Appeal 2007-3881
Application 09/833,782
The Examiner disputes the significance of the Kato reference and
GenBank entry, asserting that the researchers who deposited the GenBank
sequence
have, thus far, not disclosed actual enzymatic activity of the
protein set forth by SEQ ID NO: 2 . . . which they call
neurolysin. Search indicates that [the deposit] has not been
followed by any publication . . . showing that this sequence
does in fact have neurolysin activity. Thus, all [t]hat is
currently known of “human neurolysin” is a DNA and amino
acid sequence which shows structural homology to pig, rat,
mouse and rabbit enzyme.
(Answer 15-16.) The Examiner asserts that “nowhere in [Kato] one can find
the word ‘neurolysin’” (id. at 18).
We will reverse the rejection. The Examiner bears the initial burden
of showing that a claimed invention lacks patentable utility. See In re
Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) (“Only after the PTO provides
evidence showing that one of ordinary skill in the art would reasonably
doubt the asserted utility does the burden shift to the applicant to provide
rebuttal evidence sufficient to convince such a person of the invention’s
asserted utility.”). “Usefulness in patent law, and in particular in the context
of pharmaceutical inventions, necessarily includes the expectation of further
research and development. The stage at which an invention in this field
becomes useful is well before it is ready to be administered to humans.” Id.
Here, the Examiner has acknowledged that “the utility of animal
neurolysins was already known before the instant application was filed”
(Answer 18). Therefore, the relevant issues are (1) whether those of skill in
the art would have understood the Specification to disclose that SEQ ID
NO: 2 has the same activity as neurolysin, and (2) whether the evidence of
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