Mbo Laboratories, Inc. v. Becton, Dickinson & Co.
| Decision Date | 24 January 2007 |
| Docket Number | No. 2006-1062.,2006-1062. |
| Citation | 474 F.3d 1323 |
| Parties | MBO LABORATORIES, INC., Plaintiff-Appellant, v. BECTON, DICKINSON & COMPANY, Defendant-Appellee. |
| Court | U.S. Court of Appeals — Federal Circuit |
John M. Skenyon, Fish & Richardson P.C., of Boston, MA, argued for plantiff-appellant.
Richard J. Oparil, Patton Boggs LLP, of Washington, DC, argued for defendant-appellee. With him on the brief were Marc R. Labgold and Kevin M. Bell, of McLean, Virginia.
Before BRYSON, Circuit Judge, CLEVENGER, Senior Circuit Judge, and GAJARSA, Circuit Judge.
This appeal arises under the patent laws. Plaintiff MBO Laboratories, Inc. ("MBO") appeals a summary judgment of noninfringement of U.S. Patent No. RE 36,885 ("the RE '885 patent") granted by the United States District Court for the District of Massachusetts. After conducting a Markman hearing, the district court construed the various disputed claim terms. MBO Labs. v. Becton, Dickinson, & Co., 385 F.Supp.2d 88 (D.Mass.2005). MBO conceded that under the district court's claim construction there was no infringement of the patent claims. The district court therefore granted summary judgment in favor of defendant Becton, Dickinson & Company ("Becton"). MBO timely appealed the claim construction to this court.
For the reasons given below, we affirm the district court's construction of the disputed term "immediately" except as that construction affects claims 32 and 33, and we reverse as to "slidably receiving," "relative movement," "adjacent," "proximity," and "mounted on said body," and remand for further proceedings consistent with this opinion.
The RE '885 patent is directed generally to a design for a hypodermic safety syringe. The patented invention, the accused device, and relevant prior art syringes all include features intended to protect health care workers and bystanders from inadvertent needle sticks following an injection or drawing of fluid. This largely involves ensuring that the contaminated parts of the cannula or needle, especially the sharp point at the end of the cannula that enters the body, are covered in some manner soon after removal from the patient.
MBO's syringe is described in detail in the patent, but it is essentially structured by having the needle or cannula mounted inside a guard sleeve. The needle's sharp end protrudes through a hole in the front of the guard, permitting it to be inserted into the patient. When the needle is removed from the patient, the health care worker slides the needle backwards relative to the guard. A "blocking flange" is mounted on the guard and held in spring tension against the needle. When the needle's point slides behind this flange, the flange moves vertically in relation to the guard, covering the tip of the needle and preventing it from being inadvertently re-exposed. The needle's tip is covered by the flange and the rest of the contaminated needle is sheathed inside the guard. Once the flange is activated, the needle is encapsulated by the guard sleeve and rendered safe.
The RE '885 patent has a complex prosecution history which will be described here in some detail. The first patent application covering MBO's invention1 was issued in January 1993 as U.S. Patent No. 5,176,655 ("the '655 patent"). Prior to the issuance of the '655 patent, MBO filed two continuation applications claiming priority to the original application: a continuation-in-part application, issued in March 1995 as U.S. Patent No. 5,395,347 ("the '347 patent"), and a continuation application, ultimately issued in May 1998 as U.S. Patent No. 5,755,699 ("the '699 patent"). MBO subsequently requested a broadening reissue of the '699 patent pursuant to 35 U.S.C. § 251, which was granted in September 2000 as U.S. Patent No. RE 36,885. The RE '885 patent is the only one asserted in this litigation, but the entire prosecution history of its relatives is relevant to the claim construction analysis. See Microsoft Corp. v. Multi-Tech Sys., 357 F.3d 1340, 1349-50 (Fed.Cir.2004).
In the application that culminated in the original '655 patent, the first office action rejected all the claims as anticipated or obvious in view of U.S. Patent No. 4,943,281, issued to Kothe. MBO then amended the claims by adding additional limitations. It distinguished the invention from the prior art by noting that MBO's invention was capable of "precluding the inadvertent reemergence [of the needle]." Reply Letter to Finkel, Examiner, In the Patent Application of McCormick et al., S/N 07/610,583, at 5 (Sept. 12, 1991).
