d) Dr. Youle testified that in mammalian cells, “the addition of a special ‘leader
sequence’ would be required to steer the protein to the secretory pathway” that would be
necessary “for any hope of proper glycosylation of the antibodies.” According to Dr. Youle, the
Cabilly application does not teach the addition of such a leader sequence (Exh. 2012 at ¶ 18).
A therapeutic method
46. Glaxo argues that the Cabilly applications do not teach a therapeutic method as
required by the ‘611 claims and proposed Count 2 (Paper 49 at 9-10 and Paper 51 at 20-21).
47. Proposed Count 2 is directed to a method of treating one of the following:
a. a human suffering from a disease or disorder (‘403 claim 1)
b. a human suffering from a T-cell mediated disorder (‘404 claim 1)
c. a human suffering from cancer (‘405 claim 1)
d. a human suffering from a disease (‘611 claim 53)
e. a human suffering from an attack by a substance or organism (‘611
claim 55)
48. In a first portion of the application entitled “Background of the Invention”, the
Cabilly applications state that (Exh. 2103 and Exh. 2102 at 3:26 to 4:2):
In another important use, antibodies can be directly injected into subjects
suffering from an attack by a substance or organism containing the antigen in
question to combat this attack. This process is currently in its experimental
stages, but its potential is clearly seen. Third, whole body diagnosis and
treatment is made possible because injected antibodies are directed to specific
target disease tissues, and thus can be used either to determine the presence of the
disease by carrying with them a suitable label, or to attack the diseased tissue by
carrying a suitable drug.
49. In a second portion of the application entitled “Detailed Description”, the Cabilly
applications state that chimeric antibodies having human constant regions are “less likely to
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