`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`VERASONICS, INC.,
`
`Petitioner
`
`v.
`
`SUPERSONIC IMAGINE, S.A.
`
`Patent Owner.
`
`________________________
`
`Inter Partes Review No. IPR2019-00799
`
`U.S. Patent No. 7,252,004
`________________________
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT
`
`NO. 7,252,004 PURSUANT TO 35 U.S.C. §§ 311-319, 37 C.F.R. § 42
`
`
`
`
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`TABLE OF CONTENTS
`
`I. 
`
`II. 
`
`V. 
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(b) ......................... 1 
`A. 
`Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1) ....................... 1 
`B. 
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................ 1 
`C. 
`Lead and Backup Counsel Under 37 C.F.R. § 42.8(b)(3) ................ 1 
`D. 
`Service Information Under 37 C.F.R. § 42.8(b)(4) .......................... 2 
`REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 ....................... 2 
`A.  Grounds for Standing Under 37 C.F.R. § 42.104(a) ........................ 2 
`B. 
`Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested ......................................................................................... 3 
`III.  OVERVIEW OF THE STATE OF THE ART AND THE ’004
`PATENT ..................................................................................................... 4 
`A. 
`State of the Art ................................................................................. 4 
`1. 
`Ultrasound Imaging ............................................................... 4 
`a) 
`Focused and Unfocused Ultrasound Waves ................ 5 
`Shear Wave Elastography ...................................................... 6 
`2. 
`The ’004 Patent ................................................................................ 7 
`The Alleged Advance of the ’004 – Shear Wave
`Generation Using Focused Ultrasound Waves – Was
`Well-Known in the Prior Art .......................................................... 10 
`1. 
`The Prior Art Discloses the ’004’s Shear Wave
`Generation Method .............................................................. 11 
`The Prior Art Taught the Advantages of Using
`Focused Ultrasound to Generate Shear Waves .................... 12 
`The ’004 Patent Prosecution History ............................................. 14 
`D. 
`IV.  THE BOARD SHOULD NOT DECLINE REVIEW UNDER
`SECTION 325(d) ...................................................................................... 16 
`CLAIM CONSTRUCTION AND LEVEL OF ORDINARY
`SKILL IN THE ART ................................................................................ 21 
`
`B. 
`C. 
`
`2. 
`
`i
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`A. 
`
`Claim Construction ........................................................................ 21 
`1. 
`at
`least one movement parameter of
`the
`viscoelastic medium is determined at different
`points of the observation field .............................................. 22 
`Focused ultrasound wave ..................................................... 24 
`2. 
`Claim Indefiniteness ............................................................ 25 
`3. 
`Persons of Ordinary Skill in the Art ............................................... 26 
`B. 
`VI.  OVERVIEW OF THE PRIOR ART TO THE ’004 PATENT ................ 27 
`A. 
`The ’616PCT .................................................................................. 27 
`1. 
`Excitation Step – Shear Wave Generation ........................... 28 
`2. 
`Shear Wave Observation Step – Detecting and
`Recording Echoes Generated by an Unfocused
`Ultrasound Compression Wave ........................................... 29 
`Processing Step – Determining Propagation
`Images of
`the Shear Wave and Movement
`Parameters of the Viscoelastic Medium .............................. 31 
`Sarvazyan’971 ................................................................................ 33 
`B. 
`VII.  THE CHALLENGED CLAIMS ARE UNPATENTABLE ..................... 37 
`A. 
`[Ground 1A]—Claims 1, 5 and 13 are Rendered Obvious
`by the ’616PCT in View of Sarvazyan’971 ................................... 37 
`1. 
`Claim 1 ................................................................................. 37 
`a) 
`The ’616PCT Teaches the Preamble and
`Elements a) through c2 of Claim 1 of the
`’004 ............................................................................ 37 
`(1) 
`The ’616PCT Teaches the Preamble ............... 38 
`(2) 
`The
`’616PCT and Sarvazyan’971
`Each Teach Excitation Step a .......................... 38 
`The ’616PCT Teaches Observation
`Step b ............................................................... 39 
`The ’616PCT Teaches Observation
`Substep b1 ....................................................... 40 
`
`(4) 
`
`3. 
