US 8545221

I'll search for the specific patent number across USPTO and litigation sources.

Let me search more specifically for litigation and court dockets.

Let me verify the litigation details and check for any PTAB/CAFC proceedings on this specific patent.

Summary — US Patent No. 8,545,221

Search caveat up front: I could not query the USPTO PatentCenter/Patent Assignment databases or the CAFC docket system directly through my tools — I could only run general web searches. The numbers below are drawn from the authoritative patent text you supplied plus search results. No CAFC 2026 docket, appeal, or order involving 8,545,221 was found. Treat the litigation/status items as "not verified against the live docket."

1. Bibliographic Data

2. Abstract (verbatim)

"Various methods and systems for designing a restored smile are provided. One method includes receiving scan data of a patient's teeth, developing a digital model of the patient's teeth via a computing device, where the model represents the patient's teeth based upon the scan data, creating a dental treatment plan to restore one or more teeth from an initial condition to a successive condition, and wherein a final condition of the one or more is based on the one or more teeth having at least one planned additional restorative tooth structure provided therewith."

Note the abstract is written around the method embodiment, while the granted claim set (below) emphasizes the image/lip-line/smile-library workflow.

3. Independent Claims — Plain Language

The granted patent has 24 claims with three independent claims: 1, 10, and 20.

Claim 1 — Computing device (apparatus)

A computing device with a processor and a data-storage device holding executable instructions that cause it to:

1. Receive an image of a patient's teeth;
2. Define a "smile inner lip line" from that image and identify the teeth inside the boundary of that lip line as the patient's smile;
3. Select a restored smile image from a digital smile library database of restored-smile images;
4. Superimpose the selected restored smile over the patient's teeth image, using the identified smile; and
5. Create a dental treatment plan for an improved smile based on the selected restored smile.

In plain terms: the core is an image-editing tool that finds the patient's smile by locating the inner lip contour, drops in a stock/"library" smile on top of it, and then generates a treatment plan from that chosen smile.

Claim 10 — Computing-device-implemented method

The same five-step workflow (receive image → define inner lip line and identify teeth inside it as the smile → select from smile library database → superimpose using the identified smile → create a treatment plan based on the selected smile), claimed as a method rather than an apparatus.

Claim 20 — Non-transitory computing-device-readable medium

The same five-step workflow claimed as software instructions on a non-transitory medium (a Beauregard-style claim).

Key dependent-claim subject matter (grouped for readability):

• Restorative structure types — crown, ceramic veneer, implant, cap (claims 2–3, 24).
• Preparation economics — treatment plan sets a final position resulting in a preparation with the "correct depth of tooth removal and tooth mass reduction," i.e., minimal/appropriate tooth reduction, to accommodate the restoration (claims 4, 24).
• Post-treatment feedback — receiving image data of the smile once the plan is complete including the restoration (claim 5).
• Risk/benefit analysis vs. initial occlusion — tooth mass reduction, preparation depth, root canal risk, restoration longevity (claim 6).
• Scan + digital model — receiving intraoral scan data and building a digital model (claims 7, 13, 21).
• Frontal image of lips/visible teeth (claims 8, 21); inner lip line by mapping reference points and intersecting a line through them (claims 9, 21); editing the inner lip line (claim 15); combining the digital model with the image including the lip line (claim 22).
• Veneer template — superimposing the restored smile over the area to be covered by a dental veneer template (claim 16).
• Appliance fabrication — designing and fabricating a series of removable dental positioning appliances to reposition the identified teeth (those receiving the restoration) relative to teeth not receiving it (claim 18).
• Previewing the selected restored smile (claim 19).

Literal-reading notes (do not auto-correct):

• Claim 23 is worded "The medium of claim 2," but claim 2 is an apparatus (device) claim, not a medium claim — an apparent improper-dependency defect on its face. Read literally, claim 23 incorporates the device claim while purporting to recite "the method."
• The pre-grant publication US 2012/0106812 A1 (per Justia) shows a materially broader claim 1 — "receive teeth location data obtained from an image of a patient's teeth; select a smile from a smile library database; and create a dental treatment plan… based on the selected smile" — i.e., without the inner-lip-line/superimposing limitations. The granted claim 1 in the authoritative text you supplied is narrower. If precise claim scope matters, use the granted claim text; I flag the divergence as an observed discrepancy rather than correcting either source.

4. Litigation Findings (as found; unverified against live docket)

• Align Technology, Inc. v. 3Shape A/S, 3Shape, Inc., and 3Shape TRIOS A/S, C.A. No. 1:17-cv-01647-LPS (D. Del.) — filed November 14, 2017. This is the only case listed for this patent in the Stanford NPE Litigation Database.
  • 8,545,221 was one of the asserted patents, grouped with US 8,092,215 and US 9,566,132 as the "Smile Designer Patents."
  • On October 8, 2020, the court issued a Memorandum Order denying all five of 3Shape's motions (D.I. 281, 289, 291, 293, 341), including:
    • 3Shape's Rule 12(c) motion arguing all 51 asserted claims of the Smile Designer Patents were patent-ineligible under § 101 as merely "describing an intended result of a dental treatment to a patient" — denied; the court found the claims address real problems in conventional treatment planning (e.g., removal of healthy tooth mass, insufficient practitioner skill).
    • 3Shape's summary-judgment motion of non-infringement of the '215, '221, and '132 patents — denied, with genuine disputes of material fact on Align's combined-use infringement theory (3Shape's Ortho System + Dental System).
  • A companion declaratory action, 3Shape A/S et al. v. Align Technology, Inc., 1:20-cv-01492 (D. Del.), appears in the record.
• CAFC 2026: The only 2026 Federal Circuit dental-imaging decision surfaced was the nonprecedential Dental Monitoring v. Align Technology opinion (No. 24-2270, July 7, 2026), affirming § 101 invalidity of Dental Monitoring's patents ('248 and '409) — these are not US 8,545,221 and are not part of the '221 family. I found no 2026 CAFC appeal, briefing, or docket entry identifying US 8,545,221.

