Case3:12-cv-05501-SI Document56 Filed05/03/13 Page1 of 5
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`
`
`EDWARD R. REINES (Bar No. 135960)
`edward.reines@weil.com
`DEREK C. WALTER (Bar No. 246322)
`derek.walter@weil.com
`MICHELE A. GAUGER (Bar No. 281769)
`michele.gauger@weil.com
`AARON Y. HUANG (Bar No. 261903)
`aaron.huang@weil.com
`WEIL, GOTSHAL & MANGES LLP
`Silicon Valley Office
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Telephone: (650) 802-3000
`Facsimile: (650) 802-3100
`
`Attorneys for Plaintiffs
`VERINATA HEALTH, INC.
`and
`THE BOARD OF TRUSTEES OF THE
`LELAND STANFORD JUNIOR
`UNIVERSITY
`
`DAVID I. GINDLER (Bar No. 117824)
`dgindler@irell.com
`ANDREI IANCU (Bar No. 184973)
`aiancu@irell.com
`AMIR A. NAINI (Bar No. 226627)
`anaini@irell.com
`IRELL & MANELLA LLP
`1800 Avenue of the Stars
`Suite 900
`Los Angeles, CA 90067
`Telephone: (310) 277-1010
`Facsimile: (310) 203-7199
`
`Attorneys for Defendants
`ARIOSA DIAGNOSTICS, INC.
`and
`LABORATORY CORPORATION OF
`AMERICA HOLDINGS
`
`UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`SAN FRANCISCO DIVISION
`
`
`
`
`Case No. 3:12-cv-05501-SI
`
`JOINT CLAIM CONSTRUCTION
`AND PREHEARING STATEMENT
`
`Claim Construction Hearing:
`Date: August 7-9, 2013
`Time: 3:30 PM
`Judge: Hon. Susan Illston
`
`
`VERINATA HEALTH, INC., and THE BOARD
`OF TRUSTEES OF THE LELAND
`STANFORD JUNIOR UNIVERSITY,
`
`Plaintiffs,
`
`v.
`
`ARIOSA DIAGNOSTICS, INC.,
`
`Defendants/Counterclaim-
`Plaintiffs,
`
`and
`
`LABORATORY CORPORATION OF
`AMERICA HOLDINGS,
`
`Defendants/Counterclaim-
`Plaintiffs,
`
`v.
`
`VERINATA HEALTH, INC. and THE
`BOARD OF TRUSTEES OF THE LELAND
`STANFORD JUNIOR UNIVERSITY,
`
`Counterclaim-Defendants.
`
`
`JOINT CLAIM CONSTRUCTION STATEMENT
`
`
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`Case3:12-cv-05501-SI Document56 Filed05/03/13 Page2 of 5
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`Pursuant to Northern District of California Patent Local Rule 4-3, Verinata Health, Inc.
`
`(“Verinata”), The Board of Trustees of the Leland Stanford Junior University (“Stanford”),
`
`Ariosa Diagnostics, Inc. (“Ariosa”) and Laboratory Corporation of America Holdings
`
`(“LabCorp”) jointly submit this Joint Claim Construction and Prehearing Statement.
`
`I.
`
`PROPOSED CLAIM CONSTRUCTIONS AND SUPPORTING EVIDENCE
`
`Pursuant to Patent Local Rule 4-2(c), the parties have met and conferred regarding the
`
`submission of this Joint Claim Construction and Prehearing Statement. The proposed
`
`constructions and supporting evidence for U.S. Pat. Nos. 8,296,076 (“the ’076 patent”) and
`
`8,318,430 (“the ’430 patent”), including agreed constructions are identified in Exhibits A and B
`
`hereto, respectively.
`
`A.
`
`Construction of Terms on Which the Parties Agree
`
`Pursuant to Patent Local Rule 4-3(a), the parties identify the following terms and
`
`corresponding constructions on which the parties agree:
`1.
`
`’076 patent: “sequence tags”
`
`B.