`
`(3) 
`
`ii
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`(5) 
`
`(6) 
`
`b) 
`
`c) 
`
`(a)  Array of Transducers That Are
`Controlled
`Independently of
`One Another .......................................... 40 
`(b)  Array
`Emits
`Unfocused
`Ultrasound Compression Wave
`Shots at a Rate of at Least 500
`Shots Per Second ................................... 41 
`The ’616PCT Teaches Observation
`Substep b2 ....................................................... 42 
`The ’616PCT Teaches Processing
`Substep cl ........................................................ 43 
`The ’616PCT Teaches Element c2 .................. 44 
`(7) 
`Sarvazyan’971 Teaches
`Shear Wave
`Generation Using
` Focused Ultrasound
`Wave Emitted From a Transducer Array .................. 45 
`The
`’616PCT
`in Combination With
`Sarvazyan’971
`Teaches
`the
`‘004’s
`Remaining Limitations .............................................. 47 
`Claim 13 ............................................................................... 48 
`a) 
`The ’616PCT and Sarvazyan’971 Teach the
`Preamble .................................................................... 49 
`The ’616PCT Teaches an Electronic Central
`Unit That Causes Shear Wave Generation ................ 51 
`The ’616PCT Teaches an Electronic Central
`Unit Adapted to Perform the Observation
`Steps ........................................................................... 53 
`The ’616PCT Teaches the Processing Steps ............. 54 
`Sarvazyan’971 Teaches
`Shear Wave
`Generation Using Focused Ultrasound ...................... 55 
`The ’616 PCT Teaches the Claim 5 Element ...................... 55 
`POSITA Would be Motivated to Combine the
`’616PCT and Sarvazyan ’971 .............................................. 56 
`
`2. 
`
`3. 
`4. 
`
`b) 
`
`c) 
`
`d) 
`e) 
`
`iii
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`B. 
`
`C. 
`
`D. 
`
`[Ground 1B]–Claim 2 is Rendered Obvious by the
`’616PCT in View of Sarvazyan ’971 and Bohs ............................. 62 
`[Ground 2]–Claim 2 is Rendered Obvious by the
`’616PCT in View of Sarvazyan’971 and Hossack ......................... 65 
`[Ground 1C]--Claims 3 and 7 are Rendered Obvious by
`the ’616PCT in View of Sarvazyan’971 and Nightingale ............. 67 
`a) 
`Claim 3 ....................................................................... 67 
`b) 
`Claim 7 ....................................................................... 69 
`[Ground 3] – Claim 7 is Obvious Over the ’616PCT in
`View of Sarvazyan’971 and Mourad ............................................. 71 
`[Ground 1D]—Claim 6 is Obvious Over the ’616PCT in
`View of Sarvazyan’971 and Andreev ............................................ 73 
`VIII.  CONCLUSION ......................................................................................... 74 
`IX.  PAYMENT OF FEES – 37 C.F.R. § 42.15(a) ......................................... 74 
`
`
`E. 
`
`F. 
`
`iv
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`TABLE OF AUTHORITIES
`
`CASES 
`American Express Co. v. Signature Systems, LLC,
`No. CBM2018-00035, Paper No. 11, at 38-39 (Nov. 11, 2018) ....... 18, 20
`Becton, Dickinson and Company v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 at 17-28 (PTAB Dec. 15, 2017) ...................... 21
`Celltrion, Inc. v Genentech, Inc.,
`IPR2017-01139, Paper 30 at 12 (PTAB Jan. 25, 2018) .......................... 17
`Cultec, Inc. v. StormTech LLC,
`IPR2017-00777, Paper 7 at 8-13 (PTAB Aug. 22, 2017) ....................... 20
`Donghee America, Inc., et al. v. Plastic Omnium Advanced Innovation
`and Research,
`IPR2017-01654, Paper 9 at 18 (PTAB Jan. 19, 2018) ............................ 17
`Google Inc. v. Blackberry LTD.,
`IPR2017-00914, Paper 3 at 20-21 (PTAB Sept. 11, 2017) ..................... 17
`Intellectual Ventures II LLC v. Ericsson Inc.,
`685 F. App’x 913 (Fed. Cir. 2017) .......................................................... 19
`Jazz Pharm., Inc. v. Amneal Pharm., Inc.,
`895 F.3d 1347 (Fed. Cir. 2018) ............................................................... 19
`Kayak Software v. IBM Corp.,