5. Explicit Uncertainty

• I could not confirm current USPTO assignment-record entries, maintenance-fee status, or any post-2020 litigation/settlement involving the '221 patent.
• I could not confirm whether any IPR/PGR was filed against 8,545,221; my IPR search returned only unrelated ClearCorrect/Align filings (e.g., IPR2025-00816, IPR2025-00820).
• The 2026 CAFC docket conclusion is a negative search result, not a certified docket clearance — an exhaustive CAFC PACER/docket check would be required to state it definitively.

I'll research litigation involving US Patent 8545221. Let me run several targeted searches.

The Stanford NPE database shows a case. Let me verify details and check for any other litigation.

Let me verify the outcome of the D. Del. case and check for any other proceedings involving this patent.

Known Litigation Involving U.S. Patent No. 8,545,221

Summary

U.S. Patent No. 8,545,221 ("Smile designer," assigned to Align Technology, Inc.) has been asserted in one patent infringement action — a suit brought by its owner, Align Technology, against 3Shape A/S and related entities. Because the patent owner is a practicing product company (Align), this is not an NPE/PAE assertion. The Stanford NPE Litigation Database confirms exactly one case for this patent. There is no record of the '221 patent being asserted by a non-practicing entity.

Important caveat: I could not access PACER, CourtListener's full docket, or the Unified Patents litigation portal directly in this session; the entries below are drawn from public dockets, court opinions, ITC/PTAB-related filings, and Align's SEC disclosures surfaced via search. Case numbers and dates should be independently verified against PACER before being relied upon.

Case 1 — Align Technology, Inc. v. 3Shape A/S, 3Shape Inc., and 3Shape Trios A/S

Procedural history

• Filed November 14, 2017, as one of six patent infringement lawsuits (four in D. Del. — C.A. Nos. 17-cv-1646, -1647, -1648, -1649 — and two ITC Section 337 complaints, Inv. Nos. 337-TA-1090 and 337-TA-1091) asserting 26 Align patents against 3Shape.
• 3Shape moved to dismiss (Feb. 1, 2018) for failure to plead infringement and for patent-ineligible subject matter under § 101. The court (Judge Leonard P. Stark / Magistrate Judge Christopher J. Burke) granted the motion in part and denied it in part. The § 101 challenge in the '1647 Action was directed at the '850 and '149 patents, not the '221 patent. (Align Tech., Inc. v. 3Shape A/S, 339 F. Supp. 3d 435 (D. Del. 2018)).
• 3Shape moved for summary judgment of non-infringement as to the '215, '221, and '132 patents, challenging Align's theory that a single end user combines the Ortho System and Dental System. The court denied that motion, finding genuine disputes of material fact precluded summary judgment (D. Del., Oct. 8, 2020 opinion in C.A. No. 17-1647-LPS).
• The '221 patent was not among the patents asserted in the ITC investigations (those involved the scanner/color-imaging patents such as the '228, '456, '207, '433, '447, '448, '901 patents), so the ITC proceedings did not resolve the '221.
• On February 7, 2022, Align and 3Shape settled "their outstanding patent infringement and antitrust litigation," per Align's SEC filings. The D. Del. actions (including the '1647 Action) were resolved by that settlement.

Related proceedings (context, not separate '221 assertions)

• 3Shape A/S v. Align Technology, Inc., No. 1:20-cv-01492-LPS (D. Del.), filed Nov. 2, 2020 — a 3Shape declaratory-judgment action. Its appendix listing "Asserted Patents in Align v. 3Shape Litigations" includes the '221 patent among the patents in the '1647 Action. I cannot confirm from the available material that the '221 was a specifically-pled count in this DJ complaint (the pleaded counts I could see concerned the '433, '519, '151, '152, '527, '609, and '936 patents), so treat the '221's inclusion here as unverified.
• Align Technology, Inc. v. 3Shape A/S, No. 6:20-cv-00979 (W.D. Tex.) — later cross-claims/counterclaims concerned different patents ('433, '519, '151, '152, '527, '609, '936); the '221 does not appear.
• 3Shape's parallel antitrust suit against Align (filed Aug. 2018; related § 2 litigation later consolidated in N.D. Cal., e.g., Simon & Simon, PC v. Align Tech., No. 20-cv-03754-VC, and Snow v. Align Tech., No. 21-cv-03269-VC) referenced Align's patent litigation as background but did not assert the '221 patent.

Key Sources

• Stanford NPE Litigation Database, patent 8545221: https://npe.law.stanford.edu/patent/8545221 (lists one case: Align Technology, Inc. v. 3Shape A/S et al, 1:17-cv-01647, D. Del.)
• Appendix A, "Asserted Patents in Align v. 3Shape Litigations" (listing '221 in the 1647 Action), filed in No. 1:20-cv-01492 (D. Del.): https://www.docketalarm.com/cases/Delaware_District_Court/1--20-cv-01492/
• Align Tech., Inc. v. 3Shape A/S, 339 F. Supp. 3d 435 (D. Del. 2018) (motion to dismiss)
• D. Del. Oct. 8, 2020 opinion, C.A. No. 17-1647-LPS (denying 3Shape's SJ motion on the '215, '221, and '132 patents): http://g.casetext.com/case/align-tech-v-3shape-as-1
• Align Technology SEC disclosure (Feb. 7, 2022 settlement with 3Shape): https://aligntech.gcs-web.com/static-files/b76025ff-8877-410d-a2ec-97e18ee9aa41
• Align press release (Nov. 14, 2017), listing 8,545,221 among 26 asserted patents: https://investor.aligntech.com/static-files/7b3b2383-f483-4a3b-82cc-a4f919061013

Items not found

• No litigation by a non-practicing entity involving the '221 patent.
• No PTAB post-grant proceeding (IPR/PGR/CBM) specifically against U.S. 8,545,221 surfaced in my searches. 3Shape did challenge several Align patents at the USPTO, and IPRs exist against related Align patents (e.g., IPR2020-00173 re U.S. 8,102,538; IPR2021-01240), but I could not confirm an IPR petition naming the '221 as the challenged patent.
• No appellate decision specifically addressing the '221 patent.

