Federal Circuit Finds That Statements In Specification Combined With Testimonial Evidence Support Holding Of Invalidity For Lack Of Enablement Of Full Scope Of Properly Construed Claims

In Liebel-Flarsheim Co. v. Medrad, Inc., 82 USPQ2d 1113 (Fed. Cir. 2007), Liebel-Flarsheim Company and its parent Mallinckrodt, Inc. (“Liebel”) sued Medrad, Inc., for infringing claims 10, 11, 13, and 16-19 of Liebel’s U.S. Patent No. 5,456,669 (the “‘669 patent), and claims 1, 8, 9, 11-13, 15, 16, 18, 22, 27, 28, 30-33, and 34-37 of Liebel’s U.S. Patent No. 5,658,261(the “‘261 patent).  While Liebel also sued Medrad for infringing certain claims of Liebel’s U.S. Patent Nos. 5,662,612 and 5,928,197, these patents are not at issue on appeal.

The ‘669 and ‘261 patents are directed to a front-loading fluid injector system with a replaceable syringe capable of withstanding high pressures for delivering a contrast agent to a patient.  In a previous appeal to the Federal Circuit (Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 69 USPQ2d 1801 (Fed. Cir. 2004), the Federal Circuit reversed the determination of the United States District Court for the Southern District of Ohio that the asserted claims of the ‘669 and ‘261 patents require a pressure jacket.  Based on that determination, the district court had granted Medrad’s motion for summary judgment of noninfringement because Medrad’s accused devices do not contain a pressure jacket.

On remand, and in light of the Federal Circuit’s determination that the asserted claims of Liebel’s patents do not require a pressure jacket, the district court determined that Medrad’s accused devices did infringe the claims of Liebel’s patents, but granted Medrad’s motion for summary judgment that the claims of Liebel’s patents were invalid for lack of compliance with the written description and enablement requirements of 35 USC §112, first paragraph.  Liebel appealed.

On appeal, the Federal Circuit noted that, in light of its previous determination that the claims do not require a pressure jacket, the full scope of Liebel’s claims includes injector systems both with and without a pressure jacket.  The court held that this full scope must be enabled, and found that the district court had correctly determined that it was not enabled.

Specifically, the Federal Circuit noted that the specifications of the ‘669 and ‘261 patents do not describe an injector system with a disposable syringe without a pressure jacket, and actually teach away from such an invention by stating that a disposable syringe without a pressure jacket is “impractical.”  The court held that 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,” relying on AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, (Fed. Cir. 2003).

The Federal Circuit also noted that the specifications of the ‘669 and ‘261 patents do not provide any guidance or suggestion of how to make or use a disposable syringe for high pressure use without a jacket; that all of the figures in the patents show a pressure jacket; and that all the discussion of the figures in the specifications refer to the pressure jacket.  Furthermore, the court noted that the testimony presented during the trial in the district court supports a conclusion that no genuine issue of material fact exists as to whether undue experimentation would have been required to make and use an injector system with a disposable syringe without a pressure jacket.  The inventors admitted that they tried unsuccessfully to make such an injector system.  They admitted that more experimentation and testing would have been required to make such an injector system, and that they decided not to proceed with such an approach because it was “too risky.”  The court noted that the district court had relied on statements by the inventors that testing of a syringe without a pressure jacket had been unsuccessful, and that they were unaware of any other similar testing being conducted at that time.  Nothing in the record indicated that a prototype of an injector system with a disposable syringe without a pressure jacket had been made such that there was no evidence that the claims were supported for the syringe without the jacket.

Liebel argued that its position was supported by language in Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 3 USPQ2d 1737 (Fed. Cir. 1987), that states that if an invention pertains to an art where the results are predictable, such as in the mechanical arts, then disclosure of a single embodiment can enable a broad claim.  Liebel argued that because the specifications of the ‘669 and ‘261 patents enable one mode of making and using the invention in its preferred embodiment, namely, an injector system with a pressure jacket, the enablement requirement is satisfied and the enquiry should end there, relying on Engle Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 20 USPQ2d 1300 (Fed. Cir. 1991).

The Federal Circuit disagreed.  Specifically, the Federal Circuit distinguished Spectra-Physics since, in Spectra-Physics, the specification disclosed various attachment means for making the claimed invention, but failed to disclose the best attachment means known to the inventors.  As such, the claims in Spectra-Physics were held to be invalid for failure to comply with the best mode requirement of 35 USC 112, first paragraph, even though the specification enabled the practice of the claims.  However, the court in Spectra-Physics did note that the best attachment means known to the inventors was disclosed in other patents, and thus the failure of the specification to disclose that attachment means was “not fatal to enablement under § 112.”  The Liebel court noted that in Spectra-Physics, the disclosure of one attachment means permitted one skilled in the art to make and use the invention as broadly as it was claimed, which included other attachment means known to one of ordinary skill in the art.  In contrast, the court noted that the disclosure in Liebel’s specifications of an injector system with a pressure jacket does not permit one skilled in the art to make and use the invention as broadly as it was claimed, including without a pressure jacket.

According to the Federal Circuit, the facts are more analogous to AK Steel than to Spectra-Physics.  In AK Steel, the patentee argued, as does Liebel, that the patent disclosed several embodiments within the properly construed claim, and that the specification need not teach the full claimed scope in order for the claims to be enabled.  The claims in AK Steel read on steel strips with either a Type 1 or Type 2 aluminum coating, but the specification clearly described only Type 2 aluminum coating.  The AK Steel court stated that “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.”  The AK Steel court explained that the specification need not necessarily describe how to make and use every embodiment of the invention “because the artisan’s knowledge of the prior art and routine experimentation can often fill in the gaps.”  However, because the full scope of the claims included both Type 1 and Type 2 aluminum coating, the relevant inquiry became whether one skilled in the art would have been able to make and use a steel strip containing a Type 1 aluminum coating at the time of the patent’s effective filing date.  The AK Steel court held that the specification taught against using a Type 1 aluminum coating, and therefore the claims were invalid for lack of enablement.

Similarly, in the instant case, the Federal Circuit held that the asserted claims read on, and the full scope of the claimed invention includes, an injector system with and without a pressure jacket, and that there must be “reasonable enablement of the scope of the range” (AK Steel).  As such, the claims need to be enabled for both injector systems with and without a pressure jacket.  The Federal Circuit concluded that the statements in Liebel’s specifications teaching away from an injector system with a disposable syringe without a pressure jacket, combined with the testimonial evidence presented during trial that such an injector system could not have been produced at the time of Liebel’s applications were filed, supports the district court’s conclusion that Liebel’s specifications do not comply with the enablement requirement of 35 USC 112, first paragraph.  The court noted that since it had resolved the appeal on the enablement ground of the holding of invalidity, it did not need to consider the written description ground of the holding of invalidity.

Significance To Patent Applicants

In Liebel-Flarsheim, Liebel’s statement in the specifications that a disposable syringe without a pressure jacket is “impractical” was fatal to its subsequent attempt to interpret its claims as covering Medrad’s accused devices that did not include a pressure jacket.  While it is arguable that the same result may have been reached even if Liebel specifications had not included such a statement, the inclusion of the statement sealed Liebel’s fate.  Thus, it is best never to make any statements definitively stating that a feature is impractical, not desirable, or otherwise not suitable for the invention being disclosed to avoid a later interpretation that such statements teach away from an alleged infringer’s accused device and thus limit the potential true scope of the claimed invention

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