Appeal No. 2004-2202 Page 7
Application No. 10/016,324
Without being limited as to theory, PEG(5000)-DMPE is believed to stabilize
the therapeutric [sic] compositions by preventing further aggrregation [sic]
of formed amphiphile/DNA complexes. . . .
pCF1-CFTR plasmid . . . is provided in water-for-injection. . . .
Complexing of the plasmid and amphiphile is then allowed to proceed by
gentle contacting of the two solutions for a period of 10 minutes.
Thus, Marshall does not provide any examples in which the therapeutic DNA is
included in the aqueous medium used to rehydrate the lipid-containing film (thus
forming liposomes, if any liposomes indeed form), nor does Marshall characterize any of
the disclosed compositions as comprising liposomes with entrapped DNA. Both the
methods disclosed by Marshall and Marshall’s characterization of the resulting product
support Appellants’ position that the DNA in the compositions is associated with the
surface of the cationic amphiphile/colipid structures (as a “complex”) rather than being
entrapped in structures that would be classified as liposomes.
Since Marshall does not disclose all of the limitations of the claims, it does not
anticipate. The rejection under 35 U.S.C. § 102(e) is reversed.
2. Obviousness
The examiner rejected claim 29, among others, as obvious in view of Marshall,
alone or combined with Mihalko. The examiner argues that it would have been obvious
to administer the composition disclosed by Marshall via inhalation, because Marshall
suggests that route of administration (column 34, lines 20-30) and because Mihalko
“shows that this route [is] a successful mode of administration of liposomes.”
Examiner’s Answer, page 6.
We will reverse this rejection. Marshall, as we have just discussed, does not
disclose compositions comprising a therapeutic agent entrapped within liposomes.
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 Next
Last modified: November 3, 2007