`
`Proposed Constructions of Disputed Terms
`
`Pursuant to Patent Local Rule 4-3 (b), the parties attach Exhibits A and B which set forth
`
`each party’s proposed construction of each disputed term and identify any intrinsic and/or
`
`extrinsic evidence known to each party, respectively, on which the party intends to rely.
`
`C.
`
`Identification of Significant Terms
`
`Pursuant to Patent Local Rule 4-3(c), the parties (jointly or separately) identify the
`
`following terms as most significant to resolution of the case:
`
`Terms agreed as being most significant:
`
`
`’076 patent:
`• “sequencing predefined subsequences of the maternal and fetal DNA” / “sequencing
`
`predefined subsequences”
`
`
`’430 patent:
`• “selectively enriching a plurality of non-random polynucleotide sequences of each
`
`
`JOINT CLAIM CONSTRUCTION STATEMENT
`
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`

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`Case3:12-cv-05501-SI Document56 Filed05/03/13 Page3 of 5
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`
`
`fetal and maternal cell-free genomic DNA sample”/ “selective enriching” /
`
`
`
`Terms identified by Ariosa and LabCorp as being most significant:
`
`’076 patent:
`• “first chromosome suspected of having an abnormal distribution”
`• “second chromosome presumed to be normally distributed”
`
`
`’430 patent:
`• “fetal and maternal cell-free genomic DNA”
`•
`
` “non-random polynucleotide sequences of each fetal and maternal cell-free
`
`genomic DNA sample”
`• “generate a library derived from”
`• “reference chromosome”
`• “sequence reads corresponding to”
`• “chromosome control region”
`
`II.
`
`ANTICIPATED LENGTH OF TIME NECESSARY FOR CLAIM CONSTRUCTION
`HEARING
`
`The Court has scheduled a consolidated patent technology tutorial for all of the related
`
`cases for 3:30 PM on July 31, 2013, which is estimated to last 2-3 hours. A claim construction
`
`hearing of about 2-3 hours in this case will be held at 3:30 PM on one of the three days (August
`
`6-8, 2013) designated by the Court for claim construction hearings in the related cases. See Dkt.
`
`No. 48.
`
`III. THE PARTIES DO NOT ANTICIPATE LIVE TESTIMONY AT THE CLAIM
`CONSTRUCTION HEARING
`
`As stated in the Joint Case Management Statement, the parties do not anticipate the need
`
`for any live testimony at the claim construction hearing. With regard to expert testimony, the
`
`parties have agreed to exchange expert declarations concerning the construction of disputed terms
`
`on May 3, 2013, in connection with the instant Patent Local Rule disclosure. See, e.g., Dkt.
`
`No. 30 at 20-21.
`
`
`JOINT CLAIM CONSTRUCTION STATEMENT
`
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`Case3:12-cv-05501-SI Document56 Filed05/03/13 Page4 of 5
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`
`
`Dated: May 3, 2013
`
`WEIL, GOTSHAL & MANGES LLP
`
`Respectfully submitted,
`
`By:
`
`/s/ Derek C. Walter
`Derek C. Walter
`Attorneys for Plaintiffs
`Verinata Health, Inc. and The Board
`of Trustees of the Leland Stanford
`Junior University
`
`
`
`Dated: May 3, 2013
`
`IRELL & MANELLA LLP
`
`By:
`
`/s/ Amir Naini
`Amir Naini
`Attorneys for Defendants Ariosa
`Diagnostics, Inc. and Laboratory
`Corporation of America Holdings
`
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`JOINT CLAIM CONSTRUCTION STATEMENT
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`Case No. 3:12-cv-05501-SI
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`Ariosa Exhibit 1009, p. 4
`
`

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`Case3:12-cv-05501-SI Document56 Filed05/03/13 Page5 of 5
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`
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`CERTIFICATION
`
`I, Derek C. Walter, am the ECF User whose identification and password are being used to
`
`file this Stipulation. In compliance with General Order 45.X.B, I hereby attest that Amir Naini
`
`has concurred in this filing.
