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
`___________________
`
`
`
`DECLARATION OF GARY HEATH IN SUPPORT OF
`NXSTAGE MEDICAL, INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`9353112.8
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`NxSTAGE Ex 2006-1
`Nipro v NxStage
`IPR2016-00744
`
`

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`
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`I, Gary Heath, declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I understand that Petitioner NIPRO Corporation (“Nipro”) has filed a petition
`
`seeking institution of inter partes review proceedings concerning various claims of U.S.
`
`Patent 8,092,414, which is owned by NxStage Medical, Inc. (“NxStage”).
`
`2.
`
`I have been retained as an independent expert witness on behalf of NxStage
`
`to opine on certain matters relevant to Nipro’s petition. I understand that this Declaration is
`
`being submitted along with Patent Owner’s Preliminary Response to Nipro’s Petition. At
`
`this time, I opine only with respect to certain issues that are discussed in this declaration. By
`
`doing so, however, I do not necessarily agree with the other positions taken by Nipro that I
`
`do not address here. Indeed, should Nipro’s petition be granted, I reserve the right to and
`
`anticipate that I will submit another declaration detailing my opinions concerning various
`
`additional issues raised in Nipro’s petition.
`
`II.
`
`RESOURCES CONSULTED
`
`3.
`
`I have reviewed the ’414 Patent, its file history, and Nipro’s Petition for Inter
`
`Partes Review filed with the United States Patent and Trademark Office on March 11, 2016
`
`(Paper No. 1). I have also reviewed the Declaration of Mr. Charles E. Clemens (Ex. 1002)
`
`and all references cited in this declaration.
`
`III. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`I am an expert in the research, development, manufacturing, operations,
`
`management, and regulatory aspects of medical devices, and in particular with medical
`
`equipment, single use-sterile disposables and sterile injectable solutions. I have studied,
`
`taught, practiced, consulted, and researched in the foregoing fields for over 37 years. I am
`
`presently Co-Owner and Principal Engineer for Evergreen Research, Inc. (“ERI”). ERI
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`IPR2016-00744
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`specializes in Contract R&D, Contract Manufacturing, and Contract RA/QA services for the
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`Medical Device Industry
`
`5.
`
`I received a Bachelor of Science in Mechanical Engineering Technology
`
`from the University of Southern Colorado/CSU Pueblo, in 1979, and a Masters in Business
`
`Administration from the University of Phoenix in 1984.
`
`6.
`
`I have had extensive experience in the medical device industry and technical
`
`fields relevant to the asserted patents. I have been the Co-Owner and Principal Engineer for
`
`ERI since November 2009. Prior to that, I was the President and Founder of Gary Heath &
`
`Associates, a medical device consulting company, from August 2007 to October 2009. Prior
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`to that, I was the Director, Vice President, President, and Chief Operating Officer of
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`COBE/Gambro/Terumo BCT, Inc. I worked in these positions from 1988 to 2007. During
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`that time, I was extensively involved in single use disposables and their associated
`
`instruments that were developed and produced within the company. As President and COO
`
`of Gambro BCT, I was responsible for the patent estate of the company and the patent
`
`counsel of the company reported to me. I was involved in numerous patent issues, during
`
`my tenure in Gambro BCT. Prior to that, I was the Senior Manufacturing and R&D
`
`Engineer, Engineering Manager and Manufacturing Manager for COBE Laboratories, Inc.
`
`from 1983 to 1988. During my time at COBE, I was the lead design engineer on a team that
`
`created unique designs in the dialysis and blood banking markets, enabling COBE to replace
`
`generic disposables, with patent protected proprietary products. I spent approximately 5
`
`years during this period of time as the recognized materials expert for the company, in
`
`regard to the selection, processing, and commercialization of single use disposables plastic
`
`materials. Prior to that, I worked at various other medical device companies.
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`7.
