The ’938 patent describes a study to “determine the safety and tolerability of talimogene laherparepvec in combination with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.” Ex. 1001, 18:34–19:37.
3 Natarajan discloses that the agents discussed in the article “are enabling the rational design of novel combination trials to simultaneously increase antigen presentation, deplete regulatory T cells and block immune
Natarajan discloses that OncoVEXGM-CSF is “an oncolytic herpes simplex virus type 1 (HSV-1) [strain JS1] that has been engineered” to include “deletion of ICP34.5”; “deletion of ICP47”; and “insertion of the open-reading frame of GM-CSF” and discusses the results of clinical trials of OncoVEXGM-CSF administered to patients with stages IIIc to IV melanoma.
Second, we credit the unrebutted testimony of Dr. Sosman that “a POSA would have been motivated to combine OncoVEXGM-CSF and ipilimumab because she would have known, among other things, their respective biological compositions, mechanisms of action, common patient population, successful clinical trial results, and dosing regimens.” Ex. 1002 ¶¶ 74–76 (citing references disclosing the properties of these agents).
Overall, on the current record, we determine that Petitioner sufficiently explains why an ordinarily skilled artisan would have been motivated to combine OncoVEXGM-CSF with ipilimumab for the treatment of a patient with stage IIIb to IV melanoma based on the disclosure in Natarajan, and would have had a reasonable expectation of success in doing so.