Appeal No. 2006-0139
Application No. 09/583,228
The examiner concludes (Answer, page 4)
It would have been obvious to one of ordinary skill in the art at the
time the invention was made to make the particular composition
containing the specific ingredients herein in amounts herein.
One of ordinary skill in the art would have been motivated to make
the composition [c]laimed herein since a substantially similar composition
is taught in the prior art.
We find the examiner has provided sufficient evidence to support a prima facie
case of obviousness. In particular, with respect to claim 1, Morella describes a core
element which contains a drug and further includes a filler of as much as 10% by weight
of hydroxypropylmethyl cellulose1 or polyvinylpyrollidone. Morella, column 11, lines
24-50. Morella further describes a coating layer including an enteric polymer such as a
methacrylic acid copolymer or "a cellulose" (column 9, lines 17-31) and 0-75% of a filler
such as silicon dioxide (column 10, lines 4-9). The pharmaceutical pellet of Morella
may be in tableted form. Column 13, lines 32-34.
We further note that appellant's claims are broad and are not limited to a specific
dissolution profile. Morella discloses that the desired dissolution profile of the drug can
be selected by adjusting the amounts of ingredients in the coating layers. Morella
discloses (Column 8, line 63 to column 9, line 1) that "[t]he rate of dissolution at highly
acidic pH of the hybrid core coating will depend on the amount of the at least one
1 Specification, page 3, lists hydroxypropylmethylcellulose as a gelling agent.
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