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B. Braun Melsungen AG v. Becton, Dickinson and Co.

United States District Court, D. Delaware

August 8, 2017

B. BRAUN MELSUNGEN AG, B. BRAUN MEDICAL INDUSTRIES SDN. BHD. and B. BRAUN MEDICAL, INC., Plaintiffs;
v.
BECTON, DICKINSON AND COMPANY and BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC. Defendants.

          Gregory E. Stuhlman, Esq., GREENBERG TRAURIG, LLP, Wilmington, DE; Julie P. Bookbinder, Esq. (argued), GREENBERG TRAURIG, LLP, New York, NY; Scott J. Bornstein, Esq., GREENBERG TRAURIG, LLP, New York, NY; Allan A. Kassenoff, Esq. (argued), GREENBERG TRAURIG, LLP, New York, NY; Joshua L. Raskin, Esq. (argued), GREENBERG TRAURIG, LLP, New York, NY. Attorneys for Plaintiffs.

          Frederick L. Cottrell, Esq., RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Katharine L. Mowery, Esq., RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Nicole K. Pedi, Esq., RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; William F. Lee, Esq., WILMER CUTLER PICKERING HALE AND DORR LLP, Boston, MA; William G. McElwain, Esq. (argued), WILMER CUTLER PICKERING HALE AND DORR LLP, Washington, DC; Tracey C. Allen, Esq., WILMER CUTLER PICKERING HALE AND DORR LLP, Washington, DC; Omar A. Khan, Esq. (argued), WILMER CUTLER PICKERING HALE AND DORR LLP, New York, NY. Attorneys for Defendants.

          MEMORANDUM OPINION

          ANDREWS, U.S DISTRICT JUDGE.

         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent Nos. 9, 149, 626 ("the '626 patent'), 8, 540, 728 ("the '728 patent"), 8, 337, 463 ("the '463 patent"), 8, 333, 735 ("the '735 patent"), 8, 328, 762 ("the '762 patent"), 8, 460, 247 ("the '247 patent"), 8, 587, 249 ("the '249 patent"), 9, 370, 641 ("the '641 patent"), 8, 414, 539 ("the '539 patent"), 8, 444, 605 ("the '605 patent"), and 8, 545, 454 ("the '454 patent"). The Court has considered the Parties' Joint Claim Construction Brief. (D.I. 110). The Court heard oral argument on June 8, 2017. (D.I. 130).

         I. Background

         Plaintiffs brought this infringement action on June 6, 2016, alleging infringement often patents. (D.I. 1). On July 25, 2016, Plaintiffs filed their First Amended Complaint adding an additional count alleging infringement of an eleventh patent. (D.I. 16). The parties divide the patents into three families: the Woehr/Raines patents (the '626, '728, '463, '735, and '762 patents), the Woehr/Zerbes patents (the '247, 249, and '641 patents), and the Kuracina patents (the '539, '605, and '454 patents). All of these patents claim catheter insertion devices with needle protection components.

         II. Legal Standard

         "It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. A WH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotation marks omitted). "'[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources 'in light of the statutes and policies that inform patent law.'" SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Of these sources, "the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 4l5F.3datl3l5 (internal quotation marks omitted).

         "[T]he words of a claim are generally given their ordinary and customary meaning.... [Which 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 1312-13 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314.

         When a court relies solely upon the intrinsic evidence-the patent claims, the specification, and the prosecution history-the court's construction is a determination of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015). The court may also make factual findings based upon consideration of extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks omitted). Extrinsic evidence may assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

         "A claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int'l Trade Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation and internal quotation marks omitted).

         III. CONSTRUCTION OF DISPUTED TERMS

         A. The Patents-in-Suit

         1.The Woehr/Raines Patents

         The Woehr/Raines patents are directed to devices, systems, and methods for catheter insertion. The only disputed terms in the '626 patent appear in claim 11, which reads as follows:

11. A catheter insertion device comprising:
a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached to a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube in a ready position and comprises a needle tip;
a valve positioned inside the interior cavity of the catheter hub and in contact with the interior cavity, said valve being sized and shaped to obstruct fluid flow and comprises a wall surface comprising a slit;
said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub to actuate the valve, the valve actuating element comprising a nose section having a tapered end for pushing the valve to open the slit and a plunger end extending proximally of the nose section;
the plunger end transferring a distally directed force to the nose section to push the valve to open the slit when pressed upon; and
a needle protective device spaced from the needle tip in the ready position and movable relative to the needle tip, at least in part distally of the needle tip to prevent unintended needle sticks.

('626 patent, claim 11) (disputed terms italicized).

         Claim 1 of the '728 patent is representative and reads as follows:

1. A catheter insertion device comprising:
a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve sized and shaped to obstruct fluid flow comprising a wall surface comprising a slit positioned inside the interior cavity of the catheter hub and in contact with the interior cavity;
said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the catheter hub and abuts a shoulder formed in the interior cavity of the catheter hub;
a valve actuating element slidingly disposed in the catheter hub to actuate the valve, the valve actuating element comprising a nose section having a tapered end for pushing the valve to open the slit of the valve and a plunger end having at least two plunger elements extending proximally of the nose section and having a gap therebetween to permit fluid flow to flow therethrough; the two plunger elements being sufficiently rigid to transfer a distally directed force to the nose section to push the valve to open the slit;
a needle protective device spaced from the needle tip in a ready position and movable relative to the needle tip to a protective position, at least in part, distally of the needle tip to prevent unintended needle sticks.

('728 patent, claim 1) (disputed terms italicized).

         Disputed terms in the '463 patent appear in claims 1 and 10. Claim 1 reads as follows:

1. A catheter insertion device comprising:
a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve sized and shaped to obstruct fluid flow through the catheter hub comprising a wall surface comprising a slit positioned inside the interior cavity of the catheter hub and abutting a shoulder in the interior cavity of the catheter hub;
said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub to actuate the valve, the valve actuating element comprising a nose section having a tapered end for pushing the valve to open the slit of the valve and at least two plunger elements extending proximally of the nose section and having a gap there between to permit fluid flow to flow therethrough;
the two plunger elements structured to transfer a distally directed force to the nose section to push the valve to open the slit;
a needle protective device spaced from the needle tip in a ready position and movable relative to the needle tip to a protective position, at least in part, distally of the needle tip to prevent unintended needle sticks.

('463 patent, claim 1) (disputed terms italicized).

         Claim 10 of the '463 patent reads as follows:

10. A catheter insertion device comprising:
a first hub comprising an interior cavity, a perimeter defining an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the first hub:
a needle having a needle shaft defining a needle axis projecting distally of an end of a second hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve sized and shaped to obstruct fluid flow comprising a slit positioned inside the interior cavity of the first hub and having a distal surface pushed against a shoulder in the interior cavity;
said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the first hub; a valve actuating element slidingly disposed in the first hub to actuate the valve, the valve actuating element comprising a projection, a nose section having a tapered end with an opening structured to push the valve to open the slit, and at least two plunger elements extending proximally of the nose section and having a gap therebetween;
wherein the at least two plunger elements with the gap therebetween are disposed distally of the proximal end of the first hub and are slidable distally when a male implement projects into the opening of the first hub to transfer a distally directed force to the nose section to push the valve to open the slit;
a needle protective device positioned proximal of the valve and at least in part around the needle and distal of the proximal end of the second hub in a ready position, the needle protective device is moveable to prevent unintended needle sticks in a protective position.

('463 patent, claim 10) (disputed terms italicized).

         Claims 1 and 18 of the '735 patent are representative as to the disputed terms. Claim 1 reads as follows:

1. A catheter insertion device comprising:
a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter ...

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