`
`Dated: May 3, 2013
`
`
`
`
`
`
`WEIL GOTSHAL & MANGES LLP
`
`
`By: _/s/ Derek C. Walter
`Derek C. Walter
`
`
`
`
`
`JOINT CLAIM CONSTRUCTION STATEMENT
`
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`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page1 of 16
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`
`
`Exhibit A
`
`U.S. Patent No. 8,296,076 (the ’076 Patent)
`
`Agreed Constructions
`
`
`Claim Term, Phrase, or Clause
`“sequence tags”
`
`Agreed Construction
`“relatively short nucleic acid sequences that can be used to identify certain larger sequences”
`
`
`Terms for Constructions
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`Intrinsic Evidence:
`• See, e.g., Claims 1-15
`• See, e.g., Abstract, Cols.
`2:9-30, 3:31-5:33, 6:33-
`52, 7:27-8:8, 8:53-9:13,
`13:3- 14:54, 17:6-39,
`20:30-39, 22:31-23:58
`• See, e.g., Figs. 4, 9
`
`Extrinsic Evidence:
`
` •
`
` American Heritage
`
`See Intrinsic/Extrinsic Evidence
`for the claim term “sequencing
`predefined subsequences of the
`maternal and fetal DNA.”
`
`“determining the order of
`nucleotides to selectively
`capture sample molecules
`containing sequences
`selected a priori”
`
`
`
`Claim Term,
`Phrase, or
`Clause
`
`“sequencing
`predefined
`subsequences”
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and
`Stanford propose
`that the Court
`construe the term
`“sequencing
`predefined
`subsequences of
`the maternal and
`fetal DNA.”
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 1 -
`
`
`
`Ariosa Exhibit 1009, p. 6
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page2 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`Dictionary 1588 (4th ed.
`2006), AD-VER-
`00002019 at
`“sequencing”
`• Stedman’s Medical
`Dictionary 1536 (28th
`Ed. 2006) at
`“polymorphism”
`• Expert testimony
`•
`Inventor testimony
`• Prosecution counsel
`testimony
`
`
`Ariosa and LabCorp reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms,
`and supporting evidence as
`their investigation continues
`and additional discovery is
`provided. Ariosa and
`LabCorp further reserve the
`right to rely on any evidence
`cited by Verinata or
`Stanford.
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 2 -
`
`
`
`Ariosa Exhibit 1009, p. 7
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page3 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`“sequencing
`predefined
`subsequences of
`the maternal and
`fetal DNA”
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`“sequencing
`predetermined
`polymorphism
`independent
`subsequences of
`pregnant human
`female and fetal
`chromosomes”
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`
`
`Ariosa and LabCorp
`propose that the Court
`construe the term
`“sequencing predefined
`subsequences” (see entry
`above).
`
`Intrinsic Evidence:
`
`’076 Patent
`• See, e.g.,Claim 1-15.
`• See, e.g., Figs 2, 5, 7.
`• See, e.g., Cols. 2:4-17; 3:44-
`52; 3:58-66; 4:19-25; 9:17-
`21; 10:62-65; 12:38-50;
`13:65-67; 14:25-26; 18:4-55;
`20:36-39; 22:47-51.
`
`
`Extrinsic Evidence:
`• Lo et al. (2007), “Plasma
`placental RNA allelic ratio
`permits noninvasive prenatal
`noninvasive prenatal
`chromosomal aneuploidy
`detection,” Nat Med, 13:218-
`223.
`• Tong Y K, et al. (2006),
`“Noninvasive prenatal
`detection of fetal trisomy 18
`by epigenetic allelic ratio
`analysis in maternal plasma:
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 3 -
`
`
`
`Ariosa Exhibit 1009, p. 8
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page4 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`Theoretical and empirical
`considerations,” Clin. Chem.,
`52:2194-2202 (AD-VER-
`00000559-567).
`• Dhallan et al. (2007), “A
`non-invasive test for prenatal
`diagnosis based on fetal
`DNA present in maternal
`blood: a preliminary study,”
`Lancet, 369: 474-481 (AD-
`VER-00000022-29).
`• Fan H.C. & Quake S. R.
`(2007), “Detection of
`aneuploidy with digital
`polymerase chain reaction,”
`Anal. Chem., 79:7576-7579
`(AD-VER-00000205-208).
