UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`NIPRO CORPORATION,
`Petitioner,
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`v.
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`NXSTAGE MEDICAL, INC.,
`Patent Owner.
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`_____________
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`Case IPR2016-00744
`Patent 8,092,414 B2
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`____________________________________________________________
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`4841-6735-8007.1
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`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(D)
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`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`NIPRO CORPORATION,
`Petitioner,
`
`v.
`
`NXSTAGE MEDICAL, INC.,
`Patent Owner.
`
`_____________
`
`Case IPR2016-00744
`Patent 8,092,414 B2
`
`____________________________________________________________
`
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`4841-6735-8007.1
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`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(D)
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`Case: IPR2016-00744; Patent: 8,092,414 B2
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`TABLE OF CONTENTS
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`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
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`THE DECISION ERRED IN FINDING THAT THE PETITION DOES
`NOT ESTABLISH THAT MINAMI TEACHES A DEVICE THAT
`INCLUDES PRESSURE TUBING ATTACHED TO A PRESSURE
`POD OR AIR CHAMBER “AS A SEALED UNIT.” .................................... 3
`
`A.
`
`B.
`
`C.
`
`The Decision overlooked the Petition’s arguments about Minami’s
`pressure measurement mechanism, which necessarily requires a sealed
`connection between the pressure tube and the pressure
`sensing/transmitting pod. ...................................................................... 3
`
`The Decision misapprehended the purpose of Minami’s injector. ....... 9
`
`The Decision misapprehended Minami’s disclosure regarding other
`connections being “sealed” and “integral.” ......................................... 10
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`D.
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`The Decision overlooked the pressure fit shown in Minami .............. 12
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`III. THE DECISION ERRED IN APPLYING AN ANTICIPATION
`ANALYSIS TO CLAIMS 13 AND 23. ........................................................ 14
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`IV. CONCLUSION .............................................................................................. 15
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`Case: IPR2016-00744; Patent: 8,092,414 B2
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`I.
`
`INTRODUCTION
`Nipro Corporation (“Petitioner”) hereby requests rehearing of the Board’s
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`Decision (Paper No. 11, entered July 28, 2016; “Dec.”). The Board reviews a
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`request for rehearing for abuse of discretion, which “occurs when a court
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`misunderstands or misapplies the relevant law or makes clearly erroneous findings
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`of fact.” Renda Marine, Inc. v. U.S., 509 F.3d 1372, 1379 (Fed. Cir. 2007). As set
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`forth below, that standard is met.
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`According to the Decision, the distinguishing feature of the ‘414 claims over
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`Minami is an “integral” connection between a pressure tube and a pressure pod—a
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`term not found in the ‘414 specification, but which was first introduced by Patent
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`Owner during prosecution. Ex. 1010. The Decision disagreed with Petitioner’s
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`proposed construction of the term “integral.” Rather than adopt the plain
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`meaning—which would require only that the pressure tube be formed “as a unit”
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`with the pressure pod (see Pet., 16)— the Board construed “integral” to require a
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`“seal” limitation based upon the ‘414 specification, finding that the claims require
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`that the pressure tube be formed “as a sealed unit” with the pressure pod. Dec., 12.
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`The Decision overlooked arguments in the Petition establishing that Minami
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`(Ex. 1012, translation at Ex. 1013), to be operative for its intended purpose,
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`necessarily discloses that its pressure tubing is attached to its pressure pod or air
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`chamber as a sealed unit. As the Board commented in IPR2015-01454, where it
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`found that a prior art reference’s disclosure of a “computing device” necessarily
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`included a computer processor and memory even though not explicitly recited
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`therein, “a reference can anticipate a claim even if it does not expressly spell out
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`all the limitations arranged or combined as in the claim, if a person of skill in the
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`art, reading the reference, would at once envisage the claimed arrangement or
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`combination.” Paper No. 15 at p. 11 (internal quotation marks omitted) (citing
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`Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir.
