`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MOLECULAR LOOP BIOSCIENCES, INC.,
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`Plaintiff,
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`C.A. No. 24-680-RGA
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`JURY TRIAL DEMANDED
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`v.
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`ILLUMINA, INC. and
`VERINATA HEALTH, INC.,
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`
`
`
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`Defendants.
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`)
`)
`)
`)
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`DEFENDANTS’ ANSWER AND COUNTERCLAIMS TO THE COMPLAINT
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`Defendants Illumina, Inc. (“Illumina”) and Verinata Health, Inc. (“VHI”) (collectively,
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`“Defendants”) by and through their counsel, hereby submit their Answer to the Complaint of
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`Plaintiff Molecular Loop Biosciences, Inc. (“Molecular Loop” or “Plaintiff”), set forth their
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`defenses to the Complaint, and set forth their Counterclaims. The Complaint’s section headings
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`are carried over in this Answer for ease of reference only, and Defendants deny any allegations
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`contained in the section headings.
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`By submitting this Answer and Counterclaims, Defendants expressly preserve and do not
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`waive any applicable rights, defenses, or objections. Defendants also expressly reserve the right
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`to amend this Answer, their defenses, and their Counterclaims based on, inter alia, discovery,
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`factual developments, and Defendants’ ongoing investigation of Plaintiff’s claims. Unless
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`expressly stated herein, nothing in this Answer should be construed as an admission by Defendants
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`regarding the existence of any facts set forth in the Complaint.
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`Defendants hereby answer the Complaint as follows:
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`ANSWER
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`NATURE OF THE ACTION
`ANSWER TO PARAGRAPH 1: To the extent this paragraph contains legal conclusions, no
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`response is required. Defendants admit that Plaintiff purports to allege an action for patent
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`infringement arising under the patent laws of the United States, 35 U.S.C. §§ 271 et seq., but deny
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`that they have committed any acts of infringement of a valid and enforceable claim of any of the
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`Patents-in-Suit, or caused any injury or damage to Plaintiff. Defendants admit that this Court has
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`subject matter jurisdiction over actions arising under the patent laws of the United States. Except
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`as so admitted, Defendants deny the allegations of this paragraph.
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`THE PARTIES
`ANSWER TO PARAGRAPH 2: Defendants deny that Molecular Loop is a pioneering
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`company or that its technology is a fundamental part of what makes NGS more scalable, efficient,
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`and practical. Defendants lack knowledge or information sufficient to form a belief as to the truth
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`of the remaining allegations of this paragraph, and therefore deny them.
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`ANSWER TO PARAGRAPH 3: Defendants admit that Illumina is a company organized and
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`existing under the laws of the state of Delaware, with its principal place of business at 5200
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`Illumina Way, San Diego, California, 92122. Defendants admit that Illumina has appointed The
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`Corporation Trust Company, Corporation Trust Center 1209 Orange Street, Wilmington,
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`Delaware 19801, as its agent for service of process. Except as so admitted, Defendants deny the
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`allegations of this paragraph.
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`ANSWER TO PARAGRAPH 4: Defendants admit that VHI is a company organized and
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`existing under the laws of the state of Delaware. Defendants admit that VHI has appointed The
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`Corporation Trust Company, Corporation Trust Center 1209 Orange Street, Wilmington,
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`Delaware 19801, as its agent for service of process. Defendants admit that VHI is a wholly owned
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`subsidiary of Illumina. Except as so admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 5: Defendants admit that Illumina and/or certain of its
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`subsidiaries and affiliates make, use, and commercialize genetic tests marketed under the
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`tradename “VeriSeq.” Defendants admit that the VeriSeq tests utilize NGS techniques and may
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`include DNA library preparation kits that incorporate certain nucleic-acid-based adapters.
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`Defendants admit that the VeriSeq tests may be used with certain data analysis methods to reduce
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`certain errors that may arise after amplification and sequencing steps. Except as so admitted,
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`Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 6: Defendants admit that Illumina and/or certain of its
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`subsidiaries and affiliates make, use, and commercialize non-invasive prenatal tests marketed
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`under the tradename “Verifi.” Defendants admit that the Verifi tests utilize NGS techniques and
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`may include DNA library preparation kits that incorporate certain nucleic-acid-based adapters.
