Appeal No. 1996-3409
Application No. 08/092,543
in a biological sample from a test subject with a data base representative of the frequency
distribution of those same constituents in samples from epidemiologically significant
populations with, and without, that disorder. Some of the claims are limited to diagnosing
Alzheimer’s Disease or Parkinson’s Disease, etc.
The rejection of claims 1 through 20 under 35 U.S.C. § 112, first paragraph, is
based on the written description and enablement requirements of the statute. On
inspection, however, we are unable to identify reasoning which would explain why the
specification does not provide adequate written descriptive support for the claimed
invention. All of the concerns raised by the examiner appear to have a bearing on whether
the claims are based on an enabling disclosure.
It is well settled that the examiner bears the initial burden of providing reasons why a
supporting disclosure does not enable a claim. In re Marzocchi, 439 F.2d 220,
223, 169 USPQ 367, 369 (CCPA 1971). If we can summarize the examiner’s principal
position, it is that undue experimentation would be required to practice the claimed
invention because of the breadth of the claims (“the specification fails to describe in detail
the protocol needed to diagnose any one of the millions of disorders encompassed by the
. . . independent claim. . . . [it] would require an undue amount of experimentation and
follow-up to practice the instant invention for all medical disorders
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