Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 1 of 72 PageID #: 437 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

Transcription

1 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 1 of 72 PageID #: 437 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE B. BRAUN MELSUNGEN AG, B. BRAUN MEDICAL INDUSTRIES SDN. BHD., and B. BRAUN MEDICAL INC., v. Plaintiffs, BECTON, DICKINSON AND COMPANY and BECTON DICKINSON INFUSION THERAPY SYSTEMS INC., Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) Civil Action No.: 1:16-cv RGA JURY DEMANDED FIRST AMENDED COMPLAINT For their First Amended Complaint against Defendants Becton, Dickinson and Company ( BD ) and Becton Dickinson Infusion Therapy Systems Inc. ( BD Infusion ) (collectively, Defendants ), Plaintiffs B. Braun Melsungen AG ( B. Braun Germany ), B. Braun Medical Industries Sdn. Bhd. ( B. Braun Malaysia ), and B. Braun Medical Inc. ( B. Braun U.S. ) (collectively, B. Braun or Plaintiffs ) allege as follows: NATURE OF ACTION 1. This is an action for patent infringement arising under the Patent Laws of the United States, 35 U.S.C. 1 et seq., and seeking damages and injunctive relief under 35 U.S.C. 271, 281, THE PARTIES 2. Plaintiff B. Braun Germany is a German company with its principal place of business at Carl-Braun Strasse 1, Melsungen, Germany. By way of a duly executed and recorded assignment, B. Braun Germany is the owner of all right, title, and interest in and to the 1

2 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 2 of 72 PageID #: 438 patents-in-suit in this case, namely, United States Patent No. 9,149,626 (the 626 patent ); United States Patent No. 8,540,728 (the 728 patent ); United States Patent No. 8,337,463 (the 463 patent ); United States Patent No. 8,333,735 (the 735 patent ); United States Patent No. 8,328,762 (the 762 patent and collectively with the 626 patent, the 728 patent, the 463 patent and the 735 patent, the Woehr/Raines patents ); United States Patent No. 8,460,247 (the 247 patent ); United States Patent No. 8,597,249 (the 249 patent ); United States Patent No. 9,370,641 (the 641 patent and collectively with the 247 patent and the 249 patent, the Woehr/Zerbes patents ); United States Patent No. 8,414,539 (the 539 patent ); United States Patent No. 8,444,605 (the 605 patent ); and United States Patent No. 8,545,454 (the 454 patent and collectively with the 539 patent and the 605 patent, the Kuracina patents ) (the Woehr/Raines patents, the Woehr/Zerbes patents, and the Kuracina patents are collectively referred to as the patents-in-suit ). 3. Plaintiff B. Braun Malaysia is a Malaysian company with its principal place of business at Phase 2 Bayan Lepas Free Industrial Zone, Penang, Malaysia. As per a License Agreement between B. Braun Germany and B. Braun Malaysia, B. Braun Germany granted certain rights to B. Braun Malaysia with respect to the Woehr/Raines patents, including the right to manufacture, use and distribute the B. Braun Introcan Safety 3 Closed IV Catheter ( Introcan Safety 3 ), a product covered by one or more claims of each of the Woehr/Raines patents, and to sue for infringement of the Woehr/Raines patents and recover damages thereon, in all countries in which the Woehr/Raines patents and their foreign equivalents provide patent protection, including the United States. Pursuant to this contractual relationship, B. Braun Malaysia is the sole worldwide manufacturer of the Introcan Safety 3. B. Braun Malaysia began manufacturing the Introcan Safety 3 in 2012, and continues to manufacture the Introcan Safety 3. 2

3 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 3 of 72 PageID #: 439 B. Braun Malaysia sells the Introcan Safety 3 worldwide, including into the United States to B. Braun U.S., its exclusive U.S. distributor for the Introcan Safety 3, and derives substantial revenue therefrom. 4. Plaintiff B. Braun U.S. is a corporation organized under the laws of the State of Pennsylvania, having its principal place of business at 824 Twelfth Avenue, Bethlehem, Pennsylvania As per a Distributorship Agreement between B. Braun Malaysia and B. Braun U.S., B. Braun Malaysia granted B. Braun U.S. the exclusive right to sell within the United States all of its IV Cannula products, including the Introcan Safety 3, which, as mentioned above, is covered by each of the Woehr/Raines patents. Pursuant to this contractual relationship, B. Braun U.S. distributes and sells the Introcan Safety 3 in the United States, and derives substantial revenue therefrom. 5. On information and belief, Defendant BD is a corporation organized under the laws of the State of New Jersey, having a principal place of business at 1 Becton Drive, Franklin Lakes, New Jersey On information and belief, Defendant BD Infusion is a corporation organized under the laws of the State of Delaware, having a principal place of business at 9450 South State Street, Sandy, Utah On information and belief, Defendant BD Infusion is a wholly-owned subsidiary of Defendant BD. JURISDICTION AND VENUE 7. This Court has subject matter jurisdiction over this action under 28 U.S.C and 1338(a) because it arises under the patent laws of the United States, including 35 U.S.C. 271 et seq. 3

