Appeal No. 2006-0148 Page 9
Application No. 09/933,309
The instant specification states that
[a]fter thymic regeneration, the thymus should be imaged (preferably by
magnetic resonance imaging, though other methods are also acceptable)
to verify regeneration and thymic location. . . . At this time, a surgeon
skilled at thymic biopsy retrieval injects into the thymus an appropriate
sample of the tissue or organ to be transplanted later.
Page 15, lines 18-23. The examiner has not provided a reasoned explanation of why
this level of guidance is inadequate to enable those skilled in the art to practice
intrathymic injection without undue experimentation. A conclusory statement that
“intrathymic injection [is an] unpredictable and undeveloped art[ ]” (Examiner’s Answer,
page 23) is not sufficient.
Thus, the only step in the claimed method that might involve something more
than routine experimentation appears to be the first step: “restoring immune system
function by regenerating the patient’s involuted thymus.” The examiner has argued that
“[w]hile the literature submitted by Appellant teaches regeneration of age-involuted
thymus, the experiments were only executed in rats, which are not representative of the
scope of the claims, there was no significant improvement of cellular immune function
and there were harmful side effects (reduced testosterone concentrations, hepatic
tumors). . . . One of the limitations of the instant claims is restoring immune function.”
Examiner’s Answer, page 19.
Appellant argues that the specification discloses specific methods that result in
regeneration of a patient’s involuted thymus. See the Appeal Brief, page 14. Appellant
also argues that he “has submitted evidence proving that the disclosed HGH therapy is
effective for almost doubling the functional thymic mass of Appellant’s own thymus.
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