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Erbe Electromedizin Gmbh, Erbe USA Inc. v. Canady Technology

March 5, 2007

ERBE ELECTROMEDIZIN GMBH, ERBE USA INC., AND CONMED CORPORATION, PLAINTIFF,
v.
CANADY TECHNOLOGY, LLC AND DR. JEROME CANADY, DEFENDANTS.



The opinion of the court was delivered by: Ambrose, Chief District Judge.

CLAIMS CONSTRUCTION OPINION and ORDER

I. BACKGROUND

Plaintiff Erbe Elektromedizin GmbH ("Erbe") manufactures and sells flexible endoscopic probes for argon plasma*fn1 coagulation ("APC"). Erbe is the owner, by assignment, of Patent No. 5,720,745 ("Patent '745) issued on February 24, 1998, titled "Electrosurgical Unit and Method for Achieving Coagulation of Biological Tissue." It was filed as a continuation-in-part of Erbe's prior Application Serial No. 981,009 ("the '009 application'),*fn2 and had a six year prosecution history. Plaintiff Erbe USA, Inc. is a subsidiary of Erbe. Plaintiff ConMed Corporation ("Conmed") is in the business of manufacturing and selling electrosurgical generators and related devices, including argon gas-enhanced electrocoagulation equipment. ConMed is the owner, by assignment, of Patent No. 4,781,175 ("'175 patent"), which was issued on November 1, 1988, titled "Electrosurgical Conductive Gas Stream Technique of Achieving Improved Eschar for Coagulation." The '175 patent was filed on April 8, 1986, by Francis T. McGreevy, Carol Bertrand, and Karl W. Hahn, and expired on April 8, 2006.

On January 21, 2000, Erbe entered into an agreement with ConMed to license several ConMed patents, including the '175 patent. Under the Agreement, Erbe was licensed to manufacture and sell various argon gas-enhanced electrocoagulation equipment, including electrosurgical generators and flexible probes related to argon gas-enhanced electrocoagulation.

Defendant Canady Technology markets and sells single use disposable flexible APC probes that may be connected to an adapter that in turn is connected to an Erbe APC electrosurgical unit. Defendant Dr. Jerome Canady is the CEO and partial owner of Canady Technology. (The Canady Defendants are hereinafter referred to as "Canady.") Erbe has sued Canady, inter alia, for infringement of the '745 patent. (Docket No. 18, Count I). ConMed has sued Canady, inter alia, for infringement of the '175 patent. (Docket No. 18, Count II) "Determination of patent infringement is a two-step process." Leoutsakos v. Coll's Hospital Pharmacy, Inc., Civ. No. 3-1533, 2004 WL 1010162 at * 2 (Fed. Cir. May 4, 2002). "First, the court determines the scope and meaning of the patent claims asserted...." Leoutsakos, 2004 WL 1010162 at * 2, quoting, Cybor Corp. V. FAS Techs, Inc., 138 F.3d 1448, 1454 (Fed Cir. 1998). Second, the court compares the properly construed claims with the allegedly infringing device. Id.

We are at the first step of the process. The parties participated in a Markman hearing. The task now before me is to properly construe the claims in both the '745 and '175 patents.

II. GENERAL PRINCIPLES OF CLAIM CONSTRUCTION

Construction of a patent begins with the words of the claim. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir. 1996). "[T]he words of a claim are 'generally given their ordinary and customary meaning.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir. 2005), quoting Vitronics, 90 F.3d at 1582. "[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1313, citing Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 111, 1116 (Fed.Cir. 2004). In cases where the terms are not readily apparent, a court will consider the intrinsic evidence and extrinsic evidence. Id. at 1314.

The intrinsic evidence consists of the claims set forth in the patent itself, together with the specifications, the embodiments and the prosecution history. Id. at 1314. "[T]he context in which a term is used in the asserted claim can be highly instructive." Id. The specification "'is the single best guide to the meaning of a disputed term'" and is usually dispositive. Id. at 1315, quoting Vitronics, 90 F.3d at 1582. Where the specification reveals a "special definition given to a claim terms by the patentee that differs from the meaning it would otherwise possess," the inventor's lexicography governs. Id. at 1316, citing, CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir. 2002). A court should also consider the prosecution history if it is in evidence. Id. at 1317, citing Markman, 52 F.3d at 980. The prosecution history, "consists of the complete record of the proceedings before the PTO and includes the prior art cited during the examination of the patent." Id. at 1317. "[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id., citing, Vitronics, 90 F.3d at 1582-83.

