Invalidity dossier

US 11648090

Multilayer polymer sheets

Current assignee: ClearCorrect Operating, LLC

Added 9/30/2026, 12:42:54 AM

IndustryMedical (M)
At a glanceNo PTAB challenges2 lawsuits on fileasserted by ClearCorrect Operating, LLCMedical (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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US 11,648,090 B2 — Analyst Summary

Sources: Google Patents (https://patents.google.com/patent/[US11648090B2](/patent/US11648090B2)/en), PubChem patent record (https://pubchem.ncbi.nlm.nih.gov/patent/US-[11648090](/patent/11648090)-B2), USPTO PTAB records for IPR2025-00820, W.D. Tex. docket 6:24-cv-00187. Patent text provided in the task is treated as authoritative over search results.


1. Bibliographic data (verified)

Field Value
Patent number US 11,648,090 B2 (do not conflate with US 11,648,091, a sibling case)
Title "Multilayer polymer sheets" (note: some third-party databases label it "Method of Making Multilayer Dental Aligner" based on the independent claim — the official title is Multilayer polymer sheets)
Application no. US 17/858,825
Filing date July 6, 2022
Pre-grant publication US 2022/0338957 A1, published Oct. 27, 2022
Issue/grant date May 16, 2023
Earliest priority May 14, 2012 (via Application 13/470,681, now US 9,655,691)
Adjusted expiration May 14, 2032; status listed as Active
Assignee (current) Align Technology, Inc. (San Jose, CA). USPTO assignment records show Covestro LLC and Covestro Deutschland AG assigning to Align Technology, Inc. (recorded Sept. 15, 2022; confirmatory assignment May 19, 2023), and inventors Li and Chen assigning directly to Align. Original assignee also listed as Align Technology, Inc.
Inventors Chunhua Li; Yan Chen; Heinz Pudleiner; Klaus Meyer; Joerg Nickel; Craig Pehlert
Claims 11 total; one independent claim (claim 1), claims 2–11 dependent
Primary CPC A61C 7/08 (mouthpiece-type retainers); B29C 51/14; B32B 27/08, B32B 27/36, B32B 27/40, etc.

Continuity chain (from the patent's own CROSS-REFERENCE paragraph): continuation of 17/553,590 (Dec. 16, 2021) → continuation of 16/835,101 (now US 11,213,369) → continuation of 15/476,655 (now US 10,973,613) → divisional of 13/470,681 (now US 9,655,691), filed May 14, 2012. The family (Google Patents Family ID 49548874) lists 17 applications.


2. Abstract (verbatim)

"Multilayer polymer sheets are provided, as well as related methods, systems, and appliances."


3. Plain-language overview of the independent claim

Claim 1 — A method of making a multilayer dental aligner to reposition a patient's teeth from a first arrangement toward a second arrangement:

  1. Provide a three-polymer-layer multilayer sheet:
    • First layer consisting of a co-polyester with all of: flexural modulus >150,000 psi; elongation at yield >4%; tensile modulus >150,000 psi; tensile strength at yield 4,000–6,500 psi; elongation at break >70%.
    • Second layer consisting of a thermoplastic polyurethane (TPU) elastomer with: ultimate tensile strength >5,000 psi; elongation at break >200%; hardness 60A–85D.
    • A third layer (composition not further limited in claim 1).
    • The co-polyester must have an elastic modulus greater than that of the TPU elastomer (i.e., the hard/soft relationship).
  2. Provide a mold.
  3. Thermoform the sheet over the mold to form tooth-receiving cavities that receive and reposition teeth from the first arrangement toward the second.
  4. Trim excess material to form the finished aligner.

Essentially: a thermoforming method for making a clear aligner out of a "hard-core/soft-skin" multilayer sheet, where the hard co-polyester core and soft TPU skin are defined by numerical mechanical-property windows.

Dependent claims 2–11 (highlights):

  • 2: co-polyester light transmission 400–800 nm > ~75%.
  • 3: third layer is a same/different co-polyester.
  • 4: first layer disposed adjacent the third layer.
  • 5: first layer coextruded with or laminated to the third layer.
  • 6: a fourth layer of same/different TPU elastomer.
  • 7: first and third layers sandwiched between second and fourth layers (i.e., a soft–hard–hard–soft stack).
  • 8: TPU compression set at ~70 °C >40% after 24 h.
  • 9: TPU light transmission 400–800 nm > ~75%.
  • 10: co-polyester stress relaxation at 24 h in 90–100% humidity >10%.
  • 11: first layer thicker than the second.

4. Litigation and post-grant activity (2025–2026)

  • *PTAB IPR2025-00820 — ClearCorrect Operating LLC v. Align Technology, Inc..* Petition filed April 14, 2025, challenging claims 1–11 of the '090 patent. Grounds: (1) obviousness over Tadros in view of Porter, Kalili, and the Texin 990R datasheet; (2) same plus Wen (WO 2006/096558); (3) Kalili-based combinations. Status per Google Patents: instituted. Patent Owner's Response was filed Feb. 20, 2026 (due date extended by joint stipulation from Jan. 30 to Feb. 13, 2026); Petitioner's Reply due May 22, 2026; Patent Owner's Sur-reply due July 3, 2026. Align's response argues non-obviousness and relies on secondary considerations (SmartTrack/ST30 commercial success, copying).
  • W.D. Tex. 6:24-cv-00187 — Align Technology, Inc. v. ClearCorrect Operating LLC, et al. (Waco Division, Judge Albright). Four patents asserted (US 10,973,613; 11,154,384; 11,648,090; 11,648,091). Multiple sources report a jury verdict on July 2, 2026 finding ClearCorrect's ClearQuartz/Zendura FLX three-layer aligners infringe but the asserted claims invalid, with ClearCorrect's antitrust counterclaims rejected.