4 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 4 of 72 PageID #: This Court has personal jurisdiction over BD because, among other things, BD has committed, aided, abetted, contributed to, and/or participated in the commission of patent infringement in this judicial district and elsewhere. BD has placed products that practice the claimed inventions of the patents-in-suit into the stream of commerce with the reasonable expectation and/or knowledge that purchasers and users of such products were located within this District. BD has also sold, advertised, marketed, and/or distributed products in this District that practice the claimed inventions of the patents-in-suit. This Court also has personal jurisdiction over BD because, among other things, BD has established minimum contacts within the forum such that the exercise of jurisdiction over BD will not offend traditional notions of fair play and substantial justice. 9. This Court has personal jurisdiction over BD Infusion because, among other things, BD Infusion has committed, aided, abetted, contributed to, and/or participated in the commission of patent infringement in this judicial district and elsewhere. BD Infusion has placed products that practice the claimed inventions of the patents-in-suit into the stream of commerce with the reasonable expectation and/or knowledge that purchasers and users of such products were located within this District. BD Infusion has also sold, advertised, marketed, and/or distributed products in this District that practice the claimed inventions of the patents-in-suit. Moreover, BD Infusion is a Delaware corporation which, having availed itself of Delaware s corporate laws, is subject to personal jurisdiction in Delaware. This Court also has personal jurisdiction over BD Infusion because, among other things, BD Infusion has established minimum contacts within the forum such that the exercise of jurisdiction over BD Infusion will not offend traditional notions of fair play and substantial justice. 10. Venue in this judicial district is proper under 28 U.S.C and/or

5 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 5 of 72 PageID #: 441 FACTUAL BACKGROUND I. The Patents-in-Suit 11. The 626 patent, titled CATHETER INSERTION DEVICE, was duly and legally issued by the United States Patent and Trademark Office on October 6, A true and correct copy of the 626 patent is attached as Exhibit A. 12. The 728 patent, titled CATHETER INSERTION DEVICE, was duly and legally issued by the United States Patent and Trademark Office on September 24, A true and correct copy of the 728 patent is attached as Exhibit B. 13. The 463 patent, titled CATHETER INSERTION DEVICE, was duly and legally issued by the United States Patent and Trademark Office on December 25, A true and correct copy of the 463 patent is attached as Exhibit C. 14. The 735 patent, titled CATHETER INSERTION DEVICE, was duly and legally issued by the United States Patent and Trademark Office on December 18, A true and correct copy of the 735 patent is attached as Exhibit D. 15. The 762 patent, titled CATHETER INSERTION DEVICE, was duly and legally issued by the United States Patent and Trademark Office on December 11, A true and correct copy of the 762 patent is attached as Exhibit E. 16. The 247 patent, titled CATHETER ASSEMBLY AND COMPONENTS THEREOF, was duly and legally issued by the United States Patent and Trademark Office on June 11, A true and correct copy of the 247 patent is attached as Exhibit F. 17. The 249 patent, titled CATHETER ASSEMBLY AND COMPONENTS THEREOF, was duly and legally issued by the United States Patent and Trademark Office on December 3, A true and correct copy of the 249 patent is attached as Exhibit G. 5

6 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 6 of 72 PageID #: The 641 patent, titled CATHETER ASSEMBLY AND COMPONENTS THEREOF, was duly and legally issued by the United States Patent and Trademark Office on June 21, A true and correct copy of the 641 patent is attached as Exhibit H. 19. The 539 patent, titled NEEDLE TIP GUARD FOR PERCUTANEOUS ENTRY NEEDLES, was duly and legally issued by the United States Patent and Trademark Office on April 9, A true and correct copy of the 539 patent is attached as Exhibit I. 20. The 605 patent, titled NEEDLE TIP GUARD FOR PERCUTANEOUS ENTRY NEEDLES, was duly and legally issued by the United States Patent and Trademark Office on May 21, A true and correct copy of the 605 patent is attached as Exhibit J. 21. The 454 patent, titled NEEDLE TIP GUARD FOR PERCUTANEOUS ENTRY NEEDLES, was duly and legally issued by the United States Patent and Trademark Office on October 1, A true and correct copy of the 454 patent is attached as Exhibit K. 22. The patents-in-suit are currently in full force and effect and, in accordance with 35 U.S.C. 282, the patents-in-suit, and each and every claim thereof, is presumed to be valid. II. Defendants Infringing Products 23. BD s operations consist of two worldwide business units: BD Medical and BD Life Sciences. BD Medical produces a broad array of medical devices that are used in a wide range of healthcare settings. BD Medical s product lines include needles, syringes and intravenous (IV) catheters for medication delivery; regional anesthesia needles and sharps disposal containers. BD, through its BD Medical business unit, manufactures, markets, and sells IV catheters, including, but not limited to the BD Insyte Autoguard BC IV Catheter (the Autoguard BC ) and the BD Nexiva Closed IV Catheter System (the Nexiva ) to customers within and without the United States. 6

