Case 1:20-cv-01644-RGA-JLH Document 9 Filed 01/27/21 Page 1 of 26 PageID #: 2151
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`RAVGEN, INC.,
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`Plaintiff,
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`v.
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`ILLUMINA, INC. AND VERINATA HEALTH,
`INC.,
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`Defendants.
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`C.A. No. 20-1644-RGA-JLH
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`JURY TRIAL DEMANDED
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`DEFENDANTS’ ANSWER, AFFIRMATIVE DEFENSES,
`AND COUNTERCLAIMS TO RAVGEN’S COMPLAINT
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`Defendants Illumina, Inc. and Verinata Health, Inc. (collectively “Illumina”), answer and
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`respond to each of the allegations in the Complaint for Patent Infringement (“Complaint”) of
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`Plaintiff Ravgen, Inc. (“Ravgen”). Unless expressly admitted, Illumina denies each and every
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`allegation in Ravgen’s Complaint. To the extent the allegations in the Complaint purport to
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`characterize the nature or contents of the Exhibits to the Complaint, Illumina lacks sufficient
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`knowledge or information to form a belief as to the truth of those allegations and on that basis
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`denies them. Additionally, to the extent that the headings or any other non-numbered statements
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`in the Complaint contain any allegations, Illumina denies each and every such allegation.
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`NATURE OF THE ACTION
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`1.
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`Illumina admits that the Complaint purports to state a claim for patent infringement
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`of United States Patent Nos. 7,727,720 (the “’720 Patent”) and 7,332,277 (the “’277 Patent”)
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`(collectively the “Patents-in-Suit”), arising under the Patent Laws of the United States, 35 U.S.C.
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`§§ 271 et seq. Except as so admitted, Illumina denies any remaining allegations in paragraph 1.
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`THE PARTIES
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`2.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 2 and on that basis denies them.
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`3.
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`Illumina admits that Illumina, Inc. is a corporation organized under the laws of
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`Delaware with its principal place of business at 5200 Illumina Way, San Diego, California, 92122.
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`Illumina admits that it has appointed The Corporation Trust Company, Corporation Trust Center
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`1209 Orange Street, Wilmington, Delaware 19801 as its agent for service of process.
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`4.
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`Illumina admits that Verinata Health, Inc. (“VHI”) is a corporation organized under
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`the laws of Delaware with its principal place of business at 5200 Illumina Way, San Diego,
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`California 92122. Illumina further admits that VHI has appointed The Corporation Trust
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`Company, Corporation Trust Center 1209 Orange Street, Wilmington, Delaware 19801 as its agent
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`for service of process. Illumina further admits that VHI is a wholly owned subsidiary of Illumina.
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`5.
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`Illumina admits that it has commercialized noninvasive prenatal testing products
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`under the tradename “Verifi” based on sequencing cell-free DNA from a maternal blood sample
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`to screen for aneuploidy of chromosomes. Except as so admitted, Illumina denies any remaining
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`allegations in paragraph 5.
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`6.
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`Illumina admits that it has commercialized noninvasive prenatal testing products in
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`the United States on a research use only basis under the tradename “VeriSeq” based on sequencing
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`cell-free DNA from a maternal blood sample to screen for aneuploidy of chromosomes. Except
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`as so admitted, Illumina denies any remaining allegations in paragraph 6.
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`7.
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`Illumina admits that it has developed oncology testing products under the
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`tradename “TruSight” based on sequencing cell-free DNA. Illumina denies that it has provided
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`testing services based on the TruSight products for cell-free DNA. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 7.
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`8.
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`Illumina admits that it has commercialized in the United States noninvasive
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`prenatal testing under the tradename “Verifi” based on sequencing cell-free DNA from a maternal
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`blood sample to screen for aneuploidy of chromosomes. Illumina further admits that it has
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`commercialized noninvasive prenatal testing products in the United States on a research use only
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`basis under the tradename “VeriSeq” based on sequencing cell-free DNA from a maternal blood
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`sample to screen for aneuploidy of chromosomes. Illumina admits that it has developed oncology
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`testing products under the tradename “TruSight” based on sequencing cell-free DNA. Illumina
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`denies that it has provided testing services based on the TruSight products for cell-free DNA.
