Paper No. ________
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`NIPRO CORPORATION
`Petitioner
`
`v.
`
`NXSTAGE MEDICAL, INC.
`Patent Owner
`
`Patent No. 8,092,414
`Issue Date: January 10, 2012
`Title: DIAPHRAGM PRESSURE POD FOR MEDICAL FLUIDS
`_______________
`
`Inter Partes Review No. Unassigned
`____________________________________________________________
`
`PETITION FOR INTER PARTES REVIEW
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET. SEQ.
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`
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`4819-2760-7085.1
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`Patent No. 8,092,414
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`Petition for Inter Partes Review
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`TABLE OF CONTENTS
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`Notice of Lead and Backup Counsel ......................................................................... 1 
`Notice of Each Real-Party-in-Interest (RPI) .............................................................. 1 
`Notice of Related Matters .......................................................................................... 1 
`Notice of Service Information ................................................................................... 1 
`Grounds for Standing ................................................................................................. 1 
`Statement of Precise Relief Requested ...................................................................... 2 
`Threshold Requirement for Inter Partes Review ...................................................... 3 
`Statement of Reasons for Relief Requested ............................................................... 3 
`I. 
`Level of Ordinary Skill In Art in the Relevant Timeframe ............................. 3 
`II. 
`Technical Introduction ..................................................................................... 3 
`A. 
`Background on Blow Flow Sets and Pressure Monitoring ................... 4 
`B. 
`Setups with a Blood-Air Interface (Drip Chamber Type) ..................... 4 
`1. 
`Drip Chamber Alone ................................................................... 4 
`2. 
`Drip Chamber with Pressure Transmitting Device ..................... 6 
`Setups with No Blood-Air Interface (Pressure Pod Type) .................... 7 
`1. 
`Pressure Pods with a Single Blood Port ...................................... 7 
`2. 
`Pressure Pods with Two Blood Ports .......................................... 8 
`
`C. 
`
`III.  The Specification of the ‘414 Patent ............................................................... 9 
`A. 
`Embodiments Described in the ‘414 Patent .......................................... 9 
`B. 
`Problems Purportedly Addressed by ‘414 Patent Devices.................. 11 
`
`IV.  Claims Subject to Review .............................................................................. 13 
`A. 
`Independent Claims ............................................................................. 13 
`B. 
`Claim Construction ............................................................................. 13 
`1. 
`“pressure sensing pod” (claim 1) .............................................. 13 
`2. 
`“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 that is inside of said
`diaphragm” (claim 1) ................................................................ 14 
`“wherein the pressure tubing is flexible and elongate and
`integrally attached to the chamber” (claim 1); “which
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`3. 
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`tubing is integral with said pod” (claim 13); “the pressure
`tubing being integral with said pod” (claim 23) ....................... 15 
`“said diaphragm is dome shaped” (claim 12); “said
`diaphragm having a dome shape” (claims 13 and 23) .............. 17 
`“outwardly in either of two opposed directions” (claim
`12) ............................................................................................. 20 
`
`4. 
`
`5. 
`
`V. 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`F. 
`
`Claim-By-Claim Explanation Of Grounds For Unpatentability ................... 21 
`A. 
`Claims 1, 2, and 7 are anticipated by Minami (Ground 1) .................. 21 
`1. 
`Claim 1 ...................................................................................... 21 
`2. 
`Claim 2 ...................................................................................... 25 
`3. 
`Claim 7 ...................................................................................... 25 
`Claims 3 and 9 are obvious based on Minami and Kirita
`(Ground 2) ........................................................................................... 26 
`Claim 4 is obvious based on Minami, Kirita, and Isou (Ground
`3) .......................................................................................................... 28 
`Claims 5 and 6 are obvious based on Minami and Tamari
`(Ground 4) ........................................................................................... 31 
`1. 
`Claim 5 ...................................................................................... 31 
`2. 
`Claim 6 ...................................................................................... 32 
`Claim 8 is obvious based on Minami and Brugger (Ground 5) .......... 33 
`Claims 12, 13, 19, 22, 23, and 26 are obvious based on Minami
`and He, as evidenced by Gangemi, Onishi, Kersten, Calzia, and
`Kell (“the Dome References”) (Ground 6) ......................................... 34 
`1. 
`Claim 12 .................................................................................... 34 
`2. 
`Claim 13 .................................................................................... 46 
`3. 