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`Defendants admit that the Verifi tests may be used with certain data analysis methods to reduce
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`certain errors that may arise after certain amplification and sequencing steps. Except as so
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`admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 7: Defendants admit that Illumina and/or its certain of its
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`subsidiaries and affiliates make, use, and commercialize oncology tests marketed under the
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`tradename “TruSight.” Defendants admit that the TruSight tests utilize NGS techniques and may
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`include DNA library preparation kits that incorporate certain nucleic-acid-based adapters.
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`Defendants admit that the TruSight tests may be used with certain data analysis methods to reduce
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`certain errors that may arise after certain amplification and sequencing steps. Except as so
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`admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 8: Defendants admit that Illumina and/or its subsidiaries and
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`affiliates make, use, and commercialize sequencing products under the names “Illumina
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`DNA/RNA UD Indexes,” “Illumina RNA UD Indexes,” “IDT for Illumina DNA/RNA UD
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`Indexes,” “IDT for Illumina RNA UD Indexes,” “Nextera DNA Indexes,” and “AmpliSeq UD
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`Indexes for Illumina.” Defendants admit that certain of these products may be used in NGS
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`applications, including to reduce certain errors that may arise after amplification and sequencing
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`steps when combined with data analysis methods. Except as so admitted, Defendants deny the
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`allegations of this paragraph.
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`ANSWER TO PARAGRAPH 9: Defendants admit that Illumina and/or certain of its
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`subsidiaries and affiliates offer services that utilize NGS techniques to its customers, and that these
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`services may include DNA library preparation methods that include the use of certain nucleic-
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`acid-based adapters. Defendants further admit that certain of its NGS-based services may include
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`data analysis methods that reduce certain errors that occur after amplification and sequencing
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`steps. Except as so admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 10: Defendants admit that they offer and market products,
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`including products under the tradenames Verifi; VeriSeq; TruSight; Illumina DNA/RNA UD
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`Indexes, Tagmentation; IDT for Illumina DNA/RNA UD Indexes, Tagmentation; IDT for Illumina
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`Nextera UD Indexes; and AmpliSeq UD Indexes for Illumina, in the United States via Illumina’s
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`website. Except as so admitted, Defendants deny the allegations of this paragraph.
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`JURISDICTION AND VENUE
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`ANSWER TO PARAGRAPH 11: Defendants
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`repeat and
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`re-allege
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`their
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`responses
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`to
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`paragraphs 1-10 of the Complaint as if fully set forth herein.
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`ANSWER TO PARAGRAPH 12: This paragraph states legal conclusions to which no response
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`is required. To the extent a response is required, Defendants admit that Plaintiff purports to allege
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`an action for patent infringement, but deny that they have committed any acts of infringement of
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`a valid and enforceable claim, or caused any injury or damage to Plaintiff. Defendants admit that
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`this Court has subject matter jurisdiction over actions arising under the patent laws of the United
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`States. Except as so admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 13: This paragraph states legal conclusions to which no response
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`is required. For purposes of this Action only, Defendants do not contest that venue is proper in
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`this District. Defendants deny that they have committed any acts of infringement of a valid and
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`enforceable claim, or caused any injury or damage to Plaintiff. Except as so admitted, Defendants
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`deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 14: This paragraph states legal conclusions to which no response
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`is required. For purposes of this Action only, Defendants do not contest that this Court has
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`personal jurisdiction over Defendants. Defendants deny that they have committed any acts of
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`infringement of a valid and enforceable claim, or caused any injury or damage to Plaintiff. Except
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`as so admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 15: Paragraph 15 states legal conclusions to which no response
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`is required. For purposes of this Action only, Defendants do not contest that this Court has
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`personal jurisdiction over Defendants. Defendants admit that they are each entities organized
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`under the laws of the state of Delaware. Except as so admitted, Defendants deny the allegations
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`of this paragraph.