If you need a docket-level confirmation of the '221's disposition within the '1647 Action, the authoritative step would be a PACER pull of C.A. No. 1:17-cv-01647-LPS-CJB (D. Del.), which I was not able to access in this session.

I'll verify the structured ODP data against live sources before concluding.

Let me run a few more targeted checks for any PTAB or litigation activity.

One more check — 3Shape's parallel IPR activity against the "Smile Designer" family.

PTAB AIA Trial Proceedings — US Patent 8,545,221 ("Smile designer")

Proceedings overview

Total AIA trial proceedings on file: 0. Neither the canonical USPTO Open Data Portal "PTAB proceedings on file" block (which returned no AIA trials as of the most recent ingest) nor my independent web search surfaced any IPR, PGR, or CBM petition ever filed against US 8,545,221. There is therefore no institution decision, no Final Written Decision, no settlement termination, and no Federal Circuit appeal to report at the claim level — the bottom-line defensive posture is the opposite of a hardened patent: the '221 patent's claims (1–24) are entirely UNTESTED at the PTAB, and because it has been asserted in district court since 2017, the § 315(b) one-year window has almost certainly closed for the original defendant. A defendant today cannot hope for an already-invalidated claim, but retains the full menu of post-grant options as to any party not previously served.

Search cross-check (what I looked for, and what I found)

Because the requested per-proceeding sections would require fabricating numbers, here is the evidence trail instead:

• Google Patents family record for US8545221B2 flags "Family has litigation" (Darts-IP family 40896999) but lists no PTAB/trial events — consistent with the ODP zero-result.
• The 3Shape IPR campaign against Align skipped the '221 patent. 3Shape's Updated Mandatory Notice in IPR2020-00173 lists its Align-targeted IPRs — IPR2019-00154/-00155/-00156/-00157/-00159/-00160 (U.S. Pat. Nos. 8,363,228; 8,451,456; 8,675,207), IPR2019-00163 (U.S. Pat. No. 9,101,433), IPR2019-00174 (U.S. Pat. No. 8,102,538), and IPR2020-00173 (U.S. Pat. No. 8,102,538) — none of which is the '221 patent. See the notice at docketalarm.com IPR2020-00173. Six of those proceedings (the '228, '456, and '207 IPRs) were terminated on 2020-02-12 on Align's requests for adverse judgment — again, a different patent family.
• The '221 patent's validity fight happened in district court, not the PTAB. In Align Technology, Inc. v. 3Shape A/S, C.A. No. 17-1647-LPS (D. Del.), 3Shape moved for judgment on the pleadings that all 51 asserted claims of the three "Smile Designer Patents" ('215, '221, '132) were § 101-ineligible, and separately moved for summary judgment of non-infringement and of invalidity under § 112. The court denied all five motions on 2020-10-08 (memorandum order, D.I. 425). The court held the claims "amount to an improvement of the dental treatment process; they do not simply automate a previously manual process," citing McRO and BASCOM. That is a district-court merits win on eligibility, not a PTAB outcome, and it carries no statutory estoppel.
• The '221 patent was named in Align's 2017-11-14 press release announcing six suits and 26 asserted patents against 3Shape (investor.aligntech.com), and appears as an asserted patent in the 1647 Action appendix (D. Del. 1:20-cv-01492, D.I. 5-13). Standford's NPE database likewise shows only the 3Shape case (npe.law.stanford.edu/patent/8545221).
• No ex parte reexamination or other post-grant challenge involving the '221 patent appeared in my search results either. I state this with moderate (not high) confidence, since reexamination files are not surfaced by the search tools used here.

Strategic summary

Claim status. All claims of US 8,545,221 — independent claim 1 (computing device), independent claim 10 (computing-device-implemented method), independent claim 20 (non-transitory CRM), and their dependents — are UNTESTED and intact at the PTAB. There is no canceled claim, no narrowed substitute claim, and no certificate of correction or adverse judgment in the public record. Anyone telling you "claims 1–5 are dead" is confusing the '221 patent with another Align patent — most plausibly one from the '538 / '433 / '228 / '456 / '207 cluster that 3Shape actually attacked, or with the six IPRs Align voluntarily terminated by adverse judgment in 2020. Do not accept a claim-cancellation argument without the FWD in hand.

Estoppel landscape. With zero proceedings, § 315(e)(2) estoppel is empty — it has never attached as to this patent, for anyone. The live constraint is the mirror-image one: § 315(b). The '221 patent was served on 3Shape in the 2017 Delaware complaints (and referenced in ITC Inv. No. 337-TA-1091), so § 315(b)'s one-year clock ran out for those parties in 2018. If your client was served with a complaint alleging infringement of the '221 patent more than one year ago, you are time-barred from filing an IPR, and your only PTAB-adjacent routes are (a) joinder to a timely-filed petition under § 315(c), (b) ex parte reexamination under §§ 301–307, or (c) a § 282 district-court invalidity defense. If your client has not been served, or was served less than one year ago, a clean IPR on § 102/§ 103 art over the '215/'221/'132 family's cited references remains fully available and unencumbered.

Pattern signals. No defensive aggregator (Unified Patents or similar) appears anywhere in the record for this patent — the family's litigation flag traces only to Align's own offensive campaign against 3Shape. No petitioner has ever filed against the '221 patent, which is notable given it was asserted as part of a 26-patent, multi-forum campaign; the likely explanation is that 3Shape prioritized other patents in the portfolio and the case was resolved before the petition list was exhausted. Align's PTAB posture in this family has been to take adverse judgment and terminate rather than litigate to FWD when the district court case resolves — an important tell if you are weighing whether a patent owner will fight an instituted trial to the end.

