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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`MODERNA THERAPEUTICS, INC.,
`Petitioner,
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`v.
`PROTIVA BIOTHERAPEUTICS, INC.,
`Patent Owner.
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`___________________
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`Case No. IPR2019-00554
`Patent No. 8,058,069
`___________________
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`PETITIONER’S CORRECTED OPPOSITION TO
`PATENT OWNER MOTION TO STRIKE
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`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`10821224
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`Case IPR2019-00554
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`Patent No. 8,058,069
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`Moderna’s Reply appropriately addresses (1) questions that the Board
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`raised in its Institution Decision (Paper 8 (“ID”)) and (2) arguments Protiva put
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`forth in its Response. See 37 C.F.R. §42.23(b) (reply “may…respond to
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`arguments raised in…patent owner response”), Trial Practice Guide Update, 83
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`Fed. Reg. 29,989, 18 (Aug. 2018) (“TPG”) (reply may “address issues discussed
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`in the institution decision”). Unable to fill the holes in its responsive arguments,
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`Protiva seeks to limit the record available for the Board’s consideration. But, the
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`issues that Protiva claims are “new” are nothing of the sort—the Board
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`specifically acknowledged these very issues when instituting this proceeding.
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`While Protiva complains that the Reply goes beyond the Petition,
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`“expan[sion] of the same argument made in [the] Petition” to address a Patent
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`Owner’s arguments is the purpose of a Reply. See Ericsson Inc. v. Intellectual
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`Ventures I LLC, 901 F.3d 1374, 1381 (Fed. Cir. 2018). “[T]he Board is capable
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`of identifying new issues or belatedly presented evidence when weighing the
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`evidence at the close of trial … [thus] striking the entirety or a portion of a party’s
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`brief is an exceptional remedy that the Board expects will be granted rarely.”
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`TPG, 17-18. Protiva presents no basis to grant such an exceptional remedy here.
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`1. The Petition Raised Routine Optimization Arguments
`The Board has already rejected Protiva’s argument that the Petition did
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`not raise routine optimization (Mot., 1- 2). See ID, 24-25, n.11. The Petition,
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`e.g., pointed to “testing relating to the 2:40 formulation that the Patent Owner
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`Case IPR2019-00554
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`identified as a prior art formulation” as a starting point (Pet., 31; EX1008, ¶109)
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`Patent No. 8,058,069
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`and argued, e.g., that “determining the optimal proportion of cationic lipid for
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`a given lipid combination would be a simple matter of varying the proportion
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`using prior art methodologies” (Pet. 33; Ex. 1008, ¶112).
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`Protiva’s argument that disclosure of a phospholipid range in the prior art
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`is a “new” issue (Mot., 2) is similarly unfounded. The Board already determined
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`that the Petition identified an overlapping phospholipid range and rejected
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`Protiva’s arguments to the contrary: “[t]urning first to Patent Owner’s contention
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`that neither the ’196 PCT nor the ’189 Publication discusses concentration
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`ranges for phospholipids … we do not find this argument persuasive.” ID, 23-
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`24; see also Pet. 38-39 (citing 5-90% range for the non-cationic lipid (e.g., the
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`phospholipid) and noting that it must be adjusted when cholesterol (also a non-
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`cationic lipid) is included), see also id., 13, 24, 27 (citing 5-90% range). The
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`Reply properly expands on these arguments.
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`Protiva’s argument that the Petition included no motivation to include the
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`four claimed lipid components (in particular a phospholipid and cholesterol) in
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`carrier particles (Mot., 3) similarly ignores arguments from the Petition. As
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`discussed above, the Petition identified prior art testing of the 2:40 SNALP
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`formulation as a basis for its obviousness arguments and noted that “[t]his
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`formulation includes 40% cationic lipid and 2% conjugated lipid, 10%
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`Case IPR2019-00554
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`phospholipid and 48% cholesterol … [and had] [d]emonstrated efficacy in vitro
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`Patent No. 8,058,069
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`and in vivo.” Pet. 26; EX1008, ¶¶96, 109. The Petition further described that
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`“[n]on-cationic ‘helper’ lipids, e.g., certain phospholipids and/or cholesterols,
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`can be combined with the cationic lipid to influence the ability of the particles
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`to transfect cells.” Pet., 8; EX1008, ¶63. These are thus not “new” issues.
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`2. Moderna’s Rebuttal Of Evidence Of Non-Obviousness Is Proper
`After Protiva offered evidence of non-obviousness in its preliminary
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`response, the Board stated that Moderna should have “an opportunity to respond
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`… [as] Patent Owner’s evidence is better evaluated in the context of a
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`completed trial where the record has been fully developed.” ID, 27. The Reply
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`points to glaring holes in Protiva’s alleged evidence, including that patisiran, the
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`alleged commercial embodiment, does not even use the claimed formulation. See
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`EX1020, ¶¶139-141. The Board should reject Protiva’s efforts to avoid
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`Moderna’s responsive arguments showing such inaccuracies.
