Interference No. 102,572
light chains as separate molecules.
The count is broad enough to include adding a single plasmid or vector containing
both the DNA sequences encoding for at least the variable regions of the heavy and light
chains to the host cell or by adding two plasmids to the host cell each containing said DNA
sequences individually. The count does not require that the expression step directly result
in the production in the host cell of an Ig molecule or an immunological functional fragment
of Ig containing at least the variable regions of the heavy and light chains. If the process
6
results in the production of inclusion bodies, then in order to show that a useful product
was produced it would be necessary to reassociate or refold after extraction of the
inclusion bodies and denaturing its contents. Hence, while the count does not set forth any
additional steps it is clear that the count does not exclude other process steps because the
count utilizes the open-ended term “comprising “. In re Baxter, 656 F.2d 679, 686-687, 210
USPQ 795, 802-803 (CCPA 1981).
IV.
THE PARTIES BRIEFS
The requirements for the parties briefs are set forth in 37 CFR § 1.656(b). In
particular, 37 CFR § 1.656(b)(4) requires:
[a]n argument, which may be preceded by a summary, which shall contain
6Inclusion bodies are also known as refractile bodies. They are insoluble particles
which require cell lysis and solubilization in denaturant to permit recovery. (Cabilly et al.
specification, page 23, lines 18-21).
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