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`Except as so admitted, Illumina denies any remaining allegations in paragraph 8.
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`JURISDICTION AND VENUE
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`9.
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`Illumina incorporates by reference and restates its responses to paragraphs 1–8 of
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`the Complaint as though fully set forth herein.
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`10.
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`Illumina admits that the Complaint purports to state a claim for patent infringement
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`arising under the patent laws of the United States, including 35 U.S.C §§ 271, et seq. Illumina
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`further admits that this Court has subject matter jurisdiction over causes of action for alleged patent
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`infringement pursuant to 28 U.S.C. §§ 1331 and 1338(a).
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`11.
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`Illumina admits that Defendants are entities organized under the laws of Delaware
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`and that venue is proper in this District. Except as so admitted, Illumina denies any remaining
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`allegations of paragraph 11, and specifically denies that it has committed any acts of infringement.
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`12.
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`Illumina admits that it conducts business in Delaware and that this Court has
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`personal jurisdiction over Illumina. Except as so admitted, Illumina denies any remaining
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`allegations of paragraph 12, and specifically denies that it has committed any acts of infringement.
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`13.
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`Illumina admits that Defendants are entities organized under the laws of Delaware
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`and this Court has personal jurisdiction over Illumina. Except as so admitted, Illumina denies any
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`remaining allegations of paragraph 13, and specifically denies that it has committed any acts of
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`infringement in this District.
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`BACKGROUND OF THE INVENTIONS
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`14.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 14 and on that basis denies them.
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`15.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 15 and on that basis denies them.
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`16.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 16 and on that basis denies them.
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`17.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 17 and on that basis denies them.
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`18.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 18 and on that basis denies them.
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`19.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 19 and on that basis denies them.
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`20.
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`Illumina admits that Exhibit 13 appears to be an article that states, “the methods
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`described herein for increasing the percentage of free fetal DNA provide a solid foundation for the
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`development of a noninvasive prenatal diagnostic test.” Illumina denies that Exhibit 13 states “the
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`methods described herein for increasing the percentage of cell-free fetal DNA provide a solid
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`foundation for the development of a noninvasive prenatal diagnostic test.” Illumina lacks
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`sufficient knowledge or information to form a belief as to the truth of the remaining allegations set
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`forth in paragraph 20 and on that basis denies them.
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`21.
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`Illumina admits that paragraph 21 includes a reproduction of two excerpts from
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`Exhibit 14. Illumina lacks sufficient knowledge or information to form a belief as to the truth of
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`the remaining allegations set forth in paragraph 21 and on that basis denies them.
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`22.
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`Illumina admits that the articles cited in paragraph 22 of the Complaint were
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`published in 2007. Except as so admitted, Illumina denies any remaining allegations of paragraph
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`22.
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`23.
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`Illumina admits that the articles cited in paragraph 23 of the Complaint were
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`published in 2007. Except as so admitted, Illumina denies any remaining allegations of paragraph
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`23. Illumina lacks sufficient knowledge or information to form a belief as to the truth of the
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`allegations set forth in paragraph 23 and on that basis denies them.
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`24.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 24 and on that basis denies them.
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`PATENTS-IN-SUIT
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`25.
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`Illumina incorporates and restates by reference its responses to paragraphs 1–24 of
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`the Complaint as though fully set forth herein.
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`26.
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`Illumina admits that the ’277 Patent is entitled “Methods for Detection of Genetic
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`Disorders.” Illumina further admits that, on its face, the ’277 Patent states that it was issued on
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`February 19, 2008, that the named inventor is Ravinder S. Dhallan, and that the ’277 Patent is
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`assigned to Ravgen, Inc. Illumina further admits that Exhibit 1 appears to be a copy of the ’277
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`Patent. Except as so admitted, Illumina denies any remaining allegations of paragraph 26.
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`27.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 27 and on that basis denies them.