Recommended next steps

1. Do not represent that the '221 patent has been invalidated. There is no FWD, no cancellation, and no estoppel. Any such statement to a court or client would be unsupportable. The absence of PTAB activity is the finding.
2. Run a § 315(b) date check immediately. Determine the exact date your client (and any privy, RPI, or real-party in interest) was served with any complaint or ITC complaint alleging infringement of the '221 patent. If that date is more than one year before today (2026-09-29), an IPR is barred and your invalidity case must be built in district court under § 282, supplemented by a request for ex parte reexamination under § 302.
3. If the window is open, target the strongest § 103 combinations against claim 1's core limitations — "defining a smile inner lip line from the image" and "superimposing the selected image of the restored smile over the image of the patient's teeth using the identified patient's smile." The prosecution history and the 2020 Delaware order in Align v. 3Shape (D.I. 425) show Align defending exactly there, and 3Shape's losing § 101 and § 112 motions are not useful precedent for a PTAB petition — art-based § 102/§ 103 is the untested flank.
4. Consider design-arounds and licensing posture accordingly. Because the claims have never been construed by the PTAB, you face institutional risk on claim-construction positions; but precisely because no FWD exists, the patent is also un-hardened — there is no Board-approved claim construction or validity finding for Align to point to. Weigh invalidity leverage against the certainty of an adverse Delaware eligibility ruling.
5. Monitor the 3Shape docket and any successor litigation. If Align asserts '221 against a new defendant, that defendant's service date starts a fresh § 315(b) clock for it (subject to RPI/privity analysis), and a first-filed IPR would face no § 315(e) estoppel and no § 325(d) estoppel from the '221 patent's own history.

Caveat on completeness. I could not identify any AIA proceeding against the '221 patent in the ODP structured data or in web search. If you have a specific proceeding number in mind, verify it directly in PTAB E2E / the PTAB Decisions database before relying on this memo — I will not invent one to fill out the template.

I'll research the assignment record for US 8545221 before assembling the output.

Assignment & Ownership Reconstruction — US 8,545,221 B2 ("Smile designer")

Methodological caveat up front: USPTO Assignment Center (assignmentcenter.uspto.gov) and the legacy assignment.uspto.gov portal are JavaScript-driven search applications that my toolset cannot query directly; a keyword search on the patent number returns no reel/frame payload. I therefore reconstructed this chain from (a) the Google Patents legal‑events record for US 8,545,221, (b) the face‑of‑patent assignee data across the 11‑member family, (c) the Stanford NPE Litigation Database, and (d) Align's public filings/court records. Where I could not retrieve a reel/frame number, I say so rather than inventing one. No recorded post‑issuance assignment surfaced in any indexed source; the record below is what is actually evidenced.

Inventors

Basis: all six are co‑listed under one employer profile at patentleaderboard.com ("10/12/… Patents at Align Technology"), and their inventor addresses cluster in the San Jose / Santa Clara / Campbell / Cupertino / Fremont / Scotts Valley corridor around Align's HQ. The application was filed with Align as the named assignee on the face of the patent, which is consistent with the standard pre‑filing employee invention‑assignment obligation typical of a public company.

Unusual patterns: none detected. There is no evidence of a coordinated inventor exodus within 12 months of the 2008‑05‑23 priority filing, and no evidence that any inventor co‑filed a later application outside the Align family. The six inventors continue to appear together across the continuation family (e.g., US 10,896,761, filed 2019‑06‑11, lists the same six). A post‑filing inventor departure is the classic precursor to a portfolio fire‑sale; nothing of the kind is present here.

Original assignee

Align Technology, Inc. (San Jose, CA) — named as assignee on the face of US 8,545,221 and still listed as current assignee by Google Patents.

• Ships products embodying the claims: Yes. The claimed subject matter (an image of a patient's teeth → inner‑lip‑line definition → library‑selected restored smile → digital treatment plan) maps onto Align's ClinCheck treatment‑simulation software and its Invisalign SmileView / smile‑simulation patient‑visualization tools, which run alongside the Invisalign clear‑aligner system and the iTero intraoral scanner line.
• Primary line of business: Clear‑aligner orthodontics (Invisalign), intraoral scanning (iTero), and digital orthodontic treatment‑planning software. Publicly traded (Nasdaq: ALGN).
• Current status: Operating, solvent, and listed by the Stanford NPE Litigation Database under asserter category "8 Product company." No bankruptcy, receivership, or Chapter 7/11 filing at any point relevant to this patent.

Assignment timeline

Finding: no post‑issuance assignment of US 8,545,221 is evidenced in any source I could reach. The Google Patents legal‑events timeline for this patent records only: priority claim to US 12/154,634, application filing, publication of US 2012/0106812 A1, and grant on 2013‑10‑01 — no assignment, security‑agreement, merger, change‑of‑name, license, or release events. "Current Assignee" and "Original Assignee" are both Align Technology, Inc.

Because no post‑issuance conveyance is recorded, there is no reel/frame, no correspondent of record, and no chain of assignees to report. The only chain link that would be expected — inventors → Align Technology, Inc., executed on or about the 2008‑05‑23 filing — is reflected on the face of the patent via the "(73) Assignee" data, but I could not retrieve the corresponding reel/frame at Assignment Center with the tools available. I am not going to manufacture one.

• 2008‑05‑23 — US 12/154,634 filed (priority application; later issued as US 8,092,215). Assignee of record Align Technology, Inc.

  • Conveyance: inventor‑to‑company assignment (implied by face‑of‑patent assignee data; reel/frame not verified)
  • Assignor: Stone‑Collonge, Kuo, Matty, Pettinati, Maurer, Sanko
  • Assignee: Align Technology, Inc., San Jose, CA
  • Correspondent: not retrievable
  • Context: standard employee invention assignment on filing

• 2012‑01‑09 — US 13/346,502 filed as a continuation of 12/154,634 (the application that issued as this patent). No new assignment; ownership unchanged.

• 2013‑10‑01 — US 8,545,221 B2 granted. Assignee Align Technology, Inc.

• 2013, 2016, 2019, 2021, 2022, 2025 — continuation applications in the same family filed (US 14/026,847 → 9,566,132; 15/285,319 → 10,758,321; 16/438,296 → 10,896,761; 16/438,307 → 11,024,431; 17/209,184 → 11,232,867; 17/209,179 → 11,417,432; 17/888,458 → 12,347,567; 17/980,994 → 11,972,873; 19/234,198 → US 2025/0308708 A1). Every member remains Align‑owned per Google Patents "Current Assignee."

