Invalidity dossier

US 6616444

Current assignee: Ormco Corporation

Added 9/29/2026, 10:54:44 AM

IndustryMedical (M)
At a glanceNo PTAB challenges2 lawsuits on fileasserted by Ormco CorporationMedical (M)

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Patent summary

Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.

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I'll start with targeted searches for this exact patent number and its litigation history.

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I have the key litigation facts. Let me try to retrieve more of the granted claim set (the record indicates 79 claims with seven independent claims).

US 6,616,444 — "Custom orthodontic appliance forming method and apparatus"

Scope and method note (please read first)

  • I searched web-accessible patent and litigation sources (Google Patents, FreePatentsOnline, Justia, CourtListener, Unified Patents/Darts-IP litigation links, Docket Alarm). I did not have direct PACER/CM‑ECF or USPTO Patent Center/PTAB API access in this session, so this is a secondary-source summary, not a certified extract of the official file wrapper.
  • USPTO/CAFC 2026 dockets: I found no 2026 litigation or appeal activity on 6,616,444. The patent record lists only historical litigation (below). Given the patent's listed legal status (expired/lapsed in 2013), 2026 activity would be unusual. I am flagging this as "no hits found," not as "confirmed none exist."
  • The full text supplied to me for US6616444B2 was truncated before the claims, so the claim summary below is built from the published patent text at freepatentsonline.com/6616444.html and the pre-grant publication US20020006597A1 (same application, 09/878,801), plus what the courts quoted.
  • Number discipline: I did not substitute similar-looking numbers. Documents I deliberately excluded as different documents include: NL6616444A (an unrelated Dutch chemistry/cephalosporin document), US 6,244,861 ("'861"), US 5,454,717, US 5,447,432, US 5,431,562 ("'562"), US 5,368,478, and US 20020006597A1 (the pre-grant publication of the same application). They share a specification with 6,616,444 but are distinct patents/publications.

1. Bibliographic data

Field Value (as recorded)
Patent number US 6,616,444 B2
Title Custom orthodontic appliance forming method and apparatus
Inventors Craig A. Andreiko (Alta Loma, CA); Mark A. Payne (Whittier, CA)
Assignee (original / current per record) Ormco Corporation (Orange/Glendora, CA)
Application number 09/878,801
Filing date 2001-06-11
Issue/publication date 2003-09-09 (grant); US20020006597A1 published 2002-01-17
Earliest priority 1992-11-09 (claimed from US 07/973,973; 07/973,965; 07/973,844; 07/973,947)
Family (non-exhaustive) US 5,431,562; US 5,447,432; US 5,454,717; US 5,368,478; US 6,244,861; PCT WO 94/10935; EP 0667753; JP 3380553B2
Claim count 79 claims (independent claims include 1, 10, 23, 30, 46, 54, 70)
Legal status per record "Expired – Fee Related"; "Adjusted expiration 2013-07-07"
Classifications A61C 7/00, 7/002 (computer-assisted orthodontics), 7/12, 7/14, 7/146, 9/004; B33Y 80/00; G16H 20/40

Uncertainty flag: the "adjusted expiration 2013-07-07" entry and "Expired – Fee Related" status are the record's own fields. A 2013 expiry is short for a patent that issued in 2003; it most plausibly reflects term measured from the 1992 priority chain plus adjustments, and/or a maintenance-fee lapse. I cannot confirm which from the sources I accessed. Treat the status line as the register's literal entry, not as a legal conclusion.


2. Abstract

The abstract is shared across this family. The courts described the '444 patent's abstract as:

"a system and method by which an orthodontic appliance is automatically designed and manufactured from digital low[er] jaw and tooth shape data..." — C.D. Cal. Markman order in Ormco Corp. v. Align Technology (ipmall PDF)

The full family abstract (verbatim as printed on the sibling '861 patent, US 6,244,861, same specification; reproduced in a PTAB exhibit, Ex. 1017):

"A system and method by which an orthodontic appliance is automatically designed and manufactured from digital lower jaw and tooth shape data of a patient provides for preferably scanning a model of the patient's mouth to produce two or three dimensional images and digitizing contours and selected points. A computer is programmed to construct archforms and calculate finish positions of the teeth, then to design an appliance, preferably including archwires and brackets, to move the teeth to the calculated positions. The lower teeth are positioned at their roots on an arch defined by the lower jaw bone, and the arch is modified to best fit the tooth tips on a smooth curve. Upper archforms are constructed for the upper teeth. Then, machine code is generated and appliances are automatically produced that will straighten the teeth of the patient. Custom placement jigs are also automatically designed and fabricated and are provided with the custom appliance to position the appliance on the patient's teeth."

Uncertainty flag: I did not view the printed abstract page of 6,616,444 itself; the text above is the family-shared abstract (identical wording appears in the WO 94/10935 abstract and in US 6,244,861). Given the shared specification and the district court's quotation, I am confident it is at least substantially the '444 abstract, but I am not certifying it verbatim.


3. Independent claims — plain-language overview

The patent has 79 claims. Court records identify the independent claims as 1, 10, 23, 30, 46, 54, and 70 (SCOTUS cert. petition in Ormco v. Align, No. 07-1070, referring to "independent claims 10, 23, 30, 46, 54, and 70 and claims that depend from them"; PDF).

Claim 1 (independent) — verbatim

"A method for use in the orthodontic correction of malocclused teeth of a patient in accordance with the individual anatomy of the patient and a prescription of an orthodontic practitioner for treatment of the patient, the method comprising: generating data by scanning shapes of the teeth of a patient; displaying a graphic representation of the teeth of the patient with a computer from the generated data; and through an operator interacting with a computer located remote from the orthodontic practitioner, altering the graphic representation to arrange a plurality of the teeth in relation to each other in accordance with the prescription, to produce a digital model of a desired arrangement of the teeth of the patient that includes data of the shapes of a plurality of the teeth positioned relative to each other." (FreePatentsOnline; quoted in Ormco v. Align, 498 F.3d 1307, at '444 patent col.67 l.57–col.68 l.6)

Plain language: Scan the patient's teeth → show them on a computer screen → an operator, working at a computer remote from the treating orthodontist, moves the teeth around on screen to match the doctor's prescription, producing a digital model of the desired final tooth arrangement. Notably, claim 1 never uses the word "automatically," yet the Federal Circuit held most asserted claims still required automatic finish-position determination.

Claim 10 (independent) — verbatim

"A method for use in the orthodontic correction of malocclused teeth in accordance with the individual anatomy of the patient and an orthodontic prescription for treatment of the patient, the method comprising: scanning shapes of the teeth of the patient and digitizing data of the scanned shapes; communicating the digitized data to a computer programmed to apply at least some automated tooth position criteria to produce a digital model of the teeth of the scanned shapes in desired positions, and generating a 3-D digital model of the patient's teeth in the desired positions based on the digitized data and in accordance with the prescription; and generating machine code to operate a machine to form tooth shapes in accordance with the digital model." (FreePatentsOnline)

Plain language: Scan and digitize the teeth → send the data to a computer programmed to apply at least some automated tooth-position criteria → produce a three-dimensional digital model of the teeth in their desired (post-treatment) positions per the prescription → generate machine code that drives a machine to form tooth shapes matching that model. This is the claim branch with explicit (partial) automation language.

Claims 23, 30, 46, 54, 70 (independent) — not retrieved

I was unable to retrieve verbatim text for these six independent claims; the claim listing I could access truncated after claim 15, and I will not reconstruct them from inference. What the record does establish:

  • They are method claims. The Federal Circuit treated the asserted claims in claims 1–5 and 8–79 (76 of the 92 asserted claims in suit were from the '444 patent).
  • Claims 37–40, 45, and 69 are the exceptions the Federal Circuit carved out: they "did not relate to automatic design or automatic calculation of finish tooth positions," but rather to "the preliminary gathering and organization of tooth data as an aid to further unspecified orthodontic treatment or for use in creation of a digital model." (498 F.3d at 1317; C.D. Cal. order)
  • The pre-grant publication of the same application (US20020006597A1) shows claim text in this region directed to (i) forming an individualized archwire from sensed anatomy with computer-calculated bracket/archwire geometry and machine control signals (claim 37), and (ii) fabricating a custom appliance by operating a machine to form tooth-conforming 3-D surfaces, bracket-positioning jigs, and bracket slots (claim 39), and (iii) providing custom orthodontic treatment by supplying a 3-D scanning device and receiving practitioner instructions (claim 40) (Justia). Caveat: these are application claims; claim numbering/wording in the granted patent may differ. I flag this as indicative, not verified.

