Appeal No. 2004-0647 Page 4
Application No. 09/941,965
Hatta. Claim 1 is directed to an IgG fraction which has been acid hydrolyzed, heated
for 15 minutes to 1 hour at a temperature of 35°C to 40°C, and thereafter neutralized,
centrifuged and decanted. Claim 4 specifies that the treated and isolated IgG fraction
has a molecular weight of about 55,000, while claim 5 specifies that the IgG fraction
may be derived from various sources, including eggs. According to the specification,
after the starting material (an IgG fraction) is treated by acid hydrolysis at 37°C for 15
minutes to 1 hour, neutralized, centrifuged and decanted, “the supernatant contains the
desired fraction” (page 5). Thus, what is claimed is the soluble portion (fraction) of the
treated, centrifuged sample (fraction). This is illustrated by the example set forth on
page 7 (lines 25-29) of the specification, wherein a “hydrochloric acid treated and
isolated [bovine] IgG fraction was heated for 15 minutes at temperatures varying within
the range of 35°C to 40°C, thereafter neutralized, centrifuged, and the supernatant
drawn off. This supernatant is approximately 35% of the pure [untreated] bovine IgG
concentrate” (id.).
Hatta describes the “[p]roductivity and some properties of anti-Human Rotavirus
(HRV) hen egg yolk antibody (IgY)[2] . . . compared with those of anti-HRV rabbit serum
antibody (IgG)” (Hatta, Abstract). In the course of comparing the relative stabilities of
the hen and rabbit antibodies at various pHs,
antibody solution[s] (10 mg/ml PBS, pH 7.2) [were] diluted with 10 mM
phosphate buffer containing 0.15 M NaCl, of various pH. The pH of the
solutions were adjusted to the desired pH with HCl or NaOH . . . ,
incubated at 37°C for 0-8 h, and then, the pH of the solution was
2 “The blood serum IgG of hen is known to be transferred to its egg yolk . . . The
antibody in egg yolk has been called IgY . . . because its protein nature is somewhat
different from mammalian IgG in molecular weight, isoelectric point . . . , etc. It is also
known that a specific IgY against a given antigen . . . is produced in eggs from hens
immunized with the antigen” (Hatta, page 450, left-hand column, citations omitted).
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