Retractable Technologies Inc. v. Becton

• Decision Date: 31 October 2011
• Docket Number: No. 2010–1402.,2010–1402.
• Citation: 653 F.3d 1296,99 U.S.P.Q.2d 1233
• Parties: RETRACTABLE TECHNOLOGIES, INC. and Thomas J. Shaw, Plaintiffs–Appellees,v.BECTON, DICKINSON AND COMPANY, Defendant–Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

653 F.3d 1296

99 U.S.P.Q.2d 1233

RETRACTABLE TECHNOLOGIES, INC. and Thomas J. Shaw, Plaintiffs–Appellees,

v.BECTON, DICKINSON AND COMPANY, Defendant–Appellant.

No. 2010–1402.

United States Court of Appeals, Federal Circuit.

July 8, 2011.Rehearing En Banc Denied Oct. 31, 2011.*

Roy W. Hardin, Lock, Lord, Bissell & Liddell, LLP, of Dallas, TX, argued for plaintiffs-appellees. With him on the brief were Cynthia Keely Timms and Mark R. Backofen.

William F. Lee, Wilmer, Cutler, Pickering, Hale, and Dorr, LLP, of Boston, MA, argued for defendant-appellant. With him on the brief were Lisa J. Pirozzolo, and William G. McElwain and Heath A. Brooks, of Washington, DC.Before RADER, Chief Judge, and PLAGER and LOURIE, Circuit Judges.Opinion for the court filed by Circuit Judge LOURIE. Concurring opinion filed by Circuit Judge PLAGER. Dissenting-in-part opinion filed by Chief Judge RADER.LOURIE, Circuit Judge.

Becton, Dickinson and Company (“BD”) appeals from the final judgment of the United States District Court for the Eastern District of Texas in favor of Thomas J. Shaw and Retractable Technologies, Inc. (collectively, “RTI”). See Retractable Techs., Inc. v. Becton, Dickinson & Co., No. 2:07–CV–250, Final Judgment and Permanent Injunction (ECF No. 366) (E.D.Tex. May 19, 2010) (“ Final Judgment ”). The judgment follows a trial where a jury found infringement of certain claims of RTI's U.S. Patents 5,632,733 (“the '733 patent”), 6,090,077 (“the '077 patent”), and 7,351,224 (“the '224 patent”). The jury also found that the asserted patents were not invalid for anticipation or obviousness. The district court subsequently denied BD's post-trial motions for judgment as a matter of law (“JMOL”) or for a new trial on the issues of infringement and invalidity of the asserted patents. Retractable Techs., Inc. v. Becton, Dickinson & Co., Case 2:07–CV–250, Order (ECF No. 365) (E.D.Tex. May 19, 2010) (“ JMOL Order ”).

On appeal, BD challenges the district court's denial of its post-trial motions as well as the district court's claim constructions, Retractable Techs., Inc. v. Becton, Dickinson & Co., Case 2:07–CV–250, Claim Construction Order (ECF No. 122), 2009 WL 837887 (E.D.Tex. Jan. 20, 2009) (“ Claim Construction Opinion ”); Retractable Techs., Inc. v. Becton, Dickinson & Co., Case 2:07–CV–250, Order (ECF No. 239) (E.D.Tex. Sept. 21, 2009) (“ Modified Claim Construction Opinion ”), and the district court's exclusion of RTI's discovery responses from evidence, Retractable Techs., Inc. v. Becton, Dickinson & Co., Case 2:07–CV–250, Order (ECF No. 262) (E.D.Tex. Oct. 8, 2009) (“ Motion in Limine Order ”); Retractable Techs., Inc. v. Becton, Dickinson & Co., Case 2:07–CV–250, Order (ECF No. 276) (E.D.Tex. Oct. 28, 2009) (“ Motion to Strike Order ”). Because the district court erred in its construction of the claim term “body” but did not otherwise err, we affirm in part and reverse in part.

Background

This patent infringement case relates to retractable syringes, which are medical syringes that feature a needle that retracts into the syringe body after the syringe is used. The retraction of the needle reduces the risk associated with contaminated needles because the used needle, which resides in the syringe body after retraction, is less likely to accidentally stick a user. RTI and BD both design and sell retractable syringes.

The parties agree that retractable syringes generally existed by the early 1990s, and, as an invalidity defense at trial, BD relied on prior art retractable syringe patents filed in 1990 and 1991, specifically U.S. Patent 5,053,010 (“McGary”) and U.S. Patent 5,211,629 (“Pressly”). Figures 1 and 2 of McGary, reproduced below, generally show how a retractable syringe operates, with Figure 1 depicting a syringe prior to retraction of the needle (labeled 30) and Figure 2 depicting the syringe after retraction:

Image 1 (4.37" X 1.13") Available for Offline Print

Image 2 (4.41" X 1.6") Available for Offline Print As disclosed in McGary, prior to retraction, the front end of the syringe contains a compressed spring (labeled 24) that is pushed against a retainer (labeled 32). McGary, col.5 l.6–18. The plunger contains a cutting tip (labeled 42), and after the plunger is fully extended into the syringe barrel, additional force on the plunger causes the cutting tip to penetrate through the retainer, which allows the spring to decompress and retract the needle into the syringe body. Id. col.5 ll.50–61.

