Appeal No. 2001-0407 Page 7
Application No. 08/460,215
A. Method claims
Claim 37 is directed to a method for treating cyst formation in a PKD1-
associated epithelial cell, comprising contacting the cell with a normal human
PKD1 gene, or fragments thereof, capable of expressing polycystin in an amount
effective to prevent or reduce cyst formation. The examiner rejected the method
claims on the basis that the specification “fails to provide adequate guidance and
teachings such that one would have been able to have delivered any nucleic
acids so as to obtain a change in the host.” Examiner’s Answer, page 3.
The examiner cited prior art references discussing the problems remaining
to be solved before gene therapy could be successfully practiced. See the
Examiner’s Answer, pages 3-5. The examiner also noted that the specification
discloses that APKD shows dominant inheritance; i.e., the disease is manifested
when either one or two mutated copies of the gene are present. Examiner’s
Answer, pages 5 and 6. Finally, he noted that, although the specification
discloses that the claimed method of gene therapy would be “feasible if a
particular mutant PKD1 allele, when present in a single copy, merely causes the
level of the PKD1 protein to diminish below a threshold level necessary for
normal function,” the specification provided no guidance “that indicates what
forms of APKD would have been associated with PKD1 mutants that cause the
level of PKD1 protein to fall below a level necessary for normal function or that
such forms of APKD even exist.” Examiner’s Answer, page 7. He concluded
that practicing the full scope of the claimed method would have required undue
experimentation.
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