throbber
U.S. PATENT RE44,644
`Petition for Inter Partes Review
`Paper No. 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. RE44,644
`CHALLENGING CLAIMS 153–156, 161-162, AND 252–253
`UNDER 35 U.S.C. § 312 AND 37 C.F.R. § 42.104
`
`GENERAL ELECTRIC CO.
`Petitioner,
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`v.
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`UNIVERSITY OF VIRGINIA PATENT FOUNDATION,
`Patent Owner
`
`Patent No. RE44,644
`Issued: December 17, 2013
`Filed: January 15, 2009
`Inventors: John Mugler III, et al.
`Titled: Method and apparatus for spin-echo-train
`MR imaging using prescribed signal evolutions
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`Inter Partes Review No. IPR2016-00359
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`U.S. PATENT RE44,644
`Petition for Inter Partes Review
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`TABLE OF CONTENTS
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`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37 C.F.R. §
`I.
`42.22(A)) ......................................................................................................................................... 1
`II. MANDATORY NOTICES ................................................................................................... 1
`A.
`Real Party-in-Interest .................................................................................................... 1
`B.
`Related Matters .............................................................................................................. 1
`C.
`Service Information........................................................................................................ 2
`III. CERTIFICATION OF GROUNDS FOR STANDING .................................................. 2
`IV. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED................................... 2
`V. OVERVIEW .......................................................................................................................... 3
`A.
`Technical Background ................................................................................................... 4
`B.
`The ’644 Patent ............................................................................................................... 5
`(i)
`Summary of Alleged Invention of the ’644 Patent................................................... 6
`(ii) The Prosecution History ............................................................................................ 6
`(iii) Effective Filing Date Of The Challenged Claims ..................................................... 7
`C.
`The Primary Prior Art References ............................................................................. 13
`(i) Mugler 2000............................................................................................................... 14
`(ii) Mugler 1999............................................................................................................... 15
`(iii) Mugler Overview ...................................................................................................... 16
`(iv) Alsop .......................................................................................................................... 17
`VI. RELEVANT INFORMATION CONCERNING THE ’644 PATENT ....................... 18
`A.
`Person of Ordinary Skill in the Art ............................................................................ 18
`B.
`Construction of Terms Used in the Claims ................................................................ 18
`(i)
`“Substance of interest in said object . . . with corresponding T1 and T2
`relaxation times and spin density of interest” means “the inherent T1 and T2
`relaxation times and proton density of a substance in the object that is imaged” in this
`review ................................................................................................................................... 18
`(ii)
`“Time delay” means “a distinct time period, greater than zero, for recovery of
`magnetization in the tissues of interest, which can be approximated by the equation
`‘TR – (Echo spacing x ETL)” in this review..................................................................... 20
`VII. SPECIFIC GROUNDS FOR PETITION ...................................................................... 21
`A. Mugler 2000 Anticipates Claims 153–156, 161-62, and 252–253 ............................. 21
`(i)
`Independent Claim 153 ............................................................................................ 21
`(ii)
`Independent Claim 156 ............................................................................................ 32
`(iii)
`Independent Claims 161 and 162 ............................................................................ 33
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`(iv) Dependent Claims 154–155 and 252–253 ............................................................... 36
`B. Mugler 2000 In View Of Mugler Overview Renders Obvious Claims 153–156, 161-
`162, and 252–253 ..................................................................................................................... 37
`C. Mugler 1999 Anticipates Claims 153–156, 161-162, and 252–253 ........................... 40
`(i)
`Independent Claim 153 ............................................................................................ 40
`(ii)
`Independent Claim 156 ............................................................................................ 49
`(iii)
`Independent Claims 161-62 ..................................................................................... 50
`(iv) Dependent Claims 154–155 and 252–253 ............................................................... 50
`D. Mugler 1999 In View Of Alsop Renders Obvious Claims 153–156, 161-162, and
`252–253..................................................................................................................................... 52
`(i)
`Independent Claims 153 and 161 ............................................................................ 53
`(ii) Dependent Claims 154–155 and 252–253 ............................................................... 55
`E. Mugler 1999 In View Of Alsop, Further In View Of Mugler Overview Renders
`Obvious Claims 153–156, 161-62, and 252–253.................................................................... 57
`VIII. CONCLUSION ............................................................................................................. 58
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`Exhibit No.
