Medline Industries, LP. v. C.R. Bard, Inc., Civil Action No. 1:20-cv-03981-JPB (N.D. Ga., May 2, 2023)

The Medline saga began as a single patent dispute nearly ten years ago in the Northern District of Illinois. Medline Industries, LP v. C.R. Bard, Inc. (Medline I), Civil Action No. 1:14-CV-03618, Dkt. 1 (N.D. Ill. May 5, 2014). Back then, Plaintiff Medline Industries, LP, accused Defendant C.R. Bard, Inc., of infringing U.S. Patent No. 8,448,786 (“the ’786 Patent”), entitled “Catheter Tray, Packaging System, Instruction Insert and Associated Methods.” The ’786 Patent is directed to a method of using a catheterization kit which is designed to reduce the risk of catheter-associated urinary tract infections. There, the Northern District of Illinois’ order precluded Medline from including in the already pending case a newly redesigned version of the accused product. Order, Medline I, Dkt. 481 (N.D. Ill. Jan. 8, 2020). Seeking an alternative avenue of redress, Medline filed suit in the Northern District of Georgia in 2020, this time introducing the redesigned kit to the ’786 Patent dispute. See Complaint, Medline Industries, LP. v. C.R. Bard, Inc. (Medline IV), Civil Action No. 1:20-cv-03981-JPB, Dkt. 1 (N.D. Ga. May 2, 2023). In particular, Medline accuses Bard of indirectly infringing Claim 1 of the ’786 Patent. After three years of litigation, on May 2, 2023, Special Master William H. Needle submitted the Report and Recommendation regarding claim construction of Claim 1 of the ’786 Patent. Special Master’s Report and Recommendation Regarding Claim Construction (R&R), Dkt. 137, at 9. The parties battle on, now disagreeing over the qualifications of one of ordinary skill in the art, the construction of the term “catheter assembly,” and the construction of the term “reveal.”

Level of Ordinary Skill in the Art

The Special Master adopts Bard’s proposal with a slight modification. Bard proposes the person of ordinary skill in the art (“POSITA”) is “an individual with a bachelor’s degree in mechanical engineering or equivalent technical degree and at least two years of experience in the medical device field.” Dkt. 74, at 6. “[F]or the purposes of claim construction only,” Medline agrees with Bard’s proposed POSITA. Dkt. 76, at 4. Medline argues that claim construction is the only matter before the Special Master presently, and if the case proceeds to expert discovery, Medline expects its experts to opine that the person of ordinary skill in the art is in fact a team, “including one member with a [degree in nursing], and another member with . . . (1) a Bachelor of Science degree in mechanical or packaging engineering, or a degree in industrial design, or (2) a bachelor’s degree in another technical field and about two years’ experience in the packaging of medical devices.”  Dkt. 129, at 16. Medline asserts that the team, however, is only relevant for later stages of litigation, such as obviousness analysis. Id. at 9. Furthermore, Medline argues that the POSITA for purposes other than claim construction is a question of fact for the jury, relying on Monolithic Power Sys., Inc. v. O2 Micro Int’l Ltd., 558 F.3d 1341, 1348-49 (Fed. Cir. 2009) (explaining that factual questions underlying a ruling of obviousness include the level of ordinary skill in the art).

In the R&R, the Special Master questions why Medline would not assert the team definition of the POSITA at this stage if they expect to use it later. Special Master acknowledges that any determination about POSITA “may subsequently change if the Court finds, for whatever reason, it becomes necessary to revisit.” Dkt. 137, at 11 (citing Jack Guttman, Inc. v. Kopykake Enterprises, Inc., 302 F.3d 1352, 1361 (Fed. Cir. 2002) (“Courts may engage in a rolling claim construction, in which the court revisits and alters its interpretation of the claim terms as its understanding of the technology evolves.”)). However, the Special Master reasons that since the Plaintiffs know how its expected POSITA may change, the expected POSITA may be evaluated at this stage for the purposes of claim construction. Id. at 12. The Special Master determines that a clinician is not necessary for the POSITA. According to the Special Master, although a clinician is the end-user of the invention, it does not make them a person of ordinary skill “in the art of storage containers for medical devices.” Id.at 13. The Special Master ultimately adopted a phrase neither party proposed, thus recommending that a person of ordinary skill in the art here is “one who would have a bachelor’s degree in mechanical engineering or equivalent technical degree and at least two years of experience in the medical device packaging field.” Dkt. 137, at 14 (emphasis original). This addition was justified in the R&R stating, “just as a court may arrive at its own constructions of claim terms even if they differ from the constructions proposed by the parties, so should a court be able to arrive at its own construction of the qualifications of a [POSITA].” Id. at 14 (citing Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1555 (Fed. Cir. 1995), cert denied, 518 U.S. 1020 (1996) (“[T]he trial judge has an independent obligation to determine the meaning of claims, notwithstanding the views asserted by the adversary parties.”)). In the Special Master’s view, the added specificity of his POSITA, “more naturally aligns with the ’786 Patent’s description of the invention.” Id.

