Appeal No. 1997-1830
Application No. 08/389,860
suitable for therapeutic use in humans to inhibit bone reabsorption. Col. 11, lines
19-21. Finally, Rosini discloses that alendronate is much more active in
inhibiting bone reabsorption than other bisphosphonates, and in fact “exhibits an
activity which is the highest of all the bisphosphonates known up to present.”
Col. 14, lines 30-35. Rosini teaches treatment of several disorders with the
bisphosphonate aminobutanediphosphonate (columns 11-12), but does not
suggest treatment of osteoporosis with bisphosphonates, nor does Rosini
suggest treatment of any specific disease with alendronate.
The examiner concluded that Rosini rendered the claimed method
unpatentably obvious. The examiner concluded that alendronate’s high level of
activity in inhibiting bone reabsorption would have made using it to reduce the
risk of vertebral fractures obvious to a person of ordinary skill in the art.
In response, Appellants submitted a declaration under 37 CFR § 1.132 by
inventor David B. Karpf. Dr. Karpf states that increase in bone mineral density
does not necessarily correlate with decreased risk of vertebral fracture, and cites
fluoride and etidronate as illustrative examples. Second, Dr. Karpf explains that
inhibitors of bone reabsorption do not act uniformly throughout the body, so that
an activity in inhibiting bone reabsorption does not necessarily lead to inhibition
of bone reabsorption in the vertebrae. Third, Dr. Karpf states that although
bisphosphonates were known to prevent further loss of bone, it was not known at
the time of the invention that they would be effective in treating bone loss that
had already occurred. Finally, Dr. Karpf states that it was expected that the
inhibitory activity of bisphosphonates was expected to be short-lived, so that a
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