MBO LABORATORIES, INC. v. Becton, Dickinson & Co.

• Decision Date: 12 April 2010
• Docket Number: No. 2008-1288.,2008-1288.
• Citation: 602 F.3d 1306
• Parties: MBO LABORATORIES, INC., Plaintiff-Appellant, v. BECTON, DICKINSON & COMPANY, Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

602 F.3d 1306

MBO LABORATORIES, INC., Plaintiff-Appellant, v. BECTON, DICKINSON & COMPANY, Defendant-Appellee.

No. 2008-1288.

United States Court of Appeals, Federal Circuit.

April 12, 2010.

COPYRIGHT MATERIAL OMITTED

John M. Skenyon, Jolynn M. Lussier, Fish & Richardson, P.C., Boston, MA, for Plaintiff-Appellant.

Todd C. Zubler, William G. McElwain, Amy K. Wigmore, Wilmer Cutler Pickering Hale, Washington, DC, William F. Lee, Wilmer Cutler Pickering Hale, Boston, MA, Alexandra McTague, Wilmer Cutler Pickering Hale, New York, NY, for Defendant-Appellee.

Before GAJARSA, CLEVENGER, and DYK, Circuit Judges.

GAJARSA, Circuit Judge.

MBO Laboratories, Inc. ("MBO") appeals from the U.S. District Court for the District of Massachusetts' judgment in favor of Becton, Dickinson & Co. ("Becton"), invalidating MBO's U.S. Reissue Patent No. 36,885 (the "RE '885 patent") in its entirety based on the rule against recapture. Because we hold that MBO violated the rule against recapture, we affirm the district court's holding that RE '885 patent claims 27, 28, 32, and 33 are invalid, but we reverse the district court's invalidation of all other claims. We remand to the district court to address Becton's motion for summary judgment of non-infringement on original claims 13, 19, and 20.

BACKGROUND

MBO is the assignee of the RE '885 patent, which is a reissue of U.S. Patent No. 5,755,699 (the "'699 patent"). In our previous opinion, we summarized the RE '885 patent's technology and prosecution history at length. See MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1326-28 (Fed.Cir.2007). We only recount the facts relevant to this appeal below.

I. The Technology

The RE '885 patent discloses 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." Id. at 1326. In general, these syringes protect against needle-stick injuries by covering a contaminated cannula or needle "after removal from the patient." Id. The RE '885 patent teaches a syringe that protects against needle-stick injuries by sheathing a contaminated needle in a flange-covered guard. Specifically, the patent discloses a needle mounted inside a "guard body" wherein the needle can slide relative to the guard. See RE '885 patent figs.4, 6B, col.2 ll.65-67, col.3 ll. 1-3. "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." MBO, 474 F.3d at 1326. As soon as the health care worker slides the needle passed a "blocking flange," which is mounted to the guard body, the flange snaps over the needle tip and sheaths it inside the guard body. RE '885 patent at 57. The figures below from the RE '885 patent display how the needle, guard body, and flange appear before and after a health care worker uses a syringe on a patient.

II. Prosecution History

The RE '885 patent issued from the fifth application in a patent family that relates back to November 8, 1990. Those patents and applications include (1) U.S. Patent No. 5,176,655 (the "'655 patent"); (2) a continuation-in-part of the '655 patent, issued as U.S. Patent No. 5,395,347 (the "'347 patent"); (3) an abandoned continuation of the '347 patent, Application No. 08/398,772 (the "'772 application"); (4) a continuation of the '772 application, issued as the '699 patent; and (5) a reissue of the '699 patent, issued as the RE '885 patent. The '347 patent, the '772 application, the '699 patent, and the RE '885 patent share the same specification in substantial part. But the prosecution histories for only the '655 and '347 patents and the '772 application are relevant to the issue on appeal. Those prosecution histories contain the following exchanges with the U.S. Patent and Trademark Office (the "Patent Office").

