throbber
U.S. PATENT RE45,725
`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. RE45,725
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`UNDER 35 U.S.C. § 312 AND 37 C.F.R. § 42.104
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`GENERAL ELECTRIC CO.
`Petitioner,
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`v.
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`UNIVERSITY OF VIRGINIA PATENT FOUNDATION,
`Patent Owner
`
`Patent No. RE45,725
`Issued: October 6, 2015
`Filed: October 14, 2013
`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. IPR_________
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`U.S. PATENT RE45,725
`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................................... 3
`V. OVERVIEW .......................................................................................................................... 4
`A.
`Technical Background ................................................................................................... 4
`B.
`The ’725 Patent ............................................................................................................... 4
`(i)
`Summary of Alleged Invention of the ’725 Patent................................................... 4
`(ii) The Prosecution History ............................................................................................ 5
`(iii) Effective Filing Date Of The Challenged Claims ..................................................... 6
`C.
`The Primary Prior Art References ............................................................................. 18
`(i) Mugler 2000............................................................................................................... 18
`(ii) Alsop .......................................................................................................................... 20
`(iii) Mugler 1999............................................................................................................... 21
`(iv) Mugler Overview ...................................................................................................... 23
`VI. RELEVANT INFORMATION CONCERNING THE ’725 PATENT ....................... 24
`A.
`Person of Ordinary Skill in the Art ............................................................................ 24
`B.
`Construction of Terms Used in the Claims ................................................................ 24
`(i)
`“Substance of interest in said object, with corresponding T1 and T2 relaxation
`times and a spin density of interest” means “substance in the object having inherent
`T1 and T2 relaxation times and proton spin density” in this review ............................. 24
`(ii)
`“effective echo time” means “the echo time at which the center of k space is
`sampled” in this review ...................................................................................................... 25
`(iii) “echo time . . . value typical in T2-weighted clinical magnetic resonance imaging
`of the brain” means “an echo time in the range of 60 ms to 130 ms” in this review .... 26
`(iv)
`“T2-weighted contrast . . . that is substantially the same” means “T2-weighted
`contrast that has substantially the same numerical indicator of contrast or that
`visually appears similar” in this review ............................................................................ 27
`VII. SPECIFIC GROUNDS FOR PETITION ...................................................................... 28
`A. Mugler 2000 Anticipates Claims 47-80....................................................................... 28
`(i) Claim 47 ..................................................................................................................... 28
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`(ii) Claim 67 ..................................................................................................................... 35
`(iii) Claims 57 and 73 ....................................................................................................... 36
`(iv) Claims 79 and 80 ....................................................................................................... 38
`(v) Claims 48, 58, 68, and 74 .......................................................................................... 38
`(vi) Claims 49, 59, 70, and 76 .......................................................................................... 38
`(vii)
`Claims 50, 60, 69, and 75 ...................................................................................... 39
`(viii) Claims 51, 52, 61, and 62 ...................................................................................... 39
`(ix) Claims 53 and 63 ....................................................................................................... 39
`(x) Claims 54, 64, 72, and 78 .......................................................................................... 39
`(xi) Claims 55 and 65 ....................................................................................................... 40
`(xii)
`Claims 56 and 66 ................................................................................................... 41
`(xiii) Claims 71 and 77 ................................................................................................... 41
`B. Mugler 2000 In View Of Mugler Overview Renders Obvious Claims 47-80 ......... 41
`C.
`Alsop In View Of Mugler 1999 Renders Obvious Claims 47-80 .............................. 43
`(i) Claim 47 ..................................................................................................................... 44
`(ii) Claim 67 ..................................................................................................................... 54
`(iii) Claims 57 and 73 ....................................................................................................... 54
`(iv) Claims 79 and 80 ....................................................................................................... 55
`(v) Claims 48, 58, 68, and 74 .......................................................................................... 55
`(vi) Claims 49, 59, 70, and 76 .......................................................................................... 56
`(vii)
`Claims 50, 60, 69, and 75 ...................................................................................... 56
`(viii) Claims 51, 52, 61, and 62 ...................................................................................... 56
`(ix) Claims 53 and 63 ....................................................................................................... 57
`(x) Claims 54, 64, 72, and 78 .......................................................................................... 57
`(xi) Claims 55 and 65 ....................................................................................................... 57
`(xii)
`Claims 56 and 66 ................................................................................................... 58
`(xiii) Claims 71 and 77 ................................................................................................... 58
`D.
