Patent No. 7,579,019B2
PTAB Final Written Decision (Aug. 5, 2015)
Brief Summary: Monosol’s Petition based on anticipation and obviousness denied based on construction of Arius’ claims as being limited to single layer devices.
Summary: Monosol filed a Petition in January 2014 seeking IPR of claims 1-7 of Arius Two’s US 7,579,019B2 regarding a water-erodable pharmaceutical carrier device, a layered film comprising an adhesive layer and a backing layer with the pharmaceutical in one or more layers, for application to mucosal surfaces. Monosol argued claims 1-3 and 5-7 were anticipated by US 5,298,256 (“Flockhart”), claims 1-5 and 7 were anticipated by US 4,713,239 (“Babaian”), and claims 1-7 would have been obvious over US 4,764,378 (“Keith”) and Babaian. Arius filed two expert Declarations with its response. The Decision includes independent claim 1, from which claims 2-7 depend, as illustrative. The PTAB construed the claim terms “onset of activity in the subject” and “within about 30 minutes” in their Decision to Insitute and “bioerodable device” in this Final Decision under the broadest reasonable interpretation (BRI) standard. The PTAB concluded that the BRI of the term in view of the ‘019 specification is “a multilayer bioerodable device”. In making this determination, the PTAB explained that “giving claims their [BRI]…does not include giving claims a legally incorrect interpretation” (In re Kkvorecz (FC 2009) and requires that “the claims be read in light of the specification” (In re Suitco Surface, FC 2010). And it concluded the specification did not include any single layer embodiments, which is supported by the prosecution history (“In proceedings such as inter partes reviews, in which a patent has been brought back to the Office for a second review, we are to consult the prosecution history…” Microsoft, FC 2015; “[I]t is normally ‘improper to read limitations from a preferred embodiment-even if it is the only embodiment-into the claims,’ [but] that rule does not apply where there is a ‘clear indication in the intrinsic record that the patentee intended the claims to be so limited.’” Liebel-Flarsheim, FC 2004); “[W]hen a patentee refers to a particular embodiment as ‘the invention,’ and the specification does not provide any alternative embodiments, ‘[t]he public is entitled to take the patentee at his word…that the invention is’ that embodiment. Honeywell, FC 2006; see also SciMed, FC 2001 at 1341). Under this interpretation, the PTAB concluded no anticipation by Flockhart or Babaian as these only disclose single layer device. It also found “Keith does not remedy [the] deficiency” in Babaian as it only discloses “a single-layer, homogenous product” (and “distinguishe[d] its product from those in the prior art which have multiple layers”). Thus, the PTAB concluded “Monsol has not proven by a preponderance of the evidence that the prior teaches all elements of challenged claims 1-7” and ordered that claims 1-7 “are not unpatentable”.