`• Fan et. al (2008),
`“Noninvasive diagnosis of
`fetal aneuploidy by shotgun
`sequencing DNA from
`maternal blood,” Proc. Natl.
`Acad. Sci. USA
`105(42):16266-71 (AD-
`VER-00000030-35).
`• Lo et al. (2007), “Digital
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 4 -
`
`
`
`Ariosa Exhibit 1009, p. 9
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page5 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`PCR for the molecular
`detection of fetal
`chromosomal aneuploidy,”
`Proc Natl Acad Sci USA,
`104: 13116-13121 (AD-
`VER-00000064-69).
`• Chiu et al. (2009), “Non-
`invasive Prenatal Diagnosis
`by Single Molecule Counting
`Technologies,” Trends
`Genet. 25(7):324-31 (AD-
`VER-00000108-115).
`• Sachidanandam et al., (2001)
`“A map of human genome
`sequence variation
`containing 1.42 million
`single nucleotide
`polymorphisms,” Nature
`409:928-33
`(VRNTAA00005222-227).
`• Lo D. (2008), “Noninvasive
`prenatal detection of fetal
`chromosomal aneuploidies
`by maternal plasma nucleic
`acid analysis: a review of the
`current state of the art,” Intl.
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 5 -
`
`
`
`Ariosa Exhibit 1009, p. 10
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page6 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`J. Obstetrics and Gynecology
`116:152-57 (AD-VER-
`00000427-432).
`• Stephen Quake, (2012)
`“Sizing up Cell-free DNA,”
`Clinical Chemistry 58:(3):1-
`2 (VRNTAA00007599-
`7600).
`• Ashoor et al. (2012),
`“Chromosome-selective
`sequencing of maternal
`plasma cell-free DNA for
`first trimester detection of
`trisomy 21 and trisomy 18,”
`Am J Obstet Gynecol.
`322:e1-5 (AD-VER-
`00001947-51).
`• Sparks et al. (2012),
`“Selective analysis of cell-
`free DNA in maternal blood
`for evaluation of fetal
`trisomy,” Prenatal
`Diagnosis 32:3-9
`(VRNTAA00005262-68).
`• Sparks et al. (2012),
`“Noninvasive prenatal
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 6 -
`
`
`
`Ariosa Exhibit 1009, p. 11
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page7 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`detection and selective
`analysis of cell-free DNA
`obtained from maternal
`blood: evaluation for
`trisomy 21 and trisomy 18,”
`Am. J. Obstet. Gynecol.
`206:319.e1-9 (AD-VER-
`00002007-9).
`• U.S. Patent No. 7,888,017,
`issued Feb. 16, 2011, Filed
`Feb. 2, 2007, Quake & Fan
`(AD-VER-00001202-1226).
`• U.S. Patent No. 8,008,018,
`issued Aug. 30, 2011, filed
`Feb. 26, 2009, Quake & Fan.
`• U.S. Patent No. 7,332,277,
`issued Feb. 19, 2008, filed
`July 15, 2004, Dhallan (AD-
`VER-00000883-1162).
`• U.S. Patent Publication No.
`2008/0090239, published
`April 17, 2008, Shoemaker,
`et al (AD-VER-00001438-
`1520).
`• Expert Testimony and
`Opinion from Dr. George M.
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 7 -
`
`
`
`Ariosa Exhibit 1009, p. 12
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page8 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`Weinstock.
`
`
`Verinata and Stanford reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms, and
`supporting evidence as their
`investigation continues. In
`particular, Verinata and Stanford
`reserve the right to supplement
`or modify their proposed
`constructions and supporting
`evidence in view of additional
`discovery from Ariosa and/or
`LabCorp regarding the scope of
`their claim constructions and
`infringement theories. Verinata
`and Stanford further reserve the
`right to rely on any evidence
`cited by Ariosa and/or LabCorp
`in support of their proposed
`constructions.