`Alsop In View Of Mugler 1999, Further In View Of Mugler Overview Renders
`Obvious Claims 47-80 ............................................................................................................. 58
`VIII. CONCLUSION ............................................................................................................. 59
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`- ii -
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`
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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
`1008
`
`1009
`1010
`1011
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`EXHIBIT LIST
`
`Description
`U.S. Patent RE45,725 to Mugler III et al. (“the ’725 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”)
`U.S. Patent RE44,644 to Mugler III et al. (“the ’644 Patent”)
`Patent Owner’s October 16, 2015 Motion for Leave to File
`Amended Complaint
`Declaration of Dr. Norbert Pelc
`Curriculum Vitae of Dr. Norbert Pelc
`Court’s October 19, 2015 Order Granting Patent Owner’s Motion
`for Leave to File First Amended Complaint
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`Exhibit No.
`1012
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`1013
`1014
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`1015
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`1016
`1017
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`1018
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`1019
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`1020
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`1021
`
`1022
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`1023
`
`Description
`Patent Owner’s October 19, 2015 First Amended Complaint
`against Petitioner alleging infringement of ’725 patent in the GE
`Litigation
`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”)
`Comparison of claim 47 of ’725 Patent to claims 75, 82, and 85
`of ’644 Patent
`File history of the ’644 patent, July 2, 2013 Notice of Allowance
`File history of the ’725 patent, May 8, 2015 Comments on
`Statement of Reasons for Allowance
`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
`Mugler, “Magnetic resonance imaging of the body trunk using a
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`Exhibit No.
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`1024
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`1025
`1026
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`1027
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`1028
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`1029
`1030
`1031
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`
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`Description
`single-slab, 3-dimensional, T2-weighted turbo-spin-echo
`sequence with high sampling efficiency (SPACE) for high spatial
`resolution imaging: initial clinical experiences,” Investigative
`Radiology, Vol. 40, pp. 754-60 (2005) (“Kiefer 2005”)
`Patent Owner’s November 13, 2015 Letter submitted in the GE
`Litigation to the Court
`U.S. Patent No. 5,459,401 to Kiefer
`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”)
`File history of ’644 Patent, Dec. 12, 2012 Response to Office
`Action
`J.P. Mugler and B. Kiefer et al., “Practical Implementation of
`Optimized Tissue-Specific Prescribed Signal Evolutions for
`Improved Turbo-Spin-Echo Imaging,” Proceedings of the
`International Society for Magnetic Resonance in Medicine,
`Eleventh Meeting, July 2003 at 203 (“Kiefer 2003”)
`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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`U.S. PATENT RE45,725
`Petition for Inter Partes Review
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37
`C.F.R. § 42.22(A))
`
`General Electric Co. D/B/A GE Healthcare (“Petitioner”) petitions for the
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`I.
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`
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`institution of inter partes review of claims 47-80 (the “Challenged Claims”) of
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`U.S. Patent No. RE45,725 to John P. Mugler, III,, et al (“the ’725 Patent,” attached
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`as Ex. 1001). USPTO records indicate that the ’725 Patent is assigned to
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`University of Virginia Patent Foundation (“P.O.”), which is currently asserting the
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`’725 Patent against Petitioner in a concurrent litigation. See Ex. 1012.
