Appeal No. 2006-1879 Page 8
Application No. 10/010,114
adequate expression of the gene products were major areas of unpredictability at the
time of filing. See the Examiner’s Answer, pages 4-6.
We can accept, for discussion purposes, (1) that the references show that using
gene therapy to produce a therapeutically effective result would have required undue
experimentation in 1994, and (2) that gene therapy is the only in vivo use disclosed in
the specification for the claimed method. Even given those two premises, however, we
do not agree that the evidence shows that the claimed method was not enabled as of its
effective filing date.
As discussed above, the claims are not directed to a method of carrying out gene
therapy, but to a method of transferring nucleic acids into cells. That is, the claimed
method is directed to one step in, for example, a gene therapy method. The claimed
method is disclosed to overcome some of the problems discussed in the references
cited by the examiner. See the specification, pages 2 and 16:
The problems faced by [nonviral vectors or carriers] include . . . means for
mediating transport of the genetic material through the cell membrane and
into the cytoplasm of the cell; avoidance of degradation within the cell by
the reticuloendothelial system; and transport to and through the nuclear
membrane into the nucleus of the cell where transcription of the genetic
material can take place.
. . .
This multifunctional molecular complex comprises essentially the
combination of two key elements, (I) the nucleic acid composition which it
is desired to transfer to the target cell, and (II) the transfer moiety, which
. . . comprises several components whose function is . . . ii) to overcome
the incompatibility arising from the hydrophilic nature of the nucleic acid
molecule and the lipophilic nature of the cell membrane so that the former
can pass through the latter; and iii) to prevent degradation of the nucleic
acid molecule in a lysosome of said target cell, by disrupting the pre-
lysosome, endosome formation stage.
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