On November 8, 1990, MBO filed its first patent application covering a hypodermic safety syringe,¹ resulting in the '655 patent. MBO, 474 F.3d at 1326. Prosecution claim 18 of this first application covered a "disposable medical assembly" comprising, among other things, a "guide means and manipulating means being relatively movable." The examiner rejected all prosecution claims, including claim 18, as anticipated by or obvious over U.S. Patent No. 4,923,281 ("Kothe"). Id. In response, MBO amended prosecution claim 18 by adding limitations, including a means-plus-function limitation that described the needle retracting into the guide means. In its amendment, MBO described the limitation as a "means preventing distal emergence of the needle from said guide means after retraction thereof into said guide means." Referring to this amendment, MBO explained to the examiner that "a chief feature of applicants' invention, inter alia, is not only the safe retraction of the needle or cannula... into the tubular member ..., but also precluding the inadvertent reemergence thereof to present a physical and contamination hazard." After a series of amendments not relevant here, the examiner allowed the claims and the application issued as the '655 patent with prosecution claim 18 issuing as claim 14. Id. at 1327; '655 patent col. 11 ll. 59-60.

On November 6, 1992, MBO filed its continuation-in-part of the '655 patent application with claims for a hypodermic safety needle for blood collection, resulting in the '347 patent. But the examiner rejected all claims in this application as obvious over U.S. Patent No. 5,026,356 ("Smith"). MBO, 474 F.3d at 1327. "The Smith patent discloses a safety syringe with a side-mounted guard that snaps down and over the tip of the needle." Id. MBO distinguished Smith by explaining that Smith "discloses a usual needle ... fixed to and extending from a conventional syringe barrel.... The needle is not slidably received in the barrel." According to MBO, "It is intended in Smith that as the needle is withdrawn from the flesh that the slidable member ... is bodily moved forward ..., whereupon after the needle is withdrawn, the point only of the needle lies behind the leg of the side-mounted guard...." In MBO's view, this structure raised safety concerns because the needle could not retract and an operator could only manually cover the needle tip. MBO explained that "the needle in Smith ... may be fully withdrawn from the patient's flesh by an inattentive or rushed operator... with the needle point and needle end portion fully exposed and hazardous for needlestick and contamination!" "MBO thus 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'...." Id. The examiner, however, again rejected some terms as unpatentable over prior art. But the examiner eventually allowed the claims to issue as the '347 patent after MBO distinguished the prior art "on the grounds that MBO's blocking flange moved into `adjacent relation' to the front of the guard, unlike any of the cited art." Id.

On March 6, 1995, MBO filed the '772 application as continuation of the '347 patent. As before, the examiner rejected the application's claims as anticipated by U.S. Patent No. 4,850,977 ("Bayless"), "or as obvious in view of Bayless and Smith." Id. "Bayless discloses a safety needle with a spring-loaded sheath that, when manually triggered, extends out and then closes over the exposed needle tip." Id.

In response to the rejection, MBO explained that Bayless disclosed a "needle that is fixed to the body `support chamber.'" "The needle thus never moves and is immovable in the syringe." Instead of a needle moving into a guard, MBO argued that "Bayless provides a separate hollow needle sheath ... which is axially movable on the chamber ..., which is propelled forwardly by a compression spring." MBO proceeded to distinguish Bayless from its invention on five grounds, two of which are relevant to this appeal. First MBO explained that its "needle ... is recited as slidable in the guard body ... between the Fig. 3 and Fig. 6B positions." Second, MBO explained that "the guard body ... has a front surface ... through which the needle ... is initially extended (Fig.3) and subsequently slidably retracted (Fig.6B) with the needle ... no longer extending forwardly through the guard body's front surface."

Despite MBO's response, the examiner again rejected the claims as obvious over Bayless in combination with U.S. Patent No. 5,125,908 ("Cohen"). Cohen discloses a safety syringe with a needle that retracts into a syringe holder. The examiner, however, accepted MBO's argument that Bayless only disclosed a fixed needle. According to the examiner, "Bayless does not disclose a retractable needle." But the examiner found that Cohen provided the missing component, rendering MBO's syringe obvious: "Cohen discloses a retractable needle ... in the same field of endeavor for the purpose of safely disposing of a needle." After this second rejection, MBO distinguished its invention from Bayless and Cohen on three grounds. MBO argued that unlike the prior art, its invention required (1) "a guard body ... for slidably receiving a needle," (2) a safety flange that engages "when the needle is slidably retracted" into the guard body, and (3) a mount for the safety flange's spring that prevents the flange from sliding up or down the guard body. See id. at 1328. Noting that Cohen had no flange and no spring mount, MBO argued that no combination of Bayless and Cohen could provide the three points listed above. Based on these arguments, the examiner allowed the claims. But MBO abandoned the '772 application to pursue another application with additional claims, resulting in the '699 patent. Id.

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