DePuy Mitek, Inc. v. Arthrex, Inc.

MEMORANDUM in Support re MOTION for Summary Judgment of Infringement and No Inequitable Conduct

D. Mass.August 11, 2006

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS DePuy Mitek, Inc. a Massachusetts Corporation Plaintiff, v. Arthrex, Inc. a Delaware Corporation and Pearsalls Ltd. a Private Limited Company of the United Kingdom Defendants. ) ) ) ) ) ) ) ) ) ) ) Civil No. 04-12457 PBS DePuy Mitek’s Memorandum in Support of Its Motion for Summary Judgment of Infringement and No Inequitable Conduct Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 1 of 36 i Table of Contents Table of Authorities ....................................................................................................................... iv DEPUY MITEK’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF INFRINGEMENT ............................................................ 1 I. INTRODUCTION .............................................................................................................. 1 II. THE PARTIES AND THE SUTURE MARKETPLACE.................................................. 1 III. THE INVENTION IN MITEK’S 446 PATENT................................................................ 2 IV. ARTHREX’S INFRINGING FIBERWIRE SUTURE AND ITS DEVELOPMENT............................................................................................................... 2 A. FiberWire’s Construction........................................................................................ 2 B. FiberWire’s Development Mirrors the Teachings of Mitek’s 446 Patent .............. 4 V. SUMMARY JUDGMENT AND LITERAL INFRINGEMENT LAW............................. 5 A. Law Of Summary Judgment ................................................................................... 5 B. Law of Literal Patent Infringement......................................................................... 5 VI. ARTHREX’S FIBERWIRE SUTURES LITERALLY INFRINGE CLAIMS 1, 2, 8, 9, and 12 OF MITEK’S 446 PATENT ........................................................................... 6 A. FiberWire Literally Infringes Claim 1 of Mitek’s 446 Patent ................................ 6 1. If the Court Adopts Mitek’s Definition of PE Then FiberWire Literally Contains the “PE” Claim Element ............................................... 6 2. If the Court Adopts Mitek’s Definition of “Consisting Essentially Of” Then FiberWire Literally Contains the “Consisting Essentially Of” Claim Element ..................................................................................... 7 3. FiberWire Has The Remaining Claim Elements And Therefore Literally Infringes Claim 1 of Mitek’s 446 Patent...................................... 9 B. FiberWire Needle Products Literally Infringe Claim 2 of Mitek’s 446 Patent..................................................................................................................... 11 C. FiberWire Literally Infringes Claim 8 of Mitek’s 446 Patent .............................. 12 D. FiberWire Literally Infringes Claim 9 of Mitek’s 446 Patent .............................. 13 E. FiberWire Literally Infringes Claim 12 of Mitek’s 446 Patent ............................ 13 Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 2 of 36 ii VII. CONCLUSION................................................................................................................. 13 DEPUY MITEK’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF NO INEQUITABLE CONDUCT .................................. 14 VIII. THE PROSECUTION HISTORY OF MITEK’S 446 PATENT ..................................... 14 A. The Filing Of the 511 Application........................................................................ 14 B. The First Office Action: The Patent Examiner Rejects the Suture Claims Over Burgess......................................................................................................... 15 C. First Office Action Response: Applicants Argue Burgess Is Nonanalagous Art ......................................................................................................................... 16 D. Second Office Action And Response: Burgess Rejection Is Dropped & Claims Are Rejected Over Kaplan........................................................................ 17 E. Third Office Action And Response: Claims Are Amended And Allowed Over Kaplan .......................................................................................................... 17 F. Arthrex’s Inequitable Conduct Allegations .......................................................... 18 IX. LAW OF INEQUITABLE CONDUCT & SUMMARY JUDGMENT........................... 18 A. Arthrex Carries A Heavy Burden of Proving Inequitable Conduct...................... 18 B. Summary Judgment Standards.............................................................................. 20 X. SUMMARY JUDGMENT OF ARTHREX’S INEQUITABLE CONDUCT DEFENSES & COUNTERCLAIMS IS WARRANTED................................................. 20 A. Arthrex’s Allegations Should Be Rejected Because Merely Arguing With the Patent Office About The Teachings of a Disclosed Reference Is Not Inequitable Conduct .............................................................................................. 21 B. Arthrex Lacks Any Credible Evidence of Inequitable Conduct From Which A Reasonable Trier of Fact Could Find Inequitable Conduct Based on Kaplan .............................................................................................................. 22 1. Arthrex Has No Evidence Of A Material Misrepresentation Regarding Kaplan ..................................................................................... 22 2. Arthrex Has No Evidence of Intent to Deceive With Respect to Kaplan ....................................................................................................... 23 C. Arthrex Lacks Any Credible Evidence of Inequitable Conduct From Which A Reasonable Trier of Fact Could Find Inequitable Conduct Based on Burgess............................................................................................................. 24 Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 3 of 36 iii 1. Arthrex Has No Evidence Of A Material Misrepresentation Regarding Burgess .................................................................................... 24 a) Mr. Goodwin Did Not Make A Material Misrepresentation Regarding Burgess .........................................................................24 2. Arthrex’s Allegations Regarding Burgess Should be Dismissed Because Arthrex Has No Evidence of Intent To Deceive......................... 27 XI. CONCLUSION................................................................................................................. 28 Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 4 of 36 iv Table of Authorities Federal Cases AK Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003)......................................................................................7 Akzo N.V. v. U.S. Int’l Trade Commission, 808 F.2d 1471 (Fed. Cir. 1986)..............................................................................21, 26 Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003)....................................................................................24 Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986).................................................................................................5, 20 Avia Group Int’l, Inc. v. L.A. Gear California, Inc., 853 F.2d 1557 (Fed. Cir. 1988)................................................................................5, 20 Baxter Int’l Inc. v. McGraw, Inc., 149 F.3d 1321 (Fed. Cir. 1998)....................................................................................20 Beckton Dickinson & Co. v. Syntron Bioresearch Inc., 51 U.S.P.Q. 2d 1722 (S.D. Cal. 1998) .........................................................................21 Black & Decker Inc. v. Hoover Service Ctr., 765 F. Supp. 1129 (D. Conn. 1991).............................................................................21 Buildex Inc. v. Kason Industrial, Inc., 849 F.2d 1461 (Fed. Cir. 1998)....................................................................................18 Burlington Industrial Inc. v. Dayco Corp., 849 F.2d 1418 (Fed. Cir. 1988)....................................................................................14 CFMT, Inc. v. YieldUp Int’l Corp., 349 F.3d 1333 (Fed. Cir. 2003)..............................................................................21, 26 Celotex Corp. v. Catrett, 477 U.S. 317 (1986).................................................................................................5, 