GENERAL
SURGICAL INNOVATIONS WINS FAVORABLE PRIORITY DECISION ON PATENT
INTERFERENCE PROCEEDING AGAINST GUIDANT CORPORATION
Cupertino, CA - (November 12, 1998) - General Surgical
Innovations, Inc. (GSI) (Nasdaq: GSII) today announced a major
development in its interference proceeding against Origin Medsystems
Inc., a division of Guidant Corporation. GSI was informed by the
arbitrator deciding priority issues in its interference proceeding
against Origin, that Dr. Maciej Kieturakis, who assigned his rights
in certain patents to GSI, is the first and true inventor of the
contested patentable matter. The arbitrator ruled that Dr. Kieturakis
conceived this technology in June 1991 and reduced it to practice
in a hernia repair procedure shortly thereafter. The arbitrator
found that Origin did not possess the contested technology until
after it was actually reduced to practice by Dr. Kieturakis.
This decision, together with a recent Patent and Trademark Office
ruling that the contested technology is indeed patentable, means
that title to all resulting patents will belong to GSI. Origin
has asked for reconsideration by the Patent Office of its patentability
ruling. Patents resulting from the contested technology cover
certain aspects of surgical balloon dissection technology, and
are additive to the existing protection provided by other patents
already issued to GSI.
Gregory Casciaro, GSI President and CEO stated, "I believe that
the patent or patents resulting from the contested technology
will cover the use of Origin's VasoView, ExtraView, and PDB products.
These patents will add another significant measure of protection
to that already afforded by existing GSI patents".
The interference ruling is the latest development in a series
of patent confrontations between GSI and Origin. In May 1996,
Origin sued GSI for infringement under its patent number 5,520,609,
on the day Origin's patent issued. In April 1998, the United States
District Court found that Origin had obtained this patent through
inequitable conduct by misrepresenting material facts to the Patent
Office in order to gain its allowance. The Court therefore found
this patent to be unenforceable and has ruled GSI is entitled
to recover attorney fees in the amount of $990,000.
Recently, in a separate action for patent infringement brought
by GSI, the United States District Court for the Northern District
of California granted GSI's summary judgment motion that the use
of any of Origin's current balloon dissection products infringes
GSI's patent number 5,514,153. The trial on validity and damages
issues in this case is scheduled to be held in January 1999.
GSI's SPACEMAKER® tissue dissection systems are based on
the company's patented balloon dissection technology and incorporate
ancillary instruments to facilitate minimally invasive surgical
procedures. Minimally invasive, or "keyhole," surgeries were initially
limited to procedures carried out within the abdominal cavity
which provided a working space for the surgeon. Balloon dissection
methods are used to create working spaces where no naturally occurring
space exists and have enabled surgeons to extend their use of
minimally invasive techniques to a broader range of procedures.
With the use of GSI technology, patients may receive such benefits
as reduced pain and faster recovery times.
Headquartered in Cupertino, California, General Surgical Innovations,
Inc. develops, manufactures and sells tissue dissection systems
based on the company's patented balloon technology for minimally
invasive surgical procedures. The company's products are specifically
designed for endoscopic and laparoscopic techniques used in general,
cardiovascular, obstetric/gynecological, orthopedic, cosmetic
and reconstructive surgeries to create an operating space at the
surgical site, lessen tissue damage and improve patient recovery
time. The company has developed a broad range of balloon shapes
and sizes to be used for various surgical techniques, procedures
and market segments. GSI distributes its products worldwide through
a network of distribution partners and a direct sales force. For
additional information, please visit the company's World Wide
Web site at www.gsii.com.
Except for the historical information contained herein, the matters
discussed in this press release are forward-looking statements,
the accuracy of which is necessarily subject to risks and uncertainties.
Future patent rulings and market development, among other matters
discussed in this release, may differ significantly from the discussion
of such matters in the forward-looking statements. Such differences
may be based upon factors within General Surgical Innovations'
control, such as strategic planning decisions by management and
reallocation of internal resources, or on factors outside of General
Surgical Innovations' control, such as rulings in patent litigation,
scientific advances by third parties, introduction of competitive
products and delays by regulatory authorities, as well as those
factors set forth under the heading "Factors Affecting Future
Results" in General Surgical Innovations' Annual Report on Form
10-K for the year ended June 30, 1998 and other company filings
with the Securities and Exchange Commission.
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For
more information on General Surgical Innovations. via fax at no
cost,
dial 800-PRO-INFO
(908-544-2850 outside the U.S.) ticker symbol: GSII.
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