In 2007, in the KSR v. Teleflex decision, the Supreme Court rejected the Federal Circuit's standard on patent obviousness, according to which a claim is nonobvious unless the prior art includes some teaching, suggestion, or motivation to modify prior knowledge into the claimed invention. The Supreme Court held that there are many other grounds for rejecting or invalidating a claim as obvious. The USPTO embraced the new decision in its guidelines for examiners. See Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 in View of the Supreme Court Decision in KSR International. Co. v. Teleflex Inc, Federal Register, Vol. 72, No. 195, Wednesday, October 10, 2007, available at

www.uspto.gov/web/offices/com/sol/notices/72fr57526.pdf.  

In effect, the USPTO has given its examiners more discretion to reject claims, and, in our experience, examiners are using that discretion quite aggressively. Moreover, the USPTO has instituted a practice of second review by a quality assurance group, whose stated role is to reduce errors. Because of these USPTO initiatives, the allowance rate for patent applications has dropped by some measures from 70+% to about 40% in recent years, according to data that Commissioner of Patents John Doll presented last month at a meeting of the BIO IP Counsels Committee.

As a practical matter, we have responded by treating every patent prosecution more like a litigation. We try to focus early on defining the invention, especially the commercially significant aspects of the invention. We conduct more prior art searches for new invention disclosures and assess pending applications more conservatively than before. We consult closely with the inventors to identify evidence of nonobviousness, including unexpected results, documented advantages over prior art approaches (especially comparative data), public recognition of the invention, and demonstrations of why prior approaches went in the wrong direction. This evidence is key to building strong arguments of nonobviousness, and we can use the evidence in declarations submitted to the USPTO. Such evidence should ultimately be persuasive on appeal, if the examiners do not accept it. We interview examiners more frequently and often bring in their supervisors. We are having some success using these approaches, but they are more time-consuming and expensive than in past years. Ultimately there are some inventions that would have been patentable in prior years but are not now. The change is more extreme in the mechanical and material sciences, but affects biotechnology and pharmaceutical patents as well. Ultimately, innovation requires ever more careful strategic management of intellectual property, integrating patenting activities with trade secret, trademark, and copyright protections.