Appeal No. 1998-0667 Page 9
Application No. 081280,306
1055 listing "U.S. GENE THERAPY TRIALS SPONSORED BY INDUSTRY." The table
contains 14 entries. Culver states at page 175, left-hand column, "[oln the basis of
these studies, several gene therapy trials in humans have been approved . . .." Table 1
of Marshall liists a number of trials of gene therapy for cancer.
While not explicitly stated, we believe the examiner's position is based in large
part upon the possibility or perhaps even the probability that many of the protocols used
in the documented clinical trials may never be approved for clinical use in humans.
Indeed, a number of the quotes relied upon by the examiner from the references refer
to problems or obstacles in delivering the therapeutic to the target in a clinical setting.
However, as stated in Brana, that is not the standard for enablement andlor utility.
Absent a fact-based statement from the examiner which focuses on the claimed
subiect matter instead of gene therapy as a general field, we hold that the examiner has
failed to establish that the subject matter of claims 2-5 on appeal is non-enabled.
2. Sandiq.
The sole reason set forth at page 8 of the Examiner's Answer in support of this
rejection is "Sandig et al. disclose pseudocapsids formed from only the polyoma virus
major capsid antigen, VP1 , and having exogenous DNA associated therewith." Missing
from the examiner's statement of the rejection is any acknowledgment that claim 29
requires that the "pseudocapsid transfers the exogenous material into a host cell so that
the material is taken up by the cell and is biologically functional in the cell."
Appellants' position focuses on this latter requirement of claim 29. Appellants
argue that the pseudocapsids of Sandig consisting of VP1 only were not able to transfer
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