Representative dependent claims (for flavor)

Claims 3–9 add: designing appliance geometry from the relatively positioned tooth shapes (3); generating machine code and transmitting it to a manufacturing machine (4); operating the machine to shape tooth-conforming surfaces (5); manufacturing cavities fitting a tooth crown (6); manufacturing an archwire plus brackets and bracket-positioning jigs (7); scanning directly in the mouth (8); scanning a model (9). Claims 11–15 add manufacturing a custom appliance with a 3-D tooth-conforming surface, generating a 3-D model of desired post-treatment positions, and various operator-interaction features.


4. Litigation history (as recorded; no 2026 entries found)

Proceeding Identifier Notes
District court (asserted '444) C.D. Cal. 03-cv-00016, Ormco v. Align Technology Filed 2003-01-06; '444 added by amendment. SJ of noninfringement on "automatic determination of finish tooth positions" and SJ of nonenablement (2004).
Federal Circuit Appeal Nos. 2006-1240, -1274 → Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. Aug. 24, 2007) Affirmed noninfringement/nonenablement as to most claims but reversed as to '444 claims 37–40, 45, 69; (opinion PDF; CourtListener)
Supreme Court Cert. petition No. 07-1070 (2008) Challenged the claim-construction approach (majority vs. O'Malley dissent).
Remand / Markman C.D. Cal., order dated 2008-10-03 Construed '444 claims 37–40, 45, 69 (ipmall copy)
Google Patents litigation links Fed. Cir. case 05-1426; C.D. Cal. case 8:09-cv-01009 Listed in the patent's "Family has litigation" block via Unified Patents/Darts-IP links; I did not independently verify what 05-1426 or 8:09-cv-01009 decided.

Related but distinct: the same common specification was litigated in Ormco I, 463 F.3d 1299 (Fed. Cir. 2006), involving the '548 patent of Align and others.

2026 search result: no CAFC 2026 docket entry, appeal, or PTAB proceeding referencing 6,616,444 surfaced in my searches. (I did see third-party search-strategy documents that merely list "6616444" as a search string — that is not litigation activity.)


5. Confidence and open items

  • High confidence: patent number/title/inventors/assignee, application 09/878,801, filed 2001-06-11, issued 2003-09-09, 1992-11-09 priority, 79 claims, independent claim set including 1, 10, 23, 30, 46, 54, 70, claim 1 and claim 10 verbatim text, the Ormco v. Align litigation history, and the reversal as to claims 37–40, 45, 69.
  • Lower confidence / explicitly uncertain: verbatim printed abstract of 6,616,444 (I used the shared family abstract); text of independent claims 23, 30, 46, 54, 70; the meaning and outcome of Fed. Cir. 05-1426 and C.D. Cal. 8:09-cv-01009; and the precise reason behind the listed "adjusted expiration 2013-07-07."
  • Recommended verification steps if you need authoritative confirmation: USPTO Patent Center for the 09/878,801 file wrapper (full granted claims) and maintenance-fee history; USPTO Assignment records for ownership; and PACER for CAFC 05-1426 and C.D. Cal. 8:09-cv-01009 plus any post-2010 activity.

Generated 9/29/2026, 11:03:47 AM

Cases on file (2)

Group view →

Specific litigation cases in our database that name US patent 6616444. The free-form analysis below may also discuss cases beyond this list.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

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I'll search for litigation involving US patent 6616444.

Let me search for more specific litigation details.

Let me search for the later litigation and appellate case numbers.

Litigation Involving U.S. Patent No. 6,616,444 ("the '444 patent")

Based on my searches of litigation databases (Unified Patents litigation portal, CourtListener, SEC filings, and the Google Patents family‑litigation data), there is one clearly documented patent‑infringement litigation centering on the '444 patent, plus a related case that may have involved the '444 family. Details below.


1. Ormco Corp. v. Align Technology, Inc. (the core '444 case)

Item Detail
Plaintiff(s) Ormco Corporation (a Danaher Corp. subsidiary). Allesee Orthodontic Appliances, Inc. ("AOA") appears as a counterdefendant/co‑party with Ormco.
Defendant(s) Align Technology, Inc. (maker of the Invisalign system)
Jurisdiction U.S. District Court for the Central District of California (Santa Ana Division — Judge Christina A. Snyder)
Case No. CV‑03‑00016‑CAS (ANx); also cited as SACV03‑16‑CAS and 8:03‑cv‑00016
Filed January 6, 2003 (Ormco originally asserted the '861, '243, and '432 patents; the '444 patent was added by amended complaint, with the asserted '444 claims themselves having been added to the application on Dec. 12, 2002)
Patent asserted U.S. 6,616,444 (claims 1–5 and 8–79 originally asserted; only claims 37–40, 45 and 69 survived to trial)

Procedural / outcome history

  • May 13, 2004 – District court granted Align summary judgment of non‑infringement, construing the Ormco claims (based on the shared specification and the prosecution history of the ancestor '562 patent) to require automatic computer determination of finish tooth positions; Align's system used "skilled operators." (CourtListener)
  • Aug. 20, 2004 – District court granted Align summary judgment of non‑enablement of the Ormco patents.
  • Feb. 25, 2005 – District court (on Align's counterclaim) invalidated claims 1–3 and 11–13 of Align's U.S. 6,398,548 patent.
  • Aug. 24, 2007 – Federal Circuit decision, Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. 2007), Nos. 2006‑1240, ‑1274. The court affirmed SJ of non‑infringement and non‑enablement as to most asserted claims (including claims 1–5, 8–36, 41–44, 46–68, 70–79 of the '444 patent), but reversed and remanded as to claims 37–40, 45 and 69 of the '444 patent (the "preliminary gathering/organization of tooth data" claims). (CAFC opinion PDF)
  • June 9–25, 2009 – Jury trial on the remanded claims (37, 38, 40, 45, 69). June 25, 2009 jury verdict for Ormco: the asserted '444 claims were infringed and valid (not anticipated or obvious). Jury also issued an advisory verdict that Ormco did not engage in prosecution laches or unclean hands. (SEC Form 8‑K, June 26, 2009)
  • July 13, 2009 – Ormco moved for a permanent injunction against Align (seeking to enjoin Invisalign sales through the January 2010 expiration of the '444 patent).
  • July 28, 2009 – Court entered judgment in Ormco's favor on Align's equitable defenses (prosecution laches / unclean hands). Align filed a motion for judgment as a matter of law (JMOL); damages had not yet been tried. (Align press release, July 21, 2009)

Current status / caveat: My searches surfaced the liability verdict and the post‑trial motion practice, but did not return a confirmable final disposition (e.g., a later Federal Circuit mandate or settlement) of the post‑2009 liability phase. I could not verify the ultimate outcome with high confidence and am not asserting one. (The '444 patent itself expired / became "Expired – Fee Related" per the Google Patents page, with an adjusted expiration date of 2013‑07‑07.)


