Appeal No. 2001-0407 Page 3
Application No. 08/460,215
Procedural Background
This application was remanded to the examiner (Paper No. 26, mailed
October 18, 2002) because it was unclear from the record whether or not the
examiner had entered the amendment submitted by Appellants with the Reply
Brief. The examiner has made clear that the amendment was not entered. See
Paper No. 27, mailed October 30, 2002. Appellants have not petitioned to have
the examiner’s decision reviewed. Therefore, the claims on appeal do not
include the amendments submitted with the Reply Brief.
Technical Background
“Autosomal dominant polycystic kidney disease (APKD), also called adult-
onset polycystic kidney disease, is one of the most common hereditary disorders
in humans. . . . The disease is considered to be a systemic disorder,
characterized by cyst formation in the ductal organs such as kidney, liver, and
pancreas, as well as by gastrointestinal, cardiovascular, and musculoskeletal
abnormalities. . . . The most prevalent and obvious symptom of APKD, however,
is the formation of kidney cysts, which result in grossly enlarged kidneys and a
decrease in renal-concentrating ability.” Specification, pages 1-2.
“APKD exhibits a transmission pattern typical of autosomal dominant
inheritance, i.e. each offspring of an affected individual has a 50% chance of
inheriting the causative gene.” Id., page 2. The vast majority (85-90%) of cases
of APKD are caused by mutation(s) in the PKD1 gene. See id. The specification
discloses the isolation of the normal (unmutated) human PKD1 gene. See pages
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