`Claim 16 .................................................................................... 49 
`4. 
`Claim 19 .................................................................................... 49 
`5. 
`Claim 22 .................................................................................... 50 
`6. 
`Claim 23 .................................................................................... 51 
`7. 
`Claim 26 .................................................................................... 53 
`Claim 14 is obvious based on Minami and He, as evidenced by
`the Dome References and Utterberg. .................................................. 53 
`Claims 15 and 25 are obvious based on Minami, He, and Kirita,
`as evidenced by the Dome References. ............................................... 57 
`Claims 20, 21, and 28 are obvious based on Minami, He, and
`Kersten, as evidenced by the Dome References, and Sato. ................ 58 
`
`
`G. 
`
`H. 
`
`I. 
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`Patent No. 8,092,414
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`Claims 20 and 21....................................................................... 58 
`1. 
`Claim 28 .................................................................................... 59 
`2. 
`Claim 24 is obvious based on Minami and He, as evidenced by
`the Dome References and Utterberg. .................................................. 60 
`
`J. 
`
`CONCLUSION ........................................................................................................ 60 
`
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`EXHIBIT LIST
`U.S. Pat. No. 8,092,414 (“the ‘414 patent”)
`Declaration of Mr. Charles E. Clemens
`Dobrin N. Paskalev, MD, PhD, Georg Haas (1886–1971): The
`Forgotten Hemodialysis Pioneer, 30 Dialysis and
`Transplantation 828 (December 2001).
`W.J. Kolff et al., The Artificial Kidney: a dialyser with a great
`area, 8 J. Am. Soc. Nephrology 1959 (1959) (reprinted from
`CXVII Acta. Med. Scand. 124 (1944)).
`U.S. Patent No. 5,693,008 (“Brugger”).
`U.S. Patent No. 4,077,882 (“Gangemi”).
`Non-Final Office Action in U.S. Appl. No. 11/270,080 (June 30,
`2010).
`First Amendment in U.S. Appl. No. 11/270,080 (December 20,
`2010).
`Final Office Action in U.S. Appl. No. 11/270,080 (February 4,
`2011).
`Second Amendment in U.S. Appl. No. 11/270,080 (June 6,
`2011).
`U.S. Patent No. 6,526,357 (“Soussan”).
`Japanese Patent Publication No. 1986-143069 (“Minami”)
`English Translation of Japanese Patent Publication No. 1986-
`143069 (“Minami”)
`U.S. Patent No. 4,226,124 (“Kersten”)
`U.S. Patent No. 4,412,916 (“Kell”)
`Japanese Patent Publication No. 1997-24026 (“Onishi”)
`English Translation of Japanese Patent Publication No. 1997-
`24026 (“Onishi”)
`Merriam-Webster’s Collegiate Dictionary (10th ed., Merriam-
`Webster, Inc. 1998).
`Random House Webster’s Unabridged Dictionary (2nd ed.,
`Random House, Inc. 2001) (“Random House”)
`Japanese Patent Publication No. S64-29267 (“Sato”)
`English Translation of Japanese Patent Publication No. S64-
`29267 (“Sato”)
`NOT USED
`
` v
`
`
`
`1001
`1002
`1003
`
`1004
`
`1005
`1006
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`1012
`1013
`
`1014
`1015
`1016
`1017
`
`1018
`
`1019
`
`1020
`1021
`
`1022
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`1023
`1024
`1025
`1026
`
`1027
`1028
`
`1029
`1030
`
`1031
`1032
`
`1033
`
`NOT USED
`U.S. Patent No. 6,039,078 (“Tamari”)
`Chinese Patent Publication No. 2522849Y (“He”)
`English Translation of Chinese Patent Publication No. 2522849Y
`(“He”)
`Japanese Patent Publication No. S62-5172Y2 (“Kirita”)
`English Translation of Japanese Patent Publication No. S62-
`5172Y2 (“Kirita”)
`Japanese Patent Publication No. 2001-353215 (“Isou”)
`English Translation of Japanese Patent Publication No. 2001-
`353215 (“Isou”)
`French Patent Publication No. 2346238 (“Calzia”)
`English Translation of French Patent Publication No. 2346238
`(“Calzia”)
`U.S. Patent Publication No. 2002/0007137 (“Utterberg”)
`
`
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`NOTICE OF LEAD AND BACKUP COUNSEL
`Lead Counsel: Stephen B. Maebius (Reg. No. 35,264); Tel. 202-672-5569
`
`Backup Counsel: Michael D. Kaminski (Reg. No. 32,904); Tel. 202-945-6014
`
`
`
`
`
`
`
` Chase J. Brill (Reg. No. 61,378); Tel. 202-295-4787
`
`Address: Foley & Lardner LLP, 3000 K St. NW, Ste. 600, Wash., D.C. 20007
`
`Fax: 202-672-5399
`
`NOTICE OF EACH REAL-PARTY-IN-INTEREST (RPI)
`The RPI’s for this Petition are Nipro Corp. and Nipro Medical Corp.
