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Marctec, LLC v. Johnson & Johnson

March 31, 2009

MARCTEC, LLC, PLAINTIFF/COUNTERCLAIM DEFENDANT,
v.
JOHNSON & JOHNSON AND CORDIS CORPORATION, DEFENDANTS/COUNTERCLAIM PLAINTIFFS.



The opinion of the court was delivered by: Herndon, Chief Judge

FINDINGS OF FACT & CONCLUSIONS OF LAW ON CLAIMS CONSTRUCTION

On February 19, 2009, the Court conducted a claims construction hearing (a "Markman*fn1 hearing") (Doc. 156), whereby the Parties presented their respective interpretations of patent claims from U.S. Patent Nos. 7,128,753 ("the '753 patent") and 7,217,290 ("the '290 patent") (collectively, the "patents-in-suit").*fn2 Plaintiff Marctec, LLC, has asserted the patents-in-suit against the Cypher drug-eluting stent. At the conclusion of the Markman hearing, the Court took the matter under advisement. The following is the Court's findings of fact and conclusions of law regarding claim construction of the patents-in-suit, made pursuant to FEDERAL RULE OF CIVIL PROCEDURE 52.

FINDINGS OF FACT

I. THE DISPUTED CLAIM TERMS OF THE '290 PATENT

1) MarcTec has asserted claims 1-8, 10 and 14 of the '290 patent. Claim 1 is an independent claim. Claims 2-8, 10 and 14 depend from claim 1 and thus incorporate all of its limitations.

2) Claim 1 reads (the disputed claim language is indicated): An implantfor implantation in a human body comprising: a tubular member having a channel and mechanically expandable upon activation of a delivery mechanism from a contracted condition in which the tubular member has a first cross sectional size in a plane perpendicular to a longitudinal central axis of the tubular member to an expanded condition in which at least a portion of the tubular member has a second cross sectional size in a plane perpendicular to the longitudinal central axis of the tubular member, the second cross sectional size being larger than the first cross sectional size to thereby lock the tubular member against tissue in the human body;anda first component bonded to at least a portion of the tubular member and formed of a heat bondable material that includes a therapeutic agentselected from the group consisting of atissue ingrowth promoter and an antibiotic, wherein the heat bondable material is non-flowable and non-adherent at room temperature and becomes flowable, tacky, and adherent upon the application of heat.

3) Claim 2 reads (the disputed claim language is indicated): The implant of claim 1 wherein the heat bondable material is a thermoplastic material.

4) Claim 3 reads (the disputed claim language is indicated): The implant of claim 2 wherein the therapeutic agent is an antibiotic.

5) Claim 5 reads (the disputed claim language is indicated): The implant of claim 4 wherein the therapeutic agent is an antibiotic.

6) Claim 10 reads (the disputed claim language is indicated): The implant of claim 1 wherein the implant includes a laser cut surface.

7) Claim 14 reads (the disputed claim language is indicated): The implant of claim 1 wherein the heat bondable material is a composite material.

II. THE ASSERTED CLAIM TERMS OF THE '753 PATENT

8) MarcTec has asserted claims 1, 3 and 4 of the '753 patent. Claims 3 and 4 depend from claim 1 and thus incorporate all of its limitations.

9) Claim 1 reads (the disputed claim language is indicated): A surgical device for implantation in a body comprising: an implant, at least a portion of which is expandable; and a polymeric material bonded to the implant, wherein the polymeric material is a thermoplastic, includes a therapeutic agent, is non-flowable and non-adherent at room temperature, and becomes flowable, tacky, and adherent upon the application of heat.

10) Claim 3 reads (the disputed claim language is indicated): The surgical device of claim 1 wherein the therapeutic agent is an antibiotic.

III. THE SPECIFICATION

11) The '753 and '290 patents share the same specification.

A. Surgical Devices

12) The '753 patent is entitled "Surgical Devices Having a Polymeric Material With a Therapeutic Agent and Methods for Making Same," and the '290 patent is entitled "Surgical Devices Containing a Heat Bondable Material with a Therapeutic Agent." The titles of the patents-in-suit indicate that they relate to surgical devices.

13) The specification describes surgical devices having particular features. See, e.g., D.I. 70, Ex. A ('753 patent) at 1:38-39 ("The present invention relates to surgical devices such as implants or suture fastenings."), Abstract ("Surgical devices such as implants or suture fastenings," where components of those devices are "bonded to each other by . . . applying heat to the heat bondable material."), 1:63-64 ("The present invention includes an assembly for use in surgical applications in humans."), see also 2:19-21.

14) There is no description in the specification of any non-surgical devices, such as stents.

15) The specification discloses two embodiments -- both are directed to surgery and surgical devices where the surgeon has direct access to the site of the operation to custom size or seal a surgical implant. The first embodiment concerns orthopedic implants (e.g. bone plates (Figs. 1-2), hip prostheses (Fig. 3), knee prostheses (Fig. 4A-B) and other "surgical" devices (Figs. 5-6)). The second embodiment concerns suture fasteners (Figs. 7-11) that provide "surgical connections for holding adjoining tissues together . . . by melting a fastener or anchor on the end of a suture, rather than by tying or by clipping the anchor on the end of the suture." D.I. 70, Ex. A ('753 patent) at 7:20-23.