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`2015)). The same is true here, where Minami’s disclosure of a pressure sensor to
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`measure pressure in a remote pressure pod via a pressure tube necessarily includes
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`a sealed connection that one of ordinary skill in the art would “at once envisage”
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`between the tube and pressure pod.
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`While the Decision stated that the Petition does not “show sufficiently” a
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`“sealed” connection in Minami because Petitioner focused on a different claim
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`construction only requiring direct attachment (Dec., 14), the Board overlooked that
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`a sealed connection would necessarily be required by the Petition’s arguments
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`about the pressure measurement mechanism of Minami. Even if the Board
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`adopts an initial claim construction that differs from the Petition, the Board must
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`still consider all of the Petition’s arguments in relation to a particular claim
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`limitation, examining those arguments in the light of what would be “at once
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`envisaged” by one of ordinary skill in the art as to the newly adopted construction.
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`II. THE DECISION ERRED IN FINDING THAT THE PETITION DOES
`NOT ESTABLISH THAT MINAMI TEACHES A DEVICE THAT
`INCLUDES PRESSURE TUBING ATTACHED TO A PRESSURE POD OR
`AIR CHAMBER “AS A SEALED UNIT.”
`A. The Decision overlooked the Petition’s arguments about Minami’s
`pressure measurement mechanism, which necessarily requires a sealed
`connection between the pressure tube and the pressure
`sensing/transmitting pod.
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`In construing the term “integral” as requiring attachment “as a sealed unit,”
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`the Decision relies on several sections of the ‘414 patent describing the mechanism
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`by which pressure sensing occurs in the ‘414 device, including the following:
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`Movement of the diaphragm between the first and second positions is
`restricted by the fact that, in the pressure sensing process, a sealed,
`fixed volume of air exists between the diaphragm and a pressure
`sensing transducer, with the branch line pressure tubing extending
`therebetween. Thus, movement of the diaphragm toward one position
`or another position will reflect a change of the level of compression of
`the air or other compressible fluid in the fluid flow path between the
`diaphragm and the pressure sensing transducer, thus transmitting the
`pressure of the blood to the transducer.
`Ex. 1001, 5:14-23. The sealed attachment between the various parts of the
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`‘414 device is for ensuring an existence of “fixed volume of air,” which in
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`turn is for transmitting the blood pressure to the transducer. A change of
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`the blood pressure in the pressure pod causes movement of a diaphragm,
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`which causes a change of the level of compression of air in the path between
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`the diaphragm and the transducer, which transmit the blood pressure to the
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`transducer. That is, air pressure in the tube and air chamber of the pressure
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`pod will change until equilibrium with the blood pressure is established.
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`
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`However, the Decision overlooked the Petition’s arguments that Minami’s
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`system works by the exact same mechanism. For example, the Petition explains
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`that “the air chamber b is in communication with a pressure gauge 22 via a
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`pressure tube 20, so that the pressure pod 25 can be located remote from the
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`pressure gauge 22.” Pet., 9; Ex. 1002, ¶ 31. Minami states:
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`During the dialysis performed with blood pump 2 being rotated, blood
`is circulated in respective blood chambers a. Then, diaphragm 12 is
`dilated toward air chamber b by the pressure of blood. The capacity of
`air chamber b accordingly decreases and air pressure therein
`correspondingly increases, resulting in equilibrium. The pressure of
`blood can be known by measuring the air pressure at the time by
`pressure gauge 22.
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`Ex. 1013, ¶ [0011] (emphasis added) (cited in Pet. at 9, 21, 22, 26, 30, 48, and 52).
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`In other words, in both the ‘414 patent and Minami, a blood pressure is
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`measured by a transducer (pressure gauge) by the following mechanism: when
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`blood pressure increases, a diaphragm is moved toward the air chamber. Due to
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`the movement of the diaphragm, the total volume in the pressure tube and pressure
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`pod air chamber goes down, and pressure of the air in the pressure tube and
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`pressure pod air chamber goes up, and vice versa. The air pressure changes until
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`equilibrium with the blood pressure is established. Thus, a blood pressure is
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`transmitted to the transducer.
