Case Nos. 2011-1140 (Newman, Bryson, Fogel)
Have some of Column A / Try all of Column B; composition claims ain’t never had a “friend” like the Federal Circuit in last summer’s Wrigley v. Cadbury. Part I of this post looks at the case’s aggressive holding of anticipation when selecting claim elements from lists in the prior art. Part II will address Wrigley’s approach to secondary considerations in the obviousness inquiry, to be contrasted with the more recent Transocean v. Maersk II case’s approach to the same.
Wrigley sued Cadbury for infringing US Patent 6,627,233, which disclosed and claimed a chewing gum with coolant properties. At issue was a simple composition claim reciting the combination of 1) 90-99.9% gum base and bulking and sweetening agents, with 2) 0.1-10% menthol and WS-23, flavoring and cooling agents, respectively. The district court granted Cadbury’s motion for summary judgment that the claim was anticipated by a prior art patent to Shahidi, which disclosed menthol and WS-23 among several listed flavoring and cooling ingredients for gum. Wrigley appealed to the Federal Circuit.
Critical to the appeal, Shahidi disclosed gum bases that could optionally include cooling agents and/or flavoring agents. Shahidi listed WS-23 as one of three specifically-identified “particularly preferred” cooling ingredients, along with several others known in the art. Shahidi separately listed menthol as one of twenty-three specifically-identified flavoring agents “most suitable” for inclusion. On appeal, Wrigley argued that such disclosure was not anticipatory, because Shahidi did not disclose the specific WS-23 and menthol in combination, as in the claim, and because undue experimentation would have been required to select from the optional ingredient families of Shahidi the specific menthol and WS-23 combination of the ‘233 patent.
The panel majority was not moved by the taste of this argument. Where a single piece of prior art discloses all claim elements, but among several others in an optional and serial manner (i.e., in a list), anticipation can still be found if the claimed combination is immediately apparent from the prior art list. Two cases demarcated the edges of what list sizes and conditions could render a claimed combination “immediately apparent” and thus anticipated – Perricone v. Medicis (choice between 2 listed ingredients small enough to anticipate claim to 1 of the ingredients) and Impax Labs v. Aventis (lists of hundreds of pharmaceuticals and several treatable diseases too large to anticipate claim to treatment of 1 of the diseases with 1 of the pharmaceuticals). Without getting itself too involved with a specific list size requirement, the majority found the situation here otherwise unlike that in Impax:
The issue in Impax was whether the use of the drug riluzole for treating amyotrophic lateral sclerosis (“ALS”) was anticipated by U.S. Patent No. 5,236,940 (“the ’940 patent”). Id. at 1314. The ’940 patent disclosed a formula that encompassed “hundreds or thousands of compounds.” Id. at 1315. The ’940 patent also listed a number of diseases, including ALS, that could potentially be treated with compounds of the disclosed formula. Id. While we affirmed the district court’s finding that undue experimentation would have been required to practice the patent at issue in Impax, there are important distinctions between that case and this one. Unlike the prior art reference at issue in Impax, where there was no disclosed dosage information for using riluzole to treat ALS, see id., Shahidi discloses component amounts within the ranges claimed in claim 34. Even more importantly, Shahidi specifically discloses the use of both WS-23 and menthol in chewing gum, whereas the only mention of riluzole in the prior art reference in Impax was to disclaim it from the disclosed invention.
Absent the uncertainties and disparaging present in Impax, the majority found that the lists here were small enough for anticipation. Particularly, WS-23 was one of only three specifically-identified and recommended cooling agents, and menthol was an extremely well known flavoring listed with twenty-three other “most suitable” flavoring agents, any or all of which the majority reasoned would be readily included in a gum.