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`I have been granted a number of patents for my work in the dialysis and
`
`blood handling field. These patents include U.S. Patent No. 4,666,598 entitled “Apparatus
`
`for use with fluid flow transfer device,” granted on May 19, 1987; U.S. Patent
`
`No. 4,770,787 entitled “Method of operating a fluid flow transfer device,” granted on
`
`September 13, 1988; and U.S. Patent No. 4,798,090 entitled “Apparatus for use with fluid
`
`flow transfer device,” granted on January 17, 1989. These patents are all cited references on
`
`the face of the ’414 patent. See Ex. 1001.
`
`8.
`
`I have been a Senior Member of the Society of Manufacturing Engineers
`
`since 1979. In addition, I have been a Senior Member of the Society of Plastics Engineers
`
`since 1983.
`
`9.
`
`Further details regarding my education, experience, publications, and other
`
`qualifications to render an expert opinion in this matter are provided in my Curriculum
`
`Vitae. See Exhibit 2005.
`
`IV. RETENTION AND COMPENSATION
`
`10.
`
`I have been retained to offer an expert opinion as to the scope and meaning of
`
`the Challenged Claims of the ’414 patent.
`
`11. My work on this matter is being billed at a rate of $250 per hour, with
`
`reimbursement for actual expenses. My compensation is not contingent upon the outcome
`
`of this case.
`
`V.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`12.
`
`I believe that a person of ordinary skill in the art would have had any one of
`
`the following: (i) a Bachelor degree in Mechanical Engineering, Biomedical Engineering, or
`
`a related field, and about 3 years of practical experience in the field of blood handling
`
`systems; or (ii) 7 years of practical experience in the field of blood handling systems. These
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`descriptions are approximate, and a higher level of education or skill might make up for less
`
`experience, and vice-versa.
`
`VI.
`
`TECHNICAL BACKGROUND
`
`13.
`
`Conventional bloodline drip chambers rely on an air/blood interface for
`
`pressure monitoring during dialysis. The revolutionary technology disclosed in the ’414
`
`patent allows for the elimination of the air/blood interface. More specifically, the
`
`technology disclosed in the ’414 patent uses an “airless pressure chamber (called a ‘pod’)
`
`which contains a diaphragm” that is “not connected to the pressure port on the face of a
`
`dialysis machine, but is spaced therefrom.” Ex. 1001 at 2:12-17. To allow for this remote
`
`placement, the pod chamber is integrally attached to the pressure tubing, creating an air-tight
`
`seal between the air in the pod chamber and the air in the tubing. The ’414 patent also
`
`discloses the novel use of a diaphragm that is flexible and can take a first position to
`
`substantially maximize blood volume in the pod chamber, and a second position to
`
`substantially minimize but not eliminate the blood volume in the pod chamber. Specifically,
`
`and contrary to the conventional wisdom in the art at the time, the ’414 patent discloses the
`
`use of a dome-shaped diaphragm, which has two stable positions at manufacture and during
`
`shipping, prior to actual pressure measurement. The initial position of the dome optimizes
`
`the amount of air in the monitoring side needed for either measuring positive or negative
`
`pressures.
`
`14.
`
`The diaphragm shape and remotely positioned, airless pressure chamber of
`
`the ’414 patent have a number of important clinical and economic advantages. Indeed, the
`
`patent notes that with the disclosed pod, (1) it is “unnecessary to set a liquid level as in many
`
`prior art chambers, and a blood-air interface can be completely avoided,” (2) the chamber
`
`“may be significantly smaller than the drip chambers of the prior art, and thus may have a
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`IPR2016-00744
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`reduced priming volume,” (3) the “volume of the chamber can be temporarily further
`
`reduced by manipulation of the diaphragm . . . to reduce the amount of solution needed in
`
`the rinse back process.” Ex. 1001 at 2:12-67.
`
`15.
