By Donald Zuhn --
Commonwealth Biotechnologies, Inc. announced today that it has been granted U.S. Patent No. 7,338,761. According to Commonwealth's press release, while the '761 patent is assigned to Vigen Laboratories, the patent is exclusively licensed to CBI Services, a Commonwealth business unit, which developed the claimed invention under contract to Vigen Laboratories. Commonwealth's release also notes that the two named co-inventors of the '761 patent are CBI President Robert Harris and CBI Executive Vice President Thomas Reynolds. Now that the '761 patent has issued, Commonwealth and Vigen are looking to out-license the patented technology to a clinical laboratory
service provider who can commercialize the assay on a large scale, with the two companies to share equally in licensing revenue.
The '761 patent is directed to real time PCR-based assays and polynucleotide sets for detecting human herpes viruses. According to Commonwealth's statement, the platform described in the '761 patent provides a "rapid and specific assay of each of the various [human herpes viruses] down to as few as 10 copies of viral DNA in patient samples," and "has been successfully applied to peripheral blood serum, sputum, cerebrospinal fluid, and various laboratory preparations."
There are eight known human herpes viruses (HHVs), which can be divided into three classes: the alpha herpes viruses, which include HSV 1 (simplex virus), HSV 2 (simplex virus), and HHV 3 (varicellovirus); the beta herpes viruses, which include HHV 5 (cytomegalovirus), HHV 6, and HHV 7 (Roseolovirus); and the gamma herpes viruses, which include HHV 4 (Epstein Barr virus) and HHV 8 (Rhadinovirus). The herpes viruses are associated with a number of conditions, including:
• HHV 1 and 2 are the causative agents of genital herpes.
• HHV 4 is associated with infectious mononucleosis (glandular fever), chronic-fatigue syndrome, oncogenesis (particularly in relation to Burkitt’s lymphoma nasopharyngeocarcinoma), immuno-suppression, and Hodgkin’s disease.
• HHV 5 is associated with chronic-fatigue syndrome, and is known to cause lung infections in immune-suppressed persons.
• HHV 6 is associated with roseola and infantum infection in children and with immuno-compromised patients, and may perhaps be involved with multiple sclerosis and chronic fatigue syndrome.
• HHV 8 appears to be associated with Karposi’s Sarcoma.
The '761 patent issued from U.S. Application No. 10/399,872, which is a national stage application of International Application No. PCT/US01/31892, filed October 12, 2001, which claims the benefit of U.S. Provisional Application No. 60/242,903, filed October 24, 2000. Representative claims 1, 16, and 17 of the '761 patent recite:
1. A set of polynucleotide molecules wherein the set comprises the polynucleotide molecules consisting of SEQ ID NOS: 33, 34, and 35 and optionally a fourth polynucleotide molecule comprising SEQ ID NO: 57.
16. A method for detecting infection by HHV6 in a sample from an individual suspected of being infected with HHV6, comprising:
(a) amplifying, in the course of a single amplification reaction, a target segment of an HHV6 glycoprotein B gene comprising SEQ ID NO: 57 using primers and a probe consisting of SEQ ID NOS: 33, 34, and 35 and
(b) interpolating the number of HHV6 viral nucleic acid copies in the sample by comparing the number of amplification cycles required for detection of the target segment to the number of amplification cycles required to detect a known quantity of the target segment.17. A method for detecting infection by either HHV6a or HHV6b in a sample from an individual suspected of being infected with either HHV6a or HHV6b, comprising:
(a) amplifying, in the course of a single amplification reaction, a target segment of an HHV6 glycoprotein B gene comprising SEQ ID NO: 57, using primers and a probe consisting of SEQ ID NOS: 33, 34, and 35; and
(b) interpolating the number of either HHV6a or HHV6b viral nucleic acid copies in the sample by comparing the number of amplification cycles required for detection of the target segment to the number of amplification cycles required to detect a known quantity of the target segment.
How is this not subject to a 103 type rejection?
Posted by: Cathleen | March 14, 2008 at 02:42 AM