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`28.
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`Illumina admits that the ’720 Patent is entitled “Methods for Detection of Genetic
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`Disorders.” Illumina further admits that, on its face, the ’720 Patent states that it was issued on
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`June 1, 2010, that the named inventor is Ravinder S. Dhallan, and that the ’277 Patent is assigned
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`to Ravgen, Inc. Illumina further admits that Exhibit 2 appears to be a copy of the ’720 Patent.
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`Except as so admitted, Illumina denies any remaining allegations of paragraph 28.
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`29.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 29 and on that basis denies them.
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`30.
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`Illumina admits that paragraph 30 contains a reproduction of claim 81 of the ’277
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`Patent. Except as so admitted, Illumina denies any remaining allegations of paragraph 30.
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`31.
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`Illumina admits that paragraph 31 contains a reproduction of claim 1 of the ’720
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`Patent. Except as so admitted, Illumina denies any remaining allegations of paragraph 31.
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`32.
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`Illumina admits that paragraph 32 contains a reproduction of an excerpt from the
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`’277 and ’720 Patents at 32:24-39 and 33:31-46, respectively. Except as so admitted, Illumina
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`denies any remaining allegations of paragraph 32.
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`33.
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`Illumina admits that paragraph 33 contains a reproduction of an excerpt from the
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`’277 and ’720 Patents at 91:44-60 and 92:10-26, respectively. Except as so admitted, Illumina
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`denies any remaining allegations of paragraph 33.
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`34.
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`Illumina admits that paragraph 34 contains a reproduction of two excerpts from
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`exhibit 20, which appears to be an excerpt from the file history of the ’720 Patent. Except as so
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`admitted, Illumina denies any remaining allegations of paragraph 34.
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`35.
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`Illumina admits that paragraph 35 contains a reproduction of an excerpt from
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`exhibit 14. Except as so admitted, Illumina denies any remaining allegations of paragraph 35.
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`36.
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`Illumina admits that Exhibit 21 appears to be an excerpt from the file history of the
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`’277 patent. Illumina further admits that paragraph 36 contains a reproduction of claim 1 of the
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`’277 Patent. Except as so admitted, Illumina denies any remaining allegations in paragraph 36.
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`37.
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`Illumina admits that paragraph 37 contains a reproduction of three excerpts from
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`the ’277 Patent at 66:14-20, 35:28-29, and 35:32-37. Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 37.
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`38.
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`Illumina admits that paragraph 38 contains a reproduction of two excerpts from
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`Exhibit 21, which appears to be an excerpt from the file history of the ’277 Patent. Except as so
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`admitted, Illumina denies any remaining allegations of paragraph 38.
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`DEFENDANTS’ INFRINGING ACTIVITIES
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`39.
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`Illumina incorporates by reference and restates its responses to paragraphs 1–38 of
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`the Complaint as though fully set forth herein.
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`A.
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`40.
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`The Accused Prenatal Tests
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`Illumina admits that VHI began providing the Verifi prenatal test on or around
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`March 2012 to test for fetal chromosomal abnormalities. Illumina admits that Exhibit 23 to the
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`Complaint states that Illumina agreed to acquire VHI on January 7, 2013. Illumina admits it began
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`providing the Verifi Plus prenatal test in 2017. Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 40.
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`41.
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`Illumina admits that the Verifi and Verifi Plus tests are noninvasive prenatal testing
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`products based on cell-free DNA analysis from a maternal blood draw. Except as so admitted,
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`Illumina denies any remaining allegations in paragraph 41.
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`42.
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`Illumina admits that Exhibits 25-27 to the Complaint state that Streck tubes can be
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`used for sample collection for the Verifi test. Except as so admitted, Illumina denies any remaining
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`allegations in paragraph 42.
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`43.
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`Illumina admits that Exhibits 28-31 to the Complaint discuss the use of Streck blood
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`collection tubes in connection with research and development efforts. Except as so admitted,
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`Illumina denies any remaining allegations in paragraph 43.
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`44.
