Ormco Corporation v. Align Technology Inc, No. 8:2003cv00016 - Document 1076 (C.D. Cal. 2009)
Court Description: ORDER DENYING ALIGN'S MOTION FOR SUMMARY JUDGMENT OF INVALIDITY OF ORMCO'S '444 PATENT 963 ; DENYING ORMCO'S MOTION FOR SUMMARY JUDGMENT OF NO INVALIDITY OF ORMCO'S '444 PATENT 972 ; AND DENYING ORMCO'S MOTION TO EXCLUDE OPINIONS IN THE DECLARATION OF E. DIANE REKOW 1003 by Judge Christina A. Snyder: The Court DENIES Defendant Align Technology, Inc.'s motion for summary judgment of invalidity of the remaining claims 963 . The Court DENIES Plaintiff Or mco Corp.'s motion for summary judgment of no invalidity of the remaining claims 972 , except that the Court GRANTS Ormco's motion for summary judgment on the issue of indefiniteness of claim 40. The Court DENIES Ormco's motion to strike opinions in the Rekow Declaration 1003 . (gk)
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Ormco Corporation v. Align Technology Inc Doc. 1076 1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 CENTRAL DISTRICT OF CALIFORNIA 10 WESTERN DIVISION 11 12 13 14 15 16 17 18 ) ) ) ) Plaintiff, ) ) vs. ) ) Align Technology, Inc. ) ) ) Defendant ) ) ________________________________ ) ) Ormco Corporation Case No. CV 03-16 CAS (ANx) ORDER DENYING ALIGN’S MOTION FOR SUMMARY JUDGMENT OF INVALIDITY OF ORMCO’S ‘444 PATENT; DENYING ORMCO’S MOTION FOR SUMMARY JUDGMENT OF NO INVALIDITY OF ORMCO’S ‘444 PATENT; AND DENYING ORMCO’S MOTION TO EXCLUDE OPINIONS IN THE DECLARATION OF E. DIANE REKOW 19 20 21 22 23 24 25 26 27 28 I. INTRODUCTION Plaintiff Ormco Corp. (“Ormco”) filed the instant action against defendant Align Technology, Inc. (“Align”) on January 6, 2003, alleging that Align was infringing three related Ormco patents: (1) U.S. Patent No. 5,447,432 (“the ‘432 patent”); (2) U.S. Patent No. 5,683,243 (“the ‘243 patent”); and (3) U.S. Patent No. 6,244,861 (“the ‘861 patent”). Ormco later amended its complaint to allege infringement of a fourth patent, U.S. Patent No. 6,616,444 (“the ‘444 patent”). On May 13, 2004, the Court granted Align’s motion for summary judgment of Dockets.Justia.com 1 noninfringement of Ormco’s patents. See Ormco Corp. v Align Tech, Inc., 498 F.3d 2 1307, 1311 (Fed. Cir. 2007), citing Ormco Corp. v. Align Tech., Inc., No. 03-cv-00016 3 slip. op. (C.D. Cal. May 13, 2004). On August 20, 2004, the Court granted Align’s 4 motion for summary judgment of nonenablement of Ormco’s patents. See id., citing 5 Ormco Corp. v. Align Tech., Inc., No. 03-cv-00016, slip. op. (C.D.Cal. Aug. 20, 2004). 6 Ormco appealed to the Federal Circuit. On August 24, 2007, the Federal Circuit 7 affirmed the Court’s grant of summary judgment of noninfringement and 8 nonenablement as to claims 1, 9, and 10 of the ‘432 patent, claims 1 and 2 of the ‘243 9 patent, claims 1, 3, 4, 9-12 and 16-18 of the ‘861 patent, and claims 1-5, 8-36, 41-44, 10 46-68, and 70-79 of the ‘444 patent. Ormco, 498 F.3d at 1320. However, the court 11 reversed the grant of summary judgment of noninfringement and nonenablement of 12 claims 37-40, 45, and 69 of the ‘444 patent, and remanded. Id. 13 On March 24, 2008, defendant moved for a Markman hearing, requesting 14 construction of terms in the remaining ‘444 patent claims at issue. On October 3, 2008, 15 this Court issued an order construing claims. 16 On January 16, 2009, Ormco and Align each filed motions for summary 17 judgment on the issue of the validity of the remaining claims in the ‘444 patent. On 18 January 21, 2009, Ormco and Align each filed oppositions thereto. Replies were filed 19 on February 2, 2009. A hearing was held on February 9, 2009. After carefully 20 considering the arguments set forth by the parties, the Court finds and concludes as 21 follows. 22 II. 23 THE ‘444 PATENT The ‘444 patent, which is the only patent at issue herein, is a patent for “a system 24 and method by which an orthodontic appliance is automatically designed and 25 manufactured from digital low jaw and tooth shape data . . .” The ‘444 Patent, Abstract. 26 The system involves scanning a model of the patient’s mouth to “produce two or three 27 dimensional images and digitizing contours of selected points.” Id. The system allows 28 for a computer to be programmed “to calculate finish positions of the teeth, then to 2 1 design an appliance to move the teeth to the calculated positions.” Id. In its decision overturning the Court’s granting of summary judgment for 2 3 defendant on claims 37-40, 45, and 69 of the ‘444 patent, the Federal Circuit 4 distinguished these claims from the others on the ground that claims 37-40, 45, and 69 5 did not relate to “automatic design or automatic calculation of finish tooth positions.” 6 Ormco, 498 F.3d at 1317. Instead, the Court held, they relate to “the preliminary 7 gathering and organization of tooth data as an aid to further unspecified orthodontic 8 treatment or for use in creation of a digital model.” Id. Because defendant relies on 9 “skilled operators rather than a fully automated computerized process to determine 10 finish positions of the teeth,” summary judgment was proper as to those claims that 11 referred to automatic calculation or design but not to the six claims at issue. Id. 12 III. LEGAL STANDARD 13 A. Summary Judgment 14 Summary judgment is appropriate where “there is no genuine issue as to any 15 material fact” and “the movant is entitled to a judgment as a matter of law.” Fed. R. 16 Civ. P. 56(c). The moving party has the initial burden of identifying relevant portions 17 of the record that demonstrate the absence of a fact or facts necessary for one or more 18 essential elements of each cause of action upon which the moving party seeks judgment. 19 See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). 20 If the moving party has sustained its burden, the nonmoving party must then 21 identify specific facts, drawn from materials on file, that demonstrate that there is a 22 dispute as to material facts eon the elements that the moving party has contested. See 23 Fed. R. Civ. P. 56(c). The nonmoving party must not simply rely on the pleadings and 24 must do more than make “conclusory allegations [in] an affidavit.” Lujan v. National 25 Wildlife Fed’n, 497 U.S. 871, 888 (1990). See also Celotex Corp., 477 U.S. at 324. 26 Summary judgment must be granted for the moving party if the nonmoving party “fails 27 to make a showing sufficient to establish the existence of an element essential to that 28 party’s case, and on which that party will bear the burden of proof at trial.” Id. at 322. 3 1 2 See also Abromson v. American Pacific Corp., 114 F.3d 898, 902 (9th Cir. 1997). In light of the facts presented by the nonmoving party, along with any undisputed 3 facts, the Court must decide whether the moving party is entitled to judgment as a 4 matter of law. See T.W. Elec. Serv., Inc. v. Pacific Elec. Contractors Ass’n, 809 F.2d 5 626, 631 n.3 (9th Cir. 1987). When deciding a motion for summary judgment, “the 6 inferences to be drawn from the underlying facts . . . must be viewed in the light most 7 favorable to the party opposing the motion.” Matsushita Elec. Indus. Co. v. Zenith 8 Radio Corp., 475 U.S. 574, 587 (1986) (citation omitted); Valley Nat’l Bank of Ariz. v. 9 A.E. Rouse & Co., 121 F.3d 1332, 1335 (9th Cir. 1997). Summary judgment for the 10 moving party is proper when a rational trier of fact would not be able to find for the 11 nonmoving party on the claims at issue. See Matsushita, 475 U.S. at 587. 12 B. Invalidity 13 Pursuant to 35 U.S.C. § 282, all patents are presumed valid, and the burden of 14 establishing invalidity, by reason of either lack of novelty (“anticipation”) or 15 obviousness, rests upon the party asserting invalidity.1 The statute presumes each claim 16 of a patent to be valid independently of the validity of the other claims. Id. The 17 presumption of patent validity may be rebutted only by a showing of “clear and 18 convincing evidence.” Saf-Gard Products, Inc. v. Service Parts, Inc., 532 F.2d 1266, 19 1271 (9th Cir. 1976). “The burden of persuasion on invalidity must, under the statute, 20 remain at all times on the party asserting invalidity, although that burden may be carried 21 more easily by evidence consisting of more pertinent prior art than that considered by 22 23 24 25 26 27 1 35 U.S.C. § 282 states in pertinent part: A patent shall be presumed valid. Each claim of a patent (whether in independent or dependent form) shall be presumed valid independently of the validity of other claims; dependent claims shall be presumed valid even though dependent upon an invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting it. 28 4 1 the examiner.” RCA Corp. v. Applied Digital Data System, Inc., 730 F.2d 1440, 1444 2 (Fed. Cir. 1984). 