Petition for Inter Partes Review of U.S. Patent No. 9,517,219 “[i]n recent years, there has been great interest in the use of novel polymers with complex functions as emulsifiers and thickeners because the gelling capacity of these compounds allows the formulation of stable emulsions and creams by decreasing surface and interfacial tension and at the same time increasing the viscosity of the aqueous phase.” (MYLAN1015, 1).
A method for treating a dermatological condition selected from the group consisting of acne vulgaris and rosacea comprising administering to a subject having the dermatological condition selected from the group consisting of acne vulgaris and rosacea a topical pharmaceutical composition comprising: [a] about 7.5% w/w dapsone; [b] about 30% w/w to about 40% w/w diethylene glycol monoethyl ether; [c] about 2% w/w to about 6% w/w of a polymeric viscosity builder consisting of acrylamide/sodium acryloyldimethyl taurate copolymer; [d] and water; Petition for Inter Partes Review of U.S. Patent No. 9,517,219 Garrett: “In one preferred embodiment, the composition includes about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water; about 10% to 30% ethoxydiglycol; about 0.2% methylparaben; about 5% to 10% dapsone in a microparticulate and dissolved state; and about 0.1% to 2% sodium hydroxide solution.” (MYLAN1004, 4:2-5) Garrett: “In one preferred embodiment, the composition includes about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water; about 10% to 30% ethoxydiglycol; about 0.2% methylparaben; about 5% to 10% dapsone in a microparticulate and dissolved state; and about 0.1% to 2% sodium hydroxide solution.” (MYLAN1004, 4:2-5) Garrett: “Thickening agents include polymer thickeners.
Polymer thickeners that may be used include those known to one skilled in the art, such as hydrophilic and hydroalcoholic gelling agents frequently used in the cosmetic and pharmaceutical industries.” (MYLAN1004, 13:3-5) Bonacucina: “Preferably, the gelling agent comprises between about 0.2% to about 4% by weight of the composition.” (MYLAN1004, 13:10-11) “Sepineo® P 600, based on the concept of droplet hydroswelling, is a concentrated droplet dispersion of acrylamide/sodium acryloyldimethyl taurate (a viscous liquid at room temperature) in isohexadecane as the oily Petition for Inter Partes Review of U.S. Patent No. 9,517,219 dispersing phase.” (MYLAN1015, 2; MYLAN1002/1035, ¶70) “Both techniques revealed that Sepineo® P 600 thickens and gels well, a property that depends strongly on polymer concentration.
Petition for Inter Partes Review of U.S. Patent No. 9,517,219 A POSA would understand that small variations in the preparation of the composition can affect the properties (e.g., particle size, polymorph) of a resulting recrystallized precipitate.
The examiner previously considered Garrett as a secondary reference in the context of two dependent claims for the limited proposition that topical dapsone formulations had been shown to be effective in the treatment of acne vulgaris.