Appeal No. 1996-2539
Application 08/150,776
The examiner relies on “Applicants’ admission of the disclosure of McMahon” (at
page 30 of the specification, and Table II) and Okamoto to “establish the sequences of
rare subtypes having the sequences of the claimed non-permitted antigens” and concludes
that:
[I]t would have been prima facie obvious to a person having ordinary skill in
this art to include synthetic peptides having the sequences of the rare
subtypes disclosed by [Okamoto and McMahon] in a hepatitis vaccine thus
achieving the invention as a whole. One would have been so motivated in
view of the teachings of [Brown I or II] and Vyas that the 139-147 region is
the location of important protective epitopes. (Examiner’s Answer, Section
(9)).
The examiner’s rejection presupposes that one of ordinary skill in the art would have
expected that conventional HBV vaccines would fail to protect against the rare subtypes
reported by Okamoto and McMahon. Taking a step back, we find no basis in the art for
this supposition.
Okamoto teaches that various amino acid substitutions (including substitutions at
amino acid positions 144 and 145 of HBsAg) result in the loss of the HBV subtypic “d”
determinant. While Okamoto speculates that HBsAg of deficient subtype would be difficult
to identify in the presence of HBsAg of regular subtype, there is nothing in the reference to
suggest that immunization with conventional HBV vaccines containing HBsAg would fail to
protect against HBV of deficient subtype (page 203). In other words, there is nothing in
Okamoto to suggest that any of the disclosed amino acid substitutions are “non-permitted”
as that term is defined in the present specification, or that any of the disclosed variants
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