Howmedica Osteonics Corp. v. Zimmer, Inc.

640 F. App'x 951
CourtCourt of Appeals for the Federal Circuit
DecidedFebruary 26, 2016
Docket2015-1498, 2015-1503
StatusUnpublished

This text of 640 F. App'x 951 (Howmedica Osteonics Corp. v. Zimmer, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Howmedica Osteonics Corp. v. Zimmer, Inc., 640 F. App'x 951 (Fed. Cir. 2016).

Opinions

Opinion for the court filed by Circuit Judge LOURIE.

Opinion concurring in part, dissenting in part filed by Circuit Judge NEWMAN.

LOURIE, Circuit Judge.

Howmedica Osteonics Corp. (“Howmedi-ca”) appeals from an inter partes reexamination decision of the United States Patent and Trademark Office. (“PTO”) Patent Trial and Appeal Board (“the Board”) affirming the examiner’s rejection of claims 1-6 of U.S. Patent 6,818,020 (“the '020 patent”) as anticipated. See Smith & Nephew, Inc. v. Howmedica Osteonics Corp., No. 2013-007710, 2014 WL 1729260, at *12 (P.T.A.B. Apr. 30, 2014) (“Decision ”). Zimmer, Inc. (“Zimmer”) cross-appeals from the Board’s decision reversing the examiner’s rejection of claims 7-12 of the '020 patent as obvious. Id. at *16. For the reasons that follow, we affirm in part and reverse in part.

Background

Howmedica owns by assignment the '020 patent (now expired), directed to ultra-high molecular weight polyethylene (“UHMWPE”) with improved properties for use in medical implants. UHMWPE is widely used in biomedical applications, and for “articulation surfaces in artificial knee and hip replacements” in particular. '020 patent col. 1 11. 28-29. The '020 patent explains that all implant components go through a sterilization process, most often irradiation, before use. Id. col. 1 ll. 42-56. One consequence of that irradiation, however, is the generation of free radicals. Id. col. 1 ll. 57-59.

Free radicals are highly reactive and, when exposed to air, can effect “oxidative chain scission reactions.” Id. col. 2 ll. 35-36. Through those oxidative reactions, the “material properties of the [implant], such as molecular weight, tensile, and wear properties, are degraded.” Id. col. 2 ll. 36-38. If, however, irradiation occurs in an inert environment, the free radicals react with each other to form carbon-carbon cross-links. Id. col. 2 ll. 50-54. Such cross-linking decreases the implant’s overall degradation.

The '020 patent describes a method for “providing a polymeric material, such as UHMWPE, with superior oxidative resistance upon irradiation,” and thereby generating UHMWPE implants with improved material properties. Id. col. 3 11. 35-37. In particular, the '020 patent sets forth a two-step process, whereby the polymer is first irradiated and then heat treated. Both steps take place in an “oxidant-free atmosphere” to improve the [953]*953cross-linking of free radicals. Id. col. 3 1. 65-col: 4 1. 4. The '020 patent further provides that “the implant is heated for at least 48 hours at a temperature of about 37°C to about 70°C and preferably for 144 hours at 50°C.” Id. col. 4 ll. 35-37 (the preferred embodiment is further described as Method D, '020 patent col. 7 ll. 51-58, the method Howmedica states generates the claimed properties, Appellant’s Br. 5).

Claims 1-12 of the '020 patent all recite “[a] medical implant comprising an irradiated [UHMWPE] having a weight average molecular weight greater than 400,000,” and at least one of the following properties:

(1) a solubility of less than 80.9% in trichlorobenzene (claims 1-4, 7-9, and 12), and more particularly in 1,2,4-trichlorobenzene (claim 5);
(2) the level of free radicals at 1x1017 spins/gram or less (claims 2, 6, and 10);
(3) a Fourier Transform Infrared Spectroscopy (“FTIR”) oxidation index that does not increase during oven aging in air at 80°C for up to 11 days (claims 3, 7, and 9), 11 days (claims 6, 10, 11, and 12), or up to 23 days (claims 4 and 8);
(4) an FTIR oxidation index of 0.01 (claim 11) or less (claim 12); and/or
(5) a weight percent of polyethylene with a molecular weight below 100,-000 of less than 18.4% (claim 9).