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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 ’725 Patent (Ex. 1001). UVAPF v. General
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`Electric Co., No. 3:14-cv-00051-nkm (“GE Litigation”). On October 16, 2015,
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`P.O. filed a motion for leave “request[ing] that the Court permit UVAPF to file
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`[an] amended complaint” adding the ’725 Patent. Ex. 1008. On October 19, 2015,
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`the Court granted P.O.’s motion for leave (Ex. 1011), and P.O. filed an amended
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`complaint asserting the ’725 Patent against Petitioner. Ex. 1012. Thus, Petitioner
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`was not “served with a complaint” under § 315(b) until October 19, 2015. See
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`TRW Automotive US v. Magna Elecs., Inc., IPR2014-00293, Paper No. 18 at 5-11
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`(P.T.A.B. June 27, 2014) (holding that, “regardless of any prior ‘consent’ by a
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`Petitioner,” a proposed amended complaint attached to a Patent Owner’s motion
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`requesting leave to amend a pleading is “not an actual ‘complaint’ within the
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`meaning of § 315(b).”).
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`The ’725 Patent is a continuation of U.S. Patent No. RE44,644 (“the ’644
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`Patent,” Ex. 1007). In the GE Litigation, P.O. also has asserted the ’644 Patent.
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`The ’644 Patent is the subject of three instituted inter partes reviews, styled as
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`General Electric Co. v. University of Virginia Patent Foundation in Case Nos.
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`IPR2016-00357, IPR2016-00358, and IPR2016-00359 (“’644 IPRs”). The GE
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`Litigation is stayed until the resolution of the ’644 IPRs.
`
`Designation of Lead Counsel
`(37 C.F.R. § 42.8(b)(3))
`Marc S. Kaufman (Reg. #35,212)
`mskaufman@reedsmith.com
`REED SMITH, LLP
`1301 K Street, NW
`East Tower – Suite 1000
`Washington, DC 20005
`Tel: 202.414.9249 Fax: 202.414.9299
`
`Back-Up Counsel
`
`David Pollock (Reg. #48,977)
`dpollock@reedsmith.com
`Jonathan 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(a),(b) and/or for being obvious under 35 U.S.C. § 103. Specifically:
`
`A. GROUND 1: Claims 47-80 are anticipated under §§ 102(a)
`and/or 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 47-80 are obvious under § 103(a) over
`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 47-80 are obvious under § 103(a) over
`Alsop, “The Sensitivity of Low Flip Angle RARE Imaging,”
`Magnetic Resonance in Medicine, Vol. 37, pp. 176-184
`(“Alsop”) (Ex. 1004) in view of 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 47-80 are obvious under § 103(a) based
`on Alsop in view of Mugler 1999, 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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`V. OVERVIEW
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`A. Technical Background
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`Magnetic resonance imaging (MRI) uses magnetic field and radio frequency
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`(RF) pulses applied to an object, such as anatomical structures in a patient’s body,
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`to produce a signal that can be processed into images of the object. An MRI scan
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`uses an ordered combination of RF and gradient pulses, called a pulse sequence,
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`designed to acquire data to from the image. Ex. 1009 ¶¶ 40-42. There are three
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`inherent properties of all matter that are used to distinguish between types of
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`tissues in an MR scan: proton density, T1 relaxation, and T2 relaxation. Because
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`the values of these three properties are different for various substances within the
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`body, the difference in values for particular substances may be exploited to
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`generate contrast to form an image. Id. at ¶¶ 45-46. “Spin-echo” and “fast-spin-
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`echo” pulse sequences are well known sequences that have an excitation RF pulse
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`followed by one or more refocusing RF pulses. The pulses are applied at a “flip
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`angle” relative to the main magnetic field.
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`B.
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`The ’725 Patent
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`(i)
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`Summary of Alleged Invention of the ’725 Patent
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`The Challenged Claims of the ’725 Patent are substantially similar to those
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`of the ’644 Patent at issue in the ’644 IPRs. See Ex. 1015. Like the ’644 Patent, the
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`’725 Patent generally relates to spin-echo imaging. See Ex. 1001 at 3:65-4:6. The
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`’725 Patent explains its purported advancement over the prior art as incorporating
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`the effect of tissue relaxation in its determination of flip angle values. See, e.g., Ex.
