Appeal No. 2006-0251 Page 7
Application No. 10/017,697
tri-esters and therefore have a substantially bitter taste (due at least in part to the
presence of the tri-ester), which is not masked and therefore is perceptible by a
patient.” In support of this assertion appellants direct attention to the Dee
Declaration, received April 30, 2004. According to Dee (Declaration, paragraph
14), as illustrated in Exhibit 2 attached to the Declaration, testing in Dee’s
“laboratory determined that the compositions of White are unacceptably bitter.”
In response, the examiner argues (Answer, page 11), “[t]he instant
composition does not exclude the presence of tri-esters. The exhibit does not
present a parallel example where the tri-ester of White is included in the instant
composition. The tasting experiment thus focused on the composition of the
prior art and not on the instant composition, which does not exclude tri-esters.”
We cannot agree with the examiner’s assertion. According to Dee (Exhibit 2,
page 1), “a pharmaceutical composition containing acetaminophen was prepared
according to the composition and process described in White’s Example VIII.”
As discussed above (n. 4), White exemplifies several liquid pharmaceutical
formulations of which only Example VIII exemplifies a composition that contains a
drug, polyethylene glycol, polyvinylpyrrolidone, and a tri ester. Accordingly,
White’s Example VIII is the “parallel example” the examiner appears to be asking
for, wherein the tri-ester of White is included in appellants’ claimed composition,
which comprises a drug, polyethylene glycol and polyvinyl pyrrolidone. As set
forth in Dee (Declaration, paragraph 14, and Exhibit 2, page 1), the composition
was “unacceptably bitter.” Thus, the evidence of record establishes that White’s
Page: Previous 1 2 3 4 5 6 7 8 9 10 Next
Last modified: November 3, 2007