The Board issued three decisions in TC 1600 during the week of July 30, all denying institution of inter partes review. Summaries of the decisions follow.
Envirologix Inc. (“Envirologix”) v. Ionian Techs., Inc. (“Ionian”), IPR2018-00405 and Envirologix v. Ionian, IPR2018-00406 (Decisions Denying Institution, Entered July 30, 2018). Envirologix submitted two Petitions, challenging claims 1-8 and 10-35 of U.S. Patent No. 9,562,263 (“the ’263 patent) and claims 1-6 and 8-29 of U.S. Patent No. 9,562,264 (“the ’264 patent). Each of the two Petitions included three grounds of anticipation by three primary references (“Ehses,” the “Ehses Dissertation,” and “Piepenburg”), and five grounds of obviousness. Ionian filed a preliminary response. Both challenged patents relate to methods for amplifying a target polynucleotide sequence using a nicking enzyme. The sole independent claims of the ’263 and the ’264 patents are illustrative of such methods, both of which require the following dispositive limitations:
- “without first subjecting [a] target nucleic acid to a thermal denaturation step associated with amplification of the target polynucleotide sequence”;
- an “amplification reagent mixture” that includes, among other things, “a first oligonucleotide comprising a 5′ portion that comprises a nicking binding site that is non-complementary to the target nucleotide sequence and a 3′ portion that hybridizes to the target polynucleotide sequence” and “a second oligonucleotide comprising a 5′ portion that comprises a nicking binding site that is non-complementary to the target nucleotide sequence and a 3′ portion that hybridizes to the target polynucleotide sequence” (the “first and second oligonucleotide” limitations); and
- “detecting the amplified target polynucleotide sequence in real time within 10 minutes of subjecting the reaction mixture to essentially isothermal conditions”
In virtually identical decisions, the Board denied institution based on the three anticipation grounds asserted in both of Envirologix’s Petitions. First, the Board denied institution based on anticipation by the Ehses reference because the Ehses does not teach steps of omitting a thermal denaturation or detecting the amplified target polynucleotide sequence within 10 minutes.
Turning to the Ehses Dissertation, Envirologix relied on the date of the oral dissertation defense—August 7, 2005—to establish that the dissertation qualifies as prior art as a printed publication. The date of an oral dissertation defense, however, was not sufficient to establish that the dissertation was made publicly accessible as of that date. Without any additional evidence regarding the public availability of the Ehses Dissertation, the Board determined that Envirologix failed to make a threshold showing that the reference qualified as a printed publication and consequently declined to institute inter partes review based on the Ehses Dissertation.
The Board also denied institution based on anticipation by Piepenburg because Piepenburg lacks disclosure of an amplification reagent mixture that requires both a first and a second oligonucleotide, and lacks a step of detecting the amplified target polynucleotide sequence within 10 minutes.
Finally, having found that the challenged claims are not anticipated by Ehses, the Ehses Dissertation, or Piepenburg, the Board declined to institute Envirologix’s five obviousness grounds because none of the alleged prior art combinations remedy the deficiencies with respect to the anticipation grounds.
Pfizer, Inc. v. Genentech, Inc., IPR2018-00373 (Decision Denying Institution, Entered August 2, 2018). In its petition, Pfizer challenged claims 1-18 of U.S. Patent No. 9,795,672 (“the ’672 patent”) on seven grounds based on anticipation and/or obviousness by four primary references: Kabbinavar, Chen, Yang, and Patent Application Publication No. WO01/74360 to Curwen et al. (“PCT’360”). Genentech filed a preliminary response. The ’672 patent relates to methods for treating cancer in a patient who has hypertension as a result from treatment with bevacizumab—a humanized anti-VEGF antibody known as “rhuMAb VEGF” or “Avastin™.” The claimed methods require steps of “administering to a patient an effective amount of bevacizumab, wherein the patient has a grade III hypertensive event resulting from the bevacizumab administration” and “administering to the patient an antihypertensive agent in an amount sufficient to manage the grade III hypertensive event while continuing bevacizumab treatment being carried out without altering the dosage regimen.”
In its decision construing the claims, the Board agreed with Pfizer that “a grade III hypertensive event” should be construed according to the National Cancer Institute’s Common Toxicity Criteria to mean “hypertension requiring therapy or more intensive therapy than previously administered.” But the Board’s agreement with Pfizer ended at claim construction.
First, the Board denied institution of the two grounds related to the Yang reference because Pfizer failed to establish Yang was available as prior art for the challenged claims. The ’672 patent claims priority to a provisional patent application filed on May 30, 2003—two months before Yang’s publication date of July 31, 2003. In its Petition, Pfizer argued that the ’672 patent was not entitled to the May 30, 2003, priority date because the claims lacked written description support in the provisional application. The Board disagreed, finding that Genentech provided relevant written description support for the challenged claims in the provisional application that Pfizer had failed to address. Having found that the ’672 patent claims are entitled to the priority date of the provisional application, the Board concluded that Yang did not qualify as prior art and declined to institute an inter partes review based on that reference.
Next, the Board exercised its discretion under 35 U.S.C. § 325(d) to deny institution of the three grounds related to Kabbinavar and Chen. Pfizer acknowledged that both Kabbinavar and Chen were considered by the Examiner during prosecution, but urged the Board to reconsider both references because the Examiner had not considered Pfizer’s argument that the ’672 patent is not entitled to the May 2003 priority date, and because Kabbinavar “was only avoided by an In re Katz declaration insufficient in this proceeding.” Pfizer did not address why the Board should ignore the fact that Chen was already considered during prosecution. Citing its decision regarding the provisional application as it related to the Yang reference, and Pfizer’s failure to address Chen, the Board exercised its discretion under section 325(d) and declined to consider grounds based upon Kabbinavar and Chen that had already been considered by the Patent Office.
Finally, the Board considered the last two grounds based on the PCT’360 reference. The PCT’360 reference was directed to therapeutic combinations of antihypertensive and antiangiogenic agents that may be beneficial in several diseases associated with angiogenesis, including cancer. Among the numerous antiangiogenic agents disclosed by PCT’360 is an anti-VEGF antibody—but the only relevant experimental results related to treatment using a small-molecule VEGF receptor tyrosine kinase inhibitor. Pfizer argued that the challenged claims would have been obvious in view of the drug combinations disclosed in PCT’360, further combined with standard clinical practice and a secondary reference, Presta. Siding with Genentech, the Board recognized that although PCT’360 included an anti-VEGF antibody in the laundry list of potential anti-angiogenic agents, Pfizer failed to demonstrate that one skilled in the art would have reasonably expected the teaching and experimental results related to the VEGF receptor tyrosine kinase inhibitor in PCT’360 to apply to an anti-VEGF receptor antibody like bevacizumab. Placing the final nail in the coffin for Pfizer’s challenge to the ’672 patent, the Board therefore declined to institute inter partes review for the grounds based on PCT’360.