Paper No. ___
`Filed: March 30, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION,
`Patent Owner.
`_____________________________
`
`Case IPR2019-00554
`Patent No. 8,058,069
`_____________________________
`
`PATENT OWNER’S MOTION TO STRIKE
`
`
`Filed: March 30, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION,
`Patent Owner.
`_____________________________
`
`Case IPR2019-00554
`Patent No. 8,058,069
`_____________________________
`
`PATENT OWNER’S MOTION TO STRIKE
`
`
`
`I.
`
`INTRODUCTION
`This Motion to Strike is filed pursuant to the Board’s authorization of March
`
`12, 2020. See also stipulated extension of time, Paper 27, filed March 18, 2020.
`
`Reply arguments are deemed improperly new where they seek to take the
`
`case in a new direction or where they are used to belatedly present evidence to fill
`
`in gaps in the prima facie case presented in the petition. Consol. Prac. Guide., 73-
`
`74. Petitioner’s Reply does both. Petitioner based its petition on overlapping ranges
`
`caselaw, overlooking that this legal theory is based on a routine optimization
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`rationale. This was made clear by Petitioner’s embrace of the complexity and
`
`unpredictability of the technology in its Petition. Indeed, Dr. Janoff expressly
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`disavowed Petitioner’s routine optimization theory.
`
`The petition lacks critical evidence necessary to support a prima facie case
`
`of obviousness in view of the overlapping range caselaw. E.g., POR, 14-19. In an
`
`attempt to backfill these holes, the Reply advances new evidence and argument.
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`This is improper. A such, the Reply should be struck in its entirety. Alternatively,
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`and at a minimum, the portions of the Reply identified below should be struck or
`
`ignored by the Board.
`
`II.
`
`Petitioner’s New Phospholipid Theory
`The Reply (5) argues that disclosure of “non-cationic/neutral lipid range of
`
`5-90mol%” suffices as an overlapping range for the claimed phospholipid range.
`
`
`
`-1-
`
`
`
`This is improperly new. The Petition (39, 57-58) presented a different theory that
`
`overlapping ranges of 0-19% or 0-19.5% phospholipid could be derived from the
`
`prior art by assuming levels for cationic lipid, cholesterol, and conjugated lipid.
`
`See also D.I., 23, 36. This new argument is untimely, improper, and waived. The
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`Board should strike it from the Reply.
`
`III. Assertions of Routine Optimization are Untimely
`The Reply’s main arguments are premised on a routine optimization theory.
`
`Specifically, the Reply (7-22) assumes that a POSA would begin with four
`
`components (i.e., cationic lipid, phospholipid, cholesterol, and conjugated lipid)
`
`then seek to optimize the level of each to obtain the claimed nucleic acid-lipid
`
`particles. The Reply provides no evidence that might support such a rationale and
`
`the introduction of this new theory is improper. See also D.I. 26, fn 11. Contrary to
`
`these new arguments, Petitioner and Dr. Janoff conceded that optimization of the
`
`prior art ranges would not be routine. Dr. Janoff admitted the broad lipid ranges in
`
`the cited art would require “undue experimentation, not simple optimization” and
`
`emphasized the unpredictability of the technology. E.g., EX2033, 42:7-10, 60:5-16,
`
`19:25-20:15. Petitioner cannot now decide to replace its old insufficiently plead
`
`arguments with new arguments advanced by its new expert. The Board should
`
`strike each paragraph related to Petitioner’s new routine optimization theory.
`
`
`
`-2-
`
`
`
`IV. Motivation to Include Optional Lipids Is Untimely
`The challenged claims recite specific concentration ranges for each
`
`component which comprise nucleic acid-lipid particles. Under the overlapping
`
`ranges legal framework, a presumption of obviousness only exists where there is
`
`motivation to include the recited components in nucleic acid-lipid particles along
`
`with disclosure of overlapping ranges for each lipid component. To the extent the
`
`Petition (7-8) has any discussion of the cholesterol, phospholipid, and conjugated
`
`lipid components, it is limited to general allegations the level of each can affect
`
`properties of lipid particles. The Petition is devoid of any motivation to include all
`
`three of these components in lipid particles. This omission is glaring because the
`
`prior art, including the grounds references, identify these components as optional.