3 A patent claim is anticipated under 35 U.S.C. § 102, only when each and every 4 element of a claim at issue is found either expressly or inherently in a single prior art 5 reference. Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 6 976 F.2d 1559, 1565 (Fed. Cir. 1992); Bristol-Myers Squibb v. Ben Venue 7 Laboratories, Inc., 246 F.3d 1368, 1374 (Fed. Cir. 2001). In addition, “the prior art 8 reference . . . must not only disclose all elements of the claim within the four corners of 9 the document, but must also disclose those elements arranged as in the claim.” Net 10 Moneyin, Inc. v. Verisign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Furthermore, 11 “[t]o serve as an anticipating reference, the reference must enable that which it is 12 asserted to anticipate.” Elan Pharms, Inc. v. Mayo Found. For Med. Educ. & Research, 13 346 F.3d 1051, 1054 (Fed. Cir. 2003). In other words, “[t]o anticipate, the reference 14 must also enable one of skill in the art to make and use the claimed invention.” 15 Bristol-Myers Squibb, 246 F.3d at 1374. 16 “Whether an invention is anticipated is a question of fact.” Elan Pharms, 346 17 F.3d at 1054. “When the examiner considered the asserted prior art and basis for the 18 validity challenge during patent prosecution,” the burden on the party asserting 19 invalidity “becomes particularly heavy.” Impax Labs., Inc. v. Aventis Pharms. Inc., 545 20 F.3d 1312, 1314 (Fed. Cir. 2008). 21 A patent claim may also be invalid as obvious under 35 U.S.C. § 103 “if the 22 differences between the subject matter sought to be patented and the prior art are such 23 that the subject matter as a whole would have been obvious at the time the invention 24 was made to a person having ordinary skill in the art to which said subject matter 25 pertains.” Obviousness is ultimately a legal question, based on underlying factual 26 determinations. Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353, 1356 (Fed. 27 Cir. 2008). The factual determinations underlying the question of obviousness are “1) 28 the scope and content of the prior art, 2) the level of ordinary skill in the art, 3) the 5 1 differences between the claimed invention and the prior art, and 4) evidence of 2 secondary factors, also known as objective indicia of non-obviousness.” Id. 3 IV. 4 5 DISCUSSION A. Align’s Motion for Summary Judgment of Invalidity of the Remaining Claims of the ‘444 patent 6 Align moves for summary judgment, arguing that, as a matter of law, the 7 remaining claims of the ‘444 patent – claims 37, 38, 39, 40, 45, and 69 (“the remaining 8 claims”) – are invalid. 9 1. Prior Art References 10 Align argues that the remaining claims in Ormco’s ‘444 patent are invalid, 11 because they are not novel as required by 35 U.S.C. § 102 and are therefore anticipated. 12 Align’s arguments of anticipation center around two particular prior art references: (1) 13 an article published by Denis Laurendeau entitled “A Computer-Vision Technique for 14 the Acquisition and Processing of 3-D Profiles of Dental Imprints: An Application in 15 Orthodontics” (the “Laurendeau reference”) and (2) U.S. Patent No. 4,611,288, issued 16 pursuant to a patent application filed by Francois Duret (the “Duret patent”). 17 The Laurendeau reference describes a system of computer-assisted classification 18 of skeletal and dental malocclusions, or misalignments of teeth. Mot. at 7-8; SUF ¶ 16; 19 SGI ¶ 16. Specifically, the Laurendeau reference describes a technique whereby a 20 patient bites into a piece of wax, and subsequently the wax impressions are scanned 21 using a laser scanner in order to generate 3D images of the dental imprints for the 22 detection of interstices between the teeth. See Laurendeau reference at 453, 461. 23 The Duret patent discloses a system whereby “[d]ental prostheses, such as 24 crowns, inlays or dentures are produced automatically based upon an optical impression 25 taken of the oral region with nontraumatic radiation.” Duret Patent, Abstract. The 26 optical device captures 3D data of a stump of a tooth where dental restoration, such as a 27 crown, was to be added. SUF ¶ 24; SGI ¶ 24. Data associated with the tooth stump is 28 identified in order to determine the shape of the interior portion of the crown to fit over 6 1 the stump. SUF ¶ 28; SGI ¶ 28. In addition, data relating to the teeth adjacent to the 2 stump is identified from the scan in order to determine the boundaries of the area for the 3 crown. SUF ¶ 27; SGI ¶ 27. The Duret patent was considered by the Patent Office 4 prior to issuing the ‘444 patent. Ormco’s Additional Undisputed Facts ¶ 84; Align’s 5 Response to Ormco’s Additional Undisputed Facts ¶ 84. 6 7 8 2. Claim 37 Align argues first that claim 37 in the ‘444 patent is anticipated by the Laurendeau reference. Claim 37 provides: 9 A method of processing digital data for use in facilitating the 10 orthodontic treatment of a patient comprising: scanning three- 11 dimensional surfaces that have the shapes of a plurality of the teeth 12 of a patient and generating data thereof; from the generated data, 13 producing separate digital representations of the shapes of each of 14 a plurality of individual teeth of the patient. 15 16 ‘444 Patent, Col. 71: 21-29. a. First Element of Claim 37: “Scanning Three- 17 Dimensional Surfaces That Have the Shapes of a 18 Plurality of the Teeth of a Patient and Generating 19 Data Thereof” 20 Align argues that the first element of claim 37 – “scanning three-dimensional 21 surfaces that have the shapes of a plurality of the teeth of a patient and generating 22 data thereof” – in anticipated, because the Laurendeau reference discloses scanning 23 3D wax impressions of the shapes of the occlusal surfaces (i.e. the biting or 24 chewing surfaces) of a plurality of teeth in a patient’s jaws using a 3D scanner and 25 generating data thereof. Mot. at 10. The Laurendeau reference, in its own words, 26 describes “a computer vision technique for the acquisition of the 3-D profiles of 27 dental imprints recorded on a wax dental bite wafer, and an algorithm for the 28 detection of the interstices between the teeth . . .” Mot. at 11; SUF ¶ 32; 7 1 Laurendeau Reference at 454. Align notes that Ormco’s expert, Dr. Roberts 2 (“Roberts”), has admitted that a scan of a wax bite, as disclosed in the Laurendeau 3 reference, would result in undifferentiated data of partial shapes of a plurality of 4 teeth. Mot. at 11; SUF ¶ 34; SGI ¶ 34. 5 Ormco, however, argues that the Laurendeau reference does not, in fact, 6 disclose the generation of data containing the “shapes” of a plurality of teeth. 7 Opp’n at 4. The crux of Ormco’s argument, as set forth by Roberts, is that the 8 Laurendeau reference fails to disclose the scanning of separate 3D tooth shapes and 9 does not produce 3D representations of individual teeth. Miotke Decl. Ex. 2 10 (Roberts Report) at 15. Roberts states that, in determining whether prior art 11 references disclosed the generation of data from an undifferentiated scan of a 12 plurality of teeth, Roberts looked for the disclosure of tooth shape data similar to 13 that disclosed in the ‘444 patent; in particular, Roberts looked for shape data that 14 included the tooth undercuts (the portion of the tooth that lies between its height of 15 contour and the gingivae), which, he argues, are necessary for modeling orthodontic 16 treatment. Opp’n at 5; Motke Decl., Ex. 2 (Roberts Report) at 14-15 (“even in its 17 most basic example, the ‘444 patent discloses a 3D shape that includes a precise 2D 18 profile, of the clinical crown from the occlusal surface to the gingival margin, as 19 well as its full width in the mesio-distal direction”). Ormco argues that the wax bite 20 scanned in the Laurendeau reference only captures the tooth’s occlusal surface, and 21 not the height of the tooth or the tooth’s shape below the occlusal surface. Opp’n at 22 4. Therefore, Ormco argues, the scan of the wax bite is not a scan of “three- 23 dimensional surfaces that have the shapes of a plurality of the teeth.” Opp’n at 4. 