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`1001 at 3:38-62 (contrasting the prior art, which “derived variable flip-angle series
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`. . . when T1 and T2 relaxation are neglected,” with “[t]he present invention
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`method and apparatus” which “explicitly consider the T1 and T2 relaxation times
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`for the tissues of interest and thereby permit the desired image contrast … .”).
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`Consideration of T1 and T2 relaxation times occurs as part of a 4-step algorithm
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`for calculating the flip angles. Ex. 1001 at 10:33-11:14. It is this algorithm for
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`calculating, or selecting, the flip angles for an MR pulse sequence, which includes
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`the effects of T1 and T2 relaxation, that the ’725 Patent regards as its advancement
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`over the prior art. Ex. 1009 ¶ 51-56.
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`(ii) The Prosecution History
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`
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`The ’725 Patent is a continuation of the ’644 Patent, which is a reissue of
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`U.S. Pat. No. 7,164,268 (“the ’268 Patent”) (Ex. 1013). See Ex. 1001 at 1. Each
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`claim of the ’268 Patent required a “calculating flip angles” step that includes “i)
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`selecting values of T1 and T2 relaxation times and selecting proton density,” “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 . . . .”, and “iii) selecting characteristics of
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`said contrast-preparation step, said data-acquisition step and a magnetization-
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`recovery step . . . .” Ex. 1013 at cls. 1-46.
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`In contrast, each of the Challenged Claims of the ’725 Patent omits each of
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`the three “selecting” steps in each claim of the ’268 Patent directed to the disclosed
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`algorithm for determining flip angles. Ex. 1001 at cls. 47-80.
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`(iii) Effective Filing Date Of The Challenged Claims
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`
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`The ’725 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). It is P.O.’s burden to show
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`that the ’182 Application provides written description support for the Challenged
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`Claims. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
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`1378 (Fed.Cir. 2015)(affirming P.T.A.B. that party asserting that a patent is
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`entitled to the benefit of a provisional filing date has the burden of demonstrating
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`written description support in the provisional application). To comply with the
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`written description requirement, the specification “must describe the invention
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`sufficiently to convey to a person of skill in the art that the patentee had possession
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`of the claimed invention at the time of the application, i.e., that the patentee
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`invented what is claimed.” Lizardtech, Inc. v. Earth Resource Mapping, Inc., 424
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`F.3d 1336, 1345 (Fed Cir. 2005). In particular, the written description must
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`provide sufficient information to indicate to a person of ordinary skill that the
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`inventor had possession of the “full scope” of the claims. See, e.g., In re Wertheim,
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`541 F.2d 257, 262-64 (C.C.P.A. 1976) (emphasis added). “[A]ll the limitations
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`must appear in the specification” of the priority application, as “[t]he question is
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`not whether a claimed invention is an obvious variant of that which is disclosed
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`in the specification.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed.
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`Cir. 1997) (emphasis added) (expert testimony that claimed subject matter was
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`“well known” to persons skilled in the art was insufficient to provide written
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`description support and meant, at best, that the claimed subject matter would have
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`been obvious to persons skilled in the art). Rather, “one skilled in the art, reading
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`the original disclosure, must immediately discern the limitation at issue in the
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`claims.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir.
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`2000). Although the exact terms of the claims need not be used in haec verba to
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`provide written description, see Eiselstein v. Frank, 52 F.3d 1035, 1038, 34
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`USPQ2d 1467, 1470 (Fed.Cir.1995), “possession” of an invention can only be
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`shown by describing the invention with all its claim limitations, even if they are
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`obvious, and is measured as of the filing date sought. See, e.g., Lockwood, 107
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`F.3d at 1572. The Challenged Claims are directed to an “invention” that was not
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`disclosed as being within the inventor’s possession at the time of filing of the ’182
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`Application. Accordingly, the Challenged Claims are not entitled to the effective
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`filing date of the ’182 Application.