7 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 7 of 72 PageID #: On information and belief, Defendant BD Infusion functions as part of the BD Medical business unit. On information and belief, BD Infusion, in concert with Defendant BD and as part of the BD Medical business unit, manufactures the Autoguard BC and Nexiva at its Sandy, Utah facility. On information and belief, BD Infusion, in concert with Defendant BD and as part of the BD Medical business unit, markets and sells the Autoguard BC and Nexiva to customers within and without the United States. 25. According to a Section 5-510(k) premarket notification of intent to market the BD Insyte Autoguard BC catheter submitted by Defendant Becton Dickinson Infusion Therapy and subsequently granted 510(k) Number K (the Autoguard BC PMA ), [t]he BD Insyte Autoguard BC catheter s catheter hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. BD Insyte Autoguard BC device is an over-theneedle, peripheral intravascular catheter that incorporates a spring-activated needle-shielding technology. Each catheter needle-shielding component includes a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber, and a needle. The Autoguard BC PMA further states that [t]he BD Insyte Autoguard BC catheter needle-shielding technology provided [sic] the clinician with a user-activated button, the clinician pushes it to initiate the needle s retraction into the needle-shielding barrel. Once the button has been pushed and the needle retracted, the user cannot override the shielding mechanism to re-expose the needle tip. 7

8 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 8 of 72 PageID #: As described in detail in Counts I VIII below, as a result of the foregoing features, among others, the Autoguard BC meets every limitation of at least one claim of each of the Woehr/Raines patents and every limitation of at least one claim of each of the Woehr/Zerbes patents. 27. According to a Section 5-510(k) premarket notification of intent to market the BD Nexiva Closed IV Catheter System submitted by Defendant Becton Dickinson Infusion Therapy and subsequently granted 510(k) Number K (the Nexiva PMA ), the Nexiva product can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the Nexiva device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or a BD Q-Syte luer access port. As described in detail in Counts IX XI below, as a result of the foregoing features, among others, the Nexiva meets every limitation of at least one claim of each of the Kuracina patents. 28. As a direct and proximate consequence of Defendants infringement, and unless Defendants are enjoined by the Court from manufacturing, importing, offering to sell, selling, or using within the United States products covered by the claims of the patents-in-suit, Plaintiffs are being and will continue to be substantially and irreparably harmed in their business and property rights. 8

9 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 9 of 72 PageID #: 445 III. Defendants Knowledge of the Patents-in-Suit 29. Defendants have had knowledge of the Woehr/Raines patents since at least as of August 18, For example, and without limitation: A United States patent in the same family as the Woehr/Raines patents and to which the Woehr/Raines patents claim priority, U.S. Patent No. 7,736,339, issued on June 15, 2010, and has been cited during the prosecution of twenty-five U.S. patents issued in the name of BD, the earliest-issued of which, U.S. Patent 8,357,119, issued on January 22, During the prosecution of U.S. Patent 8,357,119, Becton Dickinson disclosed U.S. Patent No. 7,736,339 to the U.S.P.T.O. in an Information Disclosure Statement dated August 18, On March 5, 2014, B. Braun Germany s counsel sent an to counsel for Becton Dickinson GmbH stating that their client has identified several granted US patents as enumerated in the attached document which may show an overlap with your client s products as also enumerated in the attached document. Attached to the was a document listing the 728, 463, 735, and 762 patents (the four Woehr/Raines patents that had issued at that time). On information and belief, Becton Dickinson GmbH is a wholly-owned subsidiary of BD. In the Australian litigation captioned Becton Dickinson Pty. Ltd. v. B. Braun Melsungen AG, No. NSD1297/2014 (filed Dec. 10, 2014), B. Braun Germany filed a cross-claim on December 22, 2014 asserting Australian patent , which claims priority to the same German patent application as does each of the Woehr/Raines patents, and is part of the same patent family. On 9