`CBM2016-00075, Paper 16 at 11 (PTAB Dec. 15, 2016) ...................... 17
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398, 82 U.S.P.Q.2d 1385 (2007) ............................ 18, 19, 20, 21
`Nike, Inc. v. Adidas AG,
`812 F.3d 1326 (Fed. Cir. 2016) ......................................................... 19, 58
`Par Pharmaceutical, Inc. v. Horizon Therapeutics, LLC,
`IPR2017-01767, Paper 10 at 16 (PTAB Jan. 30, 2018) .......................... 17
`Perfect Web Techs., Inc. v. InfoUSA, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) ............................................................... 19
`Spectrum Pharm., Inc. v. Sandoz Inc.,
`802 F.3d 1326 (Fed. Cir. 2015) ............................................................... 57
`
`v
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`Unified Patents Inc. v. John L. Berman,
`IPR2016-01571, Paper 10 at 9-13 (PTAB Dec. 14, 2016) ...................... 20
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................... 57
`STATUTES 
`35 U.S.C. § 102(b) ........................................................................................ 4
`35 U.S.C. § 103 ............................................................................................. 3
`35 U.S.C. § 103(a) ...................................................................................... 13
`35 U.S.C. § 325(d) ...................................................................................... 20
`RULES 
`37 C.F.R. § 42.104 ........................................................................................ 2
`37 C.F.R. § 42.104(a) .................................................................................... 2
`37 C.F.R. § 42.104(b) ................................................................................... 3
`37 C.F.R. § 42.15(a) .................................................................................... 73
`37 C.F.R. § 42.24(d) ................................................................................... 74
`37 C.F.R. § 42.8(b) ....................................................................................... 1
`37 C.F.R. § 42.8(b)(1) ................................................................................... 1
`37 C.F.R. § 42.8(b)(2) ................................................................................... 1
`37 C.F.R. § 42.8(b)(3) ................................................................................... 1
`37 C.F.R. § 42.8(b)(4) ................................................................................... 2
`
`
`vi
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`LIST OF EXHIBITS
`
`Exhibit # Reference Name
`
`VRS-1001 U.S. Patent No. 7,252,004 (“the ’004”)
`
`VRS-1002 Prosecution History of the ’004 (“the Prosecution History”)
`
`VRS-1003 Declaration of Kevin J. Parker, Ph.D.
`
`VRS-1004 Curriculum Vitae of Dr. Parker
`
`VRS-1005 PCT Publication No. WO 00/55616 (Published in French, the
`Certified English Translation is provided) (“the ’616PCT”)
`
`VRS-1006 U.S. Patent No. 5,606,971 to Sarvazyan (“Sarvazyan’971”)
`
`VRS-1007
`
`Bohs, L. N., et al., Ensemble Tracking for 2D Vector Velocity
`Measurement: Experimental and Initial Clinical Results, IEEE
`Transactions on Ultrasonics, Ferroelectrics, and Frequency Control,
`vol. 45, no. 4, July 1998 (“Bohs”)
`
`VRS-1008
`
`Andreev, V. G. et al., “Remote generation of shear wave in soft
`tissue by pulsed radiation pressure,” J. Acoust. Soc. Am.
`102(5):3155 (November 1997) (“Andreev”)
`
`VRS-1009 U.S. Patent No. 6,102,865 to Hossack et al. (“Hossack”)
`
`VRS-1010 Reserved
`
`VRS-1011
`
`Thurston, R. N., Allan D. Pierce, and Emmanuel P. Papadakis.
`Ultrasonic Instruments and Devices I. Reference for Modern
`Instrumentation, Techniques, and Technology, San Diego, Calif:
`Academic Press, (1999), pp. 106-107.
`
`VRS-1012 U.S. Patent No. 5,810,731 to Sarvazyan et al., (“Sarvazyan’731”);
`
`vii
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`VRS-1013
`
`VRS-1014
`
`Sarvazyan, A., et al., “Shear Wave Elasticity Imaging: A New
`Ultrasonic Technology of Medical Diagnostics,” Ultrasound in Med.
