Intellectual Property for Life Sciences, Chemistry and Biotechnology
On January 3, 2017, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a decision of the Patent Trial and Appeals Board (PTAB) holding that an obvious rejection is proper even when there is no explicit teaching, suggestion, or motivation to combine prior art references in In re Ethicon, Inc., No. 2015-1696.
Ethicon is the owner of U.S. Patent No. 7,591,844 (‘844 Patent) directed to intraluminal medical devices for the local delivery of drugs, such as drug-eluting stents, and methods for maintaining drugs on such devices. During the course of reexamination of the ‘844 Patent, Ethicon cancelled claims 18 and 24 and the PTAB affirmed the Examiner’s rejection of the remaining claims 1-17 and 19-23 as obvious over a combination of prior art references. With regard to a motivation to combine the references, the PTAB stated:
the reason to combine [the references] could be provided by the “normal desire of scientists or artisans to improve upon what is already generally known.” (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Ethicon appealed to the CAFC arguing that the PTAB’s decision does not provide any motivation for one of ordinary skill in the art to combine the prior art references. The CAFC affirmed the PTAB stating:
KSR directs that an explicit teaching, suggestion, or motivation in the references is not necessary to support a conclusion of obviousness. 550 U.S. at 415–16. The Supreme Court has instructed that “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions,” id. at 417, and apply “an expansive and flexible approach” to obviousness, id. at 415.
Judge Newman dissented stating “no reference or combination of references, or common knowledge or common sense, teaches or suggests or motivates the claimed stent.” Judge Newman further noted that the Supreme Court’s KSR decision guides that “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.”
About one month prior do the CAFC’s In re Ethicon decision a different panel of Judges from the Federal Circuit in In re Nuvasive, Inc., 2015-1670 (December 7, 2016), reversed a PTAB obviousness decision holding that explicit articulation of a motivation to combine prior art references is required to uphold an obviousness determination. A summary of the CAFC’s Nuvasive decision can be found here.
The Ethicon and Nuvasive decisions leave it unclear as to whether a specific articulation of a motivation to combine is required to support an obviousness rejection. For the present time, if a USPTO obviousness rejection does not expressly articulate such a motivation, patentees can argue that such a motivation is required based on the reasoning set forth in Nuvasive and Judge Newman’s dissent in Ethicon.
 KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).