`1001
`1002
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`1003
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`1004
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`1005
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`1006
`1007
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`1008
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`EXHIBIT LIST
`
`Description
`U.S. Patent RE44,644 to Mugler III et al. (“the ’644 patent”)
`Mugler et al, “Three-Dimensional T2-Weighted Imaging of the
`Brain Using Very Long Spin-Echo Trains,” Proceedings of the
`International Society for Magnetic Resonance in Medicine,
`Eighth Meeting, April 2000 at 687 (“Mugler 2000”)
`Mugler et al, “Three-Dimensional Spin-Echo-Train Proton-
`Density-Weighted Imaging Using Shaped Signal Evolutions,”
`Proceedings of the International Society for Magnetic Resonance
`in Medicine, Seventh Meeting, May 1999 at 1631 (“Mugler
`1999”)
`Alsop, “The Sensitivity of Low Flip Angle RARE Imaging,”
`Magnetic Resonance in Medicine, Vol. 37, pp. 176-184
`(“Alsop”)
`Mugler, “Overview of MR Imaging Pulse Sequences,” Physics of
`MR Imaging, Vol. 7, No. 4, pp. 661-697 (Nov. 1999) (“Mugler
`Overview”)
`U.S. Patent No. 5,245,282 to Mugler III et al. (“Mugler ’282”)
`Stuber et al., Submillimeter Three-dimensional Coronary MR
`Angiography with Real-time Navigator Correction: Comparison
`of Navigator Locations, Radiology, Vol. 212, Issue No. 2, pp.
`579-587 (“Stuber”)
`Melki et al., Comparing the FAISE Method with Conventional
`Dual-Echo Sequences, Journal of Magnetic Resonance Imaging,
`Vol. 1, pp. 319-326 (1991)(“Melki 1991”)
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`Exhibit No.
`1009
`1010
`1011
`
`1012
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`1013
`1014
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`1015
`1016
`1017
`1018
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`1019
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`1020
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`1021
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`1022
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`Description
`Declaration of Dr. Norbert Pelc
`Curriculum Vitae of Dr. Norbert Pelc
`Patent Owner’s Complaint against Petitioner alleging
`infringement of ’644 patent in the GE Litigation
`Verification of December 16, 2014 Service of Summons and
`Complaint
`U.S. Patent No. 7,164,268 to Mugler III et al. (“the ’268 patent”)
`U.S. Provisional Application No. 60/257,182 (“the ’182
`application”)
`File history of ’268 patent
`File history of the ’644 patent
`File history portion of U.S. App. No. 14/053,190
`Proceedings of the International Society for Magnetic Resonance
`in Medicine, Eighth Meeting, Denver, April 1–7, 2000
`Proceedings of the International Society for Magnetic Resonance
`in Medicine, Seventh Meeting, Philadelphia, May 22–28, 1999
`Mugler et al., “Shaping the Signal Response during the Approach
`to Steady State in Three-Dimensional Magnetization-Prepared
`Rapid Gradient-Echo Imaging Using Variable Flip Angles,”
`Magnetic Resonance in Medicine, Vol. 28, pp. 165-185 (“Mugler
`1992”)
`Patent Owner’s June 25, 2015 Infringement Contentions against
`Petitioner in the GE Litigation, Ex. A
`Patent Owner’s June 25, 2015 Infringement Contentions against
`Petitioner in the GE Litigation, Ex. B
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`Exhibit No.