`
`The Reply attempts to backfill this missing motivation. For example, the
`
`Reply (20) now argues that a “POSITA would be motivated to include cholesterol
`
`to provide increased rigidity to the particle.” This is improper. To the extent the
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`Petition (7-8) discussed cholesterol, it was to assert that it was optionally included
`
`in lipid particles, offering only conclusory legal arguments and providing no clear
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`evidence for motivation to include cholesterol. Similarly, the Reply (21) newly
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`argues that a POSITA would want to include “phospholipid as a bilayer stabilizing
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`component,” an argument not advanced in the Petition, and thus, improper.
`
`
`
`-3-
`
`
`
`V. Belated Argument Regarding Objective Indicia Is Improper
`Petitioner was aware of the very evidence of objective indicia that PO relies
`
`on here when it filed its petition, but failed to analyze such evidence, much less
`
`rebut it. Praxair Distribution, Inc. v. Mallinckrodt Hospital Products, IPR2016-
`
`00777, Paper 10, 9 (concluding that petitioner should have addressed available
`
`evidence of objective indicia in the petition). Any attempt to address objective
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`indicia in the Reply is therefore untimely and should be ignored.
`
`PO submitted its Response in IPR2018-00739, which included evidence of
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`objective indicia, on December 21, 2018. Petitioner filed the petition in this case
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`on January 9, 2019. Because the objective indicia evidence was already in
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`Petitioner’s possession at the time the petition was filed, it should have addressed
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`long-felt need, failure of others, skepticism, and commercial success.
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`That Petitioner waited until the Reply is particularly prejudicial here because
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`it now attempts to walk away from positions that were previously conceded. For
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`example, Dr. Janoff admitted that patisiran “contains 50% cationic lipid, 38.5%
`
`cholesterol, 10%DSPC, and 1.5% PEG.” IPR2018-00739, EX1021, ¶33. In the
`
`Reply (28), Petitioner relies on a new witness to promote a new, unexplained, and
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`contradictory theory that patisiran “does not use the claimed lipid ranges.” This is
`
`improper and the Board should strike each related paragraph.
`
`
`
`-4-
`
`
`
`VI. Attempts to Abandon Dr. Janoff’s Testimony Are Improper
`Petitioner, through its new Reply witness, simply abandons testimony of Dr.
`
`Janoff that is inconvenient to its stated case. This is improper. Dr. Janoff testified
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`that the specification defines “nucleic acid-lipid particles” more narrowly than ever
`
`advocated by PO and conceded that lipoplexes are outside the scope of the claims.
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`EX2001, 118:19-119:4, 119:9-17, 120:5-6, 121:14-25, 122:1-24. The Reply (3-4)
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`now asserts that encapsulation of nucleic acid is not required and that liposomes
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`and lipoplexes are within the scope of “nucleic acid-lipid particles.”
`
`Dr. Janoff repeatedly testified as to the complex and highly unpredictable
`
`nature of the claimed technology and unambiguously disavowed routine
`
`optimization. E.g., EX2001, 144:18-145:1, 57:19; EX2033, 42:7-10, 60:5-16,
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`19:25-20:15. The Reply (7-22) now embraces routine optimization, pretending as
`
`if the concessions of unpredictability and undue experimentation never occured.
`
`Cf. Reply, 24 (embracing unpredictability when discussing unexpected results).
`
`Dr. Janoff testified that even minor changes in the amount of phospholipid
`
`would affect the performance of lipid particles. EX1008, ¶86. The Reply (21-22)
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`now argues just the opposite. This is improper and should be stricken.
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`VII. Conclusion
`Petitioner’s Reply arguments that attempt to move the case in a new
`
`direction or backfill holes from the petition case should be stricken or disregarded.
`
`
`
`-5-
`
`
`
`Dated: March 30, 2020
`
`
`
`
`
`Respectfully submitted,
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`
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`-6-
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`
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`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Patent Owner’s Motion to Strike on March 30, 2020, 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 30, 2020
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`-7-
`
`
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