On May 22, 2020, the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office issued a decision instituting
inter partes review (“IPR”) over Patent Owner’s argument that the PTAB should exercise its discretion to deny institution because the IPR petition relied on several references that were considered by the patent examiner during prosecution of the application leading to the patent-at-issue.
Medacta USA, Inc. v. RSB Spine, LLC, IPR Case No. 2020-00264, Paper 24 (PTAB May 22, 2020). The PTAB found that the examiner “erred in a manner material to the patentability of the challenged claims” by overlooking certain aspects of the prior art references.
35 U.S.C. § 325(d) reads, in relevant part, that “[i]n determining whether to institute or order a proceeding … the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”
In order to assess whether to exercise its discretion to deny institution of an IPR based on “the same or substantially the same prior art or arguments [having been] previously … presented to the Office,” the PTAB utilizes a two-part framework advanced in the PTAB’s precedential
Advanced Bionics decision:
- 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
- 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.
Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH, IPR Case No. IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential).
As explained in the PTAB’s precedential
Becton, Dickinson decision, application of this two-step framework involves, in turn, six “non-exclusive factors”:
- the similarities and material differences between the asserted art and the prior art involved during examination;
- the cumulative nature of the asserted art and the prior art evaluated during examination;
- the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection;
- 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;
- whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and
- 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, 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph).
If, after review of factors (a), (b), and (d), the PTAB determines that the same or substantially the same art or arguments were previously presented, it continues to factors (c), (e), and (f) (related to whether the petitioner has demonstrated that the Patent Office erred in a manner material to the patentability of the challenged claims).
In the instant IPR petition, the Petitioner relied on the Fraser ’106 reference, which was cited during prosecution, and according to the Patent Owner, “is materially indistinct—and, indeed, is identical in key parts—to [Fraser ’222] that was the basis for rejection and was overcome during prosecution of the ’537 patent.” Petitioner responded that the examiner erred during original prosecution by overlooking key parts of Fraser ’106 that were
not part of Fraser ’222 and were material to the allowance of the challenged claims (including a figure that was part of the former but not the latter).
The PTAB found that the first prong of the
Advance Bionics framework was satisfied because Fraser ’106 was identified as a “Reference Cited” during prosecution.
However, the PTAB then determined that “the examiner materially erred in overlooking Figure 8 of Fraser ’106” (which was not part of Fraser ’222 relied upon by the examiner) and ultimately instituted IPR. In doing so, the PTAB considered
Becton, Dickinson factors (c), (e), and (f).
Per the PTAB, “although the examiner rejected the claims as anticipated by Fraser ’222, because the examiner did not apply Fraser ’106’s Figure 8 during examination, … factor (c) weighs against exercising our discretion to deny institution under 35 U.S.C. § 325(d).” As to factor (e), the PTAB agreed that the Petitioner had sufficiently pointed out how the examiner erred (
i.e., that “[t]he examiner conclusion that that ‘no reference’ ‘could be found which disclose[d]’ this limitation was a material error because Fraser ’106 … explicitly discloses a base plate between the vertebrae.”). And, as to factor (f), the PTAB noted that the examiner’s finding was
without the benefit of expert testimony interpreting Figure 8.
This decision provides a useful roadmap to overcoming a Section 325(d) argument, including demonstrating the importance of providing expert testimony explaining the examiner’s error.