`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
`1030
`1031
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`Description
`Patent Owner’s June 25, 2015 Infringement Contentions against
`Petitioner in the GE Litigation, Ex. E
`Patent Owner’s November 13, 2015 Letter submitted in the GE
`Litigation to the Court
`Hennig et al., “Single Shot 3D RARE: A Fast Method for
`Volumetric Acquisition,” Proceedings of the Society of Magnetic
`Resonance and the European Society for Magnetic Resonance in
`Medicine and Biology, Twelfth Meeting, Nice, France, p. 635
`(“Hennig 1995”)
`Schäffter, et al., “PSF Improvements in Single Shot GRASE
`Imaging,” Proceedings of the Society of Magnetic Resonance,
`Second Meeting, San Francisco, p. 27 (“Schäffter 1994”)
`Le Roux, et al., “Stabilization of Echo Amplitudes in FSE
`Sequences,” Magnetic Resonance in Medicine, Vol. 30, pp. 183-
`190 (“Le Roux 1993”)
`Mugler et al., Motion-Artifact-Free T2-Weighted 3D Imaging of
`the Cervical Spine, Proceedings of the International Society for
`Magnetic Resonance in Medicine, Eighth Meeting, Denver, p.
`402 (“Mugler Spine Imaging”)
`U.S. Patent No. 6,445,182 to Dean et al. (“Dean”)
`MRI Scanners, A Buyer’s Guide
`Portion of the textbook “Magnetic Resonance Imaging Of The
`Brain And Spine,” 4th Ed. Vol. 1, edited by Scott Atlas (2009),
`in Ch. 5, authored by Robert Mulkern, titled “Fast Imaging
`Principles” (“Mulkern Fast Imaging Principles”)
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`Exhibit No.
`1032
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`1033
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`1034
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`1035
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`1036
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`Description
`Melki et al., “Partial RF Planar Imaging with the FAISE Method.
`I. Experimental and Theoretical Assessment of Artifact,”
`Magnetic Resonance in Medicine, Vol. 26, pp. 328-341 (1992)
`(“Melki 1992”)
`Bottomley et al., “A review of normal tissue hydrogen NMR
`relaxation times and relaxation mechanisms from 1–100 MHz:
`Dependence on tissue type, NMR frequency, temperature,
`species, excision, and age,” Medical Physics, Vol. 11, pp.425-
`448 (1984) (“Bottomley”)
`Hennig et al., “RARE Imaging: A Fast Imaging Method for
`Clinical MR,” Magnetic Resonance In Medicine Vol. 3, pp. 823-
`833 (1986) (“Hennig 1986”)
`Slavin et al., “Dual-Echo Interleaved Echo-Planar Imaging of the
`Brain,” Magnetic Resonance in Medicine, Vol. 33, pp. 254-270
`(1995) (“Slavin”)
`Rydberg et al., “Comparison of dual-echo breathhold fast spin
`echo and dual-echo conventional T2-weighted spin echo imaging
`of liver lesions,” Proceedings of the International Society for
`Magnetic Resonance in Medicine, Fifth Meeting, at 921 (1997)
`(“Rydberg”)
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`I.
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`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37
`C.F.R. § 42.22(A))
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`General Electric Co. D/B/A GE Healthcare (“Petitioner”) petitions for the
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`institution of inter partes review of claims 153-156, 161-162, and 252-253 (the
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`“Challenged Claims”) of U.S. Patent No. RE44,644 to John P. Mugler, III,, et al
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`(“the ‘644 patent,” attached as Ex. 1001). USPTO records indicate that the ‘644
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`patent is assigned to University of Virginia Patent Foundation (“P.O.”), which is
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`currently asserting the ‘644 patent against Petitioner in a concurrent litigation. See
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`Ex. 1011.
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`II. MANDATORY NOTICES
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`A. Real Party-in-Interest
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`General Electric Co. (Petitioner) is the real party-in-interest.
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`B. Related Matters
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`P.O. has sued Petitioner in the U.S. District Court for the Western District of
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`Virginia, alleging infringement of the ’644 Patent (Ex. 1001). UVAPF v. General
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`Electric Co., No. 3:14-cv-00051-nkm (“GE Litigation”). Petitioner was served
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`with the complaint on December 16, 2014. Ex. 1012. That case is pending.