`
`Intrinsic Evidence:
`
`“maternal”
`
`“pregnant human
`female”
`
`“of the mother”
`
`Intrinsic Evidence:
`• See, e.g., Claims 1-15
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 8 -
`
`
`
`Ariosa Exhibit 1009, p. 13
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page9 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`• See, e.g.,, Abstract,
`Cols. 1:49-59, 2:4-17,
`3:31-6:32, 8:53-9:13,
`10:59-11:7, 12:5-62,
`13:41-52,18:5-45;
`19:15-36, 24:27-25:38
`
`Extrinsic Evidence:
`
` •
`
` Merriam Webster’s
`Collegiate Dictionary
`(10th ed. 2001) at
`“maternal.”
`• Expert testimony
`•
`Inventor testimony
`• Prosecution counsel
`testimony
`
`
`Ariosa and LabCorp reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms,
`and supporting evidence as
`their investigation continues
`and additional discovery is
`provided. Ariosa and
`
`
`
`’076 Patent
`• See, e.g., Claim 1-15.
`• See, e.g., Figs. 1A, 2, 5A.
`• See, e.g., Cols. 3:11-17; 3:49-
`54; 5:43-48; 6:53-57; 10:3-5;
`11:63-12:1; 12:51-56; 13:53-
`54; 14:40-42; 18:29-39; 19:1-
`5; 22:6-8.
`
`
`Extrinsic Evidence:
`
` •
`
` Ashoor et al. (2012),
`“Chromosome-selective
`sequencing of maternal
`plasma cell-free DNA for
`first trimester detection of
`trisomy 21 and trisomy 18,”
`Am J Obstet Gynecol.
`322:e1-5 (AD-VER-
`00001947-51).
`• Sparks et al. (2012),
`“Selective analysis of cell-
`free DNA in maternal blood
`for evaluation of fetal
`trisomy,” Prenatal Diagnosis
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 9 -
`
`Ariosa Exhibit 1009, p. 14
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page10 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`LabCorp further reserve the
`right to rely on any evidence
`cited by Verinata or
`Stanford.
`
`32:3-9 (VRNTAA00005262-
`68).
`• Sparks et al. (2012),
`“Noninvasive prenatal
`detection and selective
`analysis of cell-free DNA
`obtained from maternal
`blood: evaluation for trisomy
`21 and trisomy 18,” Am. J.
`Obstet. Gynecol. 206:319.e1-
`9 (AD-VER-00002007-9).
`• U.S. Patent Application No.
`13/0089863, filed Nov. 29,
`2012 (VRNTAA00007740-
`7757).
`• Expert Testimony and
`Opinion from Dr. George M.
`Weinstock.
`
`
`Verinata and Stanford reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms, and
`supporting evidence as their
`investigation continues. In
`particular, Verinata and Stanford
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 10 -
`
`
`
`Ariosa Exhibit 1009, p. 15
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page11 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`reserve the right to supplement
`or modify their proposed
`constructions and supporting
`evidence in view of additional
`discovery from Ariosa and/or
`LabCorp regarding the scope of
`their claim constructions and
`infringement theories. Verinata
`and Stanford further reserve the
`right to rely on any evidence
`cited by Ariosa and/or LabCorp
`in support of their proposed
`constructions.
`Intrinsic Evidence:
`
`’076 Patent
`
`See, e.g., Claim 1-15.
`See, e.g., Figs. 1A, 10, 13, 14.
`See, e.g., 3:31-5:62; 11:37-39;
`11:66-67; 13:53-63; 14:21-38;
`17:40-18:4; 22:31-23:58; 28:1-
`29:59.
`
`Extrinsic Evidence:
`
`No construction
`necessary.
`
`“first
`chromosome
`suspected of
`having an
`abnormal
`distribution”
`
`“first chromosome
`hypothesized prior to
`running the test to have an
`abnormal distribution”
`
`Intrinsic Evidence:
`• See, e.g., Claims 1-15
`• See, e.g., Cols. 3:31-
`5:62, 11:37-39, 11:66-
`67, 13:53-63, 14:34-38,
`17:40-18:4, 22:31-23:58
`
`Extrinsic Evidence:
`• The Concise Oxford
`English Dictionary 1404
`(9th Ed, 1995), AD-
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 11 -
`
`
`
`Ariosa Exhibit 1009, p. 16
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page12 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`• Ashoor et al. (2012),
`“Chromosome-selective
`sequencing of maternal
`plasma cell-free DNA for
`first trimester detection of
`trisomy 21 and trisomy 18,”
`Am J Obstet Gynecol.