24 Ormco argues that this position is consistent with the testimony of both Roberts, 25 Ormco’s expert, and Dr. Rekow (“Rekow”), Align’s expert, who have testified that 26 an orthodontist referring to the “shape” of a tooth would commonly understand it to 27 refer to the entire exposed portion of the tooth, i.e. the clinical crown. Opp’n at 5; 28 Miotke Opp. Dec. Ex. 7 (Rekow Dep.) at 189:14-191:10 (confirming that the 8 1 typical or ordinary meaning for three-dimensional tooth shapes for orthodontists 2 would be either the “clinical crown,” “the clinical crown, plus the roots,” or the 3 “anatomical crown, plus the roots.”) 4 Align, however, argues that, in taking this position, Ormco is attempting to 5 add an additional limitation to the term “shape” so as to require that the term 6 include the “entire clinical crown” that is visible in the mouth. Mot. at 11; SUF ¶ 7 37; Roberts Dep. at 338: 17-24 (“as I read it, that would imply the shape of a tooth, 8 the entire clinical crown of a tooth, yes”). Align argues that Ormco did not argue 9 for this construction of the term “shape” during the Markman hearing, and that 10 Roberts’ explanation for this construction is unsatisfactory. Mot. at 11-12; SUF ¶ 11 38; Roberts Dep. 342:9-14 (“Q: So if I were to go to an orthodontic textbook and 12 look at how they use the word shape, you would expect that that would be the entire 13 physical clinical crown? A: I think that would probably be true for all of dental 14 anatomy, not just orthodontics”). Furthermore, Align argues that deposition 15 testimony of Ormco’s other expert, Dr. Hall (“Hall”), contradicts Ormco’s 16 argument that “shape” is limited to a shape necessary for orthodontic treatment: 17 Q: In a single prior art reference, would you need that prior art 18 reference to disclose the shapes of teeth necessary for orthodontic 19 treatment in order to anticipate claim 37? 20 A: I believe my answer is no. If it could still scan three 21 dimensional surfaces of teeth and allow those to be used as the 22 data to produce separate digital representation of the shapes of a 23 plurality of teeth, then that would seem to satisfy claim 37. 24 Mot. at 12; SUF ¶ 12; Hall. Dep. 101:4-23. Furthermore, Align argues, Hall 25 indicated that even if the term “shape” were to be limited to a shape needed for 26 orthodontic treatment, this would not necessarily require the full clinical crown. 27 Mot. at 12; SUF ¶ 41; Hall. Dep. 99:7-11 (“I can envision cases where I just need 28 one point of contact to attach a bracket. And other cases where maybe the full three 9 1 dimensional shape is needed to determine how much to rotate or tip a tooth”). 2 Therefore, Align argues, nothing in the patent requires “shapes” to be limited to the 3 “entire clinical crown,” because, even assuming it was necessary to have enough 4 shape for orthodontic treatment, the full clinical digital crown information is not 5 required.2 Mot. at 12. 6 b. Second Element of Claim 37: “From the Generated 7 Data, Producing Separate Digital Representations of 8 the Shapes of Each of a Plurality of Individual Teeth 9 of the Patient.” 10 Align argues that the Laurendeau reference discloses the second element of 11 claim 37: “from the generated data, producing separate digital representations of the 12 shapes of each of a plurality of individual teeth of the patient.” First, Align argues, 13 the Laurendeau reference discloses detection and identification of interstices 14 between the teeth and association of data with individual teeth. Mot. at 13; SUF ¶ 15 35; See Laurendeau Reference (“The 3-D image of each side of the imprint is 16 segmented by nonlinear filtering of the 3-D data, and the interstices between the 17 teeth are detected”). After the interstices between teeth are identified, Align argues, 18 the orthodontic parameters of each tooth within the scanned data can be identified.3 19 20 21 22 23 24 25 26 27 2 Align also argues that regardless, claim 37 is not directed to orthodonitic treatment of a patient, because the preamble “facilitating orthodontic treatment” is not a limitation on the claim. Ormco disputes the assertion that the preamble should not be read into the claim. The Court need not reach this issue in deciding the motions for summary judgment herein. 3 Align argues that Roberts testified to this effect: Q. And by identifying interstices, wouldn’t that enable one to identify the position of each tooth within the scanned data? [objection omitted] 28 (continued...) 10 1 Mot. at 14. Align argues that, in fact, the Laurendeau reference explicitly indicates 2 that positions of each individual tooth must first be identified from the 3 undifferentiated dental imprint, and that subsequently, the orthodontic parameters 4 are identified. Mot. at 14, citing Laurendeau Reference at 454 (“The computation 5 of the orthodontic parameters listed in Table 1 requires a prior knowledge of the 6 position of each tooth on the dental imprint”). Align argues that “identification of 7 the position of each tooth within the scanned data necessarily requires that data be 8 associated with particular teeth. As data is being associated with particular teeth, 9 separate digital representations are being produced.” 10 11 Mot. at 14. Align also argues that Figure 8 in the Laurendeau reference identifies 12 particular teeth, which is confirmed by the discussion of the figure, which states 13 “The plots of f1(s) and f2(s) consist of peaks, valleys, and plateaus as shown in 14 figure 8. Peaks of large amplitude mostly correspond to the interstices between the 15 teeth . . . Valleys correspond to teeth.” Swanson Decl. Ex 4 (Laurendeau 16 Reference) at 457. Align further argues that Roberts confirmed this by testifying 17 that the occlusal surfaces of each individual tooth are disclosed in Figure 8, and that 18 the data in Figure 8 are segmented on a tooth-by-tooth basis. Mot. at 15; SUF ¶ 51; 19 Roberts Dep. 583: 17-23 (“so the valleys would be more the occlusal surface of the 20 tooth”) 584: 19-25 (confirming that the data in Figure 8 is “segmented on a tooth- 21 by-tooth basis”). 22 23 24 25 26 27 28 3 (...continued) In theory, yes, you would be able to identify if the interstices, if you can – if your interstices is accurate, you could just move from interstice to interstice if you know that there are two incisors, if you know there is one canine. If you already know that, you would know what this means; otherwise, you would not know that. If there’s a missing incisor, or if there’s a missing bicuspid, then you would not know that. All you would know there’s interstices that is picked up that’s one of these peaks in the colorimetric chart. 11 1 Ormco, however, argues that while the Laurendeau reference discloses that 2 “[t]he 3-D image of each side of the [wax] imprint is segmented by nonlinear 3 filtering of the 3-D data, and the interstices between the teeth are detected,” this 4 segmentation does not create separate 3D representations of the individual teeth or 5 the shapes of those teeth, but instead results in nothing more than an identification 6 of the spaces between the occlusal surfaces of the teeth. Opp’n at 6; Miotke Decl. 7 Ex. 2 (Roberts Report) App. B at 3 (“Laurendeau et al. describes the identification 8 of interstices between teeth but does not provide any disclosure regarding the 9 production of separate digital representations of teeth from undifferentiated 3D 10 data”). Furthermore, Ormco argues, because the Laurendeau reference does not 11 identify individual teeth, the computer does not associate any data points with any 12 identifiable tooth. Opp’n at 7-8; Miotke Opp. Decl. Ex. 1 (Hall Report) at 15 (“The 13 tooth data that is taken from a scan of the wax bite is initially undifferentiated. 14 Although interstices between the teeth are later found, there is no disclosure in 15 Laurendeau that suggests that the underlying undifferentiated tooth data is altered in 16 any way. And given the goal of finding interstices rather than tooth data, there is no 17 reason to assume that such data processing is occurring.”) 