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`Petitioner has filed concurrently herewith two other Petitions for Inter Partes
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`Review of the ’644 Patent. Petitioner has categorized the 260 claims of the ‘644
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`patent by subject matter. The Challenged Claims in this Petition relate to the
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`prescribed signal amplitude. The challenged claims in the other two petitions relate
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`to the contrast/duration of the spin echo train and the prescribed signal amplitude,
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`respectively. Each group of claims is addressed in a separate Petition as the subject
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`matter is distinct and there are numerous claims in each category.
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`Designation of Lead Counsel
`(37 C.F.R. § 42.8(b)(3))
`Marc S. Kaufman (Reg. #35,212)
`REED SMITH, LLP
`1301 K Street, NW
`East Tower – Suite 1000
`Washington, DC 20005
`Tel: 202.414.9249 Fax: 202.414.9299
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`Back-Up Counsel
`
`Jonathon I. Detrixhe (Reg. # 68,556)
`REED SMITH, LLP
`101 Second Street
`Suite 1800
`San Francisco, CA 94105
`Tel: 415-543-8700 Fax: 415 391 8269
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`C.
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`Service Information
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`Please direct all correspondence to lead and back-up counsel at the above
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`addresses.
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`III.
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`CERTIFICATION OF GROUNDS FOR STANDING
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`Petitioner certifies pursuant to Rule 42.104(a) that the patent for which
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`review is sought is available for inter partes review and that Petitioner is not
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`barred or estopped from requesting an inter partes review challenging the patent
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`claims on the grounds identified in this Petition.
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`IV. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED
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`
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`The Challenged Claims are unpatentable as being anticipated under 35
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`U.S.C. § 102(b) and/or for being obvious under 35 U.S.C. § 103. Specifically:
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`A. GROUND 1: Claims 153–156, 161-62, and 252–253 are
`anticipated under § 102(b) by Mugler et al, “Three-Dimensional
`T2-Weighted Imaging of the Brain Using Very Long Spin-Echo
`Trains,” Proceedings of the International Society for Magnetic
`Resonance in Medicine, Eighth Meeting, April 2000 at 687
`(“Mugler 2000”) (Ex. 1002)
`B. GROUND 2: Claims 153–156, 161-62, and 252–253 are
`obvious under § 103(a) in view of Mugler 2000 in view of
`Mugler, “Overview of MR Imaging Pulse Sequences,” Physics
`of MR Imaging, Vol. 7, No. 4, pp. 661-697 (Nov. 1999)
`(“Mugler Overview”) (Ex. 1005)
`C. GROUND 3: Claims 153–156, 161-62, and 252–253 are
`anticipated under § 102(b) by Mugler et al, “Three-Dimensional
`Spin-Echo-Train Proton-Density-Weighted Imaging Using
`Shaped Signal Evolutions,” Proceedings of the International
`Society for Magnetic Resonance in Medicine, Seventh Meeting,
`May 1999 at 1631(“Mugler 1999”) (Ex. 1003)
`D. GROUND 4: Claims 153–156, 161-62, and 252–253 are
`obvious under § 103(a) based on Mugler 1999 in view of
`Alsop, “The Sensitivity of Low Flip Angle RARE Imaging,”
`Magnetic Resonance in Medicine, Vol. 37, pp. 176-184
`(“Alsop”) (Ex. 1004)
`E. GROUND 5: Claims 153–156, 161-62, and 252–253 are
`obvious under § 103(a) based on Mugler 1999 in view of
`Alsop, further in view of Mugler Overview
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`
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`This Petition is supported by the declaration of Dr. Norbert Pelc (Ex. 1009).
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`All exhibits submitted herewith, including Dr. Pelc’s declaration (Ex. 1009), are
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`identical to the exhibits Petitioner submits in connection with Petitioner’s other
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`two petitions. Petitioner believes having a common exhibit list serves the
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`convenience of the Board.