`322:e1-5 (AD-VER-
`00001947-51).
`• Sparks et al. (2012),
`“Selective analysis of cell-
`free DNA in maternal blood
`for evaluation of fetal
`trisomy,” Prenatal Diagnosis
`32:3-9 (VRNTAA00005262-
`68).
`• Sparks et al. (2012),
`“Noninvasive prenatal
`detection and selective
`analysis of cell-free DNA
`obtained from maternal
`blood: evaluation for trisomy
`21 and trisomy 18,” Am. J.
`Obstet. Gynecol. 206:319.e1-
`9 (AD-VER-00002007-9).
`• U.S. Patent Application No.
`
`VER-00002022 at
`"suspect"
`• The Concise Oxford
`English Dictionary 670
`(9th Ed, 1995), AD-
`VER-00002025 at
`"hypothesis"
`• Expert testimony
`•
`Inventor testimony
`• Prosecution counsel
`testimony
`
`
`Ariosa and LabCorp reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms,
`and supporting evidence as
`their investigation continues
`and additional discovery is
`provided. Ariosa and
`LabCorp further reserve the
`right to rely on any evidence
`cited by Verinata or
`Stanford.
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 12 -
`
`
`
`Ariosa Exhibit 1009, p. 17
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page13 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`13/0089863, filed Nov. 29,
`2012 (VRNTAA00007740-
`7757).
`• Micale et al. (2010), “Double
`trisomy revisited – a
`multicenter experience,”
`Prenat Diagn 30:173-176
`(VRNTAA00007595–7598).
`• Expert Testimony and
`Opinion from Dr. George M.
`Weinstock.
`
`
`Verinata and Stanford reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms, and
`supporting evidence as their
`investigation continues. In
`particular, Verinata and Stanford
`reserve the right to supplement
`or modify their proposed
`constructions and supporting
`evidence in view of additional
`discovery from Ariosa and/or
`LabCorp regarding the scope of
`their claim constructions and
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 13 -
`
`
`
`Ariosa Exhibit 1009, p. 18
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page14 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`No construction
`necessary.
`
`“second
`chromosome
`presumed to be
`normally
`distributed”
`
`infringement theories. Verinata
`and Stanford further reserve the
`right to rely on any evidence
`cited by Ariosa and/or LabCorp
`in support of their proposed
`constructions.
`Intrinsic Evidence:
`
`’076 Patent
`
`See, e.g., Claim 1-15.
`See, e.g., Figs. 1A, 10, 13, 14.
`See, e.g., 3:31-5:62; 11:37-39;
`11:66-67; 13:53-63; 14:21-38;
`17:40-18:4; 22:31-23:58; 28:1-
`29:59.
`
`Extrinsic Evidence:
`• Ashoor et al. (2012),
`“Chromosome-selective
`sequencing of maternal
`plasma cell-free DNA for
`first trimester detection of
`trisomy 21 and trisomy 18,”
`Am J Obstet Gynecol.
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 14 -
`
`“second chromosome
`different from the first
`chromosome that is
`assumed with confidence
`prior to performing the test
`to have a normal
`distribution”
`
`Intrinsic Evidence:
`• See, e.g., 1-15
`• See, e.g., Cols. 3:31-
`5:62, 11:37-39, 11:66-
`67, 14:33-38, 17:40-
`18:4, 22:31-23:58
`
`Extrinsic Evidence:
`• Merriam Webster’s
`Collegiate Dictionary
`921 (10th ed. 2001),
`AD-VER-00002028 at
`“presumed”
`• Expert testimony
`•
`Inventor testimony
`• Prosecution counsel
`testimony
`
`
`
`
`
`Ariosa Exhibit 1009, p. 19
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page15 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms,
`and supporting evidence as
`their investigation continues
`and additional discovery is
`provided. Ariosa and
`LabCorp further reserve the
`right to rely on any evidence
`cited by Verinata or
`Stanford.