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`(A) The Challenged Claims are directed to the results of
`an algorithm for determining flip angles while
`omitting the entirety of the algorithm disclosed by the
`’182 Application for achieving those results
`The ’182 Application discloses that “[o]ur method explicitly considers the
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`
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`Tl and T2 relaxation times for the tissues of interest and thereby permits the
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`desired image contrast to be incorporated into the tissue signal evolutions
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`corresponding to the long echo train.” Ex. 1014 at 3 (emphasis added). Likewise,
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`the ’725 Patent states that “[t]he present invention method and apparatus
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`explicitly consider the T1 and T2 relaxation times for the tissues of interest.”
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`Ex. 1001 at 3:55-57 (emphasis added). Similarly, the ’182 Application states that
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`“[t]his invention consists of . . . for selected T1 and T2 relaxation times.” Id. at
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`4 (emphasis added). Consistent with the requirement of considering relaxation, the
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`’182 Application provides a four-step algorithm for determining flip angles that
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`includes, among other steps, selecting “the T1 and T2 relaxation parameters for the
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`‘target’ tissue.” Ex. 1014 at 6-7. This four-step algorithm is the only guidance the
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`’182 Application provides on how to select flip angles; no other algorithm is
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`disclosed. Ex. 1009 ¶¶ 67-68. As all MR pulse sequences necessarily have flip
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`angle parameters, and the ’182 Application only provides one algorithm for
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`selecting the flip angle parameters, a person of ordinary skill would understand the
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`’182 Application to require that flip angles be selected using the four-step
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`algorithm in order to achieve the described beneficial results. Id. at ¶ 68.
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`Furthermore, in the ’644 IPRs, UVAPF has relied extensively on the four-step
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`algorithm as providing support for the claimed range results. Id.
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`
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`Each Challenged Claim omits the limitation “selecting values of T1 and T2
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`relaxation times.” Furthermore, there is no requirement in any Challenged Claim
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`that Tl and T2 relaxation times for the tissues of interest be considered in any way,
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`much less explicitly considered. Ex. 1009 ¶ 69. Not only does each Challenged
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`Claim omit consideration of T1 and T2 relaxation times—which is described as
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`“the invention” —but each Challenged Claim also omits the entirety of the four-
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`step algorithm for determining flip angles. Ex. 1009 ¶ 70. This four-step algorithm
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`for determining, or calculating, the flip angles is the only disclosure in the ’182
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`Application with respect to how the flip angles are selected. Id. In addition, the
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`three imaging examples described in the ’182 Application, referred to as Example
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`Nos. 1-3, were each obtained using flip angles calculated using the four-step
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`algorithm to perform the image acquisition. Id. However, each Challenged Claim
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`merely requires that “said flip angle is selected to vary” and covers all ways of
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`selecting flip angles, whether or not the flip angles are selected using the process
`
`described in the ’182 Application. The claimed requirement that the flip angles
`
`“vary, among a majority of the total number of said refocusing pulses applied
`
`
`
`- 9 -
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`

`
`during the echo train, by decreasing to a minimum value and later increasing” is
`
`just a result of the process used to select flip angles. Id. Likewise, obtaining flip
`
`angles corresponding to pulse sequence parameters with an effective echo time that
`
`is “at least twice” is similarly a result of the process used to select the flip angles.
`
`Id. In addition, the claimed “flip angles result[ing] in a reduced power deposition”
`
`is just a result of the process used to select the flip angles. Id.; Ex. 1001 at cl. 47
`
`(emphasis added).