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`V. OVERVIEW
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`A. Technical Background
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`Magnetic resonance imaging (MRI) is a medical imaging technique that uses
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`a magnetic field and radio frequency (RF) pulses applied to an object, such as
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`anatomical structures in a patient’s body, to produce a signal that can be processed
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`into images of the object. MRI imaging devices have a magnet that generates a
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`magnetic field and a radio transmitter that generates RF pulses applied to the
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`object. All commercially available MRI systems also employ “gradient” magnetic
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`fields (“gradient pulses”) that produce magnetic fields that vary across the patient's
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`body and as a function of time. A patient’s body absorbs energy due to the RF
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`pulses applied in a magnetic field during an imaging process and thus tissue
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`heating can occur. Accordingly, in order to avoid tissue damage, the rate at which
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`energy is absorbed by the body has to be limited. See Ex. 1009 at ¶ 39.
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`An MRI scan uses an ordered combination of RF and gradient pulses, called
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`a pulse sequence, designed to acquire data to from the image. Id. at ¶¶ 40-42.
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`Every pulse sequence must accomplish two basic tasks. First, transverse
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`magnetization must be created using one or more "excitation" radio-frequency
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`(RF) pulses, and this magnetization must be manipulated so that the spatial
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`location of the source of the signal is encoded into the signal. This spatial encoding
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`is accomplished using gradient pulses so that the spatial positions of the tissues can
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`be determined to form the image. Second, the desired contrast between tissues
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`must be created, and this is done by the time of application and duration of the
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`various RF and gradient pulses. The data collection process is then repeated. See
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`Id. at ¶ 47.
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`There are three inherent properties of all matter that are used to distinguish
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`between types of tissues in an MR scan: proton density, T1 relaxation, and T2
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`relaxation. Proton density is quantified as the concentration of protons in the tissue
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`of interest relative to that in water. T1 relaxation is the process by which the
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`longitudinal component of the magnetization vector relaxes to its thermal
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`equilibrium value aligned with the main magnetic field. In particular, a tissue’s T1
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`relaxation time is defined as the time when 63% of the longitudinal magnetization
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`has recovered. T2 relaxation is the process by which the transverse component of
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`the magnetization vector relaxes to its thermal equilibrium value of zero. A tissue’s
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`T2 relaxation time is defined as the time when 63% of the transverse magnetization
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`has decayed. Because the values of these three properties are different for various
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`substances within the body, the difference in values for particular substances may
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`be exploited to generate contrast to form an image. See id. at ¶¶ 45-46.
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`“Spin-echo” and “fast-spin-echo” pulse sequences are well known. These
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`sequences have an excitation RF pulse followed by one or more refocusing RF
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`pulses. The pulses are applied at a “flip angle” relative to the main magnetic field.
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`B.
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`The ’644 Patent
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`(i)
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`Summary of Alleged Invention of the ’644 Patent
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`The ’644 patent generally relates to spin-echo imaging. See, e.g., Ex. 1001 at
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`3:48-55. The Background portion of the ’644 patent recognizes that the use of
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`“low-flip-angle refocusing RF pulses [that] lengthen its usable duration” was well
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`known. Ex. 1001 at 3:12-19. Also, “deriv[ing] variable flip-angle series” was well
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`known. Id. at 3:20-23. The ’644 patent explains its purported advancement over the
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`prior art as incorporating the effect of tissue relaxation in its determination of a
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`variable-flip-angle series. See, e.g., Ex. 1001 at 3:20-41 (contrasting the prior art,
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`which “derived variable flip-angle series . . . when T1 and T2 relaxation are
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`neglected,” with “[t]he present invention method and apparatus” which “explicitly
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`consider the T1 and T2 relaxation times for the tissues of interest and thereby
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`permit the desired image contrast … .”) (emphasis added). As discussed below, at
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`the time of the ’644 patent, incorporating the effect of tissue relaxation in
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`determination of a variable-flip-angle series was well known to a person of
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`ordinary skill in the art.