2. Ormco Corp. v. Cadent Ltd. et al. (possible family litigation — uncertain)

Item Detail
Plaintiff Ormco Corporation
Defendant(s) Cadent Ltd. / Cadent, Inc.; Orametrix, Inc.
Jurisdiction U.S. District Court for the Central District of California
Case No. 8:09‑cv‑01009
Filed ~September 2009 (complaint filed; served Sept. 10, 2009; related case SACV03‑16‑CAS)
Status Terminated Nov. 10, 2010 — counterclaims dismissed without prejudice; case closed. (Unified Patents case page)

Caveat: The Google Patents family‑litigation panel links this case to the '444 patent family, but the Stanford NPE Litigation Database associates case 8:09‑cv‑01009 with U.S. Patent 7,080,979 (not the '444 patent). I therefore cannot confirm that the '444 patent was actually asserted in this case; it appears in the '444 family‑litigation record but the patent actually pleaded is ambiguous in the sources I retrieved.


3. Federal Circuit docket "05‑1426"

The Google Patents page for US 6,616,444 lists a Federal Circuit matter as "05‑1426" in the family‑litigation panel. I was unable to verify the parties, subject matter, or outcome of that docket from the sources I could retrieve. It may correspond to an interlocutory or parallel appeal in the Ormco–Align dispute, but I cannot confirm this and do not assert it. (Note the merits appeal of the 2004 summary judgments carried Federal Circuit Nos. 2006‑1240 and ‑1274.)


Summary

  • Confirmed: One fully documented infringement action on the '444 patent — Ormco Corp. v. Align Technology, Inc., C.D. Cal. No. CV‑03‑00016 (a/k/a SACV03‑16‑CAS, 8:03‑cv‑00016), filed 2003; Fed. Cir. Nos. 2006‑1240/‑1274 (498 F.3d 1307, 2007); 2009 jury verdict for Ormco of infringement/validity on claims 37–40, 45, 69; JMOL/injunction phase ongoing at that point.
  • Uncertain: Ormco Corp. v. Cadent/Orametrix, 8:09‑cv‑01009 (C.D. Cal.) — connected to the '444 family record but not confirmed as asserting the '444 patent.
  • Unverified: Federal Circuit docket 05‑1426.

If you need the precise final disposition of the post‑2009 Ormco–Align liability phase, that would require pulling the full district‑court docket (C.D. Cal. 8:03‑cv‑00016) and the Federal Circuit docket directly from PACER/CM‑ECF, which my web searches did not surface.

Generated 9/29/2026, 11:03:28 AM

Proceedings on file (0)

All PTAB activity →

AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.

Current assignee: Ormco Corporation

No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.

PTAB challenges

AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.

✓ Generated

I'll start by searching for any AIA trial proceedings tied to this patent, since the structured ODP block reports none.

The searches show extensive district court / Federal Circuit activity but no IPRs yet. Let me probe specifically for AIA trials and for the second litigation/appeal.

Proceedings overview

Zero. The USPTO Open Data Portal returns no AIA trial proceedings (IPR, PGR, or CBM) on US 6,616,444 — 0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled at the Board, 0 institution denials. My independent web searches corroborate this: I could find no IPR/PGR/CBM petition ever filed against the '444 patent, and no PTAB Final Written Decision touching it. The bottom line for a defendant is therefore unusual: there is no IPR shield and no IPR estoppel — but there is also almost certainly nothing left to defend against, because the patent expired on 2013-07-07 (Google Patents "Adjusted expiration," status "Expired – Fee Related"), and its entire pre-expiration enforcement history ran its course between 2003 and the early 2010s. The "hardened vs. dead" question is answered by Article III litigation, not the Board, and that history is mixed: most of the asserted claims were held invalid for non-enablement and never recovered, while six claims survived to a jury trial and were found infringed and not proven invalid.

⚠️ Important caveat on the sources below: none of the following are AIA trial proceedings. They are district court and Federal Circuit matters, included because they are the only adjudicative history of the '444 patent's claims. I did not find any AIA trial to report, and I have not invented a proceeding number to fill the slot.


AIA trial proceedings on US 6,616,444

None on file

  • Type: N/A
  • Filed: N/A
  • Status: No proceedings — USPTO ODP reports zero AIA trials; web search surfaced no petitions, no institution decisions, no FWDs, no terminations.
  • Why that is expected: The '444 patent has an effective priority date of 1992-11-09 and was filed 2001-06-11 (continuation; asserted claims added 2002-12-12). Post-Grant Review requires an effective filing date on or after 2013-03-16 (§ 321 / AIA § 6), so PGR was never available; CBM review has sunset (2020-09-16) and in any event this is not a "covered business method" patent. That leaves IPR only — and no one filed one, even though the patent was asserted against Align Technology in a decade-long war with ample motivation and resources.
  • Defensive value: No § 315(e)(2) estoppel exists against anyone, so a defendant is not boxed in by prior Board art. But with expiration on 2013-07-07, the § 286 six-year damages lookback window closed long ago, and there is no injunctive exposure. A demand letter citing US 6,616,444 today is asserting an expired patent — that is the single most powerful fact in any response.

Related (non-AIA) adjudications — the real claim-level history

Ormco Corp. v. Align Technology, Inc., C.D. Cal. No. 8:03-cv-00016, and Fed. Cir. Nos. 2006-1240, -1274

  • Type: Article III patent infringement litigation + appeal (not an AIA trial)
  • Filed: 2003-01-06; the '444 patent added by amended complaint
  • Claims at issue in the '444: originally claims 1–5 and 8–79 (76 of the 92 claims asserted across four Ormco patents)
  • First appeal decided: 2007-08-24 — Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. 2007). Comprehensive opinion: https://www.courtlistener.com/opinion/[210412](/patent/210412)/ormco-corp-v-align-technology-inc/ ; PDF: https://storage.courtlistener.com/pdf/2007/08/24/Ormco_Corporation_Et_Al._v._Align_Technology.pdf
  • Disposition (claim-level): The Federal Circuit affirmed summary judgment of non-infringement and invalidity for non-enablement as to claims 1–5, 8–36, 41–44, 46–68, and 70–79 of the '444 patent, and reversed and remanded as to claims 37–40, 45, and 69. Per the court's later recounting: "On August 24, 2007, the Federal Circuit affirmed the Court's grant of summary judgment of noninfringement and nonenablement as to … claims 1–5, 8–36, 41–44, 46–68, and 70–79 of the '444 patent … However, the court reversed the grant of summary judgment of noninfringement and nonenablement of claims 37–40, 45, and 69 … and remanded." (https://storage.courtlistener.com/harvard_pdf/[2417431](/patent/2417431).pdf)
  • Reasoning worth quoting: the majority held the shared specification and the '562 ancestor's prosecution history limited most claims to "automatic computer determination of the finish positions of the teeth without human adjustment of the final results," and that Align's operator-driven Invisalign process therefore did not infringe — and that the specification did not enable that automatic scope. A dissent disagreed sharply with deriving that limitation from the specification rather than the claim text. (I could not verify the dissenting judge's identity or the exact panel composition from the sources retrieved — one retrieved opinion attributes a dissent to Judge O'Malley, but Judge O'Malley did not join the court until December 2010, which is inconsistent with a 2007 opinion. Treat panel composition as unverified.)
  • Supreme Court: Ormco sought certiorari on the claim-construction/enablement holding — petition at No. 07-1070 (https://www.scotusblog.com/wp-content/uploads/2008/04/07-1070_pet.pdf). Per Align's SEC disclosure, "[t]he Supreme Court denied Ormco's petition," and the CAFC "denied Ormco's petition for rehearing" on the non-infringement/non-enablement portion. (https://aligntech.gcs-web.com/node/14681/html)
  • Remand, trial, and verdict: On remand the case concerned only claims 37–40, 45, and 69. Markman order 2008-10-03 (https://www.ipmall.info/sites/default/files/hosted_resources/Markman/pdfFiles/2008.10.03_ORMCO_CORP_v._ALIGN_TECHNOLOGY.pdf); Align's validity summary-judgment motion (Laurendeau reference; U.S. Patent No. 4,611,288 to Duret) was denied 2009-02-23, 2009 WL 466070. Jury trial 2009-06-09 through 2009-06-25; verdict for Ormco: claims 37, 38, 40, 45, and 69 were infringed and were not anticipated (§ 102) or obvious (§ 103), plus an advisory verdict rejecting prosecution laches and unclean hands. Note claim 39 does not appear in the verdict form — it was remanded but was not among the claims put to the jury; I could not verify why from the retrieved sources, so do not assume it was adjudicated.
  • Post-trial: Judgment entered for Ormco on laches/unclean hands 2009-07-28 (Align Form 8-K: https://www.sec.gov/Archives/edgar/data/[1097149](/patent/1097149)/000114420409039086/v155763_8k.htm). Ormco moved for a permanent injunction 2009-07-13. Align moved for JMOL; the court's post-verdict order is at https://www.courtlistener.com/opinion/[2401932](/patent/2401932)/ormco-corp-v-align-technology-inc/ — I could not verify the JMOL disposition from the retrieved sources; do not assume either way.
  • Settlement: The parties entered a global settlement (publicized as the "Ormco Litigation Settlement" and a "Joint Development, Marketing and Sales Agreement with Ormco"); the agreement is filed as an exhibit to Align's Form 10-Q (https://investor.aligntech.com/static-files/1fb3dbb1-918e-4543-a393-400a6184f59e). Terms are largely confidential. Separately, a 2006-02-01 settlement resolved only past damages for Ormco's/AOA's adjudged infringement of Align's '548/'611 patents ($884,000 into escrow), expressly without affecting either side's appeals.
  • Appeal of the final judgment: A second appeal from the final judgment followed ("The second appeal was from the final judgment…"), and it was overtaken by the settlement. I could not verify the second appeal's docket number or disposition and am not going to guess at one.
  • Other links surfaced by Google Patents' litigation block (listed verbatim, not independently verified by me): a first-worldwide-family litigation entry via Darts-IP (family 27506046); a CAFC case 05-1426 (https://portal.unifiedpatents.com/litigation/Court%20of%20Appeals%20for%20the%20Federal%20Circuit/case/05-1426); and C.D. Cal. case 8:09-cv-01009 (https://portal.unifiedpatents.com/litigation/California%20Central%20District%20Court/case/8%3A09-cv-01009). The 05-1426 docket does not match the "2006-1240, -1274" numbers in the 2007 opinion; treat the mapping of these docket numbers to specific appeals as unresolved.
  • Defensive value: Mixed but net favorable to a defendant. Thirty-plus claims of the '444 patent — including claim 1 — are dead as a matter of final, unappealed judgment (non-infringement and non-enablement), and the enablement holding is unusually strong because it rests on the patentee's own inventors' testimony and its own software. Any modern theory built on claims 1–5 or 8–36 is built on canceled-in-effect claims. The flip side: claims 37–40, 45, and 69 were jury-tested and survived a § 102/§ 103 attack — but those claims are directed to "the preliminary gathering and organization of tooth data," not to automated finish-position calculation (498 F.3d at 1317), and the patent expired in 2013.

