At the Federal Circuit - Reviewing the Law of Anticipation of Ranges

Claims reciting numerical ranges face particular challenges when analyzed for patentability in view of the prior art.A claim reciting a range may sometimes be anticipated by a prior art reference that discloses an overlapping range or a point within the range.Or at other times, an overlapping range may not anticipate the claimed range at all.InIneos USA LLC v. Berry Plastics Corp., No. 2014-1540, slip op. (Fed. Cir. Apr. 16, 2015), the Federal Circuit provides a review of the prevailing analytical framework used when assessing whether a claimed range is anticipated by the prior art. This review is particularly helpful, considering the very brief treatment of the issue appearing in section 2131.03 of the Manual of Patent Examining Procedure (MPEP).

In theIneoscase, the Federal Circuit affirmed the district court’s grant of summary judgment that U.S. Patent No. 5,948,846(“Prior Art”) anticipated Ineos’s patent, U.S. Patent No. 6,846,863 (“the ’863 patent”).The ’863 patent, which claims polyethylene-based compositions, has only one independent claim:

1. Composition comprising at least [1] 94.5% by weight of a polyethylene with a standard density of more than 940 kg/m3,
2. 0.05 to 0.5% by weight of at least one saturated fatty acid amide represented byCH3(CH2)nCONH2in which n ranges from 6 to 28[,]
3. 0 to 0.15% by weight of a subsidiary lubricant selected from fatty acids, fatty acid esters, fatty acid salts, mono-unsaturated fatty acid amides, polyols containing at least 4 carbon atoms, mono- or poly-alcohol monoethers, glycerol esters, paraffins, polysiloxanes, fluoropolymers and mixtures thereof, and
4. 0 to 5% weight of one or more additives selected from antioxidants, antacids, UV stabilizers, colorants and antistatic agents.

Id.at 2-3 (alterations in original).

Neither Ineos nor Berry Plastics disputed that the Prior Art disclosed limitation [1].Likewise, neither party disputed that the Prior Art’s disclosure of stearamide falls within a “saturated fatty acid amide represented by CH3(CH2)nCONH2in which n ranges from 6 to 28” of limitation [2].The district court concluded that the Prior Art satisfied limitations [3] and [4], which claim ranges of subsidiary lubricant and additive beginning with 0%.Id.at 4.

Central to both the district court’s and the Federal Circuit’s analyses was the following passage from the Prior Art1:

The composition according to the invention includes the lubricating agent in a total quantity of at least0.1 part by weight per 100 parts by weight of polyolefin, in particular of at least 0.2 parts by weight, quantities of at least 0.4 parts by weight being the most common ones; the total quantity of lubricating agents does not exceed5 parts by weight, more especially 2 parts by weight, maximum valuesof 1 part by weight per 100 parts by weight of polyolefin being recommended.

Id.at 6 (citing Prior Art col. 2 l. 66-col. 3 l. 7). The district court concluded that this passage anticipates limitation [2] because it disclosesspecific values(e.g.,0.1 partby weight) in addition to the full range (0.1 to 5 parts by weight).Id.at 3.The Federal Circuit, however, also found that this passage anticipates limitation [2], but as anoverlapping range.

When the Prior Art Discloses Points Within a Range

“[A] range is anticipated by a prior art reference if the reference discloses a point within the range.” Id.at 6 (citing Titanium Metals Corp. v. Banner, 778 F.2d 775, 782(Fed. Cir. 1985)).

In assessing whether the Prior Art disclosed points falling within limitation [2]’s claimed range, the Federal Circuit considered a specific passage from the Prior Art: “the lubricating agent in a total quantity ofat least0.1 part by weight per 100 parts by weight of polyolefin...the total quantity of lubricating agents does not exceed5 parts by weight.”Id.According to the court, this passage discloses ranges, not specific values.Id.To make its determination, the court considered the Prior Art’s use of the qualifiers “at least” and “does not exceed,” finding that these phrases clearly establish corresponding minimum and maximum amounts of primary lubricant, i.e., arangeof primary lubricant amounts.Id.

Next, the Federal Circuit assessed whether the endpoints of the Prior Art range could anticipate limitation [2]’s range.The court restated the principle that a prior art reference’s disclosed range does not constitute specific disclosure of the endpoints of that range.Id.(quotingAtofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006)).Applying theAtofinaprinciple, the Federal Circuit held that the district court erred in finding anticipation based on a point within a range in the Prior Art.Id.at 6-7.Instead, the Prior Art was held to disclose a range that overlaps the range recited in limitation [2].

