The Federal Circuit recently reversed and remanded an Examiner’s rejection of a claim that involved an element requiring both structural and functional limitations. See In re Chudik, No. 2016-1487 (Fed. Cir. Jan. 9, 2017). Specifically, the Federal Circuit reversed the Examiner’s rejection because the record failed to establish that a single prior art reference contained the functional limitations sought of the claim at issue.
Chudik’s patent claim was directed to a surgical instrument for repairing a damaged anterior cruciate ligament (“ACL”). ACL reconstructions require an orthopedic surgeon to drill holes or “tunnel” through bone in the knee in order to access the damaged ACL and anchor a graft on which the ACL can heal. The claim on appeal was directed to a hollow, cannulated scalpel used to aid in the “tunneling” procedure. The invention used a small “guide wire” or “guide pin” at the precise point on the bone where the surgeon wanted to create a tunnel. Chudik’s cannulated scalpel could then be “passed over” the guide pin “to create a passage through the skin and soft-tissue” to the bone. In describing the scalpel blade, the claim included functional claim language: “a blade end configured for creating a passageway through skin and soft-tissue to a target site on a bone.”
The Examiner rejected the claim as anticipated by Samuels; a patent describing a hollow, “over the wire” scalpel for creating skin incisions to allow for easier insertion of percutaneous devices, such as catheter tubes. The Examiner concluded that Samuels taught all the structural limitations—which Chudik did not dispute—and that the Samuels blade was capable of creating a passageway to a target site on a bone. On appeal, Chudik argued that the Examiner had an insufficient basis to believe that the Samuels blade could reach shallow bones such as a patient’s temple, kneecap, or elbow.
The parties agreed that In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997), was applicable. Schreiber teaches that when the structural limitations are met by a single prior art reference, and when the examiner “has reason to believe” that the prior art reference inherently teaches the functional limitations, then the burden shifts to the patent applicant to show that the functional limitation cannot be met by the single prior art reference.
The Federal Circuit sided with Chudik, finding that the Examiner “gave no justification for th[e] belief” that the Samuels scalpel was inherently capable of reaching shallow bone” and that “nothing in Samuels offer[ed] an indication of the size of the blade or indicate[d] that it would be able to contact subdermal anatomical features.” The Federal Circuit concluded that “[s]ubstantial evidence [was] lacking to show that Samuels teaches the functional limitation” of the claim and reversed the Board’s rejection under § 102.
This case involved a pending application and not an issued patent that is presumed to be valid. But there is no presumption of validity in the IPR setting, and the Schreiber rule may present a basis to challenge a claim element that involves both structural and functional elements. In order to support such an argument, however, the petitioner must be careful to satisfy the requirements applied by the Chudik panel.