Appeal No. 2006-0650 Page 11
Application No. 10/007,613
temperature in a range of from about 50°C to about 65°C and exposure to
said proteolytic enzyme during a second, subsequent duration.
71. A system comprising (a) a surgical instrument contaminated with infective
prior protein; (b) means for heating the surgical instrument; (c) a proteolytic
enzyme that is thermally stable at a temperature in a range of from about 35°C to
about 100°C and proteolytically effective to at least partially destroy the infective
prion protein contaminating said surgical instrument, and (d) means for exposing
the surgical instrument to the proteolytic enzyme,
wherein said surgical instrument is characterized by a first elevated temperature
in a range of from about 100°C to about 150°C during a first duration, and
wherein said surgical instrument is characterized by a second elevated
temperature in a range of from about 35°C to about 100°C and exposure to said
proteolytic enzyme during a second, subsequent duration.
80. A system comprising:
(a) one or more articles susceptible to contamination by infectious prion protein;
(b) means for heating said articles;
(c) Bacillus lichenformis PWD-I keratinase; and
(d) means for exposing the heated articles to the Bacillus lichenformis PWD-1
keratinase,
wherein said articles are characterized by a first elevated temperature of at least
40°C and not more than about 150°C during a first duration, and wherein said
articles are characterized by second elevated temperature in a range of from
about 50°C to about 65°C and exposure to Bacillus lichenformis PWD-1
keratinase during a second, subsequent duration.
The meaning of the “wherein clause” in independent claims 39, 71, and 80 was a
significant source of contention between the examiner and Appellant in this appeal. The
examiner’s position was that the recited clause is a functional limitation that describes
an “intended use” of the claimed system. Answer, pages 8-9. Appellant disagreed,
arguing that the clause characterizes the “physical state” of the articles in the system,
and imposed “implicit structural limitations” on it. Brief, page 9; Reply Brief, paragraph
spanning pages 5-6.
The “wherein clause” reciting the two-temperature requirement was not present
in the application as originally filed. After a restriction that divided the claims into (1)
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