Statements in specification and prosecution history limit claims notwithstanding claim language
August 27, 2007

In a decision Friday, the Federal Circuit affirmed in part and reversed in part a district court's decision granting summary judgment of noninfringement and invalidity. The Federal Circuit found that the district court had properly construed most of the asserted claims as being limited to "automatic computer determination of the finish positions of teeth" based on the specification and prosecution history of the patents and related patents.

Some claims, however, were not directed toward determination of finish tooth positions, but instead were focused on initial data gathering to assist in further treatment or modeling, and as a result, those claims were improperly narrowed. The court held that because the defendant's process relied on human operators, rather than a fully automated process, to determine the finish position of the teeth, the district court's grant of summary judgment of noninfringement of those claims that required an automated process was appropriate. The court also found the patents at issue lacked enablement because one of ordinary skill in the art did not and could not accomplish "automatic computer determination of teeth finish positions" based on the patent's specification. The court found the fact that the patentee itself had not successfully developed a program that could, via a fully automated process, determine the finish positions of teeth because of variations in human anatomy particularly persuasive.More details of Ormco Corp. v. Align Tech., Inc. after the jump.

The plaintiff, Ormco, owns several patents relating to computer aided-design and manufacture of custom orthodontic appliances. Ormco filed suit alleging that Align Technology's "Invisalign" process infringed plaintiff's '861, '243, '444, and '432 patents. These patents share a common specification with Ormco's '562 patent, which was not asserted to be infringed, but is the parent of the '861, '243, and '444 patents, and was filed on the same day as the application that led to the '432 patent.Align counterclaimed for declaratory judgment of noninfringement and invalidity of the patents held by Ormco. Align also alleged infringement by Ormco of Align's '611 and '548 patents, which relate to the use of a series of orthodontic appliances to incrementally reposition teeth.In reviewing the grant of summary judgment of noninfringement of Ormco's patents, the Federal Circuit first addressed the district court's claim construction. The court agreed that most, but not all, of the asserted claims of the Ormco patents required automatic determination of finish tooth positions. The court placed great emphasis on the fact that the specification did not suggest or even allow for human adjustment of the computer-calculated tooth finish positions. The court, however, did point out that the claim language of the patents at issue did not expressly recite automatic control of the finish tooth positioning. Nonetheless, the court emphatically stated that "[t]o attribute to the claims a meaning broader than any indicated in the patents and prosecution history would be to ignore the totality of the facts of the case and exalt slogans over real meaning."Of even more interest was that the court gave only a brief look at the lack of claim construction by the district court focusing on the specific claim language. The court seemingly gave the district court a pass since they arrived at the correct conclusion and stated that:

[W]hen 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.

The court did, however, reverse the district court's summary judgment of invalidity for a few claims. These claims were not directed toward determination of the final position of teeth, but instead related 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." As a result, it was error to require these claims to be limited to a fully automated process, and the summary judgment of noninfringement was reversed for these claims.The court also sided with Align regarding the grant of summary judgment of nonenablement of the claims limited to automated processes. The Federal Circuit pointed out that the decision by the district court to grant summary judgment hinged its construction of the claims of the Ormco patents. The court noted that there was substantial doubt concerning the enablement of the invention as it appeared that Ormco's commercial products that purported to embody the patented invention could not successfully automate the determination of final tooth positions because of variances in human anatomy. The failure of the patentee to successfully implement the invention was "strong evidence" that the patent specification lacked enablement, and therefore the court affirmed the summary judgment of invalidity for those claims that required an automated process. The court did remand the issue of validity of the "non-automated" claims.Finally, the court considered Align's cross appeal regarding the district court's finding of invalidity regarding claims 1-3 and 11-48 of the '548 patent. The court agreed with Ormco that the law of the case doctrine controlled the outcome of the cross-appeal and that the claims at issue were invalid as decided in Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299 (Fed. Cir. 2006).Interestingly, Judge Kathleen O'Malley of the Northern District of Ohio, sitting by designation, dissented from the majority's decision to the extent it affirmed the district court's grant of summary judgment to Align on the issues of non-infringement and non-enablement. Judge O'Malley concluded that the district court had failed to properly construe the claim terms at issue and improperly shifted the burden of proof on the issue of enablement.

Specifically, Judge O'Malley argued that the district court had not engaged in proper claim construction, and that the majority's decision ignored its own admonitions to "begin" with the language of the claims. Judge O'Malley's issues with the majority's claim construction are best described in her own words:

By way of example, independent claim 1 of the '444 patent claims:
A method for use in the orthodontic correction of malocclused teeth of a patient in accordance with the individual anatomy of the patient and a prescription of an orthodontic practitioner for treatment of the patient, the method comprising:generating data by scanning shapes of the teeth of a patient;displaying a graphic representation of the teeth of the patient with a computer from the generated data; andthrough an operator interacting with a computer located remote from the orthodontic practitioner, altering the graphic representation to arrange a plurality of the teeth in relation to each other in accordance with the prescription, to produce a digital model of a desired arrangement of the teeth of the patient that includes data of the shapes of a plurality of the teeth positioned relative to each other.
'444 patent col.67 l.57 – col.68 l.6. Though this claim does not exclude operator involvement in the process and, indeed, claims the involvement of an operator in certain steps of the process, and though the claim never uses the term "automatically," the majority concludes that this claim, and virtually every other claim in suit, claims a process that is "completely automatic" and allows for no skilled operator involvement. In short, the majority has: imported the terms "automatically" and "automated" from the specification to the claims; found that the terms "automatically" and "automated," when used in the specification, are the same terms (without a record of how one skilled in the art would construe those terms); concluded that, in every instance, the words "automatically" and "automated" mean "completely automatically" or "completely automated;" found that, where a claim is silent on the issue, use of an operator is wholly precluded; and found that, where involvement of an operator is claimed, that operator cannot be skilled. Given the limited record in the trial court, I cannot find support either in the claims or in the record for these determinations.In reaching these conclusions, moreover, the majority necessarily ignores those places in the claims where the addition of an automatic process is discussed. For instance, claim 4 of the '444 patent recites: "The method of claim 3 further comprising: generating machine code in response to the designed geometry; and transmitting the machine code to a manufacturing machine to substantially automatically operate the machine in accordance with the shapes of the plurality of teeth." '444 patent, col. 68, ll. 19-26 (emphasis added). Why would a claim use the phrase "substantially automatically operate the machine" if the inventors intended that every claim included a requirement that the machine be operated "completely" or "wholly" automatically? Who or what completes the "substantial" operation of the machine if not an operator? These kinds of questions emphasize the need for an assessment of the actual language used in the claims, rather than a construction of the invention that is reached despite that language.

In addressing the nonenablement issue, Judge O'Malley contended that the district court and the majority only focused on whether Ormco had produced a commercially successful version of the invention. The district court also did not, according to Judge O'Malley, examine whether one of ordinary skill in the art could make and use the invention without undue experimentation, which is the ultimate test for enablement. Ultimately, Judge O'Malley felt that that the record must be further developed as to the proper construction of the claims in suit and whether, properly construed, those claims were enabled.To read the full decision in Ormco Corp. v. Align Tech., Inc., click here.

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