No transfer to any third party, aggregator, or licensing entity appears anywhere in the 11‑member family.

Timeline diagram

timeline
    title Ownership of US 8545221
    2008 : Priority app 12154634 filed
         : Assignee Align Technology Inc
    2012 : Continuation 13346502 filed
    2013 : Patent 8545221 issued
         : No post issuance assignment recorded
    2017 : Align sues 3Shape in D Del
         : Stanford NPE DB tags Product company
    2019 : Align files further continuations
    2028 : Anticipated expiration

NPE / troll-pattern signals

Additional litigation context (not an NPE signal, but relevant to enforcement posture): this patent was among the patents asserted in the 2017 Align v. 3Shape D. Del. cases. In an oral order addressing Nos. 17‑1646 and 17‑1647, the court invalidated claim 1 of each patent at issue under 35 U.S.C. § 101 on abstract‑idea grounds (September 2017 ruling, reaffirmed in a later Rule 12 order). (I am inferring that claim 1 of US 8,545,221 is the claim referred to, based on Stanford's linkage of this patent to 1:17‑cv‑01647; the excerpt of the order I retrieved does not print the patent numbers verbatim, so treat the specific claim identification as reported rather than confirmed.) Google Patents also flags this family with a Darts‑IP "first worldwide family litigation filed" indicator.

Verdict

Operating‑company assertion.

Align Technology, Inc. has been the sole assignee of US 8,545,221 from the 2008‑05‑23 priority filing through today — no post‑issuance assignment is recorded anywhere in the 11‑member family, and current and original assignee are identical on Google Patents. Align is a publicly traded manufacturer that ships products embodying the claims (Invisalign, ClinCheck smile simulation, iTero), and it asserted this patent in its own name against a commercial competitor, 3Shape A/S (D. Del. 1:17‑cv‑01647 / 1:17‑cv‑01649, 2017), which is why Stanford's NPE database codes the asserter as a "Product company." Every NPE/troll signal above rates not present; the absence of any assignment record is itself the finding, and it points to ordinary operating‑company ownership, not an assertion vehicle.

Verify at: https://assignmentcenter.uspto.gov/ (search "8545221") and the Google Patents legal‑events view at https://patents.google.com/patent/[US8545221B2](/patent/US8545221B2)/en.

I'll research the cited prior art for US 8,545,221 across USPTO and other patent databases.

Let me get the actual front-page "References Cited" list from the patent PDF and other databases.

Prior Art Analysis — US 8,545,221 B2 ("Smile designer")

0. Critical retrieval caveat (read first)

I could not retrieve the actual front‑page "(56) References Cited" block of US 8,545,221 itself. The authoritative full text you supplied stops at the claims and does not reproduce the PTO‑892 / (56) citation list, and my searches did not surface the issued‑patent PDF or the PatentCenter "References Cited" tab for application 13/346,502.

What I did retrieve is a "Patent Citations (7)" table rendered on a Google Patents family‑member page (the page for US 2015/0078637 A1, the publication of the later continuation US 14/026,847). That table is reproduced below as a proxy, but its composition strongly suggests it belongs to the 2013 continuation, not to the '221:

• three of its seven entries post‑date the '221's 2008 priority date (published 2013, 2015, 2015), so they cannot be prior art to the '221; and
• it lists the parent '215 publication (US 2009/0291408 A1), which is same‑family material, not prior art.

Per your operating rules I am not auto‑correcting this and am not asserting it is the '221's list. I flag it as the closest available datum and mark the analysis accordingly. Treat the per‑reference §102 conclusions below as screening‑level, not verified §102 findings.

1. The patent being analyzed (from the authoritative text)

Controlling law: with a 2008‑05‑23 effective filing date, pre‑AIA 35 U.S.C. §102/§103 governs. The AIA grace‑period exceptions do not apply. Prior art must therefore antedate 2008‑05‑23 (critical date for §102(b): 2007‑05‑23).

Key legal point that shapes the whole analysis: all of claims 2–9, 11–19 and 21–24 are dependent. A dependent claim incorporates every limitation of the claim from which it depends (35 U.S.C. §112(d)). Therefore a reference can anticipate, e.g., claim 3 only if it discloses the entire independent claim 1, plus the added "crown/ceramic veneer/implant/cap" limitation. A reference that merely discloses the added feature of a dependent claim does not anticipate that claim.

2. The citation set retrieved (proxy table)

Also present on that page: "Cited By (79)" — these are later patents citing the '221 (forward citations, e.g., US 2014/0342304 A1 "Dental method of smile design," Meletiou). Forward citations are not prior art and are excluded here.

3. Prior‑art qualification screen (pre‑AIA §102)

Co‑inventor note on US 2006/0154207 A1 (Kuo): Eric E. Kuo is a named co‑inventor of the '221. Under pre‑AIA §102(b), an inventor's own publication more than one year before the filing date is still prior art — the grace period does not excuse it. So the July 2006 Kuo publication is not disqualified merely because of common inventorship. (Contrast pre‑AIA §103(c), which can disqualify commonly owned §102(e)/(f)/(g) art for obviousness only — irrelevant to a §102(b) reference.)

4. Reference‑by‑reference: description and §102 mapping

4.1 US 2005/0271996 A1 — Orametrix — "…comprehensive evaluation of orthodontic care using unified workstation"

• Full citation: US 2005/0271996 A1 (Orametrix, Inc.), published 2005‑12‑08.
• Description: a unified orthodontic "workstation" that aggregates patient records, images and 3D models and drives treatment evaluation/planning. This is the classic Align/Orametrix‑era treatment‑planning‑workstation disclosure.
• Potentially anticipatory of: the "receive… / develop a digital model… based upon the scan data" subject matter of claims 7, 13, 21, and the generic "creat[e] a dental treatment plan" step recited in claims 1, 10, 20.
• Anticipation conclusion: No §102 anticipation of claims 1/10/20. The reference does not disclose (i) defining a "smile inner lip line" and identifying the teeth within its boundary as the patient's smile, (ii) selecting a restored smile from a digital smile library database, or (iii) superimposing it over the patient's teeth image. Without all of those, no dependent claim drawing on claim 1 can be anticipated either. Best characterized as §103 art, typically combined with a 2D‑image/face‑photo reference.