18 Furthermore, Ormco argues that Figure 8, referenced by Align, does not 19 support Align’s argument; although Figure 8 presents a chart showing the data 20 generated, and states that the valleys of the functions depicted in Figure 8 21 “correspond to teeth,” Figure 8 does not capture the actual shapes of the teeth and 22 does not generate individual tooth shape representations, and, Ormco argues, “one 23 could note a correspondence between the depressions in the wax bite and teeth 24 without creating any digital representations of anything.” Opp’n at 8. 25 Ormco also argues that Align has not met its burden in showing by clear and 26 convincing evidence that a person of ordinary skill in the art could make and use the 27 claimed invention based on the prior art without undue experimentation. See 28 Amgen, 457 F.3d at 1306-07. Specifically, Ormco notes that the conclusion of the 12 1 Laurendeau references states that “the next step in the development of the automatic 2 diagnosis system will be to identify the type of teeth and measure the orthodontic 3 parameters.” Miotke Decl, Ex. 7 (Laurendeau Reference) at 461. Ormco argues 4 that the failure to teach the step of identifying teeth renders the Laurendeau 5 reference incapable of serving as an anticipatory reference. 6 With regard to the second element of claim 37, the Court agrees with Ormco 7 that Align has not met its burden to establish by clear and convincing evidence that 8 claim 37 is anticipated by the Laurendeau reference.4 In particular, the Court is not 9 convinced that the Laurendeau reference discloses the production of “separate 10 digital representations of the shapes of each of a plurality of individual teeth.” See 11 ‘444 patent. Instead, it appears that the Laurendeau reference may, as Ormco 12 argues, primarily disclose the identification of interstices between the teeth, which 13 may not in and of itself be sufficient to anticipate claim 37. Furthermore, the 14 Laurendeau reference’s statement that “the next step in the development of the 15 automatic diagnosis system will be to identify the type of teeth and measure the 16 orthodontic parameters” further contradicts Align’s argument that the Laurendeau 17 reference teaches the second element of claim 37. Therefore, the Court concludes 18 that Ormco has demonstrated that there are genuine issues of material fact regarding 19 anticipation, and summary judgment is inappropriate. 20 Because claims 38, 39, and 40 are dependent claims of claim 37, the Court 21 notes as a preliminary matter that its finding with regard to claim 37 would 22 generally preclude Align from establishing that the dependent claims are 23 anticipated. See, e.g., In re Royka, 490 F.2d 981, 985 (“The dependent claims 24 rejected with claim 28, as anticipated under § 102, are not anticipated since claim 25 26 27 28 4 Because Align has not met its burden with regard to the second element of claim 37, the Court need not reach the question of whether it met its burden with regard to the first element of claim 37. However, the Court notes that it declines to find as a matter of law that the term “shape” necessarily requires the full clinical crown. 13 1 28 is not anticipated.”) Nevertheless, the Court considers the merits of Align’s 2 arguments with regard to these dependent claims as well. 3 4 5 3. Claim 38 Align argues that claim 38 is also anticipated by the Laurendeau reference. Claim 38, a dependent claim of claim 37, states: 6 The method of claim 37 wherein: the producing of the separate 7 digital representations from the generated data includes the 8 operator-interactive selection on a computer display of landmark 9 parameters of individual teeth. 10 Align argues that the Laurendeau reference anticipates claim 38, because it 11 discloses the operator interactive selection of landmark parameters of individual 12 teeth, including: (1) the interstices between the teeth and (2) orthodontic parameters 13 that define relationships between the teeth. Mot. at 16. In particular, Align argues, 14 “the Laurendeau reference disclosed a system where an automated algorithm along 15 with limited operator interaction determined interstices in the teeth (attributes of the 16 teeth derived from locations on the teeth that can be used for modeling tooth 17 movement).” Mot. at 16. Align cites Table 1 of the Laurendeau reference, which 18 identifies “orthodontic parameters” and notes that Roberts, Ormco’s expert, 19 confirmed that the sagittal canine relation and sagittal molar relation parameters, 20 both listed in Table 1 of the Laurendeau reference, are attributes of teeth that could 21 be used to model tooth movement, and that, to determine these attributes used for 22 modeling tooth movement, one would have to identify points on teeth (i.e. landmark 23 parameters). Mot. at 16, citing Roberts Dep. at 395:11-396:3 (“[the sagittal molar 24 relation is] primarily for looking at the orthopaedic change and the way that the 25 patient actually bites . . . [but] could provide some information under some 26 circumstances . . . for modeling tooth movement”). 27 Align argues that Roberts has attempted to avoid invalidity by adding a new 28 requirement to claim 38: that the attributes derived from locations on teeth must be 14 1 used to actually move teeth to final positions. Mot. at 16; SUF ¶ 61; Roberts Dep. 2 762:17-763:5 (“[Q:] But in terms of actually modeling within the computer tooth 3 movement, is it your view that in order to be a landmark parameter, the locations on 4 the tooth must be able to successfully model the movement of the teeth from initial 5 position to some final position . . . [A:] I think so. . . There could be multiple 6 landmark parameters that, according to the definition of the Court, that is a 7 possibility, yes.”). Similarly, Align cites Ormco’s other expert, Hall, who stated 8 “as I understand it, the locations on the tooth would have to be used to derive 9 attributes of the tooth for modeling tooth movement, so some deliberate attributes 10 that could be used in modeling tooth movement would have to be present.” Mot. at 11 17; Hall Dep. 129:15-20. Align argues that this is contrary to the Court’s claim 12 construction order, which, although holding that landmark parameters are defined 13 as “locations on the tooth used to derive attributes of the tooth for modeling tooth 14 movement,” held that the landmark parameters requirement “merely defines which 15 specific locations on the tooth are chosen in the step described in claim 38, 16 regardless of whether or not representations of the teeth are eventually moved to 17 finish tooth positions.” Mot. at 17, citing October 3, 2008 order. 18 Ormco, however, argues that the Laurendeau reference does not disclose 19 “landmark parameters.” Ormco notes that it is undisputed that the Laurendeau 20 reference does not disclose movement of teeth or modeling the movement of teeth. 21 Opp’n at 13. Furthermore, Ormco argues, Align’s argument that the sagittal canine 22 relation and sagittal molar relation parameters, both listed in Table 1 of the 23 Laurendeau reference, are attributes of teeth that can be used for modeling tooth 24 movement does not lead to the conclusion that landmark parameters are disclosed in 25 the Laurendeau reference, because “applying hindsight to state the attributes ‘can 26 be’ used for modeling tooth movement” is not consistent with the court’s 27 construction that landmark parameters be attributes of the tooth “for modeling tooth 28 movement.” Opp’n at 13-14. Ormco argues that Align’s expert, Rekow, has 15 1 admitted that he is essentially reading in “capable of modeling tooth movement” as 2 a clause into the claim. Mot. at 13; SUF ¶ 67. Furthermore, Rekow stated that, in 3 determining whether specific attributes of teeth qualify as landmark parameters, he 4 did not take into account how much work it would take to model tooth movement. 