These recent decisions have applied the Becton Dickenson factors for dealing with unexamined prior art which, according to the patentee, was “substantially the same” as the prior art presented in the prosecution. In the Advanced Bionics vs. MED-EL Elektromedizinische Gerate decision, the Commission analyzed the arguments advanced in respect of anticipation and invalidity and exercised its discretion to dismiss the application in light of prior art and similar arguments in the history of the lawsuit, while Oticon Medical v. Cochlear the Commission also analyzed the state of the art and the arguments made in light of the history of the prosecution, but came to the opposite conclusion and granted between the parties review.[1] Taken together, these decisions further clarify the scope of the section 325 (d) analysis that the Board applies when deciding whether or not to initiate a review of a granted patent. These decisions highlight another pitfall for applicants who do not sufficiently differentiate their arguments of anticipation from those taken into account during the initial examination by the Patent Office. They also provide fertile ground for patentees who draft their preliminary responses in which they can focus on the section 325 (d) pre-investigation, while still keeping their powder dry on the merits in case an examination. would be instituted.

Advanced Bionics, LLC v MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469 (Document 6 – refusing establishment)

In that decision, the Commission applied a two-part framework to determine whether it should exercise its discretion under section 325 (d). First, the Board considered whether the prior art and the arguments presented in the IPR petition were “the same or substantially the same” as the prior art and the arguments previously presented in the prosecution. . The Council applied the Becton, Dickinson factors and determined that the motion, which relied on a prior art reference cited in the prosecution in combination with other references that had not been cited in the prosecution, was based on the “same or substantially the same prior art ”presented above. It does not matter that the Board closely analyzed the history of the prosecution to determine that the petitioner was putting forward new references to meet certain claim limitations in much the same way that the patent examiner had done during the prosecution based on similar references. After finding the first part of the framework satisfied, the Board then considered whether the request demonstrated that the Patent Office “erred in a material way for the patentability of the contested claims”. Since the petition did not show that the examiner erred in considering the state of the art during the prosecution, the Board concluded that it was appropriate to exercise its discretion to dismiss the IPR petition. . This decision is not subject to appeal.

Oticon Medical AB v. Cochlear Limited, IPR2019-00975 (Document 10 — granting institution)

A sin Advanced bionics, the petition in Oticon Medical relied on prior art which was cited in the prosecution and other prior art which was not cited. The patentee argued in his preliminary response that the “new” state of the art was simply the accumulation of another reference which had been taken into account during the prosecution. Apply the Becton Dickinson factors, the Board closely compared the cited prior art identified by the patentee with the “new” prior art cited in the petition. The board compared the references (one describing a bone screw and the other a dental implant) and found them to be different in structure and function, and further found that the reference to the prior art in the IPR query offered a functional advantage because it dispersed the stress on the bone. The Board then determined that the Examiner disregarded the prior art teachings cited in the IPR and therefore the Examiner erred (apparently by not identifying and failing to identify it). not taken into account during the chase). The Commission therefore concluded that it would not exercise its discretion under section 325 (d).

In a separate section of the decision which also became a precedent, the Board also refused to exercise its discretion under Section 314 (a) despite the patentee’s argument that the applicant had waited for the as long as possible to gain the benefit of the “roadmap” of responses to nullity arguments in related district court proceedings. The Council determined that its instituted IPR procedure “would not duplicate the District Court’s validity review”. The Board further rejected the assertion by the patentee that the petitioner was attempting to block the action in the district court as there was no evidence that the district court action had been stayed. and that the patentee had not even provided the district court schedule. The Board instituted an examination of the contested patent and the IPR procedure will now move to the trial phase.

Impact of recent previous PTAB decisions

The Council provides a framework: The Advanced bionics and Oticon Medical the decisions provide a framework that practitioners and the Board can use when considering the Board’s discretion to deny a section 325 (d) request. The stated objective of the Council is to “rely on precedents [Patent Office] evaluations of the evidence on file, unless a material error is demonstrated. The first part of the analysis aims to determine whether the arguments of the prior art are “the same or substantially the same” as the arguments of the prior art put forward during the prosecution. This part uses the factors set out in the previous Becton Dickinson Case. When the Board concludes that it has satisfied Part One, it will then consider whether the Patent Office “erred” in examining the contested patent.

What applicants and patentees should take into account in these decisions: The Advanced bionics The decision shows that the PTAB can perform a fine comparison of the previously cited and unreported prior art before making its decision whether or not to reject an IPR request for having advanced arguments on the prior art which are different but “substantially the same ”as those examined during prosecution. For patent owners, this highlights the importance of including any specific and factual arguments available under Section 325 (d) in the preliminary response. The determination in section 325 (d) is a discretionary decision that will be taken before the institution is instituted and before the applicant is allowed to file a response as of right. Therefore, while the patentee can present credible and well-substantiated arguments, they may not be rebutted until the institution’s decision. If the Council accepts such an argument and exercises its discretion to refuse the institution, this decision will be final.

Applicants should also compare the state of the art to be argued in the petition with the art discussed in the examination in order to avoid a discretionary rejection under section 325 (d). Applicants should seek to avoid repeating arguments that the patentee has already overcome during prosecution. Ideally, the petition should advance prior art theories that are distinct from those raised above and in particular those that were the basis for the denials of claims. If not, however, the petition must clearly explain to the Board why the prior art arguments in the petition are not “substantially similar” to the earlier arguments in the prosecution. And this discussion should be detailed. The petitioner in Advanced bionics approached the Becton Dickinson factors in the petition, but did so superficially rather than engaging in the factual comparison of prior art references that the patentee made and which the Board ultimately found convincing. Where a patentee raises important questions under Section 325 (d) in the preliminary response, the applicant should also consider seeking leave to file a preliminary response brief responding to those arguments. Otherwise, the unrefuted arguments of the patentee could lead the Board to deny the institution, which, again, is a non-appealable decision.