2010 USPTO Guidelines For Examination of Obviousness

Authored by Thomas L. Irving and Ningling Wang

Obviousness under 35 U.S.C. §103 is one of the most common reasons for rejections of patent claims in the U.S. The issue of whether an invention is obvious, and therefore not eligible for a patent in the U.S., is similar to the question asked during patent examination in China: does an invention have creativity?

On September 1, 2010, the United States Patent & Trademark Office (“USPTO”) issued guidelines examiners should follow when examining patent application claims for obviousness (“Examination Guidelines Update: Developments in the Obviousness Inquiry After KSR v.Teleflex,” 75 Fed. Reg. 53,643 (Sept. 1, 2010)). These Guidelines are in addition to those issued in 2007 in the immediate aftermath of the Supreme Court’s decision in KSR v. Telefex (“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., 72 Fed. Reg. 57526 (Oct. 10, 2007)), which have now been incorporated into the USPTO Manual of Patent Examining Procedure (“MPEP”). (See MPEP § 2141 and § 2143).

The Guidelines are an instrument of USPTO internal management only; they are not law. That means failure to follow the Guidelines is not appealable. What makes the Guidelines particularly helpful to practitioners, however, is the detailed examination by the USPTO of 24 Federal Circuit cases, with comments and teaching points highlighted for each. The USPTO set forth the purpose of the Guidelines as:

The purpose of this 2010 KSR Guidelines Update is to remind Office personnel of the principles of obviousness explained by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S 398 (2007) (KSR), and to provide additional guidance in view of decisions by the United States Court of Appeals for the Federal Circuit (Federal Circuit) since KSR.

75 Fed. Reg. 53,644.

The “principles of obviousness explained…in KSR” refer to the framework set out in Graham v. John Deere, 383 U.S. 1, 17–18 (1966) (scope and content of the prior art; differences between the claimed invention and the prior art; level of ordinary skill in the art; and secondary indicia of nonobviousness). In KSR, the Supreme Court emphasized that the Graham framework establishes a flexible approach to the obviousness inquiry, and specifically rejected strict application of rigid guidelines (including, for example, strict application of the teaching-suggestion-motivation test). The USPTO’s attention to case law is a welcome development because it helps educate USPTO patent examiners, who are generally not lawyers, and provides a consistent USPTO position on that case law for examiners and practitioners alike.

The 24 Federal Circuit cases discussed in the Guidelines are grouped into four broad categories:

• combining prior art elements,
• substituting one known element for another,
• obvious to try, and
• consideration of rebuttal evidence.

The USPTO acknowledges that the actual facts of a particular case may not precisely fit into one of the categories, but rather may properly be the subject of various lines of reasoning. A brief summary of each of those categories follows.

A. Combining Prior Art Elements

Combining prior art elements may be nonobvious “when the combining step involves such additional effort that no one of ordinary skill would have undertaken it without a recognized reason to do so.” 75 Fed. Reg. 53,646.

B. Substituting One Known Element for Another

Substituting a known element for an element of a prior art invention may be prima facie obvious if “one of ordinary skill in the art would have been technologically capable of making the substitution, and the result obtained would have been predictable.” 75 Fed. Reg. 53,649. The case examples in this category show that prior art references may come from field of endeavor other than the invention, but may still be relevant for obviousness if they include teachings relevant to the problem facing the inventor or would have been recognized by those of ordinary skill in the art as useful for applicant’s purpose. This category also addresses the settled principle in chemical cases that structural similarity can provide the necessary reason to modify prior art teachings. A subgroup of ‘‘lead compound’’ cases analyzes whether it was obvious to modify a known compound to arrive at a claimed compound. Prima facie obviousness based on structural similarity may be shown by identification of some motivation that would have led one of ordinary skill in the art to select a known compound (i.e. a lead compound does not have to be the only one), and then modify it in a particular way with a reasonable expectation of success to achieve the claimed compound. “[T]here must be some reason for starting with that lead compound other than the mere fact that the ‘lead compound’ merely exists.” 75 Fed. Reg. 53,652. In other words, for the USPTO examiner to use hindsight to select the most structurally similar compound from the prior art is not necessarily a correct procedure.

C. ‘‘Obvious to Try’’

A claimed invention may be prima facie obvious if it is shown that it was “obvious to try.” This “rationale is only appropriate when there is a recognized problem or need in the art; there are a finite number of identified, predictable solutions to the recognized need or problem; and one of ordinary skill in the art could have pursued these known potential solutions with a reasonable expectation of success.” 75 Fed. Reg. 53,653.

D. Consideration of Evidence

The Guidelines remind examiners that when rebuttal evidence is submitted, all evidence must then be reevaluated to determine whether the claims are nonobvious. This is consistent with pre-KSR precedent.

Importantly, practitioners should utilize the guidelines, as appropriate, to urge patentability for claimed inventions in the U.S.

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