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`A fundamental requirement for this mechanism is that there is an inverse
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`relation between the volume of air and the pressure of air. This inverse relation
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`only exists if there is a fixed mass of air in the pressure tube and pressure pod,
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`which necessarily requires sealing. Both the ‘414 system and the Minami system
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`operate based on this fundamental law of nature governing the relationship
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`between pressure and volume, known as Boyle’s law, which is described by
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`Petitioner’s expert, Mr. Clemens, as follows:
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`According to Boyle’s law, the product of pressure and volume is
`constant for a given mass of confined gas, assuming a constant
`temperature. Thus, the product of (i) the total volume in a pressure
`pod air chamber plus the total volume in a connected pressure tube,
`and (ii) the pressure in the pressure pod air chamber and pressure
`tube, is constant.
`Ex. 1002, ¶ 133 (emphasis added). As explained by Mr. Clemens, Boyle’s law
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`applies “for a given mass of a confined gas.” Without sealed connections
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`between the pressure gauge, tube, and pressure pod, there would be no “confined
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`gas,” Boyle’s law would not apply, the equilibrium between the blood pressure and
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`the air pressure would not be established, and the mechanism by which both the
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`‘414 system and the Minami system measure blood pressure would cease to exist.
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`Consequently, Mr. Clemens’ Declaration establishes that Minami necessarily
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`requires its pressure tube 20 and its container 11 be connected “as a sealed unit.”
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`
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`In fact, Patent Owner admits that such a sealed connection is necessary in
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`systems having pressure pods that are located remotely from a pressure sensor,
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`stating that “for the pressure measuring equipment to function properly in the
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`invention, a sealed air-mass must exist,” that “the remotely-positioned pressure
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`measuring devices (41 and 43) require a sealed air-mass to accurately measure
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`pressure in the pod,” and that “[p]ositioning the pod remotely from the
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`measuring device as claimed thus requires the ‘integral attachment’ to seal
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`together as a unit the pressure tubing and the pod’s air chamber, sealing
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`together the air-masses inside of them to achieve accurate measurements.”
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`Prelim. Resp., 15-17. While Patent Owner refers to the mechanism “in the
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`invention,” there is nothing different about the ‘414 system relative to the Minami
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`system that would “require a sealed air-mass” to accurately measure pressure in the
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`pod. Rather, Patent Owner’s statements about the requirement of a sealed air-mass
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`apply equally any system operating with Boyle’s law as the mechanism to measure
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`pressure within a pressure pod. This includes the Minami system, as is clear from
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`Mr. Clemens’ explanation of Boyle’s law with respect to that system. Ex. 1002, ¶
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`133.
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`The Petition also discussed the operating requirements for dialysis, the
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`intended use of both the ‘414 system and the Minami system. See Pet., 4, 9, 11,
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`12, 26 (citing Ex. 1001, 1:6-54 and Ex. 1013, ¶¶ [0009]-[0011]); Ex. 1002, ¶¶ 29,
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`31. When the pressure of blood exceeds a certain value (about 500 mmHg) or falls
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`below a certain value (about -400 mmHg), the blood can be damaged. Pet., 4; Ex.
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`1002, ¶ 14. Thus, measuring pressure is important for monitoring a patient's blood
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`pressure during dialysis procedures, which often last many hours. See, e.g., Ex.
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`1015, 1:35-39 (referring to the “normal four to six hour hemodialysis treatment”).
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`During the extended period of a dialysis procedure, even a small air leak at the
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`connection between the pressure tube and the pressure pod would lead to an
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`inability of the pressure gauge to measure the blood pressure. This is because
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`both the '414 patent and Minami system require a fixed mass of air for pressure
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`measurement. Ex. 1013, ¶ [0011] (cited in Pet. at pp. 9, 21, 22, 26, 30, 48, and 52).
