Align Technology asserted 6,398,548 & its continuation 6,554,611 against Ormco. In summary judgment, the patents were found valid, and Ormco infringing. But the CAFC reversed the validity finding under 103(a), that the six claims left standing were anticipated by what a couple of orthodontists were doing for their patients before the patented invention.

Dr. Truax, an orthodontist, practiced an orthodontic technique that involved taking a single mold of a patient’s teeth, repositioning the “tooth cavities” on the mold to their desired positions, then at the same time making three appliances from the repositioned mold, each with a different thickness. A thinner appliance, which applied less force, was to be used before a thicker appliance. Dr. Truax gave each patient one appliance at a time, providing the next appliance in the series after reviewing the patient’s progress. The parties dispute whether Dr. Truax provided instructions to the patients regarding order of use of the appliances.

A second orthodontist, Dr. Rains, practiced a similar technique. Dr. Rains also used a series of three plastic retainers to incrementally adjust patient’s teeth. Unlike Dr. Truax, Dr. Rains generally made the appliances one at a time. During each patient visit, Dr. Rains would take a mold of the patient’s teeth and then create an appliance based on that mold with the appropriate geometry.

What defines prior art, particularly public accessibility? Again, the CAFC gives broad latitude, even to go so far that if not concealed, it's public use.

“Prior art” in the obviousness context includes the material identified in section 102(a). See Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1354 (Fed. Cir. 2003). Section 102(a) provides that a person is not entitled to a patent if “the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent.” 35 U.S.C. § 102(a). Art that is not accessible to the public is generally not recognized as prior art. See Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002); OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396, 1402 (Fed. Cir. 1997). Pertinent to this appeal, Ormco relies on Dr. Truax’s orthodontic practice, and an instruction sheet he distributed to orthodontists, in order to establish the obviousness of the disputed claims. Thus, Ormco relies on “knowledge or use by others” that is corroborated by documentary evidence. Align claims that the Truax reference was not part of the prior art because it was not publicly accessible. However, we conclude that Dr. Truax’s practice and his instruction sheet were sufficiently publicly accessible to qualify as prior art. It is undisputed that Dr. Truax promoted his system to other orthodontists through seminars and clinics and distributed his instruction sheet at those clinics. See Baxter Int'l, Inc. v. Cobe Labs., Inc., 88 F.3d 1054, 1058 (Fed. Cir. 1996) (defining “public use” in 102(b) context as including “any use of [the claimed] invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor” (quoting In re Smith, 714 F.2d 1127, 1134 (Fed. Cir. 1983)); 1-3 Chisum on Patents § 3.05 (2006) (“[A]t most the publicity requirement in Section 102(a) means the absence of affirmative steps to conceal.”).

The claim language specified that multiple devices were used, of "different geometries." In its claim construction, the district court found that the orthodontists devices didn't meet the limitation of having "different geometries," but the CAFC used the dictionary to find otherwise, after finding the specification wanting.

It is undisputed that Dr. Truax’s orthodontic system used several clear plastic appliances that fit over the patient’s teeth, each appliance composed of plastic of a different thickness (the thicknesses typically varied from 0.015 to 0.030 inches). A thinner device exerted less force on the teeth than a thicker device, and a thinner device was thus used before the next thicker device. The district court held that Dr. Truax’s practice does not meet the “geometry” limitation of claim 1 because the claim requires three or more appliances with “different geometries.” In the district court’s view, the different thicknesses of Dr. Truax’s devices do not qualify as different geometries.

In keeping with the district court’s claim construction, Align contends that appliances have different geometries only if the positions of the tooth cavities change from one appliance to another. We disagree. We first look to the specification for guidance as to the meaning of claim language, Phillips v. AWH Corp., 415 F.3d 1303, 1315-16 (Fed. Cir. 2005) (en banc). Here the specification does not define the term “geometry,” though Align points out that it discloses only appliances with different tooth positions. See ‘611 patent, col. 3, l. 22 – col. 4, l. 30; col. 9, ll. 20-61. Thus, the specification’s language does no more than describe preferred embodiments, and “we have repeatedly warned against confining the claims to [the disclosed] embodiments.” Phillips, 415 F.3d at 1323. Under these circumstances we appropriately look to dictionary definitions.5 The parties agree that resort to dictionaries is useful to determine the meaning of the term “geometry.” As the district court correctly stated, “[t]he ordinary meaning of ‘geometry’ in the context of the claims is a figure characterized by points, lines, or planes.” Ormco Corp. v. Align Tech., Inc., No. SA-CV-03-16-GLT, slip op. at 3 (C.D. Cal. Feb. 24, 2005) (citing Webster’s New World Dictionary Third College Edition 564 (1988)). In other words, geometry means “configuration” or “shape.”6 Unlike the district court, we think that objects of different thicknesses plainly have different “configurations” or “shapes.” Furthermore, the specification indicates that “[i]n a broadest sense, the methods of the present invention can employ any of the known positioners, retainers, or other removable appliances which are known for finishing and maintaining teeth positions in connection with conventional orthodontic treatment.” ‘611 patent, col. 9, ll. 25-29. Thus, we conclude that the Truax devices satisfy the “geometries” limitation of claim 1.

