In two different decisions this month, the U.S. Court of Appeals for the Federal Circuit re-confirmed basic principles underlying the question of obviousness. This article discusses each of these decisions.
‘Belden v. Berk-Tek’
On Nov. 5, 2015, in Belden v. Berk-Tek,1 the Federal Circuit, in a rare instance, reversed the Patent Trial and Appeal Board’s (PTAB) decision not to invalidate certain claims of U.S. Patent No. 6,074,503 (the ’503 patent), a patent directed to a method for making a communications cable. The court affirmed the board’s decision to reject claims 1-4, but the court reversed the board’s decision to uphold claims 5 and 6, thereby also rejecting those claims. This was only the second time that the court has reversed a PTAB decision.
In Belden, the patent at issue had several claims. Claim 5 is dependent on claim 1, meaning that it incorporates all the limitations of claim 1, which covers a method for producing a cable, comprising the steps of, among other things, (1) passing transmission media and a core through a first die (which aligns the media with core surface features and prevents twisting); (2) bunching the transmission media and core using a second die; (3) twisting the bunched transmission media to close the cable; and (4) jacketing the closed cable.
Claim 5 requires that the transmission media be “twisted pairs of insulated conductors,” and claim 6 requires four such pairs. The question presented, then, was if claims 1-4 are invalid, why distinguish—in terms of novelty—claims 5 and 6 (which were dependent on rejected claim 1). In other words, why should claims 5 and 6 survive if claims 1-4 do not?
With regard to claims 1-4, the board found that a principal reference, Japan Patent No. 19910 (JP ’910), anticipated claim 1, and that two references U.S. Patent No. 4,393,582 (US ’582) and JP ’910 together rendered claim 2 obvious, stating “that adding a third die to JP ’910 would have involve[d] merely a predictable use of a prior art element…to perform the same function it was known to perform and to yield no more than one of ordinary skill would expect from such use.” But, with regard to claim 5, the board faulted Berk-Tek for giving no “apparent reason to combine the known elements of JP ’910” and Canadian Patent No. 2,058,046 (CA ’046).
In reviewing the board’s decision, the Federal Circuit reiterated that obviousness is a question of law based on factual determinations regarding the scope and content of the prior art, differences between the prior art and the claims at issue, the level of ordinary skill in the pertinent art, the motivations to modify or combine prior art, and any objective indicia of non-obviousness. Importantly, “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”2 Moreover, the Supreme Court’s KSR Int’l Co. v. Teleflex decision3 requires more than showing that “a variation of the prior art would predictably work”—it requires “consideration of whether, in light of factors such as ‘design incentives and other market forces,’ the hypothetical skilled artisan would recognize the potential benefits and pursue the variation.”
So, in affirming the board’s rejection, the court found that the board was entitled to rely on its own reading of JP ’910 “to find that a skilled artisan would have understood the importance of aligning the core and conductors and the connection between achieving such alignment and preventing the core from twisting at the aligning die.”4
As to claims 5 and 6, the board did not deny that CA ’046 and JP ’910 in combination teach the limitations of those claims. But the board did not believe that there was a proper “motivation to combine” the references. The question was presented as follows: Would a skilled artisan have substituted the twisted pairs of CA ’046 into the method of JP ’910? Or, would a skilled artisan making the cable of CA ’046 look to the JP ’910 method to make it? The Federal Circuit answered yes.
In so finding, the Federal Circuit called out the board for focusing on irrelevant disclosures of the prior art references, and for not taking into account all of its teachings, emphasizing that a “reference must be considered for everything it teaches by way of technology and is not limited to the particular invention it is describing and attempting to protect.”
First, the board reasoned that JP ’910 showed “only conductors that are not individually insulated,” and thus, according to the board, the skilled artisan would not have been motivated to use “bare metal conductors.” But, JP ’910 “plainly discloses the need to align the conducting wires with the core and how to do so,” and the “alignment problem and solution do not depend on whether the wires are insulated.”
Second, the board faulted the petitioner Berk-Tek for not explaining why a skilled artisan would have had sufficient reason to use the S-2 stranding step of JP ’910 to manufacture the helically twisted cable of CA ’046, suggesting inconsistency. But this, again, “disregards the evident independent force of JP ’910’s teaching of the alignment problem and solution.” The “stranding” step is irrelevant to this teaching—particularly since the claims at issue simply call for “twisting” the assembly, without restriction on the particular kind of twisting.
