For the first time in nearly 15 years, the U.S. Patent and Trademark Office (USPTO) has issued “Updated Guidance for Making a Proper Determination of Obviousness” under the U.S. Supreme Court’s ruling in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The new guidance is said to reflect Federal Circuit decisions since KSR and “serves as a reminder to USPTO personnel of the flexible approach to obviousness that is required under KSR.” As with most USPTO guidance, the examples focus on scenarios that would warrant an obviousness rejection, rather than scenarios that would support a finding of nonobviousness.

The Guidance is divided into five sections, under the following headings:

I. The America Invents Act Impacted the Time Focus of the KSR Inquiry

The Guidance explains that because KSR was decided before the America Invents Act (AIA), when applying KSR to patent applications that fall under the AIA, the “time focus” for obviousness must be shifted from “the time of invention” discussed in KSR to “the effective filing date of the claimed invention” per AIA § 103. That is, for applications governed by the AIA, obviousness is assessed as of the effective filing date of the claimed invention.

II. The Graham Inquiries Continue to Control Obviousness Determinations After KSR

The Guidance notes that KSR and subsequent Federal Circuit decisions have reaffirmed the analytical framework of Graham v. John Deere Co., 383 U.S. 1 (1966), including assessing the scope and content of the prior art; ascertaining the differences between the claimed invention and the prior art; and resolving the level of ordinary skill in the art before determining obviousness or nonobviousness of the claimed subject matter. The Guidance also acknowledges that “secondary considerations” may be taken into account, such as commercial success, long felt but unsolved need, and failure of others.

III. The Federal Circuit’s Implementation of KSR Has Reiterated a Flexible Approach to Obviousness

The Guidance emphasizes that “[a] hallmark of the KSR approach to obviousness … is flexibility,” both with regard to “the proper understanding of the scope of the prior art” and with regard to “appropriate reasons to modify the prior art.” The Guidance finds that Federal Circuit opinions decided since KSR have reiterated these two aspects of “flexibility,” and discusses specific decisions as examples.

With regard to the first aspect, the Guidance refers to the oft-quoted passage in KSR that “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.” As stated in the Guidance, “Federal Circuit case law since KSR follows the mandate of the Supreme Court to understand the prior art — including combinations of the prior art — in a flexible manner that credits the common sense and common knowledge of a PHOSITA [Person Having Ordinary Skill in the Art].” Thus, “a narrow or rigid reading of prior art that does not recognize reasonable inferences that a PHOSITA would have drawn is inappropriate.”

With regard to the second aspect, the Guidance finds “the Federal Circuit has echoed KSR in identifying numerous possible sources that may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious.” Drawing from Federal Circuit language, the Guidance provides as examples:

• [M]arket forces; design incentives; the interrelated teachings of multiple patents; any need or problem known in the field of endeavor at the time of invention and addressed by the patent; background knowledge, creativity, and common sense of the person of ordinary skill (from Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343 (Fed. Cir. 2013) (quotations to KSR omitted)
• [A] PHOSITA’s desire to improve on the prior art (from In re Ethicon, Inc., 844 F.3d 1344 (Fed. Cir. 2017)

Drawing from PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186 (Fed. Cir. 2014), the Guidance also notes, “a proposed reason to combine the teachings of prior art disclosures may be proper, even when the problem addressed by the combination might have been more advantageously addressed in another way.” Thus, the Guidance concludes:

Office personnel may use any clearly articulated line of reasoning that would have allowed a PHOSITA to draw the conclusion that a claimed invention would have been obvious in view of the facts.

IV. All Evidence Relevant to the Question of Obviousness That Is Properly Before the Decision-Maker Must Be Considered

The Guidance emphasizes that “decision-makers” must “consider all relevant evidence that is properly before them” when assessing obviousness. With regard to examination, the Guidance states that “if objective indicia of nonobviousness are properly before the examiner, such as by way of incorporation into the written description as filed or submission of an evidentiary declaration after the filing date, the examiner must consider those indicia, even before the issuance of a first Office action.” Further, “[a]t each stage of USPTO proceedings, Office personnel must reweigh all evidence.” In that regard, the Guidance reminds that “[n]ewly submitted evidence in rebuttal of an obviousness rejection must not be considered merely for its knockdown value against any previously established prima facie case. However, conclusory testimony does not hold the same weight as factual evidence.

(See this article more information on the use of evidence to overcome rejections.)

The Guidance emphasizes that, in view of the requirement to consider all relevant evidence, “existence of a reason to modify the teachings of the prior art may not necessarily lead to a conclusion that a claimed invention would have been legally obvious.”

V. Office Personnel Will Continue to Apply Reasoning to Facts in Order to Reach a Proper Legal Determination of Obviousness

Building on themes from Section III, in Section V the Guidance emphasizes that “[a]ny legally proper obviousness rejection must identify facts and then articulate sound reasoning that leads to the conclusion that the claims would have been obvious to a PHOSITA.” Further, “[i]n keeping with the flexible approach to obviousness in KSR and Graham, there is no one-size-fits-all approach to crafting an obviousness rejection.” Rather, the Guidance calls on Patent Office personnel to “use their legal and technological expertise” when making and explaining an obviousness determination.

Lessons for Stakeholders

Although the Guidance is directed toward Patent Office personnel, stakeholders may benefit from understanding the analytical framework examiners are expected to follow and the standards to which they may be held. Although the Guidance emphasizes flexibility under KSR, it also requires consideration of all evidence of record and articulation of a “reasoned explanation” of obviousness. Rejections falling short of those requirements should be vulnerable to challenge in a response or ex parte appeal.