`
`Thus, clinicians using NxStage’s products can now increase blood flow rates,
`
`resulting in improved dialysis adequacy or Kt/V. Ex. 2007. NxStage’s revolutionary
`
`technology has further resulted in lower cost per treatment with reductions in heparin usage,
`
`dialysate and treatment time. Ex. 2008; see also Ex. 1001 at 2:12-67 (noting the clinical
`
`advantage of “reducing extracorporeal blood volume (priming volume),” while also
`
`reducing material costs by using “less large-bore blood tubing, but more small bore air
`
`pressure monitoring tubing” and also allowing for a “reusable pressure monitor line”).
`
`16.
`
`In addition, the dome-shape is advantageous because it allows for movement
`
`of the diaphragm reflective of pressure changes, resulting in linear pressure measurements.
`
`By contrast, a diaphragm with a flat top would prevent measurement of pressure in a linear
`
`fashion and instead result in a measurement curve that approaches a flat line when the
`
`pressure goes above or below a certain point. Thus, with the dome-shape, the sensed
`
`measurement always corresponds to the actual pressure, whereas with a flat shape it does
`
`not.
`
`VII. CLAIM CONSTRUCTION
`
`A.
`
`17.
`
`Legal Standards
`
`I am not a lawyer, but I have been informed of certain legal rules governing
`
`claim construction in patent proceedings before the Patent Trial and Appeal Board.
`
`18.
`
`I understand that, during an inter partes review, claims are to be given their
`
`broadest reasonable construction in light of the specification. My statements regarding
`
`claim construction, as well as the rest of my opinions set forth in this declaration, would also
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`IPR2016-00744
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`apply if the claim terms are construed as they would have been understood by a person
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`having skill in the art as of the filing date of the patent.
`
`B.
`
`“integrally attached to the chamber” (Claim 1), “integral with said pod”
`(Claims 13/23)
`
`19.
`
`Claim 1 of the ’414 patent recites that the pressure tubing is “integrally
`
`attached to the chamber” and claims 13 and 23 similarly require that the pressure tubing is
`
`“integral with said pod.” Nipro and its expert propose that the term “integrally” in claim 1
`
`be replaced with the word “directly” and that the term “integral with” in claims 13 and 23 be
`
`replaced with “directly attached to.” I disagree. Instead, it is my opinion that the terms
`
`“integrally attached” and “integral with” require more than a direct attachment—they
`
`require that the components be “bonded or locked together as a sealed unit.”
`
`20.
`
`Nipro acknowledges that the ordinary meaning of “integral” is “formed as a
`
`unit with another part.” Pet. at 16 (citing Ex. 1018 at 607). This ordinary meaning is
`
`consistent with the claim language and the specification. For example, the plain language of
`
`the claim limits the recited connection to an “integral” attachment—where the components
`
`are bonded or locked together as a sealed unit—rather than a mere connection—where the
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`components could be simply directly attached to one another. Ex. 1001 at 14:50-15:2
`
`(reciting that the pressure tubing is “connected” to both the pod chamber and the pressure
`
`measuring equipment, but further requiring that the pressure tubing’s connection “at one
`
`end”—i.e., the end that connects to the pod chamber—is “integrally attached”).
`
`21.
`
`In addition, the specification supports a meaning of “integral” that requires
`
`more than a direct connection, noting in the “Description of the Invention” that “[t]he
`
`pressure tubing may be permanently connected to the connection port, the pod, or releasably
`
`connected as previously described.” Ex. 1001 at 7:14-17; see also id. at 3:1-30 (noting that
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`tubing can be “permanently attached” or “releasable” by using “an appropriate mating
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`connector” to the pod connector); 3:52-59 (noting that the pressure tubing can be attached to
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`the pod via a “male luer lock” that is “compatible for connection with the sealed port carried
`
`on the pod”).