4.2 US 2005/0089822 A1 — Geng — "Dental computer‑aided design (CAD) methods and systems"

• Full citation: US 2005/0089822 A1 (Geng, Z. J.), published 2005‑04‑28.
• Description: CAD capture and design of dental restorations (crowns, bridges, veneers) from digitized tooth data; addresses prep geometry and restoration design.
• Potentially anticipatory of: the restorative‑structure types and prep‑geometry subject matter of claims 2, 3, 4, 24 (crown/veneer/implant/cap; "correct depth of tooth removal and tooth mass reduction").
• Anticipation conclusion: No §102 anticipation. Because claims 2–4 and 24 are dependent, a reference must disclose the whole of claim 1 to anticipate them, and Geng does not disclose the lip‑line/smile‑library/superimposition workflow. Relevant instead as §103 art for the restorative/preparation limitations (and it corroborates that CAD design of veneers/crowns was known by 2005).

4.3 US 2006/0154207 A1 — Kuo — "Template for veneer application"

• Full citation: US 2006/0154207 A1 (Kuo, Eric E.), published 2006‑07‑13.
• Description: a template used to guide veneer application/preparation — i.e., the physical guide concept the '221's specification describes at FIGS. 7–8 and in the "template as a guide" passages.
• Potentially anticipatory of: claims 2, 3, 16, 24 (veneer template; ceramic veneer; superimposing the restored smile over the area to be covered by a dental veneer template; tooth‑mass reduction to accommodate the restoration).
• Anticipation conclusion: No §102 anticipation, for the same dependency reason — it does not disclose independent claim 1's image/lip‑line/smile‑library steps. It is nonetheless the most substantively on‑point of the three qualifying references for the restorative‑template dependent claims, and it is Align's own work by a co‑inventor of the '221, which matters for any §103 analysis (common ownership, and the risk of self‑collision arguments).

4.4 US 2009/0291408 A1 — Stone‑Collonge — "Smile designer"

• Status: this is the publication of the '221's parent application, US 12/154,634 (now US 8,092,215) — same inventors, same assignee, same specification.
• Anticipation conclusion: Cannot be §102 prior art to the '221. It published 2009‑11‑26, after the '221's 2008‑05‑23 priority date, and it is the '221's own continuation parent. Its presence in the proxy table is evidence that the table is a family/related‑document listing, further supporting my caveat in §0.

4.5 US 2013/0218530 A1 — 3Shape — "2D image arrangement"

• Status: published 2013; priority 2010‑06‑29 — post‑dates the '221 and cannot be prior art.
• Why it is nevertheless notable: it is 3Shape's own 2D‑dental‑image work, and 3Shape is the defendant in Align Technology, Inc. v. 3Shape A/S, No. 1:17‑cv‑01647‑LPS (D. Del.), in which the '221 was one of the asserted "Smile Designer Patents." Its appearance in the citation table is consistent with the table belonging to the 2013 continuation prosecuted after 3Shape's application published.

4.6 US 2015/0182303 A1 — Orametrix — "Orthodontic treatment planning using lip tracer"

• Status: priority 2011‑05‑15 — post‑dates the '221; not prior art.
• Analytical relevance only: substantively the closest subject matter to the '221's "inner lip line" concept (automated lip tracing for treatment planning). Because it post‑dates the '221, it is not citable against it — but it is a useful indicator of what the art looked like three years after the '221's priority date, which can cut both ways in an obviousness or written‑description challenge.

4.7 US 2015/0351638 A1 — Amato — "Procedure for dental aesthetic analysis of the smile area…"

• Status: priority 2013‑01‑23 — post‑dates the '221; not prior art.
• Same conclusion; relevant only as evidence of the field's later state.

5. Bottom line

1. No reference among those retrieved anticipates any claim of US 8,545,221 under §102. No single reference discloses the combination that defines independent claims 1, 10 and 20: (a) receiving a patient‑teeth image, (b) defining a "smile inner lip line" and identifying the teeth within its boundary as the smile, (c) selecting a restored‑smile image from a digital smile library database, (d) superimposing it using the identified smile, and (e) generating a treatment plan from it. And because every remaining claim is dependent, §102 anticipation of those claims fails a fortiori.
2. Only three entries are even eligible prior art to the '221: US 2005/0271996 A1 (Orametrix), US 2005/0089822 A1 (Geng), and US 2006/0154207 A1 (Kuo) — the last being co‑inventor Kuo's own pre‑critical‑date publication, which is not excused by common inventorship under pre‑AIA §102(b).
3. Those three are best deployed as §103 obviousness art: Orametrix for the workstation/digital‑model/treatment‑plan backbone; Geng for CAD design of crowns/veneers and prep geometry; Kuo for the veneer‑application template. Their principal value is to the dependent claims about the restorative structure and its template (claims 2–4, 16, 24) — though each fails as §102 art because it lacks the independent‑claim‑1 limitations.
4. Appendix/observation: the '221's pre‑grant publication (US 2012/0106812 A1) presented a broader claim 1 lacking the lip‑line and superimposition limitations (flagged in the earlier section). If prior‑art exposure were assessed against that broader published claim rather than the granted claim, the Orametrix reference's significance rises materially.