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`Protiva’s position that a Petitioner must guess what evidence of non-
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`obviousness a patent owner may offer or be foreclosed from responding is
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`untenable. Protiva’s case support, Praxair Distribution, Inc. v. Mallinckrodt
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`Hospital Products, IPR2016-00777, Paper 10, dealt with (1) serial IPRs
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`regarding the same patent (id., 2), (2) likelihood of success in the initial
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`determination (id., 9), and (3) the lack of analysis of non-obviousness evidence
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`Case IPR2019-00554
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`from the original patent file wrapper (id.). Here, the Board already found a
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`Patent No. 8,058,069
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`likelihood of success, this is the first IPR on the ’069 patent, and the Petition
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`addressed alleged unexpected results discussed in the file wrapper (Pet., 12-14).
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`3. Protiva’s Mischaracterizations Of Dr. Janoff’s Opinions
`Moderna’s original expert, Dr. Janoff, passed away in December 2019.
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`Petitioner’s new expert, Dr. Anchordoquy stated: “I may have emphasized
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`different points or stated things differently, I agree with the general premises set-
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`forth regarding the invalidity of the ’069 patent as stated [by Dr. Janoff]”
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`EX1020, ¶3. Protiva’s argument that Moderna “abandons testimony of Dr.
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`Janoff” (Mot., 5) is simply wrong. Moreover, Protiva had the opportunity to
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`depose Dr. Anchordoquy on any alleged inconsistencies (EX2043) and could
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`have presented any such inconsistencies to the Board in its sur-reply.
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`The Board should reject Protiva’s mischaracterizations of Dr. Janoff’s
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`opinions to manufacture alleged inconsistencies. Protiva points to ambiguous
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`testimony from the ’435 IPR arguing that Dr. Janoff opined that the claims
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`should be limited to SNALPs (Mot., 4-5), but in that proceeding he testified that
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`the broad definition of a “lipid particle” from the specification should inform the
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`meaning of “nucleic acid-lipid particle.” EX2001, 200:4-201:9. In this
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`proceeding, Dr. Janoff unambiguously agreed with the Board’s prior refusal to
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`limit the claims to SNALPs. EX1008, ¶88; EX1022, 10-13 (Board decision). Dr.
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`Anchordoquy agrees that the claims are not limited to SNALPs and encompass
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`Patent No. 8,058,069
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`all types of nucleic acid-lipid particles, including potentially lipoplexes and
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`liposomes. See EX1020, ¶¶36-37. These positions are not inconsistent.
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`Protiva also points to statements from Dr. Janoff that the field is complex
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`and unpredictable to argue that Dr. Anchordoquy is offering contradictory
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`opinions by asserting routine optimization. Mot., 5. When you have a defined,
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`efficacious system like the 2:40 formulation tested in the prior art the
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`unpredictability in the field is minimized. EX1020, ¶56; EX2033:51:7-18 (Dr.
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`Janoff's reference to an “immense” range refers to the “hundreds of cationic
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`lipids known”), 60:5-15 (unpredictable because of that immense range of
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`available lipid species). Thus, both Drs. Anchordoquy and Dr. Janoff opine that
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`varying the lipid component percentages using such a defined system as a
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`starting point would require mere routine optimization. Id., ¶57; Ex. 1008, ¶112.
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`Finally, Protiva argues that Dr. Janoff admitted that patisiran uses the
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`claimed formulation citing a declaration from the ’435 IPR. Mot., 5. Dr. Janoff
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`cited to Protiva’s expert’s assertion regarding the patisiran formulation.
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`IPR2018-00739, EX1021, ¶33. The opinions of Protiva’s expert containing the
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`incorrect factual assertion regarding the patisiran formulation are part of the
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`record in this proceeding. See EX2004, ¶192.
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`For these reasons, Protiva’s motion to strike should be denied.
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`Case IPR2019-00554
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`Dated: April 6, 2020
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`Patent No. 8,058,069
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`Respectfully submitted,
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` /C. Maclain Wells/
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`Michael R. Fleming, Reg. No. 67,933
`C. Maclain Wells, Reg. No. 48,991
`IRELL & MANELLA LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, CA 90067-4276
`Telephone: (310) 277-1010
`Fax: (310) 203-7199
`Attorneys for Petitioner
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`Case IPR2019-00554
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`Patent No. 8,058,069
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that, pursuant to 37 CFR § 42.6(e), a
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`copy of the foregoing PETITIONER’S CORRECTED OPPOSITION TO
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`PATENT OWNER MOTION TO STRIKE PURSUANT TO 37 CFR §
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`42.64 was served electronically, as agreed to by the parties, on counsel for the
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`Patent Owner as follows:
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`WILSON SONSINI GOODRICH & ROSATI
`Michael T. Rosato, Reg. No. 52,182
`mrosato@wsgr.com
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`Steven W. Parmelee, Reg. No. 31,990
`sparmelee@wsgr.com
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`Sonja R. Gerrard, Reg. No. 72,802
`sgerrard@wsgr.com
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`Lora M. Green, Reg. No. 43,541
`lgreen@wsgr.com
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`
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`By: /Susan M. Langworthy/
` Susan M. Langworthy
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`April 6, 2020
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