During the week of September 10, the Board issued two decisions in Technology Center 1600, each of which instituted an inter partes review (“IPR”) proceeding.  The decisions are as follows:

Moderna Therapeutics, Inc., v. Protiva Biotherapeutics, Inc., No. IPR2018-00680 (Decision Entered September 12, 2018).  Moderna Therapeutics, Inc. (“Moderna”) challenged claims 1­–22 of U.S. Patent No. 9,404,127 (“the ’127 Patent”) as anticipated by and/or obvious in view of six references.  The ’127 Patent “relates to stable nucleic acid-lipid particles (SNALP) that have a non-lamellar structure and that comprise a nucleic acid.”  IPR2018-00680, Paper 13 at 3 (internal quotations omitted).   Both Moderna and Protiva Biotherapeutics, Inc. (“Protiva”) advanced a claim construction of the term “nucleic acid-lipid particle.”  Moderna proposed that “nucleic acid-lipid particle” means “a composition of lipids and a nucleic acid for delivering a nucleic acid to a target site of interest.”  Protiva contended such a construction is unreasonably broad, and the term should be defined as “non-lamellar particles formulated to fully encapsulate the nucleic acid component and to be stable in serum following systemic (in vivo) administration.”  Id. at 7-8 (internal citations omitted).  According to the Board, Moderna’s “proposed construction is a general restatement of the composition recited in claim 1 and a use thereof as set forth in the ’127 patent,” while Protiva’s “proposed construction is not consistent with claim 1.”  Id. at 8.  Solely for the purpose of deciding whether to institute IPR, the Board defined “nucleic acid-lipid particle” consistent with the ’127 Patent specification’s definition of lipid particle.

Ground 1: Moderna’s “anticipation challenge is based on the contention that the only limitation from claim 1 of the ’127 patent not disclosed explicitly in U.S. Patent No. 8,058,069 (“the ’069 Patent”) is 95% of the claimed particles having a non-lamellar morphology, but that [Protiva] . . . uses several of the formulations disclosed in the ’069 patent to illustrate in the later ’127 patent a greater than 95% non-lamellar morphology among such particles.”  Id. at 11 (internal citations omitted).  Moderna alleged that the final wherein clause of claim 1 is inherently anticipated by the ’069 Patent which results from “(1) the lipid composition of a SNALP formulation and (2) the formation process used to prepare the SNALP formulation”.  The particle composition and methods of making the claimed particle are disclosed in the ’069 Patent and “the ’127 Patent itself identifies these variables as resulting in the claimed property.”  Id. at 11-12 (internal citations omitted).  The Board found Protiva’s burden-shifting arguments improper despite Protiva’s argument that “Ground 1 [was] not presented with the requisite degree of particularity as it states alternate theories of challenge and lacks clarity as to the particular references on which the alternate obviousness theory rests.”  Protiva’s “arguments fail to appreciate that there is a significant difference between a petitioner’s burden to establish a reasonable likelihood of success at institution, and actually proving invalidity by a preponderance of the evidence at trial. … [T]he analysis at the institution stage is very different and made under a qualitatively different standard than the standard applicable in reaching the Final Written Decision.”  Id. at 13 (internal citations and quotations omitted).  The Board also dismissed Protiva’s allegation that Moderna left the task of evaluating the cited disclosure of the ’069 Patent as overly burdensome to the Board and to Protiva “given that the ’069 patent and the ’127 patent are commonly owned by Protiva and have overlapping named inventors.”  Id. at 14 (internal citations and quotations omitted).  Finally, Protiva argued that Moderna’s anticipation analysis suffers from “mixing and matching different embodiments” of the ’069 Patent.  Id. at 15.  The Board disagreed at least because the basis for Protiva’s arguments rested on features of the claimed particle that were not expressly recited in the claims but rather described in the specification.  Moreover, Moderna’s alleged “mixing and matching” included just one component of the claimed particle that were listed in the alternative in the ’069 Patent as examples of the component.  Id. at 16.  Moderna relied on incorporation by reference and disclosed prior art ranges to allegedly anticipate each of dependent claims 2-22.  The Board noted that possible issues may develop during trial with respect to the dependent claims, and the Board invited Moderna to submit extrinsic evidence in support of its obviousness position as an alternative to anticipation.


Grounds 2-4: Similar to Ground 1, Moderna alleged that claims 1-22 are anticipated by and/or obvious in view of five references.  Protiva asserted that Moderna failed to meet its burden with respect to articulating how claims 1-22 were anticipated by and/or obvious in view of these five references and, rather, advanced several conclusory statements in an attempt to support its position.

Despite Protiva’s complaints, the Board instituted IPR on claims 1-22 because Moderna “established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’127 Patent.  Id. at 2.

Moderna Therapeutics, Inc., v. Protiva Biotherapeutics, Inc., No. IPR2018-00739 (Decision Entered September 12, 2018).  Moderna challenged claims 1­–20 of U.S. Patent No. 9,364,435 (“the ’435 Patent”) as anticipated by and/or obvious in view of seven references.  The ’435 Patent is directed to subject matter similar to that of the ’127 Patent.  Moderna and Protiva advanced the same claim constructions for the term “nucleic acid-lipid particle” here as in the ’680 IPR described above and the Board arrived at the same conclusion, instituting IPR.

Ground 1: Moderna alleged that claims 1-20 would have been obvious in view of two references, the combination of which disclosed “nucleic acid-lipid particles that comprise a nucleic acid, and the lipid components—a cationic lipid, a non-cationic lipid, and a conjugated lipid—in mol percentage ranges that overlap with the claimed ranges.”  Id. at 18.  Protiva responded the claimed ranges for at least the cationic lipid component were “contrary to the conventional wisdom concerning the community’s aversion to the toxicity and poor in vivo efficacy associated with formulations with a high level of cationic lipid.”  However, the Board credited Moderna’s expert who stated that “determining the optimal proportion of cationic lipid for a given lipid combination would be a simple matter of varying the proportion using prior art methodologies” in determining the explicit disclosure of overlapping ranges.  Id. at 18-19.  Protiva also relied on unexpected results and argued that 1) “the claimed formulations are well-tolerated and possess favorable in vivo transfection efficiency at far lower dosages than prior art formulations,” and 2) “the claimed formulations are well-tolerated following systemic delivery.”  Id. at 25.  The Board pointed back to its construction of the term “nucleic acid-lipid particle” as not nearly as narrow as advanced by Protiva and stated that “such a fact intensive inquiry concerning unexpected results is best vetted during trial on a full record.”  Id.  Accordingly, the Board found that “the disclosure in the prior art of the overlapping ranges to the claimed invention shows a reasonable likelihood [Moderna] will prevail in establishing that at least claim 1 of the ’435 patent would have been obvious to one of skill in the art.”  Id. at 19.

Grounds 2 and 3: Similar to Ground 1, Moderna alleged that claims 1-20 were anticipated by and/or would have been obvious in view of five references.  As pointed out by Protiva, Moderna “picks and chooses and thus, mischaracterizes the teachings” of two of these references and in particular, disclosures that teach away from Moderna’s proposed combinations.  Id. at 30.  Protiva also alleged that Moderna failed to sufficiently explain how one of ordinary skill in the art would combine the various references to arrive at the claimed invention with a reasonable expectation of success.  Id.  While the Board seemed to agree with Protiva, the Board found that the sufficiency of these grounds should be vetted during trial on the full record.  Id. at 32-33.

Accordingly, the Board instituted IPR on claims 1-20 because Moderna “established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’435 Patent.  Id. at 3.