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`The long time periods involved with dialysis mean that sealing is necessary to
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`maintain the integrity of the pressure measurements. See, e.g., Ex. 1001, 9:20-25
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`(stating that pressure measurement “on preferably a moment-by-moment, real time
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`basis . . . is important in the field of extracorporeal blood handling.”). If any leak
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`of air exists, the mass of air will not be fixed during the extended period of dialysis,
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`and the mechanism for blood pressure measurement will be lost.
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`Thus, when Minami states that its dialysis system “solve[s] the various
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`problems associated with the use of such an air chamber by enabling pressure
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`measurement,” it teaches that the connections between its pressure sensor 22,
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`pressure tube 20, and container 11 of pressure pod 25 are necessarily sealed
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`connections. Ex. 1013, ¶ [0006]. Put another way, if the Minami device enables
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`pressure measurement, then the connection between the tube 20 and the container
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`11 must be sealed enough to allow the device to operate.
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`
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`In In re Shoner, the Federal Circuit addressed a similar situation and found
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`that “[Patent Owner] does not dispute that [the prior art reference] teaches an air
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`chamber, 10, that is ‘pressurized.’ Although [the prior art reference] does not
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`disclose an inner tube or other structure in which to seal and pressurize the air
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`chamber, the air chamber must be sealed, otherwise it could not be pressurized.”
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`In re Shoner, 341 Fed. Appx. 642, 647 (Fed. Cir. 2009). The same is true here.
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`Patent Owner does not dispute that Minami teaches space including an air chamber
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`b and a space within pressure tube 20 that is pressurized by movement of the
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`diaphragm 12. Although Minami does not explicitly state that this space is sealed,
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`it must be sealed, otherwise it could not be pressurized, and pressure could not be
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`measured.
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`B.
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`The Decision misapprehended the purpose of Minami’s injector.
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`
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`Patent Owner’s suggestion that the injectors 23a, 23b of Minami are used to
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`replace air lost from chamber b during use is incorrect. Prelim. Resp., 49 (cited in
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`Dec., 15). Minami explicitly states that the injectors 23a, 23b are for zeroing out
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`the pressure gauge and for reduction of deformation of the diaphragm 12, neither
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`of which occurs during blood pressure measurement. Ex. 1013, ¶ [0011] (cited in
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`Pet., 9, 21, 22, 48, 52). Minami states that zeroing out the pressure gauge is
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`performed [w]ith a blood pump 2 suspended.” Ex. 1013, ¶ [0011]. The reduction
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`of deformation of the diaphragm is performed to prevent pressure overshoot, which
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`would occur if the diaphragm contacted a wall of the air chamber, so that any
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`further increase in pressure could not be measured. This procedure also cannot be
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`done during a continuous measurement of blood pressure, because the clamp 24 of
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`Minami, which is closed during pressure measurement to separate the injector 23
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`from the air chamber (Ex. 1013, ¶ [0009]), must be opened to allow injection of air
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`by the injector 23. If clamp 24 were open, blood pressure could not be measured
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`because any movement of a diaphragm would simply cause movement of the
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`plunger of the injector 23 instead of causing compression of air. After the position
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`of the diaphragm is adjusted, the clamp is closed, thereby ensuring a fixed-mass of
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`air during a continuous measurement of blood pressure. Ex. 1013, ¶ [0011].
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`The injectors 23a, 23b are not used to address leaks at the connection
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`between the pressure tube and the pressure pod. On the contrary, the manner in
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`which the injectors 23a, 23b are used further supports the fact that the connection
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`between the pressure tube 20 and the pressure pod 25 is necessarily a sealed
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`connection for Minami to be operative. The use of the injectors 23 indicates that
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`the connection between the pressure tube 20 and pressure pod 25 is sealed.
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`Without a sealed connection, air injected by the injector 23 would leak from the
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`connection and would not cause an adjustment of the zero point or a reduction of
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`the deformation of the diaphragm.
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`C.
`The Decision misapprehended Minami’s disclosure regarding
`other connections being “sealed” and “integral.”