`
`NOTICE OF RELATED MATTERS
`U.S. Patent No. 8,491,518 issued from U.S. Appl. No. 13/299,868, which
`
`claims the benefit of U.S. Appl. No. 11/270,080 (“the ‘080 application”), which is
`
`the application from which the ‘414 patent issued.
`
`Pending U.S. Appl. No. 13/928,454 claims the benefit of the ‘080 application.
`
`NOTICE OF SERVICE INFORMATION
`Please address all correspondence to the lead counsel at the address shown
`
`above. Petitioner consents to electronic service by email at:
`
`mkaminski@foley.com, smaebius@foley.com, and cbrill@foley.com.
`
`GROUNDS FOR STANDING
`Petitioner hereby certifies that the patent for which review is sought is available
`
`for inter partes review and that the Petitioner is not barred or estopped from
`
`requesting an inter partes review challenging the patent claims on the grounds
`
`identified in the petition. The Commissioner is hereby authorized to charge any
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`additional fees which may be required regarding this Petition under 37 C.F.R.
`
`§§ 1.16-1.17, or credit any overpayment, to Deposit Account No. 19-0741.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`Petitioner requests that claims 1-9, 12-16, 19-26, and 28 of the ‘414 patent be
`
`cancelled based on the following grounds of unpatentability explained in detail
`
`below. The anticipation rejection is under 35 U.S.C. § 102(b). The obvious
`
`rejections are under 35 U.S.C. § 103(a).
`
`Ground 1. Claims 1, 2, and 7 are anticipated by Minami.
`
`Ground 2. Claims 3 and 9 are obvious based on Minami and Kirita.
`
`Ground 3. Claim 4 is obvious based on Minami, Kirita and Isou.
`
`Ground 4. Claims 5 and 6 are obvious based on Minami and Tamari.
`
`Ground 5. Claims 8 is obvious based on Minami and Brugger.
`
`Ground 6. Claims 12, 13, 16, 19, 22, 23, and 26 are obvious based on Minami
`
`and He, as evidenced by Gangemi, Onishi, Kersten, Calzia, and Kell (“the Dome
`
`References”)
`
`Ground 7. Claim 14 is obvious based on Minami and He, as evidenced by the
`
`Dome References and Utterberg.
`
`Ground 8. Claims 15 and 25 are obvious based on Minami, He, and Kirita, as
`
`evidenced by the Dome References.
`
`Ground 9. Claims 20, 21, and 28 are obvious based on Minami, He, and
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`Kersten, as evidenced by the Dome References, and Sato.
`
`Ground 10. Claim 24 is obvious based on Minami and He, as evidenced by the
`
`Dome References and Utterberg.
`
`THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW
`A petition for inter partes review must demonstrate “a reasonable likelihood
`
`that the Petitioner would prevail with respect to at least one of the claims
`
`challenged in the petition.” 35 U.S.C. § 314(a). The Petition meets this threshold.
`
`All elements of claims 1-9, 12-16, 19-26, and 28 of the ‘414 patent are taught in
`
`the prior art as explained below in the proposed grounds of unpatentability, and
`
`reasons to combine are established for each ground under 35 U.S.C. § 103.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`I. Level of Ordinary Skill In Art in the Relevant Timeframe
`As supported by Petitioner’s expert, in 2004-2005, 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. Ex. 1002, ¶ 11.
`
`These descriptions are approximate, and a higher level of education or skill might
`
`make up for less experience, and vice-versa. Id.
`
`II. Technical Introduction
`The following technical introduction is supported by the Declaration of Mr.
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`Charles E. Clemens, Ex. 1002.