In 1995, Thomas Shaw filed a patent application for a “Tamperproof Retractable Syringe.” Shaw subsequently filed a series of continuation and continuation-in-part applications from the parent application, and these applications issued as the '733, '077, and '224 patents. The patents contain a detailed structural disclosure of a particular retractable syringe assembly. See Claim Construction Opinion, at 2–3. While multiple claims are at issue on appeal, claim 43 of the '224 patent, reproduced below, is generally representative of the asserted claims, reciting a syringe assembly that contains a “body” and a “retraction mechanism” in the front end portion of the “body,” where the “retraction mechanism” contains a “needle holder” and a “retainer member” that surrounds the inner head of the “needle holder”:

43. A syringe assembly having a retractable needle that is rendered unusable after a single injection of fluid into a patient, the assembly comprising:

a hollow syringe body comprising a barrel and having a front end portion and a back end portion, the back end portion further comprising at least one radially extending member providing finger grips for the syringe body;

a retraction mechanism disposed in the front end portion, the retraction mechanism further comprising a needle holder having a head portion, an elongated needle holding portion, and a longitudinally extending fluid passageway through the head portion and the elongated needle holding portion, the head portion further comprising an inner head, a continuous retainer member surrounding the inner head, and a bridging portion disposed between the continuous retainer member and the inner head, wherein said bridging portion couples the continuous retainer member and the inner head to form a fluid seal between the fluid passageway and the barrel prior to retraction, and a compressed retraction spring surrounding at least part of the elongated needle holding portion and biasing the inner head toward the back end portion prior to retraction;

a retractable needle extending into the front end portion of the body through an opening in the front end portion of the body, the retractable needle being held in fixed relation to the elongated needle holding portion of the needle holder and in fluid communication with the longitudinally extending fluid passageway through the head portion and the needle holding portion;

a plunger reciprocally disposed inside the barrel and forming a variable chamber between the plunger and the needle holder prior to and during injection, the plunger being receivable into the barrel through the back end portion of the body and comprising an outer wall, a retraction cavity disposed inwardly of the outer wall, a plunger seal element providing sliding, sealed engagement between the plunger and the barrel and preventing fluid leakage between the plunger and the barrel, the plunger seal element being restrained from sliding longitudinally along the outer wall of the plunger, and a back end with an end cap having an outer periphery; and

a barrier disposed in the front end portion of the body that limits forward motion of the needle holding portion and the retractable needle relative to the body as the plunger is depressed inside the barrel during injection and retraction;

wherein the continuous retainer member is releasable from the inner head of the needle holder when the plunger is further depressed inside the barrel following injection.

'224 patent, col.22 l.35–col.23 l.19 (emphases added). Generally, the retraction mechanism contains a needle holder and spring combination. '733 patent, col.2 l.58–col.3 l.7.¹ The needle holder contains a circular head, and a clamping or frictional force on the head holds the needle holder in position. Id. col.3 l.7–24. When the plunger is depressed to a “retraction position,” this force causes the retraction mechanism to activate and release the needle holder. Id.

Important for the purposes of this appeal, the patents disclose what RTI refers to as the “bridge” embodiment. In this embodiment, the head of the needle holder contains two parts, an inner head and a retainer member that surrounds the inner head. Id. col.3 l.25–46. The retainer member and the inner head of the needle holder are connected by a weld that creates a bridge portion. Id. col.3 ll.39–46, col.9 ll.7–17. Figure 8, reproduced below, depicts the “bridge” embodiment, with the inner head of the needle holder (labeled 72a) connected to the retainer member (labeled 66a) by a “bridge” that is created by welding the raised portion of the inner head (labeled 73) to the retainer member:

Image 3 (4.27" X 3.17") Available for Offline Print In this embodiment, when the plunger is fully extended into the barrel, additional force on the plunger causes the bridging portion to be “ruptured, fractured or otherwise separated” so the weld no longer holds the needle holder in place. Id. col.8 ll.18–56. This allows the compressed spring (labeled 24) to expand and thereby retract the needle (labeled 28) and the needle holder (labeled 22a). Id.

In 2007, RTI sued BD in the Eastern District of Texas, alleging that BD's 1 mL and 3 mL Integra™ syringes infringe various claims of the '733, '077, and ' 224 patents. Excluding the plunger, the 3 mL syringe contains two pieces, a syringe body and a needle assembly that screws into the body. The needle assembly contains an inner hub and an outer hub that are connected to each other. The outer hub contains the...