232 (Oxford University Press 1985) (“monoclinic Analysis: A Primer form” means unit cell in which there is a two-fold rotation axis “a parallel to one cell axis (usually chosen as An example of a b).”) …. monoclinic unit cell is shown below: Nothing in the specification (or elsewhere in the intrinsic evidence) suggested … that the inventors wished to depart from the conventional meaning of “monoclinic form.” (Ex. 1019 at 41-42 (citation omitted).) In so stating, the Patent Owner argued that form,” as used in this claim, encompass unit cells “monoclinic “could of many different shapes and sizes,” and should not that broad claim term to “limit a single unit cell having the precise parameters described in column 2, lines 58 to 61 of the patent specification.” (Ex. 1019 at 42.) Petitioner agrees. Thus, any ’364 observed variations from the particular monoclinic form disclosed in the ’364 patent do not affect Petitioner’s anticipation analysis. anticipates dependent claims 24 and 26. EP 475 Claim 24 depends from claim 1 and adds the limitation that Form A is produced by the process of: dissolving (−) hydrochloride of Form B in acetonitrile together with active carbon, heating the solution to the boiling point, removing the active carbon by filtering, stirring the solution at a temperature below 40o C.,
Analysis: A Primer 232 (Oxford University Press 1985) (“monoclinic form” means “a unit cell in which there is a two-fold rotation axis parallel to one cell axis (usually chosen as b).”) …. An example of a monoclinic unit cell is shown below: … Nothing in the specification (or elsewhere in the intrinsic evidence) suggested that the inventors wished to depart from the conventional meaning of “monoclinic form.” (Ex. 1019 at 41-42 (citation omitted).) In so stating, the Patent Owner argued that “monoclinic form,” as used in this claim, “could encompass unit cells of many different shapes and sizes,” and should not “limit that broad claim term to a single unit cell having the precise parameters described in column 2, lines 58 to 61 of the ’364 patent specification.” (Ex. 1019 at 42.) Petitioner agrees. Thus, any observed variations from the particular monoclinic form disclosed in the ’364 patent do not affect Petitioner’s anticipation analysis. EP 475 anticipates dependent claims 24 and 26. Claim 24 depends from claim 1 and adds the limitation that Form A is produced by the process of: dissolving (−) hydrochloride of Form B in acetonitrile together with active carbon, heating the solution to the boiling point, removing the active carbon by filtering, stirring the solution at a temperature below 40o C.,
DepoMed-Nucynta-7994364-IPR-draft.docx