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`(ii) The Prosecution History
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`The ’644 patent is a reissue of U.S. Pat. No. 7,164,268 (“the ’268 patent”)
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`(Ex. 1013). See Ex. 1001 at 1. Each claim of the ’268 patent required “i) selecting
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`values of T1 and T2 relaxation times and selecting proton density” and “ii)
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`selecting a prescribed time course of the amplitudes and phases of the radio-
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`frequency magnetic resonance signals . . . .” Ex. 1013 at cls. 1-46.
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`Approximately two years after issuance of the ’268 patent, P.O. filed an
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`application for reissue. Reissue claims 1-43 of the ’644 patent are amended
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`versions of claims 1–43 of the ’268 patent and claims 47–74 are very similar
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`thereto (6 and 44-46 were cancelled). See Ex. 1001 at cls. 1–74. The rest of the
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`reissue claims, however, were added as new claims. Id. at cls. 75–260. Each of
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`these added claims, which includes all Challenged Claims, omits the “selecting
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`values of T1 and T2 relaxation times and selecting proton density” limitation of the
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`’268 patent. Id.
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`(iii) Effective Filing Date Of The Challenged Claims
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`The ’644 patent claims the benefit of priority to U.S. Provisional App. No.
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`60/257,182 (“the ’182 application”) (Ex. 1014). The priority claim to the ’182
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`application is ineffective because the subject matter of the Challenged Claims was
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`not disclosed in the ‘182 application in the manner required by 35 U.S.C. § 112, ¶
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`1. See, e.g., SAP America, Inc. v. Pi-Net Int’l, Inc., IPR No. 2014-00414, Paper No.
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`11 at 11-14 (P.T.A.B. August 18, 2014) (relying on § 112 case law is proper in an
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`inter partes review to establish effective filing date). 35 U.S.C. § 112, ¶ 1 requires,
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`inter alia, that “[t]he specification shall contain a written description of the
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`invention.” To comply with the written description requirement, the specification
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`“must describe the invention sufficiently to convey to a person of skill in the art
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`that the patentee had possession of the claimed invention at the time of the
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`application, i.e., that the patentee invented what is claimed.” Lizardtech, Inc. v.
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`Earth Resource Mapping, Inc., 424 F.3d 1336, 1345 (Fed Cir. 2005). “[A]ll the
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`limitations must appear in the specification” of the priority application, as “[t]he
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`question is not whether a claimed invention is an obvious variant of that which is
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`disclosed in the specification.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565,
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`1572 (Fed. Cir. 1997). Although the exact terms of the claims need not be used in
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`haec verba to provide written description, see Eiselstein v. Frank, 52 F.3d 1035,
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`1038, 34 USPQ2d 1467, 1470 (Fed. Cir. 1995), “possession” of an invention can
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`only be shown demonstrated by describing the invention with all its claim
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`limitations, even if they are obvious, and is measured as of the filing date sought.
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`See, e.g., Lockwood, 107 F.3d at 1572.
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`The challenged claims are directed to an “invention” that was not disclosed
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`as being within the inventor’s possession at the time of filing of the ’182
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`application. Accordingly, the effective filing date of the Challenged Claims is no
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`earlier than the December 21, 2001 filing date of International App. No.
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`PCT/US01/50551 to which the ’644 patent claims priority.
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`(A) The ’182 application does not describe that selection
`of T1 and T2 relaxation times may be omitted
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`The ’182 application discloses that “[o]ur method explicitly considers the Tl
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`and T2 relaxation times for the tissues of interest and thereby permits the desired
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`image contrast to be incorporated into the tissue signal evolutions corresponding to
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`the long echo train.” Ex. 1014 at 3 (emphasis added). Similarly, the ’182
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`application states that “[t]his invention consists of the methodology for using a
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`series of refocusing RF pulses with variable flip angles and, optionally, variable
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`phase angles, in a spin-echo-train MRl pulse sequence wherein the flip-angle
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`series is specifically designed to achieve a prescribed signal evolution during the
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`echo train for selected T1 and T2 relaxation times.” Id. at 4 (emphasis added).
