Appeal No. 2005-0416 Page 3
Application No. 09/970,020
reduce the adverse side effects of nausea and/or dizziness
believed to be associated with that enantiomer.
The examiner recognizes, however, that while “Gilbert teaches that any
conventional controlled-release technology can be used to achieve the desired
tablet formulation[,] Gilbert does not expressly teach the heteropolysaccharide
and polysaccharide gum excipients formulation” required by appellant’s claimed
invention. Answer, page 3. The examiner relies on Baichwal to make up for this
deficiency in Gilbert.
According to the examiner (id.), Baichwal teaches “a free-flowing slow
release excipient formulation comprising a heteropolysaccharide … and a
polysaccharide….”3 In addition, the examiner finds (Answer, page 5), Baichwal
“teaches that the excipients system can be used with a wide variety of drugs that
are soluble and/or insoluble and that this system is less expensive and easily
compressed in the preparation of the tablets.”
Based on this evidence the examiner concludes (Answer, page 4),
It would have been [prima facie] obvious to a person of ordinary
skill in the art [at the time the invention was made] to incorporate
the free-flowing slow release excipients formulation taught by
Baichwal into the bi-layer tablet that has a controlled release and
immediate release profile for tramadol taught by Gilbert because
Gilbert teaches that any conventional controlled-release technology
can be used to achieve the desired controlled release excipients for
delivery of an active agent … [that] is inexpensive to manufacture
and can be easily compressed into tablets which eliminates the use
of expensive manufacturing equipment.
In response, appellants argue (Brief, page 4), “[n]othing in Baichwal
suggests use of the disclosed sustained release excipients in two-part
3 Appellants recognize (Brief, page 3), “Baichwal teaches a heteropolysaccharide and
polysaccharide gum excipients for controlled release delivery of a drug.” See also Reply Brief,
page 2.
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Last modified: November 3, 2007