Appeal No. 1996-2240
Application No. 08/105,482
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 and the limited number of working examples
in the specification (“[it] would require an undue amount of experimentation and follow-up to
practice the instant invention for every one of the medical disorders ever known, which is
what the instant claims encompass . . . ; there is [are] no working examples of diagnosing
diseases other than Alzheimer’s Disease . . . and Parkinson’s Disease . . . ; there are no
working examples in the specification concerning analyzing all of the other body fluids
encompassed by the claims . . .”). See the Examiner’s Answer, pages 3 through 6.
The examiner is further concerned with the absence of absolute certainty in the
specification (“it is not clear how one knows with absolute certainty that the abnormality in
the profile arises because of a particular one of the millions of medical disorders presently
recognized; . . . there is no conclusive evidence presented for each and every one of the
disorders encompassed . . . by the claims”), and with the absence of certain specific
information (“[t]he specification fails to identify the method used to classify the samples
into control and disease groups”). See the Examiner’s Answer, pages 4 and 6.
The claims are indeed broad, and generating a frequency distribution data base
for diseases and/or biological samples encompassed by the claims, but not
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