`
`A. Background on Blow Flow Sets and Pressure Monitoring
`The ‘414 patent describes blood flow sets used for extracorporeal (outside the
`
`body) blood handling (e.g., during dialysis), and parenteral solution sets used to
`
`administer parenteral solutions (e.g., saline and heparin solutions). See, e.g., Ex.
`
`1001 at 1:6-10.
`
`As admitted in the ‘414 patent, one advancement in blood flow sets prior to
`
`2004-2005 was the use of pressure monitoring devices to monitor blood pressure.
`
`Ex. 1001 at 1:6-54. When the pressure of blood exceeds a certain value (about 500
`
`mmHg) or falls below a certain value (about -400 mmHg), the blood can be
`
`damaged (these numbers may vary slightly depending on the flow rate, which
`
`causes sheer stress on the blood). Ex. 1033 at ¶¶ [0007]-[0008]. Thus, measuring
`
`pressure is an important aspect of a dialysis systems. Pressure monitoring devices
`
`are located either upstream or downstream of blood pump(s), and are typically
`
`configured to measure either positive pressure (downstream of a pump) or negative
`
`pressure (upstream of a pump). See, e.g., Ex. 1014 at 2:52-3:2. In the 2004-2005
`
`timeframe, there were two basic setups: (1) setups in which a blood-air interface
`
`exists, and (2) setups in which no blood-air interface exists. Ex. 1002, ¶15.
`
`B. Setups with a Blood-Air Interface (Drip Chamber Type)
`1. Drip Chamber Alone
`Many pressure monitoring systems simply included a pressure transducer that
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`was coupled directly to air in a drip chamber (also called a “bubble trap” or “air
`
`trap”). Examples are shown in Figs. 9 and 10 of Minami (Ex. 1012, Eng. Trans. in
`
`Ex. 1013), and described in its background section. See Ex. 1013 at ¶¶ [0003]-
`
`[0005]. This system includes two drip chambers 6a, 6b. Drip chamber 6a is
`
`located upstream of a dialyzer 3, while drip chamber 6b is located downstream of
`
`the dialyzer 3. Blood c enters drip chamber 6a, 6b from a tube connected at a top
`
`of the drip chamber, and exits drip chamber 6a, 6b from a tube 5 connected at a
`
`bottom of the drip chamber. A pressure gauge 7a, 7b is in communication with air
`
`d above the blood c. The pressure of the air d is essentially the same as the
`
`pressure of the blood c. Thus, the pressure of the blood c can be determined by
`
`measuring the pressure of the air d with the pressure gauge 7a, 7b. See Ex. 1013 at
`
`¶¶ [0003]-[0005]. Ex. 1002, ¶¶ 16-17.
`
`Systems with drip chambers suffer from several drawbacks, as is recognized in
`
`Minami. Problem 1 is that, if the blood level in the drip chamber becomes too
`
`high, damage to pressure gauge can result and blood can become contaminated;
`
`and if the blood level becomes too low, air can potentially enter the patient, which
`
`can be life threatening. Problem 2 is that use of the drip chamber causes decreased
`
`handleabilty , because the drip chamber must be kept in an upright position;
`
`Problem 3 is that a blood-air interface accelerates coagulation of blood, which can
`
`clog the dialyzer. See Ex. 1013 at ¶¶ [0003]-[0005], [0012], and [0020]; see also
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`Ex. 1006 at 1:42-52. Ex. 1002, ¶ 18.
`
`2. Drip Chamber with Pressure Transmitting Device
`To address Problem 1 above, some pressure monitoring systems utilized a
`
`pressure transmitting device to prevent direct contact with between the blood and
`
`the pressure gauge. These pressure transmitting devices typically included a
`
`housing having two separate chambers, with a diaphragm isolating a first chamber
`
`on a blood side of the device from a second chamber operatively connected to a
`
`pressure transducer. The diaphragm prevents the blood from damaging the
`
`pressure gauge, and prevents contaminants from the pressure gauge from entering
`
`the blood. Ex. 1002, ¶ 19.
`
`For example, Kersten (Ex. 1014) describes a pressure transmitting device for
`
`use with a drip chamber, as illustrated in Figs. 3 and 4. The Kersten device 34
`
`includes a pressure chamber 38 having an inlet portion 40 and an outlet portion 42
`
`separated by a membrane 66. The inlet portion 40 is connected by a tube 62 to a
`
`drip chamber (bubble trap 14, 24 (not illustrated)). The outlet portion 42 is
`
`connected by a tube 64 to a pressure monitor 32. Ex. 1014 at 2:61-3:15. The
`
`Kersten system addresses the possibility of blood damaging the pressure gauge and
`
`becoming contaminated with bacteria and other foreign material from the pressure
`
`gauge. However, because the Kersten system includes a drip chamber, it does not
`
`address the coagulation and handleability issues (Problems 2 and 3) associated
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`with drip chambers. Ex. 1002, ¶¶ 20-21.