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`BACKGROUND OF THE “INVENTIONS”
`ANSWER TO PARAGRAPH 16: Defendants deny that Molecular Loop has novel techniques
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`in targeted sequencing or has demonstrated a basis to innovate the field of sequencing. Defendants
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`lack knowledge or information sufficient to form a belief as to the truth of the remaining allegations
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`of this paragraph, and therefore deny them.
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`ANSWER TO PARAGRAPH 17: Defendants lack knowledge or information sufficient to form
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`a belief as to the truth of the allegations of this paragraph, and therefore deny them.
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`ANSWER TO PARAGRAPH 18: Defendants admit that NGS applications are capable of
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`processing multiple samples collected from different patients or sample types that are pooled
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`together to be sequenced at the same time, and that such techniques may decrease costs and
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`increase efficiency relative to prior methods of DNA analysis. Defendants admit that methods of
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`processing multiple samples collected from different patients or sample types that are pooled
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`together to be sequenced at the same time are generally known as multiplex sequencing. Except
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`as so admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 19: Defendants admit that errors are sometimes introduced
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`during NGS (for example during amplification and sequencing) and may impact the ability to
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`accurately analyze sequencing reads. Defendants deny that the Patents-in-Suit are inventive or the
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`first to provide a solution to this issue. Defendants further deny that the Patents-in-Suit are valid
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`and enforceable. Defendants lack knowledge or information sufficient to form a belief as to the
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`truth of the remaining allegations of this paragraph, and therefore deny them.
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`ANSWER TO PARAGRAPH 20: Defendants admit that there are various types of errors that
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`may arise during sequencing or amplification. Defendants deny that the Patents-in-Suit are
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`inventive or the first to provide a solution to this issue. Defendants further deny that the Patents-
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`in-Suit are valid and enforceable. Defendants lack knowledge or information sufficient to form a
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`belief as to the truth of the remaining allegations of this paragraph, and therefore deny them.
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`ANSWER TO PARAGRAPH 21: Defendants admit that, in general, various types of errors that
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`may arise during sequencing workflows may have effects on the accuracy of downstream data
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`analysis. Except as so admitted, Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 22: Denied.
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`ANSWER TO PARAGRAPH 23: Defendants deny that the Patents-in-Suit are inventive or the
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`first to provide a solution to this issue. Defendants further deny that the Patents-in-Suit are valid
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`and enforceable. Defendants lack knowledge or information sufficient to form a belief as to the
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`truth of the remaining allegations of this paragraph, and therefore deny them.
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`ANSWER TO PARAGRAPH 24: Defendants
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`repeat and
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`re-allege
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`their
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`responses
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`to
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`THE PATENTS-IN SUIT
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`paragraphs 1-23 of the Complaint as if fully set forth herein.
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`ANSWER TO PARAGRAPH 25: Denied.
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`A. The ’852 Patent
`
`ANSWER TO PARAGRAPH 26: Defendants admit that what purports to be a true and correct
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`copy of U.S. Patent No. 11,041,852, entitled “Methods for Maintaining the Integrity and
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`Identification of a Nucleic Acid Template in a Multiplex Sequencing Reaction” is attached to the
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`Complaint as Exhibit 1. Defendants admit that the ’852 Patent states on its face that its inventors
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`are Gregory Porreca, Mark Umbarger, and George Church. Defendants admit that ’852 Patent
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`states on its face that Molecular Loop Biosciences, Inc. is the assignee. Except as so admitted,
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`Defendants deny the allegations of this paragraph.
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`ANSWER TO PARAGRAPH 27: This paragraph states a legal conclusion to which no
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`response is required. To the extent a response is required, Defendants lack knowledge or
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`information sufficient to form a belief as to the truth of the allegations of this paragraph, and
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`therefore deny them.
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`ANSWER TO PARAGRAPH 28: Defendants admit that Paragraph 28 reproduces Claim 1 of
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`the ’852 Patent. Defendants deny that the ’852 Patent is inventive or the first to provide a solution
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`to errors that may arise during sequencing workflows. Defendants further deny that the ’852 Patent
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`is valid and enforceable. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 29: Denied. The specification and figures of the ’852 Patent
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`speak for themselves.
