April 17, 2020
The PTAB recently designated two decisions as precedential and one decision as informative with respect to 35 U.S.C. § 325(d). These cases discuss the Board’s process for deciding when to use their discretion to deny institution because a Petition raises issues that the Patent Office previously considered in other proceedings (e.g., during prosecution, prior reexams).
Until recently, only the Becton Dickinson precedential case addressed section 325(d) (though several informative decisions existed). The Becton Dickinson case dictated a number of factors the Board should weigh in making a determination under 325(d), including but not necessarily limited to:
(a) the similarities and material differences between the asserted art and the prior art involved during examination;
(b) the cumulative nature of the asserted art and the prior art evaluated during examination;
(c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection;
(d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art;
(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and
(f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments.
Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18, (PTAB Dec. 15, 2017) (precedential).
The newly-designated Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, Case No. IPR2019-01469 (USPTO Feb. 13, 2020) (Deshpande, APJ) (designated precedential on Mar. 24, 2020) provides additional guidance, setting forth a two-part framework for evaluating whether “the same or substantially the same prior art or arguments previously were presented to the Office.” The two-part test is: (1) whether the same or substantially the same (a) art or (b) arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.
In that case, the Board reiterated that it will defer to previous Office evaluations such that if a petitioner fails to establish material error, or if reasonable minds could differ about the purported treatment of the art or arguments, then it cannot be said the Office erred. This makes it increasingly difficult for a petitioner to rely on art that was previously considered by the Office.
The Board also provided guidance on showing prior error, noting that if the Office’s previous record is silent or not well developed, then a petitioner may be able to show that the Office overlooked something persuasive. But, if the alleged error is merely a disagreement with a specific finding, then the petitioner must overcome persuasively that specific finding.
In the second newly-designated case, Oticon Medical AB v. Cochlear Ltd., Case No. IPR2019-00975 (USPTO Oct. 16, 2019) (Worth, APJ) (designated precedential as to §§ II.B and II.C on Mar. 24, 2020), the Board set forth additional detail with respect to evaluating whether the art in the petition is substantially the same prior art or “new, noncumulative prior art.” In that instance, the Board reviewed the relevant structures disclosed in each prior art reference and the problems each structure was attempting to solve, ultimately determining that the references disclosed different structures that served different purposes, and as a result, were not “substantially the same” under § 325(d).
Finally, the informative case PUMA North America, Inc. v. NIKE, Inc., Case No. IPR2019-01042 (USPTO Oct. 31, 2019) (Wieker, APJ) (designated informative on Mar. 24, 2020), examined a situation where the petitioner relied on the same combination of references that the examiner had twice used in rejecting the claims. The Board found a “high degree of overlap” because they applied the same references to the same limitations and combined them in the same way. Having found the art and arguments similar, the Board turned to the two alleged “errors” in the examiner’s obviousness analysis—following the two-part framework set forth in Advanced Bionics. Neither error was deemed sufficient, and thus the Board used its discretion to deny institution under § 325(d).
While not limited to the life sciences, section 325(d) has become a hot topic in recent years, and often presents a separate and threshold hurdle that a petitioner must confront when seeking institution of trial for a given patent. For the responding patent owner, section 325(d) provides an opportunity to convince the board that the petitioner’s arguments (and art) are simply a rehash of what was reviewed and considered by the PTO. In short, what used to be a seemingly throwaway patent owner argument has been picking up steam and is becoming a viable, and even reliable, defense in the right circumstances.