Appeal No. 2001-2497 Page 10
Application No. 08/855,744
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
met, does the burden of coming forward with evidence or argument shift to the
applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993).
In this case, the examiner has not made out a prima facie case of
obviousness. One obvious defect in the examiner’s rejection is that it fails to
account for several of the limitations of the claims. In addition to a conjugate
made up of two VH-VL binding molecules, the claims require the use of either
TNF or IL-1 as the therapeutic agent, in combination with liposomes conjugated
with antibodies specific for the conjugate. The examiner’s rejection, however,
does not explain why it would have been obvious to use TNF or IL-1 as the
therapeutic agent, nor why it would have been obvious to use antibody-
conjugated liposomes. Obviousness is determined based on the claimed
“subject matter as a whole.” 35 U.S.C. § 103. Express limitations of the claims
cannot be ignored. See General Foods Corp. v. Studiengesellschaft Kohle mbH,
972 F.2d 1272, 1275, 23 USPQ2d 1839, 1840 (Fed. Cir. 1992) (“[E]ach claim is
an entity which must be considered as a whole.” (emphasis in original)).
In addition, the examiner has not adequately explained how the
combination of the reference disclosures would have suggested the claimed
method. In the imaging method disclosed by Goodwin, a tumor-binding molecule
is administered and allowed to bind its target, then the blood is cleared of excess
binding molecule, and finally, a radiolabel is administered. Since Goodwin’s
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