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`ANSWER TO PARAGRAPH 30: Denied. The specification and figures of the ’852 Patent
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`speak for themselves.
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`ANSWER TO PARAGRAPH 31: Denied. The specification and figures of the ’852 Patent
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`speak for themselves.
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`ANSWER TO PARAGRAPH 32: Denied. The “teaching” in the reproduced language was
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`substantially taken from another company’s prior published patent application. Defendants further
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`aver that the cited portion of the ’852 Patent was copied substantially from, for example, pages 5-
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`7 of PCT Patent Publication No. WO 2010/056728 to Steinman et al., which was assigned to
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`Helicos Biosciences Corporation. Defendants therefore further deny that the quoted portions
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`reflect any invention that could be attributed to the named inventors of the ’852 Patent or Molecular
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`Loop.
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`ANSWER TO PARAGRAPH 33: Denied. The “teaching” in the reproduced language was
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`taken from Illumina’s prior published patent application. Defendants further aver that the cited
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`portion of the ’852 Patent was copied nearly verbatim from paragraphs 33 through 37 of U.S.
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`Patent Publication No. 2009/0226975 A1 (Sabot), which was assigned to Illumina. Defendants
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`therefore further deny that the quoted portions reflect any invention that could be attributed to the
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`named inventors of the ’852 Patent or Molecular Loop.
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`B. The ’200 Patent
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`ANSWER TO PARAGRAPH 34: Defendants admit that what purports to be a true and correct
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`copy of U.S. Patent No. 11,768,200, entitled “Methods for Maintaining the Integrity and
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`Identification of a Nucleic Acid Template in a Multiplex Sequencing Reaction” is attached to the
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`Complaint as Exhibit 2. Defendants admit that the ’200 Patent states on its face that its inventors
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`are Gregory Porreca, Mark Umbarger, and George Church. Defendants admit that ’200 Patent
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`states on its face that Molecular Loop Biosciences, Inc. is the assignee. Except as otherwise
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`admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 35: This paragraph states a legal conclusion to which no
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`response is required. To the extent a response is required, Defendants lack knowledge or
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`information sufficient to form a belief as to the truth of the allegations of this paragraph, and
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`therefore deny them.
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`ANSWER TO PARAGRAPH 36: Defendants admit that the ’200 Patent states on its face that
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`it is a continuation of the ’852 Patent. Defendants further admit that Paragraph 36 reproduces
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`Claim 1 of the ’200 patent. Defendants deny that the ’200 Patent is inventive or the first to provide
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`a solution nucleic acid sequences during multiplex sequencing reactions. Defendants further deny
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`that the ’200 Patent is valid and enforceable. Except as otherwise admitted, Defendants deny the
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`allegations in this paragraph.
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`ANSWER TO PARAGRAPH 37: Denied. The “teaching” of the cited language was taken
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`from Helicos’s and Illumina’s prior published patent applications. Defendants further aver that
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`the cited portions of the ’200 Patent were copied nearly verbatim from, for example, pages 5-7 of
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`PCT Patent Publication No. WO 2010/056728 to Steinman et al., which was assigned to Helicos
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`Biosciences Corporation, and paragraphs 33 through 37 of U.S. Patent Publication No.
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`2009/0226975 A1 (Sabot), which was assigned to Illumina. Defendants therefore further deny
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`that the quoted portions reflect any invention that could be attributed to the named inventors of the
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`’200 Patent or Molecular Loop.
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`C. The ’730 Patent
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`ANSWER TO PARAGRAPH 38: Defendants admit that what purports to be a true and correct
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`copy of U.S. Patent No. 11,840,730 entitled “Methods and Compositions for Evaluating Genetic
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`Markers” is attached to the Complaint as Exhibit 3. Defendants admit that the ’730 Patent states
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`on its face that its inventors are Gregory Porreca and Uri Laserson. Defendants admit that the ’730
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`Patent states on its face that Molecular Loop Biosciences, Inc. is the assignee. Except as otherwise
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`admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 39: This paragraph states a legal conclusion to which no
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`response is required. To the extent a response is required, Defendants lack knowledge or
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`information sufficient to form a belief as to the truth of the allegations of this paragraph, and
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`therefore deny them.
