A Diagnostics & Imaging Week

VisEn Medical (Woburn, Massachusetts) filed an inter partes re-examination request with the U.S. Patent and Trademark Office (USPTO) to invalidate and revoke claims of the Caliper Life Sciences (Hopkinton, Massachusetts) patent 7,255,851, which was issued this week.

Caliper reported earlier this week that Novartis (Basel, Switzerland) has signed a multi-year license to Caliper’s patented non-invasive optical imaging methods.

According to Caliper, non-invasive optical imaging, an increasingly critical technology for drug discovery and development, allows scientists to visualize, track and quantify biological processes at the molecular level in living animals with high throughput and relatively low cost. Caliper provides commercial and academic customers with a selection of in vivo offerings including imaging systems, reagents, applications, patented methods and services that improve drug discovery and development efforts.

Caliper’s Xenogen family of IVIS instrument systems, reagents, and proprietary methods are designed to deliver non-invasive in vivo imaging along with high sensitivity, ease of use and exceptional data quality, the company said.

VisEn said it filed the request “as part of its mission to enable leading research, pharmaceutical, and clinical institutions worldwide to develop, apply, and expand their use of fluorescence in vivo imaging from pre-clinical research through clinical medicine”. As a basis for the filing, VisEn said it presented 15 published prior art references demonstrating the invalidity of the ‘851 patent, the majority of which had not been previously considered by the USPTO, the company noted.

The claims in the Caliper patent relate to basic methods in optical in vivo imaging, VisEn said. However, prior to the July 1994 priority date of the ‘851 patent, numerous investigators worldwide had researched, developed, and published on basic methods, as well as on significant advances, in the field of optical in vivo imaging, including the use of: light-generating systems used to propagate light through tissues; light-emitting molecules, conjugates, and entities used in vivo to enhance image contrast and specificity; and instrumentation and methods for the detection and images construction of the emitted light, according to VisEn. Collectively, this early research set the foundation for the further development of the optical in vivo imaging technologies now used in the fields of research, drug development and healthcare, the company noted.

“The field of fluorescence in vivo imaging is already beginning to have a profound impact on the life-science and healthcare space,” said Kirtland Poss, president/CEO of VisEn. “Since VisEn’s founding, it has been our mission to work with leaders in the field to enable and support continued innovation, application, and expansion of the very best in fluorescence in vivo imaging technology. While we generally respect the contributions of Caliper/Xenogen to the field of bioluminescence imaging, we believe it is clear, and also fundamentally understood in the industry, that the basic methods of fluorescence in vivo imaging were well known and in use before the priority date of the ‘851 patent, and therefore that the claims therein are clearly invalid. With this action today, our continued aim is to enable customers and partners in the space to innovate, apply and expand the power of fluorescence in vivo imaging broadly in their programs worldwide. We are confident that the rich history of optical in vivo imaging and the clear sequence of prior art references speak for themselves, and we look forward to continuing the development of all aspects of molecular imaging along with the leadership in the field.”

In other patent news:

• After a three-week trial in the U.S. District Court for the District of Massachusetts, CytoLogix (Cambridge, Massachusetts), received a jury verdict of $10.7 million in damages in patent infringement claims against Ventana Medical Systems (Tucson, Arizona). CytoLogix technologies contain unique slide-staining methods used by pathologists in the diagnosis of cancer and other diseases, the company said.

CytoLogix was founded by Steven Bogen, MD, PhD, a pathologist affiliated with the Boston University School of Medicine. Jack Pirozzolo and Vickie Henry of Foley Hoag led the CytoLogix trial team. Litigation on the CytoLogix family of patents covering this diagnostic technology is expected to continue.

CytoLogix’ last legal victory against Ventana was in the spring of 2004 when Judge Rya Zobel of the U.S. Federal Court in Boston issued a permanent injunction against Ventana.

That injunction covered Ventana’s Benchmark and Discovery systems and any variation of those products that infringed CytoLogix U.S. patent nos. 6,180,061 (’061) or 6,183,693 (’693).

• SonoSite (Bothell, Washington) said it has filed an amendment to its patent infringement lawsuit against General Electric (GE; Fairfield, Connecticut) and certain of its affiliates in the U.S. District Court for the Western District of Wisconsin. The lawsuit and the amendment are filed as a counterclaim to the complaint GE and its affiliates filed against SonoSite on May 15 in the same court. SonoSite filed its original answer to the GE complaint on July 5, denying all of GE’s claims and alleging that GE’s asserted patents are either invalid, not infringed, or both.

In its original counterclaim complaint, SonoSite asserted that GE and its affiliated companies infringe SonoSite’s U.S. Patent Nos. 6,569,101, “Medical Diagnostic Instrument with ECG Module, Authorization Mechanism and Methods of Use,” and 5,817,024, “Handheld Ultrasonic Diagnostic Instrument with Digital Beamformer.” In its Aug. 17 amendment, SonoSite asserts that GE and its affiliated companies also infringe SonoSite’s U.S. Patent Nos. 6,962,566, “Medical Diagnostic Ultrasound Instrument with ECG Module, Authorization Mechanism and Methods of Use,” and 6,364,839, “Ultrasound Diagnostic Instrument Having Software in Detachable Scanhead.” GE and its affiliated companies allegedly infringe SonoSite’s patents through their sales of ultrasound products, including sales of their Vivid and LOGIQ compact products and certain transducers and GE’s Vivid 7 cart-based system. SonoSite’s patents cover various core ultrasound related technologies. The complaint seeks unspecified monetary damages and a court injunction against future infringement by GE and its affiliates, according to SonoSite.

“We continue to believe that GE’s claims of patent infringement are without merit and we have now expanded our claims against them,” said Kevin Goodwin, SonoSite president/CEO. “We will continue to vigorously assert our rights.”

• Cytyc (Marlborough, Massachusetts), a provider of surgical and diagnostic products targeting women’s health and cancer diagnostics, and Xoft (Fremont, California), a point-of-care radiation therapy company, reported a settlement to the intellectual property dispute involving the balloon-based brachytherapy technologies developed by both companies for the treatment of breast cancer patients.

Specific financial terms were not disclosed, however, the agreement calls for Xoft to make certain royalty payments.

Both companies agreed that the settlement would end the current legal dispute between them. Xoft will have the freedom of operation in the ongoing sales of its Axxent Electronic Brachytherapy system. The companies said they have also agreed to discuss potential collaboration in the development of technologies in several areas, including women’s health.