`
`322:e1-5(AD-VER-
`00001947-51).
`• Sparks et al. (2012),
`“Selective analysis of cell-
`free DNA in maternal blood
`for evaluation of fetal
`trisomy,” Prenatal Diagnosis
`32:3-9 (VRNTAA00005262-
`68).
`• Sparks et al. (2012),
`“Noninvasive prenatal
`detection and selective
`analysis of cell-free DNA
`obtained from maternal
`blood: evaluation for trisomy
`21 and trisomy 18,” Am. J.
`Obstet. Gynecol. 206:319.e1-
`9 (AD-VER-00002007-9).
`• U.S. Patent Application No.
`13/0089863, filed Nov. 29,
`2012 (VRNTAA00007740-
`7757).
`• Micale et al. (2010), “Double
`trisomy revisited – a
`multicenter experience,”
`Prenat Diagn 30:173-176
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 15 -
`
`
`
`Ariosa Exhibit 1009, p. 20
`
`

`

`Case3:12-cv-05501-SI Document56-1 Filed05/03/13 Page16 of 16
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata and
`Stanford’s
`Proposed
`Construction
`
`Verinata and Stanford’s
`Proposed Intrinsic/Extrinsic
`Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`(VRNTAA00007595–7598).
`• Expert Testimony and
`Opinion from Dr. George M.
`Weinstock.
`
`
`Verinata and Stanford reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms, and
`supporting evidence as their
`investigation continues. In
`particular, Verinata and Stanford
`reserve the right to supplement
`or modify their proposed
`constructions and supporting
`evidence in view of additional
`discovery from Ariosa and/or
`LabCorp regarding the scope of
`their claim constructions and
`infringement theories. Verinata
`and Stanford further reserve the
`right to rely on any evidence
`cited by Ariosa and/or LabCorp
`in support of their proposed
`constructions.
`
`EXHIBIT A TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 16 -
`
`
`
`Ariosa Exhibit 1009, p. 21
`
`

`

`
`
`
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata’s
`Proposed
`Construction
`
`“fetal and
`maternal cell-
`free genomic
`DNA”
`
`No construction
`necessary.
`
`Case3:12-cv-05501-SI Document56-2 Filed05/03/13 Page1 of 29
`
`Exhibit B
`
`U.S. Patent No. 8,318,430 (the ’430 Patent)
`
`Terms for Constructions
`
`Verinata’s Proposed
`Intrinsic/Extrinsic Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`“DNA previously contained
`in chromosomes of the
`mother and the fetus that
`has been released from cells
`into the maternal
`circulation”
`
`Intrinsic Evidence:
`
`’430 Patent
`• See, e.g., Claim 1-30.
`• See, e.g., Cols. 1:23-2:36,
`3:18-48, 4:15-32, 5:47-6:53,
`7:49-57, 8:19-48, 9:48-10:6,
`10:27-47, 11:36-52, 14:32-
`55, 17:53-67
`
`Extrinsic Evidence:
`• Lo et al. (1999), “Increased
`Fetal DNA Concentrations in
`the Plasma of Pregnant
`Women Carrying Fetuses
`with Trisomy 21,” Clinical
`Chemistry 45(1):1747-51
`(AD-VER-00000385-9).
`• Stephen Quake, (2012)
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`Intrinsic Evidence:
`• See, e.g., 1-30
`• See, e.g., Cols. 1:23-
`2:36, 3:18-48, 4:15-32,
`5:47-6:53, 7:49-57,
`8:19-48, 9:48-10:6,
`10:27-47, 11:36-52,
`14:32-55, 17:53-67
`• See, e.g., Fig. 8A
`
`Extrinsic Evidence:
`• Dorland’s Medical
`Dictionary 764 (30th ed.
`2003), AD-VER-
`00002031 at “genome”
`• American Heritage
`Dictionary 734 (4th ed.
