The PTAB has provided guidance on the standard for exercising its discretion to deny institution under § 325(d).  The guidance comes in the form of two decisions designated as precedential and one decision designated as informative, discussed below.

The Board’s Two-Part Framework for Applying § 325(d)

In determining whether to institute trial, the Board takes into account whether the same or substantially the same prior art or arguments were previously presented to the Office in accordance with 35 U.S.C. § 325(d).  The Board routinely considers the factors set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) in making such determinations.

In Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential), the Board applied the Becton Dickinson factors as a two-part framework:

[U]nder § 325(d), the Board uses the following two-part framework: (1) 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, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.

Becton Dickinson factors (a), (b), and (d) relate to the first part of the framework and factors (c), (e), and (f) relate to the second part of the framework:

If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.

Concerning the second part of the analysis, the Board provided examples of material errors that could justify denial:

An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.  Another example may include an error of law, such as misconstruing a claim term, where the construction impacts patentability of the challenged claims.

The Board also explained that “if the alleged error is a disagreement with a specific finding of record by the Office, then ordinarily the petitioner’s required showing of material error must overcome persuasively that specific finding of record.”

Applying its two-part framework to the facts of the case, the Board determined that (1) the petition presents the same or substantially the same prior art previously presented to the Office and (2) the petitioner failed to show that the examiner materially erred as to the patentability of challenged claims.  Thus, the Board exercised its discretion and denied institution.

Petitioner’s Reliance on the Same Prior Art Results in Denial of Institution

In PUMA North America, Inc. v. NIKE, Inc., IPR2019-01042, Paper 10 (PTAB Oct. 31, 2019) (informative), the Board considered a petition containing invalidity grounds that relied on the same combination of prior art that the examiner applied during prosecution of the challenged patent.  The Board found that the examiner rejected the challenged claims over the same combination of references in the same manner as proposed in the petition:

[T]here is a high degree of overlap between the arguments made during examination and the manner in which Petitioner relies upon the prior art. Specifically, the Examiner and Petitioner rely upon the same references, for the same claim limitations.  Indeed, the Examiner and Petitioner propose the same modification of those references….  Moreover, the Examiner and Petitioner provide substantially the same rationale for this modification….

Thus, the Board focused on “how” and “why” the references would have been combined as proposed in the petition and during prosecution.  The Board also found that the petitioner failed to show any examiner error.  Thus, the Board denied institution under § 325(d).

The Board’s two-step analysis in PUMA is similar to the two-part framework articulated in Advanced Bionics.  Like Advanced Bionics, the panel in PUMA considered (1) whether the same or substantially the same art/argument previously was presented to the Office, and (2) whether the petitioner demonstrated that the Office erred in a manner material to the patentability of challenged claims.

Prior Art Differing in Structure and Purpose Determined to Be Non-Cumulative

In Oticon Medical AB v. Cochlear Limited, IPR2019-00975, Paper 15 (PTAB Oct. 16, 2019) (precedential as to sections II.B and II.C), the Board declined to exercise its discretion under 35 U.S.C. § 325(d) to deny institution.  The Board determined that the art relied on in the petition is not cumulative to the art considered during prosecution and that the Examiner erred in not considering the art during prosecution.

Patent Owner argued that a reference (“Choi”) relied on in the petition was cumulative over a reference (“Härle”) that was considered during prosecution.  Choi was not previously considered by the Office.  The Board provided a detailed analysis of the references and determined that Choi was distinguishable from Härle in both structrure and intended purpose:

Choi is not cumulative over Härle because Choi’s circumferential groove and Härle’s circumferential groove are different structures that serve different purposes.

The Board also determined that the overlooking of Choi during prosecution weighed against denial:

[W]e determine that there was error in the prosecution leading to the issuance of the ’807 patent because Choi, with its teaching of circumferential grooves, was not considered.  It seems that the Examiner was simply not aware of Choi’s teaching in this regard.

Thus, the Board determined not to exercise its discretion to deny the petition under § 325(d).  Like PUMA, the two-step analysis applied by the panel in Oticon is similar to the two-part framework articulated in Advanced Bionics.

In Oticon, the Board also declined to exercise its discretion to deny institution under 35 U.S.C. § 314(a).  Under § 314(a), the Board considers whether any parallel district court litigation is in an advanced state, and whether the same prior art and arguments are being advanced at district court and the PTAB.  See NHK Spring Co. v. IntriPlex Technologies, Inc., IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) (precedential).  In Oticon, the Board distinguished NHK because no trial date had been set in the parallel district court proceeding.  The Board also determined that the IPR would not be duplicative of the district court’s consideration of validity.

Conclusion

The Board’s recent precedential and informative decisions provide guidance on how the Board applies the Becton Dickinson factors in § 325(d) determinations.  The Board considers (1) whether the same or substantially the same art/argument previously was presented to the Office, and (2) whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.  The decisions can be found at the PTAB’s Precedential and informative decisions page.