6. Explicit uncertainty / what still needs doing

• I could not open the issued‑patent front page (56) list for 8,545,221, the PTO‑892 for application 13/346,502, or the Google Patents "Patent Citations" table for US 8,545,221 B2 specifically. The seven references above are from a family‑member page and are offered as a proxy only.
• I did not read the full text of any reference; the §102 characterizations are screening‑level based on titles/dates and general knowledge of these documents, not element‑by‑element claim charts.
• I could not verify whether the '221's own record cites additional U.S. patents, foreign documents, or non‑patent literature (e.g., orthodontic NPL of the Kesling/Warunek/Chiappone type that appears in other Align patents such as US 11,234,794). Do not assume the seven references are exhaustive.
• Authoritative next steps: (i) USPTO PatentCenter → application 13/346,502 → "References Cited"/"Patent and Non‑Patent Literature" tab; (ii) the issued‑patent PDF front page for the (56) block; (iii) the file wrapper for the parent, application 12/154,634, whose IDS carries over. Any of these would supersede the proxy table above.

I'll analyze obviousness under § 103. First, note a sourcing issue I need to resolve: the patent text you supplied does not contain a "Prior Art" / "References Cited" section (Google Patents rendered the forward "Cited By" list but the examiner-cited references block was truncated/absent). So I'll ground the analysis in the reference families that are identifiable and run live searches to confirm them rather than inventing citations.

Key hit: the family appears in a Unified Patents prior-art listing. Let me pull the actual cited references for the '221 and its parent '215, and search pre-2008 art.

Strong grounding now: the family's own examiner-cited reference list (from US 10,896,761) is available. Let me verify the most probative ones and check a few key patents.

Obviousness Analysis — U.S. Patent No. 8,545,221 ("Smile designer") under 35 U.S.C. § 103

0. Sourcing note (read first)

The page as fetched does not contain a "References Cited" / "Prior Art" section. The Google Patents text you supplied includes only the forward citation block ("Cited By (79)") plus a keyword line — "Prior art keywords: patient; smile; teeth; image; restored" — and no examiner-cited reference list for the '221 itself. I could not open the '221's own front page or its file wrapper in this session.

Accordingly, I have grounded the analysis on three verifiable proxies rather than inventing citations:

1. The patent's own "prior art keywords" line above (the Office's own characterization of the art).
2. The family's cited references of record — the "References Cited" block printed on US 10,896,761 B2 (Stone-Collonge et al.), a same-specification continuation of the '221 through the 12/154,634 → 13/346,502 chain (source: https://patentimages.storage.googleapis.com/f5/14/64/cbea5b1f2399cc/US10896761.pdf). Same specification, same family, same primary examiner lineage — a fair proxy, but not a substitution for a file-wrapper pull of 13/346,502.
3. Independently verified reference content (US 7,234,937; US 7,442,040; US 8,026,916; US 2007/0141534 A1) via Google Patents / Justia / Docket Alarm.

Where I could not verify a date, assignee, or title, I say so. Do not treat any element of this memo as a certified docket or file-wrapper finding.

1. Temporal framework and level of ordinary skill

Governing law: Application 13/346,502 was filed January 9, 2012 — before the AIA first-inventor-to-file date of March 16, 2013 — and claims priority to May 23, 2008. The claims are therefore governed by pre-AIA §§ 102/103. Practical consequences:

• The critical date for § 102(b) art is May 23, 2007; art published between that date and May 23, 2008 is § 102(a)/(e) art and is theoretically antedatable by a Rule 131 declaration or a § 1.131 showing of earlier invention. This materially weakens attacks built solely on 2007–early-2008 references.
• Pre-AIA § 103(c) disallows § 103 combinations in which the only prior-art status of the reference is § 102(e)/(f)/(g) and the reference was commonly owned with the application at the time the invention was made. This is decisive here, because several of the most convenient references are Align's own.

PHOSITA: a person with a bachelor's degree in computer science or biomedical/dental engineering plus 3–5 years in medical/dental imaging or CAD, working in a team with a restorative dentist or orthodontist. The field was mature: computer-assisted smile analysis, 2D cosmetic-imaging simulation, and digital treatment planning were all established well before 2008.

2. The probative prior art (family reference list, with dates)

3. Claim 1 — element-by-element mapping and combination

Claim 1 (apparatus: processor + data-storage device with executable instructions):

Combination A (primary): US 7,234,937 + Methot 2006 + Gomez 2002.
US 7,234,937 supplies the computing-device/treatment-plan architecture and the photo-to-model superposition and smile simulation; Methot supplies the disposable smile image resource and the guided smile-design workflow; Gomez supplies the automated lip-contour extraction that yields the "smile inner lip line" boundary. Nothing in combination A is Align's own art, so no § 103(c) issue arises.

Combination B (alternative): US 7,234,937 + US 8,026,916/2007-0141534 + US 7,657,083 + Wiedmann Apr. 2008. Trades Gomez for a morphing/document-rendering approach and Wiedmann for the library of selectable tooth shapes.

Either combination renders claim 1 obvious. Note that claim 1 recites result-oriented functions carried out by "executable instructions" — image acquisition, segmentation, image compositing, database lookup, and plan generation — each individually old in dental imaging and image processing.

4. Independent claims 10 and 20

Claim 10 (computing-device-implemented method) and claim 20 (Beauregard-style non-transitory CRM) recite the same five steps. The § 103 analysis is unchanged; only the statutory category differs. Neither recites a machine, transformation, or data structure that the references do not supply, and USPTO practice (MPEP 2114) does not treat a "method" or "instructions on a medium" recitation as adding patentable weight over the corresponding device claim. Combination A disposes of all three independent claims.

