Appeal No. 2006-0148 Page 6
Application No. 09/933,309
• “[t]he disclosure does not provide immunological or endocrine assays or
employ experiments such as magnetic resonance imaging or morphology studies, which
would discern that a thymus has been regenerated” (id.);
• “[t]he specification provides no guidance or working examples for intrathymic
injection” (id.); and
• “[t]he specification fails to teach or disclose working examples for transplanting
an organ or grafting of tissue” (id.).
The examiner concluded that
[d]ue to the large quantity of experimentation necessary to regenerate an
involuted thymus, administer an intrathymic injection and transplant an
organ or tissue, the lack of direction/guidance presented in the
specification regarding same, the absence of working examples directed
to same, the complex nature of the invention, and the state of the prior art
which establishes the unpredictability of intrathymic injections and
organ/graft transplants, undue experimentation would be required of the
skilled artisan to make and/or use the claimed invention in its full scope.
Id., page 8.
Appellant argues that “the specification expressly teaches techniques for
regenerating an involuted thymus,” and that the examiner has conceded that at least the
Greenstein1 and McCormick2 references show regeneration of an involuted thymus.
Appeal Brief, page 14. Appellant also argues that
[a] surgeon skilled at thymic biopsy retrieval (one of ordinary skill in the
art) would know how to achieve the intrathymic injection without undue
experimentation, and a skilled transplant surgeon would know how to
transplant an organ or graft a tissue without undue experimentation.
Accordingly, each of the individual steps of the claimed method may be
achieved by those having ordinary skill in the art without undue
1 Greenstein et al., “Regeneration of the thymus in old male rats treated with a stable analogue of LHRH,”
J. Endocr., Vol. 112, pp. 345-350 (1987).
2 McCormick et al., “A murine model for regeneration of the senescent thymus using growth hormone
therapy,” AGING: Immunology and Infectious Disease, Vol. 3, pp. 19-26 (1991).
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