`2006), AD-VER-
`00002034 at “genome”
`
`EXHIBIT B TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 1 -
`
`
`
`Ariosa Exhibit 1009, p. 22
`
`

`

`
`
`Case3:12-cv-05501-SI Document56-2 Filed05/03/13 Page2 of 29
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata’s
`Proposed
`Construction
`
`Verinata’s Proposed
`Intrinsic/Extrinsic Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`“Sizing up Cell-free DNA,”
`Clinical Chemistry 58(3):1-2
`(VRNTAA00007599-7600).
`• Chiu et al.(2009), “Non-
`invasive prenatal diagnosis
`by single molecule counting
`technologies,” Trends in
`Genetics 25(7):324-331 (AD-
`VER-00000108-115).
`• Fan et al. (2008),
`“Noninvasive diagnosis of
`fetal aneuploidy by shotgun
`sequencing DNA from
`maternal blood,” Proc. Natl.
`Acad. Sci. USA
`105(42):16266-71 (AD-
`VER-00000030-35).
`• Ashoor et al. (2012),
`“Chromosome-selective
`sequencing of maternal
`plasma cell-free DNA for
`first trimester detection of
`trisomy 21 and trisomy 18,”
`Am J Obstet Gynecol.
`322:e1-5 (AD-VER-
`00001947-51).
`• Sparks et al. (2012),
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`• Lo, et al. (1997) Lancet
`350:485-87, AD-VER-
`00002035
`• Expert testimony
`•
`Inventor testimony
`• Prosecution counsel
`testimony
`
`
`Ariosa and LabCorp reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms,
`and supporting evidence as
`their investigation continues
`and additional discovery is
`provided. Ariosa and
`LabCorp further reserve the
`right to rely on any evidence
`cited by Verinata or
`Stanford.
`
`EXHIBIT B TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 2 -
`
`
`
`Ariosa Exhibit 1009, p. 23
`
`

`

`
`
`Case3:12-cv-05501-SI Document56-2 Filed05/03/13 Page3 of 29
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata’s
`Proposed
`Construction
`
`Verinata’s Proposed
`Intrinsic/Extrinsic Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`“Selective analysis of cell-
`free DNA in maternal blood
`for evaluation of fetal
`trisomy,” Prenatal Diagnosis
`32:3-9 (VRNTAA00005262-
`68).
`• Sparks et al. (2012),
`“Noninvasive prenatal
`detection and selective
`analysis of cell-free DNA
`obtained from maternal
`blood: evaluation for trisomy
`21 and trisomy 18,” Am. J.
`Obstet. Gynecol. 206:319.e1-
`9 (AD-VER-00002007-9).
`
`Ariosa website,
`http://www.ariosadx.com/about-
`the-science/what-is-cfDNA-
`testing/.
`
`Verinata and Stanford reserve
`the right to supplement or
`modify their proposed
`constructions, for all terms, and
`supporting evidence as their
`investigation continues. In
`
`EXHIBIT B TO JOINT CLAIM CONSTRUCTION STATEMENT
`CASE NO. 3:12-CV-05501-SI
`
`
`- 3 -
`
`
`
`Ariosa Exhibit 1009, p. 24
`
`

`

`
`
`Case3:12-cv-05501-SI Document56-2 Filed05/03/13 Page4 of 29
`
`Claim Term,
`Phrase, or
`Clause
`
`Verinata’s
`Proposed
`Construction
`
`Verinata’s Proposed
`Intrinsic/Extrinsic Evidence
`
`Ariosa and LabCorp’s
`Proposed Construction
`
`Ariosa and LabCorps’s
`Intrinsic/Extrinsic
`Evidence
`
`particular, Verinata and Stanford
`reserve the right to supplement
`or modify their proposed
`constructions and supporting
`evidence in view of additional
`discovery from Ariosa and/or
`LabCorp regarding the scope of
`their claim constructions and
`infringement theories. Verinata
`and Stanford further reserve the
`right to rely on any evidence
`cited by Ariosa and/or LabCorp
`in support of their proposed
`constructions.
`See Intrinsic/Extrinsic Evidence
`for the term “selectively
`enriching a plurality of non-
`random polynucleotide
`sequences of each fetal and
`maternal cell-free genomic DNA
`sample”
`
`“selectively
`enriching”
`
`Verinata pr