Claim Construction

With the POSITA issues decided, the Special Master turns to the claim construction issues.  For each of the two disputed definitions in Claim 1, the Special Master adopted definitions similar to Medline’s proposals with some alterations. For Claim 1, the parties disagree about how to define the phrases “catheter assembly” and “reveal an additional layer of wrap and the catheter assembly.” Id. at 15.

Here, the Special Master recommends the same construction initially adopted in the Northern District of Illinois in Medline I. In Medline I, the Court imported the term “coiled” to describe the medical device in the catheter assembly, but later, the Illinois Court found it necessary to further define “coiled” as “having at least one complete 360-degree turn.” Anticipating the same dispute to arise over the definition of coiled in this case, Medline proposed that this Court adopt the same construction ultimately arrived at in Medline I. Dkt. 73, at 14. Here, the Special Master declines to adopt the final construction of Medline I, finding sufficient support in the specification and proposed embodiments for a “coiled” device but comparatively little support for the level of specificity proposed by Medline. Dkt. 137, at 17 (citing Johnson & Johnson Vision Care v. Ciba Vision Corp., 540 F.Supp.2d 1233, 1242 (M.D. Fla. 2008) (finding a district court has an independent obligation to determine the meaning of the claims and is not automatically bound by the construction of another district court)).

The Special Master similarly rejects Bard’s proposed construction, finding no support in the specification for the terms “unit” or “parts.” Special Master cites Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2015) (en banc) to support his position that the claim language that most naturally aligns with the patent’s description of the invention is the correct construction. The Special Master notes that importing the terms “unit” and “parts” have little intrinsic support in the patent. Dkt. 137, at 18. Further, adding new terms risks confusing the jury, therefore, the imported terms would likely require their own constructions. Id. Bard argues that including the term “coiled” improperly limits the scope of Claim 1. Bard asserts that claims must be given the full scope of their meaning and if Medline was acting as their own lexicographer, they would have to do so unambiguously. Dkt. 74, at 16. Bard relies on GE Lighting Solutions., LLC v. AgiLight, Inc., 750 F.3d 1304, 109 (Fed. Cir. 2014) to argue that to limit the meaning of “catheter assembly,” Medline would have to do so by either acting as their own lexicographer or disavowing the full scope of the term. The Special Master declines to view the six instances of “coiled” appearing in the patent to be nonlimiting examples because even Bard’s expert acknowledges that catheters are typically coiled in the packaging because of practical considerations apparent to one skilled in the art. Dkt. 137, at 23-24. Bard also argues that the assembly should not include the drainage bag. However, the Special Master rejects this argument and pointed to evidence in the ’786 Patent that the drainage bag and tubing were never identified separately from the catheter assembly. Id. at 22-23.

Finally, the Special Master addresses the dispute over the term “reveal.” The Special Master recommends a common-sense approach and rejects Bard’s proposition that the claim is indefinite. Both parties agree that the claims do not require the entire catheter assembly to be visible, but Bard urges “the Court to go further and decide as a matter of claim construction exactly how much must be uncovered.” Id. at 26. Bard asserts that otherwise, the claim would be indefinite because there would be no way for one of ordinary skill in the art to know the scope of the claim. The Special Master disagrees with this argument because Courts may “tolerate some modicum of uncertainty” when a person of ordinary skill in the art would be “reasonably certain” about the scope of the invention. Id. at 27 (citing Cox Communications, Inc. v. Sprint Communications Co, LP, 838 F.3d 1224, 1229 (Fed. Cir. 2016)). Therefore, “reveal does not render Claim 1 indefinite because it does not prevent the claim, read in light of the specification and the prosecution history, from informing those skilled in the art about the scope of the invention with reasonable certainty.” Id. Furthermore, the Special Master finds the parenthetical in Medline’s proposed construction redundant and potentially confusing. Id. The Special Master’s recommendation on the construction of “reveal” is consistent with the construction in Medline I.

At the stage of claim construction, the two cases, Medline I and Medline IV, have not diverged significantly. Medline I was resolved on summary judgment in Medline’s favor as to infringement of Claim 1, but litigation of other issues continues. It will be interesting to see if Judge Boulee adopts Special Master Needle’s recommendations wholesale or makes any changes which may cause this case to diverge from the result reached in Medline I with respect to Claim 1. Here, the both the term “coiled” and the question of how much of the assembly must be revealed introduce “a modicum of uncertainty” which could allow a judge or jury the latitude to reach a different conclusion about infringement of Claim 1.