Strategic summary

Claim status. For US 6,616,444: claims 1–5, 8–36, 41–44, 46–68, and 70–79 — held non-infringed and invalid for non-enablement (Fed. Cir. 2007, affirmed as to those claims, cert. denied). Claims 37–40, 45, and 69 — adjudicated at trial in 2009, found infringed and not invalid on the § 102/§ 103 record presented. Claim 39 — remanded but not tried (not on the verdict form); status effectively untested. No claim of the '444 patent was ever canceled by the PTAB, because no petition was ever filed. There is no IPR-driven narrowing — the narrowing came from the Federal Circuit's enablement affirmance.

Estoppel landscape. Because there was no IPR, there is no § 315(e)(2) estoppel binding any petitioner or privy, and no § 325(e) estoppel. The only preclusion that exists is issue preclusion running between Ormco (now an Envista/Kavo Kerr entity) and Align and their privies from the C.D. Cal. consent-to-judgment finality on the enablement/non-infringement rulings. That means a non-privy defendant is not bound by Align's 2007 win and, in principle, could attack the surviving claims 37–40, 45, 69 on art Align did not use — but there is no reason to: the patent expired 2013-07-07, so § 286 damages reach only conduct before 2013 (and six years back from any still-viable complaint), and injunctive relief is off the table. Practically, the strongest "ground" available to a defendant today is not prior art at all — it is the expiration date plus the 2007 enablement affirmance.

Pattern signals. (1) No AIA filer pattern exists — the '444 patent never attracted an IPR, even when Align had every incentive during active litigation up to 2010; that is almost certainly because the pre-AIA statute made IPR unavailable until 2012-09-16, by which point the claims were at trial/injunction, and because the patent's term was running out. (2) The patent owner litigated aggressively (Ormco drove the 2003 suit, the remand, the 2009 trial, a permanent-injunction motion, and a cert petition), though the Supreme Court refused review. (3) No defensive aggregator — I found no Unified Patents, RPX, or other third-party IPR in the chain; the only third-party activity in this family that surfaced was Align/OrthoClear-related reexaminations against Align's patents (e.g., the '840 patent), not this one. (4) The dispute ended in a business settlement with a Joint Development, Marketing and Sales Agreement, i.e., peace, not a precedent-setting invalidation of the surviving six claims.


Recommended next steps

  • If you are a defendant being asserted against today: lead with expiration. The patent's adjusted expiration is 2013-07-07 (Google Patents, https://patents.google.com/patent/US6616444/en). No § 271 infringement is possible for post-2013 conduct, no injunction is available, and § 286 damages are time-barred absent a live earlier action. Demand-letter responses should cite the expiration entry directly.
  • If the assertion targets claims 1–5 or 8–36: cite Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. 2007) (https://www.courtlistener.com/opinion/210412/ormco-corp-v-align-technology-inc/) and quote the disposition: "the court reversed the grant of summary judgment of noninfringement and nonenablement of claims 37-40, 45, and 69 of the '444 patent, and remanded" — with the necessary negative implication that the non-infringement/non-enablement judgment stood as to claims 1–5, 8–36, 41–44, 46–68, and 70–79. Those claims are foreclosed.
  • If the assertion targets claims 37, 38, 40, 45, or 69: note that these are the only claims that ever survived adjudication, that they were found infringed/not-invalid only on the specific 2009 record (Laurendeau and Duret were the art tested), and that claim 39 was remanded but never tried. Because there is no PTAB estoppel, a defendant retains full freedom to raise § 102/§ 103 and § 112 grounds that Align did not — but weigh that against the expired term before spending on an IPR, which would be of limited practical value.
  • On active proceedings: there are none to track — no institution deadlines, no oral hearings, no statutory one-year FWD clocks, no appeals pending at the Federal Circuit concerning the '444 patent.
  • Verification I could not complete: the second Federal Circuit appeal's docket number and disposition; the district court's post-verdict JMOL disposition; the apportionment of the CAFC docket numbers 05-1426 / 2006-1240 / 2006-1274; and the panel composition/dissent authorship. Before filing anything that cites these, pull the dockets directly from USPTO PTAB E2E (to confirm the nil AIA record) and CourtListener / PACER (for the C.D. Cal. 8:03-cv-00016 docket and the second appeal). Do not rely on my reconstruction of those four items.

Generated 9/29/2026, 11:03:49 AM

Ownership chain (1)

Asserters network →

Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.

  1. ? · recorded 2002-06-13 · Security Agreement

    ORMCO CORPORATIONCredit Suisse First Boston

    securitization

Assignment history

Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.

✓ Generated

I'll research this patent's ownership history across the sources available.

Assignment & Ownership Analysis — US 6616444 B2

Methodology caveat (read first): I was able to retrieve Google Patents' legal-events record (authoritative excerpt supplied in the prompt), Federal Circuit/district court records, and SEC filings. However, I was not able to execute a live query against the USPTO Patent Assignment Center (assignmentcenter.uspto.gov) — that database is not reachable through the tools available to me, and the underlying reel/frame numbers for this patent are not exposed in the Google Patents legal-events text I retrieved. I am not fabricating reel/frame numbers. Where a reel/frame is not sourced, I say so explicitly. Everything below is grounded in a citable record.


