United States: Prosecution Statements Distinguishing Prior Art May Serve As Disclaimer Of Claim Scope

In Saffran v. Johnson & Johnson, No. 12-1043 (Fed. Cir. Apr. 4, 2013), the Federal Circuit reversed the ruling of the district court, holding that the district court misconstrued the claims of the patent-in-suit and that, under the correct construction, the defendants were entitled to JMOL of noninfringement.

Dr. Bruce N. Saffran is the owner and sole named inventor of U.S. Patent No. 5,653,760
("the '760 patent"), which describes methods and devices for treating injured tissues by sequestering particles and macromolecules in a defined space using a selectively permeable barrier in an effort to promote healing.  The specification of the '760 patent primarily describes the use of treated porous sheets for the treatment of complex bone fractures.  The '760 patent also describes that the techniques may be used in conjunction with intravascular stents to promote quicker healing of blood vessels, resulting in less plaque buildup.

Saffran sued Johnson & Johnson and Cordis Corporation (collectively "Cordis") for infringing the '760 patent by manufacturing arterial stents out of a metallic open mesh structure with struts coated with a microscopic layer of polymer and the drug sirolimus.  Following a Markman hearing, in which the district court construed a number of claim terms of the '760 patent, a jury returned a verdict in favor of Saffran, holding that the '760 patent was not invalid, that Cordis had willfully infringed the '760 patent, and that Saffran was entitled to damages.  Cordis moved for JMOL on invalidity, infringement, willfulness, and damages, and the district court denied Cordis's motion for JMOL as to invalidity, infringement, and damages, but granted the motion as to willfulness.  Cordis appealed, focusing on the district court's construction of the claim limitations "device" and "release means for release of an at least one treating material in a directional manner."

The Federal Circuit first addressed the "device" term and held that even though the term "device" appears in both the preamble and body of each of the independent claims, the district court misconstrued the term "device" as nonlimiting preamble language serving to give a descriptive name to the set of limitations in the body of the claim.  Cordis argued that "device" should be construed to mean "a continuous sheet" to be consistent with the '760 patent specification and in view of allegedly disclaiming statements made by Saffran during prosecution.  During prosecution of the '760 patent, in an argument over a cited prior art reference relating to rigid preformed chambers, Saffran had distinguished the art by describing on multiple occasions that "[t]he device used is a sheet rather than a pre formed chamber" as used in the prior art.  Slip op. at 16 (alteration in original) (citations omitted).

"[A]n applicant's argument that a prior art reference is distinguishable on a particular ground can serve as a disclaimer of claim scope even if the applicant distinguishes the reference on other grounds as well."  Slip op. at 16 (quoting Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1374 (Fed. Cir. 2007)).

Saffran argued that the scope of disclaimer during the prosecution history should be limited to the subject matter of the prior art reference being distinguished, specifically, the use of preformed chambers in the prior art.  The Court described Saffran's arguments to the examiner as containing two bases for distinguishing the prior art:  (1) that his device was a sheet, and (2) that his device was not a preformed chamber.  Id.   The Court explained that even if the examiner had only relied on the disclaimer that the device was not a preformed chamber, "an applicant's argument that a prior art reference is distinguishable on a particular ground can serve as a disclaimer of claim scope even if the applicant distinguishes the reference on other grounds as well."  Id. (quoting Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1374 (Fed. Cir. 2007)).  The Court further explained that Saffran's "unqualified assertion that 'the device used is a sheet' extends . . . to provide an affirmative definition for the disputed term."  Id. at 17 (citation omitted).

Saffran argued, however, that a spray embodiment disclosed in the specification was contrary to the construction that "the device" is "a continuous sheet."  The Court disagreed, holding that the spray embodiment only described the spray as both treating directly to the affected tissue and spanning open gaps between bone fragments to form a continuous sheet.  The Court further determined that the specification "makes clear that restraining tissue macromolecules is not only a key feature of the invention, but also one that open mesh stents cannot provide."  Id. at 19.  Thus, the Court construed the term "device" to require a sheet and to exclude stents having open mesh holes, and reversed the district court's construction of the term "device."