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`Illumina admits that paragraph 44 includes a reproduction of certain material from
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`paragraph 32 of the Complaint. Otherwise, Illumina lacks sufficient knowledge or information to
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`form a belief as to the truth of the allegations set forth in paragraph 44 and on that basis denies
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`them.
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`45.
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`Illumina admits that Verifi and Verifi Plus Tests entail the analysis of cell-free
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`DNA from a sample of maternal blood. Illumina further admits that paragraph 45 of the complaint
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`includes a reproduction of materials from Exhibits 28, 29, and 33 to the Complaint. Except as so
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`admitted, Illumina denies any remaining allegations in paragraph 45.
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`B.
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`46.
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`The Accused VeriSeq Tests
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`Illumina admits that it began commercializing the VeriSeq NIPT Solution in 2017
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`and the VeriSeq NIPT Solution v2 in 2019, both are available in the US solely on a research use
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`only basis. Illumina denies any remaining allegations in paragraph 46.
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`47.
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`Illumina admits that Exhibit 36 states, inter alia, VeriSeq is a “test intended for use
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`as a sequencing‐based screening test for the detection of fetal aneuploidies from maternal
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`peripheral whole blood samples in pregnant women of at least 10 weeks gestation.” Except as so
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`admitted, Illumina denies any remaining allegations in paragraph 47.
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`48.
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`Illumina admits that the VeriSeq NIPT Microlab STAR system is marketed for
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`NIPT testing. Illumina further admits that VeriSeq is a trademark of Illumina. Except as so
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`admitted, Illumina denies any remaining allegations in paragraph 48.
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`49.
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`Illumina admits paragraph 49 includes a reproduction of material in Exhibit 36 and
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`40 to the Complaint. Except as so admitted, Illumina lacks sufficient knowledge or information
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`to form a belief as to the truth of the remaining allegations set forth in paragraph 49 and on that
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`basis denies them.
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`50.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 50 and on that basis denies them.
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`51.
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`Illumina admits that paragraph 51 contains a reproduction of an image from Exhibit
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`10 to the Complaint. Illumina further admits that paragraph 51 contains a reproduction of material
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`in Exhibits 36 and 38 to the Complaint. Except as so admitted, Illumina denies any remaining
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`allegations in paragraph 51.
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`52.
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`Illumina admits that it provides equipment and reagents to certain customers that
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`allows them to perform non-invasive prenatal testing. Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 52.
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`53.
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`Illumina admits that it provides equipment and reagents to certain customers that
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`allows them to perform non-invasive prenatal testing. Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 53.
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`54.
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`Illumina admits that it provides equipment and reagents to certain customers that
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`allows them to perform non-invasive prenatal testing . Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 54.
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`55.
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`Illumina admits that it provides equipment and reagents to certain customers that
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`allows them to perform non-invasive prenatal testing. Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 55.
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`C.
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`56.
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`The Accused TruSight Tests
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`Illumina admits that it began commercializing the TruSight Oncology 500 ctDNA
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`(“TSO 500 ctDNA”) solution for detecting cancer biomarkers in 2019. Except as so admitted,
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`Illumina denies any remaining allegations in paragraph 56.
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`57.
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`Illumina admits that it began commercializing the TruSight Tumor 170 solution in
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`2016. Illumina also admits that it published product literature on the TruSight Tumor 170 solution,
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`entitled “Using TruSight Oncology UMI Reagents with TruSight Tumor 170 DNA Content for
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`Detection of Low-Frequency Variants in Cell-Free DNA” on April 12, 2018. Illumina denies any
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`remaining allegations in paragraph 57.
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`58.
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`Illumina admits that the TSO 500 ctDNA and TruSight Tumor 170 products appear
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`on Illumina’s website and that Illumina’s website provides some documents related to these
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`products. Defendants further admit certain of those publications describe the use of Streck blood
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`collection tubes in connection with certain research and development efforts related to oncology
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`testing products based on the use of cell-fee DNA. Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 58.
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`59.