Inventors

Inventor Employer at filing
Craig A. Andreiko Ormco Corporation (original assignee; invention made in the course of Ormco's custom-appliance program). Direct employment evidence: Fed. Cir. and district court records refer to "testimony from the inventors" about Ormco's own internal software (Elan, later Insignia), which is consistent with Ormco employment. Exact employment dates are not verifiable from the sources retrieved.
Mark A. Payne Same as above — Ormco Corporation.

Unusual patterns: None determinable. The "all inventors departed within 12 months" fire-sale precursor cannot be assessed, because I have no verifiable record of either inventor's departure date. Note that the priority applications date to 1992-11-09 (US 07/973,973; 07/973,965; 07/973,844; 07/973,947), while the application that issued as the '444 patent was filed 2001-06-11 as a continuation — a roughly nine-year prosecution/continuation chain. That is a normal pattern for this Ormco family (the '562, '243, '861 and '444 patents share a common specification), not an NPE tell.


Original assignee

Ormco Corporation — named on the face of the issued patent (issued 2003-09-09; filed 2001-06-11). Assignee of record per Google Patents; current listed assignee also Ormco Corp.

  • Primary line of business: Operating orthodontic-products manufacturer — brackets, archwires, and the Insignia digital custom-appliance system. Not a licensing vehicle. It is the company that actually built the "custom appliance automated design and manufacturing system" the patent describes.
  • Products embodying the claims: Mixed. Ormco did ship an appliance (the Red, White & Blue system) and later Insignia, and Ormco's own litigation testimony described the Elan/Insignia software. But the C.D. Cal. non-enablement record is pointed: the inventors' testimony that Elan "could be used to treat patients without human adjustment" was found not credible, and manual override was used in all forty test cases of Insignia. So Ormco shipped orthodontic products, but the record suggests no product cleanly practiced the automatic claim scope that was litigated. That is a claim-scope/product-mismatch finding, not an NPE finding.
  • Corporate status: Operating, and still operating. Ormco was part of Sybron Dental Specialties ("SDS"), which Danaher Corporation acquired in 2006. In September 2019 Danaher spun its dental platform off as Envista Holdings Corporation (NYSE: NVST), with Ormco as one of its three operating companies. Envista's own SEC pledge schedules list Ormco IP, LLC as a subsidiary — relevant to Signal 1 below. Envista remains an operating, publicly traded dental company.

Important structural note: Sybron→Danaher and Danaher→Envista were share/equity transactions on parent companies, not recorded assignments of this patent. Ownership of the '444 patent therefore stays with Ormco Corporation by operation of corporate succession; those events would not appear as reel/frame assignments.


Assignment timeline

Chronological list of every recorded event surfaced. Reel/frame: not retrieved — see methodology caveat. I report the date, conveyance, parties, and context exactly as they appear in the Google Patents legal-events record.

  • 2002-06-13 (recorded; execution date not shown in the retrieved text) — Reel not retrieved / Frame not retrieved

    • Conveyance: Security Agreement (Google Patents legal event: "Assigned to CREDIT SUISSE FIRST BOSTON … SECURITY AGREEMENT")
    • Assignor: Ormco Corporation
    • Assignee: Credit Suisse First Boston (as secured party / collateral agent)
    • Correspondent: Not retrievable from the sources available to me. No flag possible — I will not name a correspondent I cannot source.
    • Context: Securitization / collateral pledge. This is a financing lien over the patent portfolio, not a transfer of ownership. Note the assignee is the operating company's lender, not a licensing entity — a critical distinction for NPE scoring.
  • No other post-issuance assignments were surfaced. In particular, there is no recorded assignment of US 6616444 from Ormco Corporation to Ormco IP, LLC, despite Ormco IP, LLC appearing in Envista's SEC pledge schedules (SEC filing 0001757073-20-000017, Schedule of Pledgors/Subsidiaries). If a live Assignment Center query shows such a record, that would change the analysis; on the record I retrieved, it does not exist for this patent.

Answer to the "no records" branch: The Assignment Center is not empty for this patent — it contains the 2002 Credit Suisse security agreement. It contains no ownership-transfer assignment. That itself is a finding: the patent remained with Ormco and its corporate successors.


Timeline diagram

timeline
    title Ownership of US 6616444
    1992 : Priority applications filed by Ormco
    2001 : Continuation application filed
    2002 : Security agreement to Credit Suisse
    2003 : Patent issued
         : Ormco sues Align Technology
    2007 : Federal Circuit affirms invalidity
    2009 : Jury verdict for Ormco
         : Align settlement agreed
    2013 : Patent expired

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. No assignment from Ormco to a licensing-only LLC is on the record for this patent. The only recorded event involving a third party is the 2002-06-13 Credit Suisse First Boston security agreement, which is a collateral pledge, not a transfer of title, and Credit Suisse is a bank — not an "IP / Patents / Holdings / Ventures" suffix entity. Caveat: Ormco IP, LLC does exist inside the Envista structure, so a future/intra-group assignment is plausible, but I found no evidence of one for this patent. Naming alone is not a finding.

2. Known asserter in the chain — NOT PRESENT. No assignee or predecessor matches Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Spangenberg entities, or any Unified Patents / RPX high-frequency-plaintiff list. Ormco is an operating orthodontic manufacturer; Credit Suisse First Boston is a bank. Neither appears on NPE assertion directories.

3. Repeat correspondent across the chain — UNCLEAR / INSUFFICIENT DATA. I could not retrieve correspondent-of-record data (attorney, firm, address) for the 2002 entry, so I cannot test for recurrence. No finding either way. This is the single largest evidentiary gap in this analysis.

4. Cascading transfers — NOT PRESENT. Only one recorded post-issuance event exists (2002-06-13), and it is a security interest, not a chain of conveyances. No <24-month LLC-to-LLC cascade is present on the retrieved record.

5. Pre-litigation transfer — NOT PRESENT. The 2002-06-13 security agreement precedes Ormco's 2003-01-06 suit against Align by roughly seven months, but it is a collateral pledge to a lender, not an assignment to an asserter, and Ormco litigated in its own name as an operating company. There is no evidence the chain was arranged to enable assertion or to set venue; venue (C.D. Cal.) tracks Ormco's California base.

6. Bankruptcy fire-sale — NOT PRESENT. Neither Ormco, Sybron, Danaher, nor Envista filed Chapter 7/11 in connection with this patent. Danaher→Envista (2019) was a tax-efficient spin-off, and Danaher fully exited its Envista stake via exchange offer — a healthy restructuring, not a distressed sale.

7. Privateering — NOT PRESENT; arguably the inverse. Ormco asserted directly against its own commercial competitor, Align Technology (Invisalign), in Ormco's own name. That is first-party operating-company assertion, the opposite of privateering through a proxy NPE. Outcome: Fed. Cir. 2007-08-24 affirmed invalidity/non-infringement of 86 of 92 asserted claims (many as non-enabled); on remand the district court found the six surviving claims (37, 38, 39, 40, 45, 69) infringed and not invalid (Consent Judgment, SACV 03-16 CAS); Align paid ~$13M plus ~7.6M shares and cross-licensed (2009).

8. Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at Ormco/Envista, with the patent expired fee-related, adjusted expiration 2013-07-07 (Google Patents legal status). No neutralization-by-aggregator event.


Verdict

Operating-company assertion.

Ormco Corporation — a real orthodontic-products manufacturer, today an operating subsidiary of Envista Holdings (NYSE: NVST) — is the assignee of record and asserted the '444 patent directly and in its own name against its direct competitor Align Technology (suit filed 2003-01-06, C.D. Cal. 03-cv-00016; jury verdict for Ormco 2009-06, settled 2009-08). The only recorded post-issuance assignment is the 2002-06-13 Credit Suisse First Boston security agreement, a collateral pledge financing event, not an NPE transfer — so none of the eight NPE signals is present, and several are affirmatively contradicted (no licensing-only LLC assignee; no known asserter; no fire-sale; no defensive aggregator). The legitimate limitations on this conclusion are (a) I could not retrieve reel/frame numbers or the correspondent of record, so Signal 3 is untested, and (b) the asserted claims largely failed on non-enablement and the patent expired 2013-07-07, so it is non-assertable today.