10 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 10 of 72 PageID #: 446 information and belief, Becton Dickinson Pty. Ltd. is a wholly-owned subsidiary of BD. 30. Notwithstanding such knowledge, Defendants continue to infringe the Woehr/Raines patents; such infringement is and has been willful. 31. Defendants have had knowledge of the Woehr/Zerbes patents and their respective published applications since at least as of December 15, For example, and without limitation: A United States patent application in the same family as the Woehr/Zerbes patents and to which the Woehr/Zerbes patents claim priority, U.S. App. Ser. No. 11/592,595, was published on May 8, 2008 as US A1, and has been cited during the prosecution of twenty-five U.S. patents issued in the name of BD, the earliest-issued of which, U.S. Patent 7,938,805, issued on May 10, During the prosecution of U.S. Patent 7,938,805, Becton Dickinson disclosed U.S. Patent Application Publication US A1 to the U.S.P.T.O. in an Information Disclosure Statement dated December 15, Becton Dickinson continued to disclose the Woehr/Zerbes family publication in over two dozen of its patent applications, including during the prosecution of U.S. App. Ser. No. 13/042,154 (the BD 154 Application ), in an Information Disclosure Statement filed on August 23, In that application, the Woehr/Zerbes family publication was then repeatedly cited by the Examiner as part of the basis for an obviousness rejection of the then-pending claims of the BD 154 Application. Becton Dickinson argued in responses to office actions on February, , June 19, 2013, July 18, 2013 and October 28, 2013 that the 10

11 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 11 of 72 PageID #: 447 then-pending claims of its patent application were not rendered obvious by the Woehr/Zerbes family publication. Becton Dickinson devoted more than a full page of its October 28, 2013 response to a discussion of the teachings of the Woehr/Zerbes family publication. At the time of that submission, and the June 19, 2013 and July 18, 2013 submissions that preceded it, the 247 Patent had already issued, on June 11, On February 18, 2014 Becton Dickinson again disclosed the Woehr/Zerbes family publication in U.S. App. Ser. No. 14/065,040 (the BD 040 Application ). In that application, the Examiner subsequently rejected ten then-pending claims as anticipated by the Woehr/Zerbes family publication, in an office action dated July 11, At that time, both the 247 patent and the 249 patent had issued to B. Braun. On information and belief, the BD 154 Application and the BD 040 Application list as inventors one or more BD employees involved in the development of the Autoguard BC. For example, and without limitation, Figure 6c of each of those applications depicts a valve actuator substantially similar to the valve actuator used in the Autoguard BC: Excerpt of Figure 6c Autoguard BC Valve Actuator On information and belief, one or more of these BD employees involved in the development of the Autoguard BC, and/or their attorneys, had knowledge of the Woehr/Zerbes patents, which share substantially identical specifications with, and 11

12 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 12 of 72 PageID #: 448 claim priority to, the Woehr/Zerbes family publication, on or around the times of their respective issue dates. On information and belief, one or more BD employees involved in the development of the Autoguard BC, and/or their attorneys, had knowledge, as of the respective issue dates of the Woehr/Zerbes patents, that the Autoguard BC infringes one or more claims of each of those patents. 32. Notwithstanding such knowledge, Defendants continue to infringe the Woehr/Zerbes patents; such infringement is and has been willful. 33. Defendants have had knowledge of the Kuracina patents since at least as of November 15, For example, and without limitation: A United States patent in the same family as the Kuracina patents and to which the Kuracina patents claim priority, U.S. Patent No. 6,443,929, issued on September 3, 2002, and has been cited during the prosecution of twenty-three U.S. patents issued in the name of BD, the earliest-issued of which, U.S. Patent 7,041,066 issued on May 9, During the prosecution of U.S. Patent 7,041,066, Becton Dickinson disclosed U.S. Patent No. 6,443,929 to the U.S.P.T.O. in a Supplemental Information Disclosure Statement dated November 15, Becton Dickinson GmbH filed an Opposition to EP B1, a European patent claiming priority to the same U.S. provisional patent applications as does each of the Kuracina patents, and is part of the same patent family. On March 5, 2014, B. Braun Germany s counsel sent an to counsel for Becton Dickinson GmbH stating that their client has identified several granted 12

13 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 13 of 72 PageID #: 449 US patents as enumerated in the attached document which may show an overlap with your client s products as also enumerated in the attached document. Attached to the was a document listing the Kuracina patents. 34. Notwithstanding such knowledge, Defendants continue to infringe the Kuracina patents; such infringement is and has been willful. COUNT ONE INFRINGEMENT OF THE 626 PATENT 35. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein. 36. Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 626 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC. 37. For example, and without limitation, the Autoguard BC infringes claim 1 of the 626 patent. 38. The preamble of claim 1 of the 626 patent recites [a] catheter insertion device. The Autoguard BC is or comprises a catheter insertion device. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids. 39. Claim 1 of the 626 patent recites that the catheter insertion device comprises a catheter hub comprising an interior cavity having an opening at a proximal end. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 13