The examiner rejected the claims again based on prior art: namely, U.S. Patent Nos. 4,915,697, 4,887,998, and 4,917,672, issued respectively to du Pont, Martin, and Terndrup. Following an interview with the examiner, MBO narrowed its claims in this first application significantly to include specific features found on its syringe product, such as "flexible wing-like sections," which flex to allow or preclude relative movement between the needle and guard, as needed. MBO also amended some, but not all, of its independent claims to require "shield means . . . for automatically precluding" the needle from coming back out or being accessed. Reply Letter to Stright, Examiner, In the Patent Application of McCormick et al., S/N 07/610,583, at 2-3 (July 17, 1992). As it had before, MBO differentiated the three cited prior art patents for failing to prevent the reemergence of the needle. Id. at 7-8. MBO additionally differentiated the du Pont reference as lacking "the automatic and immediate safety means of the present invention." Id. at 7. After these specific amendments, the application issued as the '655 patent.
Before the '655 patent issued, MBO filed a continuation-in-part application claiming priority from the first application. The examiner rejected all claims in this application as obvious in view of prior art U.S. Patent No. 5,026,356, issued to Smith. The Smith patent discloses a safety syringe with a side-mounted guard that snaps down and over the tip of the needle. MBO amended its claims to distinguish from Smith on the basis that its needle guard fully surrounded the needle as opposed to only covering the "tip of the point," and also that the needle in Smith "may be fully withdrawn from the patient's flesh by an inattentive or rushed operator in [the unsafe] state . . . !" Reply Letter to Alexander, Examiner, In the Patent Application of Blecher et al., S/N 07/972,013, at 8 (Nov. 15, 1993) (emphasis in original). The examiner once again rejected certain claims as unpatentable over other prior art. MBO distinguished the additional references on the grounds that its blocking flange moved into "adjacent relation" to the front of the guard, unlike any of the cited art. Reply Letter to Alexander, in the Patent Application of Blecher et al., S/N 07/972,013, at 2 (June 3, 1994). After this argument, the examiner allowed the claims and the continuation-in-part application issued as the '347 patent.
The next stage in the prosecution of this invention was a continuation application also claiming priority to the original application. The examiner rejected the new claims as anticipated by U.S. Patent No. 4,850,977, issued to Bayless, or as obvious in view of Bayless and Smith, supra. Bayless discloses a safety needle with a spring-loaded sheath that, when manually triggered, extends out and then closes over the exposed needle tip. MBO distinguished its invention from Bayless on three grounds: 1) MBO's invention included "a [guard] body . . . for slidably receiving a needle," 2) MBO's invention included a safety flange that engages "when the needle is slidably retracted" into the body, and 3) the safety flange is mounted to keep it from sliding up or down the guard body. Reply Letter to Alexander, Examiner, In the Patent Application of Blecher et al., S/N 08/398,772, at 5 (May 17, 1996). The examiner then allowed the claims. MBO abandoned this application and filed a new continuation with additional claims. This last application issued as the '699 patent in May 1998.
After issuance of the '699 patent, MBO sought a broadening reissue pursuant to 35 U.S.C. § 251 in July 1999. In its reissue application, it argued the claims of the '699 patent were narrow and that it had a right to broader claims. Specifically, it noted that it was entitled to claim a system having "any relative movement between the needle and the body," not just a "system wherein the needle must be bodily moved toward the safety device." The PTO allowed the reissue application without objection, and the RE '885 patent issued in September 2000.
MBO filed suit against Becton in the United States District Court for the District of Massachusetts, asserting infringement of claims 13, 19, 20, 27, 28, 32, and 33 of the RE '885 patent. MBO, 385 F.Supp.2d at 91. Claims 13, 19, and 20 were original to the '699 patent; claims 27, 28, 32, and 33 were added during the reissue process. Id. at 103. The district court conducted a hearing to construe the claims pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed.Cir. 1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Several claim terms were disputed by the parties, namely: "immediately," "relative movement," "slidably receiving," "adjacent," "proximity," and "mounted on said body." The district court's Markman order covers each of these terms.
The term "immediately" appears in the preamble of claims 13, 19, and 27: "A method of immediately and positively precluding needlestick injury from a contaminated needle comprising the steps of . . . ." RE '885 patent col. 10 ll.24-26, col. 12 ll.34-36, col.15 ll.5-7. The district court determined that the preamble limited these claims. MBO, 385 F.Supp.2d at 105. It construed "immediately" to mean "simultaneously with the needle's withdrawal from the donor." Id. at 106. It...
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...has taken on a life of its own, unbounded by the patent claims." Id. at 28-29. (2.) See MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323 (Fed. Cir. 2007) (where the court did not use the doctrine of equivalents analysis, but instead used a more holistic approach to interpretati......