In Sandoz Inc. v. Acerta Pharma B.V. (IPR2023-00478), a Patent Trial and Appeal Board (“PTAB”) panel denied IPR institution where the asserted prior art was cumulative of that considered during prosecution. This denial included prior art that was not cited during prosecution, but otherwise disclosed the same limitations that the Examiner previously found in different references.
Petitioner alleged that several claims of U.S. Patent No. 10,272,083—related to methods of treating leukemia with a BTK inhibitor—were obvious over Barf (US 9,758,524) in view of Cheson, or Barf-PCT (WO 2013/010868) in view Cheson. Barf-PCT disclosed a genus of BTK inhibitor compounds that can be used in a variety of dosages to treat, inter alia, leukemia. Barf has the same specification as Barf-PCT, but different claims. Cheson is an article that similarly teaches that the BTK inhibitor ibrutinib is effective against leukemia.
In its preliminary response, Patent Owner argued “that the same or substantially the same prior art and arguments that Petitioner relies on for its grounds of unpatentability—namely, Barf, Barf-PCT, and Cheson—were presented previously to the Office.” Specifically, Patent Owner argued that the PTAB should deny institution for the following reasons: (1) the Examiner cited Barf-PCT in an office action, (2) Barf is the US counterpart to Barf-PCT containing the same disclosures, and (3) Cheson is cumulative of other references. Petitioner countered that the PTAB should institute review because the claims in Barf were not before the Examiner. Further, Petitioner contended the Examiner cited Barf-PCT “only as a secondary reference in combination with two other references—Smyth and Evarts—that Petitioner does not rely on.”
Section 325(d) provides that the PTAB may “reject the petition” if “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). Here, the PTAB analyzed this issue under a two-part framework: “(1) [determining] whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, [determining] whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” See Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (introducing the framework used by the PTAB under § 325(d)).
Under the first part of the test, the PTAB found it undisputed “that Barf-PCT was before the Office [because] Barf-PCT was listed on a form PTO-892 by the Examiner and is listed on the face of the ’083 patent as a considered-reference.” The Examiner certified that Barf-PCT was considered and cited Barf-PCT in an office action. Thus, Barf-PCT was “previously presented art.” Regarding Barf and Cheson, the PTAB found they were “‘substantially the same art’ as that previously presented to the Office.” Barf was “substantially the same” as Barf-PCT because it had the same specification. And Cheson was “substantially the same” as Smyth and Evarts because Petitioner only relied on it for “the ‘twice-daily’ [dosage] limitation,” which the Examiner cited Smyth and Evarts for. Thus, the PTAB determined that all of Petitioner’s references were “the same or substantially the same art that were previously presented to the Office.”
Under the second part of the test, the PTAB considered whether the Examiner materially erred by incorrectly citing the wrong example in Barf-PCT, or by crediting Patent Owner’s evidence of unexpected results. First, the PTAB found the Examiner’s initial misidentification was not material because the Examiner’s rejection reflected that he understood the Barf-PCT disclosure. And during prosecution, Patent Owner alerted the Examiner to the mistake. Second, the PTAB found that because the Examiner allowed the claims, it was reasonable to conclude the Examiner found Patent Owner’s evidence of the unexpected results from a twice-daily dosage was sufficiently persuasive to overcome the rejection over Barf-PCT. The PTAB was unpersuaded by Petitioner’s argument that the Examiner failed to consider different prior art that Petitioner alleged would undermine the unexpected results, but which Petitioner did not rely on in its asserted grounds for unpatentability.
Accordingly, the PTAB found “no error in the Office’s previous consideration of the prior art of record during prosecution, which is the same and/or substantially the same as that asserted” in the IPR petition here. For these reasons, the PTAB determined “that both parts of the two-part framework of Advanced Bionics [we]re satisfied.” Thus, the PTAB exercised its “discretion pursuant to 35 U.S.C. § 325(d) to deny institution of trial.”
Takeaway: Petitioners should carefully evaluate the prosecution history of a patent before asserting prior art references that were considered during prosecution, or even related applications that have similar disclosures to ensure they are not presenting arguments made by the examiner during prosecution.