5 Mot. at 13; SUF ¶ 68. Ormco argues that even if the parameters listed in the 6 Laurendeau reference could, in hindsight, be used to model tooth movement, the 7 reference does not teach claim 38, because it has nothing to do with modeling 8 movement of teeth and does not even express this possible use of the tooth 9 locations. Opp’n at 14. Ormco argues that to read “capable of” into the claim is 10 11 unduly expansive and against the Court’s construction. Opp’n at 14. The Court finds that Ormco is correct that Align has failed to establish that 12 claim 38 discloses the selections of landmark parameters. Align’s reading of 13 landmark parameters as an attribute of the tooth “capable” of modeling tooth 14 movement appears to be contrary to the Court’s October 3, 2008 claim construction 15 order, which construed landmark parameters as “locations on the tooth used to 16 derive attributes of the tooth for modeling tooth movement.” As the Court stated in 17 that order, this construction is not contrary to the holding of the Federal Circuit, 18 because this construction does not require that the teeth actually be moved to finish 19 tooth positions, but instead “defines which specific locations on the tooth are 20 chosen in the step described in claim 38.” In other words, the “for modeling tooth 21 movement” construction reflects the purpose for which the attributes of the specific 22 teeth are selected. Therefore, Align’s argument that this construction includes any 23 attributes of the tooth which, in hindsight, could have been “capable of modeling 24 tooth movement,” even if the attributes were not selected for that purpose, appears 25 overly broad. As a result, the Court finds that Align has failed to meet its burden in 26 establishing that the Laurendeau reference teaches the selection of landmark 27 parameters. 28 4. Claim 39 and Claim 40 16 1 2 Align also argues that the Laurendeau reference discloses the additional limitations of claim 39 and claim 40. Claim 39 states: 3 The method of claim 37 wherein: the producing of the separate 4 digital representations from the generated data includes 5 representing each of the plurality of teeth by a two-dimensional 6 contour. 7 Claim 40 states: 8 The method of claim 37 wherein: the producing of the separate 9 digital representations from the generated data includes separating 10 an image of the plurality of teeth into individual data-sets each 11 representing an individual tooth 12 Specifically, Align argues that claim 39 is anticipated, because the 13 Laurendeau reference discloses that during the producing of the separate digital 14 representations, 2D contours, used to represent teeth, are generated from the 3D data 15 along the curved axis of the dental imprint. Mot. at 17; SUF ¶¶ 49, 64, 65. Align 16 also argues that claim 40 is anticipated by the Laurendeau reference, because the 17 Laurendeau reference discloses using an image on a screen to produce separate 18 digital representations. Mot. at 18; SUF ¶ 43; Laurendeau reference at 457 (“the 19 first segmentation step is to complete the coordinates of the center point of the top 20 horizontal line of the WR-image”). 21 However, the Court finds that because Align has failed to establish that the 22 Laurendeau reference discloses the production of separate digital representations of 23 individual teeth, summary judgment with regard to claims 39 and 40 is 24 inappropriate. 25 26 27 28 5. Claim 45 Align argues that claim 45 is anticipated by the Duret patent. Claim 45 states: A method of processing digital data for use in facilitating the 17 1 orthodontic treatment of a patient comprising: scanning the shapes 2 of the teeth of a patient directly from the mouth of a patient and 3 generating data thereof; grouping the generated data into separate 4 digital representations of the shapes of each of a plurality of 5 individual teeth. 6 Align first argues that the Duret patent discloses the first part of claim 45, in 7 that it teaches using a three-dimensional laser optical probe to scan a plurality of 8 teeth directly from the mouth. SUF ¶ 69. 9 Align further argues that the Duret patent discloses the second part of claim 10 45: “grouping the generated data into separate digital representations of the shapes 11 of each of a plurality of individual teeth.” Mot. at 19. Specifically, Align argues 12 that the Duret patent 13 . . . disclosed the necessity of grouping data into separate digital 14 representations in order to determine the volume defined by six 15 planes to create the outer surface of the prosthesis. Moreover, the 16 data associated with the shape of the tooth stump was identified to 17 determine the shape of the interior portion of the crown designed to 18 fit over the stump. This process requires separation of the data 19 relating to the shapes of the teeth adjacent to the stump and using 20 that data (which includes ‘zones of contact or the boundaries 21 defined by the adjoining teeth’) to define the volume of the 22 prosthesis. 23 24 Mot. at 19.5 25 26 27 28 5 Again, Align argues that the preamble of claim 45, which has the same “facilitating orthodontic treatment” as claim 37, is not limiting, and that regardless, the Duret patent itself teaches that it should “not be considered to be limited to the dentistry field . . . since (continued...) 18 Ormco, however, argues that, like the Laurendeau reference, the Duret patent 1 2 discloses scans that generate 3D data of only one surface of the teeth – in this case the 3 surfaces that border the void to be filled with a prosthetic crown – and does not scan 4 or generate data about the occlusal surface or the other sides of these teeth. Opp’n at 5 4. 6 Furthermore, Ormco argues that, even assuming that the first part of claim 45 7 is satisfied, the second part of the claim is not, because the Duret patent “does not 8 purport to teach how to group that data into separate digital representations of the 9 shapes of each of the plurality of individual teeth.” Opp’n at 11. Ormco argues that 10 the volume of the prosthesis in the Duret patent is calculated without creation of 11 separate digital representations of each tooth. Opp’n at 12. Furthermore, Ormco 12 argues that while Duret discloses scanning the tooth stump in a scan separate from 13 the scan which captures the extended region used to determine the volume, claim 45 14 requires production of separate digital representations of each of the plurality of teeth 15 scanned, not just one tooth. Opp’n at 12. 16 The Court notes that, because the Duret patent was considered by the Patent 17 Office during prosecution of the ‘444 patent, Align’s burden is particularly high in 18 establishing anticipation. Opp’n at 11; SGI ¶ 118; Impax Labs., Inc. v. Aventis 19 Pharms. Inc., 545 F.3d at 1314 (Fed. Cir. 2008) (“When the examiner considered the 20 asserted prior art and basis for the validity challenge during patent prosecution,” the 21 burden on the party asserting invalidity “becomes particularly heavy”). The Court 22 finds that Ormco has raised significant issues regarding whether the Duret patent in 23 fact discloses separate digital representations of a plurality of teeth, and that, 24 therefore, Align has failed to meet this heavy burden of demonstrating that it is 25 entitled to summary judgment with regard to claim 45. 26 5 27 28 (...continued) it is also applicable . . . to the taking of an impression or generating a model in dental applications which are not followed by fabrication of a prosthesis.” Mot. at 20; SUF 76. 19 7. 1 In addition, Align argues that claim 69 is anticipated by the Laurendeau 2 3 Claim 69 reference for the same reasons that claim 37 is. Mot. at 20. Claim 69 states: 4 A computer-implemented method for use in generating digital 5 models of a patient’s teeth, the method comprising: receiving initial 6 data that contains a 3D representation of a plurality of the patient’s 7 teeth; identifying multiple groups of data, each group containing a 8 plurality of points from the initial data that separately digitally 9 represent the shape of one of the teeth. 10 Align argues that claim 69 differs from claim 37 only in that it merely requires 11 “receiving initial data that contains a 3D representation of a plurality of the patient’s 12 teeth” whereas claim 37 requires that scanning be done to create data which is 13 “received” in claim 69. Mot. at 20; SUF ¶ 78. Because the Court finds herein with 14 regard to claim 37 that Align has failed to demonstrate that the Laurendeau reference 15 teaches “separate digital representations” of teeth, the Court finds that summary 16 judgment with regard to claim 69 is also inappropriate. B. 17 Ormco’s Motion for Summary Judgment of No Invalidity of the Remaining Claims of the ‘444 patent 18 Align set forth its position on invalidity in its sixth supplemental response to 19 20 Ormco’s first set of interrogatories, in which it cites 76 prior art references; these prior 21 art references, Align argues, render the remaining claims anticipated or obvious. See 22 Opp’n at 5; Swenson Decl. Ex. 1. Align also sets forth its arguments on how prior art 23 invalidates the remaining claims in Ferraro’s expert report. Opp’n at 5. Ormco argues that Align has failed to raise any issue of material fact with 24 25 regard to the invalidity of the remaining claims, and that, therefore, the Court should 26 grant summary judgment finding that, as a matter of law, the remaining claims are 27 valid. 