In response to the Supreme Court’s decision, the U.S. Patent and Trademark Office (USPTO) developed guidelines to assist its examiners in making obviousness determinations.  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., 72 Fed. Reg. 57,526 (Oct. 10, 2007).  In addition to the TSM test, the 2007 Guidelines provided six examples of appropriate reasoning that could be used to support an obviousness determination.

In the three years since the KSR decision and the 2007 Guidelines, the law of obviousness has continued to develop through Federal Circuit case law.  To account for those developments, the USPTO updated its KSR guidance on September 1, 2010.  See Examination Guidelines Update:  Developments in the Obviousness Inquiry After KSR v. Teleflex, 75 Fed. Reg. 53,643 (Sept. 1, 2010).  The 2010 Guidelines provide a detailed analysis of twenty-four post-KSR Federal Circuit cases, synthesizing the lessons examiners and practitioners should learn from each and expanding upon the additional lines of reasoning set forth by the USPTO in the 2007 Guidelines.  The 2010 Guidelines provide guidance to USPTO personnel as to the contours of the obviousness inquiry after KSR and assist practitioners in drafting applications and overcoming an obviousness rejection during examination.  Notwithstanding an examiner’s rationale for formulating an obviousness rejection, the 2010 Guidelines make it clear that the Graham factual inquiries remain the foundation of any determination of obviousness.  75 Fed. Reg. at 53,644.  These inquiries include determining scope and content of the prior art and differences between the claimed invention and the prior art.  This article highlights some of the other advice contained in the 2010 Guidelines.

COMBINING PRIOR ART ELEMENTS
The Supreme Court announced 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.”  KSR, 550 U.S. at 401.  The 2010 Guidelines observe that recent cases highlight that it is especially important that an examiner, in determining obviousness, consider whether “the combination requires a greater expenditure of time, effort, or resources than the prior art teachings.”  75 Fed. Reg. at 53,646.  Consequently, “[w]hen a combination invention involves additional complexity as compared with the prior art, the invention may be nonobvious unless an examiner can articulate a reason for including the added features or steps.  This is so even where the claimed invention could have been readily implemented.”  Id.  In particular, the 2010 Guidelines reinforce that “[a]n inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.”  Id. at 53,649.  In situations involving inventions which can be viewed as a combination of prior art elements, applicants may benefit from highlighting any additional effort and skill needed to practice the claimed invention.  In addition, applicants could point out any reasons why one of ordinary skill would not have been motivated, based on the prior art, to undertake the extra work and greater expense in order to create the claimed combination.

SUBSTITUTING ONE KNOWN ELEMENT FOR ANOTHER
The 2010 Guidelines explain that “the substitution rationale applies when the claimed invention can be viewed as resulting from substituting a known element for an element of a prior art invention.”  Id.  This rationale “applies when one of ordinary skill would have been technologically capable of making the substitution, and the result obtained would have been predictable.”  Id.

In the biological and chemical arts, for example, recent Federal Circuit cases have made it clear that for a compound to serve as a lead compound, there must be a reason for starting with that compound and then modifying it to obtain the claimed compound.  In particular, the 2010 Guidelines declare that “[o]bviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify the prior art compound in a particular way to produce the claimed compound.”  Id. at 53,653.  Therefore, the 2010 Guidelines make clear that it is insufficient for an examiner to simply cite a structurally similar compound and to observe the alleged ease of transforming that compound into the claimed compound.  Instead, the examiner must articulate sufficient reasoning for selecting the structurally similar compound and modifying it in a way so as to achieve the desired compound.

THE “OBVIOUS TO TRY” RATIONALE
The question of when it is appropriate to invoke the rationale that a claimed invention is obvious because it was “obvious to try” has also been explored by post-KSR case law.  The 2010 Guidelines note that “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.”  Id.  The 2010 Guidelines observe that the Federal Circuit has clarified the meaning of “finite” in this context, defining it as “‘small or easily traversed’ in the context of the art in question.”  Id. at 53,655.  Moreover, the 2010 Guidelines caution that “Office personnel should recognize that even when only a small number of possible choices exist, the obvious to try line of reasoning is not appropriate when, upon consideration of all of the evidence, the outcome would not have been reasonably predictable and the inventor would not have had a reasonable expectation of success.”  Id. at 53,656.  Thus, a mere reference by an examiner to a relatively small number of possible choices is inadequate to make a determination of obviousness, especially in situations where the art is unpredictable.

CONSIDERATION OF EVIDENCE
The 2010 Guidelines also observe that post-KSR case law makes clear that all evidence, including evidence rebutting a prima facie case of obviousness, must be considered in an obviousness analysis.  Particularly useful to applicants is the 2010 Guidelines’ discussion of In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007), in which the Federal Circuit held that the Board of Patent Appeals and Interferences erred in failing to consider evidence of unexpected results.  See 75 Fed. Reg. at 53,657.  Applicants should insist upon a consideration of all evidence, including evidence rebutting a prima facie case of obviousness, evidence establishing that no prima facie case of obviousness has been established, or evidence probative with respect to so-called “secondary considerations” of obviousness, such as commercial success or long-felt need.