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`Nowhere does the ’182 application indicate that selection of T1 and T2 relaxation
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`times is an optional step. Ex. 1009 at ¶ 70. However, each challenged claim omits
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`the limitation “selecting values of T1 and T2 relaxation times” which was in all the
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`original claims. In fact, during prosecution, P.O. has stated regarding the reissue
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`claims that “none of the independent claims contain any recitation of . . . the
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`selection of T1, T2, or proton density values.” Ex. 1017, Comments on Statement
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`of Reasons for Allowance, dated May 8, 2015, at 2.
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`The ’182 application fails to provide an adequate written description of the
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`challenged claims. For example, in Gentry Gallery, Inc. v. The Berkline Corp., 134
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`F.3d 1473 (Fed. Cir. 1998), the Federal Circuit held that claims directed to a
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`sectional sofa that did not limit the location of controls of the sofa to be on a
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`console were not adequately supported by a specification that described the
`
`controls only as being on the console. See also ICU Med. v. Alaris Med. Sys., 558
`
`F.3d 1368, 1378 (Fed. Cir. 2009) (finding claims directed to “spikeless” medical
`
`valves not adequately supported by a specification that taught only valves having
`
`spikes).
`
`
`
`Similarly, in LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336,
`
`1346 (Fed. Cir. 2005), claims directed to an image compression algorithm were
`
`found not adequately supported by a specification that described only one mode of
`
`performing the compression when the asserted claims generally claimed all modes
`
`that could compress the image. In particular, the Federal Circuit found that a
`
`specification cannot support expansive claim language and satisfy the requirements
`
`of 35 U.S.C. § 112, ¶ 1 “merely by clearly describing one embodiment of the thing
`
`claimed.” Id. Like the claims at issue in LizardTech, the ’182 application describes
`
`only one embodiment for determining variable-flip-angles by explicitly
`
`selecting/considering T1 and T2 relaxation times (see Ex. 1009 at ¶¶ 51-52, 72),
`
`yet the challenged claims cover a broader invention not disclosed in the ’182
`
`application.
`
`(B) The ’182 application does not describe the “magnetic-
`field gradient pulses” limitation recited by each
`challenged claim
`
`
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`- 10 -
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`
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`Each challenged claim recites a “a data-acquisition step” that comprises
`
`“providing magnetic-field gradient pulses that perform at least one of encoding
`
`spatial information into at least one of the radio-frequency magnetic resonance
`
`signals that follow at least one of said refocusing radio-frequency pulses and
`
`dephasing transverse magnetization associated with undesired signal pathways to
`
`reduce or eliminate contribution of said transverse magnetization to sampled
`
`signals.” Ex. 1001 at cls. 153, 156, and 161-62 (emphasis added).
`
`
`
`The ’182 application does not provide adequate support for the “providing
`
`magnetic-field gradient pulses” limitation in two respects. First, the ’182
`
`application does not provide support for the magnetic field gradient pulses
`
`encoding spatial information into “at least one of” the RF magnetic resonance
`
`signals that follow “at least one of” said refocusing radio-frequency pulses. Ex.
`
`1009 at ¶¶ 73-79. For example, the ’182 application generally discloses that “[a]ny
`
`form of the applied spatial-encoding gradient waveforms . . . are applicable.” Ex.
`
`1014 at 6. However, disclosure of applied spatial-encoding gradient waveforms
`
`does not disclose or suggest that spatial information may be encoded into only one
`
`of the RF magnetic resonance signals for only one of the refocusing RF pulses.
`
`Ex. 1009 at ¶¶ 74-75. To the contrary, a person of ordinary skill in the art would
`
`understand that applied spatial-encoding gradient waveforms as disclosed by the
`
`
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`- 11 -
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`

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`’182 application necessarily encode spatial information for all of the refocusing RF
`
`pulses. Id.
`
`
`
`Second, the ’182 application does not provide support or written description
`
`for providing magnetic-field gradient pulses as part of a data-acquisition step that
`
`performs “dephasing transverse magnetization associated with undesired signal
`
`pathways to reduce or eliminate contribution of said transverse magnetization to
`
`sampled signals.” Ex. 1009 at ¶¶ 76-79. For example, the ’182 application does not
`
`even contain any of the following words: “dephase,” “dephasing,” “transverse
`
`magnetization,” or “undesired signal pathways.” Id. at ¶76. No support or written
`
`description for gradient pulses performing dephasing during a data-acquisition step
`
`is present in the ’182 application. Id.
