Appeal No. 1996-3016
Application 08/008,859
Suffice it to say that the examiner has cited no legal authority for the proposition that
claims pending in a patent application must be limited to the subject matter which “yields
the surprising and unexpected synergistic result.” Nor do we know of any legal authority
which requires the claims to be so limited. Absent a fact-based explanation from the
examiner as to why one skilled in the art would not be able to practice the claimed invention
throughout its scope without undue experimentation, we do not find the examiner has
sustained his initial burden of establishing a prima facie case of lack of enablement. The
rejection under 35 U.S.C. § 112, first paragraph (enablement) is reversed.
2. Obviousness
As a result of the election of species requirement, the subject matter under review in
this appeal involves the combined use of 2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic
acid as a bone-active phosphonate and estradiol as an estrogen hormone for the purpose
of treating osteoporosis. The so-called admissions relied upon by the examiner are merely
appellant’s description of phosphonates and estrogens which are described in the prior
art as being useful individually to treat osteoporosis. That much is not disputed by
applicant. What is disputed by applicant is whether the applied prior art reasonably
suggests the use of an estrogen hormone for the treatment of osteoporosis in the claimed
amount of “from about 0.2 to about 0.8 LED.” The acronym “LED” stands for “least
effective dose.” As set forth at page 18, lines 8-17 of the specification, the least effective
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