B. Heat Bonding

16) The surgical devices that are described in the specification all have components that are bonded by the application of heat at the site of surgery.

17) There is no disclosure in the specification of any bonding other than through the direct application of heat.

18) The Abstract of the patents-in-suit describes heat bonding: Surgical devices such as implants or suture fastenings are assembled from a plurality of discrete components, one of which components includes a heat bondable plastic material for bonding the components together. At least two components are bonded to each other by applying heat to the heat bondable plastic material of one component. D.I. 70, Ex. A ('753 patent) (emphasis added).

19) All seven paragraphs of the "Summary of the Invention" section concern heat bonding, with the first paragraph of the section defining "the present invention" in terms of bonding by the application of heat:

The present invention includes an assembly for use in surgical applications in humans. The assembly may include two components, at least one of which comprises a heat bondable material. The first and second components are bond to each other by the application of heat to the heat bondable material, to make the heat bondable material soften, become tacky, and bond to the other component. D.I. 70, Ex. A ('753 patent) at 1:63-2:2.

20) The specification defines the terms "bondable" or "bondable material" to refer to heat bonding: "any material, suitable for use in surgical applications, which can be softened and made flowable by the application of heat, and which when softened, will become tacky and bond to other materials and flow to fill available space." D.I. 70, Ex. A ('753 patent) at 3:52-57 (emphasis added); see id. at 3:59-65.

21) The specification goes on to describe how the benefits of the invention derive from the application of heat to heat bondable material:

[T]he present invention gives the surgeon the ability to immediately modify the shape and size of almost any existing surgical part including a prosthesis, in order to better fit the particular application for use in the body. This is accomplished by heat bonding a piece of bondable material onto the prosthesis, to make an assembly designed for the particular application. The piece can be custom shaped in the operating room . . . by heating and bonding of a polymer or composite.

D.I. 70, Ex. A ('753 patent) at 5:61-6:3. In Figures 9-11, the sutures are put in place by "melting a fastener or anchor on the end of a suture," id. at 7:19-23, such that "[e]ither the anchor alone or the anchor and the suture are melted together to lock them into position," id. at 7:27-28. The specification teaches that "a melted anchor provides a stronger bond than the mechanical interlock of a suture knot." Id. at 7:34-35; see id. at 7:61-65, 8:7-11.

22) In numerous places, the invention is described as requiring the addition of heat directly to the heat bondable material to make it flow, become tacky and adhere. See D.I. 70, Ex. A ('753 patent) at 2:4-6 ("the application of heat to the heat bondable material . . . causes the heat bondable material to soften and bond"); 2:7-11; 2:15-19; 3:54-57 ("can be softened and made flowable by the application of heat, and which, when softened, will become tacky and bond"); 4:46-48 ("the bondable material of the nut 16 is heated and softened to flow about the joint between the nut 16 and the bone plate 10, to bond the nut 16 to the bone plate 10"); 5:38-42 ("The connection 38 between the wedge 32 and the prosthesis 30 is secured by heating and softening the wedge 32 so that the material of the wedge 32 adheres or bonds to the prosthesis 30."); 5:50-53; 6:44-49; 6:53-58; 7:1-4.

23) The specification distinguishes and disfavors methods of bonding that do not involve heat. See D.I. 70, Ex. A ('753 patent) at 7:14-28 ("mechanical tying or crimping of sutures or K-wires, especially of polymers or biodegradables which are generally smooth, does not produce connections which are as strong as desirable, and suture connections sometimes may come untied as a result"); 7:34-37 ("[A] melted anchor provides a stronger bond than the mechanical interlock of a suture knot, because it will not unravel or come apart as a surgical knot may.").

24) The specification gives examples of heat sources to be used in practicing the invention: "any suitable heat generating apparatus can be used to heat and soften or spot weld the material, such as a hot air gun, a small welding or soldering gun, or a Bovie tip"; lasers may be used. D.I. 70, Ex. A ('753 patent) at 4:18-30; see id. at 6:36-38. Lasers are only mentioned in the specification in connection with heating and shaping the polymeric material used to cover the implant. Id. at Abstract; 4:18- 26; 5:50-53; 6:21-23; 6:36-38; 6:45-52; and 6:53-64. There is no disclosure of lasers being used for any other purpose or on any other portions of the implant.

25) The specification does not discuss or disclose solution casting -- the method by which the polymers on the Cypher stent are applied. The only bonding the specification teaches is heat bonding.

26) The specification provides a definition of composite materials: "Composite materials can include reinforced plastics, or polymers which are laminated or layered or reinforced with one or more other materials such as nylon, graphite fibers, Kevlar fibers, stainless steel fibers, etc." D.I. 70, Ex. A ('753 patent) at 3:65-4:2.

C. Therapeutic Agent

27) The term "therapeutic agent" does not appear in the specification.

28) The specification includes only one sentence relating to tissue ingrowth promoters, antibiotics and "other additives." That sentence states: "Items such as rods, bars, plates, or any type of construct useable in medical/surgical applications . . . can also include tissue ingrowth promoters, ...


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