Enzo Biochem, Enzo Life Sciences and Yale University v. Applera and Tropix (CAFC 2009-1281) precedential

With regard to indefiniteness, the district court held that the "not interfering substantially" language in the asserted claims of all three patents is indefinite because "[t]he specifications neither set forth how one would gauge substantial interference, nor delimit the threshold at which interference with the procedure prevents [the claimed] method from being implemented." Id. at *12. Alternatively, the district court found these same claims to be anticipated by at least one of three prior art references.

The district court concluded that there was no genuine issue of material fact in regard to anticipation.

On appeal, first with regard to '824, '767, and '928 -

As a preliminary matter, we observe that a claim cannot be both indefinite and anticipated. A determination that a claim is anticipated involves a two-step analysis: "the first step requires construing the claim," and "[t]he second step in the analysis requires a comparison of the properly construed claim to the prior art . . . ." Power Mosfet Techs., LLC v. Siemens AG, 378 F.3d 1396, 1406 (Fed. Cir. 2004). If a claim is indefinite, the claim, by definition, cannot be construed. Without a discernable claim construction, an anticipation analysis cannot be performed. See Honeywell Int'l, Inc. v. Int'l Trade Comm'n, 341 F.3d 1332, 1342 (Fed. Cir. 2003) (vacating finding of infringement entered after claims were properly held to be indefinite).

The CAFC has no problem giving less-than-definite claim terms a pass. Using vagaries as "substantially" cause no consternation in determining the metes and bounds of a claim. It all comes down to context in light of serious excavation for meaning.

We agree with Enzo that the claims are not indefinite. "Indefiniteness requires a determination whether those skilled in the art would understand what is claimed. To make that determination, we have explained that '[i]n the face of an allegation of indefiniteness, general principles of claim construction apply.'" Young, 492 F.3d at 1346 (quoting Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1348 (Fed. Cir. 2005)). "In that regard, claim construction involves consideration of primarily the intrinsic evidence, viz., the claim language, the specification, and the prosecution history." Id. When a "word of degree" is used, the court must determine whether the patent provides "some standard for measuring that degree." Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984). Similarly, when a claim limitation is defined in "purely functional terms," a determination of whether the limitation is sufficiently definite is "highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area)." Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008).

The district court had been too cavalier in homogenizing claim construction among the three patents. '928 should have been construed differently.

The district court, however, adopted an identical construction for all three patents that refers to both hybridization and detection: "the linkage group neither substantially interferes with the ability of the compound to hybridize with the nucleic acid nor substantially interferes with the ability of A to be detected." Claim Construction, 2006 WL 2927500, at *6 (emphases added).

As a preliminary matter, we see no basis to read a "hybridization" requirement into the claims of the '928 patent. Nothing in the claims refers to hybridization, and neither the specification nor the prosecution history contains a clear disclaimer or a contrary definition regarding the "not interfering substantially" language that would require us to read such a requirement into the claims.

We therefore modify the construction of this limitation with regard to the '928 patent to read: "the linkage group does not substantially interfere with the ability of A to be detected."

On to defining "substantially," which "can denote either language of approximation or language of magnitude." For sure. None more definite.

With regard to the '824 and '767 patents, the term "hybridization" has a definite meaning. The district court correctly understood the term to mean "the binding of two separate, complementary strands of nucleic acids to form nucleic acid hybrids." Id. at *1 n.1. The ambiguity, in the district court's view, was that a person of ordinary skill would not understand whether a linkage group interferes with hybridization "substantially."

We begin with the language of the claims. The word "substantially," when used in a claim, can denote either language of approximation or language of magnitude. See Deering Precision Instruments, LLC v. Vector Distrib. Sys., Inc., 347 F.3d 1314, 1323 (Fed. Cir. 2003). As used in the phrase "not interfering substantially," the word "substantially" denotes language of magnitude because it purports to describe how much interference can occur during hybridization, i.e., an insubstantial amount of interference. See Epcon Gas Sys., Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 1031 (Fed. Cir. 2002) ("[T]he phrase 'substantially below' signifies language of magnitude, i.e., not insubstantial."). The claims in this case provide at least some guidance as to how much interference will be tolerated. A dependent claim in both patents specifies that the linkage group has a particular structure (-CH=CH-CH2-NH-). See '824 patent col.32 ll.66-68; '767 patent col.31 ll.38-40. A person of ordinary skill would presume that a structure recited in a dependent claim will perform a function required of that structure in an independent claim. See AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003) ("Under the doctrine of claim differentiation, dependent claims are presumed to be of narrower scope than the independent claims from which they depend."). Thus, it may be presumed that the term "not interfering substantially" in the independent claims allows for at least as much interference as that exhibited when the linkage group has the structure specified in the dependent claims.⁴

In the ironic woolly bully of claim construction, §112 ¶2 is woolly, while §112 ¶1 is bully.

