Appeal No. 2005-1152
Application No. 10/202,616
lipid with a neutral charge and does not suggest a charged lipid can be substituted for a
neutral charged lipid in its particles incorporating surfactants for pulmonary drug
delivery. Thus, we do not find that Hanes provides an adequate reason, suggestion or
motivation to select or combine the disclosure of Hanes with the cationic lipids
described by Szoka.3 Appellants argue that “the rejection does not explain why it would
be obvious to turn to the teachings of Szoka to, for example, select DPePC as a lipid for
manufacturing a non-nucleic acid formulation for pulmonary delivery and achieve a
sustained release formulation.” Reply Brief, page 7.
We agree. The rejection of the claims for obviousness over Hanes and Szoka is
reversed.
According to the examiner, Hanes Iacks specific teachings of suitable lipids, and
the combined teachings of Hanes and Szoka, discussed above, Iack specific teachings
of carboxylic acid and metal salts. The examiner relies on Zuckermann for teaching
compositions and methods for increasing the uptake of polynucleotides into cells. The
composition comprises a Iipoprotein, a polynucleotide binding molecule and a
polynucleotide (col. 1, Iine 60 to col. 2, Iine 7). While teaching the synthesis of a
polycationic agent, Zuckermann discloses use of aliphatic hydroxyl groups, carboxylic
3 Compare specification, page 44, showing (1,2-dipalmitoyl-sn-glycero-3-
phosphocholine) DPPC (with neutral charge) and insulin as compared to sustained
release obtained with positively charged DPePC (1,2-dipalmitoyl-sn-glycero-3-
ethylphosphatidylcholine) and insulin; or page 48, showing negatively charged DSPG
with albuterol sulfate is 4 times slower compared to DSPC, having no net overall
charge.
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