United States: At The Federal Circuit

Secondary Considerations: Of Primary Importance in Defending Against an Obviousness Challenge

To determine whether a claim is obvious, the decision-maker must:

  1. determine the scope and content of the prior art;
  2. determine the differences between the prior art and the claim at issue;
  3. assess the level of ordinary skill in the pertinent art; and
  4. evaluate evidence of "secondary considerations" (also known as "objective indicia of nonobvousness"). 

See Graham v. John Deere Co., 383 U.S. 1, 17 (1966). 

A patentee or applicant may rely upon several types of secondary considerations, including teaching away, unexpected results, solving a long-felt but unmet need, acclaim or praise of the claimed invention by others in the field, copying of the claimed features by competitors in the field, and commercial success.  For evidence of secondary considerations to be given weight, there must be a nexus between the evidence and the merits of the claimed invention.  See, e.g., Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 306 n.42 (Fed. Cir. 1985).  But secondary considerations, such as unexpected results, do not need to be mentioned in the patent disclosure or recited in the claims.1

In spite of its name and its place as the last of the four Graham factors, "secondary" considerations of nonobviousness can be of primary importance in demonstrating the patentability of a claim.  Such evidence "can establish that 'an invention appearing to have been obvious in light of the prior art was not'" and "may be 'the most probative and cogent evidence in the record.'"  Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (citations omitted).  The Federal Circuit has emphasized that this evidence guards against the use of hindsight because "[i]t helps 'turn back the clock and place the claims in the context that led to their invention.'"  Id. (citations omitted).  As the Federal Circuit explained in three cases from August and September 2013, the USPTO and other tribunals cannot ignore evidence of secondary considerations offered by a patentee or applicant. 

Apple Inc. v. International Trade Commission, 725 F.3d 1356 (Fed. Cir. 2013), for example, concerned a patent claim covering Apple's transparent, multitouch screen used in the iPhone® and other devices.  The claimed screen is both transparent and able to detect and respond to multiple, simultaneous touches of a user's fingers, unlike prior art screens that were either transparent but not multitouch or multitouch but not transparent.  Id. at 1364-65.  The International Trade Commission (ITC) found Apple's claimed transparent, multitouch screen to be an obvious combination of the multitouch and transparency features described in two items of prior art.  See id.  Apple had offered several types of secondary consideration evidence to support the patentability of its invention, namely, praise from the industry, including news articles describing the claimed screen as "brilliant" and "the most impressive feature of the new iPhone"; evidence that nearly every competitor copied the screen shortly after Apple introduced it; and evidence of commercial success of iPhones including the inventive screen.  Id. at 1366 (citations omitted).  But the ITC did not consider this evidence.  Id.  The Federal Circuit criticized the ITC for not mentioning, let alone weighing, this secondary consideration evidence, and stated that, by failing to consider the evidence, the ITC did not follow precedent and made an error that was "not harmless."  Id. at 1365-66.  The court reiterated that secondary consideration evidence, in fact, "may be 'the most probative and cogent evidence [of patentability] in the record,'" and found that "Apple presented compelling secondary considerations evidence that may have rebutted even a strong showing under the first three Graham factors, and the ITC failed to grapple with it."  Id. at 1366 (alteration in original) (citation omitted).  As a result, the Federal Circuit vacated the ITC's decision and remanded for further consideration.  Id. at 1367.  Judge Reyna, in dissent, argued that the secondary consideration evidence was so strong that the court need not even send the case back to the ITC for further proceedings.  Id. at 1375 (Reyna, J., dissenting).

Rambus v. Rea stemmed from a reexamination proceeding at the USPTO on a patent held by Rambus concerning dynamic random-access memory (DRAM) technology.  Like Apple, Rambus submitted evidence of several types of secondary considerations to the USPTO, including satisfaction of a long-felt but unmet need, industry praise, and commercial success.  The Federal Circuit held that the USPTO had not properly considered this evidence in concluding that the claims were obvious.  For example, the court found that the USPTO did not address evidence of industry praise, including a press release by a competitor calling Rambus's invention "revolutionary and pioneering technology."  Rambus 731 F.3d at 1256-57 (citation omitted).  The court also found that the USPTO erred in concluding there was a lack of nexus between the evidence and the claimed invention, applying too strict a standard in judging nexus.  Id.  The court pointed out that "[o]bjective evidence of non-obviousness need only be 'reasonably commensurate with the scope of the claims.'"  Id. (emphasis added) (citation omitted).  Accordingly, as in Apple, the court vacated the USPTO decision and remanded for reconsideration.

The final case in this trio, Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013), also an appeal from a USPTO reexamination, emphasizes that secondary consideration evidence can be crucial in defending claimed inventions that, on their face, appear to encompass only small changes from the prior art or appear to be simple combinations of known elements.  That case concerned a pharmaceutical formulation that appeared to be a simple mixture of three ingredients—two active agents and a solvent.  The claim also recited the result-oriented limitation that the formulation is "storage stable."  Id. at 1349-50.  The USPTO found the claims invalid over a combination of three references, two reciting prior compositions comprising mixtures of the two active agents, and the third disclosing the claimed solvent.  Id. at 1350-51.  The Federal Circuit reversed, noting that, while formulations containing both active agents had been made previously, Leo Pharmaceuticals had provided evidence to the USPTO that those prior formulations would not have been able to remain stable in storage because the two active ingredients require different and incompatible conditions, and that this storage stability problem was not recognized in the prior art.  Id. at 1354-55.  During proceedings before the USPTO, Leo Pharmaceuticals had also provided evidence of unexpected results, teaching away, and commercial success.  Id. at 1353-54, 1358.  The court agreed with Leo Pharmaceuticals that the three cited references taught away from the claimed invention, and found its evidence of secondary considerations compelling.  Id. at 1355-56.  The court also noted that, while it had been known for a long time that using the two claimed active agents together was beneficial, the evidence suggested that Leo Pharmaceuticals was the first to develop a formulation comprising both active agents that was storage stable.  See generally id. at 1358-59.  The decision pointed out that "[t]he length of the intervening time between the publication dates of the prior art and the claimed invention can also qualify as an objective indicator of nonobviousness," and that the fourteen- to twenty-two-year gap in this case "speaks volumes to the nonobviousness of the . . . patent."  Id. at 1359.

These three cases highlight that bodies such as the USPTO and ITC are required to consider and weigh evidence of secondary considerations when presented by an applicant or patentee, and that such evidence can in some cases be the best evidence of patentability.  Accordingly, patent applicants, for example, should ensure that the examiner has properly considered secondary consideration evidence, and should consider bringing these cases to the examiner's attention, if not.  Applicants or patent holders defending claims that, on their face, may appear to be noninventive should be prepared to provide secondary consideration evidence to the USPTO or other tribunal as, in such cases, it might well be the best evidence to support patentability.


1 Although reciting unexpected results expressly in the claims can be helpful in withstanding a validity challenge, as noted in another article in this issue of Full DisclosureSee also Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731 (Fed. Cir. 2013).

This article previously appeared in Full Disclosure Patent Prosecution Update, January 2014.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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