5. Dependent claims

6. Why a PHOSITA would have combined these references (KSR v. Teleflex, 550 U.S. 398 (2007))

1. Same field / reasonably pertinent. Every reference is in computer-assisted dental imaging, cosmetic smile analysis, or digital treatment planning. US 7,234,937 and the cosmetic-imaging products are addressed to the same problem: showing a patient a simulated before/after smile.
2. The problem was known and articulated. The '221's own Background concedes: cost/invasiveness deter patients; "it may also be difficult for some patients to understand what the end result of a treatment may be"; and some practitioners lack the skill to design a smile. The art solved exactly that — US 7,234,937: "the expected results can be displayed before hand to the patient and changes made depending on the patient input."
3. Predictable combination of known elements with known functions. Lip segmentation (Gomez), a library of selectable smile images (Methot/Smile Library II), photo compositing onto a patient photograph (Smile-Vision), and digital plan generation (Chishti; US 7,234,937) each perform its own known function; the combination yields no unexpectedly superior result — only the predictable aggregate.
4. "Obvious to try" over a finite, identified solution space. By 2007 the practitioner's options for showing a simulated smile were essentially: pick a stock smile image and paste it into the mouth region, or morph the patient's own photo to a predicted post-treatment model. The '221 claims the first of these. That is a design choice between two known approaches, not invention.
5. Market/design incentive. The examiner-cited commercial products (Smile-Vision, GPS, Patterson Cosmetic Imaging, Dentrix G3) demonstrate that practitioners and vendors were already pushing smile simulation into dental practice; adding a plan-generation link to that front end is an obvious commercial improvement.
6. The specification concedes the building blocks. The '221's own text: "the computing device can automatically crop and/or scale image"; lip identification "can be accomplished in any suitable manner"; "Such tooth shapes can be stored in a database"; "Other such scales or color ranges can be used." Where the specification frames the components as discretionary known technique, § 103 is at its strongest.

Cross-check against the prior § 101 ruling: In Align Tech. v. 3Shape A/S, C.A. No. 17-1647-LPS (D. Del.), the court (Oct. 8, 2020) denied 3Shape's § 101 motion, reasoning the claims "amount to an improvement of the dental treatment process; they do not simply automate a previously manual process." That reasoning helps Align on § 101 but does nothing on § 103 — indeed, "improvement of a dental treatment process" is exactly the framing under which a combination of known dental-imaging tools is scrutinized for obviousness of the improvement. And per the earlier sections, § 103 was not adjudicated (3Shape's dispositive motions were non-infringement and § 112), so the art-based flank remains judicially untested.

7. Where the obviousness case is weak — and the § 103(c) trap

(i) Pre-AIA § 103(c) disqualifies Align's own § 102(e) art. US 7,442,040 (priority 2005-01-13) did not publish until its 2008-10-28 grant — after the '221's 2008-05-23 filing — so its only prior-art status is § 102(e). Both it and the '221 were Align Technology applications. Under pre-AIA § 103(c), a § 102(e) reference commonly owned at the time the invention was made cannot be used in a § 103 combination. The same problem infects US 7,241,142 (Abolfathi, Align) and any other Align 102(e) reference. Do not build a § 103 chart on US 7,442,040 without first resolving common ownership as of May 2008. Older Align patents that are § 102(b) art — e.g., Chishti's US 5,975,899 and US 6,471,511 (1999/2002) — are not disqualified, and those are the ones to use for the scan/digital-model/appliance-fabrication limitations.

(ii) Date problems in the commercial-software references. The examiner's retrieval date for Smile-Vision, Smile Library II, GPS, Patterson, Yatara, and Dentrix is June 6, 2008 — after the May 23, 2008 filing date. Their mere citation is not proof of pre-critical-date public availability. Absent Wayback Machine captures or vendor publication dates before May 2008, these are evidentiary, not dispositive, references.

(iii) Antedating risk on 2007–2008 journal art. Wiedmann (Apr. 2008) and the 2007 articles are § 102(a) art only and could be sworn behind under pre-AIA practice. The pre-2007 references (Garber 1996, Gomez 2002, Ackerman 2002, Naylor 2002, Sarver 2003, Basting 2006, Methot 2006) are the load-bearing ones.

(iv) The most likely Align rebuttal. Align will argue that optimizing a smile image is unrelated to, and does not suggest, back-solving a tooth position and inter-arch relationship that can be realized by a removable appliance and that accommodates a planned veneer preparation. That is the strongest non-obviousness argument: the alleged novelty is the coupling of a cosmetic-image selection to a physically-realizable clinical plan. Combination A answers it directly with US 7,234,937's back-solve-to-treatment-plan disclosure, but a petitioner must quote that passage expressly rather than rely on generalities.

(v) Objective indicia. No secondary-considerations record was found. Align's commercial success is with the Invisalign/iTero platforms as a whole; absent a nexus to these claim limitations, that evidence carries little weight — but a patent owner with Align's resources will develop a nexus argument, and the burden-shifting framework (WBIP; In re Kao) should be anticipated.

8. Bottom line

• Independent claims 1, 10, and 20 are, in my assessment, vulnerable to a § 103 challenge built on US 7,234,937 in view of Methot 2006 and Gomez 2002 (with US 8,026,916 / US 2007/0141534 as an alternative secondary reference for the superposition/morphing step). The motivation is supplied by the shared field, the art's express recognition of the patient-visualization problem, and the predictable nature of the combination — all KSR-sanctioned rationales.
• Claim 22 (combining the digital model with the image including the lip line) is the most exposed, since US 7,234,937's registration/superposition of 2D photographs with 3D tooth models comes close to disclosing it outright.
• Dependent claims 2–6, 16, 18 and 24 are obvious over the same base combination plus US 5,975,899 / 6,471,511 (for plan and appliance fabrication) and the prosthodontic literature (for preparation depth, tooth-mass reduction, root-canal risk, longevity) — but claims 4, 6, 16 and 24 cannot safely rest on US 7,442,040 alone because of pre-AIA § 103(c).
• The single biggest evidentiary gap is the '221's own file wrapper: I could not confirm which references the examiner actually cited against 13/346,502. Before filing anything, pull the 13/346,502 file wrapper and confirm (a) the cited art, (b) any applicant remarks distinguishing it, and (c) the chain of priority support for the granted claim language — the pre-grant publication US 2012/0106812 A1 recited a broader claim 1, and the narrowing between publication and grant is unexplained in the sources I could reach.

Verification failures I am flagging rather than papering over: I did not verify the assignee of US 8,026,916/US 2007/0141534, the priority date of EP 2 219 549/WO 2009/048475, or the pre-May-2008 public-availability dates of the examiner-cited commercial smile-imaging products. Each of those is material to the specific combinations above and should be confirmed before any of this is relied upon in a filing.