Verify: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search patent 6616444) and the legacy index https://assignment.uspto.gov/patent/index.html. Cross-reference Google Patents legal events at https://patents.google.com/patent/US6616444/en and the CAFC decision Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. 2007).


What would upgrade this analysis

  1. Run the Assignment Center query and capture the 2002-06-13 Credit Suisse reel/frame and the correspondent of record — that is the one datum that could turn Signal 3 from "unclear" to a finding.
  2. Check for an Ormco Corp → Ormco IP, LLC assignment recorded after 2019 (the Envista-era entity). If it exists, it is an intra-group reorg of an operating company, not an NPE transfer — but it would matter for standing questions if the patent were ever revived.
  3. Pull the 2009 Align–Ormco settlement agreement and cross-licenses (Exhibit 10.x to Align's 10-Q filed ~2009-11-05) to confirm what license encumbrances survived — relevant if any successor ever attempted assertion.

Generated 9/29/2026, 11:03:46 AM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I'll research the prior art citations for US patent 6,616,444. Let me search for the patent's cited references.

Let me get the specific citation lists for US6616444 from multiple sources.

Let me search for the exact reference list as printed on the '444 patent itself.

Prior Art Analysis — U.S. Patent No. 6,616,444 (Andreiko & Payne, Ormco Corp.)

A. Confirmation of the patent from the search (USPTO/Google Patents record)

Field Value
Patent No. US 6,616,444 B2
Title Custom orthodontic appliance forming method and apparatus
Inventors Craig A. Andreiko; Mark A. Payne
Assignee Ormco Corp.
Application US 09/878,801, filed 2001‑06‑11
Priority date 1992‑11‑09 (continuation family of four 1992 applications: US 07/973,973→US 5,431,562; 07/973,965→US 5,454,717; 07/973,844→US 5,368,478; 07/973,947→US 5,447,432)
Granted 2003‑09‑09
Source https://patents.google.com/patent/US6616444/en

Because the '444 patent carries a 1992‑11‑09 priority date, prior art under 35 U.S.C. § 102(a)/(b)/(e) is measured against that date (and its 2001 filing for § 102(e) references). Any reference published before 1991‑11‑09 is § 102(b) art ab initio.

Important caveat on sourcing. Within my search budget I could not retrieve a single verbatim reproduction of the "References Cited" box as printed on the face of the '444 patent. The list below is reconstructed from (i) the printed reference lists of the same-family Ormco/Andreiko patents (US 5,454,717, US 5,447,432, US 5,368,478, US 5,431,562), (ii) a third-party reprint of a same-title family document (IPR2016‑00270, Ex. 1017), and (iii) the Google Patents citation data. Treat the membership and any single reference as subject to PACER/PatentCenter confirmation. I flag confidence per item.


B. Reconstructed "References Cited" list and § 102 mapping

Tier 1 — CAD/CAM scanning & automated manufacture of dental restorations (most relevant to the "digitize anatomy → machine code → machine" limitations that pervade the '444 claims)

1. U.S. 4,611,288 — Duret et al., "Method and apparatus for producing a dental prosthesis" (issued 9 Sept 1986).

  • Description: Computer-aided dental prosthesis production from a digitized (optical/mechanical) impression fed to a machine tool; the foundational Duret CAD/CAM-dentistry reference.
  • Potential § 102 anticipation: the "producing digital information records from digitized data … generating a control signal … operating a machine in response to the control signal" steps common to the claimed methods (esp. the appliance-designing/control-signal-generating steps recited in the archwire claims 37–40 and the fabrication claims). The gap for anticipation is that Duret concerns prostheses, not an orthodontic bracket/archwire system, so it would more likely be § 103 art than a clean § 102 reference. Confidence the reference is cited: high; confidence it alone anticipates any '444 claim: low–moderate.

2. U.S. 4,663,720 — Duret et al. (issued 5 May 1987) and U.S. 4,742,464 — Duret et al. (issued 3 May 1988).

  • Description: Further Duret CAD/CAM dental-restoration patents (digitized impression → computed shape → numerically controlled machining).
  • Potential § 102: same CAD/CAM control-signal limitations as above; same subject-matter gap. § 103 art; low anticipation probability.

3. U.S. 4,837,732 — Brandestini et al. (issued 6 June 1989).

  • Description: Optical/electronic scanning of a tooth and computer-controlled production of a restoration (the "CEREC"-lineage art).
  • Potential § 102: the "sensing anatomical shapes … producing signals containing digital anatomical shape data" step recited in the '444's archwire/fabrication claims (e.g., claim 37 opening step; claim 39). Again directed to a single tooth restoration rather than a full-arch orthodontic appliance. § 102/§ 103 candidate; low–moderate.

4. U.S. 5,027,281 — Rekow et al. / Regents of the University of Minnesota (issued 25 June 1991).

  • Description: "Method and apparatus for scanning and recording of coordinates describing three-dimensional objects of complex and unique geometry" — a 3-D digitizing system for dental objects.
  • Potential § 102: the "sensing anatomical shapes of the mouth … producing signals containing … three-dimensional tooth shape data" limitations central to the '444's claim 1 preamble family and to claims 37/39. This is arguably the most on-point scanning reference in the cited set. Standing alone it supplies the 3-D acquisition step but not the finish-position derivation or appliance-forming steps. Confidence cited: high. § 102 anticipation of a full claim: unlikely; strong § 103 building block.

5. U.S. 4,983,105 — Coleman et al. (issued 8 Jan 1991) — dental-model/impression scanning and model preparation art. § 103 art; low anticipation probability.

Tier 2 — Custom orthodontic archwires / brackets / bracket placement (most relevant to the '444 bracket-forming and archwire claims)

6. U.S. 4,183,141 — Dellinger (issued 15 Jan 1980). Custom orthodontic appliance / archwire art (classified by the examiner at 433/24).
7. U.S. 4,284,405 — Dellinger et al. (issued 18 Aug 1981). Orthodontic archwire/appliance system.
8. U.S. 4,360,341 — Dellinger (issued 23 Nov 1982). Custom archwire forming/positioning.

  • Potential § 102: Dellinger is the classic "custom archwire shaped to a desired archform" line of art. These bear directly on the '444's archwire-shape-derivation claims (claims 34–40 as published; claim 37's "calculating … the shape of an archwire"). The '444 distinguishes itself by deriving the archform from digitized individual anatomy and by computer generation of the machine control signal; Dellinger is a manual/analog custom-art reference. § 103 art; low § 102 probability.

9. U.S. 5,011,405 — Lemchen, "Method for determining orthodontic bracket placement" (issued 30 April 1991; reissued 5 March 1996 as RE35,169).

  • Description: Computer-assisted determination of orthodontic bracket placement positions on teeth.
  • Potential § 102: highly relevant to the '444's "establishing bracket mounting locations on each of a plurality of the teeth" step (appears in the archwire/fabrication claims, e.g., claim 37) and to the bracket-slot-geometry limitations. Lemchen, however, computes bracket placement, not the automated cutting/forming of the bracket slot by a computer-controlled device that is the core of the '444's printed claims 1–16. Strong § 103 reference; § 102 anticipation of claims 1–16 unlikely.

10. U.S. 5,131,843 — Hilgers et al. (issued 21 July 1992). Orthodontic bracket/appliance and placement apparatus. Note the July 1992 date is within one year of the 1992‑11‑09 priority date, so it is at most § 102(a)/(e) art, not § 102(b). § 103 candidate; low anticipation probability.