14 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 14 of 72 PageID #: Claim 1 of the 626 patent recites that the catheter insertion device comprises a catheter tube having a distal end opening extending distally of the catheter hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 41. Claim 1 of the 626 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 14

15 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 15 of 72 PageID #: Claim 1 of the 626 patent recites that the catheter insertion device comprises a valve positioned inside the interior cavity of the catheter hub, said valve obstructing fluid flow and comprises a slit; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 15

16 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 16 of 72 PageID #: Claim 1 of the 626 patent recites that the catheter insertion device comprises a valve actuating element slidingly disposed in the interior cavity of the catheter hub to actuate the valve in a distal direction, the valve actuating element comprising a tapered nose section with an opening structured to push the valve to open the slit, and at least one plunger element extending proximally of the nose section and having a cross-sectional dimension smaller than the nose section and a proximal end surface; wherein the at least one plunger element is slidable distally within the catheter hub when the proximal end surface is pressed distally to push the valve to open the slit. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 16

17 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 17 of 72 PageID #: Claim 1 of the 626 patent recites that the catheter insertion device comprises 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 needle hub in a ready position, the needle protective device is movable to prevent unintended needle sticks. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 17

18 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 18 of 72 PageID #: Defendants infringing acts are, have been, and continue to be willful. 46. As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C

19 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 19 of 72 PageID #: 455 COUNT TWO INFRINGEMENT OF THE 728 PATENT 48. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein. 49. Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 728 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC. 50. For example, and without limitation, the Autoguard BC infringes claim 1 of the 728 patent. 51. The preamble of claim 1 of the 728 patent recites [a] catheter insertion device. The Autoguard BC is or comprises a catheter insertion device. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids. 52. Claim 1 of the 728 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 19

20 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 20 of 72 PageID #: Claim 1 of the 728 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 54. Claim 1 of the 728 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 20

21 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 21 of 72 PageID #: Claim 1 of the 728 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 21

22 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 22 of 72 PageID #: Claim 1 of the 728 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 22

23 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 23 of 72 PageID #: Defendants infringing acts are, have been, and continue to be willful. 58. As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C

24 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 24 of 72 PageID #: 460 COUNT THREE INFRINGEMENT OF THE 463 PATENT 60. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein. 61. Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 463 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC. 62. For example, and without limitation, the Autoguard BC infringes claim 1 of the 463 patent. 63. The preamble of claim 1 of the 463 patent recites [a] catheter insertion device. The Autoguard BC is or comprises a catheter insertion device. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids. 64. Claim 1 of the 463 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 24

25 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 25 of 72 PageID #: Claim 1 of the 463 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 66. Claim 1 of the 463 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 25

26 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 26 of 72 PageID #: Claim 1 of the 463 patent recites that the catheter insertion device comprises 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 therebetween 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 26

27 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 27 of 72 PageID #: Claim 1 of the 463 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 27

28 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 28 of 72 PageID #: Defendants infringing acts are, have been, and continue to be willful. 70. As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C

29 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 29 of 72 PageID #: 465 COUNT FOUR INFRINGEMENT OF THE 735 PATENT 72. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein. 73. Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 735 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC. 74. For example, and without limitation, the Autoguard BC infringes claim 1 of the 735 patent. 75. The preamble of claim 1 of the 735 patent recites [a] catheter insertion device. The Autoguard BC is or comprises a catheter insertion device. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids. 76. Claim 1 of the 735 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 29

30 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 30 of 72 PageID #: Claim 1 of the 735 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 78. Claim 1 of the 735 patent recites that the catheter insertion device comprises a valve configured to obstruct fluid flow comprising a wall surface comprising a slit positioned inside 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 30

31 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 31 of 72 PageID #: Claim 1 of the 735 patent recites that the catheter insertion device comprises a valve actuating element slidingly disposed in the catheter hub configured 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 therebetween to permit fluid flow to flow therethrough; the two plunger elements configured to transfer a distally directed force to the nose section to push the valve to open the slit. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 31

32 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 32 of 72 PageID #: Claim 1 of the 735 patent recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 32

33 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 33 of 72 PageID #: Defendants infringing acts are, have been, and continue to be willful. 82. As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C

34 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 34 of 72 PageID #: 470 COUNT FIVE INFRINGEMENT OF THE 762 PATENT 84. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein. 85. Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 762 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC. 86. For example, and without limitation, the Autoguard BC infringes claim 33 of the 762 patent. 87. The preamble of claim 9 of the 762 patent, from which claim 33 depends, recites a catheter insertion device. The Autoguard BC is or comprises a catheter insertion device. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids. 88. Claim 9 of the 762 patent, from which claim 33 depends, recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 34