`
`22. Moreover, all of the disclosed embodiments describe the tubing as either
`
`“permanently bonded” to the pod chamber or connected via a “sealing and/or locking
`
`means” such as a “male luer connector [], having locking sleeve.” Id. at 11:15-24; 12:4-16
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`(noting that the embodiment in Fig. 1 shows “pressure tubing 42a” that is “permanently
`
`bonded to pod 80” whereas Fig. 11 shows pressure tubing that attached via a “male luer
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`connector 106”). Figures 12-17 (as annotated below) show in greater detail how a male luer
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`lock connector can be used to “integrally attach” the pressure tubing by locking it via screw-
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`threading to a female luer lock, tapered fit connector on the chamber connection port to form
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`a sealed unit:
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`23. 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 achieve
`
`the same result of bonding or locking the two components together as a sealed unit. Id.
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`11:16-19 (“Pressure sensing pod 80 carries sealed port 116, which may be generally of the
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`design of a female luer lock connector, having lugs or screw threads 118 in conventional
`
`manner, or other sealing and/or locking means.”). (Emphasis added.)
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`24.
`
`A construction of the “integral” element that requires that the components be
`
`“bonded or locked together as a sealed unit” is also supported by the file history. Indeed, the
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`“integral” requirement was added to the claims during prosecution. See, e.g., Ex. 2002,
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`June 6, 2011 amendment and response, at pages 2, 4 and 6. The patentee noted that the
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`pressure tubing of Soussan was “integral” with the processing device, as opposed to
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`“integral” with 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.
`
`Id. (underlining in original). This requirement that the pressure tubing is integral with the
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`pod chamber is an important advantage over the prior art. Id. at 10 (noting that integrally
`
`attaching (i.e., bonding/locking) the tubing to the pod/chamber as opposed to the pressure
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`measuring equipment allows the pod to “be placed at the most desirable locations on the
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`blood flow set . . . while at the same time inexpensive air pressure monitoring tubing may be
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`used to connect the pod or pods to the machine, to permit the blood flow set to have a
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`minimum length of blood flow tubing”). Indeed, the “integral” attachment that creates a
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`seal between the air in the pressure tubing and the air in the chamber of the pod allows the
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`pressure in the pod to be accurately sensed, even when the pod is positioned “remotely”
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`from the pressure measuring equipment.
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`25.
`
`Despite the plain meaning of “integral” and extensive support in the intrinsic
`
`record for construing the “integral” element consistently with that meaning, Nipro attempts
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`to read out the requirement by proposing a construction that requires merely a direct
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`connection. In support of this argument, Nipro claims “it is nonsensical for a length of
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`tubing and a space to be attached to one another, much less formed as a single unit.” Pet. at
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`16. But, to the contrary, this is precisely the point of the “integral” requirement—i.e., to seal
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`together the air-mass inside of the tubing and the chamber, via cohesive solvent bonding of
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`the components or locking means. The specification explains that the integral attachment
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`that joins the tube and interior chamber space of the diaphragm creates a seal that results in
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`an integrated unitary air-mass. Ex. 1001 at 9:11-14. Indeed, for the pressure measuring
`
`equipment to function properly in the invention, a sealed air-mass must exist. The pressure
`
`measuring devices work by sensing the expansion or compression of air within a confined
`
`space. This is depicted, for example, in Figure 1, annotated below:
`
`
`
`26.
`
`As shown, there is a fixed amount of air both in pod chamber 24 and pressure
`
`tubing 42 when the diaphragm is in position 26a, for example (note that the blue volume
`
`inside the chamber is enlarged for illustration purposes). These two spaces are combined by
`
`bonding pressure tubing 42 at connection port 40 to seal together one integrated air-mass in
`
`the combined, integrated space. This integral attachment is important to the invention
`
`because the remotely-positioned pressure measuring devices (41 and 43) require a sealed
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`air-mass to accurately measure pressure in the pod.
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`27.
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`Positioning the pod remotely from the measuring device as claimed thus
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`requires the claimed “integral attachment” to seal together as a unit the pressure tubing and
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`the pod’s air chamber, sealing together the air-masses inside of them to achieve accurate
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`measurements.
`
`28.
`
`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 materials.”
