`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 1 of 13 PageID #: 29604
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`) )
`
`) )
`
`Plaintiff,
`
`) C.A. No. 20-038 (CFC) (CJB)
`)
`(CONSOLIDATED)
`
`) )
`
`)
`
`Defendant.
`
`JOINT VERDICT FORM (PHASE ID
`
`NATERA,INC.,
`
`V.
`
`CAREDX,INC.,
`
`Instructions: When answering the following questions and completing this Verdict
`Form,please follow the directions provided and follow the Jury Instructions that you
`have been given. Your answer to each question must be unanimous. Someof the
`questions contain legal terms that are defined and explainedin the Jury Instructions.
`Please refer to the Jury Instructions if you are unsure about the meaning or usage of
`any legal term that appears in the questions below.
`
`Asused herein:
`
`1. “Natera” refers to Plaintiff Natera, Inc.
`
`2. “CareDx”refers to Defendant CareDx,Inc.
`
`3. The “’544 Patent” refers to U.S. Patent No. 11,111,544.
`
`4. The “’180 Patent” refers to U.S. Patent No. 10,655,180.
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 2 of 13 PagelD #: 29605
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 2 of 13 PageID #: 29605
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`PHASE I - FINDINGS ON INFRINGEMENT
`
`QUESTION 1:
`
`Did Natera prove, by a preponderanceofthe evidence, that CareDxinfringed
`
`any of the following claims by using AlloSure in the United States?
`
`(“YES”is a finding in favor of Natera, and “NO” is a finding in favor
`
`of CareDx.)
`
`
`
`
`
`
`
`
`Continue to the next question.
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 3 of 13 PagelD #: 29606
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 3 of 13 PageID #: 29606
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`QUESTION2:
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`Did Natera prove, by a preponderanceof the evidence, that CareDx infringed
`
`any of the following claims by using AlloSeq in the United States?
`
`(“YES” is a finding in favor of Natera, and “NO”is a finding in favor
`
`of CareDx.)
`
`
`
`
`
`
`
`
`
`
`
`
`Continue to the next question.
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 4 of 13 PagelD #: 29607
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 4 of 13 PageID #: 29607
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`QUESTION3
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`Did CareDx proveby clear and convincing evidencethat the Asserted Claims
`
`of the ’544 patentare not entitled to a priority date of September 22, 2006?
`
`(“YES”is a finding in favor of CareDx, and “NO”is a finding in favor of
`
`Natera)
`
`Continue to the next question.
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 5 of 13 PagelD #: 29608
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 5 of 13 PageID #: 29608
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`QUESTION 4
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`Did CareDx prove, by clear and convincing evidence,
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`that any ofthe
`
`following claims of the Asserted Patents are invalid because they would have been
`
`obvious to a person of ordinary skill in the art?
`
`(“YES”is a finding in favor of CareDx, and “NO”is a finding in favor
`
`of Natera.)
`
`
`
`
`
`Continue to the next question.
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 6 of 13 PagelD #: 29609
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 6 of 13 PageID #: 29609
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`QUESTION5:
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`Did CareDx prove, by clear and convincing evidence, that any of the
`
`following claims are invalid for a lack of adequate written description?
`
`(“YES” is a finding in favor of CareDx, and “NO”is a finding in
`
`favor of Natera.)
`
`
`
`
`[544Patent,Claim21|
`
`
`
`544Patent,Claim26|
`
`a4Patent,Claim27||
`
`
`
`180Patent,Claim1d|
`
`
`[180Patent,Claim15|
`
`Continue to the next question.
`
`
`
`_ Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 7 of 13 PagelD #: 29610
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 7 of 13 PageID #: 29610
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`QUESTION6:
`
`Did CareDx prove, by clear and convincing evidence, that the individual
`
`limitations of the following claims were well-understood, routine, and conventional,
`
`as of September 22, 2006?
`
`(“YES”is a finding in favor of CareDx, “NO”is a finding in favor of
`
`Natera.)
`
`°544 Patent,
`21[b]
`
`loci.
`
`°544 Patent, Claim|A method for preparing a preparation
`21 [Preamble]
`of amplified DNA derived from a
`biological
`sample
`of
`a_
`second
`individual
`useful
`for determining
`genetic data for DNA froma first
`individual
`in the biological sample,
`the method comprising:
`°544 Patent, Claim|extracting cell-free DNA from the
`21[a]
`biological sample;*
`this
`that
`*The parties do not dispute
`limitation was well-understood, routine, and
`conventional, as of September 22, 2006.
