Chapter §9.09 The Prima Facie Case of Obviousness

• Jurisdiction: United States

§9.09 The Prima Facie Case of Obviousness

[A] Generally

The concept of a prima facie case of obviousness is central to USPTO examination of patent application claims for compliance with the nonobviousness requirement.⁷²⁰ The prima facie case is a rebuttable legal conclusion drawn by the agency that a claimed invention would have been obvious, generally based on the USPTO's findings on the first three Graham factors.⁷²¹ The prima facie case thus represents a rebuttable presumption of obviousness.

The prima facie case construct is a procedural tool not limited to any particular subject matter.⁷²² Many of the cases raising prima facie obviousness arise in the pharmaceutical arts, however. The Circuit has held that in the context of assessing pharmaceutical obviousness "a prima facie case of obviousness requires 'structural similarity between claimed and prior art subject matter . . . where the prior art gives reason or motivation to make the claimed compositions.' "⁷²³

Applicants have a number of strategies for responding to the USPTO's assertion that it has made out a prima facie case of obviousness. A patent applicant may attempt to rebut it, for example, by arguing that the examiner has mischaracterized the teaching of the cited references; that a particular reference teaches away from the claimed invention; that there is no teaching, suggestion, motivation, or other reason for a person having ordinary skill in the art ("PHOSITA") to have combined the references in the manner claimed; or that the PHOSITA would not have had a reasonable expectation of success in so combining. Alternatively, the applicant may attempt to rebut the USPTO's assertion of a prima facie case by submitting evidence of unexpectedly superior results achieved by the claimed invention, typically in the form of data or other information submitted via a declaration under 37 C.F.R. §1.132. These types of responses directly challenge the establishment of a prima facie case by attacking the agency's findings on Graham factors (1) through (3). In addition, an applicant may also submit "secondary considerations" evidence (e.g., commercial success or the failure of others) under Graham factor (4).

When the applicant comes forward with relevant rebuttal evidence in response to a prima facie case of obviousness, the USPTO must reconsider all the evidence.⁷²⁴ An examiner must "consider the [rebuttal] evidence as a whole before reaching a conclusion on the claims' patentability under 35 U.S.C. § 103(a)."⁷²⁵ The rebuttal evidence cannot simply be considered as an afterthought or weighed against the strength of the initial prima facie case merely for its "knockdown ability."

The concept of a prima facie case implicates burdens of production (i.e., going forward with evidence) as well as the ultimate burden of proof (i.e., burden of persuasion) on the question of nonobviousness. As the CCPA explained in In re Rinehart,⁷²⁶

[t]he concept of rebuttable prima facie obviousness is well established. . . . It is not, however, a segmented concept. When prima facie obviousness is established and evidence is submitted in rebuttal, the decision-maker must start over. Though the burden of going forward to rebut the prima facie case remains with the applicant, the question of whether that burden has been successfully carried requires that the entire path to decision be retraced. An earlier decision should not, as it was here, be considered as set in concrete, and applicant's rebuttal evidence then be evaluated only on its knockdown ability. Analytical fixation on an earlier decision can tend to provide that decision with an undeservedly broadened umbrella effect. Prima facie obviousness is a legal conclusion, not a fact. Facts established by rebuttal evidence must be evaluated along with the facts on which the earlier conclusion was reached, not against the conclusion itself. Though the tribunal must begin anew, a final finding of obviousness may of course be reached, but such finding will rest upon evaluation of all facts in evidence, uninfluenced by any earlier conclusion reached by an earlier board upon a different record. ⁷²⁷

In In re Piasecki,⁷²⁸ the Federal Circuit relied on Rinehart to criticize the USPTO's evidentiary procedure in a case involving the patentability of a lighter-than-air craft. With controls like a helicopter, the craft was useful for lifting very heavy loads. By giving insufficient or no weight to the patent applicants' "secondary considerations" evidence, the USPTO had improperly shifted to the applicants the ultimate burden of proof (rather than merely the burden of production) on the issue of nonobviousness:

In the case at bar appellants submitted extensive evidence of peer recognition, long-felt need, and commercial interest. Yet the Board's treatment of the rebuttal documents impels us to the conclusion that the Board did exactly that which Rinehart warns against: they viewed each piece of rebuttal evidence solely "on its knockdown ability." Under the Board's approach the prima facie case took on a life of its own, such that each fact presented in rebuttal, when it was evaluated at all, was evaluated against the conclusion itself rather than against the facts on which the conclusion was based. The prima facie case remained "set in concrete." ⁷²⁹

The USPTO Board's error meant that the conclusion of obviousness flowing from it could not stand. Concluding that the totality of the applicants' rebuttal evidence carried "persuasive weight," the Federal Circuit reversed the Board's decision that the claimed invention would have been obvious.⁷³⁰

The Federal Circuit in its 2018 decision, In re Brandt, emphasized the importance of the prima facie case concept as a procedural aid to the USPTO in the initial stages of patent examination, explaining why it "makes sense" in the patent prosecution context:

Given the back-and-forth nature of examination, it is important for the examiner to have a few procedural tools to aid her efforts to issue as patents only those claims that meet the requirements of the Patent Act—the fundamental obligation of the Patent Office. One of these procedural tools is the prima facie case, an evidentiary burdenshifting device available to the examiner in the initial stage of examination. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). An examiner can find a prima facie case of unpatentability upon initial review of the prior art or on any other statutory condition of patentability. In re Oetiker, 977 F.2d at 1445. If the examiner establishes a prima facie case, the burden shifts to the applicant to come forward with rebuttal evidence or argument. Id.; see Mouttet, 686 F.3d at 1330. The examiner then considers the evidence as a whole before reaching a conclusion on the claims' patentability under 35 U.S.C. § 103(a). Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1357 (Fed. Cir. 2013) ("Whether before the Board or a court, this court has emphasized that consideration of the objective indicia is part of the whole obviousness analysis, not just an afterthought."); In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). This burden-shifting framework makes sense during patent examination because an examiner typically has no knowledge of objective considerations, and those considerations "may not be available until years after an application is filed." In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1080 n.7 (Fed. Cir. 2012). ⁷³¹

[B] In re Dillon (1990) (en banc)

Although the inventions in Piasecki and Brandt involved mechanical or electromechanical devices, the concept of a prima facie case is routinely encountered in cases involving chemical and biotechnological inventions. For example, the Circuit's 1990 en banc decision, In re Dillon, is one of the foundational cases for understanding what constitutes a prima facie case in the chemical arts.⁷³²

Patent applicant Dillon discovered that adding certain tetra -orthoester compounds (i.e., compounds having four orthoester groups attached to a central carbon atom) to hydrocarbon fuel compositions would reduce soot emission when the fuel burned. She claimed a composition comprising a hydrocarbon fuel plus a sufficient amount of the tetra-orthoester to reduce soot (i.e., particulate emissions) during combustion. A prior art patent to Sweeney described compositions of hydrocarbon fuels with tri -orthoesters, useful for a different purpose—scavenging water from the fuels. A second prior art patent to Elliot evidenced the equivalence of tri- and tetra-orthoesters as water scavengers in hydraulic (i.e., nonhydrocarbon) fluids.

The Federal Circuit went en banc in Dillion to decide whether the USPTO had properly established a prima facie case of obviousness when it rejected Dillon's claims in view of the prior art. Although the tetra-orthoesters in Dillon's claimed compositions were structurally similar to the triorthoesters in the prior art compositions, the latter compositions had a different use. Dillon's new use of the tetra-orthoesters for the purpose of reducing soot (i.e., particulate emissions) was not shown or suggested by the prior art.⁷³³

After a panel of the court initially reversed the USPTO,⁷³⁴ the Federal Circuit reheard the case en banc and affirmed the USPTO's rejection of Dillon's claims for obviousness. The USPTO had properly established a prima facie case of obviousness based on the chemical structural similarity between Dillon's compositions and the prior art compositions. Even though "all evidence of the properties of the claimed compositions and the prior art must be considered in determining the ultimate question of patentability," the en banc Federal Circuit emphasized that "the discovery that a claimed composition possesses a property not disclosed for the prior art subject matter [] does not by itself defeat a prima facie case."⁷³⁵ In other words, it...