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`ANSWER TO PARAGRAPH 40: Defendants admit that that Paragraph 40 reproduces Claim 1
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`of the ’730 Patent. Defendants deny that the ’730 Patent is inventive or the first to provide a
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`solution to this issue. Defendants further deny that the ’730 Patent is valid and enforceable. Except
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`as otherwise admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 41: Defendants admit that this paragraph contains what purports
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`to be a quotation from the ’730 Patent. Defendants deny that the ’730 Patent is inventive or the
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`first to provide a solution to this issue. Defendants further deny that the ’730 Patent is valid and
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`enforceable. Except as otherwise admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 42: Defendants admit that this paragraph contains what purports
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`to be a quotation from the ’730 Patent. Defendants deny that the ’730 Patent is inventive or the
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`first to provide a solution to this issue. Defendants further deny that the ’730 Patent is valid and
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`enforceable. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 43: Defendants admit that this paragraph contains what purports
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`to be a quotation from the ’730 Patent. Defendants deny that the ’730 Patent is inventive or the
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`first to provide a solution to this issue. Defendants further deny that the ’730 Patent is valid and
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`enforceable. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 44: Defendants admit that this paragraph contains what purports
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`to be a quotation from the ’730 Patent. Defendants deny that the ’730 Patent is inventive or the
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`first to provide a solution to this issue. Defendants further deny that the ’730 Patent is valid and
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`enforceable. Except as so admitted, Defendants deny the allegations in this paragraph.
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`DEFENDANTS’ ACTIVITIES
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`ANSWER TO PARAGRAPH 45: Defendants
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`repeat and
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`re-allege
`
`their
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`responses
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`to
`
`paragraphs 1-44 of the Complaint as if fully set forth herein.
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`A. The Accused Verifi Prenatal Tests
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`ANSWER TO PARAGRAPH 46: Defendants admit that VHI announced the launch of a non-
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`invasive prenatal test on March 15, 2012. Defendants admit that on January 7, 2013 Illumina
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`announced that it had signed a definitive agreement to acquire VHI. Defendants admit that it began
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`providing the Verifi Plus prenatal test in 2017. Defendants admit that the Verifi Plus prenatal test
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`is marketed as containing “everything in the Verifi Prenatal Test and includes additional panels.”
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`Defendants admit that Verifi Prenatal Test and Verifi Prenatal Plus Test are both currently offered
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`on Illumina’s website. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 47: Defendants aver that the cited exhibits speak for themselves,
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`and admit that this paragraph purports to quote from such exhibits. Except as so admitted,
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`Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 48: Defendants admit that performance of the Verifi Tests may
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`entail incorporating nucleic acid adapters into segments of nucleic acids to be analyzed.
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`Defendants aver that the cited exhibits speak for themselves, and admit that this paragraph purports
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`to quote from such exhibits. Except as so admitted, Defendants deny the allegations in this
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`paragraph.
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`ANSWER TO PARAGRAPH 49: Defendants admit that performance of the Verifi Tests may
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`entail pooling multiple DNA samples. Defendants aver that the cited exhibits speak for
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`themselves, and admit that this paragraph purports to quote from such exhibits. Except as so
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`admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 50: Defendants admit that performance of the Verifi Tests
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`entails amplifying the DNA to be analyzed on the surface of a flow cell. Defendants aver that the
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`cited exhibit speaks for itself, and admit that this paragraph purports to quote from such exhibit.
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`Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 51: Defendants admit that the Verifi Tests entail a sequencing
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`step. Defendants aver that the cited exhibits speak for themselves, and admit that this paragraph
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`purports to quote from such exhibits. Except as so admitted, Defendants deny the allegations in
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`this paragraph.