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`
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`The Decision incorrectly inferred that Minami’s use of the term “sealed” and
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`“integral” in other contexts suggests that the connection between the pressure tube
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`20 and the pressure pod 25 (specifically, port 16) is not sealed. As noted in the
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`Decision, Minami refers to its pressure pod as including a “sealed container 11.”
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`Ex. 1013, ¶ [0009] (cited in Pet., 9, 21, 22, 24, 29, 47, et al.) (cited in Dec., 13).
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`Minami also states that “container 11 is composed of two container members 11a
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`and 11b divided in halves in an identical shape and facing each other” and that,
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`with the diaphragm 12 interposed therebetween, “[t]hese members are welded to
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`one another to be tightly sealed.” Ex. 1013, ¶ [0010] (cited in Pet., 9, 21, 22, 47, et
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`al.). Also as noted in the Decision, Minami describes the container 11 as being
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`"integral" with the connection port 16. Ex. 1013, ¶ [0010] (cited in Dec., 15)
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`Minami does not suggest that other connections, such as the connection
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`between pressure tube 20 and pressure pod 25, are not sealed. On the contrary,
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`Minami’s disclosure that certain connections of the air path between the diaphragm
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`12 and the pressure gauge 22 are "sealed" or "integral" suggests that the other
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`connections of the same air path—i.e., the connections between the port 16 and the
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`pressure tube 20, and between the pressure tube 20 and the pressure gauge 22—are
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`also sealed. This is because "sealed" or "integral" formation of some connections
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`of the air path would be a waste of effort if the other connections of the same air
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`path are not sealed.
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`
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`As one specific example, Patent Owner does not dispute the assertion in the
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`Petition and Declaration that Minami teaches that its pressure tube is “for sealed
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`connection at its other end to a remote pressure connector.” Petition, 48; Decl., ¶
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`129. It is illogical for the Decision to conclude that Minami has no seal on the
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`pressure pod 25 side of the pressure tube 20 in the face of the undisputed evidence
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`showing a sealed connection of the container 11, and a sealed connection on the
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`pressure gauge 22 side of Minami’s pressure tube 20.
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`
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`Consequently, Minami implicitly teaches that the connection between the
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`pressure tube 20 and the pressure pod 25 (specifically, port 16) is sealed. The
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`Decision erred in failing to account for this implicit suggestion. See, e.g., In re
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`Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968) (“[I]n considering
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`the disclosure of a reference, it is proper to take into account not only specific
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`teachings of the reference but also the inferences which one skilled in the art would
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`reasonably be expected to draw therefrom.”). The proper test for anticipation is
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`“whether one skilled in the art to which the invention pertains could take the
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`description of the invention in the printed publication and combine it with his own
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`knowledge of the particular art and from this combination be put in possession of
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`the invention on which a patent is sought.” In re LeGrice, 301 F.2d 929, 939
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`(CCPA 1962). Minami satisfies this test.
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`D. The Decision overlooked the pressure fit shown in Minami
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`
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`The Decision found that the figures of Minami “appear to depict a slip
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`friction fit, which may or may not be sealed,” following the argument made by
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`Patent Owner with respect to Figure 1 of Minami. Dec., 15; Prelim. Resp, ¶ 49.
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`The Petition and Declaration relied on Figure 1 of Minami for teaching the integral
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`attachment between the pressure tube and the pressure pod. Pet., 25; Decl. ¶¶ 73-
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`75. However, the Decision overlooked the fact that Figure 1 of Minami shows that
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`the connecting portion of the pressure tube 20 is expanded due to insertion of the
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`wider connection port 16 of the pressure pod 25 into the narrower opening of the
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`pressure tube 20. Below is a close-up of this connection from Figure 1 of Minami.
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`See also Ex. 1002, ¶ 30.
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`The expansion of the pressure tube 20 is plainly visible in Figure 1, indicating that
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`the connection between the pressure tube 20 and the pressure pod 25 is not merely
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`a “slip friction fit,” but rather a tight slip-on connection by pressure fit, which was
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`known to a person of ordinary skill to be one way to establish a sealed connection.