28 1. Ferraro’s Expert Report 20 1 First, Ormco argues that the expert report on invalidity submitted by Ferarro, 2 Align’s expert, should not be considered, because Ferraro is not an orthodontist, and 3 therefore is not a person of ordinary skill in the art. However, as stated in the Court’s 4 order on Ormco’s motion to strike Ferraro’s testimony, the Court finds that Ferraro is 5 qualified as an expert, and therefore considers Ferraro’s opinions on invalidity 6 presented in his report. 2. 7 Anticipation 8 Ormco next argues that, even if Ferraro’s report is considered, summary 9 judgment should nonetheless be granted in favor of Ormco on the issue of invalidity, 10 because Align’s evidence of invalidity fails to raise any genuine factual issue so that a 11 reasonable fact finder could find that the claims are invalid due to anticipation. a. 12 13 Anticipation of Claims 37, 45, and 69 Ormco first argues that none of the prior art cited by Align discloses separation 14 of undifferentiated 3D scans of the shapes of a plurality of teeth into individual 3D 15 representations of tooth shapes, as required by claims 37, 45, and 69. Mot. at 8. For 16 example, Ormco argues that the prior art references Rickets 39, Brook 74, and Brook 17 75 disclose only multiple views of 2D data, rather than 3D data.6 Mot. at 9. 18 Furthermore, Ormco argues that Yamamoto 50, Yamamoto 51, Yamamoto 52, and 19 Lemchen 59 do not disclose undifferentiated 3D scans of a plurality of teeth, because 20 Yamamoto 50 and 52 disclose only scanning one tooth at a time, Yamamoto 51 does 21 not disclose any relevant details regarding the scanning method employed, and 22 Lemchen 59 does not disclose a single 3D scan of multiple teeth that would result in 23 undifferentiated data. Mot. at 9. Furthermore, Ormco argues that Laurendeau 26 (also 24 referred to herein as the Laurendeau reference), Duret 12, Duret 54 (also referred to 25 herein as the Duret patent), Duret 55 and Rekow 62 do not disclose separating 26 6 27 28 Both parties refer to prior art references by the name of the author/inventor and a number assigned to each reference in the Ferraro report appendix (e.g. “Yamamoto 50"). The Court uses this convention herein as well. 21 1 2 undifferentiated data into individual tooth representations. Mot. at 10. Align, however, disputes Ormco’s characterization of the remaining claims and 3 the prior art references. First, Align argues that prior art references that disclose 4 multiple 2D scans do, in fact, disclose the creation of 3D data. Opp’n at 8; Swenson 5 Decl. Ex. 2 (Hall Dep.) at 54:9-15 (stating that “the wonder of a CT scanner is we can 6 produce a two-dimensional slice and then do that in different levels . . . to stack up a 7 full three-dimensional description of an object.”). Next, Align disputes Ormco’s 8 position that the Yamamoto references do not disclose undifferentiated 3D scans of a 9 plurality of teeth, arguing that Hall, Ormco’s expert, admitted that they in fact do. 10 Opp’n at 9; Swenson Decl. Ex 2 (Hall Dep.) at 176:12-18 (“Q: So, with respect to 11 Yamamoto reference 50, do you believe that it discloses scanning three-dimensional 12 surfaces that have the shapes of a plurality of the teeth of the patient and generating 13 data thereof according to claim 37. A: Yes.”), 174:22-175:9 (stating that the 14 Yamamoto references 51 and 52 describe the same system as Yamamoto 50.) 15 Furthermore, Align argues that Lemchen 59 disclosed more than scans of a single 16 tooth and instead disclosed generation of digital information about the entire jaw. 17 Opp’n at 10; Miotke Decl. Ex. 12 (Lemchen 59) at col 1: 54-69 (“generating digital 18 information which defines the shape and location of the malocclused tooth in the 19 patient’s jaw, from which a mathematical model of the tooth and jaw is generated”). 20 With regard to the second step of claim 37, Align argues that Laurendeau, Duret, 21 Yamamoto, and Lemchen all disclose separate digital representations of the shapes of 22 a plurality of teeth.7 Opp’n 9-10. b. 23 Anticipation of Claim 38 24 25 26 27 28 7 Align’s arguments with regard to Laurendeau and Duret 54 are discussed in more detail in reference to Align’s motion for summary judgment of no invalidity. Although the Court denied summary judgment for Align with regard to the question of whether Laurendeau discloses the second step of claim 37, the Court finds that Align has raised a sufficient issue of fact so as to survive Ormco’s motion for summary judgment. 22 1 Ormco further argues that Align has failed to demonstrate that claim 38 is 2 anticipated, because, contrary to Align’s arguments, neither Laurendeau, Ricketts, 3 Duret, or Brook disclose “landmark parameters.” Mot. at 13. Specifically, Ormco 4 argues that (1) Yamamoto 50, Yamamoto 52, and Rickets 39 relate to tooth movement 5 after orthodontic treatment, and none teaches how to prospectively model tooth 6 movement for orthodontic treatment, (2) Rekow and Duret are directed to restorative 7 dentistry, not orthodontics, (3) the Laurendeau reference only identified parameters 8 concerning tooth relationships instead of locations on the teeth, and (4) Brook 74 and 9 Brook 75 were concerned with measuring the size of teeth, not modeling tooth 10 movement. Mot. at 15. 11 Align, however, argues that its references cited, do, in fact, disclose landmark 12 parameters. The essence of part of the dispute between Align and Ormco appears to 13 be whether a reference that discloses retrospective, rather than prospective, tooth 14 movement, can anticipate claim 38. Align argues that one of skill in the art would 15 understand that tooth movement could be modeled either prospectively or 16 retrospectively. Opp’n at 15; Rekow Decl. ¶ 16 (“It is often necessary to create a 17 prospective model or series of models that indicate the desired path of tooth 18 movement for a particular orthodontic treatment. Likewise, retrospective modeling of 19 tooth movement by modeling and measuring differences in models over a period of 20 time can provide critical information about a particular orthodontic treatment and can 21 be used to confirm, change, or modify further orthodontic treatment as well as 22 expanding the evidence base of the science of tooth movement.”). Align notes that, 23 for example, Yamamoto 50, Yamamoto 51, and Yamamoto 52 each describes a 24 system “where the computer calculates the change in position and orientation of teeth 25 and creates a simulations (or “model”) of tooth movement.” Opp’n at 15. Align 26 further argues that, in so doing, each discloses landmark parameters. Opp’n at 15; see, 27 e.g., Ferraro Decl ¶ 90 (“Yamamoto [50] disclosed an interactive selecting of 28 landmark parameters (e.g., locations from which the centroid of the occlusal surface 23 1 and orientation of the tooth could be derived)”), ¶ 93, ¶ 96. Ormco, however, counters 2 that the ‘444 patent only discloses modeling prospective treatment. Reply at 16. c. 3 4 Conclusion In considering the arguments of the parties, the Court finds that Align has 5 presented sufficient evidence of anticipation to raise a question of fact as to whether 6 the prior art references anticipate the remaining claims. First, contrary to Ormco’s 7 argument, Align has raised an issue of fact as to whether various prior art references 8 disclose separation of undifferentiated 3D scans of the shapes of a plurality of teeth 9 into individual 3D representations of tooth shapes. 