Yesterday the United States Court of Appeals for the Federal Circuit issued a precedential opinion in American Medical Systems, Inc. v. Biolitec, Inc. The decision dealt with the scintillating topic of whether a term in the preamble of the claim is limiting. The district court determined it was, and so did the dissenting Judge on the panel, Judge Dyk. The majority of the panel (Judges Bryson and Prost), however, determined it was not limiting, and I think correctly reached that decision. What is of particular interest, however, is the fact that Judge Dyk in dissent came out and said that it was time for the Federal Circuit to en banc decide the appropriate standard for when the preamble is limiting because any fair reading of Federal Circuit “preamble jurisprudence” is difficult to reconcile. While I disagree with Judge Dyk on this case, I am all for settling of the law and in areas where there are conflicting panel decisions, which is pretty much everywhere. The Federal Circuit should aspire to certainty wherever possible. After all, that was why the Court was formed in the first place.
The invention in question, which is embodied in U.S. Patent No. 6,986,764, can be used to treat Benign Prostatic Hyperplasia (“BPH”), a condition in which growth of the prostate gland restricts the passage of urine out of the bladder and through the urethra. As many men can tell you, BPH or any problems with your prostate can significantly, and negatively, impact quality of life. Prior art tissue vaporization systems were inefficient when used with continuous irrigation, and they frequently caused side effects including residual tissue coagulation, which led to swelling, transient urinary retention, and infection. The ineffectiveness of the prior art systems was due in part to their use of longer wavelengths of laser radiation, such as 2100 or 1064 nanometers (“nm”).
The inventors of the ’764 patent determined that the use of a high amount of energy delivered to a given volume of tissue would result in increased vaporization efficiency while minimizing residual coagulation. Accordingly, the patent was directed to various methods and devices for achieving high volumetric power density for tissue vaporization, by manipulating variables such as wavelength, output power, beam quality, irrigant composition, and distance between the optical fiber and the tissue.
Following a Markman hearing, the district court issued an order construing several key terms in the asserted claims, chief among them for purposes of the appeal was the disputed term “photoselective vaporization,” which was found only in the preamble of the claims. The illustrative claim selected by the majority was claim 31, which reads:
A method for photoselective vaporization of tissue, comprising:
delivering laser radiation to a treatment area on the tissue, the laser radiation having a wavelength and having irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of tissue than a volume of residual coagulated tissue caused by the laser radiation, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 10 kiloWatts/cm2 in a spot size at least 0.05 mm.
The plaintiffs argued that the preamble language simply describes the invention as a whole and should not be construed as a limitation of any of the asserted claims. The district court, however, ruled that the repeated use of the phrase “photoselective vaporization” in the specification and claims indicated that “photoselective vaporization” is a “fundamental characteristic” of the invention, albeit not its central innovative feature. As a result, the district court construed the term “photoselective vaporization” to mean “using a wavelength that is highly absorptive in the tissue, while being absorbed only to a negligible degree by water or other irrigant.”
In light of the district court’s claim construction ruling, Biolitec moved for summary judgment of noninfringement. The district court granted Biolitec’s motion and began by noting certain undisputed facts concerning the properties of 980 nm laser light (as in the accused product), as compared with 532 nm laser light (the wavelength of the ’764 patent’s preferred and commercial embodiment). The district court also observed that Biolitec’s accused device operates by placing the device in direct contact with the target tissue so as to prevent absorption of the energy by the water irrigant. In light of those facts, the court concluded that “[w]hen compared to 532 nm laser light, 980 nm laser light is more than negligibly absorbed by the water irrigant” and thus did not satisfy the “photoselective vaporization” limitation of the ’764 patent, as the district court construed it. Based on this determination the district court determined that there was no literal infringement.
Judge Bryson, writing for the majority, started the substantive analysis discussing the law relative to whether a preamble term is considered limiting. Judge Bryson wrote:
While there is no simple test for determining when a preamble limits claim scope, we have set forth some general principles to guide that inquiry. “Generally,” we have said, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Nonetheless, the preamble may be construed as limiting “if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). A preamble is not regarded as limiting, however, “when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” Catalina, 289 F.3d at 809. If the preamble “is reasonably susceptible to being construed to be merely duplicative of the limitations in the body of the claim (and was not clearly added to overcome a [prior art] rejection), we do not construe it to be a separate limitation.” Symantec Corp. v. Computer Assocs. Int’l, Inc., 522 F.3d 1279, 1288-89 (Fed. Cir. 2008). We have held that the preamble has no separate limiting effect if, for example, “the preamble merely gives a descriptive name to the set of limitations in the body of the claim that completely set forth the invention.” IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434-35 (Fed. Cir. 2000).
