Becton, Dickinson v. B. Braun (IPR2017-01586): The § 325(d) Factors

Section 325(d) of the Patent Act lets the Director take into account whether “the same or substantially the same prior art or arguments” were previously presented to the Office. Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586 (Paper 8, December 15, 2017), is the decision that organized that inquiry into a list of factors. It is listed here with the Board’s informative decisions. Designations can change, so check the USPTO’s current list of precedential and informative decisions.

The petition challenged claims 18, 22 and 25 of B. Braun’s U.S. Patent No. 8,328,762, which concerns a catheter insertion device with a valve and a needle guard. The patent was also in litigation in the District of Delaware.

Background

Becton, Dickinson asserted four obviousness grounds. The first combined Woehr, a spring-clip safety catheter patent, with Tauschinski, a self-sealing valve connector. The patent owner argued that the Board should deny that ground under § 325(d). During prosecution of the parent patent, the examiner had rejected claims over Woehr combined with Rogers, another check-valve reference, and separately over Bialecki combined with Tauschinski. The applicant overcame those rejections with detailed technical arguments, and the ‘762 patent issued as a continuation subject to a terminal disclaimer.

What the Board decided

The Board began from the premise that institution is discretionary and listed six non-exclusive factors it had used in earlier cases:

• (a) the similarities and material differences between the asserted art and the art involved in examination;
• (b) the cumulative nature of the asserted art and the art evaluated in examination;
• (c) the extent to which the asserted art was evaluated during examination, including whether it was the basis for a rejection;
• (d) the extent of overlap between the arguments made in examination and the way the petitioner relies on the art or the patent owner distinguishes it;
• (e) whether the petitioner has sufficiently pointed out how the examiner erred; and
• (f) the extent to which additional evidence and facts in the petition warrant reconsideration.

Applying them, the Board found that Woehr was used as the base reference in the same way the examiner had used it. Tauschinski and Rogers worked the same way, and the structural differences between them were not material, particularly because the petition did not rely on them. Tauschinski itself had been substantively applied by the examiner for the same teaching. The petitioner’s reasoning for combining the references closely tracked the examiner’s. The petition did not identify any examiner error or engage with the applicant’s arguments during prosecution.

On factor (f), the Board acknowledged that the petitioner’s expert declaration was new to the Office. But it found the testimony lacked factual underpinnings for its “routine design” opinion and gave it little weight under 37 C.F.R. § 42.65(a). New testimony alone did not warrant reconsidering art and arguments already evaluated. The Board therefore exercised its discretion not to institute on the Woehr and Tauschinski ground.

The decision did not end there. The Board instituted trial on the three grounds based on Van Heugten, alone or combined with Lynn or Tauschinski, finding a reasonable likelihood of success on each challenged claim. The decision predates SAS Institute Inc. v. Iancu (2018), after which the Board stopped instituting on only some grounds.

Why it matters

The factors give patent owners a structured way to argue that a petition repeats what the examiner already did, and give petitioners a checklist for distinguishing their case. A new combination of old references is not automatically new; what matters is whether the art and reasoning are materially different. Petitioners who rely on art seen in prosecution should explain why the examiner erred, and expert testimony needs factual support to move the needle; see evidentiary considerations in PTAB trials.

Section 325(d) sits beside the general threshold for institution; see the different threshold standards. For an earlier informative application of § 325(d), see Cultec v. StormTech.

Later developments

In Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469 (Paper 6, 2020) (precedential), the Board set out a two-part framework for § 325(d). It asks first whether the same or substantially the same art or arguments were previously presented to the Office, and then whether the petitioner has shown that the Office erred in a manner material to patentability. The Becton, Dickinson factors are used within that framework. The USPTO’s discretionary-denial practice has changed repeatedly since then, so readers should check current USPTO guidance.

Key takeaways

• Becton, Dickinson lists six non-exclusive factors for deciding whether to deny institution under § 325(d).
• The Board denied one ground that reused the examiner’s base reference and a cumulative secondary reference with overlapping reasoning.
• A new expert declaration without factual support did not justify reconsidering art already evaluated.
• Advanced Bionics (2020) later folded these factors into a two-part framework; check current guidance.