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`ANSWER TO PARAGRAPH 52: Defendants aver that the cited exhibits speak for themselves,
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`and admit that this paragraph purports to quote from such exhibits. Defendants admit that the
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`Verifi Tests may entail a step of demultiplexing samples. Except as so admitted, Defendants deny
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`the allegations in this paragraph.
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`B. The Accused VeriSeq Tests
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`ANSWER TO PARAGRAPH 53: Defendants admit that Illumina announced the launch of the
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`VeriSeq NIPT solution in April 2017 and that Illumina announced the launch of the VeriSeq NIPT
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`Solution v2 in June 2019. Defendants admit that they currently offer the VeriSeq Solution v2 for
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`sale on their website, and that this product is sold and distributed in the United States. Defendants
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`aver that the cited exhibits speak for themselves, and admit that this paragraph purports to quote
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`from such exhibits. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 54: Defendants aver that the cited exhibit speaks for itself, and
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`admit that this paragraph purports to quote from such exhibit. Except as so admitted, Defendants
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`deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 55: Defendants admit that performance of the VeriSeq Tests
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`may entail incorporating nucleic acid adapters into segments of nucleic acids to be analyzed.
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`Defendants aver that the cited exhibit speaks for itself, and admit that this paragraph purports to
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`quote from such exhibit. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 56: Defendants admit that performance of the VeriSeq Tests
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`may entail pooling multiple DNA samples. Defendants aver that the cited exhibits speak for
`
`themselves, and admit that this paragraph purports to quote from such exhibits. Except as so
`
`admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 57: Defendants admit that performance of the VeriSeq Tests
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`entails amplifying the DNA to be analyzed on the surface of a flow cell. Defendants aver that the
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`cited exhibits speak for themselves, and admit that this paragraph purports to quote from such
`
`exhibits. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 58: Defendants admit that performance of the VeriSeq Tests
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`entails sequencing nucleic acid segments. Defendants aver that the cited exhibits speak for
`
`themselves, and admit that this paragraph purports to quote from such exhibits. Except as so
`
`admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 59: Defendants admit that the VeriSeq tests may entail
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`demultiplexing sequencing data. Defendants aver that the cited exhibit speaks for itself, and admit
`
`that this paragraph purports to quote from such exhibit. Except as so admitted, Defendants deny
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`the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 60: Defendants admit that Illumina requests that users of its Web
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`User Interface for the VeriSeq NIPT v2 product to accept an End User License Agreement.
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`Defendants aver that the cited exhibit speaks for itself, and admit that this paragraph purports to
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`quote from such exhibit. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 61: Defendants admit that Illumina offers product support,
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`training solutions, and on-site service to at least certain of its customers that purchase VeriSeq
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`tests. Defendants aver that the cited exhibit speaks for itself, and admit that this paragraph purports
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`to quote from such exhibit. Defendants admit that they provide certain consumable materials to
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`users of the VeriSeq Tests. Except as so admitted, Defendants deny the allegations in this
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`paragraph.
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`ANSWER TO PARAGRAPH 62: Defendants admit that Illumina provides customers with
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`installation instructions, product manuals, and other informational materials regarding the usage
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`of the VeriSeq Tests. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 63: Defendants admit that they offer a software guide for
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`VeriSeq NIPT Solution v2, which is attached to the Complaint as Exhibit 30. Except as so
`
`admitted, Defendants deny the allegations in this paragraph.
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`C. The Accused TruSight Tests
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`ANSWER TO PARAGRAPH 64: Defendants admit that on October 30, 2018 Illumina
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`announced the launch of TruSight Oncology 500, a comprehensive pan-cancer assay designed to
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`identify known and emerging tumor biomarkers s. Defendants further admit that on November 5,
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`2019, Illumina announced the upcoming launch of TruSight Oncology 500 ctDNA and TruSight
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`Oncology 500 High-Throughput. Defendants admit that TruSight Oncology ctDNA is a liquid
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`biopsy solution for detecting cancer biomarkers. Except as so admitted, Defendants deny the
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`allegations in this paragraph.
