Talk:Metabolit Laboratories, Inc. and Competitive Technologies, Inc. v. Laboratory Corporation of America Holdings, 370 F.3d 1354 (2004)

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In most cases, the best source for discerning the proper context of claim terms is the patent specification wherein the patent applicant describes the invention. In addition to providing contemporaneous technological context for defining claim terms, the patent applicant may also define a claim term in the specification "in a manner inconsistent with its ordinary meaning." Boehringer Ingelheim Vetmedica, Inc. v. Schering-PloughCorp., 320 F.3d 1339, 1347 (Fed.Cir.2003) (citing Teleflex, 299 F.3d at 1325-26). In other words, a patent applicant may define a term differently from its general usage in the relevant community, and thus expand or limit the scope of the term in the context of the patent claims. Id. Therefore, the primary aids to supply the context for interpretation of disputed claim terms are in the intrinsic record. Vitronics, 90 F.3d at 1582 (Fed.Cir.1996). 19

("[C]onsultation of extrinsic evidence is particularly appropriate to ensure that [the court's] understanding of the technical aspects of the patent is not entirely at variance with the understanding of one skilled in the art."); Vitronics, 90 F.3d at 1585. Another excellent source of context for disputed terms is dictionary definitions and treatises. See, e.g., Tex. Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202 (Fed.Cir.2002) ("[D]ictionaries, encyclopedias and treatises are particularly useful resources to assist the court in determining the ordinary and customary meanings of claim terms."). 21

An examination of the prosecution history of this patent brings the meaning of the preamble into focus. As originally filed, claim 13 did not contain the "correlating" step. The examiner rejected claim 13 under 35 U.S.C. § 112 because it did not "recite discrete, sequential process steps, for example, obtaining a sample,contacting the sample with, etc. The final step should be clearly related to the preamble of the claim." Rather than add a second step as the examiner suggested, however, the applicant responded: "[A]s applicants are the first to detect cobalamin or folate deficiency by assaying body fluids for total homocysteine, it is believed that they are entitled to a claim of equivalent scope, not limited to any particular steps or methods." After this response, the examiner dropped the § 112 objection, but rejected claim 13 under § 102: "In the absence of a correlation step, the preamble of claim 13 merely recites an intended use of the invention. The claim lacks a positive limitation for correlating to a particular condition and has only one method step recited." At that point, the applicant added the recommended "correlating" step. The examiner then allowed claim 13. 27 ("Liability for either active inducement of infringement or for contributory infringement is dependent upon the existence of direct infringement.") Active Inducement 38 Section 271(b) of title 35 provides: "Whoever actively induces infringement of a patent shall be liable as an infringer." 35 U.S.C. § 271(b) (2000). Although not express in the statute, this section requires proof of intent to induce infringement. See, e.g., Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed.Cir.1990) ("proof of actual intent to cause the acts which constitute the infringement is a necessary prerequisite to finding active inducement"). A patentee may prove such intent through circumstantial evidence, much like direct infringement as discussed above. See Water Techs. v. Calco, Ltd., 850 F.2d 660, 668 (Fed.Cir.1988) (noting that "circumstantial evidence may suffice" in proving intent). 39

Therefore, this court affirms the finding of indirect infringement based on the inducement analysis. This court declines to consider contributory infringement.

Invalidity 42 A patent issued from the United States Patent and Trademark Office (PTO) bears the presumption of validity under 35 U.S.C. § 282. An accused infringer, therefore, must prove patent invalidity under the clear and convincing evidentiary standard. Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272 (Fed.Cir.2000)