Judge Newman, in dissent, emphasized that the majority had not correctly determined whether one skilled in the art could “at once envisage” the claimed WS-23 and menthol combination. The dissent spends quite a bit of time discussing Perricone and how that case does not transform every prior art listing into a case of anticipation. Getting to the juicy center of the dispute, Judge Newman found Shahidi did not direct the selection of the specific claimed ingredients from such large lists:
Shahidi’s lists include humectants, surfactants, thickeners, abrasives, stannous salts, copper salts, flavoring agents, sweeteners, and cooling agents, which can be combined in over a million possible combinations, see Wrigley Br. 18. Shahidi names three known preferred cooling agents: WS-3, WS-23, and TK-10, as well as a large number of other cooling agents in five identified U.S. Patents. ’491 patent col.4 ll.14–32.
Shahidi also states that flavoring agents “well known in the art” can be used, naming anise, cassia, clove dihydroanethole, estragole, eucalyptol, menthol, methyl salicylate, peppermint, axanone, phenyl ethyl alcohol, sweet birch, eugenol, spearmint, cinnamic aldehyde, menthone, alpha-ionone, ethyl vanillin, limonene, isoamylacetate, benzaldehyde, thymol, ethylbutryate, and “many others.” Id. at col.7 ll.16–22. Shahidi does not describe any specific composition containing either WS-23 or menthol, nor the combination of WS-23 and menthol for any purpose. . .
It was not disputed that a person of ordinary skill would not at once envisage Wrigley’s combination of WS-23 and menthol from Shahidi’s lists. See Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1375 (Fed. Cir. 2006) (“To anticipate, a prior art reference must place the inventive compound or composition in the possession of the public.”). From the large number of listed ingredients and possible combinations of ingredients, and the absence of any selection of the combination of WS-23 and menthol in chewing gum, Shahidi does not anticipate the combination of WS-23 and menthol in chewing gum.
Invalidity of Wrigley’s ‘233 patent as anticipated affirmed.
Lessons: Wrigley is a tough piece of caselaw for composition claims up against laundry lists in the prior art. To the degree it is followed, Wrigley makes anticipation fair game even when claim elements are scattered among several different and discretionary options useable in a prior art embodiment. Even taking the optionality out of the fact pattern of Wrigley – as if the prior art had indicated mandatory use of a coolant and flavorant – there were still sixty-nine different combinations among the listed ingredients in the prior art. This number was more than within the bounds of anticipation for one of the combinations. As such, it is likely fruitless to argue against anticipation as defeated by too many possible disclosed combinations in situations with similar or fewer options or list members. Note that the court was unfazed in its anticipation holding by the claimed combination being gathered from very different portions and among several different incorporated by reference options of a piece of prior art whose primary focus was not even the claimed synergistic cooling + favoring agent. It is very common for US patents dealing with compositions to give seriatim examples of various useable materials and options; Wrigley makes these pieces of prior art real patent killers.
The majority in Wrigley does emphasize that other factors, such as negative treatment of a claim element or missing fabrication/application/utility methods in the prior art, might confound enablement / show undue experimentation more than disclosure of several options alone in the prior art. This lesson was already clear from Impax, but strongly consider looking for other general non-enablement factors and arguments to tie in before hanging your hat on a mere multiplicity of encompassing options within a prior art embodiment. Finally, keep in mind that this is an anticipation regime – secondary considerations, teaching away, and lack of motivation to select the exact claimed combination will not work, except to the extent they can show non-enablement.
Comment: I think Judge Newman has the much better argument here. The number of unemphasized options and combinations in the prior art patent just seemed way too large for someone to readily picture the specific claimed option. If this were a genus/species or range/value case with a similar ratio of “big prior art thing to little claim thing,” I think we would be in an obviousness situation, and the patentee would at least have the opportunity to show criticality. Moreover, if the prior art patentee here had tried to add a post-filing claim to the exclusive WS-23 + menthol combination, I would think it would fail as an unsupported species (or sub-genus?).
Given that this case is essentially Judge Bryson versus Judge Newman, I’m hopeful that subsequent cases trim Wrigley’s authority. Situations of multiple options in the prior art crop up quite a bit; I’m surprised there isn’t already richer and contravening caselaw on this topic.