`
`
`
`Claiming only the results of an algorithm while omitting the steps of the
`
`algorithm for achieving the results does not comply with the written description
`
`requirement. In LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1346
`
`(Fed. Cir. 2005), the patentee disclosed one algorithm for performing a type of
`
`image compression referred to as “a seamless DWT” that included a step of
`
`summing DWT coefficients. The Federal Circuit held that claims directed only to
`
`the disclosed results of the algorithm that omitted the steps of the algorithm for
`
`achieving those results were invalid for lack of written description. See id. at 1344:
`
`The trouble with allowing claim 21 to cover all ways of performing
`DWT-based compression processes that lead to a seamless DWT is
`that there is no support for such a broad claim in the specification.
`The specification provides only a single way of creating a seamless
`DWT, which is by maintaining updated sums of DWT coefficients.
`There is no evidence that the specification contemplates a more
`generic way of creating a seamless array of DWT coefficients.
`
`
`
`- 10 -
`
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`
`

`
`(emphasis added). Thus, the Federal Circuit held that “the description of one
`
`method for creating a seamless DWT does not entitle the inventor of the ’835
`
`patent to claim any and all means for achieving that objective.” Id. at 1346
`
`(emphasis added). Because the ’182 Application describes only one method of
`
`selecting flip angles—using the four-step algorithm— but the Challenged Claims
`
`cover all methods of selecting flip angles that achieve the claimed results, the
`
`Challenged Claims run afoul of exactly the same written description shortcoming
`
`that resulted in the invalidation of the claims at issue in LizardTech.
`
`
`
`The invalid claimed combination at issue in LizardTech lacked written
`
`description support even though each individual limitation of the claim was
`
`adequately described. See id. at 1346 (rejecting argument that “section 112 requires
`
`only that each individual step in a claimed process be described adequately”
`
`because that approach “would lead to sweeping, overbroad claims because it would
`
`entitle an inventor to a claim scope far greater than what a person of skill in the art
`
`would understand the inventor to possess.”) Similarly, even if P.O. could somehow
`
`show that each limitation of the Challenged Claims is described in the ’182
`
`Application, P.O. cannot show support for its overbroad claims that cover all ways
`
`of selecting flip angles—including ways other than the only way described in the
`
`’182 Application, the four-step algorithm, and including other ways not yet even
`
`
`
`- 11 -
`
`
`
`

`
`conceived. Accordingly, the Challenged Claims lack written description support
`
`because each covers a broader invention not disclosed in the ’182 Application.
`
`
`
`Likewise, the Challenged Claims lack written description support because
`
`the four-step algorithm is the only method provided by the specification for
`
`selecting flip angles and a person of ordinary skill would not understand the named
`
`inventors of the ’182 Application to have invented an MR pulse sequence that uses
`
`flip angles other than those derived according to the four-step algorithm. Ex. 1009
`
`¶¶ 72-74. See ICU Medical, Inc. v. Alaris Medical Systems, Inc., 558 F.3d 1368,
`
`1377 (Fed. Cir. 2009)(applying LizardTech to affirm district court’s grant of
`
`summary judgment that claims directed to a “spikeless” or “spike-optional”
`
`medical device were invalid for lack of written description because the
`
`“specification describes only medical valves with spikes” and “a person of skill in
`
`the art would not understand the inventor . . . to have invented a spikeless medical
`
`valve.”)
`
`(B) The ’182 Application does not describe the “magnetic-
`field gradient pulses” limitation recited by each
`Challenged Claim
`
`
`
`Each of the Challenged Claims 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
`
`
`
`- 12 -
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`
`

`
`resonance signals . . . and dephasing transverse magnetization . . . .” Ex. 1001 at
`
`cls. 75, 140, 157-58, and 176-177 (emphasis added).
`
`
`
`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 ¶¶ 75-77. The ’182 Application 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
`
`¶¶ 75-77. The plain meaning of the claimed “at least one” limitation encompasses
`
`within its full scope encoding spatial information into only one of the RF magnetic
`
`resonance signals for only one of the refocusing RF pulses. However, a person of
`
`ordinary skill in the art would understand that applied spatial-encoding gradient
`
`waveforms as disclosed by the ’182 Application necessarily encode spatial
`
`information for all of th

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