Third, the board was critical of Berk-Tek for not explaining why a skilled artisan would have had sufficient reason to use the final jacketing/ extrusion step of JP ’910 (which serves to insulate) to make a cable comprising twisted pairs of individually insulated conductors that do not require additional electrical insulation. But the final jacketing step as set forth in the claim, does not require that the jacket be insulating at all. Again, the board was improperly focused on irrelevant disclosures.
Lastly, the board made passing reference to the patent owner’s argument that modifying the cable of JP ’910 to include twisted pairs would destroy the circular shape of JP ’910’s quad wire. But, again, nothing in the ’503 patent describes or claims the circularity of the cable produced by its methods.
In short, the court found that JP ’910 “taught a solution to the problem of aligning cable components that a skilled artisan would have been motivated to use in making CA ’046’s cables.” Accordingly, the court found invalid all the claims of the ‘503 patent.
On Nov. 10, 2015, the Federal Circuit5 again addressed obviousness and again found a patent owned by Prometheus (U.S. 6,284,770, “the ’770 patent”) invalid. This time the relevant field was life sciences, and specifically the ’770 patent included claims covering a method of treatment for IBS-D (irritable bowel syndrome from diarrhea) utilizing alosetron (known by the brand name Lotronex). The court found the ’770 patent invalid over U.S. 5,360,800 (the ’800 patent), also owned by Prometheus, and which also covered the use of alosetron for treatment of IBS.
The prior art ’800 patent broadly claimed a “method of treating a condition” such as IBS which is ameliorated by introducing into a patient “an effective amount of alosetron.” The ’770 patent sought to claim a particular “species” of the ’800 patent’s genus. More specifically, the ’770 patent claims “treating a subset of those IBS patients—those who (1) are women (2) with IBS-D (3) who have expressed symptoms for at least six months and (4) who have had moderate pain.”
As the Federal Circuit made clear, it is certainly possible to obtain a patent on a species member of a previously patented genus:
To be sure, “[i]t is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus.” [citations omitted]. An “earlier disclosure of a genus does not necessarily prevent patenting a species member of the genus.” Eli Lilly & Co. v. Bd. of Regents of Univ. of Wash., 334 F.3d 1264, 1270 (Fed. Cir. 2003).
The genus-species distinction may have particular relevance in the field of personalized medicine, where, for example, a particular treatment may be effective with respect to one subset of patients and ineffective (and even harmful) to another subset of patients. See, e.g., Margaret A. Hamburg and Francis S. Collins, The Path to Personalized Medicine, 363 New Eng. J. Med. 301, 301 (2010). Singling out a particular subset of patients for treatment (for example, patients with a particular gene) may reflect a new and useful invention that is patent eligible despite the existence of prior art or a prior art patent disclosing the treatment method to patients generally. An obviousness rejection likely would not be appropriate where the new patient subset displayed unexpected results.
But this was not the case in Prometheus. Here, the district court correctly found that, at the time of the ‘770 patent, it would have been obvious for a person skilled in the art to have separately treated the limited subset claimed in the ‘770 patent with alosetron, and that “any unexpected results were attributable to factors exogenous to the ‘770 patent.” More specifically, it would have been obvious for a skilled artisan reading the prior art ’800 patent “to treat female patients with IBS-D who had symptoms for at least six months and who had experienced at least moderate pain.” There was nothing special, unforeseen, unexpected or unusual about the particular subset identified in the ‘770 patent and, therefore, it was invalidated.
In both Belden and Prometheus, the Federal Circuit re-confirmed basic principles of obviousness— and made clear that patents, in order to survive, must sufficiently counter obviousness attacks focused on (1) the differences between the claimed invention and the prior art; and (2) whether one of skill in the art would be motivated, based on individual prior art disclosures, to make modifications, alterations and/or combinations, to achieve the claimed invention.
1Belden v. Berk-Tex, 610 F. App’x 997 (Fed. Cir. 2015).
3KSR Int’l Co. v. Teleflex, 550 U.S. 398, 417 (2007).
5Prometheus Labs. v. Roxane Labs., No. CIV. 11-1241 FSH, 2013 WL 6627640 (D.N.J. Dec. 16, 2013) aff’d. No. 2014-1634, 2015 WL 6875218 (Fed. Cir. Nov. 10, 2015).