Howmedica Osteonics Corporation v. Tranquil Prospects, Ltd.

401 F.3d 1367, 74 U.S.P.Q. 2d (BNA) 1680, 2005 U.S. App. LEXIS 4906, 2005 WL 697513
CourtCourt of Appeals for the Federal Circuit
DecidedMarch 28, 2005
Docket2004-1302
StatusPublished
Cited by19 cases

This text of 401 F.3d 1367 (Howmedica Osteonics Corporation v. Tranquil Prospects, Ltd.) 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 Corporation v. Tranquil Prospects, Ltd., 401 F.3d 1367, 74 U.S.P.Q. 2d (BNA) 1680, 2005 U.S. App. LEXIS 4906, 2005 WL 697513 (Fed. Cir. 2005).

Opinion

RADER, Circuit Judge.

Tranquil Prospects, Ltd. (Tranquil) is the owner by assignment of United States Patent Nos. 5,222,985 (June 29, 1993) and 4,636,214 (Jan. 13, 1987) (the ’985 and ’214 patents respectively) concerning the implantation of intramedullary prostheses. Howmedica Osteonics Corp. (Howmedica) sought a declaratory judgment in the Northern District of Indiana that the claims of the ’985 and ’214 patents are invalid, unenforceable, and not infringed. Tranquil counterclaimed for patent infringement. On September 25, 2003, the district court construed the disputed terms in the claims. Howmedica Osteonics Corp. v. Tranquil Prospects, 288 F.Supp.2d 939 (N.D.Ind. 2003) (Construction Order). Because it was unable to construe the term “transverse sectional dimensions,” the district court found that the claims were indefinite. Id., at 945. The district court also construed the claims of the ’985 patent to require a coating on the prosthetic before implantation in the bone. Id., at 940-41. Because the district court erred in holding the phrase “transverse sectional dimensions” indefinite and in construing the claims of the ’985 patent to require precoating the prosthetic prior to insertion into the bone, this court reverses in part, vacates in part and remands.

I

The ’985 and ’214 patents have identical written descriptions. 1 The ’214 patent claims methods for surgical orthopedic implantation of an intramedullary prosthesis; the ’985 patent claims an intramedullary prosthesis apparatus. Intramedullary prostheses replace the ball of the hip joint. ’214 patent, col. 1, 11. 15-25. “[T]he patient’s ball and a part of the neck from the upper end of the femoral bone” are removed. Id. A portion of the “centrally-positioned, softer, cancellous bone of the medullary canal [is] rasped to form a bone cavity [or stem socket] which [is] able to accept therein the stem of the prosthesis.” Id. “A metal prosthesis implant, having a ball, neck, and stem, [is] then inserted into the medullary canal of the femur.” Id.

Prior art intramedullary prostheses were substantially smaller than the stem sockets to avoid fracturing the femoral bone during installation. Id. at 11. 26-31 & 52-56. These prior art prostheses, however, lacked the required stability and load transfer to allow patients a full range of motion without pain. Id. at 11. 33-37 & 52-63.

In an attempt to stabilize the prostheses, the prior art filled the stem socket with bone cement to help stabilize the prosthesis within the stem socket. This process did not work well because an uneven distribution of the bone cement within the stem socket often caused the same problems. Id. at col. 1,11. 64-68 & col. 2,11. 35-42. These bone cement prostheses also tended to wear out and break more quickly due to the poor fit of the undersized prostheses and uneven distribution of the stabilizing cement. Id. at col. 2, 11. 38-52. Finally, the bone cement also introduced new problems, namely “migration of un-reacted monomer from the bone cement to tissue, and the need for the bone cement to undergo an exothermic polymerization ....” Id. at col. 2,11. 58-63.

*1369 To avoid the problems of bone cement, the prior art coated the stem of prostheses with a composite porous outer coating. Id. at col. 2, 11. 64-68. Although coated stems ameliorated some of the bone cement problems, patients continued to experience problems because the stems were undersized relative to the medullary canal. Id. at col. 8,11.13-20. “[T]he void space in the stem socket was surrounded substantially by relatively soft cancellous bone which could not sustain the mechanical stress loads imposed thereon.” Id. at col. 3, 11. 15-18.

The ’985 and ’214 patents overcame these problems in the prior art by introducing methods and apparatus for installation of a intramedullary prosthetic that is substantially the same size and shape as the medullary canal, as defined by the softer cortical bone or cortex. Id. at 11. 50-58. Substantially conforming the stem of the prosthesis to the shape of the me-dullary canal and rasping a complementary stem socket results in improved stem stabilization, improved load transfer from the stem to the surrounding dense cortical bone, and reduced localized stress zones. Id. at 11. 39-48.

Claim 1 of the ’214 patent is representative of the claim language at issue in that patent, and states:

1. A method of surgical orthopedic implantation of an intramedullary prosthesis device having an elongate stem with distal and proximate ends into the me-dullary canal of a long bone defined by the cortex of a long bone and comprising the steps of:
forming in said medullary canal a stem socket;
sizing the stem socket with an appropriately sized tool to form a socket defined substantially by the inner periphery of compact bone formed by cortical or dense cancellous bone, said stem having transverse sectional dimensions along substantially its entire length which are undersized with respect to adjacent cor-‘ responding transverse sectional dimensions of said stem socket;
then injecting bone cement in the completed stem socket; and
finally pushing said stem into said stem socket with said bone cement therein surrounding the stem for its entire length including its distal and proximate ends whereby said cement forms a liner around the outer surface of said stem between the stem and the adjacent compact bone, the transverse sectional dimensions of the liner and stem constituting at least around seventy percent (70%) of the corresponding transverse sectional dimensions of the long bone defined by cortical bone or metaphyseal and epiphyseal segments of said long bone, and at least around ninety percent (90%) of the corresponding transverse sectional dimensions of the long bone defined by cortical bone of the diaphy-seal segment of said long bone.

Claim 1 of the ’985 patent is representative of the claim language at issue in that patent, and states:

1. An intramedullary prosthesis comprising:
an elongate stem having distal and proximal ends and adapted to be forcibly inserted within an elongated stem socket having its inner periphery defined by compact bone formed by cortical bone or dense cancellous bone of a long bone, said stem having transverse sectional dimensions along substantially its entire length undersized with respect to corresponding transverse sectional dimensions of said socket;
a layer of coating material surrounding said undersized stem along its entire length including its distal and proximal ends and covering substantially the entire outer surface of said stem, the coat *1370

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401 F.3d 1367, 74 U.S.P.Q. 2d (BNA) 1680, 2005 U.S. App. LEXIS 4906, 2005 WL 697513, Counsel Stack Legal Research, https://law.counselstack.com/opinion/howmedica-osteonics-corporation-v-tranquil-prospects-ltd-cafc-2005.