Intellectual Property for Life Sciences, Chemistry and Biotechnology
Practitioners have another tool at their disposal in combating 103 rejections. The Court of Appeals for the Federal Circuit (CAFC) vacated a decision of the Patent Trial and Appeals Board (PTAB) in December 2016, finding that judicial review of the obviousness determination could not be achieved without sufficient articulation of a motivation to combine the prior art references.
The CAFC’s ruling stems from an inter partes review (IPR) of a patent assigned to NuVasive, Inc., a medical device company specializing in minimally disruptive spinal surgical products. The patent at issue, U.S. Patent No. 8,361,156 (the ‘156 patent) is related to spinal fusion. The specific claims at issue recited a spinal fusion implant including “radiopaque markers . . . proximate to [a] medial plane.”
The IPR was instituted on a petition by Medtronic, Inc. In the IPR, Medtronic argued that the claims would have been obvious over a combination of medical brochures and device guides (the Telamon references) in view of U.S. Patent Application Publication No. 2003/0028249 to Baccelli et al. (Baccelli). Medtronic’s expert asserted that it would be “common sense” to combine the Telamon references with Baccelli “to provide additional information regarding the orientation or location of an implant.” The PTAB agreed, finding the claims at issue obvious over the references and therefore invalid.
By way of background, under AIA 35 U.S.C. § 103 and pre-AIA 35 U.S.C. § 103(a), a claim is invalid if the differences between the prior art and the claim, considered as a whole, would have been obvious to a person having ordinary skill in the art (PHOSITA) at the time the invention was made. The Supreme Court in KSR held that the CAFC’s “TSM” test on obviousness—i.e., whether the prior art must provide a teaching, suggestion, or motivation to combine references to arrive at the claimed invention—should not be treated so rigidly. According to the Supreme Court, the motivation to combine references need not be found expressly in the prior art itself but may be explained by the fact finder using even common sense. The Supreme Court noted, however, that it is “important to identify a reason that would have prompted [PHOSITA] to combine the elements in the way the claimed new invention does.”
The CAFC went one step forward in subsequent cases, determining that the PTAB must:
(1) articulate a reason why a PHOSITA would combine the prior art references;
(2) have an adequate evidentiary basis for that finding; and
(3) provide a “satisfactory explanation” for the motivation finding that includes an express and “rational” connection with the evidence presented.
In the case of NuVasive’s ‘156 patent, the basic question was whether it would have been obvious to combine prior art teaching the spinal fusion implant with references showing the use and importance of radiopaque markers in implants. The CAFC agreed with NuVasive’s argument that the PTAB’s decision did not adequately explain a reason why a PHOSITA would have been motivated to modify the prior art, to place radiopaque markers “proximate to said medial plane,” as required by the challenged claims. The decision deemed the “common sense” conclusory statement by Medtronic’s expert insufficient. The CAFC additionally distinguished the PTAB’s present decision from previous cases where the PTAB acceptably articulated why a PHOSITA would have combined references.
Although the CAFC acknowledged that common sense did play a factor in dictating that “additional information” could potentially be obtained by a combination of the references, the Court remanded the case, reasoning that without articulation of a reason why a PHOSITA would have been motivated to seek out the “additional information,” the PTAB’s findings amounted to “nothing more than conclusory statements.”
The CAFC’s present ruling marks another rare victory for the patentee where the PTAB’s obviousness finding was vacated because the Board had not adequately set forth its reasoning for ruling that the medical device patent was obvious in view of the cited art. The CAFC’s decision indicates that a proper justification to combine prior art references includes a specific articulation of both a benefit obtained by the combination and a motivation that a PHOSITA would have combined the references. The determination by the CAFC of the PTAB’s lack of articulation of a motivation to combine the references beyond “common sense” also suggests the Court’s preference for a motivation stated in the prior art references themselves.
This decision is thus an important reference to include in the growing list of tools to rebut obviousness findings. Consequently, practitioners facing obviousness rejections should first identify whether the prior art reference discusses a motivation to seek out the benefit. If it does not, or if the Examiner or PTAB fails to provide specific articulation of a benefit of the combination or a motivation to combine the references to obtain a benefit, then the CAFC’s present ruling may be one additional case at the practitioners’ disposal to counter such obviousness rejections.