When the Prior Art Discloses an Overlapping Range

“If the prior art discloses its own range,...then the prior art is only anticipatory if it describes the claimed range with sufficient specificity such that a reasonable fact finder could conclude that there is no reasonable difference in how the invention operates over the ranges.” Id.at 6 (citing Atofina, 441 F.3d at 999).

After determining that the Prior Art range overlapped the range recited in limitation [2], the Federal Circuit considered whether limitation [2]’s range is “critical” to the operability or functionality of the invention. Id.at 7. While ultimately concluding that Ineos did not raise a genuine issue of fact about the criticality of the range, the court restated prior case law dealing with establishing criticality. In its review, the Federal Circuit emphasized the importance of a relationship existing between evidence of criticality of the range on one hand, and the operability or functionality of the claimed invention on the other.

InAtofinaandOSRAM Sylvania v. American Induction Technologies, Inc., 701 F.3d 698 (Fed. Cir. 2012), the Federal Circuit found that the claimed range was critical to the operation of the invention.InAtofina, the Federal Circuit, reversing the district court, found that the patent and the prosecution history highlighted the criticality of the claimed range.Ineos, No. 2014-1540, slip op. at 7.The prior art’s claimed range—100 °C to 500 °C—overlapped with Atofina’s 330 °C to 450 °C range.Atofina successfully argued, however, that the synthesis reaction would not operate as claimed outside of the claimed temperature range. Id.An important aspect of the court’s conclusion was that a person of ordinary skill in the art would have expected the synthesis reaction to operate differently, or not at all, outside of the claimed temperature range.InOSRAM, the Federal Circuit reversed the district court’s grant of summary judgment of anticipation where the patentee raised a genuine dispute of material fact concerning the criticality of a claimed range.Id.at 8.To counter the allegation of anticipation by the prior art range, the patentee presented expert testimony and other evidence to establish the criticality of the claimed range.The unrebutted expert testimony established that the recited range was critical to the operation of the claimed lamp.Id.at 8-9.

By contrast, inClearValue,Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340 (Fed. Cir. 2012), the Federal Circuit held that the prior art range anticipated the overlapping claimed range.In this case, ClearValue did not argue that “the claimed range was critical to the invention or that the claimed method would work differently within the prior art range.”Ineos, No. 2014-1540, slip op. at 8.ClearValuedemonstrates the value of providing evidence that shows the “considerable difference between how the method would operate within the claimed range and within the range disclosed in the prior art” to defend against an anticipation challenge.Id.

InIneos, the Federal Circuit also pointed out that certain types of evidence do not demonstrate the criticality of a recited range.Ineos presented unrebutted evidence that the limitation [2] range was critical to avoid unnecessary manufacturing costs and blemishes on the bottle caps.Id.at 9.However, for a claimed range to be critical and not anticipated by the prior art, the disclosed operability or functionality of the claimed invention must differ if the overlapping prior art range were used.According to the court, Ineos’s evidence did not establish that the disclosed functionality or operability of the composition recited in the claims would be improved by using the claimed narrower range instead of the broader range disclosed in the Prior Art.Id.at 9-10.Further, the Federal Circuit found that no relationship had been shown between the disclosed properties of the claimed invention on the one hand, and the evidence of avoided manufacturing costs and avoided blemishes on the other.

The analytical framework inIneosexpands on the approach set forth in MPEP §2131.03, which does not fully articulate how evidence of criticality of a range weighs on an anticipation analysis. UsingIneos’s framework as a roadmap, patent applicants might consider focusing on the criticality of a claimed range as a way to possibly overcome a potentially anticipatory genus range.In addition, applicants should consider whether to include evidence supporting the criticality of the claimed range during prosecution. Where appropriate, this approach may include discussing the importance of the range, and its relevance to the functionality and operability within the claimed invention when drafting an application and submitting expert declarations.

1As noted by the Federal Circuit, Ineos and Berry Plastics agreed for purposes of the appeal that the “% by weight” measurement used in the ’863 patent is equivalent to the “parts by weight” measurement in the Prior Art.Ineos, No. 2014-1540, slip op. at 3 n.1.