"In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term." Vitronics, 90 F.3d at 1583. Where the ambiguities cannot be resolved by a consideration of the intrinsic evidence alone, however, the court may consider extrinsic evidence. Id. Expert testimony, dictionaries, and learned treatises are helpful sources of extrinsic evidence. Phillips, 415 F.3d at 1317. Extrinsic evidence is less significant than intrinsic evidence. Id. Thus, an expert's testimony that is at odds with the written record of the patent should be discounted. Id. at 1318, quoting, Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 716 (Fed. Cir. 1998). "When construing patent claims, there is a heavy presumption that the language in the claim carries its ordinary and customary meaning amongst artisans of ordinary skill in the relevant art at the time of the invention." Housey Pharmaceuticals, Inc. v. Astrazeneca UK Ltd., Civ. No. 3-1193 and Civ. No. 3-1210, 2004 WL 1005573 at * 5 (Fed. Cir. May 7, 2004). A court may also consider dictionaries and learned treatises in order to gain insight into the customary meaning accorded a term. Id., citing, Tex. Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202-03 (Fed. Cir. 2002).

Pursuant to the doctrine of "claim differentiation," limitations contained in dependant claims are not to be read into the independent claims from which they depend. Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971-72 (Fed.Cir. 1999). In other words, dependent claims may aid in interpreting the scope of the claims from which they depend, Laitram Crop. v. NEC Corp., 62 F.3d 1388, 1392 (Fed.Cir. 1995), because the court should "not interpret an independent claim in a way that is inconsistent with a claim which depends from it." Wright Med. Tech., Inc. v. Ostronics Corp., 122 F.3d 1440, 1445 (Fed.Cir. 1997). Claim language drafted in a "means-plus-function" format is limited by statute.

35 U.S.C. §112, ¶6. A claim element is presumed to be a means-plus-function limitation if the word "means" appears in the claim element. Personalized Media Communications, LLC v. Int'l Trade Comm'n, 161 F.3d 696, 703 (Fed.Cir. 1998). A claim element subject to §112, ¶6 must be construed as covering the structure disclosed in the specification that performs the claimed function and all equivalents of that structure. 35 U.S.C. §112, ¶6; Sofamor Danek Group, Inc. v. Depuy-Motech, Inc., 74 F.3d 1216, 1220 (Fed.Cir. 1996). "Therefore, §112, ¶6 requires both identification of the claimed function and identification of the structure in the written description necessary to perform that function. The statute does not permit limitation of a means-plus-function claim by adopting a function different from that explicitly recited in the claim. Nor does the statute permit incorporation of structure from the written description beyond that necessary to perform the claimed function." Micro Chemical, Inc. v. Great Plains Chem. Co., Inc., 194 F.3d 1258, 1258 (Fed.Cir. 1999), citing, Rodime PLC v. Seagate Tech., Inc., 174 F.3d 1294, 1302 (Fed Cir. 1999). On the other hand, if the word "means" does not appear in the claim element, there is a rebuttable presumption that §112, ¶6 does not apply. CCS Fitness, 228 F.3d at 1369. The presumption can be rebutted "by showing that the claim element recite[s] a function without reciting sufficient structure for performing that function." Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1023 (Fed.Cir. 2006), citing, Watts v. XL Sys. Inc., 232 F.3d 887, 880 (Fed.Cir. 2000). The presumption flowing from the absence of the term 'means', however, is "one that is not readily overcome." Id., citing, Lighting World, Inc. v. Birchwood Lighting, Inc., 382 F.3d 1354, 1358 (Fed.Cir.2004).

There are two patents before me awaiting construction. I begin with the '745 patent.

III. THE '745 PATENT

According to the Amended Complaint, the '745 patent claims are directed to electrosurgical units and methods for achieving argon gas-enhanced electrocoagulation and, in particular, to the use of flexible endoscopic probes for gastrointestinal and tracheobronchial argon plasma coagulation. The '745 patent includes forty-eight claims. Ten of the forty-eight claims (Claims 1, 3, 4, 11, 13, 35, 37, 38, 39, and 41) are being asserted against Canady. Two claims are independent and eight are dependent. Claim 1 is independent and Claims 3, 4, 11, and 13 are dependent on Claim 1. Claim 35 is independent and Claims 37, 38, 39, and 41 are dependent on Claim 35. The parties disagree as to the interpretation of 15 claim terms contained therein.

