Appeal No. 2004-0647 Page 7
Application No. 09/941,965
adequately explained how the claimed product (i.e., an acid hydrolyzed and neutralized
IgG fraction that has been clarified by centrifugation to remove insoluble material) can
be “identical or substantially identical” (id.) to Hatta’s acid hydrolyzed and neutralized
IgG fraction that was not centrifuged and decanted to remove insoluble material.
“[E]very limitation of a claim must identically appear in a single prior art reference
for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457, 43 USPQ2d
1030, 1032 (Fed. Cir. 1997). Moreover, “the Patent Office has the initial burden of
coming forward with some sort of evidence tending to disprove novelty.” In re Wilder,
429 F.2d 447, 450, 166 USPQ2d 545, 548 (CCPA 1970). On this record, it is
unreasonable to shift the burden to appellant to establish that Hatta anticipates the
claimed composition. Accordingly, the rejection of claims 1, 4 and 5 under 35 U.S.C. §
102(b) as anticipated by Hatta is reversed.
II. Obviousness over Hatta
Claims 1-3 stand rejected under 35 U.S.C. § 103 as unpatentable over Hatta.
According to the examiner, Hatta does not describe hydrolyzing the IgG fraction with
0.1 N to 0.2 N hydrochloric acid, but it would have been obvious to do so because
“adjusting the pH of any immunoglobulin solution using any acid at [a] concentration
such as 0.1 N to 0.2 N is within the purview of one [of] ordinary skill in the art” (Answer,
page 6).
As the examiner’s rejection does not address the underlying deficiencies of
Hatta’s teachings (discussed above), the rejection of claims 1-3 under 35 U.S.C. § 103
is reversed.
III. Obviousness over Kempf
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