`volume of the chamber is not eliminated so that it can still contain flowing blood.
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`Ex. 2006 ¶ 33. Because blood continues to flow, the pressure of flowing blood in
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`the blood circuit can continue to be sensed. Id. By contrast, in the claims that
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`merely recite a “pressure transmitting pod,” there is no requirement that the blood
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`volume in the chamber not be eliminated. Ex. 1001 at cl. 13, 23. Instead, in those
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`claims, pressure may be transmitted to such an extent that blood volume may or
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`may not be fully eliminated in a blood circuit. Id. But if blood volume were
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`eliminated, there could be no flowing blood; blood requires a volume in which to
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`flow. While this may be permissible in the “pressure transmitting pod” of claims
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`13 and 23, it is not permitted by the plain terms of claim 1 directed to a “set” with
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`a “pressure sensing pod.” Ex. 2006 ¶ 34.
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`The distinction between a “pressure sensing pod” and a “pressure
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`transmitting pod” is further supported by the specification and figures. For
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`example, Figure 5 and Figure 1, annotated below, support the distinction (the
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`relevant portion of Figure 1 was excerpted from the larger figure):
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`As depicted, when the diaphragm is in the second position, as in position 26a in
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`Figure 1, it minimizes, but does not eliminate blood volume in the pod. The
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`diaphragm continues to be “in contact on one side thereof with flowing blood” as
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`claimed. Ex. 1001 at 14:64-65. The “flowing blood” of claim 1 is depicted in pink
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`on Figures 1 and 5 above. In these embodiments, the blood continues to flow under
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`the diaphragm in its “second position” because of channel 50, shown for example
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`in Figure 5. The specification explains at 9:49-59:
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`The lower compartment portion 22 of pod 12 has a
`bottom wall which defines a transverse channel 50,
`which extends between blood inlet port 30 and blood
`outlet port 32. Channel 50 is shown to be of U-shaped
`cross-section, being substantially aligned with, and
`having a size similar to, the inner diameter of the blood
`flow port 30, 32 and the tubing which they carry, to
`provide efficient fluid flow, even when diaphragm 26 is
`in its second position, as shown in FIG. 4 as diaphragm
`26a. The presence of channel 50 assures that there will
`not be major blocking of blood flow when diaphragm
`26 is in its second position.
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`(Emphasis added).
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`Thus, claim 1 is a “pressure sensing pod” because it expressly claims
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`structure that minimizes but does not eliminate blood volume, unlike claims 13 and
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`23. The “sensing” is always possible by “assur[ing] that there will not be major
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`blocking of blood flow when diaphragm 26 is in its second position.” In this way,
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`there will always be flowing blood in the chamber, having a corresponding
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`pressure in the blood circuit to sense. Ex. 2006 ¶ 37. The plain text of this element
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`of claim 1, as well as the difference between the text of claim 1 and the text of
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`claims 13 and 23, make this clear.
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`Moreover, the specification describes that pressure “sensing” is a key feature
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`of the claimed “pressure sensing pod”:
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`The pressure monitor system that utilizes the pressure
`sensing pod is thus capable of monitoring pressure of
`the entire length of the blood flow tubing extending
`downstream from the extracorporeal blood processing
`device, typically a dialyzer. This is a significant area for
`pressure monitoring, because it is typically the majority
`of the extracorporeal blood flow circuit that operates
`under positive pressure. A serious blood leak or kink
`anywhere along the line downstream of the dialyser can
`thus be detected by a pressure fluctuation, if there is
`constant monitoring through the pressure sensing
`chamber.
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`Ex. 1001 4:40-50 (emphasis added). It would thus be an error to replace the claim
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`term “sensing” with a different word, “transmitting.” As explained, “sensing” is
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`distinct from simply “transmitting” a pressure. Nipro’s assertion that the language
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`chosen by the patentee is somehow a “misnomer” ignores several express
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`teachings and purposes of the invention, and is improper. Accordingly, the Board
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`should give this claim element its plain and ordinary meaning.
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`C.
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`“said diaphragm being moveable between first and second
`positions . . .” (Claim 1)
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`NxStage’s Proposal
`Plain Meaning
`
`Nipro’s Proposal
`“said diaphragm being moveable
`between first and second positions,
`the diaphragm in said first position
`bowing outwardly to substantially
`maximize volume in a portion of said
`chamber that communicates with said
`blood flow tubing, the diaphragm in
`said second position bowing inwardly
`to substantially minimize but not
`eliminate the blood volume in said
`portion of said chamber.”
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`Nipro seeks to convert the words “said chamber” to “a portion of said
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`chamber.” As noted above, such attempts to rewrite the claim text
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