Are the claimed variants dominated by claims to wild-type telomerase? The question is moot for the constructed deletion variants of the second set because they are also owned by Geron. The claimed splice variants are not owned by Geron however, and so the answer to the question is of paramount importance. This question can’t be definitively answered here; an answer requires additional documents and considerable legal analysis. But, an educated guess can be hazarded.
As discussed in the section on wild-type telomerase, some of the claims at first blush appear to read on certain RNA splice variant sequences (e.g., hybridizing molecules will encompass polymorphisms, small base changes, some insertions and deletions). Under current United States patent law, sequences must be fully described and enabled. Recent case law indicates that the threshold amount and type of disclosure to satisfy the written description (especially) and enablement requirements is exacting. For the most part, claims to undisclosed sequences aren’t patentable. Geron disclosed wild-type telomerase and did not disclose splice variants. Moreover, Geron’s disclosures for wild-type telomerase are directed to full-length molecules. Analysis above of the key claims for wild-type telomerase preliminarily concluded that hybridizing molecules were directed to full-length telomerase; in addition, fragments of wild-type and related telomerases aren’t likely to encompass or contemplate splice variants. Furthermore, the key claims for wild-type telomerase require catalytic activity. Therefore, the splice variants that do not have catalytic activity should fall outside these claims. Taken all together, a credible interpretation can conclude that claims to splice variants of telomerase are not dominated by Geron’s claims to wild-type telomerase and related molecules.
The impact of this conclusion, if correct, will be most keenly felt by CAMBIA and any of its licensees who will be able to practice the invention without needing permission or a license from Geron.