`
`C. Setups with No Blood-Air Interface (Pressure Pod Type)
`As an alternative, systems having no drip chamber, and thus no blood-air
`
`interface, have been used. In these devices, a pressure-transmitting device (often
`
`termed a “pressure pod”) is used without a drip chamber, and blood, or saline in
`
`contact with the blood, enters the pressure transmitting device via either a single
`
`blood port or two blood ports. These systems address all of Problems 1-3 above.
`
`Ex. 1002, ¶ 22.
`
`1. Pressure Pods with a Single Blood Port
`An example of a single blood port system is disclosed in Gangemi (Ex. 1006).
`
`Gangemi teaches a “blood isolation and pressure transferring means” 22 that
`
`includes a pressure chamber 24. A first housing segment 40 of the pressure
`
`chamber 24 includes an outlet portion 30 connected by a tube 32 to a pressure
`
`transducer 18. A second housing segment 42 includes an inlet portion 26
`
`connected by a tube 28 to a pumping and purifying portion 12. A thin, flexible
`
`blood isolating and pressure transmitting membrane 60 is disposed within the
`
`pressure chamber, isolating the inlet portion 26 from the outlet portion 30. Thus,
`
`pressure of blood in the pumping and purifying portion 12 can be sensed by the
`
`transducer 18, via the tube 28, second housing segment 42, membrane 60 (i.e., a
`
`diaphragm), first housing segment 40, and tube 32. Ex. 1006 at 3:48-4:27, 4:49-
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`57, Fig. 1. Ex. 1002, ¶¶ 23-24.
`
`2. Pressure Pods with Two Blood Ports
`Unlike pressure pods with a single blood port, pressure pods with two blood
`
`ports allow blood to flow through a chamber in the pressure pod. Ex. 1002, ¶ 25.
`
`a. Pressure Pod Mounted to Dialysis Machine
`Brugger (Ex. 1005) described in the ‘414 patent, teaches one such pressure pod
`
`with two blood ports. In the Brugger system, shown for example in Fig. 3, a
`
`pressure pod 150 is mounted directly to a dialysis apparatus 20 using a mounting
`
`assembly 206. Ex. 1005 at 5: 4-54, 6:41-50. Ex. 1002, ¶¶ 26-28.
`
`As recognized in the ‘414 patent, it can be disadvantageous for a pressure pod
`
`to be mounted directly to a pressure transducer on a dialysis machine, as in
`
`Brugger. According to the ‘414 patent, this is a problem because the blood tubing
`
`must be long enough for the pressure pod to reach the dialysis machine, and that a
`
`long length of blood flow tubing is expensive and increases the clottable surface
`
`area of blood in the tubing. Ex. 1001 at 1:55-67. What the ‘414 patent fails to
`
`mention is that there were many other known pressure monitoring systems in
`
`which, rather than being mounted directly to a pressure transducer on a dialysis
`
`machine, a pressure pod was instead connected to a pressure transducer via an
`
`elongated pressure tube. Ex. 1002, ¶ 29.
`
`a. Pressure Pod Connected to Pressure Transducer via
`Pressure Tube
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`One system in which a pressure pod is connected to a pressure transducer via a
`
`pressure tube is described in Minami, the primary reference in the grounds of
`
`unpatentability below. The Minami measuring device 26 includes a “pressure
`
`converter” (i.e., a pressure pod) 25, which includes a container 11 and an elastic
`
`diaphragm 12. The container 11 has a first container member 11a defining an air
`
`chamber b and a second container member 11b defining a blood chamber a. The
`
`diaphragm 12 separates the blood chamber a from the air chamber b. Blood flows
`
`into and out of the blood chamber a via inlet 15, outlet 15, and associated blood
`
`tubing 18, 19. Ex. 1013 at ¶¶ [0009]-[0011]. However, unlike in Brugger, the
`
`measuring device 26 of Minami is not mounted to a dialysis machine. Rather, the
`
`air chamber b is in communication with a pressure gauge 22 via a pressure tube 20,
`
`so that the pressure pod 25 can be located remote from the pressure gauge 22—and
`
`therefore remote from the dialysis system if the pressure gauge 22 is in the dialysis
`
`system. Ex. 1013 at ¶¶ [0009]-[0011]. Ex. 1002, ¶ 30-33.
