Appeal No. 2005-1152
Application No. 10/202,616
It is the examiner’s position that (Paper No. 6, pages 2-3):
Unger teaches cationic Iipid compounds which comprises [sic] at Ieast two
cationic groups. The cationic Iipid compounds are particularly suitable for
use as carriers in intracellular delivery of bioactive agents, including
pharmaceuticals and genetic material (col. 5, lines 13-38). Cationic lipid
compound refers to a Iipid which comprises a cationic group and which
functions generally as a positively charged ion, for example, in solution
(col. 8, Iines 39-44). Bioactive agent refers to a substance which is
capable of exerting a biological effect [sic, and?] is preferably therapeutic
in nature. The bioactive agents may be neutral or positively or negatively
charged. Preferably the bioactive agents are negatively charged.
Examples of suitable bioactive agents include proteins (col. 9, Iines
43-57). [?]In combination with[”] refers to the incorporation of a bioactive
agent with a cationic lipid compound. The cationic Iipid compound can be
combined with the bioactive agent in any of a variety of different ways
such as hydrogen bonding, covalent bonding (col. 10, lines 15-38).
Unger discloses that a wide variety of materials which act to
stabilize the composition may be added. Also, the intracellular delivery of
bioactive agents through the use of cationic Iipid compositions may be
enhanced by the presence of a gaseous substance. The preferred
gaseous precursor is a salt such as alkali metal salt. Examples of the
gaseous precursor materials include potassium carbonate, sodium
carbonate, magnesium bicarbonate (col. 23, lines 22-29., col. 24, Iines
1-15).
According to the examiner, “Unger also discloses that the formulations can be
administered to a patient in a variety of forms adapted to the chosen route of
administration, namely, parenterally, orally, pulmonary inhalation, nasal inhalation, etc
(col. 27, Iines 1-10). The weight ratio of cationic lipid compound to bioactive agent is
preferably from about 1:1 to about 15:1, with a weight ratio of about 5:1 to about 10:1
being more preferred (col. 27, Iines 35-50).” Paper No. 6, page 3.
Appellants concede “that there may be some combinations of the agents and
excipients generically disclosed by Unger that will result in a sustained release profile
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