Appeal No. 2004-2134 Page 6
Application No. 09/425,075
the production of many heterologous proteins due to the fact that
(1) a detailed understanding of the growth characteristics of the
organism in high-density fermentors is known, (2) the ability to
place foreign DNA into the genome in a precisely controlled
manner, and (3) promoters are tightly regulated and efficiently
transcribed to produce proteins at high levels (See page 40). In
addition, one of ordinary skill in the art would have been motivated
to produce the claimed method and vectors and host cells because
the Invitrogen Catalog teach a Pichia expression vector called
pPICZ which is based on homologous recombination comprising;
several restriction sites for cloning of recombinant proteins, a
promoter (AOX1), termination sequences, selectable markers
(zeocin), and alpha-factor secretion signal for expression in P.
pastoris of antibodies and the vector is designed for production of
proteins as high as grams per liter (see pages 14-15 and 18).
Moreover, one of ordinary skill in the art would have been
motivated to produce the claimed method and vectors and host
cells because Robinson [ ] teach[es] production in yeast of chimeric
or humanized antibodies using a vector with both a light chain and
a heavy chain linked to promoters and terminators in a single
plasmid and the vectors can further comprise yeast leader
sequences for antibody secretion (see columns 15-16).
Id. at 5-6.
The rejection also contends that there is a reasonable expectation of
success because Horwitz teaches the production of antibodies in yeast that have
the ability to bind to antigen. See id.at 6. Moreover, Cregg teaches that the
production of heterologous proteins in P. pastoris may be easily scaled up, and
the Invitrogen Catalog teaches that “the expression vector and P. pastoris makes
‘an ideal tool for laboratory research as well as industrial applications.’” Id. at 6-
7.
“[T]he Examiner bears the burden of establishing a prima facie case of
obviousness based upon the prior art. ‘[The Examiner] can satisfy this burden
only by showing some objective teaching in the prior art or that knowledge
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