`
`III. The Specification of the ‘414 Patent
`A. Embodiments Described in the ‘414 Patent
`The focus of the ‘414 patent is on pressure pod type devices like those
`
`discussed directly above. See, e.g., Ex. 1001, 2:12-15, 3:3-7:23. The ‘414
`
`specification describes three primary embodiments of a pressure pod. The first is
`
`best shown in Figs. 2-5, the second in Figs. 8 and 9, and the third in Figs. 18 and
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`19. The remaining figures show systems utilizing the various embodiments of the
`
`pressure pods, or specific components of the pressure pods. Ex. 1002, ¶ 34.
`
`As seen in Fig. 2 of the ‘414 patent, the pressure pod 12 of the first
`
`embodiment includes a lower compartment-defining portion 22, an upper
`
`compartment-defining portion 24, and a flexible diaphragm 26. The diaphragm 26
`
`has a central portion 24 that bulges into the upper compartment of the portion 24.
`
`The lower compartment-defining portion 22 includes a blood inlet port 30 and a
`
`blood outlet port 32, for connection with blood tubing, and an access port 34 for
`
`connection with tubing 35 to allow for administration of parenteral solution,
`
`heparin, etc. The upper compartment-defining portion 24 includes a connection
`
`port 40 for connection to pressure tubing 42. The pressure tubing is connectable at
`
`its other end to a pressure measurement equipment connector 41, which
`
`communicates with a pressure transducer 43, as shown in Fig. 1 of the ‘414 patent.
`
`Thus, when a pressure is applied to the diaphragm 26 by the blood, the diaphragm
`
`26 moves until pressures on both sides of the diaphragm 26 are balanced, thereby
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`allowing the pressure of the blood to be measured by the pressure transducer 43.
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`Ex. 1001 at 8:31-9:25. Ex. 1002, ¶¶ 35-36.
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`The second embodiment of the ‘414 patent pressure pod, best shown in Figs. 8
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`and 9, differs from the first embodiment in that the diaphragm 26a of the second
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`embodiment is “of slightly different design” than that of the first embodiment, and
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`in that the upper compartment 92 has a port 112 for testing and a connection port
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`116 with a breakable partition 120. Ex. 1001 at 11:1-24. Ex. 1002, ¶¶ 37-38.
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`The third embodiment of the ‘414 patent pressure pod, best shown in Figs. 17
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`and 18, differs from the first and second embodiments in that the pod 150 and
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`diaphragm 154 of the third embodiment are elongated. The pod 150 of the third
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`embodiment includes a port 160 having a breakable partition, like the second
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`embodiment, but does not include the testing port of the second embodiment. Ex.
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`1001 at 13:55-14:15. Ex. 1002, ¶¶ 39-40.
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`B. Problems Purportedly Addressed by ‘414 Patent Devices
`The ‘414 patent alleges to address three problems of previous devices, when
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`those problems were actually solved well before the application leading to the ‘414
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`patent was filed. Ex. 1002, ¶ 41.
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`First, the ‘414 patent allegedly addresses a disadvantage that “sets which fit the
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`great majority of the world’s dialysis machines . . . have drip chambers . . . .” Ex.
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`1001 at 2:7-11, 20-25. However, as discussed above, the problems with drip
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`chambers were known well before the 2004-2005 time frame and solved by using
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`blood flow-through devices without drip chambers, such as that described in
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`Minami. See Ex. 1013 at ¶¶ [0003]-[0005]. Ex. 1002, ¶ 42.