35 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 35 of 72 PageID #: Claim 9 of the 762 patent, from which claim 33 depends, recites that the catheter insertion device comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 90. Claim 9 of the 762 patent, from which claim 33 depends, recites that the catheter insertion device comprises a valve for regulating fluid flow positioned inside the interior cavity of the catheter hub for regulating fluid flow into the interior cavity; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub and said valve being in contact with a valve actuating element when in an open position for fluid flow. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 35

36 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 36 of 72 PageID #: Claim 9 of the 762 patent, from which claim 33 depends, recites that the catheter insertion device comprises a needle protective device for preventing unintended needle sticks, said needle protective device positioned in-line with the catheter hub and the needle hub and having at least a portion extending distally of the proximal end of the catheter hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 36

37 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 37 of 72 PageID #: Claim 15 of the 762 patent, which depends from claim 9, and from which claim 33 depends, recites a catheter insertion device wherein the valve actuating element is formed as a hollow cylinder with a truncated cone-shaped distal end section. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 93. Claim 33 of the 762 patent recites a catheter insertion device wherein the valve actuating element further comprises at least two legs extending proximally of the truncated coneshaped distal end section; said at least two legs define a gap for fluid flow to flow therebetween 37

38 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 38 of 72 PageID #: 474 and wherein said at least two legs are configured to transfer a distally directed force to the truncated cone-shaped distal end section to open the valve. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 94. Defendants infringing acts are, have been, and continue to be willful. 95. As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will 38

39 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 39 of 72 PageID #: 475 continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C COUNT SIX INFRINGEMENT OF THE 247 PATENT 97. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein. 98. Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 247 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC. 99. For example, and without limitation, the Autoguard BC infringes claim 12 of the 247 patent The preamble of claim 12 of the 247 patent recites [a] safety catheter assembly. The Autoguard BC is or comprises a safety catheter assembly. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids Claim 12 of the 247 patent recites that the safety catheter assembly comprises a first hub comprising an interior cavity, an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the first hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 39

40 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 40 of 72 PageID #: Claim 12 of the 247 patent recites that the safety catheter assembly comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 103. Claim 12 of the 247 patent recites that the safety catheter assembly comprises a valve comprising a slit for obstructing fluid flow positioned inside the interior cavity of the first hub; said valve remaining inside the interior cavity when the needle is removed from the catheter 40

41 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 41 of 72 PageID #: 477 tube and the first hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 104. Claim 12 of the 247 patent recites that the safety catheter assembly comprises a valve actuating element slidingly disposed in the first hub for actuating the valve, the valve actuating element comprising a nose section having a tapered end with an opening configured to push the valve to open the slit and at least two leg elements extending proximally of the nose section and having a gap therebetween; wherein the at least two leg elements with the gap therebetween are disposed distally of the opening at the proximal end of the first hub and are slidable distally by a male implement projecting 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 41

42 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 42 of 72 PageID #: Claim 12 of the 247 patent recites that the safety catheter assembly comprises a needle protective device positioned proximally of the valve and at least in part around the needle and distal of a proximal end of the second hub in a ready position and configured to prevent unintended needle sticks in a protective position. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 42

43 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 43 of 72 PageID #: Claim 12 of the 247 patent recites a safety catheter assembly wherein an arm extends distally of a third hub and is located at least in part in the first hub in a ready position. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 43

44 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 44 of 72 PageID #: Claim 12 of the 247 patent recites a safety catheter assembly wherein a portion of the needle protective device springs relative to the needle to move to the protective position. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 44

45 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 45 of 72 PageID #: Defendants infringing acts are, have been, and continue to be willful As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C COUNT SEVEN INFRINGEMENT OF THE 249 PATENT 111. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 249 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC For example, and without limitation, the Autoguard BC infringes claim 1 of the 249 patent The preamble of claim 1 of the 249 patent recites [a] catheter assembly. The Autoguard BC is or comprises a catheter assembly. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids. 45

46 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 46 of 72 PageID #: Claim 1 of the 249 patent recites that the catheter assembly comprises a first hub comprising an interior cavity, an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the first hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 116. Claim 1 of the 249 patent recites that the catheter assembly comprises 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. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 46

47 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 47 of 72 PageID #: Claim 1 of the 249 patent recites that the catheter assembly comprises a valve comprising a slit for obstructing fluid flow and a skirt section positioned inside the interior cavity of the first hub such that the skirt section contacts the interior cavity of the first hub; said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the first hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 47

