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Integra Lifesciences Corp. v. Hyperbranch Medical Technology, Inc.

United States District Court, D. Delaware

August 4, 2017

INTEGRA LIFESCIENCES CORP., INTEGRA LIFESCIENCES SALES LLC, CONFLUENT SURGICAL, INC., and INCEPT LLC, Plaintiffs,
v.
HYPERBRANCH MEDICAL TECHNOLOGY, INC., Defendant.

          REPORT AND RECOMMENDATION

          CHRISTOPHER J. BURKE, UNITED STATES MAGISTRATE JUDGE

         In this action filed by Plaintiffs Integra LifeSciences Corp. ("Integra"), Integra LifeSciences Sales LLC ("Integra Sales"), Confluent Surgical, Inc. ("Confluent") and Incept LLC ("Incept") (collectively, "Plaintiffs") against Defendant HyperBranch Medical Technology, Inc. ("HyperBranch" or "Defendant"), Plaintiffs allege infringement of United States Patent Nos. 6, 566, 406 (the '"406 patent"), 7, 009, 034 (the "'034 patent"), 7, 332, 566 (the '"566 patent"), 7, 592, 418 (the '"418 patent"), 8, 003, 705 (the '"3705 patent") and 8, 535, 705 (the '"5705 patent") (collectively, the "patents-in-suit" or "asserted patents"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court find that the two terms discussed in this Report and Recommendation are indefinite.[1]

I. BACKGROUND

         The Court incorporates by reference herein the factual and procedural background regarding this case and the patents-in-suit set out in the Court's July 27, 2017 Report and Recommendation regarding claim construction. (D.I. 307 at 2-5)

         II. STANDARD OF REVIEW

         The Court also incorporates by reference herein the discussion of general principles of claim construction, as well as the legal standard relating to the definiteness requirement, which were set out in its July 27, 2017 Report and Recommendation. (Id. at 5-7, 30-32)

         III. DISCUSSION

         The Court takes up the two disputed terms addressed herein in the order in which the parties addressed them at the Markman hearing.

         A. "molecular weight"

         The term "molecular weight" appears in claims 1, 12 and 23 of the '406 patent. The use of the disputed term in claim 1 is representative:

1. A method for preparing a biocompatible crosslinked polymer hydrogel, comprising:
providing a biocompatible small molecule crosslinker with a molecular weight of 2000 or less ... providing a synthetic biocompatible functional polymer with a molecular weight of at least about 7 times more than the crosslinker . . . combining the crosslinker and functional polymer to react the crosslinker functional groups with the functional polymer functional groups to form a hydrogel. . .

('406 patent, col. 30:29-49 (emphasis added)) Defendant contends that the term is indefinite under 35 U.S.C. § 112. (D.I. 231 at 2-5) In response, Plaintiffs assert that the term is not indefinite (or that such an argument is premature at this time), and that it should be construed to mean "[t]he mass of a molecule which is often expressed in Daltons or g/mol[.]" (D.I. 230 at 18)[2]

         The claims refer to the molecular weight of a small molecule crosslinker and a functional polymer. Polymers are large molecules made up of many repeat units, formed by joining (in a process known as polymerization) small molecules called monomers. (D.I. 232 at ¶ 28) In the polymerization process, the monomers randomly react with one another, resulting in a polymer product that includes a mix of individual polymer molecules with small, medium and long chains (with the non-uniformity of the chain lengths of polymer products referred to as "polydispersity"). (Id. at ¶ 29; see also D.I. 159 at 125)

