Appeal No. 1997-2751
Application No. 08/159,096
Page 123, left-hand column. By contrast, a patient who was continued on
diphosphonate therapy after fracture showed “no healing of the fracture . . . 6
months later.” Id. When diphosphonate administration was discontinued, bone
union promptly occurred. Id.
Similarly, Henricson found that in rats treated with aminopropane
diphosphonate, bone fracture healing (in particular inductive callus and
enchondral bone formation) occurred more slowly than in control animals. In
addition, Lenehan found that administration of ethane-1-hydroxy-1,1-
diphosphonate caused a dose-dependent inhibition of fracture healing in dogs
(see the abstract). Lenehan also stated that the effects on humans would be
expected to be similar because of the similarity in bone remodeling between
humans and dogs (page 507).
Thus, the prior art in the record shows that those skilled in the art would
have expected administration of diphosphonate compounds to inhibit, rather than
aid, the healing of bone fractures. The evidence thus shows that those skilled in
the art would have doubted the efficacy of the claimed method, based on the
evidence available at the time of the invention.
The instant specification presents no evidence to show that this
expectation was incorrect. In fact, the record contains no evidence showing that
the compounds recited in the claims have any beneficial effect on fracture
healing. The specification contains a single example, which appears to be
prophetic. The example (pages 4-5 of the specification) is presented in the
present tense, suggesting that the work described had not actually been carried
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