⁴ Of course, if this particular embodiment is inoperable, because a linkage group having the structure -CH=CH-CH2-NH- entirely precludes hybridization, then the basis for invalidity would be a lack of enablement, not indefiniteness. Exxon Research & Eng'g Co. v. United States, 265 F.3d 1371, 1382 (Fed. Cir. 2001) (stating that inoperable embodiments present "an issue of enablement, and not indefiniteness"); Miles Labs., Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir. 1993) ("The invention's operability may say nothing about a skilled artisan's understanding of the bounds of the claim.").

"Substantially" gets pinned down. All that one of skill in the art needs to do to determine the meaning of this crucial claim term is read the specification, and prosecution history, then apply the Solomonic wisdom which eludes a district court but is within the ready grasp of the CAFC. No need to have a "wherein substantially comprises..." element in the claim to meet §112 ¶2.

The specification provides additional examples of suitable linkage groups, including some criteria for selecting them...

The prosecution history of these patents is also helpful....

Because the intrinsic evidence here provides "a general guideline and examples sufficient to enable a person of ordinary skill in the art to determine [the scope of the claims]," In re Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983), the claims are not indefinite even though the construction of the term "not interfering substantially" defines the term without reference to a precise numerical measurement, see Young, 492 F.3d at 1346 (holding that a word of degree was definite, even without a numerical claim construction); Exxon, 265 F.3d at 1381 (same); Marosi, 710 F.2d at 803 (same); In re Mattison, 509 F.2d 563, 565 (CCPA 1975) (same). When deciding whether a particular linkage group is or is not "substantially" interfering with hybridization within the meaning of the district court's construction, a person of ordinary skill would likely look to the thermal denaturation profiles and hybridization properties (including Tm) of the modified nucleotide, to see whether they fall within the range of exemplary values disclosed in the intrinsic evidence. See Young, 492 F.3d at 1346 (stating that a figure in the specification "provides a standard for measuring the meaning of the term 'near,'" even without a numerical claim construction); Exxon, 265 F.3d at 1380 (stating that a "period sufficient," recited in the claim, can be ascertained by performing activity checks).

The claims are not indefinite simply because the binding strength of a DNA strand will vary based on the strand's length and sequence. See Young, 492 F.3d at 1346 (holding claim definite even though "the size of the appendage and the amount of skin required to be incised will vary from animal to animal based on the animal's size").

Thus, we hold that the claim language regarding "hybridization" is not indefinite.

With regard to "detection," we agree with Enzo that the claims are not indefinite for most of the same reasons discussed in connection with "hybridization."

As to anticipation, Enzo raised "a genuine issue of material fact" for '767 and '824, but '928 went down. Conflicting declarations raised the issue for '767 and '824.

See Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309, 1315 (Fed. Cir. 1998) ("In deciding whether summary judgment was appropriate, we view the evidence in a light most favorable to the party opposing the motion with doubts resolved in favor of the opponent.") (internal citations omitted).

'830 went into the teeth of claim scope breadth.

The specification lends no support to Enzo's proposed construction because it contains no disclosure whatsoever of direct detection. This fact alone is not dispositive, of course, because "it is improper to read limitations from a preferred embodiment described in the specification--even if it is the only embodiment--into the claims absent a clear indication in the intrinsic record that the patentee intended the claims to be so limited." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir. 2004).

The claim language held a strong suggestion to the same, and, in the CAFC's backhanded double-negative, "the prosecution history is not to the contrary."

Because Enzo stipulated that it cannot prove infringement under this construction, we affirm the judgment of noninfringement of the '830 patent.

'824 and '767 live to fight another day (reversed). '928 invalidated as anticipated (affirmed). '830 claim construction correct, thus non-infringement affirmed. Remanded.