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Genetic Technologies Ltd.’s Non-coding DNA Patent Upheld on Reexamination
The USPTO has recently upheld Genetic Technologies Ltd.’s (GTG’s) patent for non-coding DNA technologies. U.S. Patent No. 5,612,179 titled “Intron sequence analysis method for detection of adjacent locus alleles as haplotypes” claims a method for facilitating the detection of specific gene variations.
The third party initiated ex parte re-examination Control No. 90/010,318, was filed on October, 15, 2008 requesting that each of claims 26-32 be found invalid in view of a new reference, which was not previously cited in the prosecution of the ‘179 patent; namely a printed publication titled “Comparison of Multiple HLA-A Alleles at the DNA Level by Using Southern Blotting and HLAA-A-Specific Probes” by Beverly Koller et al. (“Koller I”). The request submitted that Koller I raised a substantial new question of patentability and renders claims 26-30 and 32 of the ‘179 patent invalid as anticipated under § 102(b) and claim 31 invalid under § 103(a). The request further argued that Koller I discloses characterizing the alleles of the multi-allelic HLA-A genetic locus using polymorphisms found in non-coding regions of that locus, including polymorphisms in introns and polymorphisms in flanking regions of the HLA-A locus.
In a reply filed July 24, 2009, GTG argued that the Koller I reference cannot be used as an anticipatory reference because Figure 4 of Koller I is not drawn to scale and does not accurately depict the presence or absence of restriction sites in the mapped alleles. Furthermore, regarding the Group I polymorphisms, GTG argued that the PvuII sites were not in actuality polymorphisms, and both the SstI site and the BglII site (absent from HLA-23 and A24) are disclosed as being in coding, not non-coding regions of DNA. GTG further provided a Declaration on December 17, 2009 supporting the above arguments.
In view of GTG’s reply and the subsequently filed declaration, the USPTO confirmed claims 26-32, withdrawing the anticipation rejection over claims 26-30 and 32 and the obviousness rejection over claim 31 in a Notice of Intent to Issue Ex Parte Reexamination Certificate, mailed February 4, 2010. The Reexamination Certificate issued on May 4, 2010.
Prior to the issuance of the Reexamination Certificate, the non-coding DNA technology of the ‘179 patent had been licensed to over 39 parties.
I think the take-home lesson from this reexamination is that the Requestor needs to do their homework and “test-out” the new prior art submitted for enablement. Those of us who have more “success” with reexamination requests generally have multiple SNQ’s submitted (often 10 or more). Further, we will support the enablement of the new prior art in the SNQ’s with declaration evidence proving what a prior art document teaches a person of ordinary skill in the art at the time the target patent application was filed. In that way, one can head off the Patentee’s natural tendency to provide a declaration trying to characterize the prior art as non-enabling, as was done here with GTG.
In this GTG case, the reexamination request was over 80 pages, there was very little substance in it. Given the number of references cited in the IDS, some creative SNQ formation was possible.
Lastly, since I also represent one of the 39 non-exclusive licensees, the cost is so low that we have bigger (and more egregious) fish to fry with our reexamination dollars.