`
`Pet. at 16. But there is no technical or mechanical reason that would prevent different
`
`materials from being solvent bonded or locked together in this context. Indeed, it is
`
`common in the medical device disposables industry to bond two components of different
`
`materials and/or rigidities together with a solvent agent such a cyclohexanone, which creates
`
`a hermetic seal of the bonded components whether they are the same material/rigidity or not,
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`as long as the dissimilar materials being bonded are both affected by the applied solvent
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`bonding material. By way of example, Fresenius’s dialysis blood tubing sets, Baxter Renal
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`Corporation’s dialysis blood tubing sets, and Terumo BCT’s apheresis blood tubing sets
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`each have flexible/semi-rigid tubing that is bonded to similar and different plastic material
`
`based, rigid and semi-rigid drip chambers, rigid access sites, or patient dialyzer connectors
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`using solvents that create hermetically sealed units. Similarly, the ’414 patent explains that
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`a male luer lock could be used to “integrally attach” the tubing to the pod chamber. A male
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`luer lock attachment could certainly be used to connect components consisting of different
`
`materials and/or rigidities.
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`29.
`
`Nipro further argues that dependent claim 16—which requires that the
`
`pressure tubing “is capable of disconnection from the connection port of the pod”—
`
`precludes the pressure tubing from being permanently attached to the pod. But Nipro has
`
`not shown that permanent attachment is required. As noted above, the specification clearly
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`describes various “integral” attachments formed via locking means—such as a luer lock—
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`that are releasable but still result in the pod chamber and pressure tubing being locked
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`together as a sealed unit.
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`30.
`
`The only other support Nipro purports to provide for its proposed
`
`construction is a conclusory statement that it is “consistent” with the patent’s figures. But
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`Nipro’s 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 and the
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`tubing must be more than a mere direct attachment. Indeed, as noted above, the figures
`
`show a permanent bond (Figure 1) or a screw-threaded lock (Figures 11-17).
`
`C.
`
`31.
`
`“pressure sensing pod” (Claim 1)
`
`Claim 1 of the ’414 patent uses the term “pressure sensing pod.” Nipro and
`
`its expert claim that this term should be construed as being equivalent to the term “pressure
`
`transmitting pod” that is used in claims 13 and 23. I disagree.
`
`32.
`
`Nipro argues that the term “pressure sensing pod” is “a misnomer” because,
`
`according to Nipro, “the pod itself does not sense pressure, but rather only transmits
`
`pressure from a blood circuit.” Pet. at 13-14. But there is no “misnomer” in the claim. The
`
`plain language of claim 1 unambiguously requires a “pressure sensing pod,” which is
`
`different in several key technical respects from the “pressure transmitting pod” of claims 13
`
`and 23 (which do not use this language).
`
`33.
`
`The “pressure sensing pod” as recited in claim 1 is sensing pressure of
`
`flowing blood in a blood circuit. To that end, claim 1 recites the unique feature of “said
`
`second position bowing inwardly to substantially minimize but not eliminate the blood
`
`volume in said chamber, said diaphragm in use being in contact on one side thereof
`
`with flowing blood.” Ex. 1001 at 14:59-63 (emphasis added). This limitation specifies that
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`even when the diaphragm is in the inwardly bowed position where blood volume is
`
`substantially minimized, the blood volume of the chamber is not eliminated so that it can
`
`still contain flowing blood. Because blood continues to flow, the pressure of flowing blood
`
`in the blood circuit can continue to be sensed.
`
`34.
`
`By contrast, in the claims that merely recite a “pressure transmitting pod,”
`
`there is no requirement that the blood volume in the chamber not be eliminated. Instead, in
`
`those claims, pressure may be transmitted to such an extent that blood volume may or may
`
`not be fully eliminated in a blood circuit. But if blood volume were eliminated, there could
`
`be no flowing blood; blood requires a volume in which to flow. While this may be
`
`permissible in the “pressure transmitting pod” of claims 13 and 23, it is not permitted by the
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`plain terms of claim 1 directed to a “set” with a “pressure sensing pod.”
`
`35.