First, LabCorp contends that the "correlating" step in claim 13 is indefinite. 35 U.S.C. § 112, second paragraph, provides: "The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." 35 U.S.C. § 112, ¶ 2 (2000). The requirement to "distinctly" claim means that the claim must have a meaning discernible to one of ordinary skill in the art when construed according to correct principles. Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 692 (Fed.Cir.2001); Rosemount, Inc. v. Beckman Instruments, Inc., 727 F.2d 1540, 1547 (Fed.Cir.1984). Only when a claim remains insolubly ambiguous without a discernible meaning after all reasonable attempts at construction must a court declare it indefinite. Exxon Research & Eng'g Co. v. United States, 265 F.3d 1371, 1375 (Fed.Cir.2001). In this case, as already noted, the claim construction exercise at the trial court produced a discernible and clear meaning. No "material ambiguities" cloud the meaning of "correlating" to the extent that one of skill in the art would find the claim wholly indefinite. All Dental Prodx, LLC v. Advantage Dental Prods., Inc., 309 F.3d 774, 780 (Fed.Cir.2002) ("Only after a thorough attempt to understand the meaning of a claim has failed to resolve material ambiguities can one conclude that the claim is invalid for indefiniteness."). This court affirms the trial court's denial of JMOL on this ground. 44 LabCorp next argues that the specification does not adequately describe the claimed invention under 35 U.S.C. § 112, first paragraph: 45 The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains or with which it is most nearly connected, to make and use the same.... 46 35 U.S.C. § 112, ¶ 1. This language contains both the written description and enablement tests for sufficiency of the specification's disclosure. 47 With regard to the written description test, this court has previously explained, "the test for compliance with § 112 has always required sufficient information in the original disclosure to show that the inventor possessed the invention at the time of the original filing." Moba, 325 F.3d at 1320 (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed.Cir.1991)).

The prior art reference (Refsum) does not anticipate claim 13 under 35 U.S.C. § 102. "A prior art reference anticipates a patent claim if the reference discloses, either expressly or inherently, all of the limitations of the claim." EMI Group N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1350 (Fed.Cir.2001) (citation omitted).

A prior art reference that discloses a genus still does not inherently disclose all species within that broad category. See Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1262 (Fed.Cir.1989) ("Under [defendant's] theory, a claim to a genus would inherently disclose all species. We find [this] argument wholly meritless...."). 53

The test of obviousness in 35 U.S.C. § 103 is the primary condition of patentability. Obviousness hinges on four factual findings: "(1) the scope and content of the prior art; (2) the differences between the prior art and the claims; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness." Nat'l Steel Car, Ltd., v. Can. Pac. Ry., Ltd., 357 F.3d 1319, 1334 (Fed.Cir.2004).

("Obviousness cannot be established by combining the teachings of the prior art to produce the claimed invention, absent some teaching or suggestion supporting the combination." (quoting ACS Hosp. Sys., Inc. v. Montefiore Hosp., 732 F.2d 1572, 1577 (Fed.Cir.1984))). 

Beyond these points, however, the record contains evidence of objective indicia that support the jury's nonobviousness verdict. The record, for example, shows that skilled artisans were initially skeptical about the invention. See Hughes Tool Co. v. Dresser Indus., Inc., 816 F.2d 1549, 1556 (Fed.Cir.1987) (initial skepticism of experts is relevant to nonobviousness). The record also shows that Metabolite has licensed the invention to eight companies. In re Sernaker, 702 F.2d 989, 996 (Fed.Cir.1983) (extensive licensing supports nonobviousness). Substantial evidence, therefore, supports the implied jury factual findings that support its legal conclusion that claim 13 is not obvious in light of the Refsum article and the cited secondary references. 56

Accordingly, a licensor who has implicitly covenanted not to sue a licensee by virtue of the license agreement itself cannot seek a declaratory judgment of infringement. Moreover, in light of LabCorp's continuing royalty payments on the panel test, LabCorp cannot itself challenge the validity of a claim for which it continues to pay royalties.

The jury found that "LabCorp breached the license agreement by terminating it" for the Abbott test. LabCorp contends that it did not formally terminate the contract, because the contract requires that the licensee provide written notice. The record contains no evidence of a written termination. The record does show, however, that LabCorp stopped paying royalties on the total homocysteine tests. Refusal to pay royalties is a material breach of the license.

Read, 970 F.2d at 828 ("To enable appellate review, a district court is obligated to explain the basis for the award, particularly where the maximum amount is imposed.").

SCHALL, Circuit Judge, concurring-in-part, dissenting-in-part. 77 I begin with what I see as the controlling principles of claim construction. When interpreting the claims of a patent, the court should look first to the intrinsic evidence of record: the claim, the specification, and, if in evidence, the prosecution history. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996). There exists within the intrinsic evidence a "hierarchy of analytical tools." Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1344 (Fed.Cir.1998). First, the language of the claim should be considered — "[t]he actual words of the claim are the controlling focus." Id. The claim language defines the bounds of claim scope. Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 619-20 (Fed.Cir.1995). Because the claims define the patentee's right to exclude others, "the claim construction inquiry, therefore, begins and ends in all cases with the actual words of the claim." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed.Cir.1998). 86

