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August 26, 2007

Pulling Teeth

Ormco asserted four orthodontic software and appliance patents in the same family against Align Technology (5,447,432; 5,683,243; 6,244,861 and 6,616,444). Align counterclaimed with 6,554,611 and 6,398,548. All asserted claims by both parties were found unenforceable. Ormco and Align appealed.

Ormco and Allesee Orthodontic Applicance v. Align Technology (CAFC 2006-1240, -1274)

Align got a district court summary judgment of noninfringement: Ormco claimed an automated process, whereas Align's process involved manual labor.

In a May 13, 2004, Order, the trial court granted Align’s motion for summary judgment of noninfringement. Ormco Corp. v. Align Tech., Inc., No. 03-cv-00016, slip op. (C.D. Cal. May 13, 2004). In that Order, the court found that statements in the shared specification of the Ormco patents, the prosecution history of the ’562 patent, the prosecution history of the abandoned 07/775,589 application (of which the ’432 patent is a continuation-in-part), and the prosecution history of the ’432 patent limited the claims of the Ormco patents to a process in which final treatment positions for teeth are automatically determined. The court then determined that there were no genuine issues of material fact precluding summary judgment. The court accordingly granted summary judgment of noninfringement in favor of Align because Align’s system relies on “skilled operators” rather than computers to determine the finish positions of the teeth.

Ormco also got nailed for nonenablement by the district court, because "Ormco software had never been used to automatically determine tooth positions without any human intervention."

With regard to noninfringement of the Ormco patents, the CAFC generally agreed that most of the claims required automation.

“It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (citation and internal quotations omitted); see also Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“[W]e look to the words of the claims themselves . . . to define the scope of the patented invention.”). However, “claims ‘must be read in view of the specification, of which they are a part,’” Philips, 415 F.3d at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996)), and “[t]he construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention will be, in the end, the correct construction,” id. at 1316 (quoting Renishaw PLC v. Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998)) (emphasis added).

Consistent with that precedent, we conclude that the district court correctly determined, as to most, but not all, of the asserted claims of the Ormco patents, that requiring automatic determination of finish tooth positions is a proper construction of the asserted claims. Interpreting most of the claims to require automatic determination of finish tooth positions “most naturally aligns with the patent’s description of the invention.”... Nowhere does the specification suggest or even allow for human adjustment of the computer-calculated tooth finish positions...

“[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.” Phillips, 415 F.3d at 1317 (emphasis added). While all those statements by the inventors in the specification of the Ormco patents, standing alone, may not be conclusive in showing that the claims require completely automatic determination of final tooth positions, those in the prosecution history make it even clearer.

A few claims escape the ax, as they don't require automated tooth positioning.

We reach a different conclusion with respect to claims 37-40, 45, and 69. The district court treated those claims in the same manner as all the others... Those claims relate to the preliminary gathering and organization of tooth data as an aid to further unspecified orthodontic treatment or for use in creation of a digital model, not to the specific automatic determination of finish tooth positions. Such preliminary gathering and organization do not, by themselves, determine finish tooth positions. We therefore conclude that claims 37-40, 45, and 69 do not require automatic computer determination of finish positions of teeth, and that the district court thus erred in so concluding.

The CAFC concured on nonenablement, essentially agreeing with Align that "an inventor’s inability to actually practice his invention is proof of lack of enablement."

If an inventor attempts but fails to enable his invention in a commercial product that purports to be an embodiment of the patented invention, that is strong evidence that the patent specification lacks enablement. Substantial doubt concerning the enablement of the invention was cast by the inventors in this case. The district court so concluded, and we have no reason to disagree.

This was, in part, a 2-1 decision. The majority (Lourie and DYK) take a procedural shortcut.

We accept that Ormco’s argument, and that of the dissent, that the district court failed to conduct a claim construction in this case focusing on specific claim language, is not lacking in force. However, we review decisions, not opinions, see Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1540 (Fed. Cir. 1983), and when we are able to fully comprehend the specification, prosecution history, and claims and can determine that, to the extent we have indicated, the district court arrived at the correct conclusion, we need not exalt form over substance and vacate what is essentially a correct decision.

District Court Judge O'Malley, sitting in the appeals panel, wailed in dissent, objecting to the holistic de novo treatment, and pointing to inconsistency with precedent. Below is a taste of a well-thought and strongly worded opinion. Hal Wegner on the dissent: "The author is highly regarded as a District Judge with patent savvy, one of a handful of trial judges suggested as possible candidates for one of the many expected openings on the Federal Circuit in the very near term."

I believe that the district court failed to construe properly the relevant claim terms, and improperly analyzed and shifted the burden of proof on the issue of enablement. I further believe that an insufficient record exists to support an attempt to correct the district court’s omissions by construing the claims on appeal. I find further that the majority’s decision, while acknowledging the need to construe the claims, improperly imports limitations from both the specifications and an ancestor patent into many of those claims. For these reasons, I would reverse and remand.