11. U.S. 4,597,739 — Rosenberg (issued 1 July 1986). Orthodontic (bonding/placement) art. 12. U.S. 4,494,931 — Wildman (issued 22 Jan 1985) and U.S. 5,100,316 — Wildman (issued 31 Mar 1992) — orthodontic bracket/appliance art (examiner-classified at 433/3, i.e., bracket structure).

Tier 3 — General orthodontic bracket/method background art (cited as background; weak § 102 relevance to the '444 claims)

  • U.S. 3,477,128 — Andrews (issued 11 Nov 1969).
  • U.S. 3,660,900 — Andrews (issued 2 May 1972). (Andrews = origin of the "straight-wire"/facial-axis concepts the '444 expressly builds on at its step (600).)
  • U.S. 3,686,762 — Sutter (issued 22 Aug 1972).
  • U.S. 3,738,005 — Cohen et al. (issued 5 June 1973).
  • U.S. 3,906,634 — Aspel (issued 23 Sept 1975).
  • U.S. 3,949,478 — Schüthammer (issued 6 Apr 1976).
  • U.S. 4,014,909 — Dellinger (issued 29 Mar 1977).
  • U.S. 4,160,322 — Frazier (issued 3 July 1979).
  • U.S. 4,324,546 — Heillinger et al. (issued 13 Apr 1982).
  • U.S. 4,415,330 — Daisley et al. (issued 15 Nov 1983).

These are bracket/wire structural or general-fabrication references. They do not appear to disclose the claimed computer-derived slot-cutting/archwire-forming automation and would serve, at most, as evidence of the bracket/archwire environment of the claims. § 102 anticipation: very low.

Tier 4 — Foreign patent documents

  • WO 89/11257 (published Nov 1989). Confidence: high (appears in the family citation box).
  • WO 90/08512 (published Aug 1990). This same document also appears in the PCT search-report citation data of the '444's sibling WO 94/10935 ("Cited Documents: EP0502227; WO9008512"), corroborating it as a cited reference.
  • Relevance: both are pre-1991 § 102(b) documents in the dental/CAD-CAM or orthodontic-appliance field. Their exact disclosures were not retrievable in my search window, so I will not assign claim-specific anticipation.

Tier 5 — Non-patent literature ("Other Publications")

  1. Rekow, D., "Computer-Aided Design and Manufacturing in Dentistry: A Review of the State of the Art," Journal of Prosthetic Dentistry, Vol. 58, Oct. 1987, pp. 513–516. — A survey of dental CAD/CAM; § 102(b) printed publication. Relevant to the CAD/CAM control-signal limitations (same caveat as the Duret/Brandestini art).
  2. Leinfelder, K.F. et al., "A New Method for Generating Ceramic Restorations: A CAD-CAM System," JADA, Vol. 118, June 1989, pp. 703–707. — CAD/CAM restoration art; § 102(b) printed publication.

C. The prior art that actually drove the litigation (context that matters more than the face citations)

Because the '444 claims that reached trial were the "preliminary gathering/organization of tooth data" claims 37–40, 45 and 69 — not the bracket-cutting claims — the art that mattered was the 3‑D intra-oral/dental scanning and CAD/CAM line (Rekow, Duret, Brandestini, and the Rekow Journal of Prosthetic Dentistry review). In Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. 2007), the district court's summary judgment of non‑infringement turned on claim construction (the "automatic" determination requirement, read in light of the shared '562 specification/prosecution history), not on § 102; Align's § 112 enablement attack likewise succeeded at SJ for most claims. The 2009 jury then found the surviving claims infringed and not anticipated or obvious over the art of record — i.e., the cited references above were expressly presented to and rejected by the jury on claims 37, 38, 40, 45 and 69. (Sources: Google Patents family-litigation panel; CourtListener Fed. Cir. opinion; SEC Form 8‑K, June 26, 2009.)


D. Bottom line

Reference Date Best § 102 target in the '444 Anticipation likelihood
US 5,011,405 (Lemchen) / RE35,169 1991‑04‑30 bracket-mounting-location & placement steps (archwire/fabrication claims) Low (strong § 103)
US 5,027,281 (Rekow) 1991‑06‑25 3‑D anatomical sensing / shape-data steps Low (strong § 103)
US 4,611,288 / 4,663,720 / 4,742,464 (Duret) 1986–1988 digitize→compute→NC control-signal steps Low–moderate
US 4,837,732 (Brandestini) 1989‑06‑06 scanning + computed restoration steps Low–moderate
US 4,183,141 / 4,284,405 / 4,360,341 (Dellinger) 1980–1982 custom-archwire-shape derivation Low
Rekow (1987) & Leinfelder (1989) articles 1987 / 1989 CAD/CAM control-signal limitations Low
WO 89/11257, WO 90/08512 1989 / 1990 field-level § 102(b) art Unverified

No cited reference, on the record I could retrieve, appears to disclose the complete combination the '444 claims require — i.e., (a) digitized individual patient tooth shape data, (b) computer derivation of finish tooth positions, and (c) machine code driving a numerical-control machine to automatically form the bracket slot/archwire/jig. Each cited reference supplies at most one or two elements; accordingly the citations are properly characterized as § 103 prior art, consistent with the 2009 jury's no-anticipation/no-obviousness verdict on the surviving claims.

Limitations I must state plainly: (1) I could not retrieve the '444 face's "References Cited" box verbatim within my search budget, so the list above is reconstructed from family documents and reprints and should be confirmed against the printed patent or PatentCenter; (2) I could not retrieve the substantive disclosures of WO 89/11257 and WO 90/08512; (3) several of the 1969–1983 references are background bracket/wire patents whose claim-specific § 102 relevance I cannot responsibly assert beyond the general field.

Generated 9/29/2026, 11:04:21 AM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

I'll research the prior art cited on the '444 patent and the obviousness record from the Ormco–Align litigation.

Now let me gather details on the specific prior-art references used in the obviousness challenge.

Obviousness Analysis — U.S. Patent No. 6,616,444 under 35 U.S.C. § 103

Important scope note before the analysis. The authoritative patent text supplied to me (the Google Patents fetch of US 6,616,444) does not contain a machine-readable "Patent Citations / References Cited" list. The only prior-art field it exposes is:

"Prior art keywords: teeth, patient, computer, tooth, data" … "Prior art date: 1992‑11‑09"

plus the four priority‑claim ancestors (US 5,431,562; US 5,454,717; US 5,368,478; US 5,447,432 — all filed 1992‑11‑09, same Ormco family). I therefore supplemented the page with the operative prior-art record from the Ormco v. Align litigation file, where the §103 case was actually litigated. I hit my tool-step limit before I could retrieve the remainder of the Google Patents citation list, so the reference set below is the litigation-verified set, not a verbatim reproduction of the patent's "References Cited" section. Where I am uncertain about a claim's exact text I say so.


1. Threshold issues that control the §103 analysis

(a) Which claims. Only six claims survived as the live obviousness battleground: 37, 38, 40, 45, and 69 (with 39 also litigated). The Federal Circuit in Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307 (Fed. Cir. 2007) held that these claims do not require "automatic" computer determination of finish tooth positions; they are directed to "the preliminary gathering and organization of tooth data as an aid to further unspecified orthodontic treatment or for use in creation of a digital model." (CAFC opinion; Markman opinion, Oct. 3, 2008)

That construction is decisive for obviousness: it strips the "automated appliance design" gloss and reduces the claims to 3‑D scanning + segmentation of teeth into separate digital data-sets. That is precisely the subject matter of the 1990–1991 dental-imaging literature.

(b) Effective filing date is contested and matters. The '444 patent carries a 1992‑11‑09 priority date, but the live claims were added to the application by amendment (Dec. 12, 2002, per the earlier litigation summary). If claims 37–40/45/69 lack §112 support in the 1992 ancestors — which is the same written-description vulnerability that produced the non-enablement summary judgment on the other claims — then the effective date is 2001‑06‑11, and the entire 1992–2001 art (including Align's own patents and the interim CAD/CAM literature) becomes available. Either way, Laurendeau (Sept. 1991) and Yamamoto (1990/1991) predate the earliest possible date, so the analysis below holds under either priority theory.


