Claim 25 of the Patent merely requires solid pharmaceutical ’364 “A composition comprising, as an active ingredient,” the crystalline Form A of claim 1, at least one suitable additive or auxiliary substance.” (Id. at 19:56-63.) “and As with respect to claim 1, inherently discloses tapentadol HCl Bartholomaeus Form A. further discloses in Example 1 tablets” containing Bartholomaeus “Matrix methylcellulose,” cellulose,” disperse “Hydroxypropyl “Microcrystalline “Highly silicon dioxide,” and stearate.” (Ex. 1009 at 18.) Thus, “Magnesium explicitly discloses a solid pharmaceutical composition comprising Bartholomaeus least one suitable additive or auxiliary substance” in addition to the inherently “at disclosed Form A, anticipating claim 25. (Ex. XX ¶ XX.) (Compare Ex. 1001 at to 4:24-30 (stating that suitable additives and auxiliary substances include “carrier materials, fillers, solvents, diluents, coloring agents and/or binders, and may be administered as liquid medicament preparations in the form of injectable solutions, drops or juices, as semi-solid medicament preparations in the form of granules, tablets, pellets, patches, capsules, plasters or aerosols.”) anticipates dependent claims 2–4. Bartholomaeus Claim 2 depends from claim 1 and adds the limitation that Form A exhibits least X-ray lines (2-theta values) in a powder diffraction pattern when measured “at using Cu Kα radiation at 14.5±0.2, 18.2±0.2, 20.4±0.2, 21.7±0.2 and 22.5±0.2.” (Id. at 19:7-10.)
Claim 25 of the ’364 Patent merely requires “A solid pharmaceutical composition comprising, as an active ingredient,” the crystalline Form A of claim 1, “and at least one suitable additive or auxiliary substance.” (Id. at 19:56-63.) As with respect to claim 1, Bartholomaeus inherently discloses tapentadol HCl Form A. Bartholomaeus further discloses in Example 1 “Matrix tablets” containing “Hydroxypropyl methylcellulose,” “Microcrystalline cellulose,” “Highly disperse silicon dioxide,” and “Magnesium stearate.” (Ex. 1009 at 18.) Thus, Bartholomaeus explicitly discloses a solid pharmaceutical composition comprising “at least one suitable additive or auxiliary substance” in addition to the inherently disclosed Form A, anticipating claim 25. (Ex. XX ¶ XX.) (Compare to Ex. 1001 at 4:24-30 (stating that suitable additives and auxiliary substances include “carrier materials, fillers, solvents, diluents, coloring agents and/or binders, and may be administered as liquid medicament preparations in the form of injectable solutions, drops or juices, as semi-solid medicament preparations in the form of granules, tablets, pellets, patches, capsules, plasters or aerosols.”) Bartholomaeus anticipates dependent claims 2–4. Claim 2 depends from claim 1 and adds the limitation that Form A exhibits “at least X-ray lines (2-theta values) in a powder diffraction pattern when measured using Cu Kα radiation at 14.5±0.2, 18.2±0.2, 20.4±0.2, 21.7±0.2 and 22.5±0.2.” (Id. at 19:7-10.)
DepoMed-Nucynta-7994364-IPR-draft.docx