5,456,669 and 5,658,261 were a family, directed to a front-loading fluid injector.

The ’669 and ’261 patents (hereinafter the “front-loading patents”) share a common specification and are directed to a front-loading fluid injector with a replaceable syringe capable of withstanding high pressures for delivering a contrast agent to a patient.

'669 and 261 claims were broadened during prosecution to snag Medrad. The broadening was by removing reference in the claims to a pressure jacket, which was all that had been disclosed.

The claims in the originally-filed application explicitly recited a pressure jacket in front of the syringe receiving opening. During the prosecution of the front-loading patents, Liebel removed all references in the claims to a pressure jacket. Medrad asserted, and the district court agreed, that during the prosecution of the front-loading patents, the applicants became aware of Medrad’s jacketless injector system and then deleted all references to a pressure jacket in the asserted claims in order to encompass Medrad’s injector within the scope of the claims. The examiner allowed the claims, and the claims as issued do not contain an explicit recitation of a pressure jacket.

In the first round at district court, the court construed the claims as requiring the pressure jacket, a construction which the CAFC reversed.

Even though the claims do not expressly recite a pressure jacket, the district court initially construed the asserted claims of the front-loading patents as requiring a pressure jacket. Based on that construction, the district court granted summary judgment of noninfringement in favor of Medrad because Medrad’s accused devices do not contain a pressure jacket.

In the first appeal to this court, we reversed the district court’s claim construction and determined that the asserted claims of the front-loading patents do not require a pressure jacket.

With the broader construction, the claims were found wanting for support in the specification: too broad to be considered fully enabled. Liebel had argued that, as the claims do not require a pressure jacket, but that an embodiment had been disclosed which had one, ergo the full scope of the claims had been enabled. Liebel also contended that it would not have taken "undue experimentation" to enable an injector without a pressure jacket, only "additional work."

On remand and in light of our claim construction, the district court concluded that Medrad’s devices did infringe the asserted claims of the front-loading patents, but that those claims were invalid for lack of compliance with the written description and enablement requirements of the statute. The district court reasoned that the claims were invalid for lack of written description because the specification does not describe a jacketless injector. The court noted that the written description of the invention is directed to the improvement of “loading and unloading a syringe given the constraints presented by the pressure jacket.”

The district court also concluded that the asserted claims were invalid for lack of enablement after considering the specification and the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988). The court observed that a pressure jacket was necessary to “maintain the integrity of the syringe housing against pressures the syringe encounters during operation of the injector.” The court further noted that the inventors themselves testified as to the importance of the pressure jacket around the syringe and that the experiments with and testing of jacketless systems were unsuccessful.

The court also observed that the written description and enablement requirements often rise and fall together and determined that the asserted claims of the front-loading patents “are of a far greater scope than [Liebel’s] specification of what it invented or possessed when it filed its application.” The court concluded that the specification failed to fulfill both the written description and enablement requirements set forth in § 112, ¶ 1.

In concurrence, the CAFC ruled that "the full scope of the claimed inventions includes injectors with and without a pressure jacket. That full scope must be enabled, and the district court was correct that it was not enabled." Further, the court took teaching away from not using a pressure jacket as evidence of requiring significant experimentation to practice the invention.

Turning first to consideration of the specification, we find that nowhere does the specification describe an injector with a disposable syringe without a pressure jacket. In fact, the specification teaches away from such an invention... As we have held previously, where the specification teaches against a purported aspect of an invention, such a teaching “is itself evidence that at least a significant amount of experimentation would have been necessary to practice the claimed invention.”

The inventors admitted that they tried unsuccessfully to produce a pressure-jacketless system and that producing such a system would have required more experimentation and testing. The inventors decided not to pursue such a system because it was “too risky.” The district court relied on various statements in the record by the inventors that testing of a syringe without a pressure jacket proved unsuccessful and that the inventors were not aware of any other similar testing being conducted at that time. Moreover, there was no indication of any prototype of a pressure-jacketless injector having been made.

As the CAFC pointed out, this ruling is a reiteration of AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1238-39 (Fed. Cir. 2003): "“as part of the quid pro quo of the patent bargain, the applicant’s specification must enable one of ordinary skill in the art to practice the full scope of the claimed invention."

Liebel was egregious in its overreaching. Claims typically undergo two constructions - First, the patent office supposedly construes the claims broadly in light of the prior art. Second, a plaintiff has the opportunity to construe the claims before the court. Liebel consistently went wide, and paid the price, albeit these patents, rather blatantly, should never have been allowed. If a jacketless injector had been within the prior art, the ruling would have been different.

5,662,6122 and 5,928,197 were of a different family, "directed to a computer-controlled injector wherein a motor advances and retracts a plunger located within the syringe." 5,383,858 was found to invalidate these patents. The owner of '858: Medrad!

Although the burden of showing invalidity is “especially difficult” when the prior art reference was before the examiner during prosecution, we find that Medrad has met that burden here. See Glaxo Group Ltd. v. Apotex, Inc., 376 F.3d 1339, 1348 (Fed. Cir. 2004).

Liebel argued for a broad construction of the term “physical indicia” and in fact broadened its claims during prosecution to recite physical indicia other than those indicating the length of an extender. Once again, Liebel argued for a broad meaning, and succeeded, but suffers a Pyrrhic victory.