By Donald Zuhn --
Last month, Larkspur, California-based biotech Jivan Biologics, Inc. announced that the U.S. Patent and Trademark Office had granted its request for an ex parte reexamination of U.S. Patent No. 6,881,571, which is owned by ExonHit Therapeutics S.A. The '571 patent is directed to devices for identifying differentially spliced gene products. ExonHit, which is based in Paris, France, had originally asserted the '571 patent against Jivan in an infringement suit filed in the U.S. District Court for the Northern District of California on March 12, 2007 (see complaint here).
In its Order
granting the reexamination, the Patent Office stated that Jivan, in a request filed in mid-March, had identified nine references each of which raised a substantial new question of patentability. Independent claims 1 and 12 of the '571 patent recite:
1. A device for identifying at least one differentially spliced gene product, wherein said device comprises a solid support material and single-stranded oligonucleotides of between 5 and 100 nucleotides in length attached to said support material, wherein said oligonucleotides comprise at least a first and a second oligonucleotide molecule arranged serially on the support material, wherein said first oligonucleotide molecule comprises a first sequence that is complementary to and specific for an exon or an intron of a first gene, and wherein said first sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, and wherein said second oligonucleotide molecule comprises a second sequence that is complementary to and specific for an exon-exon or exon-intron junction region of said first gene, and wherein said second sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, said device allowing, when contacted with a sample containing at least one nucleic acid molecule under conditions allowing hybridisation to occur, the determination of the presence or absence of said differentially spliced gene product.
12. A method of producing a device comprising a support material and single-stranded oligonucleotide of between 5 and 100 nucleotides in length attached to said solid support material, wherein said method comprises: (a) providing said oligonucleotides, wherein said oligonucleotides comprise at least a first and a second oligonucleotide molecule, wherein said first oligonucleotide molecule comprises a first sequence that is complementary to and specific for an exon or an intron of a first gene, and wherein said first sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, and wherein said second oligonucleotide molecule comprises a second sequence that is complementary to and specific for an exon-exon or exon-intron junction region of said first gene, and wherein said second sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing; and (b) arranging and immobilizing said oligonucleotides serially on said support material, said device allowing, when contacted with a sample containing at least one nucleic acid molecule under conditions allowing hybridisation to occur, the determination of the presence or absence of at least one differentially spliced gene product.
In its press release, Jivan CEO Dr. Subha Srinivasan stated that the company was "pleased to hear that the USPTO has decided to reexamine the validity of this patent," and expected that the Office would either require ExonHit to amend the claims or invalidate the claims in their entirety.
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