Appeal No. 2002-0872 Page 4
Application No. 08/470,849
In considering the examiner=s position, we believe the statement of the rejection
resulted from a misapplication of the principles enunciated in In re Best, 562 F.2d 1252,
1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote omitted), where the court stated:
Where, as here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes, the
PTO can require an applicant to prove that the prior art products do not
necessarily or inherently possess the characteristics of his claimed product....
Whether the rejection is based on ‘inherency’ under 35 U.S.C. ' 102, on ‘prima
facie obviousness’ under 35 U.S.C. ' 103, jointly or alternatively, the burden of
proof is the same, and its fairness is evidenced by the PTO's inability to
manufacture products or to obtain and compare prior art products.
Best is directed to a particular set of circumstances where examiners in the USPTO
cannot readily determine whether a difference exists between the subject matter of a
given claim and a particular prior art document. However, in order to invoke the
principles of Best, the examiner must first make factual findings which support the
conclusion that the claimed and prior art products prima facie are “identical or
substantially identical.” This determination, however, must be made on a case-by-case
basis, based upon the facts in the individual case.
We do not find the examiner has adequately established under the principles of
Best, a prima facie case that the claimed and prior art products are “identical or
substantially identical” to appropriately shift the burden to appellant to establish a
patentable distinction between the claimed and referenced methods. On this record,
appellants provide evidence of the arts’ recognition that “glycoproteins from a single cell
line are likely to show varying carbohydrate structures due to variations in the cell
culture process used….” Brief, page 5. In addition, appellants’ specification discloses
that variations in culture conditions result in variations in the oligosaccharide component
of an expressed glycoprotein. See id. In contrast, as appellants point out (Brief, page
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