We have repeatedly stated that "[c]ourts can neither broaden nor narrow claims to give the patentee something different than what he has set forth." Tex. Instruments Inc. v. U.S. Int'l Trade Comm'n, 988 F.2d 1165, 1171 (Fed.Cir.1993) (quoting Autogiro Co. v. United States, 181 Ct.Cl. 55, 384 F.2d 391, 396 (1967)); Oak Tech., Inc. v. Int'l Trade Comm'n, 248 F.3d 1316, 1329 (Fed.Cir.2001). In this case, however, the majority has permitted claim 13 to be infringed even when homocysteine assays result in unelevated levels. The majority thereby broadens claim 13 to also include, although it is not expressly claimed, correlating unelevated levels of homocysteine with the absence of a vitamin deficiency. 90


This court reviews a denial of JMOL without deference by reapplying the JMOL standard. Thus, this court will affirm a denial of JMOL unless substantial evidence does not support the jury's factual findings or the verdict rests on legal errors. Waner v. Ford Motor Co., 331 F.3d 851, 855 (Fed.Cir.2003). 14

Whether a specification complies with the written description requirement of 35 U.S.C. § 112, paragraph 1, is a question of fact that this court reviews for substantial evidence. Union Oil v. Atl. Richfield Co., 208 F.3d 989, 996 (Fed.Cir.2000). Enablement is a matter of law that this court reviews without deference; however, this court reviews the factual underpinnings of enablement for substantial evidence. BJ Servs. Co. v. Halliburton Energy Servs., Inc., 338 F.3d 1368, 1371-72 (Fed.Cir.2003). Similarly, this court reviews the legal determination of obviousness without deference, but reviews its factual underpinnings for substantial evidence. Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1323 (Fed.Cir.2002). This court reviews a legal finding of indefiniteness without deference. BJ Servs., 338 F.3d at 1371-72. Whether a prior art reference anticipates a patent is a factual determination that this court reviews for substantial evidence. Teleflex, 299 F.3d at 1323. 15

Whether infringement was willful is a question of fact that this court reviews for substantial evidence. Crystal Semiconductor Corp. v. TriTech Microelecs. Int'l, Inc., 246 F.3d 1336, 1346 (Fed.Cir. 2001). This court reviews an award of enhanced damages and grant of a permanent injunction for abuse of discretion. Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1272 (Fed.Cir.1999).

The specification confirms that the claim language does not require as part of the method a confirmation that the elevated level causes some deleterious symptoms or abnormalities. LabCorp points to portions of the specification that discuss the relationship between the elevated levels and either clinical or hematologic symptoms. See, e.g., '658 patent, col. 10, ll. 56-61; col. 12, ll. 8-15. LabCorp would expand those references to require some confirmatory step in the claim. The specification, however, does not require such a confirmatory step. Rather, the specification at one juncture acknowledges that the method can show vitamin deficiency without any clinical symptoms: "These findings led us to conclude that large numbers of patients with cobalamin deficiency lack the `typical' clinical and hematologic features usually expected to be present in cobalamin deficiency...." Id. at col. 11, ll. 40-45. In other words, the specification shows that the method can show an association between elevated levels and vitamin deficiency without any further clinical symptoms. Thus, the district court properly refused to import into the claims LabCorp's proposed limitation from the specification. The specification itself does not support such a limitation on the meaning of the claims. 29

As noted earlier, the district court construed "correlating" to mean a "mutual or reciprocal relationship between" the elevated levels and the vitamin deficiencies. The inventors discovered that assaying total homocysteine correlated with (or predicted relatively accurately) whether a patient had a deficiency of cobalamin or folate. Id. at col. 4. ll. 17-23; col. 10, ll. 35-42. The specification explains that an elevated level of total homocysteine often indicates a deficiency, while a non-elevated level indicates no deficiency. For example, the overview of the invention notes: "This invention pertains to ... methods for determining whether said warm-blooded animal has a cobalamin deficiency, a folic acid deficiency, neither, or both." Id. at col. 1, ll. 13-15 (emphasis added). Next, in the summary of the invention, the patentee stated: "Accordingly, assays for homocysteine can be used to determine the presence or absence of cobalamin and/or folic acid deficiency in warm-blooded animals." Id. at col. 5, l. 66-col. 6, l. 1 (emphasis added). This court observes that the perfect symmetry between "mutual or reciprocal" and "presence or absence" shows that the district court correctly placed the term "correlating" in its proper context with its proper meaning.