A. '745 Patent Claims

Claim 1 provides as follows:

1. An electrosurgical unit for achieving coagulation of tissue, comprising: an endoscope having: a proximal end and an opposing distal end, and a plurality of working channels extending between the two ends, each channel having a predetermined diameter and having an opening at each end; a flexible, hollow tube having a longitudinal axis disposed in one of the working channels of the endoscope, the tube having a diameter which is less than the diameter of the channel through which it is inserted, the tube, including: a distal end and an opposing proximal end, each end of the tube having an opening, the tube having an inside and an outside, the tube positioned within the endoscope such that a portion of the tube including the opening at the distal end of the tube protrudes beyond the opening at the distal end of the endoscope and such that a gas stream exits from the opening at the distal end of the tube in order to establish an inert gas atmosphere between the distal end of the tube and the region of the tissue to be coagulated, and an electrode for ionizing the inert gas positioned inside the tube and offset from the opening at the distal end of the t ub e a pr edet er mined minimum safety distance, such that the electrode can not come in contact with the tissue; a source of pressurized ionizable, inert gas connected to the opening at the proximal end of the tube and pressurized such that a stream of gas flows from the source, through the tube and exits through the opening at the distal end of the tube at a low flow rate of less than about 1 liter/minute; optical means positioned within a second working channel of the endoscope and protruding sufficiently from the opening at the distal end of the second channel of the endoscope to view the distal end of the tube and the tissue to be coagulated; and the portion of the tube protruding from the distal end of the endoscope positioned such that the longitudinal axis of the tube is arranged sidewardly of the area of tissue to be coagulated.

See, '745 patent (Docket No. 42, Ex. 1)(emphasis added to disputed claim terms). Claim 3 provides as follows:

3. The electrosurgical unit for achieving coagulation of tissue of claim 1, wherein the opening at the distal end of the tube positioned longitudinally from the tube.

See, '745 patent (Docket No. 42, Ex. 1)(emphasis added to disputed terms).

Claim 35 provides as follows:

35. A method for coagulating tissue during endoscopic surgery comprising the following steps: providing a surgical endoscope, the endoscope having a proximal end, and opposing distal end, an opening at each end, and a plurality of working channels, extending between the openings at each end, each channel having a predetermined diameter, the endoscope having a flexible, hollow tube having a longitudinal axis inserted through one of the working channels of the endoscope, the tube having a diameter which is less than the diameter of the channel through which it is inserted, the tube having a distal end, an opposing proximal end connected to a source of ionizable, inert gas, an opening at each end, a channel extending between the two ends, an inside, an outside; and an electrode, arranged stationarily inside the tube and being offset from the opening at the distal end of the tube a predetermined minimum safety distance in such a manner that the electrode can not come into contact with the tissue; the tube positioned within the working channel of the endoscope such that the opening at the distal end Of the tube protrudes beyond the opening at the distal end of the endoscope, and can be observed through optical means provided at or near the distal end of said endoscope; supplying the inert gas from the source of said gas through the tube to the distal end opening of said tube with such a low flow rate, that gas exiting through said distal end opening is a not directed, non laminar stream but forms an inert gas atmosphere between the distal end of the tube and the region of the tissue to be coagulated, which the distal end opening is maintained at a distance from the tissue to be coagulated in which situation the area of tissue to be coagulated is positioned sidewardly of the extended longitudinal axis of the said protruding end portion of said tube; ionizing said inert gas atmosphere by activating a high frequency voltage source connected to the electrode by establishing an electric field in the inert gas atmosphere between the electrode and the sidewardly arranged area of tissue to be coagulated; and supplying an electric current by means of a plasma jet as a function of the direction of said electric field and the electric conductivity of the tissue surface to be coagulated, and coagulating an area of the tissue sidewardly of the extended longitudinal axis of the protruding end of the tube while the distal end opening of the tube is maintained in a substantially stationary position at a predetermined distance from the tissue to be coagulated, and while the ionized gas is being supplied through the distal end opening of the tube as a not directed, non laminar stream with a low flow rate.

See, '745 patent (Docket No. 42, Ex. 1)(emphasis added to disputed terms).