`preparing a preparation of amplified
`DNA by amplifying a plurality of
`target
`loci on the cell-free DNA
`extracted from the biological sample
`to generate amplified DNA;
`analyzing the preparation of amplified
`DNA by sequencing the amplified
`DNA using sequencing-by-synthesis
`to obtain genetic data of the plurality
`of target loci;
`determining the most likely genetic
`data for DNA from thefirst individual
`based on allele frequencies in the
`genetic data at the plurality of target
`
`°544 Patent,
`21[c]
`
`°544 Patent,
`21[d]
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 8 of 13 PagelD #: 29611
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 8 of 13 PageID #: 29611
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`°544 Patent, Claim|The method of claim 21, wherein the
`amplifying comprises targeted PCR
`and universal PCR.
`°544 Patent, Claim|The method of claim 21, wherein the
`27 sequencing-by-synthesis|comprises
`
`clonal amplification of the amplified
`DNA and measurement of sequences
`
`of the clonally amplified DNA.
`
`Continue to the next question.
`
`
`
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`QUESTION7:
`
`Did CareDx prove, by clear and convincing evidence,that the limitations of
`
`the following claims as a combination were well-understood,
`
`routine, and
`
`conventional, as of September22, 2006?
`
`(“YES”is a finding in favor of CareDx, “NO”is a finding in favor of
`
`Natera.)
`
`544 Patent, Claim 21
`
`544 Patent, Claim 27
`
`544 Patent, Claim 26
`
`Continue to the next question.
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 10 of 13 PagelD #: 29613
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 10 of 13 PageID #: 29613
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`QUESTION8:
`
`Did CareDx prove, by clear and convincing evidence, that the individual
`
`limitations ofthe following claims were well-understood, routine, and conventional,
`
`as of October 3, 2011?
`
`(“YES”is a finding in favor of CareDx, “NO”is a finding in favor of
`
`Natera.)
`
`of
`
`°180 Patent, Claim|A method for measuring an amount of
`14 [Preamble]
`DNA in a biological
`sample,
`the
`method comprising:
`°180 Patent, Claim] a_targetedperforming PCR
`
`
`
`amplification for more than 100 SNP
`14[a]
`loci on one or more chromosomes
`expected to be disomic in a single
`reaction mixture using more than 100
`PCRprimerpairs, wherein the reaction
`mixture
`comprises
`cell-free DNA
`extracted from a biological sample of a
`subject comprising DNA of mixed
`origin, wherein the DNA of mixed
`origin comprises DNAfrom the subject
`and DNA from a genetically distinct
`individual, wherein neither the subject
`northe genetically distinct individualis
`a fetus, wherein the DNA of mixed
`
`origin comprises DNA_from a
`transplant, and wherein the amplified
`SNP loci comprise SNP loci on at least
`chromosome1, 2, or 3;
`"180 Patent, Claim|measuring a quantity of eachallele at a
`14[b]
`plurality of amplified SNP loci
`that
`comprise an allele present
`in the
`genetically distinct individual but not
`the subject, wherein the quantity
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 11 of 13 PagelD #: 29614
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`individual.
`
`each allele at a plurality of amplified
`SNP loci
`are measured by _high-
`throughput sequencing;
`"180 Patent, Claim|measuring an amountof the DNA from
`14[c]
`the genetically distinct individualin the
`biological sample using the quantity of
`each allele at
`the SNP loci and an
`expected quantity of each allele at the
`SNPloci for different DNA fractions,
`°180 Patent, Claim] wherein the method is_performed
`14[d]
`without prior knowledge of genotypes
`of the genetically distinct individual.
`°180 Patent, Claim |The method of claim 14,
`further
`15
`comprising determining a bias of the
`PCR amplification, and using the bias
`to statistically correct the determined
`quantity of each allele at the plurality
`of SNP loci on the one or more
`chromosomes expected to be disomic
`before the quantity of each allele is
`used to determine the amount of the
`DNA from the genetically distinct
`
`Continue to the next question.
`
`
`
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 12 of 13 PagelD #: 29615
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 12 of 13 PageID #: 29615
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`QUESTION9:
`
`Did CareDx prove, by clear and convincing evidence, that the limitations of
`
`the following claims as a combination were well-understood,
`
`routine, and
`
`conventional, as of October 3, 2011?
`
`(“YES” is a finding in favor of CareDx, “NO”is a finding in favor of
`
`Natera.)
`
`
`
`
`
`.
`
`« Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 13 of 13 PagelD #: 29616
`Case 1:20-cv-00038-CFC-CJB Document 460 Filed 01/26/24 Page 13 of 13 PageID #: 29616
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`UNANIMOUS VERDICT
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`You have now reachedthe end ofthe verdict form and you should reviewit to ensure
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`that it accurately reflects your unanimousdeterminations. All jurors should then sign
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`the verdict form in the space below and notify the Court Security Officer that you
`
`have reacheda verdict. The Foreperson should retain possession of the verdict form
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`and bringit to the courtroom with the jury.
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`Signed:
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`Forepeisupy
`
`Juror
`
`Juror
`
`Juror
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`Juror
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`Juror
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`Juror
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`Juror
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`12
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`Dated: f Ab Agay
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`