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`Illumina admits that paragraph 59 contains a reproduction of material in Exhibits
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`11, 49, 51, and 52 to the Complaint. Illumina denies that Exhibit 49 states “NGS-based assay that
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`assesses multiple variant types in 523 cancer-related genes from cellfree DNA (cfDNA).” Except
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`as so admitted, Illumina denies any remaining allegations in paragraph 59.
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`60.
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`Illumina admits that paragraph 60 contains a reproduction of material in Exhibits
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`51-53 to the Complaint. Except as so admitted, Illumina lacks sufficient knowledge or information
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`to form a belief as to the truth of the allegations set forth in paragraph 60 and on that basis denies
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`them.
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`61.
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`Illumina lacks sufficient knowledge or information to form a belief as to the truth
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`of the allegations set forth in paragraph 61 and on that basis denies them.
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`62.
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`Illumina admits that paragraph 62 contains a reproduction of an image from Exhibit
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`54 to the Complaint, and a reproduction of material in Exhibits 51 and 55 to the Complaint. Except
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`as so admitted, Illumina denies any remaining allegations in paragraph 62.
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`63.
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`Illumina admits that paragraph 63 contains a reproduction of an image from Exhibit
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`56 to the Complaint, and a reproduction of material in Exhibits 52 and 57 to the Complaint. Except
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`as so admitted, Illumina denies any remaining allegations in paragraph 63.
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`64.
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`Illumina admits that it provides equipment and reagents to certain customers that
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`allows them to perform certain forms of oncology testing. Illumina further admits that it has a
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`relationship with Frederick National Laboratory related to the validation of the TSO 500 test.
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`Illumina denies any remaining allegations in paragraph 64.
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`65.
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`Illumina admits that it provides equipment and reagents to customers that allows
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`them to perform certain forms of oncology testing. Except as so admitted, Illumina denies any
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`remaining allegations in paragraph 65.
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`66.
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`Illumina admits that it provides equipment and reagents to certain customers that
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`allows them to perform certain forms of oncology testing. Except as so admitted, Illumina denies
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`any remaining allegations in paragraph 66.
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`67.
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`Illumina admits that paragraph 67 contains a reproduction of material from Exhibit
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`51 to the Complaint. Illumina admits that it provides equipment and reagents to customers that
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`allows them to perform the certain forms of oncology testing. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 67.
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`D.
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`68.
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`69.
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`Defendants’ Knowledge Of The Ravgen Patents
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`Denied.
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`Illumina denies that it has infringed the Patents-in-Suit and that it was willfully
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`blind to the Patents-in-Suit or any such infringement as alleged. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 69.
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`70.
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`Illumina denies that it has infringed the Patents-in-Suit and that it was willfully
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`blind to the Patents-in-Suit or any such infringement as alleged. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 70.
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`71.
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`Illumina admits that the ’277 Patent and/or U.S. Patent Application Publication No.
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`2004/0137470 were cited during prosecution of the patents listed in paragraph 71 of the Complaint,
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`and that the listed patents issued over the Ravgen patents and applications. Illumina denies that it
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`has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any such
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`infringement as alleged. Except as so admitted, Illumina denies any remaining allegations in
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`paragraph 71.
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`72.
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`Illumina admits that the ’277 Patent and/or U.S. Patent Application Publication No.
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`2004/0137470 were cited during the prosecution of the patent applications listed in paragraph 72
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`of the Complaint. Illumina denies that it has infringed the Patents-in-Suit and that it was willfully
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`blind to the Patents-in-Suit or any such infringement as alleged. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 72.
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`73.
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`Illumina admits that the ’720 Patent and/or U.S. Patent Application Publication No.
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`2006/0121452 were cited during prosecution of the patents listed in paragraph 73 of the Complaint,
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`and that the listed patents issued over the Ravgen patents and applications. Illumina denies that it
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`has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any such
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`infringement as alleged. Except as so admitted, Illumina denies any remaining allegations in
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`paragraph 73.
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`74.
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`Illumina admits that the ’720 Patent and/or U.S. Patent Application Publication No.