`
`The distinction between a “pressure sensing pod” and a “pressure
`
`transmitting pod” is further supported by the specification and figures. For example, Figure
`
`5 and Figure 1, annotated below, support the distinction (the relevant portion of Figure 1
`
`was excerpted from the larger figure):
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`36.
`
`As depicted, when the diaphragm is in the second position, as in position 26a
`
`in Figure 1, it minimizes, but does not eliminate blood volume in the pod. The diaphragm
`
`continues to be “in contact on one side thereof with flowing blood” as claimed. Ex. 1001 at
`
`14:64-65. The “flowing blood” of claim 1 is depicted in pink on Figures 1 and 5 above. In
`
`these embodiments, the blood continues to flow under the diaphragm in its “second
`
`position” because of channel 50, shown for example in Figure 5. The specification explains
`
`9:49-59:
`
`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).
`
`37.
`
`Thus, claim 1 is a “pressure sensing pod” because it expressly claims
`
`structure that minimizes but does not eliminate blood volume, unlike claims 13 and 23. The
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`“sensing” is always possible by “assur[ing] that there will not be major blocking of blood
`
`flow when diaphragm 26 is in its second position.” In this way, there will always be flowing
`
`blood in the chamber, having a corresponding pressure in the blood circuit to sense. The
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`plain text of this element of claim 1, as well as the difference between the text of claim 1
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`and the text of claims 13 and 23, make this clear.
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`38. Moreover, the specification describes that pressure “sensing” is a key feature
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`of the claimed “pressure sensing pod”: “The pressure monitor system that utilizes the
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`pressure sensing pod is thus capable of monitoring pressure of the entire length of the
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`blood flow tubing extending downstream from the extracorporeal blood processing device,
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`typically a dialyzer. This is a significant area for pressure monitoring, because it is
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`typically the majority of the extracorporeal blood flow circuit that operates under positive
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`pressure. A serious blood leak or kink anywhere along the line downstream of the dialyser
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`can thus be detected by a pressure fluctuation, if there is constant monitoring through
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`the pressure sensing chamber.” Ex. 1001 4:40-50 (emphasis added). It would thus be an
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`error to replace the claim term “sensing” with a different word, “transmitting.” As
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`explained, “sensing” is distinct from simply “transmitting” a pressure.
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`9353112.8
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`NxSTAGE Ex 2006-16
`Nipro v NxStage
`IPR2016-00744
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`D.
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`“said diaphragm being moveable between first and second positions, the
`diaphragm in said first position bowing outwardly to substantially
`maximize volume in 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
`chamber” (Claim 1)
`
`39.
`
`Claim 1 of the ’414 patent further recites the limitation that “said diaphragm
`
`being moveable between first and second positions, the diaphragm in said first position
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`bowing outwardly to substantially maximize volume in said chamber that communicates
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`with said blood flow tubing, the diaphragm in said second position bowing inwardly to
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`substantially minimize but not eliminate the blood volume in said chamber.” Nipro and its
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`expert claim that this term should be construed as “said diaphragm being moveable between
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`first and second positions, the diaphragm in said first position bowing outwardly to
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`substantially maximize volume in a portion of said chamber that communicates with said
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`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.” I disagree
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`with Nipro and its expert.
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`40.
`
`Claim 1 requires a diaphragm that moves between two specific positions: 1) a
`
`first position to “substantially maximize volume in said chamber” and 2) a second position
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`to “substantially minimize but not eliminate the blood volume in said chamber.” These
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`recited positions are also reflected in the patent’s figures (note the two minimum/maximum
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`positions of the diaphragm annotated in blue below):
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`9353112.8
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`NxSTAGE Ex 2006-17
`Nipro v NxStage
`IPR2016-00744
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`41.
