Statements in Prosecution History of a Related Patent Are Relevant in Claim Construction and Failure to Enable an Invention in a Commercial Product Is Strong Evidence That the Patent Specification Lacks Enablement
August 24, 2007
Last Month at the Federal Circuit - September 2007
Lourie (author), Dyk, O’Malley (concurring-in-part and dissenting-in part, District Judge sitting by designation)
[Appealed from: C.D. Cal., Judge Snyder]
In Ormco Corp. v. Align Technology, Inc., Nos. 06-1240, -1274 (Fed. Cir. Aug. 24, 2007), the Federal Circuit affirmed-in-part and reversed-inpart the district court’s grant of SJ in favor of Align Technology, Inc. (“Align”), holding that the district court correctly granted SJ of noninfringement and nonenablement as to some, but not all, of the claims of Ormco Corporation’s (“Ormco”) patents. The Court also affirmed the district court’s grant of SJ in favor of Ormco and Ormco’s subsidiary, Allesee Orthodontic Appliances, Inc. (“AOA”), holding that the district court correctly granted SJ of invalidity with respect to Align’s patent.
Ormco sued Align for infringement of Ormco’s U.S. Patent Nos. 6,616,444 (“the ’444 patent”), 6,244,861 (“the ’861 patent”), 5,683,243 (“the ’243 patent”), and 5,447,432 (“the ’432 patent”) (collectively the “Ormco patents”). The Ormco patents relate to a computer-aided design and manufacture of custom orthodontic appliances. They share a common specification, which is also shared with additional patents not asserted in this case, including U.S. Patent No. 5,431,562 (“the ’562 patent”). The ’562 patent is the parent of the ’243, ’861, and ’444 patents. Ormco alleged that Align’s Invisalign process infringed the Ormco patents.
Align counterclaimed for DJ of noninfringement and invalidity, and also alleged infringement by Ormco and AOA of U.S. Patent Nos. 6,554,611 (“the ’611 patent”) and 6,398,548 (“the ’548 patent”). The ’611 and the ’548 patents relate to the use of a series of individual orthodontic appliances to incrementally reposition teeth.
Align moved for SJ of noninfringement and nonenablement with respect to the Ormco patents, while Ormco and AOA moved for SJ of invalidity with respect to Align’s ’548 patent. The district court granted all three motions. With respect to Align’s noninfringement motion, the district court found that statements in the shared specification of the Ormco patents, the prosecution history of the ’562 patent, the prosecution history of the 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. Because Align’s system relied on “skilled operators” rather than computers to determine the finish positions of the teeth, the district court granted Align’s SJ motion of noninfringement. As for Align’s nonenablement motion, the district court found that the testimony of the inventors indicated that Ormco’s software had never been used to automatically determine tooth positions without any human intervention and that other inventor and expert testimony was either unpersuasive or not credible. Accordingly, the district court granted Align’s SJ motion of nonenablement. With respect to Ormco’s SJ motion, the district court found that prior use of a certain system for orthodontic treatment anticipated certain claims of the ’548 patent and, thus, granted Ormco’s SJ motion of invalidity. Ormco appealed and Align cross-appealed.
On appeal, the Federal Circuit first addressed the district court’s SJ of noninfringement. Ormco argued that the district court erred when it interpreted the claims to require automatic determination of finish tooth positions, contrary to their plain language, and when it failed to tie that interpretation to specific language in each claim. Ormco further argued that the statements referenced by the district court to support its application of the automatic determination limitation did not meet the standard for an intentional disavowal of claim scope and that statements from the prosecution history of the ’562 patent were limiting only as to the particular claim language with respect to which they were made. The Federal Circuit, however, rejected these arguments.
The Court noted that “[i]t 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.” Slip op. at 6 (citation omitted). It observed that the “claims must be read in view of the specification, of which they are a part,” and that “[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 6-7 (alteration in original) (citations and internal quotation marks omitted). Consistent with these principles, the Court concluded 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 was a proper construction of the asserted claims. The Court explained that “[i]nterpreting most of the claims to require automatic determination of finish tooth positions ‘most naturally align[ed] with the patent’s description of the invention.’” Id. at 7.
Specifically, the Court found that from the beginning of the common specification of the Ormco patents, it was clear that the inventors’ primary basis for distinguishing their invention was its high level of automation in the design of custom orthodontic appliances as compared to the prior art. It noted that “[n]owhere [did] the specification suggest or even allow for human adjustment of the computer-calculated tooth finish positions.” Id. at 8. Accordingly, it concluded that “[t]he specification . . . provide[d] clear indication that the invention is in the automatic determination of tooth position.” Id. at 9.
The Court added that “[w]hile 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 [made] it even clearer.” Id. It noted that “[t]he prosecution history can often inform the meaning of the claim language,” id. (alteration in original) (citation omitted), and that “prosecution disclaimer may arise from disavowals made during the prosecution of ancestor patent applications.” Id. (citation omitted). The Court observed that “[w]hen the application of prosecution disclaimer involves statements from prosecution of a familial patent relating to the same subject matter as the claim language at issue in the patent being construed, those statements in the familial application are relevant in construing the claims at issue.” Id.
The Court noted that in this case, the specification of the prior ’562 patent, which is the parent of the three patents at issue, and all presently litigated patents have the same content. Accordingly, it concluded that the prosecution history of the claims of the application that led to the ’562 patent is relevant in construing the claims of the Ormco patents. The Court then reviewed the prosecution history of the ’562 patent and noted that the statements made in that prosecution history were not limited to particular claims of that patent.