`& Biol., V.24, No. 9 (1998), pp. 1419-1435 (“Sarvazyan Article”)
`
`Nightingale, K.R. et al., “Investigation of real-time remote palpation
`imaging,” Proc. SPIE 4325, Medical Imaging 2001: Ultrasonic
`Imaging and Signal Processing (May 30, 2001) (“Nightingale”)
`
`VRS-1015 Reserved
`
`VRS-1016
`
`Sandrin, Laurent, et al. “Time-resolved pulsed elastography with
`ultrafast ultrasonic imaging.” Ultrasonic Imaging 21.4 (1999): 259-
`272 (“Sandrin”)
`
`VRS-1017 U.S. Patent No. 6,875,176 to Mourad et al. (“Mourad”)
`
`VRS-1019
`
`VRS-1018 Kremkau, Frederick W., Diagnostic Ultrasound: Principles and
`Instruments, 5th Ed. (1998): 60
`Thomas, J-L., and Mathias A. Fink, “Ultrasonic beam focusing
`through tissue inhomogeneities with a time reversal mirror:
`application to transskull therapy.” IEEE Transactions on
`Ultrasonics, Ferroelectrics, and Frequency Control 43.6 (1996):
`1122-1129 (“Thomas”).
`VRS-1020 MPEP guidelines issued in view of KSR, 72 Fed. Reg. 57526
`(October 10, 2007)
`
`
`
`viii
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`Verasonics, Inc. (“Petitioner”) respectfully requests inter partes review
`
`(“IPR”) of claims 1-3, 5-7, and 13 of U.S. Patent No. 7,252,004 (“the ’004”).
`
`Petitioner asserts that it is more likely than not that at least one of claims 1-3, 5-7,
`
`and 13 (“the Challenged Claims”) is unpatentable on the grounds set forth herein.
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(b)
`A. Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)
`Petitioner, Verasonics, Inc., is the real party-in-interest.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`The ’004 Patent is the subject of a civil action in Verasonics, Inc. v.
`
`Supersonic Imagine, S.A., Case No. 2:17-cv-01764 pending in the U.S. District
`
`Court for the Western District of Washington (“the Litigation”).
`
`C. Lead and Backup Counsel Under 37 C.F.R. § 42.8(b)(3)
`Verasonics provides the following designation of counsel:
`
`Lead Counsel
`
`Backup Counsel
`
`E. Russell Tarleton
`USPTO Reg. No. 31,800
`SEED INTELLECTUAL PROPERTY
`LAW GROUP LLP
`701 Fifth Avenue, Suite 5400
`Seattle, Washington 98104
`Tel.: 206-622-4900
`RussT@seedip.com
`
`
`Thomas A. Shewmake
`USPTO Reg. No. 69,510
`SEED INTELLECTUAL PROPERTY
`LAW GROUP LLP
`701 Fifth Avenue, Suite 5400
`Seattle, Washington 98104
`Tel.: 206-622-4900
`TomShewmake@seedip.com
`
`1
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`
`
`
`
`
`
`Eric S. Walters
`USPTO Reg. No. 45,422
`WALTERS WILSON LLP
`702 Marshall St., Suite 611
`Redwood City, California 94063
`Tel.: 650-817-5625
`Eric@walterswilson.com
`
`Erica D. Wilson
`USPTO Reg. No. 42,230
`WALTERS WILSON LLP
`702 Marshall St., Suite 611
`Redwood City, California 94063
`Tel.: 650-248-4586
`EricaWilson@walterswilson.com
`
`
`D.
`Service Information Under 37 C.F.R. § 42.8(b)(4)
`Please address all correspondence and service to the address listed above.
`
`Petitioner consents to electronic service by email at RussT@seedip.com,
`
`TomShewmake@seedip.com, Eric@walterswilson.com,
`
`EricaWilson@walterswilson.com, and LitStaff@seedip.com.
`
`
`
`II. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner certifies that the ’004 is available for IPR. The ’004 issued
`
`August 7, 2007, and this Petition is being filed within one year of service of a
`
`counterclaim against Petitioner for infringement of the ’004 in the Litigation.
`
`2
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`Petitioner certifies that it is not barred or estopped from requesting IPR of the
`
`Challenged Claims.