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`By inserting the word “portion,” Nipro effectively reads out the specific first
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`and second positions recited in the claims. In fact, Nipro’s proposed construction would
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`encompass a flat, stretching based diaphragm such as the one in Minami, which is flat and
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`may stretch in one direction or another. During this stretching, a flat diaphragm may
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`minimize or maximize some unidentified “portion” of the chamber. However, one skilled in
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`the art would understand that this is not what is claimed in the ’414 patent. Instead, the
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`claimed diaphragm moves between two very specific positions in the chamber, not some
`
`vague and unidentified “portion” of the chamber. Those positions are clear: substantially
`
`minimizing or maximizing volume “in said chamber.” That is to say, the diaphragm moves
`
`between positions that substantially maximize or minimize the volume of the entire
`
`chamber, not merely some portion of it.
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`9353112.8
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`NxSTAGE Ex 2006-18
`Nipro v NxStage
`IPR2016-00744
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`42.
`
`Nipro’s addition of the word “portion” also adds ambiguity rather than
`
`clarifying anything. Indeed, under Nipro’s proposed construction it would not be clear
`
`which portion of the chamber needs to be maximized or minimized to satisfy the claim.
`
`Some of it? All of it? 50% of it? 10%? 1%? Nipro provides no benchmark from which to
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`gauge its “portion” with any reasonable certainty.
`
`43.
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`The other structural feature of the “second position” is also clear from the
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`claim text. When the diaphragm is used in either position, because blood volume is never
`
`eliminated, the configuration ensures “said diaphragm in use being in contact on one side
`
`thereof with flowing blood.” Ex. 1001at 14:64-65 (emphasis added). That is to say, in
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`either of the two maximum/minimum diaphragm positions, there will always be blood
`
`flowing past the diaphragm and blood flow in the chamber. Any other understanding of the
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`two positions would be unreasonable because the claim expressly recites that the diaphragm
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`remains in contact with “flowing blood.”
`
`44.
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`In my opinion, the meaning of the claim is plain, and no express construction
`
`is needed. By its terms, the claim requires that the diaphragm moves between a first and
`
`second position. These positions are: 1) a first position to “substantially maximize volume
`
`in said chamber” and 2) a second position to “substantially minimize but not eliminate the
`
`blood volume in said chamber.” No further construction is necessary.
`
`E.
`
`45.
`
`“dome shaped” (Claim 12), “having a dome shape.” (Claims 13/23)
`
`Claims 12, 13 and 23 require a “dome” that “bows” in two directions. Nipro
`
`and its expert propose a construction for “dome shaped” and “having a dome shape” that
`
`does not require a “dome” at all—namely that “said diaphragm has a hollow, bulging central
`
`portion.” I disagree with Nipro and its expert. In my opinion, the plain and ordinary
`
`meaning of the word “dome” requires that these terms be construed as “shaped with a
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`NxSTAGE Ex 2006-19
`Nipro v NxStage
`IPR2016-00744
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`convex outer surface that has at least some curvature or arch continuously along the
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`surface.”
`
`46.
`
`Nipro acknowledges, as it must, that the term dome has a well-understood
`
`and “ordinary” meaning—i.e., a particular shape, often correlated with a “hemisphere.” Pet.
`
`at 18. Nevertheless, Nipro contends that the term “dome” should not be given its plain
`
`meaning in the context of the ’414 patent because—according to Nipro—the embodiment
`
`depicted in Figures 18 and 19 “has neither a circular plan, nor has a hemispherical shape”
`
`but instead “has a general ovular or stadium plan and a flat top.” Pet. at 19. But a “dome” is
`
`not limited to curved shapes with a circular plan but instead can encompass those with a
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`plan of another shape, for example a polygonal or elliptical base. See, e.g., Ex. 2001
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`American Heritage Dictionary (“A vaulted roof having a circular, polygonal, or elliptical
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`base and a generally hemispherical or semispherical shape.”).
`
`47. Moreover, Nipro’s description of Figures 18 and 19 reflects a technical
`
`misunderstanding of those diagrams. The specification and figures uniformly depict a
`
`curved surface on the claimed dome-shaped diaphragm. Nipro’s assertion that the
`
`diaphragm depicted in Figures 18 and 19 “has a general ovular or stad