20 Dawn Equip. Co. v. Kentucky Farms Inc., 140 F.3d 1009 (Fed. Cir. 1998)......................................................................................6 Digital Control Inc. v. Charles Machine Works, 437 F.3d 1309 (Fed. Cir. 2006)....................................................................................19 Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 5 of 36 v Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332 (Fed. Cir. 2003)....................................................................................19 FMC Corp. v. Manitowoc Co., Inc., 835 F.2d 1411 (Fed. Cir. 1987)....................................................................................14 Gardco Mfg., Inc. v. Herst Lighting Co., 820 F.2d 1209 (Fed. Cir. 1987)....................................................................................18 Gargoyles Inc. v. United States, 33 U.S.P.Q. 2d 1595 ....................................................................................................21 Hebert v. Lisle Corp., 99 F.3d 1109 (Fed. Cir. 1996)......................................................................................19 Hoffman-La Roche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003)....................................................................................18 Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005)....................................................................................23 Jumpsport, Inc. v. Jumpking, Inc., Nos., 05-1182, 05-1196, 05-1197, 2006 U.S. App. LEXIS 18448 (Fed. Cir. July 21, 2006).........................................................................................................19, 27 Life Techs., Inc. v. Clontech Labs., Inc., 224 F.3d 1320 (Fed. Cir. 2000)..............................................................................21, 26 M. Eagles Tool Warehouse, Inc. v. Fisher Tooling Co., Inc., 439 F.3d 1335 (Fed. Cir. 2006)..............................................................................19, 27 Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544 (Fed. Cir. 1990)......................................................................................19 Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995)..........................................................................................5 Mentor H/S, Inc. v. Medical Device Alliance, Inc., 244 F.3d 1365 (Fed. Cir. 2001)....................................................................................19 Miller Pipeline Corp. v. British Gas PLC, 69 F. Supp. 2d 1129 (S.D. Ind. 1999) ..........................................................................21 Old Town Canoe Co. v. Confluence Holdings Corp., 448 F.3d 1309 (Fed. Cir. 2006)..............................................................................19, 24 Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 6 of 36 vi W.E. Hall Co., Inc. v. Atlanta Corrugating, LLC, 370 F.3d 1343 (Fed. Cir. 2004)......................................................................................7 Federal Statutes 35 U.S.C. §121 ..................................................................................................................15 35 U.S.C. § 271(a) ...............................................................................................................5 Federal Regulations 37 C.F.R. §1.142 ................................................................................................................15 37 C.F.R. §1.56 ..................................................................................................................19 Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 7 of 36 1 DEPUY MITEK’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF INFRINGEMENT I. INTRODUCTION Plaintiff, DePuy Mitek, Inc. (“Mitek”) moves for summary judgment that Arthrex, Inc. literally infringes claims 1, 2, 8, 9, and 12 of Mitek’s U.S. Patent No. 5,314,446 (“446 Patent”) by selling its FiberWire surgical suture.1 Mitek’s motion is predicated on the Court adopting Mitek’s proposed constructions of the claim terms “PE” and “consistently essentially of.”2 If the Court adopts Mitek’s construction for those two terms, then summary judgment of infringement should be granted because there are no genuine issues of material fact with respect to the structure of Arthrex’s accused FiberWire products. II. THE PARTIES AND THE SUTURE MARKETPLACE Mitek is a company in Raynham, Massachusetts, and Defendants are Arthrex, a company in Naples, Florida and Pearsalls, Ltd., a UK company that manufactures the FiberWire suture for Arthrex. Mitek and Arthrex sell products, including sutures, used in orthopedic surgery. Sutures are a thread-like material that doctors and surgeons use for wound, tissue, tendon, or muscle repair. Sutures can be sold as “free strands” (i.e., suture alone) or attached to a needle or anchor.3 Pearsalls exclusively manufactures and imports FiberWire bulk suture into the United States for Arthrex. Pearsalls and Arthrex have worked together extensively as partners to design, develop, manufacture, and sell the accused FiberWire products. 1 This memorandum is supported by “DePuy Mitek’s Statement of Facts in Support of its Motion for Summary Judgment of Infringement and No Inequitable Conduct,” and Exhibits attached thereto. Mitek’s Statement of Material Facts is cited as “Mitek Fact #.” 2 Mitek, of course, does not concede non-infringement if the Court does not adopt its construction of the terms “PE” and “consisting essentially of.” There will just likely be issues of fact that could preclude dispositive adjudication. 3 Suture anchors are devices that implant into bone and are used in conjunction with a suture to reattach tendons, muscles, or ligaments to bone. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 8 of 36 2 III. THE INVENTION IN MITEK’S 446 PATENT Mitek’s 446 Patent claims a braided suture (Mitek Fact #1). The braided suture is formed from at least two sets of yarns, with each yarn formed of multiple filaments of a fiber-forming material (id.). The first set of yarns is selected from the materials “PTFE, FEP, PFA, PVDF, PETFE, PP, and PE,” and the second set of yarns is selected from the materials “PET, nylon, and aramid” (id.). The first and second sets of yarns are braided so that at least one yarn from the first set of yarns is in direct intertwining contact with at least one yarn from the second set of yarns (id.). In making the braids disclosed and claimed in Mitek’s 446 Patent, the inventors departed from tradition and discovered that by braiding two yarns of the different materials listed above, in a certain configuration where at least one yarn from the first set is in direct intertwining contact with a yarn from the second set, a braid could be made with improved properties relative to a braid of just one of the materials (Mitek Fact #7). In fact, Mitek’s 446 Patent states that “it is possible to tailor the physical and biological properties of the braid by varying the type and proportion of each of the dissimilar fiber forming materials used, as well as adjusting the specific configuration of the braid” (Mitek Fact #6). IV. ARTHREX’S INFRINGING FIBERWIRE SUTURE AND ITS DEVELOPMENT A. FiberWire’s Construction There is no dispute about the structure of Arthrex’s FiberWire sutures.4 FiberWire 4 TigerWire is also a suture made by Pearsalls and sold by Arthrex (Mitek Fact #8). TigerWire is basically identical to FiberWire with the exception that one PET yarn is replaced by one nylon yarn (Mitek Fact #9). TigerWire is braided in the same way as FiberWire (Mitek Fact #10). TigerWire infringes Mitek’s 446 Patent for the same reasons that FiberWire infringes. Except as noted otherwise, Mitek refers to both FiberWire and TigerWire as “FiberWire.” Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 9 of 36 3 sutures contain a sheath or cover formed by braiding yarns of polyethylene (“PE”)5 and yarns of polyethylene terephthalate (“PET”) (Mitek Fact #12). The PE and PET yarns are braided in direct intertwining contact (Mitek Fact #18). The FiberWire suture is available in many different sizes; however, Arthrex has admitted that different FiberWire sizes are braided in the same manner (Mitek Fact #23).6 The following drawings7 illustrate the sheath/core arrangement and PE/PET braid construction of the FiberWire suture. Sheath FiberWire is sold by Arthrex in the United States as a free strand (not attached to anything), attached to needles, and attached to suture anchors (Mitek Fact #48 and #51). Whether FiberWire is attached to a needle or anchor is irrelevant to the question of infringement because the structure of the FiberWire suture is the same whether it is attached to needle, anchor, or sold as a free strand. Arthrex sells FiberWire under numerous product codes.8 Mitek moves 5 FiberWire is made from ultra high molecular weight PE (“UHMW PE”), which is a type of PE (Mitek Fact #21). Arthrex documents refer to UHMW PE as simply PE (Mitek Fact #22). 