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`2006/0121452 were cited during the prosecution of the patent applications listed in paragraph 74
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`of the Complaint. Illumina denies that it has infringed the Patents-in-Suit and that it was willfully
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`blind to the Patents-in-Suit or any such infringement as alleged. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 74.
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`75.
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`Illumina admits that the ’277 Patent owned by Ravgen was cited in connection with
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`certain inter partes review proceedings involving U.S. Patent No. 8,318,430, and that U.S. Patent
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`No. 8,318,430 was determined to be valid in view of the ’277 Patent. Illumina denies that it has
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`infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any such
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`infringement as alleged. Illumina further admits that the ’277 Patent owned by Ravgen was cited
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`in connection with certain inter partes review proceedings involving U.S. Patent No. 8,682,592,
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`and that the Patent Trials and Appeals Board determined the skilled artisan would not have had a
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`reasonable expectation of being able to successfully carry out the claimed processes of U.S. Patent
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`No. 8,682,592 based on the disclosure of the Ravgen ’277 Patent. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 75.
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`76.
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`Illumina admits that VHI was a party in Case Nos. IPR2013-00276 and IPR2013-
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`00277 at the PTAB.
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`77.
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`Illumina admits that the ’277 Patent owned by Ravgen was cited in connection with
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`certain inter partes review proceedings involving U.S. Patent No. 8,318,430, and that U.S. Patent
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`No. 8,318,430 was determined to be valid in view of the Ravgen patent. Illumina denies that it
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`has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any such
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`infringement as alleged. Except as so admitted, Illumina denies any remaining allegations in
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`paragraph 77.
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`78.
`
`Illumina admits that the ’277 Patent owned by Ravgen was cited in connection with
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`certain inter partes review proceedings involving U.S. Patent No. 8,318,430 and appeals thereof.
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`Illumina further admits that U.S. Patent No. 8,318,430 was determined to be valid in view of the
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`Case 1:20-cv-01644-RGA-JLH Document 9 Filed 01/27/21 Page 14 of 26 PageID #: 2164
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`’277 Patent and that this decision was affirmed by the United States Court of Appeals for the
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`Federal Circuit. Illumina denies that it has infringed the Patents-in-Suit and that it was willfully
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`blind to the Patents-in-Suit or any such infringement as alleged. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 78.
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`79.
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`80.
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`Illumina admits that it was a party in Case No. IPR2018-01317 at the PTAB.
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`Illumina admits that the ’277 Patent owned by Ravgen was cited in connection with
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`certain inter partes review proceedings involving U.S. Patent No. 9,493,831 for the purpose of
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`explaining that the PTAB previously determined that U.S. Patent No. 8,318,430 was valid in view
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`of the ’277 Patent. Illumina further admits that the PTAB declined to institute review of U.S.
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`Patent No. 9,493,831. Illumina denies that it has infringed the Patents-in-Suit and that it was
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`willfully blind to the Patents-in-Suit or any such infringement as alleged. Except as so admitted,
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`Illumina denies any remaining allegations in paragraph 80.
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`81.
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`Illumina admits it initiated and was a party in Case No. IPR2019-01201 at the
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`PTAB.
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`82.
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`Illumina admits that the ’277 Patent owned by Ravgen was cited in connection with
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`certain inter partes review proceedings filed by Illumina on June 13, 2019 involving U.S. Patent
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`No. 8,682,592, and that the Patent Trials and Appeals Board determined the skilled artisan would
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`not have had a reasonable expectation of being able to successfully carry out the claimed processes
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`of U.S. Patent No. 8,682,592 based on the disclosure of the Ravgen ’277 Patent. Illumina denies
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`that it has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any
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`such infringement as alleged. Except as so admitted, Illumina denies any remaining allegations in
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`paragraph 82.
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`Case 1:20-cv-01644-RGA-JLH Document 9 Filed 01/27/21 Page 15 of 26 PageID #: 2165
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`83.
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`Illumina admits that the ’277 Patent owned by Ravgen was cited in connection with
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`certain inter partes review proceedings involving U.S. Patent No. 8,682,592, and that the Patent
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`Trials and Appeals Board determined the skilled artisan would not have had a reasonable
`
`expectation of being able to successfully carry out the claimed processes of U.S. Patent No.
