Appeal No. 95-4471
Application No. 07/963,475
The applicants' invention, as described at page 6 of the specification, is directed to
a diagnostic method for fibrotic disease which employs a series of steps wherein discrete
regions of organ tissue are examined for abnormalities in extracellular matrix (ECM)
synthesis and degradation. The described steps include tissue biopsy, microdissection,
reverse transcription, and polymerase chain reaction (PCR). The biopsy and
microdissection are said to serve to parse out particular tissues for study and the reverse
transcription and PCR serve to amplify molecules available on in trace amounts in the
dissected tissue. The method is said to overcome obstacles previously encountered in the
diagnosis of fibrotic disease.
The Rejection under 35 U.S.C. § 112, first paragraph
Claim 1-16 stand rejected under 35 U.S.C. § 112, first paragraph, as being based
on a non-enabling disclosure.
In setting forth the basis of this rejection, the examiner states (Answer, page 8):
Thus, in view of the generic scope of the claim, disclosure of only
specific examples, lack of specific guidance as to how to practice the
broadly claimed invention and unpredictability due to the lack of
understanding of the molecular basis of fibrotic disease, it would require
undue experimentation to practice the claimed inventions.
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