Appeal No. 2003-1126 Page 5
Application No. 08/444,285
reasonably provide enablement for the breadth of the claims to
transgenic rodents, rabbits, goats, pigs, cattle or sheep expressing
any genetic material of interest under obtainable conditions, and
methods of producing a polypeptide of interest in the above listed
transgenic mammals. . . . The specification does not enable any
person skilled in the art to which it pertains, or with which it is most
nearly connected, to make and use the invention commensurate in
scope with these claims.
Examiner’s Answer, pages 3-4.
The rejection addresses the relevant Wands factors. See In re Wands,
858 F.2d 731, 737, 8 USPQ2d 1400, 1403 (Fed. Cir. 1988). Factors that should
be considered in determining whether a specification is enabling, or if it would
require an undue amount of experimentation to practice the invention include: (1)
the quantity of experimentation necessary to practice the invention, (2) the
amount of direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state of the prior art, (6)
the relative skill of those in the art, (7) the predictability or unpredictability of the
art, and (8) the breadth of the claims. See id.
With respect to the nature of the invention, the examiner comments that
the claimed invention is drawn
to a transgenic nonhuman mammal whose genome contains at
least one heterologous gene and a transcriptional control sequence
operatively associated where the mammal expresses the gene at a
detectable level in a plurality of the mammal’s cells, and the
methods of producing a polypeptide or protein in the transgenic
mammal or progeny of the transgenic mammal. The mammal can
be anyone of a rodent, rabbit, goat, pig, cattle and sheep. The
protein can be any polypeptide or protein.
Examiner’s Answer, page 4. According to the rejection, “[a] compelling feature of
a transgenic mammal is that the heterologous genetic material is present in all, or
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