In light of this law, Judge Bryson, who was joined by Judge Prost, concluded that the preamble language in the asserted claims of the ’764 patent did not constitute a limitation of the claims. The majority reached this conclusion for three separate reasons, with the third being considered the most persuasive by the Court. The reasons were:
- Upon review of the prosecution history there was no reason to believe that the inventors added the phrase “photoselective vaporization” in order to distinguish their invention from the prior art. In fact, the examiner’s primary reason for approval was the claims’ use of high power densities to vaporize tissue without causing significant residual tissue damage.
- The preamble term “photoselective vaporization of tissue” did not provide a necessary antecedent basis for the term “the tissue” in the bodies of each of the independent claims.
- The descriptor “photoselective” did not embody an essential component of the invention. Instead, Court determined that the term “photoselective vaporization” was simply a descriptive name for the invention defined in the claims.
Judge Dyk filed a dissenting opinion in the case and specifically pointed out that the Federal Circuit’s case law relative to whether the preamble is limiting is extremely unclear. He also suggested that it would be appropriate for the entire Federal Circuit to consider this matter en banc. Judge Dyk wrote:
As the majority itself appears to recognize, we have not succeeded in articulating a clear and simple rule. As a result of the lack of clarity as to whether a preamble should be construed as limiting, our case law has become rife with inconsistency, both in result and in the articulation of the test. As the leading treatise on patent law observes, “the decisions are difficult to reconcile.” Donald S. Chisum, Chisum on Patents § 8.06[d] (2010).
It seems to me that a rule recognizing that all preambles are limiting would make better sense and would better serve the interests of all concerned…
Neither the Supreme Court nor our court sitting en banc has ever addressed the preamble limitation issue. I think the time may have come for us to eliminate this
vague and confusing rule.
In reading Judge Dyk’s dissent it is clear he simply disagrees with the majority’s conclusion, although his point about the uncertainty of the law relative to the preamble is well taken. Nevertheless, I disagree with Judge Dyk’s analysis as it pertains to this particular case. In his dissent he writes:
The applicant took considerable care to add new matter to the specification describing and defining photoselective vaporization. The term appears in the title of the patent (once), the abstract (once), the Field of the Invention section (twice), the Summary of the Invention section (twice), and the Detailed Description section (once). For example, the Field of the Invention section states: “The present invention relates generally to laser treatment of soft tissue, and more particularly to photoselective vaporization of the prostate PVP, and to photoselective vaporization of other tissue.”
The “new matter” Judge Dyk speaks of is matter that was inserted for the first time as part of a continuation-in-part, so not the type of “new matter” that might be attempted to be snuck into an application contrary to the prohibition against new matter. Confusing I know, but the term “photoselective vaporization” arrived at the time of the filing of the continuation-in-part, so technically is was not “new matter,” but rather viewed best as additional matter that received the benefit of the filing date of the continuation-in-part.
With that out of the way, allow me to point out that what Judge Dyk seems to be focusing on is the use of the term photoselective vaporization as a characterization. I see no evidence that it is being used as an element or limitation, and agree with the marjority that the term is nothing more than a characterization. It is a way to refer to the totality of the invention claimed, not a particular aspect, element or limitation of the invention.
I would also like to take issue with Judge Dyk’s statement that it would simply be easier, and better, to say that anything in the preamble is limiting. Yes, that would certainly be easier and probably a better approach than the nebulous standard presently in place, but I doubt that would be to the Supreme Court’s liking given they seem to detest bright line rules, even when they make sense. I also protest such an approach because that has, as far as I can tell, never been the law, or at least not at any time during my practice career. So regardless of whether it is a better test it absolutely should not be applied retroactively to affect those rights obtained under the belief that what is in the preamble is not limiting.
The Federal Circuit has been famous over the years for announcing rules and then pretending that the rule is not new and has always been that way. The reality is this stuff is not academic, and changing for the sake of change does nothing to infuse certainty. All it proves is that the system can be certain right up until the mind of the Judges are changed, and then the law is made certain in a different direction. Such pendulum swinging is never appropriate when dealing with property rights, and would be objectively bad for the millions of patents obtained under a regime that is directly contrary to the stated preference of Judge Dyk.