Appeal No. 1999-1330
Application No. 08/527,373
tumors, the lack of direction or guidance provided by the
specification, the absence of working examples for in vivo
cancer therapy, the breadth of the claims, and the
unpredictable and undeveloped state of the art with respect
to in vivo cell transformation and gene therapy, it would have
required undue experimentation for one skilled in the art to
practice the claimed invention.
In response to the examiner’s position, the appellants urge that Wills and Liu,
relied on by the examiner in the prior art rejection, also employ a nude mouse model
and that “the nude mouse model . . . is an acceptable animal model for the treatment of
tumors.” (Brief, page 8). In response to the examiner’s criticism of the direction and
guidance provided by the specification, the appellants urges that the specification
provides (Brief, page 9):
dosage ranges for adenoviral vectors at Pages 11 and 17 of
the specification, and dosage ranges for retrovial vectors at
Page 15. Examples of methods of administration of the viral
vectors, such as, for example, direct administration to the
tumor, intravenous, intraarterial, or intraperitonal [sic]
administration, are provided at Pages 10 and 11. [Thus]
[o]ne skilled in the art would understand readily that the
exact dosage of viral vector to be administered and the
method of administration are dependent upon a variety of
factors, including the age, weight, and sex of the patient, the
type of tumor being treated, and the severity thereof.
Appellants, additionally, note that the specification provides two working examples,
Examples 3 and 4, in which squamous cell carcinoma was treated with the claimed
combination of radiation and an adenoviral vector including the wild-type p53 gene in an
animal model.
Therefore, the issue presented by this rejection is whether applicants' disclosure
would have enabled one skilled in the art to make and use the claimed invention
throughout its scope without undue experimentation. In such cases, the Patent and
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