Appeal No. 2005-1171
Application No. 09/469,485
III. Claim 18 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over
Builder and Valenzuela as applied to claims 8-16 above, and further in view of Even-
Chen.
We reverse.
Discussion
As indicated by claim 8 above, the appellants’ invention is said to be directed to
increasing the antigenicity of recombinant hepatitis B surface antigen (rHBsAg) using a
redox buffer.
In Rejection I, the examiner relies on Builder for disclosing the use of a redox
buffer to “recover biologically active protein from cell culture.” Answer, p. 4. The
examiner argues that Builder discloses “adding 10mM GHS: 1mM GSSG to solubilize
protein and incubating the mixture overnight at 37°C to permit the proper refolding into
correct disulfide bond formation such as 10 mM GSH: 1mM GSSG, and incubating the
protein and buffer at 37°C for 24 hours to permit proper refolding.” Id., p. 5. According
to the examiner, “[t]he purified protein exemplified by the method of Builder et al. has a
much higher activity than unpurified protein.” Id. The examiner acknowledges that
Builder does not disclose purifying rHBsAg. To that end, the examiner relies on a
publication by Valenzuela which is said to “establish that immunogenicity of HBsAg . . .
strongly depends on the integrity and proper formation of disulfide bonds within the
antigen.” Id. The examiner points to pages 348-350 of Valenzuela for support.
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