The issue of how to determine what would have been obvious at the time the invention was made, however, continued to plague those prosecuting and examining patent claims. Attempting to bring further uniformity to the analysis, the United States Court of Customs and Patent Appeals, the predecessor to the CAFC, asserted the rule that a combination of the prior art is not obvious “unless the art also contains something to suggest the desirability of the proposed combination.” This rule, requiring that the applied art contain some teaching, suggestion, or motivation to combine the disclosures therein (TSM test), soon became revered as a vital safeguard against improper hindsight reasoning.
Interestingly, the Supreme Court’s pivotal decision in Graham v. John Deere Co., which set forth the modern standard for determining obviousness, did not include the TSM test among its essential factors. Nonetheless, courts continued to apply the TSM test as an integral indicator of obviousness. In fact, the TSM test became so crucial to the obviousness analysis that it was added to the Manual of Patent Examining Procedure (MPEP) in 1995 as the primary criterion for determining obviousness.
In 2007, however, strict reliance on the TSM test was called into question by the Supreme Court in KSR. Although agreeing that the TSM test provided helpful insight as to what a person having ordinary skill in the art might have done at the time a claimed invention was made, the Supreme Court instilled a flexible approach for determining obviousness. Requiring a concentration on resolving the Graham factors and setting forth an explicit analysis in support of the ultimate conclusion, the Supreme Court stated that “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”
Thereafter, the United States Patent and Trademark Office amended the MPEP to assert that the conclusion of obviousness should be determined in view of the Graham factors, and must be supported by an explicit and “clear articulation of the reason(s) why the claimed invention would have been obvious.” The previously all-powerful TSM test was replaced with seven exemplary rationales for supporting a finding of obviousness. Although the TSM test was not excluded altogether, it was relegated to last place. And so, post-KSR, a teaching, suggestion, or motivation to combine the cited references became an insignificant and often ignored rationale in obviousness determinations. Recent CAFC decisions, however, appear to signal a potential shift marking the revival of at least a flexible TSM requirement.
In In re NuVasive, Inc., the CAFC recently vacated a final written decision in an inter partes review (IPR) because the Patent Trial and Appeal Board (PTAB) failed to sufficiently articulate a motivation to combine prior art references. The CAFC reviews such final written decisions through the lens of the Administrative Procedure Act (APA), whereby the standard for factual determinations is substantial evidence, and the standard for legal determinations is de novo. Both standards are relevant to the review of final written decisions because the PTAB must: (1) make the necessary findings and have an adequate evidentiary basis for its findings; and (2) examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made. The CAFC found that the final written decision in NuVasive failed to meet these minimum standards.
A primary issue in the final written decision in NuVasive was whether a combination of references rendered unpatentable a spinal fusion implant having radiopaque markers in the medial plane (i.e., near the middle of the implant). During the IPR, the petitioner argued that it would have been obvious to include the radiopaque markers of the secondary reference in the implants of the primary references in order to provide “additional information” regarding the location and/or orientation of the implant, both during surgery and after implantation. The patent owner responded by arguing that the reason articulated (i.e., the “additional information”) is simply a vague explanation with no rational underpinning. Specifically, the patent owner argued that the petitioner’s expert did not provide a rational explanation for what the “additional information” would be, and that the additional information would be redundant or even cause confusion. Although agreeing with the petitioner, the PTAB “never articulated why the additional information would benefit a [skilled artisan] when implanting a posterior lumbar interbody fusion implant.” The PTAB also “failed to explain the type of additional information a [skilled artisan] would obtain or how the [skilled artisan] would use that information.” Therefore, the CAFC held that the PTAB did not sufficiently articulate a motivation to combine the references. Accordingly, the CAFC vacated the final written decision of the PTAB because the CAFC could not provide meaningful review of the motivation to combine reasoning due to the insufficiency.
In PersonalWeb Technologies, LLC v. Apple, Inc., the CAFC again addressed whether the PTAB had sufficiently supported its conclusion of obviousness in an IPR. The petitioner, arguing that the claims were invalid for being obvious over a combination of two references, asserted that a person having ordinary skill in the art “would have understood” that the combination thereof would have achieved the claimed features. In its analysis, the PTAB merely concluded: “We agree in this regard and are persuaded that the combination of [the cited references] renders claims . . . unpatentable under 35 U.S.C. § 103.” On appeal, the CAFC noted that this “reasoning seems to say no more than that a skilled artisan, once presented with the two references, would have understood that they could be combined. And that is not enough; it does not imply a motivation to pick out those two references and combine them to arrive at the claimed invention.” Rooting its decision in the expansive and flexible approach set forth in KSR, the CAFC noted that it is important to clearly articulate why a person having ordinary skill in the art would have been motivated to combine the applied references “because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known.”
Even though NuVasive and PersonalWeb were decided in the context of a review of an agency decision under the APA, the underlying reasoning is also applicable during patent examination. For instance, in In re Van Os, the CAFC specifically applied the reasoning from NuVasive to vacate and remand a PTAB decision addressing an appeal during patent examination because the PTAB’s actions were “insufficiently or inappropriately explained.” In Van Os, the PTAB agreed with the examiner’s analysis that the claims at issue were obvious because combining the cited references “would have been ‘intuitive.’” However, the CAFC held that “[a]bsent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’ Such a conclusory assertion with no explanation is inadequate to support a finding that there would have been a motivation to combine.” Recognizing the importance of safeguarding against hindsight reasoning, the CAFC explained that “[t]his type of finding, without more, tracks the ex post reasoning KSR warned of and fails to identify any actual reason why a skilled artisan would have combined the elements in the manner claimed.”
In view of the decisions in NuVasive and PersonalWeb, patent practitioners should be vigilant to consider carefully the examiner’s reasons for combining the applied art, rather than merely focusing on the elements of the references themselves. In particular, PersonalWeb emphasizes that just because two references can be combined does not necessarily mean that one skilled in the art would have had a motivation to do so. Also, an obviousness determination, even during prosecution, cannot be supported by merely relying on “obvious improvements” or “common sense.”
The CAFC decisions discussed above highlight the resurging focus on a well-articulated motivation to combine in supporting an obviousness determination. In practice, arguing insufficiency of motivation to combine can be difficult during prosecution because examiners tend to rely on the broadest statements of KSR. However, the CAFC has recently reminded the PTAB not only of the importance of the motivation analysis but also that it “knows how to meet [its] burden.” Therefore, recent CAFC decisions suggest that patent practitioners should consider appeals where motivation to combine is a central issue during prosecution, and that the PTAB will carefully scrutinize examiners’ rationales for combining references.