Appeal No. 1995-3021
Application 07/949,347
while larger amounts of codeine result in severer side effects. Appellant also acknowledged in
this portion of the specification that compositions were available containing 300 mg of
acetaminophen or acetyl salicylic acid and lower amounts of codeine such as 7.5 mg or 15 mg.
These compositions are stated to have been used for children or patients with small body
weight.
The claimed invention differs from the acknowledged prior art in that the present unit
dosage form must contain 1,000 mg of acetyl salicylic acid or acetaminophen or a combination
of the two in which 10 to 80% of the combination may be acetyl salicylic acid and 20 to 90% may
be acetaminophen. Importantly, the claimed unit dosage forms contain 7.5 to 20 mg of codeine.
Appellant asserts at page 3, lines 6-15 of the specification that the claimed compositions having
a relatively lower amount of codeine are still an effective analgesic. In support of this assertion,
appellant relies upon what is termed a “certification” from Dr. Wayne Pasanen. A copy of the
certification is attached to the “Reply of Appellant To Supplemental Examiner's Answer” filed
April 23, 1998 (Paper No. 24). Dr. Pasanen indicates that he has been collaborating with
appellant in a clinical study involving the present invention since 1985. The study included a
“Treatment A” wherein 300 mg of acetaminophen with 30 mg of codeine was used and a
“Treatment B” wherein a treatment involving 1,000 mg of acetaminophen with 15 mg of codeine.
Dr. Pasanen states in paragraph 4 that he has “examined and made comments on the protocol
of the study, and I believe that it is a well controlled investigation, with methodology that is quite
relevant to clinical practice.” In relevant part, Dr. Pasanen states in paragraph 5:
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