`
`
`
`To the extent any of the many articles that the ’182 application purports to
`
`incorporate by reference disclose gradient pulses that perform dephasing transverse
`
`magnetization, such incorporation by reference is impermissible to provide support
`
`for claimed subject matter. See, e.g., 37 CFR 1.57(c)–(e). However, even if such
`
`incorporation by reference to non-patent publications is found to be proper, the
`
`articles incorporated by reference in the ’182 application do not provide support or
`
`written description for gradient pulses performing dephasing during a data-
`
`acquisition step. Ex. 1009 at ¶77.
`
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`- 12 -
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`

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`(C) The ’182 application does not describe the “signal
`amplitude . . . decreas[ing] . . . to a value that is no
`more than approximately two-thirds” limitation
`Each challenged independent claim recites a limitation specifying that “the
`
`
`
`signal amplitude decreases, within the first approximately 20% of the total
`
`number of echoes, to a value that is no more than approximately two-thirds of the
`
`initial value for said signal evolution.” Ex. 1001 at cls. 153 and 161 (emphasis
`
`added).
`
`
`
`The ’182 patent states only that the signal amplitude evolution “may assume
`
`any physically-realizable shape.” Ex. 1014 at Fig. 2, p. 7. However, there is no
`
`mention of decreasing by any particular amount, minimum amount, maximum
`
`amount, or range of amounts. Ex. 1009 at ¶ 101. Nor does the ’182 application
`
`disclose that the signal amplitude must decrease by any such amount within any
`
`specified number of echoes. Id. at ¶¶ 100-03. Further, the ’182 application does not
`
`provide support or written description for claimed range of “no more than
`
`approximately two-thirds of the initial value” because support for claimed ranges
`
`must be specifically disclosed to satisfy §112, ¶ 1. See, e.g., Nissan North America,
`
`Inc. v. Board of Regents, The Univ. of Texas System, IPR No. 2012-00037, Paper
`
`No. 24 (P.T.A.B. March 19, 2013) (holding that broad disclosure of a range does
`
`not provide written support for a narrower range.)
`
`C. The Primary Prior Art References
`
`
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`- 13 -
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`(i) Mugler 2000
`
`
`
`Mugler 2000 is an abstract presented and published as part of the
`
`Proceedings of the International Society for Magnetic Resonance in Medicine,
`
`Eighth Meeting, held in Denver on April 1–7, 2000. Ex. 1009 at ¶ 139. For
`
`example, Mugler 2000 was published on a CD-ROM of the ISMRM proceedings
`
`in 2000 as Abstract No. 687. See Ex. 1018 at 219 (“Using the ISMRM 2000 CD-
`
`ROM”); id. at 72 (listing Mugler 2000 as Abstract No. 687); id. at 219 (“Click on a
`
`session name and the session and its abstracts are displayed.”). In addition, the
`
`published Mugler 2000 abstract was distributed at least to attendees of the ISMRM
`
`proceedings. Ex. 1009 at ¶ 139. Accordingly, Mugler 2000 is prior art at least
`
`under 35 U.S.C. § 102(b) (pre-AIA) because Mugler 2000 pre-dates by more than
`
`one year the effective filing date of the Challenged Claims, which can claim
`
`priority no earlier than December 21, 2001. Mugler 2000 also is prior art to the
`
`’644 patent under 35 U.S.C. § 102(a) (pre-AIA) because it was publicly presented
`
`at the ISMRM proceedings.
`
`
`
`Mugler 2000 discloses substantially identical subject matter as that which is
`
`disclosed in the ’644 patent. For example, Mugler 2000 discloses the use of “very
`
`long SE trains based on prescribed signal evolutions which explicitly consider the
`
`T1s and T2s of interest,” which are used to calculate a “variable flip-an

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