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`8,682,592 based on the disclosure of the Ravgen ’277 Patent. Illumina denies that it has infringed
`
`the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any such infringement
`
`as alleged. Except as so admitted, Illumina denies any remaining allegations in paragraph 83.
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`84.
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`Illumina admits that the ’277 Patent and the application that matured into the’720
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`Patent (U.S. Patent Application Publication No. 2006/0121452) owned by Ravgen were cited in
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`connection with certain reexamination proceedings involving U.S. Patent No. 8,318,430, and that
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`those reexaminations were terminated. Illumina denies that it has infringed the Patents-in-Suit and
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`that it was willfully blind to the Patents-in-Suit or any such infringement as alleged. Except as so
`
`admitted, Illumina denies any remaining allegations in paragraph 84.
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`85.
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`Illumina admits a request for reexamination was filed on January 8, 2016
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`challenging U.S. Patent No. 8,318,430. Illumina denies any remaining allegations in paragraph
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`85.
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`86.
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`Illumina admits that VHI filed motions at the PTAB to terminate the ’678
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`Reexamination in February 2016 and that the Patent Office reexamination unit terminated those
`
`reexaminations. Illumina denies that it has infringed the Patents-in-Suit and that it was willfully
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`blind to the Patents-in-Suit or any such infringement as alleged. Except as so admitted, Illumina
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`denies any remaining allegations in paragraph 86.
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`87.
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`The cited correspondence does not refer to the Patent-in-Suit, and on this basis
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`Illumina denies the allegations of paragraph 87.
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`Case 1:20-cv-01644-RGA-JLH Document 9 Filed 01/27/21 Page 16 of 26 PageID #: 2166
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`88.
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`Illumina admits that Exhibit 66 of the Complaint reflects email correspondence
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`between Grainger Greene and Dr. Dhallan, between January 21, 2009 and February 4, 2009.
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`Except as so admitted, Illumina denies any remaining allegations in paragraph 88. Illumina denies
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`that it has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any
`
`such infringement as alleged.
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`89.
`
`Illumina admits that Exhibit 66 of the Complaint reflects email correspondence
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`between Grainger Greene and Dr. Dhallan, between January 21, 2009 and February 4, 2009.
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`Except as so admitted, Illumina denies any remaining allegations in paragraph 89. Illumina denies
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`that it has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit or any
`
`such infringement as alleged.
`
`90.
`
`Illumina admits that VHI changed its name from Artemis Health to Verinata Health,
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`Inc. in 2011. Except as so admitted, Illumina denies any remaining allegations in paragraph 90.
`
`Illumina denies that it has infringed the Patents-in-Suit and that it was willfully blind to the Patents-
`
`in-Suit or any such infringement as alleged.
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`91.
`
`Illumina admits that Exhibit 69 of the Complaint reflects email correspondence
`
`between Frank Garofalo and certain employees at Illumina, between May 3, 2016 and June 3,
`
`2016. Except as so admitted, Illumina denies any remaining allegations in paragraph 91. Illumina
`
`denies that it has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit
`
`or any such infringement as alleged.
`
`92.
`
`Illumina admits that Exhibit 69 of the Complaint reflects email correspondence
`
`between Frank Garofalo and certain employees at Illumina, between May 3, 2016 and June 3,
`
`2016. Except as so admitted, Illumina denies any remaining allegations in paragraph 92. Illumina
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`Case 1:20-cv-01644-RGA-JLH Document 9 Filed 01/27/21 Page 17 of 26 PageID #: 2167
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`denies that it has infringed the Patents-in-Suit and that it was willfully blind to the Patents-in-Suit
`
`or any such infringement as alleged.
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`93.
`
`Illumina admits that Exhibits 69 and 70 of the Complaint reflect email
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`correspondence between Frank Garofalo and certain employees at Illumina on June 10, 2016.
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`Except as so admitted, Illumina