`
`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`Petitioner requests IPR of the Challenged Claims on the grounds listed
`
`below:
`
`Ground
`
`Claims Basis
`
`1A. ’616PCT - Sarvazyan’971
`
`1, 5, 13
`
`35 U.S.C. §103
`
`1B. ’616PCT - Sarvazyan’971 - Bohs
`
`2
`
`35 U.S.C. §103
`
`1C. ’616PCT - Sarvazyan’971 -Nightingale 3, 7
`
`35 U.S.C. §103
`
`1D. ’616PCT - Sarvazyan’971 - Andreev
`
`2. ’616PCT - Sarvazyan’971 - Hossack
`
`3. ’616PCT–Sarvazyan’971 - Mourad
`
`6
`
`2
`
`7
`
`35 U.S.C. §103
`
`35 U.S.C. §103
`
`35 U.S.C. §103
`
`
`
`The ’004 (VRS-1001) was filed March 2, 2005, as U.S. Patent Application
`
`Serial No. 10/526,407 claiming priority to PCT/FR03/02516, filed August 12,
`
`2003, which claims priority to French Application No. 0210838, filed September 2,
`
`2002.
`
`Sarvazyan’971 (VRS-1006), published March 4, 1997; Sarvazyan’731
`
`(VRS-1012), published September 22, 1998; Andreev (VRS-1008) published
`
`November 1997; Bohs (VRS-1007) published July 4, 1998; Hossack (VRS-1009)
`
`3
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`published August 15, 2000; Nightingale (VRS-1014) published May 30, 2001, and
`
`the ’616PCT (VRS-1005) published September 21, 2000. Each qualify as prior art
`
`under at least 35 U.S.C. §102(b) because they were published over one year before
`
`the earliest claimed priority date (September 2, 2002) of the ’004.
`
`Mourad (VRS-1017) filed November 28, 2001 is prior art under 35
`
`U.S.C.§102(e) because it is a U.S. Patent the application for which was filed prior
`
`to September 2, 2002. Prior art references cited herein or in the Parker Declaration
`
`(VRS-1003) but not applied to the claims are supplied to provide information
`
`regarding the state of the art as of September 2, 2002.
`
`III. OVERVIEW OF THE STATE OF THE ART AND THE ’004 PATENT
`A.
`State of the Art
`1.
`Ultrasound Imaging
`Decades before the ’004 it was well-known to POSITA that ultrasound
`
`imaging could be used in diagnosing a wide variety of disease states and
`
`conditions. VRS-1003, ¶44. In ultrasound imaging, high-frequency sound waves
`
`(ultrasound compression waves) are created by applying a voltage to a transducer
`
`(e.g., a piezoelectric crystal element). Multiple transducer elements (each of which
`
`can be independently controlled) are located in a device called a “transducer array”
`
`or “probe” or simply a “transducer” or “array.” VRS-1003, ¶¶31-35.
`
`4
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`a)
`Focused and Unfocused Ultrasound Waves
`It was well-known in the prior art that ultrasound compression waves
`
`emitted from a transducer array can take one of two forms: (1) focused on a point
`
`or region in front of the transducer array, or (2) unfocused. VRS 1003, ¶¶40-43.
`
`Because the transducer array elements are independently controlled,
`
`ultrasound compression waves can be “focused” by adjusting the timing in which a
`
`voltage is applied to each element in a group of elements, thus causing sound
`
`waves emitted from the elements to arrive simultaneously at a desired focal point
`
`or region in the tissue. As shown below, by adding appropriate delays, despite
`
`having different path lengths to the focal point/region, the ultrasound waves
`
`emitted by each element arrive at the focal point/region at the same time. The
`
`ultrasound waves from each element add to one another to create a narrow, intense
`
`beam that is focused on the focal point/region. VRS-1003, ¶¶40-42.
`
`Focused Ultrasound Waves
`
`
`
`5
`
`
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`Focal Region
`
`
`
`A common “unfocused ultrasound compression wave” is one in which all
`
`transducer elements in the group emit ultrasound waves simultaneously, thus
`
`“illuminating” the entire field of observation. VRS-1003, ¶43.Ultrasound waves
`
`emitted into the body encounter changes in tissue structure, boundaries between
`
`different tissues, and reflecting particles known as “speckle.” At these places, a
`
`small portion of the wave (an “echo”) reflects back toward the transducer array.
