We own five issued US patents and nine corresponding issued patents in Australia, Canada, Europe, Hong Kong, and Japan as well as pending patent applications in the US, Europe, and Japan. These patents have claims directed to a collection device for nipple aspirate fluid; for the method of making a diagnosis from NAF, using “whole cells, cell fragments, cell membranes, a protein, a peptide, a glycoprotein, a lipid, a glycolipid, a DNA polynucleotide, an RNA polynucleotide, or a combination thereof;” and the use of the drug oxytocin to increase the amount of NAF produced.
The patent and application numbers, by country, are:
Europe: EU 97938551.1 and one pending EU application.
Hong Kong: HK Patent 00100654.7 and HK application 03105927.4.
Japan: JP Patent 4,050,612 and one pending JP divisional application.
PCT Application: PCT/US97/14863, Expired but National Phase entered, and EU 01993422.3 – Published.
We believe our patents will prevent laboratories other than Atossa from performing the cytology or biomarker services. Specifically, US patent 6,887,210 (the “’210 patent”) includes multiple claims to the patient NAF specimen kit vial, for example, to “a cytology vial having one or more air ports that communicate between an outer wall and inner lumen of the vial to form a gaseous connection between the lumen of the vial, the vacuum pump means, and the breast engaging member” and another claim to “a modified cytology vial.” The collection kits we will provide, which are covered by the ‘210 patent, will be sold under a limited “collection only” patent license, which permits the physician to collect the sample but does not provide a patent license for other uses of the vial, including transporting the sample or preparing cytology slides or conducting biomarker studies with the NAF sample. US patent 6,689,073, which will not be licensed with the kit sales, contains claims to the steps of transferring and processing samples to detect or quantify breast disease markers. The foreign patent counterparts contain similar claims.
The Company believes its patent estate could permit the Company to license to third party laboratories rights under the 6,689,073 patent to transfer, process, and make diagnoses from NAF samples and receive patent royalty revenue.
We have applied to the U.S. Patent and Trademark Office for registration of the use of the marks Atossa, MASCT, and Oxy-MASCT as trademarks and the pink, stylized Atossa Genetics logo as a service mark of the Company.