         It is undisputed here that, when determining the molecular weight of a polymer, different statistical measures could be used, such as number-average molecular weight ("Mn") or weight-average molecular weight ("Mw"). (D.I. 232 at ¶¶ 31, 33, 34; see also D.I. 10, ex. 13 at ¶ 381 (Plaintiffs' expert Dr. Jimmy W. Mays explaining that "I understand that the term 'molecular weight' when referring to polymers may be one of several types, such as 'number average molecular weight' or 'weight average molecular weight'")) Mn refers to the arithmetic mean, or the total mass of all molecules in the sample divided by the total number of molecules, whereas Mw is calculated differently, and encompasses the different mass contributions of the different chains of molecules making up a polymer product. (D.I. 232 at ¶ 31) It is also undisputed here that these different measures are generated using different calculations and can yield different numerical values for a given polymer. (Id. at ¶¶ 32, 39); see also Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1341 (Fed. Cir. 2015) (explaining that the term '"molecular weight'" could refer to, inter alia, Mw or Mn and that "each of these measures is calculated in a different way and would typically yield a different result for a given polymer sample"). Defendant argues that the intrinsic evidence does not indicate which measure of molecular weight should be used, and that this renders the term indefinite, because a polymer might simultaneously satisfy and not satisfy the claim limitations reciting "molecular weight" depending upon which measure is used to determine claim scope. (D.I. 231 at 3-4; D.I. 243 at 4-5)

         Defendant relies heavily on the decision of the United States Court of Appeals for the Federal Circuit in Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015) ('Teva II') in support of its argument, a case that analyzed indefiniteness with respect to the same term (albeit one found in different patents than the one at issue here). In Teva II, the claim at issue recited a method of manufacturing a product called copolymer-1 "having a molecular weight of about 5 to 9 kilodaltons." 789 F.3d at 1338 (certain emphasis omitted). The Teva II Court explained that there were three different relevant measures of molecular weight including Mn and Mw (as well as a third measure, Mp, or peak average molecular weight), with each measure being calculated differently and yielding different values for a given polymer sample. Id. The district court had agreed with the patentee's position that the record compelled a conclusion that "molecular weight" meant Mp in the context of the claimed invention. Id. at 1338-39.

         In reaching its conclusion, the district court had credited the plaintiffs expert's testimony that Example 1 in the specification of the asserted patent (which corresponded to Figure 1 in the specification) described an analytical method utilizing a chromatogram and calibration curve, from which Mp is the only type of average molecular weight that could be obtained. Id. at 1338. While experts testified that Mn and Mw could also be obtained from the chromatogram and calibration curve, the district court noted that doing so would require additional data manipulation and calculations that were not described in the specification; for this reason, the district court credited the plaintiffs expert's opinion that Example 1 implied the use of Mp. Id. The district court also rejected the defendant's argument that Figure 1 did not disclose Mp because the peaks of the depicted curves did not match the molecular weight values reported in the legend. Instead, the district court accepted the plaintiffs expert's explanation that a person of ordinary skill in the art ("POSITA") would understand that a shift in the peak of the curves could occur when transferring data from a chromatogram. Id. at 1338-39. The district court also relied on the patentee's statement during prosecution of a later related patent (to the effect that "average molecular weight" meant Mp) in reaching its conclusion that the term was not indefinite. Id. at 1339.

         On appeal, the Federal Circuit reversed the district court's conclusion as to definiteness. Id. The Supreme Court of the United States then vacated that decision and remanded for the Federal Circuit to review the district court's subsidiary fact findings for clear error. Id. at 1339-40.

         On remand, the Teva II Court again considered whether the claim was indefinite for its inclusion of the term "molecular weight, " looking to the intrinsic record (i.e., the claims, specification and prosecution history) to "ascertain if [it] convey[s] to one of skill in the art with reasonable certainty" the measure of molecular weight to be used. Id. at 1341. Ultimately, the Teva II Court again reversed the district pourt on this question.

         The Court prefaced its holding by differentiating between fact finding and legal analysis with respect to this issue. On the one hand, it explained that "[t]he meaning one of skill in the art would attribute to the term molecular weight in light of its use in the claims, the disclosure in the specification, and the discussion of this term in the prosecution history is a question of law." Id. at 1342. Even if an expert offers an opinion regarding a term's meaning in the context of a patent, that does not "transform [the issue] into a factual matter[, ]" the Court noted, since "[determining the meaning or significance to ascribe to the legal writings which constitute the intrinsic record is legal analysis." Id. Put another way, a party may not "transform legal analysis about the meaning or significance of the intrinsic evidence into a factual question simply by having an expert testify on it." Id. On the other hand, factual issues are those regarding "[understandings that lie outside the patent documents about the meaning of terms to one of skill in the art or the science or state of the knowledge of one of skill in the art[.]" Id.; see also Id. (noting that the "Supreme Court made clear ...


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