`
`The array elements convert echoes into electrical signals that are used to construct
`
`an image of the medium. This imaging technique is known as ultrasonic “pulse-
`
`echo imaging.” VRS-1003, ¶¶36-39.
`
`2.
`Shear Wave Elastography
`It was well-known in the prior art that certain types of diseased tissue (e.g.,
`
`certain cancerous tissues or liver cirrhosis) are typically harder than healthy tissue.
`
`VRS-1003, ¶¶44-45. Long before September 2, 2002, ultrasound techniques
`
`known as “elastography” were used to study tissue hardness or elasticity – i.e., the
`
`ability of tissue to yield to an applied force and resume its original shape after
`
`6
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`removal of the force or to resist deformation in response to an applied force – and
`
`thus identify diseased tissue. VRS-1003, ¶48. “Shear wave elastography” was a
`
`well-known prior art technique for assessing tissue elasticity in order to detect
`
`disease. Id., ¶¶47-62.
`
`“Shear waves” are mechanical waves that travel through a medium in a
`
`direction that is transverse to an applied force. VRS-1003, ¶46. It was well-known
`
`that shear waves travel faster through hard tissues than soft ones; therefore
`
`determination of shear wave speeds could show pathologies in tissues. VRS-1003,
`
`¶50. As of September 2, 2002, there were two primary ways of generating shear
`
`waves in tissue using sound: (1) a vibrator source; and (2) acoustic radiation force
`
`from a focused ultrasound wave. VRS-1003, ¶51. The prior art taught that as
`
`shear waves propagate through tissue, they produce movements in the medium that
`
`can be tracked using ultrasound compression waves in pulse-echo imaging
`
`techniques. VRS-1003, ¶¶51-62.
`
`B.
`The ’004 Patent
`The ’004 is generally directed to ultrasound imaging methods and apparatus
`
`“using shear waves for observing a diffusing viscoelastic medium [e.g., a human
`
`body] containing particles that reflect ultrasound compression waves.” VRS-1001,
`
`1:11-14; VRS-1003, ¶63. The methods of the ’004 include three primary steps
`
`(VRS-1003, ¶64):
`
`7
`
`

`

`Petition for IPR of U.S. Patent No. 7,252,004
`
`(a) Excitation: “an elastic shear wave is generated in the viscoelastic
`
`medium”. VRS-1001, 1:15-16, 10:15-16 (claim 1 step a); VRS-1003, ¶65.
`
`(b) Observation: “the propagation of the shear wave is observed
`
`simultaneously at a multitude of points in an observation field in the viscoelastic
`
`medium”. “Observation” comprises two “substeps”:
`
`(b1) Transmitting unfocused ultrasound compression wave shots:
`
`“causing an array of transducers that are controlled independently of one another to
`
`emit into the viscoelastic medium a succession of unfocused ultrasound
`
`compression wave shots at a rate of at least 500 shots per second”; and
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`(b2) Detecting and recording echoes from “reflecting particles”:
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`“sound signals received from the viscoelastic medium [are] detected and recorded
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`in real time, said sound signals comprising the echoes generated by the unfocused
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`ultrasound compression wave interacting with the reflecting particles in said
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`viscoelastic medium.” VRS-1001, 1:17-31, 10:17-32 (claim 1 steps b, b1 and b2).
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`See also VRS-1003, ¶¶66-71.
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`(c) Processing. “Processing” comprises two substeps:
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`(c1) Determining shear wave propagation images: “the sound
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`signals received successively from the viscoelastic medium during substep b2) are
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`processed in order to determine successive propagation images of the shear wave;
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`and”
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`Petition for IPR of U.S. Patent No. 7,252,004
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`(c2) Determining movement parameters: “at least one movement
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`parameter of the viscoelastic medium is determined at different points of the
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`observation field.” VRS-1001, 1:38-40, 10:33-40 (claim 1 steps c, c1 and c2);
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`VRS-1003, ¶¶72-75.