Id. col. 12 ll. 1-54. Claims 7-12 further require the UHMWPE to be “annealed at a temperature greater than 25°C for a sufficient time” to achieve one or more of the above properties. Id. col. 12 ll. 24-54.

In 2005, Howmedica sued Zimmer in the U.S. District Court for the District of New Jersey, alleging infringement of claims 1-3, 5-7, and 10-12 of the '020-patent, as well as the claims of three related patents.1 Howmedica Osteonics Corp. v. Zimmer, Inc., Civ. No. 05-897, 2008 WL 3871733, at *1 (D.N.J. Aug. 19, 2008). In 2007, the district court issued its Markman Order, construing various disputed terms. Id. Notably, it construed “annealed at a temperature greater than 25°C” to mean “annealed at a temperature greater than,25°C and less than the melting point of the material — approximately 140°C.” Id. at *2. In light of that construction, Zimmer moved for partial summary .judgment of noninfringement of claims 7, 10, 11, and 12 of the '020 patent. Id. at *1. The court granted the motion, concluding that Zim-mer’s accused products were annealed above the melting temperature, i.e., at or about 150°C, and thus did not satisfy the •limitation as construed, either literally or under the doctrine of equivalents. Id. at *7 (“Absolutely distilled, Plaintiffs argument is: ignore the specific language and meaning of the claim element. Unmelt is the same as melt. An antonym is a synonym. Accordingly, the Court finds that there is no genuine issue of material fact____”).

In 2009, Zimmer requested inter partes reexamination of claims 1-12 of the '020 patent. The- PTO granted the request, and the district court stayed its remaining proceedings pending the outcome of the reexamination.

The examiner adopted many of Zim-mer’s proposed rejections, and rejected claims 1-12 over various prior art refer-[954]*954enees and combinations thereof. Joint App. (“J.A.”) 706-21. In particular, the examiner rejected claims 1-6 as inherently anticipated by Ching-Tai Lue, “Effects of Gamma Irradiation and Post Heat Treatments on the Structure and Mechanical Properties of Ultra High Molecular Weight Polyethylene (UHMWPE),” Masters Thesis, University of Lowell, 1979 (“Lue”), as evidenced by the declaration of Dr. Robert L. Clough (“Clough declaration”). J.A. 710-12. The examiner also rejected claims 7-12 as obvious over Lue in view of U.S.- Patent 3,362,897 (“Law-ton”). J.A. 715-16. Howmedica timely appealed to the Board.

The Board first affirmed the examiner’s rejection of claims 1-6 as inherently anticipated by Lue as evidenced by the Clough declaration. It noted that “[i]t is undisputed that Lue describes UHMWPE that has been irradiated in an inert atmosphere and heat treated at 150°C- for one hour. Lue does not[, however,] teach all the properties recited in the claims.” Decision, 2014 WL 1729260, at *3. The Board accordingly examined whether Lue’s material inherently possesses the claimed properties, and found that it does.

Turning to the Clough declaration, the Board noted that Dr. Clough testified to acquiring two different resins of UHMWPE and followed a detailed protocol reproducing the irradiation and heating procedures in Lue. Id. at *9. Dr. Clough then measured the treated UHMWPE for solubility, level of free radicals, and FTIR oxidation index, closely following the testing procedures in the '020 patent. Id. Dr. Clough testified that the resulting measurements fell within the ranges recited in the '020 patent. Id.

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640 F. App'x 951, Counsel Stack Legal Research, https://law.counselstack.com/opinion/howmedica-osteonics-corp-v-zimmer-inc-cafc-2016.