Another claim construction tidbit: for infringement, the accused device must meet a limitation, not be simply modifiable to conform to that limitation. The claims had been written to require that all the orthodontics appliances be in a single "package."

We also disagree with the district court’s construction of claim 1 in one other respect. We reject the district court’s conclusion that the “single package” limitation of claim 1 of the ‘611 patent merely requires that devices be “capable of” being provided to the patient in a single package. Here, the claims are written to require that the devices actually be in a single “package.” In similar contexts, our cases have rejected claim constructions that would merely require that infringing devices be capable of being modified to conform to a specified claim limitation. ⁷

⁷ See, e.g., Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1310-11 (Fed. Cir. 2005) (rejecting argument that “to directly infringe, Medtronic need only make devices that are capable of being converted into infringing devices”); Zygo Corp. v. Wyko Corp., 79 F.3d 1563, 1570 (Fed. Cir. 1996) (rejecting the argument that “a device which is capable of infringing use does not escape infringement although not actually used in an infringing manner,” where the claims were written to cover actual use); High Tech Med. Instruments, Inc. v. New Image Indus., Inc., 49 F.3d 1551, 1555 (Fed. Cir. 1995) (“The question is not what [a device] might have been made to do, but what it was intended to do and did do . . . . [T]hat a device could have been made to do something else does not of itself establish infringement.” (quoting Hap Corp. v. Heyman Mfg., Co., 311 F.2d 839, 843 (1st Cir. 1962))). Our conclusion is consistent with Hilgraeve Corp. v. Symantec Corp., 265 F.3d 1336, 1343 (Fed. Cir. 2001). Hilgraeve did not suggest that a device would directly infringe a product claim simply because the device could be modified to render it infringing.

Now we get to what the noise is about in KSR v. Teleflex - "suggestion, teaching, or motivation." Here the court reiterates that an implicit showing may be anticipatory.

A claim can be obvious even where all of the claimed features are not found in specific prior art references, where “there is a showing of a suggestion or motivation to modify the teachings of [the prior art] to the claimed invention.” SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed. Cir. 2000) (concluding that patent would have been obvious in light of teachings in prior art which provided motivation and suggestion to modify existing techniques to arrive at method in question).⁸ “A suggestion, teaching, or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, as ‘the teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references . . . . The test for an implicit showing is what the combined teachings, knowledge of one of ordinary skill in the art, and the nature of the problem to be solved as a whole would have suggested to those of ordinary skill in the art.’” In re Kahn, 441 F.3d 977, 987-88 (Fed. Cir. 2006) (quoting In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000)).⁹

⁸ See also Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364,1375 (Fed. Cir. 2005); Valmet Paper Mach., Inc. v. Beloit Corp., 105 F.3d 1409, 1413 (Fed. Cir. 1997) (concluding, without relying on a specific reference, that it would have been obvious to a person of ordinary skill in the art to modify a prior art reference to meet a limitation of a claim); B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1582 (Fed. Cir. 1996); In re O'Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988).

⁹ See also Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125 (Fed. Cir. 2000) (stating that evidence of a motivation to combine prior art references “may flow from the prior art references themselves, the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved”).

Align contended that Dr. Truax taught away from the claimed invention, because he didn't give his patients more than one appliance at a time.

However, a reference that “teaches away” from a given combination may negate a motivation to modify the prior art to meet the claimed invention. See, e.g., Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). “A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Kahn, 441 F.3d at 990 (quoting In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)) (internal quotation marks omitted).

Truax taught that the treatment was more effective if the orthodontist determined when to change appliances, rather than providing several appliances to the patient and allowing the patient to change from one appliance to the next. Under these circumstances, argues Align, it would not have been obvious to provide all appliances to a patient in a single package.

Align argued that Truax required patients to visit him to change appliances, thus failing to meet the "single package" limitation. But, as the CAFC pointed out, nothing in the claim specified going to the dentist, or not. And, as far as the single package limitation being patentably novel, you've got to be kidding.

The patented device here (and Truax) avoided the necessity for adjustment by the dentist by the use of multiple appliances that were changed periodically. Align asserts that there is an important difference between the patented device and Truax in that the patented device avoids a visit to the dentist in order to determine when substitution of the new device is appropriate. But there is nothing in the claim language that requires the devices be substitutable by the patient. In other words, the claims do not require that the device be capable of replacement by the patient rather than the dentist, or preclude visits to the dentist during the treatment regimen. Indeed, the specification makes quite clear that the patient may periodically visit the dentist during treatment. The claim does not preclude returning to the dentist to determine the appropriate time to replace appliances, just as Truax taught.

Under these circumstances, we do not think that the single package limitation makes the device of the ‘611 patent claims patentably distinct. Providing the devices to the patient in one package, as opposed to two packages or three packages is not a novel or patentable feature in the light of the well-known practice of packaging items in the manner most convenient to the purchaser.