10 Furthermore, the Court finds that Align has raised a question of fact as to 11 whether the prior art references anticipate the landmark parameters disclosed in claim 12 38. Specifically, the Court declines to find as a matter of law that a prior art reference 13 disclosing the use of landmark parameters for retrospective modeling of tooth 14 movement cannot anticipate claim 38. Ormco did not argue for a limitation requiring 15 prospective modeling at the claim construction hearing, and nothing on the face of the 16 Court’s construction would appear to require prospective, rather than retrospective, 17 modeling. Furthermore, Align’s expert, Rekow has stated that a person of ordinary 18 skill in the art would understand the term modeling to include both prospective and 19 retrospective modeling, and that retrospective modeling could be used to “confirm, 20 change, or modify further orthodontic treatment.” See Rekow Decl. ¶ 16. Therefore, 21 the Court finds that summary judgment is inappropriate.8 9 22 23 24 25 26 27 28 8 Ormco also argues that summary judgment should be granted in its favor, because Align has failed to demonstrate how the references it relies upon as anticipatory enable the inventions claimed by Ormco. In particular, Ormco argues, Yamamoto 50, Yamamoto 52, and Lemchen fail to enable the remaining claims. “A reference is enabled when its disclosures are sufficient to allow one of skilled in the art to make and use the claimed invention.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1306 (Fed. Cir. 2006). “When considering whether or not a prior art reference requires undue (continued...) 24 3. 1 Obviousness 2 Ormco also argues that although Align “asserts that literally hundreds of 3 combinations of the prior art render obvious the asserted claims,” that Ferraro’s 4 opinions are “general and not applied with particularity to show how identified 5 teachings from specific prior art references could be combined and why there would 6 be a motivation to make that specific combination.” Mot. at 15. First, Ormco argues, 7 none of the prior art discloses undifferentiated scans of a plurality of teeth that 8 includes the dental undercuts, which, Ormco argues, must be included in any model of 9 tooth movement for use in facilitating orthodontic treatment. Mot. at 17. 10 Furthermore, Ormco reiterates its argument that none of the prior art discloses 11 landmark parameters, identification of which, Ormco argues, is “the key to creating a 12 3D computer model that could be used to facilitate the orthodontic treatment of a 13 patient” and without which “a person of ordinary skill would be completely adrift in 14 attempting to define a usable 3D digital representation of individual tooth shapes.” 15 Mot. at 18. 16 17 18 19 20 21 22 23 24 25 26 27 28 8 (...continued) experimentation we look at the reference from the perspective of a person of ordinary skill in the art.” Id. at 1306-07. In its reply with regard to Align’s motion for summary judgment, however, Align argues that Ormco’s argument that Align’s experts did not consider whether the prior art references were enabling is incorrect, because “Align’s experts reviewed the prior art from the perspective of one of skill in the art and determined that they disclosed each of the elements of the asserted claims.” Reply at 12, n. 10. “While enablement is ultimately a question of law, it is based on underlying factual findings.” Bruning v. Hirose, 161 F.3d 681, 686 (Fed. Cir. 1998). The Court finds that, despite Ormco’s arguments, it cannot determine as a matter of law that Align’s prior art references fail to enable the remaining claims. 9 Align and Ormco dispute whether the “for facilitating orthodontic treatment” language should be read into the claim. Because the Court finds herein that, even if the “for facilitating orthodontic treatment” language is read into the claims, that Align has raised an issue of fact as to whether the claims are invalidated, the Court need not reach this issue. 25 1 Align responds that summary judgment in favor of Ormco is not warranted, 2 because Ormco’s motion fails to address all of the prior art references asserted by 3 Align and its experts. Opp’n at 8. Moreover, Align disputes Ormco’s characterization 4 of its expert report, arguing that it contains a detailed discussion of all of the 5 references and provides information on the exact combination of references that 6 render each claim invalid, discusses which elements of the claims are present in the 7 references, and discusses, both generally and with respect to particular references, 8 why one would be motivated to combine references in the way described in the report. 9 Opp’n at 16; Ferraro Decl. ¶¶ 39-83. Furthermore, Align disputes Ormco’s argument 10 that prior art references would have to disclose scans of a plurality of teeth including 11 the dental undercuts, arguing that “orthodontic treatment can be readily accomplished 12 without full clinical crown digital information or dental undercut information.” Opp’n 13 at 17; Swenson Decl. Ex. 2 (Hall Dep.) (“I can envision cases where I just need one 14 point of contact to attach a bracket. And other cases where maybe the full three- 15 dimensional shape is needed to determine how much to rotate or tip a tooth”). Align 16 also disputes Ormco’s assertions that the prior art references fail to disclose “landmark 17 parameters” as discussed herein, and notes that “landmark parameters” are only 18 contained in claim 38. 19 Because the Court finds that Align has raised a genuine issue of material fact as 20 to whether (1) the prior art discloses undifferentiated scans that have the shapes of a 21 plurality of teeth10 and (2) the prior art discloses landmark parameters, the Court finds 22 summary judgment inappropriate.11 23 24 25 26 27 28 10 As the Court has stated herein, the Court declines to find that as a matter of law that shape requires inclusion of dental undercuts. 11 At the hearing, Ormco argued that Align has failed to set forth any evidence that someone of ordinary skill in the art would have a reasonable expectation of success in making the claimed invention. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (continued...) 26 4. 1 Invalidity of Claim 40 Due to Indefiniteness 2 “Indefiniteness is a matter of claim construction, and the same principles that 3 generally govern claim construction are applicable to determining whether allegedly 4 indefinite claim language is subject to construction.” Praxair, Inc. v. ATMI, Inc., 543 5 F.3d 1306, 1319 (Fed. Cir. 2008). “A claim will be found indefinite only if it is 6 insolubly ambiguous, and no narrowing construction can properly be adopted . . . . . 7 On the other hand, if the meaning of the claim is discernible, even though the task 8 may be formidable and the conclusion may be one over which reasonable persons will 9 disagree, we have held the claim sufficiently clear to avoid invalidity on indefiniteness 10 grounds.” Id. “Indefiniteness, like claim construction, is a question of law.” Praxair, 11 Inc. v. ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008). 12 13 Align has asserted that Ormco’s claim 40 is invalid as indefinite, because it has identical scope to claim 37. Claim 37 reads: 14 15 16 17 18 19 20 21 22 23 24 25 26 27 11 (...continued) (Fed. Cir. 2006) (“If all the elements of an invention are found in a combination of prior art references, a proper analysis under 35 U.S.C.S. § 103 requires, inter alia, consideration of two factors: (1) whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process; and (2) whether the prior art would also have revealed that in so making or carrying out, those of ordinary skill would have a reasonable expectation of success”); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007) (“the burden falls on the patent challenger to show by clear and convincing evidence that a person of ordinary skill in the art would have had reason to attempt to make the composition or device, or carry out the claimed process, and would have had a reasonable expectation of success in doing so”). A reasonable expectation of success is a question of fact. Id. at 1165. The Court finds that although Ferraro’s expert report does not appear to explicitly address the issue of reasonable expectation of success, the Court cannot find, based on the totality of the opinions asserted by Ferraro regarding the obviousness of the remaining claims, that a reasonable juror could not find that a person of ordinary skill in the art would have a reasonable expectation of success in making the claimed invention. 28 27 1 A method of processing digital data for use in facilitating the 2 orthodontic treatment of a patient comprising: scanning three- 3 dimensional surfaces that have the shapes of a plurality of the teeth of 4 a patient and generating data thereof; from the generated data, 5 producing separate digital representations of the shapes of each of a 6 plurality of individual teeth of the patient. 