48 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 48 of 72 PageID #: Claim 1 of the 249 patent recites that the catheter assembly comprises a valve opener disposed in the first hub for actuating the valve, the valve opener comprising a nose section for pushing the valve to open the slit when activated and a leg element extending proximally of the nose section; wherein the leg element is slidable distally within the interior cavity of the first hub by a male implement to transfer a distally directed force to the nose section to push the valve to open the slit. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 48

49 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 49 of 72 PageID #: Claim 1 of the 249 patent recites that the catheter assembly comprises a needle protective device spring loaded in a ready to use position and positioned proximally of the valve and at least in part around the needle to prevent unintended contact with the needle tip in a protective position. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 49

50 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 50 of 72 PageID #: Claim 1 of the 249 patent recites a third hub positioned substantially proximally of the first hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 121. Defendants infringing acts are, have been, and continue to be willful. 50

51 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 51 of 72 PageID #: As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C COUNT EIGHT INFRINGEMENT OF THE 641 PATENT 124. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 641 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Autoguard BC For example, and without limitation, the Autoguard BC infringes claim 25 of the 641 patent The preamble of claim 25 of the 641 patent recites [a] safety catheter assembly. For example, and without limitation, the Autoguard BC PMA states that [t]he BC Insyte Autoguard BC catheter is inserted into a patient s vascular system to sample blood, monitor blood pressure, or administer fluids. 51

52 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 52 of 72 PageID #: Claim 25 of the 641 patent recites that the safety catheter assembly comprises a catheter hub comprising a housing comprising an exterior surface and an interior surface defining an interior cavity having an interior shoulder and an open proximal end. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 129. Claim 25 of the 641 patent recites that the safety catheter assembly comprises a catheter tube attached to a distal end of the catheter hub and having a distal opening. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 52

53 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 53 of 72 PageID #: Claim 25 of the 641 patent recites that the safety catheter assembly comprises a needle hub having a needle with a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube with the needle tip extending out the distal opening. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 131. Claim 25 of the 641 patent recites that the safety catheter assembly comprises a valve for limiting fluid flow and a valve opener in cooperative arrangement therewith positioned in the interior cavity of the catheter hub, said valve opener comprising a projection abutting the 53

54 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 54 of 72 PageID #: 490 interior shoulder of the catheter hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 132. Claim 25 of the 641 patent recites that the safety catheter assembly comprises a safety device for covering the needle tip comprising a tip protector housing having a housing section positioned proximally of the catheter hub and a projection positioned at least in part in the open proximal end of the catheter hub. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 54

55 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 55 of 72 PageID #:

56 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 56 of 72 PageID #: Claim 25 of the 641 patent recites that the safety catheter assembly comprises at least two proximally extending legs having a gap therebetween of the valve opener being sized and shaped to be pushed distally to transfer a distally directed force to the valve to open one or more slits on the valve. The Autoguard BC includes elements that meet this limitation, for example, and without limitation, as shown below: 134. Defendants infringing acts are, have been, and continue to be willful As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will 56

57 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 57 of 72 PageID #: 493 continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C COUNT NINE INFRINGEMENT OF THE 539 PATENT 137. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 539 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Nexiva For example, and without limitation, the Nexiva infringes claim 1 of the 539 patent The preamble of claim 1 of the 539 patent recites [a]n intravenous catheter assembly. The Nexiva is or comprises an intravenous catheter assembly. For example, and without limitation, the Nexiva PMA states [t]he BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte luer access port, and a passive needle-shielding mechanism Claim 1 of the 539 patent recites that the intravenous catheter assembly comprises a catheter hub with a catheter tube. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 57

58 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 58 of 72 PageID #: Claim 1 of the 539 patent recites that the intravenous catheter assembly comprises a needle having a needle shaft, a proximal end attached to a needle hub, a sharpened distal end, and a change in profile. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 143. Claim 1 of the 539 patent recites that the intravenous catheter assembly comprises a needle guard slidably disposed about said needle shaft, said needle guard comprising a needle trap, the needle trap comprising an extending arm and a projection for releasably holding the catheter hub in a ready to use position; the needle guard further comprising an inner chamber and a slot for fixedly attaching the needle trap into the slot. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 58

59 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 59 of 72 PageID #: Claim 1 of the 539 patent recites wherein the projection is free to move to allow the catheter hub to separate from the needle guard when the needle trap is no longer biased by the needle. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 59

60 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 60 of 72 PageID #: Claim 1 of the 539 patent recites that the intravenous catheter assembly comprises an opening on the needle guard for interacting with the change in profile to limit distal advancement of the needle guard along the needle. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 146. Defendants infringing acts are, have been, and continue to be willful As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C