While a seemingly trivial issue, this is a significant finding by the appeals court - that a limitation not patentably distinct may be disregarded as obvious. Let critics who deride the current court requirement of "suggestion, teaching, or motivation" as being too strict chew on that.

A dependent method claim relied upon replacing the appliances at an interval "from 2 days to 20 days." Align argued Dr. Truax's practice didn't meet that range, but the court pointed out that his instruction sheet was within the claimed range, and that was good enough.

We reject the district court’s holding that the “intervals” limitation of this claim merely requires that the devices be “capable of” being replaced within a 2 to 20 day interval. Method claims are only infringed when the claimed process is performed, not by the sale of an apparatus that is capable of infringing use.¹² Thus, this claim requires that the devices actually be replaced within the specified period.

¹² See, e.g., Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 773 (Fed. Cir. 1993) (holding that “[t]he sale of [an apparatus capable of performing a claimed process is] not a direct infringement because a method or process claim is directly infringed only when the process is performed”); Standard Havens Prods., Inc. v. Gencor Indus., Inc. 953 F.2d 1360, 1374 (Fed. Cir. 1991) (holding method claims were not directly infringed by the mere sale of an apparatus capable of performing the claimed process).

Where a claimed range overlaps with a range disclosed in the prior art, there is a presumption of obviousness. See Iron Grip, 392 F.3d at 1322; In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997). The presumption can be rebutted if it can be shown that the prior art teaches away from the claimed range, or the claimed range produces new and unexpected results. Iron Grip, 392 F.3d at 1322; In re Geisler, 116 F.3d at 1469; Haynes Int'l, Inc. v. Jessop Steel Co., 8 F.3d 1573, 1577 n.3 (Fed. Cir. 1993) (“[W]hen the difference between the claimed invention and the prior art is the range or value of a particular variable, then a prima facie rejection is properly established when the difference in range or value is minor.”) (emphasis omitted); In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974) (claimed invention is rendered prima facie obvious by the teachings of a prior art reference that discloses a range that touches the range recited in the claim).

Here, Align argues that Dr. Truax’s appliances “were made sequentially every 4 to 6 weeks,” and thus did not overlap the claimed range. Appellant’s Br. at 46. However, Align fails to address the express disclosure in Dr. Truax’s instruction sheet, clearly indicating that the appliances are to be replaced every 14 to 21 days. This interval substantially overlaps with the interval specified in claim 17. Align has also failed to show that Truax teaches away from the claimed range or that the claimed range produces new and unexpected results. Under these circumstances, Align has failed to rebut the presumption that the claimed range would have been obvious.

In a last gasp, Align contended that the success of its product argued for its claims' validity.

In Graham, the Supreme Court held that “[s]econdary considerations [such] as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented” and “may have relevancy” as indicia of obviousness. 383 U.S. at 17-18. A nonmovant may rebut a prima facie showing of obviousness with objective indicia of nonobviousness. WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999); see also In re Kahn, 441 F.3d at 990.

Evidence of commercial success, or other secondary considerations, is only significant if there is a nexus between the claimed invention and the commercial success. As we explained in J.T. Eaton & Co. v. Atlantic Paste & Glue Co., 106 F.3d 1563 (Fed. Cir. 1997), “[w]hen a patentee can demonstrate commercial success, usually shown by significant sales in a relevant market, and that the successful product is the invention disclosed and claimed in the patent, it is presumed that the commercial success is due to the patented invention.” Id. at 1571; see also Brown & Williamson, 229 F.3d at 1130 (stating the presumption that commercial success is due to the patented invention applies “if the marketed product embodies the claimed features, and is coextensive with them.”). Thus, if the commercial success is due to an unclaimed feature of the device, the commercial success is irrelevant.¹³ So too if the feature that creates the commercial success was known in the prior art, the success is not pertinent.¹⁴

¹³ See Brown & Williamson, 229 F.3d at 1130; Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1377 (Fed. Cir. 2000); J.T. Eaton, 106 F.3d at 1571.

¹⁴ See J.T. Eaton, 106 F.3d at 1571 (“[T]he asserted commercial success of the product must be due to the merits of the claimed invention beyond what was readily available in the prior art.”); Richdel, Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir. 1983) (holding claims obvious despite purported showing of commercial success when patentee failed to show that “such commercial success as its marketed system enjoyed was due to anything disclosed in the patent in suit which was not readily available in the prior art”).

But the CAFC was in no way convinced that the product's success was due to its supposed novel features. Poo on secondary considerations.

We conclude that the evidence does not show that the commercial success was the result of claimed and novel features. Nor has Align submitted probative evidence that claimed and novel features met a long-felt but unresolved need.

There is a striking inconsistency here, related to the "single package" limitation. For infringement, the limitation is significant: the accused product must meet the limitation. But for prior art anticipation, if a limitation is not patentably distinct, it may be assumed obvious. The lesson for prosecutors is to limit claim limitations that offer no patentable distinction.