Appeal No. 2004-0647 Page 5
Application No. 09/941,965
neutralized by 100-fold dilution with PBS (pH 7.2). The remaining
antibody activity after heat and pH treatment was measured by ELISA or
the [virus] neutralization titer method (Hatta, page 451, left-hand column).
Figure 4 of Hatta shows the anti-HRV IgY activity of IgY solutions adjusted to pH 2, 3 or
4, and incubated for various periods of time, including 1 hour, at 37°C.
According to the examiner, Hatta’s acid hydrolyzed samples (i.e., those
incubated at 37°C for 1 hour and then neutralized) anticipate the claimed composition
inasmuch as Hatta teaches that
the treated IgG fraction can be isolated by protein A Superose column
chromatography that involves the steps of centrifuging, decanting and
running the protein on a gel by electrophoresis to determine the molecular
weight . . . [and] [t]he reference treated isolated IgG fraction (lane 3 and 4
of Fig 2) has a molecular weight of between 43,400 (See Fig 2 marker (e),
in particular) and 66,267 (See Fig 2 marker (d), in particular) which is
about 55,000 Dalton . . . (page 3).
There are a number of problems with the examiner’s analysis of Hatta’s
teachings, not least of which is that the examiner’s conclusions appear to be based on
the intermingled results of two different experiments (“Purification of Antibody” (page
450 and Figure 2) and “Heat- and pH- Stability Examination of IgY and rabbit IgG”
(page 451 and Figure 4)). The samples run out on the gel shown in Figure 2 are
purified antibody samples - the samples were “isolated by . . . [a process] that involves
the steps of centrifuging, [and] decanting” (Answer, page 3), but they were not treated
by acid hydrolysis at 37°C, etc. Thus, Figure 2 merely shows the bands associated with
the heavy and light chains of purified, but otherwise untreated, chicken IgY and rabbit
IgG; moreover, “molecular weights were estimated to be 70 kDa for IgY H-chain and 21
kDa for IgY L-chain, and 50 kDa for IgG H-chains and 22 kDa for IgG L-chain” (Hatta,
page 451, right-hand column). Hatta provides no information about the molecular
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