`Filed: March 29, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION,
`Patent Owner.
`_____________________________
`
`Case IPR2018-00739
`Patent No. 9,364,435
`_____________________________
`
`PATENT OWNER’S NOTICE OF OBJECTION TO EVIDENCE
`
`
`
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner submits the following
`
`objections to evidence submitted in the Petitioner’s Reply. Patent Owner’s
`
`objections apply the Federal Rules of Evidence (“FRE”).
`
`II. OBJECTIONS
`A.
`Reply Declaration of Dr. Andrew S. Janoff (EX1021)
`Patent Owner objects to the admissibility of EX1021.
`
`Grounds for Objection: F.R.E. 401 (Test for Relevant Evidence); F.R.E. 402
`
`(General Admissibility of Relevant Evidence); F.R.E. 403 (Excluding Relevant
`
`Evidence for Prejudice, Confusion, Waste of Time, or Other Reasons).
`
`For example, paragraphs 23, 24, 25, and 28 are not relevant to arguments
`
`made in the petition materials. Further, to the extent this exhibit is deemed
`
`relevant, admission of the exhibit would be unduly prejudicial, misleading, and a
`
`waste of time because the opinion is not based on record evidence. Moreover,
`
`EX1021 is not admissible because it is not based on facts or data that the expert
`
`has been made aware of or personally observed.
`
`B.
`
`Kauffman, et al. Optimization of Lipid Nanoparticle Formulations
`for mRNA Delivery in Vivo with Fractional Factorial and
`Definitive Screening Designs (EX1024)
`Patent Owner objects to the admissibility of EX1024 and any document
`
`relying on EX1024.
`
`
`
`-1-
`
`
`
`Grounds for Objection: F.R.E. 401 (Test for Relevant Evidence); F.R.E. 402
`
`(General Admissibility of Relevant Evidence); F.R.E. 403 (Excluding Relevant
`
`Evidence for Prejudice, Confusion, Waste of Time, or Other Reasons); F.R.E. 106
`
`(Remainder of or Related Writings).
`
`EX1024 is not cited in the petition and is not prior art to the ’435 patent.
`
`Accordingly, this exhibit is not relevant to the proceeding. Further, to the extent
`
`this exhibit is deemed relevant, admission of the exhibit would be unduly
`
`prejudicial, misleading, and a waste of time because the opinion is not based on
`
`record evidence.
`
`C.
`
`Decision on Appeal, Appeal No. 2016-008388 (PTAB July 18,
`2018) (EX1025)
`Patent Owner objects to the admissibility of EX1025 and any document
`
`relying on EX1025.
`
`Grounds for Objection: F.R.E. 401 (Test for Relevant Evidence); F.R.E. 402
`
`(General Admissibility of Relevant Evidence); F.R.E. 403 (Excluding Relevant
`
`Evidence for Prejudice, Confusion, Waste of Time, or Other Reasons).
`
`EX1025 is a Board decision addressing patentability of claims in an
`
`application not owned by Protiva. Accordingly, this exhibit is not relevant to the
`
`proceeding. Further, to the extent this exhibit is deemed relevant, admission of the
`
`exhibit would be unduly prejudicial, misleading, and a waste of time because the
`
`opinion is not based on record evidence.
`-2-
`
`
`
`
`
`D.
`Declaration of Dr. Andrew S. Janoff (EX1007)
`Patent Owner objects to the admissibility of EX1007.
`
`Grounds for Objection: F.R.E. 401 (Test for Relevant Evidence); F.R.E. 402
`
`(General Admissibility of Relevant Evidence); F.R.E. 403 (Excluding Relevant
`
`Evidence for Prejudice, Confusion, Waste of Time, or Other Reasons); F.R.E. 703
`
`(Bases of an Expert).
`
`The Petitioner’s Reply confirms that Dr. Janoff’s opinions were based on the
`
`petition. Paper 28 at 24. That is, Dr. Janoff’s opinions are not based on evidence,
`
`but rather attorney argument. Accordingly, this exhibit is not relevant to the
`
`proceeding. Further, to the extent this exhibit is deemed relevant, admission of the
`
`exhibit would be unduly prejudicial, misleading, and a waste of time because the
`
`opinion is not based on record evidence. Moreover, EX1007 is not admissible
`
`because it is not based on facts or data that the expert has been made aware of or
`
`personally observed.
`
`III. CONCLUSION
`Exhibits 1021, 1024 and 1025 were filed and served on March 22, 2019.
`
`These objections are made within five business days of service.
`
`
`
`Dated: March 29, 2019
`
`
`
`
`
`
`
`Respectfully submitted,
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`-3-
`
`
`
`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Patent Owner’s Objection to Evidence was served on March 29, 2019,
`
`on the Petitioner at the correspondence address of the Petitioner as follows:
`
`Michael Fleming
`C. Maclain Wells
`IRELL & MANELLA LLP
`mfleming@irell.com
`mwells@irell.com
`ModernaIPR@irell.com
`
`
`
`
`
`
`
`
`
`Dated: March 29, 2019
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`-4-
`
`
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