7 Claim 40 reads: 8 The method of claim 37 wherein: the producing of the separate 9 digital representations from the generated data includes separating an 10 image of the plurality of teeth into individual data-sets each 11 representing an individual tooth. 12 Ormco argues that claims 37 and 40 are not identical, because claim 37 requires 13 separation of “data” as part of the second step, which could involve separation of an 14 image that is generated on a screen or manipulation of data within a computer that is 15 not reflected as an image on a screen. Miotke Decl. Ex. 2 (Roberts Report) at 26. 16 Ormco argues that claim 40 is more restricted than claim 37, because it requires an 17 “image” so that separation of data not reflected in “image” form would not meet claim 18 40's requirements. Miotke Decl. Ex. 2 (Roberts Report) at 26-27. 19 Align, however, counters that claim 40 should be found indefinite as a matter of 20 law because, in fact, the ‘444 patent uses the terms “data” and “image” 21 interchangeably, and one of skill in the art would not understand how claim 40 differs 22 from claim 37. Opp’n at 19; Ferraro Decl. ¶ 35. Specifically, Align argues that the 23 term “image” as used in the ‘444 patent refers not to an image on a computer screen 24 but instead, more generally, a representation of something. Opp’n at 19. For example, 25 Align argues, 26 the ‘444 patent talks about three-dimensional images being a 27 representation of the teeth, not a picture displayed on a computer 28 screen: “scanning a model of the patient’s mouth to produce two or 28 1 three dimensional images . . .”; and “three dimensional imaging of 2 the teeth and jaw of the patient is carried out with laser or other 3 scanner to form full three dimensional images of the teeth and jaw of 4 the patient. The images may be formed from the patient’s teeth and 5 jaw or from a model thereof.” 6 7 Opp’n at 19. The Court finds that Align has failed to set forth clear and convincing evidence, 8 other than vague references to sections of the patent, that demonstrate that the term 9 “data” and “image” are interchangeable, so as to render claim 40 identical to claim 37. 10 Therefore, the Court grants summary judgment in favor of Ormco on the issue of 11 indefiniteness of claim 40. 12 C. Exclusion of Rekow’s Declaration 13 On January 26, 2009, Ormco filed a motion to exclude the “new” opinions in the 14 declaration of Diane E. Rekow, which was submitted in support of Align’s motion for 15 summary judgment of invalidity. Align filed an opposition on February 2, 2009. A 16 reply was filed on February 5, 2009. Ormco argues that, to support its motion for 17 summary judgment on invalidity of the remaining claims of the ‘444 patent, Align has 18 improperly submitted a declaration from Rekow, Align’s expert, four paragraphs of 19 which, Ormco argues, assert substantial new opinions on invalidity not contained in 20 Rekow’s expert report. Mot. to Exclude at 1. 21 Under Fed. R. Civ. P. 26(a)(2)(B), a submitted expert report must contain a 22 “complete statement of all opinions to be expressed and the basis and reasons for 23 them” and “the data or other information considered by the witness in forming them.” 24 Mot. to Exclude at 2. Under Fed. R. Civ. P. 37(c)(1), a party who fails to properly 25 disclose information as required by Fed. R. Civ. P. 26(a) “is not allowed to use that 26 information or witness to supply evidence on a motion, at a hearing or at a trial” unless 27 the party’s failure to disclose was “substantially justified” or “harmless.” 28 In its opposition, Align counters that Rekow’s declaration does not, in fact, 29 1 contain any new or different opinions than those disclosed in her expert report and 2 deposition testimony. Opp’n at 4. Align’s opposition presents a side-by-side 3 comparison of statements made in Rekow’s declaration and in her expert report to 4 bolster its argument that Rekow’s declaration does not present any new opinions, but 5 instead, merely paraphrases her opinions as presented in her expert report. 6 The Court first notes that, regardless of the opinions contained in the Rekow 7 declaration, the Court herein determines that Align has failed to set forth clear and 8 convincing evidence of invalidity with regard to the Laurendeau reference and the 9 Duret patent. Therefore, with regard to Align’s motion for summary judgment, 10 striking the Rekow declaration would not in any way change the denial of summary 11 judgment for Align, and therefore, the motion to strike need not be decided in 12 connection with Align’s motion. 13 The Court further notes that Align has also submitted some of the disputed 14 portions of the declaration in support of its opposition to Ormco’s motion for summary 15 judgment of no invalidity. In declining to grant summary judgment in favor of Ormco 16 on the issue of invalidity, the Court does not rely on any portion of the Rekow 17 declaration, with the exception of paragraph 16 of the declaration submitted in support 18 of Align’s opposition (paragraph 17 in the declaration submitted in support of Align’s 19 motion), in which Rekow states her opinion that both retrospective and prospective 20 modeling of tooth movement can be useful for orthodontic treatment. Therefore, the 21 Court need only reach the issue of whether the opinions in this particular paragraph 22 were disclosed in Rekow’s expert report. 23 Specifically, the disputed portion of the Rekow declaration states: 24 25 It is often necessary to create a prospective model or series of 26 models that indicate the desired path of tooth movement for a 27 particular orthodontic treatment. Likewise, retrospective modeling 28 of tooth movement by modeling and measuring differences in 30 1 models over a period of time can provide critical information about a 2 particular orthodontic treatment and can be used to confirm, change, 3 or modify further orthodontic treatment as well as expanding the 4 evidence base of the science of tooth movement. In either situation, 5 models of tooth movement are useful in performing orthodontic 6 treatment. 7 Rekow Decl. in Support of Align’s Opposition to Ormco’s Motion for Summary 8 Judgment ¶ 16. 9 In examining Rekow’s expert report, the Court concludes that Rekow’s expert 10 report does in fact disclose the essence of the opinions stated in paragraph 16, and that, 11 regardless, any failure to disclose the level of detail contained in the Rekow declaration 12 is nonetheless harmless to Ormco. 13 14 Two passages of Rekow’s expert report specifically discussed retrospective tooth movement related to orthodontic treatment: 15 Separate digital tooth representations were routinely used prior to 16 1991 to model tooth movement (including quantifying tooth 17 movement in response to orthodontic treatment) . . . 18 Rogaski Decl. (Rekow Report) at 8; and: 19 The mathematical techniques described to move teeth [i.e. prospective 20 tooth movement] are identical to those used to quantify tooth 21 movement [i.e. retrospective tooth movement] in response to 22 orthodontic treatment. 23 Rogaski Decl. (Rekow Report) at 2. 24 Although these statements do not necessarily disclose the full detail of Rekow’s 25 opinion as stated in her declaration, her statement that retrospective modeling of tooth 26 movement can be used to “quantify tooth movement in response to orthodontic 27 treatment,” would, by logical extension, indicate that she would view such modeling as 28 providing “critical information about a particular orthodontic treatment” and useful to 31 1 “confirm, change, or modify further orthodontic treatment.” Therefore, the Court 2 declines to strike paragraph 16 in Rekow’s opposition declaration. 3 IV. 4 CONCLUSION For the foregoing reasons, the Court DENIES Align’s motion for summary 5 judgment of invalidity of the remaining claims. The Court DENIES Ormco’s motion 6 for summary judgment of no invalidity of the remaining claims, except that the Court 7 GRANTS Ormco’s motion for summary judgment on the issue of indefiniteness of 8 claim 40. The Court DENIES Ormco’s motion to strike opinions in the Rekow 9 Declaration. 10 IT IS SO ORDERED. 11 12 13 Dated: February 23, 2009 __________________________________ CHRISTINA A. SNYDER UNITED STATES DISTRICT JUDGE 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 32
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