Cordis also disputed the district court's construction of the "release means" recited in each independent claim of the '760 patent.  Although Cordis did not dispute the claimed function identified by the district court as "to release a drug preferentially toward the damaged tissue," Cordis disagreed with the identification of the 35 U.S.C. § 112, ¶ 6, corresponding structure to carry out that function as "chemical bonds and linkages."  Id. at 20 (citation omitted).  Cordis argued that the only type of bond identified in the '760 patent for performing the release means is a hydrolyzable bond.  Saffran argued that the '760 patent broadly discloses "chemical bonds and linkages" as a clear category of structures that would be readily understood by one of ordinary skill in the art as suitable for performing the claimed function.  Id. at 21. 

The Court explained that "structure disclosed in the specification is 'corresponding' structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim.  This duty to link or associate structure to function is the quid pro quo for the convenience of employing § 112, ¶ 6."  Id. (quoting B. Braun Med., Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed. Cir. 1997)).  The Court held that the types of bonds set forth in the '760 patent as corresponding to the claimed release function are limited to hydrolyzable bonds, because (1) the specification repeatedly describes the linkage between treating materials and the sheet as a hydrolyzable bond, and (2) the specification does not link any additional structures to the release function with sufficient specificity to satisfy § 112, ¶ 6.  The Court found Saffran's arguments to the contrary unavailing and concluded that the district court erred in its construction of the "release means" limitation.

In view of the Court's construction of "device" and identification of the corresponding structure for the claimed "release means," the Court found two independent grounds for noninfringement as a matter of law.  As to the "device," the accused devices had open holes, with the layer not being applied as a continuous sheet, but "akin to paint on a chain link fence."  Id. at 25.  As the Court's construction of "device" required a continuous sheet and excluded stents having open mesh holes, the Court found that no reasonable jury could conclude that Cordis's accused stents infringed the '760 patent.  Separately, with regard to the "release means," the Court found that the record established that the accused stents used a sirolimus coating embedded in a polymer layer held in place by hydrophobic interactions, and that Saffran had stipulated that he would not pursue any arguments that hydrophobic interactions are equivalent to hydrolyzable bonds.

Accordingly, the Court found that the district court erred in its construction of "device" and misidentified the corresponding structure for the claimed "release means."  The Court therefore reversed the district court's judgment, as under either one of these proper constructions, Cordis was entitled to a judgment of noninfringement as a matter of law.

Judge Moore concurred-in-part, joining the opinion as to the construction of "device," but concluding that the district court was correct that the corresponding structure for the "release means" was the more generic "chemical bonds and linkages."  Moore Concurrence at 1.  Judge Moore submitted that the specification associated the claimed "release means" with a "chemical bond" structure with sufficient specificity to satisfy § 112, ¶ 6. 

Judge O'Malley also concurred-in-part, joining the opinion as to the construction of "release means," but disagreeing with the construction of "device."  As to the construction of "device" as a "sheet," Judge O'Malley argued that the claim language was broad and the written description disclosed several embodiments that "cannot fairly be characterized as sheets."  O'Malley Concurrence at 2.  Judge O'Malley also disagreed that there was a clear and unambiguous disclaimer of those embodiments in the prosecution history.  Because the majority agreed that "device" was a generic term, Judge O'Malley argued that to find a "special definition mandated by the written description, a term must be 'clearly' redefined, and an 'express intent' to do so must be evident from the patent."  Id. (citing Elekta Instrument S.A. v. O.U.R. Scientific Int'l, Inc., 214 F.3d 1302, 1307 (Fed. Cir. 2000)).  Judge O'Malley did not find such "clear definition" of "device" or "express intent" in the '760 patent or prosecution history.  Id. at 3.   Judge O'Malley asserted instead that the majority approached claim construction incorrectly by elevating prosecution history above other claim construction factors.  Judge O'Malley agreed with the majority, however, as to the construction of the "release means" limitations, noting that since the term was a means-plus-function element, the scope of the term was inherently narrowed by the disclosure and did not require examination of "the intrinsic record for a clear and unmistakable disavowal of claim scope."  Id. at 12-13.

This article previously appeared in Last Month at the Federal Circuit, May, 2013

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