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`The ’004 admits that these steps – and their substeps – are known in the
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`prior art. The “Background of the Disclosure states that the “invention relates to” a
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`method comprising the foregoing steps and “[d]ocument WO-A-00/55616 [VRS-
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`1005] describes an example of such a method.” Id., 1:12-40, 49-51; VRS-1003,
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`¶76. The ’616PCT (which has overlapping inventors with the ’004) exemplifies a
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`nearly identical imaging apparatus to that in the ’004. Compare VRS-1001, 4:53-
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`55 with VRS-1005 at 8 (each discussing Figure 1):
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`FIG. 1 of ’004 Patent
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`
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`FIG. 1 of prior art ’616PCT
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`Petition for IPR of U.S. Patent No. 7,252,004
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`C. The Alleged Advance of the ’004 – Shear Wave Generation Using
`Focused Ultrasound Waves – Was Well-Known in the Prior Art
`The ’004 characterizes the alleged advance over the prior art as using the
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`same transducer array to: (1) generate shear waves by emitting a focused
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`ultrasound wave into the medium; and (2) observe propagation of the shear wave
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`using the pulse-echo imaging technique disclosed in the ’616PCT involving
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`emission of unfocused ultrasound compression waves into the medium, with the
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`focusing and timing of the focused and unfocused waves adapted “so that at least
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`some of said unfocused ultrasound waves penetrate into the observation field while
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`the shear wave is propagating in the observation field.” VRS-1001, 2:5-14; see
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`also id., 2:15-25; VRS-1003, ¶77.
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`The ’616PCT also taught embodiments where the same ultrasound probe
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`both generates shear waves and emits unfocused ultrasound compression wave
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`shots in the Observation step. See, e.g., VRS-1005 at 4-5:
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`In the preferred embodiments of the method according to the
`invention,
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`. . .
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`-bursts of ultrasonic compression waves are transmitted and the
`echoes that are generated by the reflecting particles of the viscoelastic
`medium are detected by means of an array of transducers . . . the
`shearing wave being applied to the viscoelastic medium by applying
`a pulsed displacement on said array of transducers.
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`Petition for IPR of U.S. Patent No. 7,252,004
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`(Emphasis added.)
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`Figure 2 of the ’616PCT depicts an arrangement in which the probe 6 (which
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`is a transducer array (see VRS-1005 at 10)) “is carried by the speaker or vibrator
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`2,” and “it is the probe that then generates the shearing wave.” VRS-1005 at 14.
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`
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`Thus, the sole difference between the ’616PCT and the ’004 is that the
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`
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`’616PCT does not disclose generating shear waves by emitting focused ultrasound
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`waves from the transducer array. VRS-1003, ¶¶90-101, 122.
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`1.
`
`The Prior Art Discloses the ’004’s Shear Wave Generation
`Method
`Generating shear waves in a viscoelastic medium with the acoustic radiation
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`force of a focused ultrasound wave emitted from a transducer array was well-
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`known in the prior art, as was using the same transducer array to both generate
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`shear waves and remotely detect them in tissue. VRS-1003, ¶¶102-111. Long
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`before the ’004’s earliest claimed priority date, Sarvazyan’971 disclosed shear
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`wave elasticity imaging (“SWEI”), the “core” of which was “shear wave
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`generation by radiation force of focused energy such as ultrasound from an
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`ultrasound transducer.” VRS-1006, 2:30-37; VRS-1003, ¶102. Sarvazyan’971
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`taught using “an ultrasonic phased array” to generate the shear wave (VRS-1006,
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`Petition for IPR of U.S. Patent No. 7,252,004
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`3:54-55), which persons of ordinary skill in the art at the time of the alleged
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`invention (“POSITA”) would know can emit both focused and unfocused
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`ultrasound compression waves. VRS-1003, ¶102-103.
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`Sarvazyan’971 taught “[t]hese remotely induced [shear] waves are detected
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`and the tissue viscoelastic properties evaluated from the measured propagation
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`speed and attenuation of the shear waves.” VRS-1006, 2:37-40; VRS-1003, ¶104.
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`Sarvazyan’971 taught that the shear wave could be “detected remotely using [an]
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`ultrasonic pulse-echo imaging technique” (VRS-1006, 5:18-24), and “[s]ince the
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`excitation and interrogation ultrasonic waves [i.e., ultrasound compression waves
`
`used to image the medium] are of the same frequency range, the ‘the same . . .
