Summary – The Patent Appeal Board (“PAB”) rejected the Applicant’s (Delcath Systems Inc.) arguments that an Examiner’s Final Action is exhaustive and that, if the defects raised therein are overcome, the application must be allowed. The PAB considered the Examiner’s post-Final Action obviousness rejection and recommended amendments to the claims in order to comply with the Patent Act and Patent Rules. The Applicant may now choose to amend the claims as suggested by the PAB. If the claims are not amended as suggested, the Commissioner will refuse the application. The decision is appealable to the Federal Court (“FC”).
Analysis – Claims 1, 2, 4, 9, 10, 12 and 13 of the application were rejected in a Final Action as being anticipated by a single reference, “Wright”. In response to the Final Action, the Applicant amended the claims to include limitations which were supported by the originally filed application, but were not previously recited in any claim. In response to the amendments, the Examiner rejected the claims for being obvious having regard to Wright and three new references, “Foreman”, “Walker” and “Ya” in the Summary of Reasons submitted to the PAB.
The Applicant made no submission to the PAB in regards to the obviousness rejection, but submitted that, in accordance with the Commissioner decisions in Bartley and Belzberg: (i) the Final Action must contain all outstanding defects; (ii) the PAB may not raise new defects; and (iii) since the amendment overcame the anticipation rejection in the Final Action, the Commissioner must grant the patent. It should be noted that the Applicant received three Office Actions rejecting the claims as anticipated before the Final Action and the subsequent amendment to the claims.
The PAB differentiated the facts of the present case from those in Bartley and Belzberg. In respect of Belzberg, the continued prosecution after a PAB decision was characterized by the FC as “a problem which had arisen during earlier examination, but which had not been raised in the Final Action report and not considered by the PAB”. In respect of Bartley, the FC found that the PAB’s recommendation to return the application to the Examiner to address outstanding matters was unsatisfactory and lacking in due process. Unlike in Belzberg and Bartley, in the present case, the PAB stated that there were new issues created by the amendments made in response to the Final Action and that the FC’s statements in Belzberg and Bartley that the Final Action must include all outstanding defects are not absolute, but fact specific. Rejecting the Applicant’s arguments, the PAB considered the obviousness rejection in light of the newly cited art and, applying the obviousness test stated in the Supreme Court of Canada’s Sanofi decision, rejected the claims as being obvious having regard thereto.
The PAB then issued the finding that the amendment of independent claims 1, 9 and 13 to incorporate dependent claims 3, 11 and 14 was necessary to comply with the Patent Act and Patent Rules and to overcome the obviousness rejection. If these amendments are not made, the Commissioner will refuse the application.
Practice Point – Pending possible review of this decision by the FC, Applicants cannot merely rely on the defects identified in a Final Action as being exhaustive. While the facts of this case are perhaps quite specific, it is clear that the Examiner has the ability to raise in the Summary of Reasons, and the PAB will consider, new issues not identified in the Final Action if the application is deemed not to be in condition for allowance even if the response to the Final Action addresses the defects identified therein. It appears that the PAB did not wish to send the application back to the Examiner to raise the new issue in a further Action, in accordance with the decisions in Bartley and Belzberg, and instead attempted to deal with it de novo. Applicants are advised to address all issues raised in an Examiner’s Summary of Reasons submitted to the PAB regardless of whether or not they were also raised in the Final Action.