Claim 38 provides as follows:

38. The method as claimed in claim 35, whereby the stream of gas exits through said distal end opening with a flow rate of less than about one liter per minute.

See, '745 patent (Docket No. 42, Ex. 1)(emphasis added to disputed term).*fn3

Each of the disputed claim terms is analyzed below.

1. Endoscope

The first disputed claim term "endoscope" is found in Claims 1 and 35 as set forth above.

Erbe's Proposed Definition: A flexible medical instrument having a plurality of working channels.

Canady's Proposed Definition: A rigid or flexible device having at least one working channel for use in performing surgery and having reliable insulation both externally and in the instrument channel. (Docket No. 42, pp. 2-3).

a. Flexible v. Rigid or Flexible

To begin with, I agree with Defendants that the term "endoscope" is not limited in the claim to a flexible or rigid device. (Docket No. 42, Ex. 1, Claim 1). Furthermore, the specification notes that "[i]n accordance with the invention, an electrosurgical device for achieving coagulation of biological tissue preferably comprises an attachment....The attachment can be provided on a rigid or flexible endoscope...." " Docket No. 42, Ex. 1, col.2, ll. 17-19, ll. 46-47. The specification further notes that "[i]n accordance with another embodiment of the invention a tube out of electrically not conducting material is arranged in a movable manner in the working channel, which tube is preferably a flexible hose, so that in the case of a rigid and also in the case of a flexible endoscope a desired alignment of the distal end of the hose or a tilting of the end of the hose can be performed,...." Id. at col. 3, ll. 1-7.

Erbe suggests that the invention is specifically directed to endoscopic uses in the gastrointestinal tract. (Docket No. 54, pp. 16-17 and Docket No. 68, pp. 6-8). While it is true that the specification describes specific embodiments of the invention as concerning the gastrointestinal tract, such example is non limiting. See, Phillips, 415 F.3d at 1323 (warning against confining the claims to those listed in the embodiments).For example, Erbe directs the Court's attention to the following sentence in the specifications: "In the case of the invention which allows endoscopic use in the gastrointestinal tract...." Docket No. 68, p. 7, quoting, Docket No. 42, Ex. 1, col.6, ll. 58-61. The plain and unambiguous reading of this sentence leads to the conclusion it may be used in the gastrointestinal tract, as well as other endoscopic surgeries. In fact, the specifications disavow limiting the term endoscope to a flexible endoscope: "Although the invention has been described with reference to a particular arrangement of parts, features and the like, these are not intended to exhaust all possible arrangements or features, and indeed many other modifications and variations will be ascertainable to those of skill in the art." Docket No. 42, Ex. 1, col. 11, ll. 4-8. Consequently, I will not read such a limitation into the term endoscope. As such, I construe the term endoscope, in part, to mean a rigid or flexible medical instrument.

b. Plurality of Working Channels v. having at Least one Working Channel

The parties further dispute whether an endoscope comprises a plurality of working channels or has at least one working channel. Docket No. 66, p. 28; Docket No. 68, p 12. The claim language itself is unambiguous in defining an endoscope as having "a plurality of working channels...." Docket No. 42, Ex. 1, col. 11, l. 14 and col.

15. Because I find this language unambiguous, I need not look to any further intrinsic evidence to define the term. A plain, ordinary and customary reading of this language means that there is more than one working channel.

c. Reliable Insulation Both Externally and in the Instrument Channel

Canady argues that the term endoscope should include reliable insulation both externally and in the instrument channel. Docket No. 66, p. 29. The claim language itself does not reference insulation. Both parties agree, however, that the specification states: "For argon plasma coagulation only endoscopes should be used whose electric insulation is absolutely reliable both exteriorly and in the instrument channel." Docket No. 42, Ex. 1, col. 10, ll. 21-23. I recognize that there is a fine line between "using the specification to interpret the meaning of a claim and importing limitations from the specification into the claim..." Phillips, 415 F.3d at 1323, citing Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186-87 (Fed.Cir.1998). I agree with Erbe that reading such a limitation into the claim term endoscope would be importing a limitation from the specification. Consequently, I will not read such a limitation into the term.

According, the claim term endoscope is construed to be a rigid or flexible medical instrument with more than one working channel.

2. Working Channels

The second disputed claim term "working channels" is found in Claims 1 and ...


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