At the outset, it is apparent that the trial court improperly considered the question of infringement without actually construing the claim terms at issue. Indeed, the district court specifically stated that it, “was not interpreting the specific language of the claims to favor one side or another.” Ormco Corp. v. Align Tech., Inc., No. 03-cv-00016, slip op. n.1 (C.D. Cal. May 13, 2004).1 Though this court has undertaken claim construction in the first instance, it has also remanded cases for further construction in the absence of any meaningful claim construction by the district court. The court has rejected the assertion that, because it conducts a de novo review of claim construction, a district court’s claim construction “does not matter” and the absence of a claim construction is not error. Nazomi Commc’n, Inc. v. Arm Holdings, PLC, 403 F.3d 1364, 1371 (Fed. Cir. 2005).

Rather than remand the matter, the majority chooses, instead, to conduct its own infringement analysis. It opens that analysis by recognizing that claim construction begins with the language of the claims themselves. In support, the majority cites Phillips and Markman for the truisms that, “the claims of a patent define the invention to which the patentee is entitled the right to exclude,” and that, though claims, “must be read in view of the specification, of which they are a part,” it is the language of the claims that is to be construed, not the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996). The majority, nevertheless, appears to ignore its own opening admonitions in the remainder of its opinion. First, the majority does not “begin” with the language of the claims. Indeed, it never actually tells us what word or words in the claims in suit it purports to construe. At best, after examining the specification of one of the patents in suit (but not its prosecution history), and the prosecution history of a patent which is not in suit, it backs into a form of claim construction by asserting that all of the claims address themselves to the practice of determining finish tooth positions. Nowhere, however, does the majority tell us what language is used in which claims to describe that practice, or why such language is in need of interpretation.

The majority concedes, as it must, that none of the claims in suit “expressly recite automatic control of the finish tooth positioning.” Despite the absence of this language in the claims, however, the majority concludes that this unstated (and seemingly important) limitation is “what [the claims] mean.”

This court, however, has rejected a claim construction process based on the “essence” of an invention. See, e.g., Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1345 (Fed. Cir. 2002) (“It is well settled that ‘there is no legally recognizable or protected essential element, gist or heart of the invention in a combination patent.’”) (citing Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 345 (1961)). Indeed, this court has done so quite forcefully and quite recently. See MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1330-31 (Fed. Cir. 2007) (“We sympathize with the district court’s choice, since we agree that [the feature] is an essential element of the invention . . . . However, we cannot endorse a construction analysis that does not identify ‘a textual reference in the actual language of the claim with which to associate a proffered claim construction.’”) (quoting Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed. Cir. 1999)). Simply stated, “automatic determination of finish tooth positions without human adjustment of the final results” is a limitation that the majority has amalgamated from the specification of one of the patents in suit without reference to the specific language of any claim of any of the patents.

The court’s recent decision in Ventana Medical Systems, Inc. v. Biogenex Laboratories, Inc., 473 F.3d 1173 (Fed. Cir. 2006), counsels against this practice.

The district court’s rulings regarding enablement were based wholly upon this flawed claim construction and, therefore, are unsustainable as well. See Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1254 (Fed. Cir. 2004) (stating: “an enablement inquiry typically begins with a construction of the claims”).

An enablement inquiry turns on whether the specification of a challenged patent: “provide[s] sufficient teaching such that one skilled in the art could make and use the full scope of the invention without undue experimentation.” Warner-Lambert Co. v. Teva Pharm. USA, Inc., 418 F.3d 1326, 1337 (Fed. Cir. 2005) (citations omitted). “Furthermore, ‘[w]hether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.’” Id. (quoting In re Wands, 858 F.2d 731, 737 (Fed. Cir.1988)). “Some of these considerations, commonly referred to as ‘the Wands factors,’ include ‘(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.’” Id. (quoting Wands, 858 F.2d at 737).

Here, however, the district court did not examine the specifications to determine whether one of ordinary skill in the art could make and use the invention without undue experimentation. Indeed, there is no indication that the district court considered any of the factors enumerated in Wands. Ormco Corp. v. Align Tech., Inc., No. 03-cv-00016, slip op. at 3-7 (C.D. Cal. Aug. 23, 2004). Instead, Align only produced, and the district court only focused on, evidence of whether Ormco had perfected a commercially successful version of the invention. Commercial success, however, is not determinative of enablement. See CMFT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003) (“Title 35 does not require that a patent disclosure enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect.”).

Align's asserted claims remained DOA (dead on appeal), but Align declared victory. "We are extremely pleased with the Court's confirmation of the previous ruling," crowed Roger George, IP mastermind at Align. George was smoking over the Ormco decision, though Align's dead patents hadn't entirely slipped his mind: "Contrary to some erroneous reports, today's decision is an overwhelming victory for Align and does essentially nothing to diminish the strength of our patent portfolio or of our unique technology." Get real. Align counterclaimed with their strongest cards; what they thought to be aces were duds. As the CAFC said in this ruling, Align's claim variations were "not patentably significant."

Posted by Patent Hawk at August 26, 2007 8:47 PM | Claim Construction