Appeal No. 2004-0456
Application No. 08/913,699
In this case, we agree with appellant that the cited references may have made it
“obvious to try” to stimulate cholesterol efflux in an individual by administering a
replication defective virus comprising a nucleic acid sequence encoding LCAT, but they
do not support a prima facie case under § 103.
We do not agree with the examiner that the prior art establishes a reasonable
expectation of success of obtaining stimulation of cholesterol efflux in an individual.
In particular, Baer, page 8, lines 35-41, states that LCAT “should be administered under
the guidance of a physician, and pharmaceutical compositions will contain an effective
amount of the enzyme in conjunction with a conventional pharmaceutical carrier. The
dosage will vary depending upon the specific purpose for which the lecithin:cholesterol
acyltransferase is administered, usually at dosage levels sufficient to bring the patient's
plasma Lecithin:cholesterol acyltransferase to at least about 25% of the
lecithin:cholesterol acyltransferase activity in normal pooled plasma.” Thus, Baer would
reasonably appear to suggest that LCAT must be expressed at sufficiently high levels to
achieve stimulation of cholesterol efflux.
The examiner argues that “the rejection provides evidence and reasoning that it
would have been obvious to practice the claimed method to evaluate the 'promise' or
feasibility of using gene therapy to deliver LCAT or to deliver LCAT and apoA-1 for
the treatment of dyslipoproteinemia.” [Emphasis added.] Answer, page 9. However, we
do not find that the combination of references before us provides a reasonable
expectation of success that if the LCAT of Baer or McLean is expressed in an
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