Based on a review of the specification and the prosecution history, the Court concluded that all of the asserted claims of the Ormco patents, except for claims 37-40, 45, and 69 of the ’444 patent, require automatic computer determination of the finish positions of the teeth without human adjustment of the final results. The Court observed that although the claim language did not expressly recite automatic control of the finish tooth position, that is what they meant, and that was all that the specification described. It added that the prosecution history of the ’562 patent, with the same specification, made clear that the inventors understood their invention to encompass only automatic positioning because they so argued in order to distinguish their claims over prior art. The Court recognized that it must not incorporate into the claims limitations only found in the specification and that it was not doing so here. Instead, noted the Court, it was interpreting the claims in light of the specification. It found that “to attribute to the claims a meaning broader than any indicated in the patents and their prosecution history would be to ignore the totality of the facts of the case and exalt slogans over real meaning.” Id. at 13.
With respect to claims 37-40, 45, and 69 of the ’444 patent, the Court found that those claims related to the preliminary gathering and organization of tooth data, not to the specific automatic determination of finish tooth positions. It therefore concluded that those claims did not require automatic computer determination of finish positions of teeth, and that the district court thus erred in its conclusions.
The Court then turned to the district court’s noninfringement determination. It observed that Ormco had not challenged the district court’s finding that Align relied on skilled operators rather than a fully automated computerized process to determine the finish positions of the teeth. Accordingly, it affirmed the district court’s grant of SJ of noninfringement with respect to all claims, except for claims 37-40, 45, and 69 of the ’444 patent. With respect to these latter claims, because the Court determined that these claims did not require automatic computer determination of teeth finish positions, it reversed and remanded.
In deciding the noninfringement issue, the Federal Circuit noted that the district court had failed to conduct a claim construction in this case focusing on the specific claim language. It observed, however, that it “review[s] decisions, not opinions.” Id. at 16. The Court explained that “when [it is] able to fully comprehend the specification, prosecution history, and claims and can determine that, to the extent [it has] indicated, the district court arrived at the correct conclusion, [it] need not exalt form over substance and vacate what is essentially a correct decision.” Id.
The Federal Circuit next turned to the district court’s SJ grant of nonenablement. The Court observed that the district court’s grant of SJ of nonenablement hinged upon its construction of the claims of the Ormco patents. Because it had already concluded that the district court erred in construing claims 37-40, 45, and 69 of the ’444 patent, the Federal Circuit reversed the grant of SJ of nonenablement as to those claims and remanded. With respect to the other claims, the Federal Circuit affirmed. In so holding, the Court explained that “[i]f 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.” Id. at 18. The Court found that “[s]ubstantial doubt concerning the enablement of the invention was cast by the inventors in this case.” Id. For instance, the Court noted that one of the inventors of the Ormco patents testified that Ormco had never attempted to create a computerized system that automatically determined tooth positions without human decision making. He also testified that the manual override had been used on all of the approximately forty cases treated using Ormco’s software and that, while it was a goal to have the software generate final tooth positions that would not require use of the override, variations in human anatomy had prevented the attainment of the goal. The Court observed that no convincing countering evidence was produced by Ormco. Accordingly, it affirmed the district court’s SJ of nonenablement with respect to the claims that were limited to automatic computer determination of teeth finish positions.
Finally, the Federal Circuit turned to Align’s cross-appeal from the district court’s grant of Ormco’s SJ motion of invalidity due to anticipation. Align argued that the district court erred in construing certain claim terms and that there was no public use with respect to one limitation of its claims. Ormco, on the other hand, argued that the Court’s recent decision in Ormco Corp. v. Align Technology, Inc., 463 F.3d 1299 (Fed. Cir. 2006) (“Ormco I”), required it to affirm the district court’s decision and that alternatively, the district court correctly construed the claims and found anticipation. The Federal Circuit agreed with Ormco and held that under the law of the case doctrine, its decision in Ormco I controlled the outcome of the cross-appeal. The Court explained that under the law of the case doctrine, “a court adheres to a decision in a prior appeal in the same case unless one of three exceptional circumstances exist: (1) the evidence in a subsequent trial is substantially different; (2) controlling authority has since made a contrary decision of the law applicable to the issues; or (3) the earlier ruling was clearly erroneous and would work a manifest injustice.” Slip op. at 19 (citation omitted). The Court noted that none of those exceptional circumstances existed in the present case. Therefore, applying the law of the case doctrine, the Court noted that in Ormco I, it had found certain claims of the ’548 patent invalid as obvious and that as a result, those claims were invalid and that the other claims at issue in this case were invalid as obvious as well. Accordingly, it affirmed the district court’s grant of SJ of invalidity with respect to the ’548 patent.
Judge O’Malley concurred-in-part and dissented-in-part. She agreed with the majority’s decision with respect to claims 37-40, 45, and 69 of the ’444 patent and that the law of the case doctrine barred Align’s cross-appeal. She dissented, however, from those portions of the majority’s decision that affirmed the district court’s grants of SJ to Align on the issues of noninfringement and nonenablement. In her opinion, the district court failed to construe properly the relevant claim terms and that an insufficient record existed to support an attempt to correct the district court’s omissions by construing the claims on appeal. In addition, according to Judge O’Malley, the majority improperly imported limitations from both the specification and an ancestor patent into the claims.
With respect to nonenablement, she noted that an enablement inquiry turns on whether the specification of a challenged patent provides sufficient teaching such that one skilled in the art could make and use the full scope of the invention without undue experimentation and that undue experimentation is determined based on a number of factors. She noted that here, the district court did no such analysis. She opined that the district court only focused on evidence of whether Ormco had perfected a commercially successful version of the invention. According to her, commercial success is not determinative of enablement. She therefore believed that “the district court’s limited, improper examination of the enablement issue could not have supported [SJ] in Align’s favor on this issue.” O’Malley Dissent at 14.