61 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 61 of 72 PageID #: 497 COUNT TEN INFRINGEMENT OF THE 605 PATENT 149. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 605 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Nexiva For example, and without limitation, the Nexiva infringes claim 1 of the 605 patent The preamble of claim 1 of the 605 patent recites [a]n intravenous catheter assembly. The Nexiva is or comprises an intravenous catheter assembly. For example, and without limitation, the Nexiva PMA states [t]he BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte luer access port, and a passive needle-shielding mechanism Claim 1 of the 605 patent recites that the intravenous catheter assembly comprises a catheter hub with a catheter tube. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 61

62 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 62 of 72 PageID #: Claim 1 of the 605 patent recites that the intravenous catheter assembly comprises a needle having a needle shaft, a proximal end attached to a needle hub, a sharpened distal end, and a change in profile formed near the sharpened distal end. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 155. Claim 1 of the 605 patent recites that the intravenous catheter assembly comprises a needle guard slidably disposed about said needle shaft, said needle guard comprising a needle trap, the needle trap comprising an extending arm, a first projection, a fold located between the extending arm and the first projection such that the first projection releasably holds the catheter hub in a ready to use position and a sharp projection; the needle guard further comprising an inner chamber having a slot having the needle trap and the sharp projection disposed, at least in part, therein. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 62

63 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 63 of 72 PageID #: Claim 1 of the 605 patent recites that the needle trap is biased against the needle shaft, the first projection engages a shoulder on the catheter hub, and the first projection is movable to allow the catheter hub to separate from the needle guard when the needle trap is no longer biased by the needle shaft. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 63

64 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 64 of 72 PageID #: Claim 1 of the 605 patent recites an opening on the needle guard for interacting with the change in profile to limit distal advancement of the needle guard along the needle. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 64

65 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 65 of 72 PageID #: Defendants infringing acts are, have been, and continue to be willful As a direct and proximate consequence of the acts and practices of Defendants, Plaintiffs have been, are being and, unless such acts and practices are enjoined by the Court, will continue to be injured in their business and property rights, and have suffered, are suffering, and will continue to suffer injury and damages for which they are entitled to relief under 35 U.S.C As a direct and proximate consequence of their acts and practices, Defendants have also caused, are causing and, unless such acts and practices are enjoined by the Court, will continue to cause irreparable harm to Plaintiffs for which there is no adequate remedy at law, and for which Plaintiffs are entitled to injunctive relief under 35 U.S.C COUNT ELEVEN INFRINGEMENT OF THE 454 PATENT 161. Plaintiffs incorporate by reference the allegations contained in the preceding Paragraphs of this First Amended Complaint as if fully set forth herein. 65

66 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 66 of 72 PageID #: Defendants, without authorization from Plaintiffs, have infringed and are infringing at least one claim of the 454 patent, under 35 U.S.C. 271(a), by making, using, selling and/or offering for sale the Nexiva For example, and without limitation, the Nexiva infringes claim 1 of the 454 patent The preamble of claim 1 of the 454 patent recites [a]n intravenous catheter assembly. The Nexiva is or comprises an intravenous catheter assembly. For example, and without limitation, the Nexiva PMA states [t]he BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte luer access port, and a passive needle-shielding mechanism Claim 1 of the 454 patent recites that the intravenous catheter assembly comprises a catheter hub with a catheter tube. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 166. Claim 1 of the 454 patent recites that the intravenous catheter assembly comprises a needle having a needle shaft, a proximal end attached to a needle hub, a sharpened 66

67 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 67 of 72 PageID #: 503 distal end, and a change in profile. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 167. Claim 1 of the 454 patent recites that the intravenous catheter assembly comprises a needle guard slidably disposed about said needle shaft, said needle guard comprising a needle trap biased against a side of the needle shaft, the needle trap comprising an extending arm, a projection, and a fold located between the extending arm and the projection such that the projection releasably holds the catheter hub adjacent the needle guard in a ready to use position; the needle guard further comprising an inner chamber having a slot having the needle trap disposed, at least in part, therein. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 67

68 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 68 of 72 PageID #: Claim 1 of the 454 patent recites wherein the projection abuts a shoulder on the catheter hub in the ready position and is free to move to allow the catheter hub to separate from the needle guard when the needle trap is no longer biased by the needle. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 68

69 Case 1:16-cv RGA Document 16 Filed 07/25/16 Page 69 of 72 PageID #: Claim 1 of the 454 patent recites that the intravenous catheter assembly comprises an opening on the needle guard for interacting with the change in profile to limit distal advancement of the needle guard along the needle. The Nexiva includes elements that meet this limitation, for example, and without limitation, as shown below: 69