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`See, e.g., Ex. 1024, 30:30-37 (stating, with respect to connection in an
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`extracorporeal blood set, “[i]t can be advantageous to have said connections made
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`via standard Luer-lock fittings, tight slip-on connection, or through permanent
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`connections . . . .”). In fact, the same tight slip-on connection is shown for the
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`connections between the blood tube 18, 19 and the ports 14, 15. If the connection
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`were not sealed, air could enter the blood when the blood pressure becomes
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`negative during dialysis. (Pet., 4) Alternatively, where the blood pressure
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`becomes positive, blood could leak out of the extracorporeal blood set, putting the
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`patient at great risk of blood loss. Thus, the connections are plainly sealed.
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`III. THE DECISION ERRED IN APPLYING AN ANTICIPATION
`ANALYSIS TO CLAIMS 13 AND 23.
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`The proposed ground of unpatentability for independent claims 13 and 23
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`was not anticipation, but obviousness. Pet., 2. As to this ground, the Decision
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`finds that, “[f]or the same reasons discussed with respect to claim 1, . . . the
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`information presented in the Petition fails to establish a reasonable likelihood that
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`Petitioner would prevail in showing that this feature [a sealed attachment] is
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`disclosed by Minami.” Dec., 17. Yet, the earlier “reasons discussed with respect
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`to claim 1” cited by the Board for this part the Decision were all related to
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`inherency, ending with the Board’s conclusion that “the Petition has not
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`established that it is necessarily the case that Minami’s pressure tubing and
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`chamber are attached as a sealed unit, precluding the escape of air from the air
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`chamber” (emphasis in original) (Decision at p. 15).
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`
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`In performing an obviousness analysis, the question is not whether the seal
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`“necessarily” is present in Minami, but rather, whether the seal would have been
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`obvious from Minami. The prior art references must be “considered together with
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`the knowledge of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d
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`1475, 1480 (Fed. Cir. 1994). An obviousness analysis “need not seek out precise
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`teachings directed to the specific subject matter of the challenged claim, for a court
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`can take account of the inferences and creative steps that a person of ordinary skill
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`in the art would employ.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (U.S.
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`2007). While Petitioner maintains that Minami necessarily discloses a seal for the
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`reasons discussed above, when considered in the light of an obviousness grounds,
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`the case for finding that a seal would be obvious based upon Minami is even
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`stronger. A person of ordinary skill in the art would have found it obvious to
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`provide a sealed connection between the pressure tube 20 and container 11 because
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`such sealed connection is necessary in order to measure pressure using a pressure
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`sensor that is attached to a remote pressure pod via a tube.
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`IV. CONCLUSION
`For at least the reasons discussed above, the Decision erred as a matter of
`
`fact in concluding that the Petition and Mr. Clemens’ Declaration did not
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`demonstrate a reasonable likelihood that Petitioner would prevail in proving that
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`Minami discloses a device that includes pressure tubing integrally attached to a
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`chamber or pod under the Board’s construction. Petitioner thus requests rehearing
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`and institution of trial as to Grounds 1-10.
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`Dated: Aug. 26, 2016
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`Respectfully submitted,
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`By: /Stephen B. Maebius/
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`Stephen B. Maebius
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`Counsel for Petitioner
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`Registration No. 35,264
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`4841-6735-8007.1
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`15
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`Case: IPR2016-00744; Patent: 8,092,414 B2
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`Certificate of Service
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`The undersigned hereby certifies that a copy of the foregoing REQUEST FOR
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`REHEARING UNDER 37 C.F.R. § 42.71(D) and this Certificate of Service were
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`served on Aug. 26, 2016 to NXSTAGE MEDICAL, INC. by electronic mail to:
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`Michael R. Fleming (Reg. No. 67,933)
`Benjamin Haber (Reg. No. 67,129)
`Irell & Manella LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, CA 90067
`NiproIPR@irell.com
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Petitioner
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`By:
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`4841-6735-8007.1
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