2. The claims' substance (as reconstructed from the record)

Claim Substance
37 Method of processing digital data for facilitating orthodontic treatment: scanning 3‑D surfaces having the shapes of a plurality of teeth, and from the generated data producing separate digital representations of the shapes of each of a plurality of individual teeth.
38 Dependent; adds identification/use of parameters or landmarks on each tooth (the FACC-curve/facial-axis concept) to define a tooth axis.
39 Dependent on 37; the separate digital representations include a two‑dimensional contour.
40 Dependent on 37; separating an image of the plurality of teeth into individual data‑sets each representing an individual tooth.
45 Scanning the shapes of teeth directly from the mouth; grouping the generated data into separate digital representations of a plurality of individual teeth.
69 Computer-implemented method for generating digital models of a patient's teeth (text truncated in the sources retrieved; indexed to the same segmentation concept).

3. The prior art actually relied on

Reference Disclosure Source
Duret — F. Duret intraoral optical-impression patents (e.g., US 4,663,720; US 4,742,464; US 4,611,288; US 5,092,022; US 4,952,149; and FR 92.08128 / WO 94/00074) 3‑D laser optical probe scanning teeth directly in the mouth; grouping scanned data to define surfaces and boundary zones around a prepared tooth. Duret patent family listing; court: "the Duret patent was considered by the Patent Office during prosecution of the '444 patent"
Laurendeau, Guimond & Poussart (1991) — "A computer-vision technique for the acquisition and processing of 3‑D profiles of dental imprints: an application in orthodontics," IEEE Trans. Med. Imaging 10(3):453–461 CCD-based acquisition of 3‑D profiles of dental imprints, segmentation by nonlinear filtering, and detection of interstices between teeth (incisors, canines, premolars, molars). PubMed 18222848 · DOI 10.1109/42.97596
Yamamoto et al. (1990/1991) — "Three-Dimensional Measurement of Dental Cast Profiles and Its Applications to Orthodontics," Conf. Proc. IEEE Eng. Med. Biol. Soc. 12(5):2051–2053; "Optical Measurement of Dental Cast Profile…" 3‑D optical measurement of dental casts, tooth profiles, and on-screen identification of tooth parameters. Cited in US 11,298,211
Biggerstaff (1970, 1972) — "Computerized Diagnostic Setups and Simulations," Angle Orthod. 40(1):28–36; "Computerized Analysis of Occlusion in the Postcanine Dentition," Am. J. Orthod. 61(3):245–254 Interactive selection of anatomical landmarks on digitized tooth images to create separate tooth representations and model tooth movement — but in 2‑D. US 9,956,058 citation list; argued at trial as disclosing all elements of claims 37, 38, 40, 69 except 2‑D vs. 3‑D
Kuwahara (medical imaging) 3‑D medical image acquisition/processing, relied on as evidence that the computing power for volumetric scanning existed by 1991. Argued at trial (JMOL opinion)

4. Proposed §103 combinations and motivations

Ground A — Biggerstaff in view of Yamamoto (or Laurendeau / Kuwahara) → claims 37, 38, 40, 69

Rationale: Biggerstaff discloses the orthodontic half of the invention — interactive landmark/parameter identification on a digital tooth representation, and generation of separate tooth models for treatment simulation. It is limited only by being two-dimensional. Yamamoto (and independently Laurendeau) discloses the imaging half — 3‑D optical scanning of dental casts/imprints with profile generation. Because Biggerstaff himself pointed to three-dimensional modeling as the next step, and because 3‑D optical range-scanning was a known, finite set of solutions being applied to dental anatomy by 1990–91, a PHOSITA would have had both the reason and the expectation of combining them. Under KSR, this is the paradigm "known technique, known problem, predictable result" case.

Ground B — Duret in view of Biggerstaff (or Biggerstaff in view of Duret) → claim 45

Rationale: Claim 45's only distinguishing limitation is scanning directly from the mouth. Duret supplies that verbatim (intraoral optical probe). The motivation argued at trial was concrete and articulated: eliminating the impression/model step, which the record describes as "both time consuming and prone to error." That is a classic efficiency motivation with a reasonable expectation of success.

Ground C — Laurendeau in view of Biggerstaff → claims 37, 38, 39, 40, 69

Rationale: Laurendeau's segmentation of a 3‑D dental-imprint scan and detection of interstices is the "producing separate digital representations of each of a plurality of individual teeth" step in machine terms; Biggerstaff supplies the orthodontic context and the landmark-selection step claimed in claim 38. Both are in the same field (computer-aided orthodontic diagnosis).

Ground D — Yamamoto in view of Kuwahara → claims 37–40, 69

Rationale: Align's trial theory: Kuwahara (medical volumetric imaging) evidences that the computational capacity to process whole-arch data existed by 1991, so Yamamoto's admitted limitation to single teeth — attributed to his 1988 hardware constraints — would not have deterred a PHOSITA. Motivation: an engineer consulting with an orthodontist routinely looks to medical imaging art for scanning solutions, and Yamamoto himself cited non-dental anatomical scanning work.


5. Why the obviousness case is nevertheless weak, and why the jury rejected it

I must be candid: the §103 theory above lost at trial. On June 25, 2009 the jury found claims 37, 38, 40, 45, and 69 infringed and not invalid (not anticipated, not obvious). The record exposes specific weaknesses:

  1. Reasonable expectation of success is a question of fact. The district court (653 F. Supp. 2d 1016) held it could not say "a reasonable juror could not find that a person of ordinary skill in the art would have a reasonable expectation of success," citing PharmaStem v. ViaCell, 491 F.3d 1342 (Fed. Cir. 2007). Segmentation of an undifferentiated 3‑D tooth scan into anatomically-identified individual teeth in 1991 was not routine; the 28 Ormco/Align experts disputed whether segmentation produced tooth shape representations at all.
  2. Teaching-away / disclosure gaps. Laurendeau admittedly detects interstices — the spaces between teeth — which Ormco argued "does not create separate 3D representations of the individual teeth." Duret was argued to scan only the surfaces bounding a prepared-tooth void.
  3. No. 1 reference already before the PTO. The Duret patent was considered by the Examiner, which under Impax Labs. v. Aventis, 545 F.3d 1314 (Fed. Cir. 2008) makes the challenger's burden "particularly heavy."
  4. Secondary considerations. The '444 family produced a long-felt need (orthodontists hand-bending archwires), industry praise, and substantial commercial success — and Align ultimately paid ~$76.7 million to settle in August 2009 (per the PTAB exhibit recounting the parties' positions). Note the contradiction with the earlier litigation summary: the summary left the post-2009 disposition open; the PTAB record indicates an August 16, 2009 settlement valued at $76.7 million. I flag that as an update, not a correction — that PTAB passage is a party's characterization, and it dates the district court's liability finding to "February 25, 2009," which conflicts with the June 25, 2009 jury verdict I verified elsewhere. Treat the settlement figure as probable but party-sourced.

6. Bottom line

  • A facially strong §103 case exists against claims 37–40, 45, and 69 — strongest for claim 45 (Duret alone, or Duret + Biggerstaff) and claims 37/40/69 (Biggerstaff + Yamamoto/Laurendeau/Kuwahara) — because after the Federal Circuit's 2007 construction the claims reduce to 3‑D scanning plus tooth segmentation, both of which were squarely in the 1990–91 literature.
  • The case is materially weaker on claim 38 (landmark/parameter identification on 3‑D data) and on any claim read to require automatic processing, where §112/§103 overlap.
  • The prior-art citation list from the '444 patent itself could not be fully verified from the authoritative page provided; the reference set above is the litigation-verified set. If you need the Examiner-cited art verbatim, the Google Patents "Patent Citations" and "Non-Patent Citations" tables (and the file wrapper via USPTO PatentCenter) should be pulled directly.

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