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`Second, the ‘414 patent allegedly addresses a supposed disadvantage of
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`pressure pod type devices mounted on a dialysis machine (as in Brugger), that
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`because the pressure pod is mounted on the dialysis machine, “[f]low-through
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`blood tubing must convey blood to and from [a pressure pod] mounted on the face
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`of the machine.” Ex. 1001, 1:39-67. The suggestion is that the ‘414 patent solves
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`the alleged disadvantage of the prior art by allowing pressure pod to be located
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`remote from the pressure measurement machine—that is, the machine that contains
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`the actual pressure transducer used to measure blood pressure via the pressure pod,
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`such as the dialysis machine. This allegation was repeated by the Patent Owner
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`during prosecution of the application leading to the ‘414 patent, where the Patent
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`Owner argued that the claims were distinguishable from the cited prior art on this
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`basis. See, e.g., Ex. 1008 at 4, 9-13; Ex. 1010 at 9. However, contrary to these
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`allegations, by the 2004-2005 timeframe, there were many publications teaching
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`extracorporeal blood handling systems that used pressure pods that were remote
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`from the dialysis machine, including that described in Minami. Ex. 1002, ¶ 43.
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`Further, the ‘414 patent allegedly addresses a disadvantage that “the non-sterile
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`side of the diaphragm is open to atmosphere prior to being brought into sealing
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`relation with the equipment’s pressure port, and therefore may be displaced prior to
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`use.” Ex. 1001 at 2:1-6. The ‘414 purports to address this disadvantage by
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`including the breakable partition 120 in the pressure connections ports 116, 160.
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`See, e.g., Ex. 1001 at 11:16-64. However, the independent claims of the ‘414
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`patent do not recite this feature, and the dependent claims that do (claims 10, 17,
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`18, and 27) are not at issue in this proceeding. Ex. 1002, ¶ 44.
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`IV. Claims Subject to Review
`A. Independent Claims
`The ‘414 patent includes three independent claims: 1, 13, and 23. The primary
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`difference between the claims is that claims 13 and 23, unlike claim 1, recite that
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`the diaphragm is “dome-shaped.” There are some other, minor differences between
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`the claims, but they are largely insignificant. For example, claims 1 and 23 require
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`that the diaphragm be capable of bowing outwardly in two opposing directions,
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`while claim 13 does not. And the precise language relating to the flexible
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`positioning of the pressure pod relative to the “pressure sensing machine” or
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`“blood treatment machine” varies slightly among the claims. Ex. 1002, ¶¶ 46-47.
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`B. Claim Construction
`In accordance with the Trial Practice Guide, Petitioner hereby provides “a
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`simple statement that the claim terms are to be given their broadest reasonable
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`interpretation, as understood by one of ordinary skill in the art and consistent with
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`the disclosure” (77 Fed. Reg. 48764), except as discussed below. The following
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`constructions should not be construed as any admission as to constructions that
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`would be properly adopted by a district court, which may apply a different
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`standard than that applied in an IPR proceeding.
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`1. “pressure sensing pod” (claim 1)
`The term “pressure sensing pod” in claim 1 is a misnomer, because the pod
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`itself does not sense pressure, but rather only transmits pressure from a blood
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`circuit. In all embodiments disclosed in the ‘414 patent, the actual pressure sensor
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`43 is not in the pod itself. See, e.g., Ex. 1001 at 9:20-25 and Fig. 1; And in fact,
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`claims 13 and 23 recite a “pressure transmitting pod” rather than a “pressure
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`sensing pod.” For these reasons, it is clear from the specification and the context
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`of the claims that the term “pressure sensing pod” is intended to mean “pressure
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`transmitting pod.” Ex. 1002, ¶ 49.
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`2. “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 that is inside of said diaphragm” (claim 1)
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`Generally, this limitation refers to the ability of the diaphragm to move
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`between a first position, where the diaphragm is at its maximum displacement
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`toward to the pressure tubing side of the pod, and a second position, where the
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`diaphragm is at its maximum displacement toward the blood tubing side of the
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`pod. For example, Fig. 19 of the ‘414 patent shows a pod 150 with its diaphragm
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`154 in the first position, while Fig. 4 of the ‘414 patent shows a pod 12 with its
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`diaphragm 26a in the second position. Ex. 1002, ¶¶ 50-51.
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`This limitation refers to maximizing “volume in said chamber that
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`communications with said blood flow tubing.” However, claim 1 previously
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`recites “a pressure sensing pod defining a chamber” and recites “a length of
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`pressure tubing connected at one end with said chamber.” In other words, the
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`“chamber” of claim 1 includes both an air chamber section and a blood chamber
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`section. When the diaphragm is in its first position, only the volume in the blood
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`chamber section of the pod is maximized. And when the diaphragm is in its
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`second position, only the volume in the blood chamber section of the pod is
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`minimized. Ex. 1002, ¶ 52.
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`Further, this