SUNNYVALE, Calif., Sept. 17 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in transmyocardial revascularization (TMR)
technology, yesterday filed an amended complaint asking the Federal District
Court to consider evidence of inequitable conduct in the U.S. Patent Office,
while U.S. Patent No. 5,125,926 (the Rudko Patent) was being obtained by PLC
Medical Systems, Inc. (PLC). On September 10, 1996, CardioGenesis filed the
original complaint against PLC with the Federal District Court for the
Northern District of California. The original complaint sought a
determination that the Rudko Patent, listing Dr. Robert Rudko, the Chairman of
PLC, as the first named inventor, was invalid and not infringed by
CardioGenesis.
Under U.S. Patent Office rules and Federal case law, an applicant for a
patent has a duty to tell the Patent Office about material prior art. The
amended complaint asserts that the Rudko Patent is invalid and unenforceable
because material prior work of another party (prior art) was withheld from the
Patent Office by Dr. Rudko. Statements made in papers filed with the Food and
Drug Administration (FDA) by Dr. Rudko, prior to filing for the Rudko Patent,
describe prior art allegedly withheld from the Patent Office. The amended
complaint alleges Dr. Rudko committed inequitable conduct, commonly known as
fraud, because Dr. Rudko understood the materiality of the information, based
on the papers filed with the FDA, and withheld the prior art with an intent to
mislead.
In a related but separate matter, CardioGenesis was served, at its
California offices, on Friday, September 12, 1997 with a complaint filed by
PLC in Munich, Germany alleging that both CardioGenesis and its former German
sales agent have infringed EP 0 553 576, a European counterpart of the Rudko
Patent. CardioGenesis has referred the complaint to patent counsel. In
January 1997, CardioGenesis filed an opposition before the European Patent
Office challenging the validity of EP 0 553 576.
CardioGenesis Corporation, based in Sunnyvale California, develops,
manufactures and markets proprietary systems including disposable products, to
perform intraoperative transmyocardial revascularization (ITMR), catheter-
based percutaneous myocardial revascularization (PMR), and thoracoscopic
transmyocardial revascularization (TTMR) to treat patients afflicted with
debilitating angina. CardioGenesis(TM) probes and catheter systems deliver
laser energy to create channels in the oxygen-deprived (ischemic) regions of
the heart muscle (myocardium). CardioGenesis holds patents for the system and
method of percutaneous myocardial revascularization, U.S. Patent Number
5,389,096; the method for intraoperative myocardial device revascularization,
U.S. Patent Number 5,380,316; and other patents in the field of
transmyocardial revascularization. For more information on the company and
their products, visit their website at http://www.cardiogenesis.com.
SOURCE CardioGenesis Corporation
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CONTACT: AT CARDIOGENESIS: Allen W. Hill, President and CEO or Richard P. Powers, Vice President and CFO, 408-328-8500; AT FRB SAN FRANCISCO: Ann Trunko, General Info., or Kate Rajeck, Analyst Contact, 415-986-1591
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