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`ANSWER TO PARAGRAPH 65: Defendants admit that Illumina currently offers for sale the
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`TSO 500, TSO 500 ctDNA v2, and TSO500 HT (collectively the “TruSight Oncology 500
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`portfolio”) on its website. Defendants admit that this paragraph reproduces a quotation and
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`diagram from Exhibit 34, the TruSight Oncology 500 portfolio brochure, which speaks for itself.
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`Except as so admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 66: Defendants admit that TSO 500 Tests entail obtaining one or
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`more biological sample that contain one or more sequences of nucleic acids. Defendants aver that
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`the cited exhibits speak for themselves, and admit that this paragraph purports to quote from such
`
`exhibits. Except as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 67: Defendants admit that the TSO 500 Tests may entail the
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`introduction of adapters that serve as molecular identifiers to a DNA sample during library
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`preparation. Defendants aver that the cited exhibits speak for themselves, and admit that this
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`paragraph purports to quote from such exhibits. Except as so admitted, Defendants deny the
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`allegations in this paragraph.
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`ANSWER TO PARAGRAPH 68: Defendants admit that the TSO 500 Tests entail amplifying
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`nucleic acid molecules on the surface of a flow cell before sequencing. Defendants admit that the
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`TSO500 Tests generally entail sequencing on Illumina Sequencers. Defendants aver that the cited
`
`exhibits speak for themselves, and admit that this paragraph purports to quote from such exhibits.
`
`Except as so admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 69: Defendants admit that the TSO 500 Tests entail software that
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`performs error correction by collapsing certain sequences. Defendants aver that the cited exhibits
`
`speak for themselves, and admit that this paragraph purports to quote from such exhibits. Except
`
`as so admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 70: Defendants admit
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`that TSO 500 Tests may entail
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`incorporating nucleic-acid-based adapters into nucleic acid sequences to be analyzed. Defendants
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`aver that the cited exhibits speak for themselves, and admit that this paragraph purports to quote
`
`from such exhibits. Except as so admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 71: Defendants admit that TSO 500 Tests may entail pooling
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`multiple samples of nucleic acids to be sequenced together. Defendants aver that the cited exhibits
`
`speak for themselves, and admit that this paragraph purports to quote from such exhibits. Except
`
`as so admitted, Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 72: Defendants admit that the TSO 500 Tests entail amplifying
`
`nucleic acid sequences on a surface of a flow cell. Defendants aver that the cited exhibits speak
`
`for themselves, and admit that this paragraph purports to quote from such exhibits. Except as so
`
`admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 73: Defendants admit that the TSO 500 Tests entail the
`
`sequencing of nucleic acids that have been amplified. Defendants aver that the cited exhibits speak
`
`for themselves, and admit that this paragraph purports to quote from such exhibits. Except as so
`
`admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 74: Defendants admit that the TSO 500 Tests entail identifying
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`sequence reads that are determined to contain errors that arise from amplification, and that the
`
`TSO 500 Tests demultiplex DNA sequence reads. Defendants aver that the cited exhibits speak
`
`for themselves, and admit that this paragraph purports to quote from such exhibits. Except as so
`
`admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 75: Defendants admit that Illumina provides an End-User
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`Software License Agreement that users are requested to sign before utilizing its DRAGEN
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`TruSight Oncology 500 Analysis Software. Except as so admitted, Defendants deny the
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`allegations in this paragraph.
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`ANSWER TO PARAGRAPH 76: Defendants admit that Illumina offers product support,
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`training solutions, and on-site service to its customers for the TSO 500 Tests. Defendants aver
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`that the cited exhibits speak for themselves, and admit that this paragraph purports to quote from
`
`such exhibits. Except as so admitted, Defendants deny the allegations in this paragraph.
`
`ANSWER TO PARAGRAPH 77: Defendants admit
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`that Illumina provides
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`installation
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`instructions, product manuals, package inserts and other reference guides that describe the
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`operation of its products in the TruSight Oncology 500 portfolio. Except as so admitted,
`
`Defendants deny the allegations in this paragraph.
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`ANSWER TO PARAGRAPH 78: Defendants admit that Illumina’s materials describe the
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`TruSight Oncology 500 portfo