Appeal No. 2003-1126 Page 10
Application No. 08/444,285
In the response to this argument, the examiner contends that:
The key to appellants’ argument . . . is that they have
developed a method of making transgenic mammals, and they
have received broad claims to this aspect of the invention.
However, what they have not taught are the mammals themselves.
While the broad method may be enabled, the broad products are
not so enabled. Appellants are enabled for mammals expressing a
heterologous protein in their blood and methods of producing the
protein and isolating it from their blood. However, it is the breadth
of the mammals for which appellants are not enabled. The bridge
appellants have found, and patented, is to the method of making
the mammals. This may seen [sic] counter intuitive at first, but the
method’s use as disclosed in the making of transgenic nonhuman
mammals. The product uses are define [sic] in the specification as
increased growth rate and efficiency of feed utilization in animals
used to produce meat, such as the transfer of genes relating to
growth and feed utilization from a buffalo into beef cattle to create a
new species; an increase in milk production and efficiency of feed
utilization by transferring exogenous genetic material from species
or breeds of the same species which have either or both traits; the
alteration of meat flavor such as in lamb; the transfer of genes for
an in vivo analysis of gene expressing during differentiation and the
transgenic mammals can be used in the elimination or dimunation
of genetic diseases. The skilled artisan reading the specification
would see that the method is enabled as transgenic nonhuman
animals can be made by the specification. However, the uses of
the mammals and method require much more exacting phenotypes.
The specification never contemplates mere expression of a
transgenic for the mammals or the methods of producing a
polypeptide or protein in the mammals. There is no use for such a
mammal or method that is even readily apparent. If the genetic
material is only expressed but not sufficiently so as to isolate from
blood or if the expression does not meaningfully alter the
phenotype of the mammal in an art useful way, then there is no use
for either the mammal or the method of producing a polypeptide or
protein. None is disclosed and none is readily apparent.
Examiner’s Answer, pages 28-29 (emphasis added).
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