Appeal No. 2006-0139
Application No. 09/583,228
partially acid soluble component, the pH dependent and pH independent polymers, and
the thickness of the coating." "Once a minimum amount of the at least partially acid
soluble component, and/or the maximum thickness of the coating to achieve the
minimum dissolution profile at an highly acidic pH has been established, then it is simply
a matter of design choice to adjust the composition and /or thickness of the coating as
desired." Column 9, lines 5-10. In addition, Morella further describes that, "[i]t has been
found that the dissolution rate of the soluble drug at various pH's can be modified at will
by altering the ratio of polymers." Column 9, lines 11-14. Therefore, we agree with the
examiner that it would have been obvious to one of ordinary skill in the art to adjust the
thickness and amounts of the coatings described in Morella to achieve a desired
dissolution profile.
Moreover, with respect to claim 26, Morella particularly describes a hybrid
coating having more than one layer, such as a layer soluble at less acidic pH and a
layer soluble at acidic pH. Column 8, lines 34-67. Thus, Morella evidences that it is
within the skill of one of ordinary skill in the art to adjust the drug dissolution rate based
upon the coating thickness and amounts of coating ingredients, and adjust the location
of drug dissolution, either the stomach or intestine, based on the pH of the tablet
coating.
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