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`array can be used for both functions: to induce shear wave and to measure its
`
`propagation properties.’” VRS-1006, 5:26-30 (emphasis added); VRS-1003, ¶¶
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`105-113.
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`Sarvazyan’971 further taught that “[t]he functioning of shear wave
`
`generation source 102 and the detection system 106 need to be coordinated in
`
`time.” VRS-1006, 5:49-52; VRS-1003, ¶111.
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`2.
`
`The Prior Art Taught the Advantages of Using Focused
`Ultrasound to Generate Shear Waves
`The ’004’s alleged advantages over the prior art center on the use of focused
`
`ultrasound from a transducer array to generate shear waves. For example, the ’004
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`Petition for IPR of U.S. Patent No. 7,252,004
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`cites as advantages: (a) the method is “easy to implement for a user using
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`apparatus that is relatively simple and lightweight” and “low cost,” (VRS-1001,
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`2:27-29), and (b) shear waves can be generated and observed through liquid zones
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`or bone barriers that mask the observation field, “since it is possible to focus
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`ultrasound waves through such barriers . . .” VRS-1001, 2:60-64; VRS-1003,
`
`¶129.
`
`These advantages, however, were known to POSITA years earlier. For
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`example, Sarvazyan’971 stated a “significant advantage” of using focused
`
`ultrasound to generate shear waves was that “little additional equipment is needed
`
`to generate shear strain in the tissue.” VRS-1006, 3:6-8; VRS-1003, ¶134.
`
`Sarvazyan’971 also stated: “An additional important feature of SWEI is that the
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`parameters of the modulated ultrasonic pulse needed to induce shear waves in the
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`tissue are such that any conventional ultrasonic imaging system potentially can be
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`transformed into an elasticity imaging device without significant changes in its
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`hardware.” VRS-1006, 3:8-14; VRS-1003, ¶134.
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`Sarvazyan’731 taught: “SWEI can be used for assessment of brain tissue.
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`Preferably, a SWEI device transmits a pulse through the temporal bone of an intact
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`skull to generate a shear wave in the brain tissue.” VRS-1012, 4:13-16; VRS-
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`1003, ¶136.
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`Petition for IPR of U.S. Patent No. 7,252,004
`
`D. The ’004 Patent Prosecution History
`During prosecution, Applicant relied on the ’004’s use of the same
`
`ultrasound transducer array to both generate the shear wave and image the medium
`
`to argue in favor of patentability. On September 25, 2006, in the sole Office
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`Action in the case, the Examiner rejected claims 1, 5-7 and 9-13 of the ’004 under
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`35 U.S.C. § 103(a) as unpatentable over U.S. Patent 6,770,033 (“Fink”) in view of
`
`the Sarvazyan Article (VRS-1013). See VRS-1002 at p.32 (Paper No. 20060925,
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`p.2.) The Examiner found Fink disclosed all the elements of claims 1 and 13
`
`except use of the same ultrasound transducer array to generate a shear wave and
`
`subsequently image the medium.
`
`The Examiner found the Sarvazyan Article disclosed the use of a focused
`
`transducer to generate shear waves and “showed various possibilities of detection
`
`of a remotely induced shear waves,” thus rendering claims 1 and 13 obvious. Id. at
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`2-4 and 6. The Examiner found Fink disclosed the additional elements of
`
`dependent claims 5-7 and 11-12 but concluded claims 2-4 and 8 would be
`
`allowable if rewritten in independent form. Id. at 4-6.
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`On February 26, 2007, Applicant responded to the office action, arguing:
`
`[N]either Fink nor Sarvazyan [Article] disclose an array of
`transducers that generate elastic shear waves and that generate
`ultrasound compression wave shots. Consequently there can be no
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`Petition for IPR of U.S. Patent No. 7,252,004
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`prima facie case of obviousness based on the cited combination,
`because the cited combination lacks at least one claim limitation.
`
`Further, no suggestion can be found in either reference to make the
`modification needed to reach the invention of claim 1. Accordingly,
`claim 1 is allowable for at least this reason.
`
`VRS-1002 at p.22 (Paper No. 20070226, Response to Office Action and
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`Amendment at 7).
`
`The