6 The FiberWire size 4-0 suture has the same sheath configuration as the other size FiberWire sutures (Mitek Fact #24). However, the 4-0 FiberWire does not have a core, but that does not impact the infringement issues because the claims do not require a core (Mitek Fact #25). 7 These drawings are taken from U.S. Patent 6,716,234 assigned to Arthrex. 8 Arthrex’s FiberWire and TigerWire suture products include at least the products having the following Arthrex catalog product codes: AR-7200, AR-7201, AR-7202, AR-7203, AR- Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 10 of 36 4 for summary judgment that all Arthrex FiberWire products literally infringe claims 1, 2, 8, 9, and 12 including those described by the product codes set forth in footnote 8. 9 B. FiberWire’s Development Mirrors the Teachings of Mitek’s 446 Patent Don Grafton, Arthrex’s developer of FiberWire, testified that before developing FiberWire, he developed a suture having a braid of only one material, a homogeneous braid of PE (Mitek Fact #27). But he found this PE braid to be unacceptable because it had poor knot strength properties (Mitek Fact #28). As Mr. Grafton explained, the PE was so lubricous it would not hold a knot (Mitek Fact #29). To increase the knot strength, Mr. Grafton braided together two different materials, PE and PET (Mitek Fact #30). Mr. Grafton tested the PE and PET braid and found that it had improved strength properties as compared to the PE braid (i.e., the heterogeneous PE/PET braid vs. the homogeneous PE braid) (Mitek Fact #30 and #31). This braid of two different materials ultimately became FiberWire. The development of FiberWire mirrors the language of Mitek’s 446 Patent because Arthrex “tailor[ed] the physical and biological properties of the braid by varying the type and proportion of each of the dissimilar fiber forming materials used, as well as adjusting the specific configuration of the braid” (Mitek Fact #6). 7204, AR-7205, AR-7205T, AR-7207, AR-7209, AR-7209SN, AR-7209T, AR-7210, AR-7211, AR-7219, AR-7220, AR-7221, AR-7222, AR-7223, AR-7225, AR-7227-01, AR-7227-02, AR- 7228, AR-7229-12, AR-7229-20, AR-7230-01, AR-7230-02, AR-7232-01, AR-7232-02, AR- 7232-03, AR-7237, AR-7250, AR-7251, AR-1320BNF, AR-1322BNF, AR-1322-75SF, AR- 1322-752SNF, AR-1915SNF, AR-1920SNF, AR-1322SX, AR-1322SXF, AR-1324B, AR- 1324BF, AR-1324BF-2, AR-1324BNF, AR-1324HF, AR-1324SF,AR-1934BF, AR-1934BF-2, AR-1934BFT, AR-1934BFX, AR-1934BNF, AR-1934BLF, AR-1915SF, AR-1920BF, AR- 1920BF-37, AR-1920BFT, AR-1920BN, AR-1920BNF, AR-1920BNP, AR-1920BT, AR- 1920SF, AR-1920SFT, AR-1925BF, AR-1925BFSP, AR-1925BNF, AR-1925BNP, AR-1925SF, AR1927-BF, AR-1927BNF, AR-1928SF, AR-1928SF-2, AR-1928SNF, AR-1928SNF-2, AR- 2225S, and AR-2226S (Mitek Fact #26). 9 To the extent Arthrex has marketed additional product codes since it provided to Mitek the information in footnote 8, those products would also infringe for the same reasons stated herein providing the structure of FiberWire is the same as the current FiberWire products. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 11 of 36 5 V. SUMMARY JUDGMENT AND LITERAL INFRINGEMENT LAW A. Law Of Summary Judgment Under FED. R. CIV. P. 56(c), summary judgment is proper if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” FED. R. CIV. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248-50 (1986). As the moving party here, Mitek bears the initial burden of demonstrating that it is entitled to summary judgment. Celotex, 477 U.S. at 324-25. The burden then shifts to Arthrex to show that there is a genuine issue of material fact. “To create a genuine issue of fact, the nonmovant [Arthrex] must do more than present some evidence on an issue it asserts is disputed.” Avia Group Int'l, Inc. v. L.A. Gear California, Inc., 853 F.2d 1557, 1560 (Fed. Cir. 1988) (emphasis in original). Arthrex must come forward with sufficient evidence from which a reasonable trier of fact could return a verdict in its favor. Id. It is appropriate to grant summary judgment of infringement of a patent claim just as with any other kind of claims. Id. B. Law of Literal Patent Infringement Direct patent infringement is the making, using, selling, offering to sell, or importing an invention covered by the claims of a valid patent without the authority of the patentee. 35 U.S.C. § 271(a). Determining whether a patent has been literally infringed involves two steps: (1) claim construction, followed by (2) a determination whether the properly construed claim encompasses the accused structure. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995)(en banc). Claim construction is a question of law within the province of the Court. Id. at 979. The determination or application of the proper construction to FiberWire is the subject of this summary judgment motion. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 12 of 36 6 To establish infringement the plaintiff must prove that each claim element is literally present in the accused product. Dawn Equip. Co. v. Kentucky Farms Inc., 140 F.3d 1009, 1014 (Fed. Cir. 1998). VI. ARTHREX’S FIBERWIRE SUTURES LITERALLY INFRINGE CLAIMS 1, 2, 8, 9, and 12 OF MITEK’S 446 PATENT If the Court adopts Mitek’s proposed constructions of the claim terms “PE” and “consistently essentially of,” summary judgment of infringement should be granted because there are no genuine issues of material fact with respect to the structure of Arthrex’s accused FiberWire products and whether they literally have all of the elements of the asserted claims. A. FiberWire Literally Infringes Claim 1 of Mitek’s 446 Patent Arthrex’s expert and fact witnesses agree that all claim elements of the asserted claims (with the exception of “PE” and “consisting essentially of” under Arthrex’s construction) are found in FiberWire. However, if the Court adopts Mitek’s definitions of “PE” and “consisting essentially of,” then it is undisputed that FiberWire contains each and every element of the claims 1, 2, 8, 9, and 12 of Mitek’s 446 Patent. Accordingly, summary judgment of infringement is appropriate. 1. If the Court Adopts Mitek’s Definition of PE Then FiberWire Literally Contains the “PE” Claim Element Mitek proposes that the claim term “PE” means “PE includes any polymer formed from a repeating ethylene monomer (i.e. "PE” – means all types of polyethylene (“PE”) including ultra high molecular weight polyethylene).”10 It is undisputed that FiberWire has PE. Although FiberWire has one type of PE, namely UHMW PE, there can be no dispute, under Mitek’s construction, that it satisfies the “PE” limitation. 10 Mitek’s position of this issue is set forth in its Claim Construction brief being filed concurrently herewith. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 13 of 36 7 Mr. Dreyfuss, Arthrex’s lead FiberWire Engineer, testified that the FiberWire suture is made from PE yarns that are made of a plurality of filaments (Mitek Fact #16). Further, numerous Arthrex documents confirm that FiberWire is made of PE (Mitek Fact #22). Accordingly, it is undisputed that, given Mitek’s construction of PE, this claim element is literally found in Arthrex’s FiberWire. Consequently, if the Court adopts Mitek’s construction that the claim term “PE” means “all types of polyethylene (PE) including ultra high molecular weight polyethylene (“UHMW PE”) then this claim element is literally found in Arthrex’s FiberWire. 2. If the Court Adopts Mitek’s Definition of “Consisting Essentially Of” Then FiberWire Literally Contains the “Consisting Essentially Of” Claim Element Mitek proposes that the claim term “consisting essentially of” means: The “novel and basic characteristics” of the invention are a heterogeneous braid of dissimilar non-bioabsorbable yarns of the materials claimed, where at least one yarn from the first set is in direct intertwining contact with a yarn from the second set, and the dissimilar yarns have at least some different properties that contribute to the overall properties of the braid. Consisting essentially of excludes sutures that contain bioabsorbable materials as the first and second fiber-forming materials.11 The transitional phrase “consisting essentially of” has been interpreted by the Federal Circuit to denote a partially open term, which permits the inclusion of additional elements to the claim as long as those elements do not materially affect the basic and novel properties of the invention. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1239 (Fed. Cir. 2003). Thus a product can infringe a claim if it contains, in addition to the recited claim elements, immaterial elements not recited by the claim that do not affect the basic and novel properties of the invention. W.E. Hall Co., Inc. v. Atlanta Corrugating, LLC, 370 F.3d 1343, 1353 (Fed. Cir. 2004). 11 Mitek’s position of this issue is set forth in its Claim Construction brief being filed concurrently herewith. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 14 of 36 8 But if Mitek’s construction of “consisting essentially of” (i.e., the identification of the basic and novel characteristics of the invention) is adopted, there is no genuine issue of material fact because Arthrex has not disputed that any structure in FiberWire materially affects the basic and novel characteristics as defined by Mitek. FiberWire has a coating that Arthrex states acts as a lubricant (Mitek Fact #32). Dr. Brookstein, Mitek’s expert, stated that this coating does not materially affect the basic and novel characteristics of the invention as defined by Mitek (Mitek Fact #33). Regardless of the coating, FiberWire still has a heterogeneous braid of dissimilar non-bioabsorbable yarns of the type claimed, where at least one yarn from the first set is in direct intertwining contact with a yarn from the second set, and the dissimilar yarns have at least some different properties that contribute to the overall properties of the braid (Mitek Fact #34). In particular, the FiberWire coating is: (1) non-bioabsorbable; (2) does not materially affect bioabsorbability of the yarns; (3) does not materially affect at least one yarn from the first set being in direct intertwining contact with a yarn from the second set; and (4) does not materially affect each yarn from contributing to the overall properties of the heterogeneous braid (Mitek Fact #35-38). Under Arthrex’s construction of “consisting essentially of,” Arthrex contends that the coating on the FiberWire suture takes it outside the scope of the claims. But Arthrex has not offered any evidence that under Mitek’s construction of “consisting essentially of,” the coating materially affects the basic and novel characteristics of the invention. Therefore, Dr. Brookstein’s statements are undisputed. Arthrex’s TigerWire contains one nylon strand. But Dr. Brookstein, Mitek’s expert, stated that the single nylon strand does not materially affect the basic and novel characteristics as defined by Mitek for at least two reasons (Mitek Fact #40). First, nylon is expressly mentioned Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 15 of 36 9 in claim 1 as one of the fiber-forming materials from which the second set of yarns can be made (Mitek Fact #1). Thus, the inventors contemplated it as being part of their invention and not as changing the basic and novel characteristics of their invention. Second, including a nylon yarn instead of one yarn of PET (nylon makes up only 3.4% of TigerWire suture – Mitek Fact #41) does not materially affect the basic and novel characteristics of the invention because the braid is still a heterogeneous braid of non-bioabsorbable yarns of the type claimed, at least one yarn of PE is in direct intertwining contact with a PET yarn, and the nylon does not materially affect the yarns from contributing to the properties of the overall braided suture (Mitek Fact #42-44). Arthrex’s has contended that, under its construction of “consisting essentially of,” the introduction of one strand of nylon in TigerWire materially affects the basic and novel characteristics of Mitek’s claimed invention. Arthrex, however, has failed to offer any evidence that under Mitek’s construction of “consisting essentially of,” the nylon materially affects the basic and novel characteristics of the invention. Therefore, Dr. Brookstein’s statements are undisputed. Accordingly, it is undisputed that, given Mitek’s construction of “consisting essentially of,” there is nothing in FiberWire or TigerWire that materially affects the basic and novel characteristics of the invention. Consequently, if the Court adopts Mitek’s construction of the claim term “consisting essentially of,” then this claim element is literally found in Arthrex’s FiberWire. 3. FiberWire Has The Remaining Claim Elements And Therefore Literally Infringes Claim 1 of Mitek’s 446 Patent All the limitations of claim 1 (other than “PE” and “consisting essentially of”) are also literally present in FiberWire. In fact, Arthrex does not dispute that the remaining claim elements are in FiberWire. Accordingly, if the Court adopts Mitek’s construction of “PE” and Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 16 of 36 10 “consisting essentially of,” it is undisputed that FiberWire literally contains each and every element of claim 1 of Mitek’s 446 Patent and therefore summary judgment of literal infringement is appropriate. The following table shows claim language, the claim construction, and the corresponding evidence applying the claim construction to Arthrex’s FiberWire. Claim 1 of the ‘446 Patent Claim Construction FiberWire Suture Products A surgical suture consisting essentially of a heterogeneous braid composed of a first and second set of continuous and discrete yarns in a sterilized, braided construction wherein at least one yarn from the first set is in direct intertwining contact with a yarn from the second set; and Consisting essentially of – The basic and novel characteristics are a heterogeneous braid of dissimilar non- bioabsorbable yarns of the type claimed, where at least one yarn from the first set is in direct intertwining contact with a yarn from the second set, and the dissimilar yarns have at least some different properties that contribute to the overall properties of the braid Direct intertwining contact - undisputed FiberWire and TigerWire are surgical sutures (Mitek Fact #11). Q. Okay. And is the FiberWire heterogeneous braid composed of a first and second set of continuous and discrete yarns? A. Yes. Q. Okay. And is the FiberWire heterogeneous sheath braid composed of discrete yarns in a sterilized braided construction? A. Yes (Mitek Fact #13). Q. And does the FiberWire heterogeneous braided sheath have a braided construction where at least one yarn from the first set is in direct intertwining contact with a yarn from the second set? A. There is intertwining contact, yes (Mitek Fact #18). a) each yarn from the first set is composed of a plurality of filaments of a first fiber-forming material selected from the group consisting of PTFE, FEP, PFA, PVDF, PETFE, PP and PE; and PE – all types of polyethylene (PE) including ultra high molecular weight polyethylene (“UHMW PE”).” Q. What is -- How do you characterize that strand of polyethylene when Pearsalls receives it? A. It is a various -- various individual filaments make up the yarn that's received. And the yarn may be several filaments to many. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 17 of 36 11 (Mitek Fact #16). b) each yarn from the second set is composed of a plurality of filaments of a second fiber- forming material selected from the group consisting of PET, nylon, and aramid; and Undisputed Each FiberWire™ suture product has PET as a second set of yarns (Mitek Fact #49). Q. Same way? So the PET used in Arthrex's FiberWire sutures is in the form of yarn, and that PET yarn is made up of several twisted monofilaments of PET? A. Correct (Mitek Fact #17). Q. Okay. And the next part says, "Each yarn from the second set is composed of a plurality of filaments of a second fiber-forming material selected from the group of PET, nylon and aramid." Do you see that? A. Yes. Q. Does FiberWire meet that criteria? A. It has the PET in it. Q. So, it meets that criteria? A. Uh-huh. (Mitek Fact #46). c) optionally a core. Undisputed Arthrex’s FiberWire™ sutures have a core except for 4-0 FiberWire (Mitek Fact #47). Accordingly, it is undisputed that FiberWire literally contains each and every element of claim 1 of Mitek’s 446 Patent. B. FiberWire Needle Products Literally Infringe Claim 2 of Mitek’s 446 Patent Claim 2 depends on claim 1 and further recites that the suture of claim 1 is attached to a needle. It is undisputed that Arthrex sells its FiberWire attached to a needle (Mitek Fact #48). Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 18 of 36 12 Claim 2 Arthrex’s FiberWire needle products The surgical suture of claim 1 wherein the suture is attached to a needle. Arthrex’s FiberWire needle products have FiberWire suture attached to a needle12 (Mitek Fact #48). Accordingly, Arthrex’s FiberWire suture contains each and every element of claim 2 of Mitek’s 446 Patent and therefore summary judgment of infringement is proper. C. FiberWire Literally Infringes Claim 8 of Mitek’s 446 Patent Claim 8 depends from claim 1 and further recites that the second set of yarns in the suture of claim 1 is PET. It is undisputed that FiberWire’s second set of yarns is PET. Claim 8 FiberWire Structure The surgical suture of claim 1 wherein the second set of yarns is PET. Each FiberWire suture product has PET as a second set of yarns (Mitek Fact #49). Q. Same way? So the PET used in Arthrex's FiberWire sutures is in the form of yarn, and that PET yarn is made up of several twisted monofilaments of PET? A. Correct (Mitek Fact #17). Q. Okay. And the next part says, "Each yarn from the second set is composed of a plurality of filaments of a second fiber-forming material selected from the group of PET, nylon and aramid." Do you see that? A. Yes. Q. Does FiberWire meet that criteria? A. It has the PET in it. 12 Arthrex’s FiberWire and TigerWire needle products includes all Arthrex’s products that are sold with a needle attached to a FiberWire or TigerWire suture including at least the following Arthrex catalog product codes AR-7200, AR-7202, AR-7204, AR-7205, AR-7205T, AR-7207, AR-7211, AR-7219, AR-7220, AR-7223, AR-7225, AR-7227-01, AR-7227-02, AR- 7228, AR-7229-12, AR-7229-20, AR-7230-01, AR-7230-02, AR-7232-01, AR-7232-02, AR- 7232-03, AR-7250, AR-7251, AR-1320BNF, AR-1322BNF, AR-1322-752SNF, AR-1915SNF, AR-1920SNF, AR-1324BNF, AR-1920BNP, AR-1934BNF, AR-1920BN, AR-1920BNF, AR- 1925BNF, AR-1925BNP, AR-1927BNF, AR-1928SNF, and AR-1928SNF-2. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 19 of 36 13 Q. So, it meets that criteria? A. Uh-huh. (Mitek Fact #46). Accordingly, Arthrex’s FiberWire suture contains each and every element of claim 8 of the 446 Patent and therefore summary judgment of infringement is proper. D. FiberWire Literally Infringes Claim 9 of Mitek’s 446 Patent Claim 9 Arthrex’s FiberWire Products The surgical suture of claim 8 wherein the volume fraction of the first set of yarns in the braided sheath and core ranges from about 20 to 80 percent. Every FiberWire and TigerWire construction has a ratio of the cross-sectional area of ultra high molecular weight PE in the sheath and core to the total cross sectional area of all the yarns in the surgical suture that ranges from 20 to 80 percent (Mitek Fact #50). Accordingly, Arthrex’s FiberWire suture contains each and every element of claim 9 of the 446 Patent and therefore summary judgment of infringement is proper. E. FiberWire Literally Infringes Claim 12 of Mitek’s 446 Patent Claim 12 depends on claim 8 and further recites that the suture of claim 8 is attached to a needle. It is undisputed that FiberWire is sold attached to a needle. Claim 12 Arthrex’s FiberWire Needle Products The surgical suture of claim 8 wherein the suture is attached to a needle. Arthrex’s FiberWire needle products have either FiberWire suture attached to a needle (Mitek Fact #48; see also footnote 12). Accordingly, Arthrex’s FiberWire suture contains each and every element of claim 12 of the 446 Patent and therefore summary judgment of infringement is proper. VII. CONCLUSION For the foregoing reasons, Mitek requests that the Court grant summary judgment that Arthrex literally infringes claims 1, 2, 8, 9, and 12 of Mitek’s 446 Patent. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 20 of 36 14 DEPUY MITEK’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF NO INEQUITABLE CONDUCT Mitek moves for summary judgment dismissal of Arthrex’s and Pearsalls’ inequitable conduct defenses and counterclaims predicated upon those defenses.13 Arthrex alleges that the attorneys, who prosecuted the application leading to Mitek’s 446 Patent, committed inequitable conduct by making statements about references that the Examiner undisputedly considered. Arthrex does not allege that any prior art was withheld from the Examiner. Rather, Arthrex’s arguments boil down to nothing more than disagreeing with the prosecuting attorneys’ and the Examiner’s interpretation of two references. That is not inequitable conduct. Arthrex’s allegations are precisely the type of spurious inequitable conduct charges that the Federal Circuit has condemned as “an absolute plague.”14 Accordingly, Arthrex’s inequitable conduct defenses and counterclaims should be disposed of under Rule 56. VIII. THE PROSECUTION HISTORY OF MITEK’S 446 PATENT A. The Filing Of the 511 Application The application that matured into Mitek’s 446 Patent (511 application) was filed on February 19, 1992, naming Dr. Mark Steckel as a co-inventor (Mitek Fact #53 and #54). The application as originally filed had 24 claims (Mitek Fact #55). Claims 1-20 were directed to heterogeneous braids (“braid claims”), and claims 21-24 were directed to surgical sutures (“suture claims”) (Mitek Fact #56 and #57). 13 Arthrex and Pearsalls are jointly represented by the same law firm. They have made the same pleadings with respect to inequitable conduct (compare Ex. 17 with Ex. 18). Thus, Mitek generally refers to Arthrex and Pearsalls together as “Arthrex” in this portion of its memorandum. 14 Burlington Indus. Inc. v. Dayco Corp., 849 F.2d 1418, 1422 (Fed. Cir. 1988); see also FMC Corp. v. Manitowoc Co., Inc. 835 F.2d 1411, 1415 (Fed. Cir. 1987) (“‘Inequitable conduct’ is not, or should not be, a magic incantation to be asserted against every patentee.”). Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 21 of 36 15 Messrs. Matthew Goodwin and Hal Woodrow, two in-house attorneys, prosecuted the 511 application (Mitek Fact #58 and #59 ). With the filing of the 511 application, Mr. Goodwin submitted an Information Disclosure Statement in which he disclosed eleven references, including U.K. Patent Application GB 2 218 321A (“Burgess”) (Mitek Fact #60 and #61). B. The First Office Action: The Patent Examiner Rejects the Suture Claims Over Burgess In the First Office Action, the Examiner issued a restriction requirement (Mitek Fact #62 and #63).15 Per the Examiner, claims 1-20 were directed to heterogeneous braids which were independent and distinct inventions from claims 21-24 which were directed to surgical sutures (Mitek Fact #56 and #57). The Examiner stated that the inventions claimed in claims 1-20 are “deemed to be useful as a fishing line” (Mitek Fact #64). The Examiner further stated that the braid and suture inventions were “patentably distinct since there is nothing in the record to show them to be obvious variants” (Mitek Fact #65). The Examiner further ruled that the braid and suture claims “have acquired a separate status in the art because of their recognized divergent subject matter” (Mitek Fact #66). Applicants elected to prosecute the surgical suture claims (claims 21-24) (Mitek Fact #67). Although the Examiner stated that the braid and suture claims were “patentably distinct” and “not obvious variants,” (Mitek Fact #68) he also rejected the suture claims as obvious over a fishing line reference (Mitek Fact # 69) that Mr. Goodwin submitted with the IDS (Mitek Fact # 61)-- Burgess, U.K. Patent Application 2,218,312A, (“Burgess”) (Mitek Fact #70). 15 A patent examiner issues a restriction requirement when it is believed that the claims as filed are directed to more than one invention. 35 U.S.C. §121; 37 C.F.R. §1.142. The purpose of a restriction requirement is to prevent an applicant from prosecuting claims directed to more than invention in one patent. Id. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 22 of 36 16 C. First Office Action Response: Applicants Argue Burgess Is Nonanalagous Art In response to the First Office Action, Applicants distinguished Burgess from the claimed invention relying, primarily, on a nonanalagous art argument that persons wanting to make a suture would not look to the fishing line art as instructive (Mitek Fact #72-74). Similar to the Examiner’s reasoning in restricting the claims, Applicants emphasized to the Examiner that the property considerations for fishing lines, such as disclosed in Burgess, are different from the property considerations for surgical sutures (compare Mitek Fact #67 with Mitek Fact #75). For example, Applicants pointed out that an important characteristic of sutures – which hold wounds together– is knot strength, which was not even mentioned in Burgess (Mitek Fact #76 and #77). Further, Mr. Goodwin explained that sutures and fishing line have different requirements because: (i) a surgeon ties sutures into conventional square knots at a very fast pace for patient safety; (ii) surgeons generally form a pre-knot with a suture and then slide it down the suture until the knot is adjacent the body tissue desired to be stitched; and (iii) after a suture knot is placed, surgeons make additional throws for knot security (Mitek Fact #78-80). Mr. Goodwin further explained that there are no similar requirements for a fishing line (id.). Mr. Goodwin also noted that the Burgess fishing line had some filaments composed of high tensile polythene thread that, although having some good strength properties, have poor knot strength properties (Mitek Fact #81). In conclusion, Mr. Goodwin emphasized the dissimilarities in property requirements for sutures versus fishing lines (Mitek Fact #82). Applicants stated that In view of the dissimilarities in property requirements between sutures and fishing line, there would be no incentive for a medical designer who wishes to improve the properties of a braided suture to study the art related to braided fishing lines. Even if he did use the teachings of the fishing line art to modify a suture, then he would inevitably design an unacceptable suture. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 23 of 36 17 (Mitek Fact #83). D. Second Office Action And Response: Burgess Rejection Is Dropped & Claims Are Rejected Over Kaplan After receiving the response regarding Burgess, the Examiner issued a Second Office Aaction (Mitek Fact #84). The Examiner considered the Burgess rejection moot, so there was no further discussion of the reference (Mitek Fact #85 and #86). But the Examiner rejected the claims over two different patents including U.S. Patent No. 5,147,400 (Mitek Fact #87). Per the Examiner, Kaplan was relevant because it disclosed a core and a braided sheath component made from "individual filaments having more than two different chemical compositions, one or more of which optionally being nonbioabsorbable" (Mitek Fact #88). In response to the Second Office Action, the Applicants argued, inter alia, that Kaplan did not disclose the claimed yarns in direct intertwining contact (Mitek Fact #89). E. Third Office Action And Response: Claims Are Amended And Allowed Over Kaplan In the Third Office Action, the Examiner maintained the rejections of the suture claims over Kaplan but on new grounds (Mitek Fact #90-92). Per the Examiner, Kaplan disclosed a braided sheath component that may be fabricated from individual filaments having more than two different chemical compositions, one or more of which optionally being nonbioabsorable (Mitek Fact #93). The Applicants responded by, inter alia, amending the claims to exclude bioabsorbable materials as the first and second fiber-forming materials and argued that the claims were patentable over Kaplan (Mitek Fact #94-96). Mr. Woodrow explained, inter alia, that Kaplan did not anticipate or render obvious the claimed invention as amended because Kaplan disclosed sheath yarn components that are “bioabsorbable or semi-bioabsorbable,” and the amended claims recited nonbioabsorbable yarns (Mitek Fact #97). After Mr. Woodrow’s Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 24 of 36 18 response was submitted, the U.S. Patent & Trademark Office (“Patent Office”) issued a Notice of Allowance (Mitek Fact #98). F. Arthrex’s Inequitable Conduct Allegations Arthrex does not allege that any material information was withheld with respect to Kaplan (Mitek Fact #99). Rather, Arthrex merely incorrectly alleges that inequitable conduct was committed with respect to Kaplan because the applicants and their attorneys mischaracterized and misrepresented Kaplan during the prosecution (Mitek Fact #100). Arthrex’s pleaded allegations with respect to Burgess are sparse and have changed like shifting sands. Arthrex’s allegations now appear to be based on Mr. John Witherspoon’s, Arthrex’s patent law expert, opinions where he incorrectly opines that three statements Mr. Goodwin made in responding to the rejection over the Burgess fishing line reference were material misrepresentations (Mitek Fact #101-103). IX. LAW OF INEQUITABLE CONDUCT & SUMMARY JUDGMENT A. Arthrex Carries A Heavy Burden of Proving Inequitable Conduct Arthrex carries the heavy burden of proving inequitable conduct by clear and convincing evidence. Hoffman-La Roche, Inc. v. Promega Corp., 323 F.3d 1354, 1359 (Fed. Cir. 2003). Clear and convincing evidence – which is higher than a preponderance of the evidence standard – is defined as “evidence which produces in the mind of the trier of fact ‘an abiding conviction that the truth of the factual contentions [is] ‘highly probable.’” Buildex Inc. v. Kason Indus., Inc., 849 F.2d 1461, 1463 (Fed. Cir. 1998). Inequitable conduct is an equitable issue to be resolved by the Court. Gardco Mfg., Inc. v. Herst Lighting Co., 820 F.2d 1209, 1212 (Fed. Cir. 1987). There is no right to a jury trial on inequitable conduct issues, including factual issues. Id. at 1212-13. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 25 of 36 19 To prove inequitable conduct, Arthrex must show that the patent applicants failed to disclose material information or submitted materially false information to the Patent Office, and did so with intent to deceive the examiner. Jumpsport, Inc. v. Jumpking, Inc., Nos., 05-1182, 05- 1196, 05-1197, 2006 U.S. App. LEXIS 18448, at *18-19 (Fed. Cir. July 21, 2006) (Ex. A). Materiality and intent are separate and essential elements of an inequitable conduct defense. M. Eagles Tool Warehouse, Inc. v. Fisher Tooling Co., Inc., 439 F.3d 1335, 1340 (Fed. Cir. 2006) (citing Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 552 (Fed. Cir. 1990)). Further, materiality does not presume intent. Id.; see also Old Town Canoe Co. v. Confluence Holdings Corp., 448 F.3d 1309, 1322 (Fed. Cir. 2006). Information is material if a reasonable examiner would have considered it important in deciding whether to allow the patent application. Digital Control Inc. v. Charles Mach. Works, 437 F.3d 1309, 1315 (Fed. Cir. 2006).16 Information is not material when the examiner actually knows of the information or it is cumulative to disclosed information. Mentor H/S, Inc. v. Medical Device Alliance, Inc., 244 F.3d 1365, 1378 (Fed. Cir. 2001). Intent to deceive cannot be inferred solely from the fact that information was not disclosed. M. Eagles Tool Warehouse, 439 F.3d at 1340; Hebert v. Lisle Corp., 99 F.3d 1109, 1116 (Fed. Cir. 1996). Further, an actor’s conduct must be viewed in light of all the circumstances including evidence of good faith. Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1345-46 (Fed. Cir. 2003). Also, materiality and intent are judged on a sliding scale: “The more material the omission, the less evidence of 16 There has been some debate as to whether the 1992 amendments to 37 C.F.R. §1.56 changed the materiality standard. Digital Control Inc., 437 F.3d 1309 at 1315. But recently, the Federal Circuit held that the 1992 C.F.R. amendments were not intended to supplant the reasonable examiner standard and applied the reasonable examiner standard. Id. at 1316. Thus, Mitek relies on the reasonable examiner standard here. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 26 of 36 20 intent [that is] required to find that inequitable conduct has occurred.” Baxter Int’l Inc. v. McGraw, Inc., 149 F.3d 1321, 1327 (Fed. Cir. 1998). B. Summary Judgment Standards Under FED. R. CIV. P. 56(c), summary judgment is proper if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). As the movant without the ultimate burden of proof on inequitable conduct, Mitek’s burden on summary judgment is merely to demonstrate the absence of a genuine issue of material fact. Id. at 323. Once that burden has been satisfied, the burden then shifts to nonmovant Arthrex to come forward with sufficient evidence from which a reasonable trier of fact could return a verdict in its favor. Avia Group Int’l., Inc. v. L.A. Gear, Inc., 853 F.2d 1557, 1560 (Fed. Cir. 1988). To meet this burden, non-movant Arthrex must do more than present some evidence on an issue that it asserts is disputed: [T]here is no issue for trial unless there is sufficient evidence favoring the non-moving party for a jury to return a verdict for that party. If the evidence [of the non-movant] is merely colorable, or is not significantly probative, summary judgment may be granted. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-250 (1986) (citations omitted). Further, on summary judgment, the Court must view the evidence presented through the prism of Arthrex’s clear and convincing evidentiary burden. Id. at 254. X. SUMMARY JUDGMENT OF ARTHREX’S INEQUITABLE CONDUCT DEFENSES & COUNTERCLAIMS IS WARRANTED Summary disposition of Arthrex’s claims and defenses regarding both Kaplan and Burgess is proper for three independent reasons. First, merely arguing about a disclosed reference is not, as Arthrex suggests, inequitable conduct. Second, in both instances, no material Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 27 of 36 21 information was withheld from the Examiner and no material misrepresentations were made to the Examiner. Third, in both instances, Arthrex has no evidence that anyone substantively involved with the prosecution of Mitek’s 446 Patent had an intent to deceive the Examiner. A. Arthrex’s Allegations Should Be Rejected Because Merely Arguing With the Patent Office About The Teachings of a Disclosed Reference Is Not Inequitable Conduct Arthrex’s inequitable conduct claims fall short as a matter of law because the Examiner had before him the Kaplan and Burgess references that are at the heart of Arthrex’s counterclaims and defenses (Mitek Fact #69 and #104-106). The Examiner was free to reach his own conclusions about Kaplan and Burgess. Courts routinely reject inequitable conduct allegations of the type made by Arthrex.17 Arthrex’s arguments are basically that they disagree with the arguments applicants made about the disclosed references. But an infringer’s disagreement with position’s taken during prosecution do not constitute inequitable conduct. Life Techs., 224 F.3d at 1326 (Fed. Cir. 2000) (holding that inventors interpretation of a disclosed reference was not inequitable conduct); Akzo N.V. v. U.S. Int'l Trade Comm'n, 808 F.2d 1471, 1482, (Fed. Cir. 1986) (holding that applicant’s argument distinguishing prior art was not a material misrepresentation because the Examiner could reach his/her own conclusions regarding the prior art); CFMT, Inc. v. YieldUp Int'l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (reversing finding of inequitable conduct as “clear error” 17 Life Techs., Inc. v. Clontech Labs., Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000) (holding that inventors interpretation of a disclosed reference was not inequitable conduct); Miller Pipeline Corp. v. British Gas PLC, 69 F. Supp. 2d 1129, 1136-37 n.4 (S.D. Ind. 1999) (finding applicant’s argument about a disclosed reference was not inequitable conduct); Beckton Dickinson & Co. v. Syntron Bioresearch Inc., 51 U.S.P.Q. 2d 1722, 1733-34 (S.D. Cal. 1998) (finding no inequitable conduct regarding discussion of disclosed references); Gargoyles Inc. v. United States, 33 U.S.P.Q.2d 1595, 1605 (finding applicant’s attempt to distinguish prior art was not inequitable conduct); Black & Decker Inc. v. Hoover Service Ctr., 765 F. Supp. 1129, 1138 (D. Conn. 1991) (finding that mere characterization of a reference does not constitute inequitable conduct). Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 28 of 36 22 where patent applicant’s advocacy was at most an overstatement, not a misrepresentation). Although this should dispose of Arthrex’s counterclaims and defenses, Mitek has addressed Arthrex’s lack of evidence on the merits below. When Arthrex’s counterclaims and defenses are put to scrutiny against Arthrex’s burden to prove clearly and convincingly the elements of materiality and intent, Arthrex’s counterclaims and defenses fail and should be summarily dismissed. B. Arthrex Lacks Any Credible Evidence of Inequitable Conduct From Which A Reasonable Trier of Fact Could Find Inequitable Conduct Based on Kaplan 1. Arthrex Has No Evidence Of A Material Misrepresentation Regarding Kaplan It is undisputed that the Examiner fully considered Kaplan in connection with allowing the claims of Mitek’s 446 Patent – the reference was relied on and applied in two separate Office Actions (Mitek Fact #87-97 and #104-106). So Arthrex is left searching for alleged misrepresentations and mischaracterizations about Kaplan to trump up its inequitable conduct defense. Coming up short, Arthrex tries to spin Mr. Woodrow’s statements about Kaplan into misrepresentations. In particular, Arthrex strains to turn Mr. Woodrow’s interpretation that Kaplan’s sheath yarn component “always contains at least in part, a bio-absorbable portion and that Kaplan teaches away from [the claimed] combination of non-bioabsorbable yarns” into a misrepresentation (Mitek Fact #107). But there is absolutely no evidence that this interpretation is wrong, much less that Mr. Woodrow thought it was wrong, and intentionally made an argument he knew to be wrong to deceive the Examiner. Rather, the only record evidence is that Mr. Woodrow still believes the statement to be correct (Mitek Fact #108) and the Examiner thought it was correct. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 29 of 36 23 Arthrex simply has no evidence to the contrary. Neither of Arthrex’s technical experts offered any opinions regarding Kaplan’s teachings (Mitek Fact #109). Further, Arthrex’s patent law expert did not opine on any misconduct regarding Kaplan (Mitek Fact #110). Arthrex is left with nothing more than its trial counsel’s allegations. But trial counsel’s assertions are no substitute for the clear and convincing evidence Arthrex needs to establish that this statement was a material misrepresentation. See, e.g, Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1068 (Fed. Cir. 2005) (attorney argument is no substitute for substantiated expert testimony about technical evidence) (citing American Airlines, Inc. v. United States, 204 F.3d 1103, 1112 (Fed. Cir. 2000); Glaverbel Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550, 1562 (Fed. Cir. 1995) ("There must be sufficient substance, other than attorney argument, to show that the issue requires trial.")). Thus, Arthrex is left with a blank evidentiary slate as to any material misrepresentation about Kaplan. Accordingly, Arthrex’s inequitable conduct defense based on Kaplan should be dismissed. 2. Arthrex Has No Evidence of Intent to Deceive With Respect to Kaplan Even if Arthrex could establish materiality (and it cannot), Arthrex’s claim also fails because it has no evidence that anyone substantively involved with the prosecution of Mitek’s 446 Patent had any intent to deceive the Examiner with respect to Kaplan. Not only did Arthrex fail to plead any evidence of intent (Mitek Fact #111), but Arthrex failed to identify any evidence of intent to deceive in its responses to Mitek’s interrogatories (Mitek Fact #112). Arthrex deposed the prosecuting attorneys, Mr. Goodwin and Mr. Woodrow,18 and co-inventor Dr. 18 When asked about the prosecution regarding Kaplan, Mr. Woodrow testified that Kaplan was distinguishable for many reasons including those pointed out during the prosecution (Mitek Fact #108). Thus, Arthrex has no evidence that Mr. Woodrow thought Kaplan disclosed something different than what Mr. Woodrow explained to the Patent Office, much less that he intentionally misrepresented Kaplan (Mitek Fact #114). Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 30 of 36 24 Steckel, and never identified any evidence of intent (Mitek Fact #113). With the evidentiary record closed, Arthrex comes up short again. Accordingly, having no evidence of intent, Arthrex and Pearsalls defenses and counterclaims based on Kaplan should be dismissed.19 C. Arthrex Lacks Any Credible Evidence of Inequitable Conduct From Which A Reasonable Trier of Fact Could Find Inequitable Conduct Based on Burgess Like its claims regarding Kaplan, Arthrex’s allegations regarding Burgess fail because Arthrex has no clear and convincing evidence to prove the materiality and intent elements of its inequitable conduct counterclaims and defenses. 1. Arthrex Has No Evidence Of A Material Misrepresentation Regarding Burgess a) Mr. Goodwin Did Not Make A Material Misrepresentation Regarding Burgess It is undisputed that the Examiner fully considered Burgess in connection with allowing the claims of Mitek’s 446 Patent – not only did Applicants provide it to the Examiner (Mitek Fact #60 and #61), but the Examiner applied the reference in rejecting the claims (Mitek Fact #69). Just as with Kaplan, the trained patent examiner was free to reach his own conclusions about Burgess. Thus, Arthrex is again left trying to concoct an argument about alleged misrepresentations regarding a reference, Burgess, that was fully considered by the Examiner. In its efforts to string together an argument, Arthrex’s allegations have shifted throughout this case and now appear to be found in the rebuttal expert report of Mr. John Witherspoon, Arthrex’s patent law expert. Mr. Witherspoon and Arthrex try to spin three statements by Mr. Goodwin about fishing line and the Burgess reference into material misrepresentations on the 19 Old Town Canoe Co., 448 F.3d at 1322 (affirming JMOL that inequitable conduct was not committed where infringer lacked evidence of intent to deceive); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1358 (Fed. Cir. 2003) (“[W]e will not find inequitable conduct on an evidentiary record that is completely devoid of evidence of a patentee’s intent to deceive the [Patent Office].”). Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 31 of 36 25 incorrect belief that these statements were inconsistent with co-inventor, Dr. Steckel’s deposition testimony regarding sutures (Mitek Fact #101-103). Thus, Arthrex’s argument hinges on first proving that Mr. Goodwin’s fishing line statements are inconsistent with Dr. Steckel’s testimony regarding his suture development (Mitek Fact #127). But since there is no inconsistency, no reasonable trier of fact could find Mr. Goodwin’s statements materially inconsistent with Dr. Steckel’s testimony. Mr. Witherspoon cites to the following three statements made by Mr. Goodwin in the office action response regarding Burgess: 1. In fact, the fishing line of Burgess would have poor knot strength properties because of its braided construction; 2. The property requirements for fishing line yield a braid with poor knot strength and security, and the requirements for sutures yield a braid which has by necessity excellent knot strength and security; 3. Even if [a medical designer] did use the teachings of the fishing line art to modify a suture then he would inevitably design an unacceptable suture. (Mitek Fact #102). Mr. Witherspoon incorrectly alleges that these statements are material misrepresentations because they are allegedly inconsistent with Dr. Steckel’s deposition testimony about his work developing sutures and what would make “an acceptable suture.” (Mitek Fact #115). But Dr. Steckel’s testimony is not inconsistent with Mr. Goodwin’s cited statements. Mr. Goodwin’s first cited statement is about the “fishing line of Burgess” (Mitek Fact #102). Dr. Steckel’s allegedly inconsistent statement is about sutures, not fishing line or Burgess (Mitek Fact #115). Mr. Goodwin’s second cited statement is about “the property requirements for fishing line” (Mitek Fact #102). Dr. Steckel’s cited testimony says nothing about fishing lines, much less the property requirements for fishing lines (Mitek Fact #115). Mr. Goodwin’s third cited statement is about what a medical designer would do if he used the teachings of the fishing line art to modify suture (Mitek Fact #102). Dr. Steckel’s cited Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 32 of 36 26 testimony says nothing about what a medical designer would do if he used the teachings of fishing line art (Mitek Fact #115). In fact, there is no evidence that Dr. Steckel was familiar with fishing line properties or considered designing sutures from fishing lines (Mitek Fact #116 and #117). Nor is there any evidence that Dr. Steckel disagreed with Mr. Goodwin’s argument that Burgess was nonanalogous art (Mitek Fact #118). Thus, there is no inconsistency between Mr. Goodwin’s statements to the Patent Office and Dr. Steckel’s work and no material. Life Techs., Inc., 224 F.3d at 1326; Akzo N.V., 808 F.2d at 1482. Accordingly, because there is no inconsistency, there was no misrepresentation, much less a material misrepresentation. In any event, Mr. Goodwin’s advocacy in responding to an office action does not rise to the level of a misrepresentation. CFMT, 349 F.3d at 1342 (reversing finding of inequitable conduct as “clear error” where patent applicant’s advocacy was at most an overstatement, not a misrepresentation). Even Mr. Witherspoon, Arthrex’s patent law expert, admitted that there was insufficient record evidence to conclude that Mr. Goodwin did anything wrong. Mr. Witherspoon carefully limited his opinions to stating that there “may” have been a violation of the duty of disclosure (Mitek Fact #119). He reaffirmed at his deposition that on the present record he could not formulate an opinion about whether there was inequitable conduct (Mitek Fact #120). Mr. Witherspoon admitted that “[b]ut I would be -- I would not be inclined, at this point, to say that they, in fact, did violate it, knowing only what I know now” (id.). The evidentiary record is closed and Arthrex’s evidentiary slate about Burgess, just as with Kaplan, is blank. Accordingly, Arthrex’s inequitable conduct claim should be summarily dismissed. Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 33 of 36 27 2. Arthrex’s Allegations Regarding Burgess Should be Dismissed Because Arthrex Has No Evidence of Intent To Deceive Even if Arthrex could establish materiality (and it cannot), Arthrex’s claim also fails because it has no evidence that anyone substantively involved with the prosecution of Mitek’s 446 Patent had any intent to deceive the Examiner with respect to Burgess. Intent is an essential and separate element of Arthrex’s inequitable conduct defense. M. Eagles Tool Warehouse, 439 F.3d at 1340. Yet, Arthrex has no evidence of any intent to deceive, much less the required threshold level of intent. Jumpsport, 2006 U.S. App. LEXIS 18448 at *19 (Ex.A). Not only did Arthrex fail to plead any evidence of intent (Mitek Fact #121), but Arthrex failed to identify any evidence of intent to deceive in its responses to Mitek’s interrogatories (Mitek Fact #122). Arthrex deposed the prosecuting attorneys, Mr. Goodwin and Mr. Woodrow, and co-inventor Dr. Steckel, and never identified any evidence of intent (Mitek Fact #123). Further, its experts have not pointed to any evidence of intent in connection with Burgess. Arthrex comes up short again of having clear and convincing evidence to submit to a trier of fact. Not only is there is no evidence of any intent to deceive, there is evidence of good faith. Mr. Goodwin cited the Burgess reference to the Examiner (Mitek Fact #61). If Mr. Goodwin wanted to deceive the Examiner about Burgess – as Arthrex suggests – he would simply have not cited it at all. Arthrex’s allegations defy common sense. Further, Dr. Steckel testified that he disclosed to the Examiner the information that Arthrex claims was allegedly withheld information20 (Mitek Fact #124). Thus, as Dr. Steckel believed he disclosed, what Arthrex alleges was withheld, he could not have intended to deceive the Examiner. 20 There can also be no misrepresentation because the 446 Patent discloses Dr. Steckel’s allegedly withheld testimony about polyethylene (Mitek Fact #125). Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 34 of 36 28 XI. CONCLUSION Arthrex’s and Pearsalls’ inequitable conduct allegations are precisely the type of meritless allegations that the Federal Circuit has criticized as a “plague.” No material information was withheld, and no material misrepresentations were made. The Examiner fully considered the references. Further, there is no evidence of intent to deceive. Summary judgment of Arthrex’s inequitable conduct defenses and claims is warranted. Dated: August 11, 2006 DEPUY MITEK, INC., By its attorneys, _/s/ Erich M. Falke____________ Dianne B. Elderkin Lynn A. Malinoski Michael J. Bonella Erich M. Falke WOODCOCK WASHBURN LLP One Liberty Place - 46th Floor Philadelphia, PA 19103 (215) 568-3100 Daniel J. Gleason (BBO #194900) Michelle Chassereau Jackson (BBO #654825) Nutter McClennen & Fish LLP World Trade Center West 155 Seaport Boulevard Boston, MA. 02210-2604 Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 35 of 36 29 CERTIFICATE OF SERVICE I certify that I am counsel for DePuy Mitek, Inc. and that true and correct copies of: DePuy Mitek, Inc.’s Motion for Summary Judgment of Infringement and No Inequitable Conduct; and DePuy Mitek’s Memorandum In Support of Its Motion for Summary Judgment of Infringement and No Inequitable Conduct; and DePuy Mitek’s Statement of Facts In Support of Its Motion for Summary Judgment of Infringement and No Inequitable Conduct were served on counsel for Defendants Arthrex, Inc. and Pearsalls Ltd. on this date via the Court’s e-mail notification with the following recipients being listed as filing users for Defendants: Charles W. Saber Dickstein Shapiro 1825 Eye Street, NW Washington, DC 2006 saberc@dicksteinshapiro.com Raymond P. Ausrotas Todd & Weld LLP 28 State Street, 31st Floor Boston, MA 02109 rausrotas@toddweld.com Dated: August 11, 2006 /s/ Erich M. Falke____________________ Erich M. Falke Case 1:04-cv-12457-PBS Document 37 Filed 08/11/2006 Page 36 of 36 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 1 of 8 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 2 of 8 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 3 of 8 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 4 of 8 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 5 of 8 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 6 of 8 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 7 of 8 Case 1:04-cv-12457-PBS Document 37-2 Filed 08/11/2006 Page 8 of 8