⚠️ Date caveat (stated explicitly per the rules): the task states the current date as April 26, 2026, but the search results above reference events dated July 2 and July 7, 2026 (jury verdict; a Federal Circuit opinion in Dental Monitoring SAS v. Align Technology, No. 24-2270). I am reporting the search results literally rather than reconciling them; if the April 2026 date is correct, those July 2026 items would be future-scheduled/erroneous and should be re-verified.


5. CAFC 2026 docket search — finding and uncertainty

  • I could not identify any Court of Appeals for the Federal Circuit docket in 2026 that is specifically an appeal concerning US 11,648,090. The '090 patent's contested proceedings appear to be at the PTAB (IPR2025-00820) and the district court (6:24-cv-00187) as of the search results.
  • The one 2026 CAFC Align-related decision surfaced — Dental Monitoring SAS v. Align Technology, Inc., No. 24-2270 (Fed. Cir. July 7, 2026, nonprecedential) — concerns US patents relating to deep-learning dental image analysis (referred to in the opinion as the '248 and '409 patents), not the '090 multilayer-sheet patent. Do not conflate these.
  • Uncertainty: PTAB final written decisions in IPRs instituted in 2025 would generally be due roughly one year after institution, so any CAFC appeal from IPR2025-00820 would likely post-date mid-2026. I have no authoritative confirmation of a CAFC appeal docketed for the '090 patent, and none should be assumed.

6. Verification notes / limitations

  • Patent number, title, application number, filing date, issue date, inventors, and claim set are verified against the full patent text supplied in the task and Google Patents/PubChem.
  • The assignee statements are based on recorded USPTO assignment data summarized by Google Patents; I have not independently confirmed the underlying assignment documents.
  • The PTAB docket details (due dates, filings) are sourced from docket aggregators (Docket Alarm) and PTAB filings; treat dates as reported rather than independently confirmed.
  • No results were found for any similar patent number beyond the intended family members (e.g., US 11,648,091), which I have flagged rather than substituted.

Generated 9/30/2026, 4:04:11 AM

Cases on file (2)

Group view →

Specific litigation cases in our database that name US patent 11648090. 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.

✓ Generated

I'll search for litigation involving US patent 11648090 across patent litigation sources.

Let me dig deeper into the specific cases identified — the PTAB IPR and the Texas district court case.

I found key litigation. Let me get more detail on the outcome and the related ITC action.

Litigation Report: U.S. Patent No. 11,648,090

Patent identified: U.S. 11,648,090 B2 ("Multilayer polymer sheets"), Align Technology, Inc., granted May 16, 2023; application 17/858,825 filed July 6, 2022; priority date May 14, 2012.

Based on my searches of patent-litigation sources (Google Patents' family/litigation data, Docket Alarm PTAB records, PTAB/PTABCTS filings, Law360, and Align's SEC disclosures), the following matters involve the '090 patent or its patent family.


1. Align Technology, Inc. v. ClearCorrect Operating, LLC, et al. (district court)

Field Detail
Plaintiff / Counterclaim-Defendant Align Technology, Inc.
Defendants / Counterclaim-Plaintiffs ClearCorrect Operating, LLC; ClearCorrect Holdings, Inc.; Institut Straumann AG; Straumann USA, LLC
Jurisdiction U.S. District Court for the Western District of Texas, Waco Division (Judge Alan D. Albright; Magistrate Judge Derek T. Gilliland)
Case No. 6:24-cv-00187-ADA-DTG
Filing Date April 11, 2024 (Complaint for Damages and Injunctive Relief, ECF No. 1)
Status / Outcome Jury trial held; verdict reported July 7, 2026 — jury found claims in four asserted patents were infringed but invalid, and rejected ClearCorrect's antitrust counterclaims. Post-trial proceedings/motions remain in play.

The '090 patent's role: It was one of nine "Asserted Patents" in the case. Align grouped the '613, '384, '090, and '091 patents as the "Materials Patents." Align's Preliminary Infringement Contentions (served July 18, 2024) asserted claims 1–3, 5, and 9–10 of the '090 patent (Source: ClearCorrect's Preliminary Invalidity Contentions and related PTAB exhibits).

ClearCorrect counterclaimed for declaratory judgment of non-infringement (Count 17) and declaratory judgment of invalidity (Count 18) of the '090 patent, asserting invalidity under 35 U.S.C. §§ 101, 102, 103, 112, 116 and/or 256, listing extensive prior art. A claim construction order issued June 5, 2025. A motion hearing was set for May 27, 2026 on ClearCorrect's Motion for Preclusion (Dkt. 340), Align's Partial Motion for Summary Judgment of Validity (Dkt. 354), and ClearCorrect's Motion for Summary Judgment of Invalidity Under § 101 (Dkt. 357).

⚠️ Caveat: The Law360 report states the jury found claims in four asserted patents invalid, but the available snippets do not identify which four. I cannot confirm with high confidence whether the '090 patent was among those four. This should be verified against the verdict form/docket.

Sources: https://www.law360.com/healthcare-authority/cases/661860ac86143c48226cbd77 ; https://www.docketalarm.com/cases/Texas_Western_District_Court/6--24-cv-00187/ ; https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557669](/patent/1557669)/download-documents


2. ClearCorrect Operating, LLC v. Align Technology, Inc. (PTAB inter partes review)

Field Detail
Petitioner ClearCorrect Operating, LLC
Patent Owner Align Technology, Inc.
Forum USPTO Patent Trial and Appeal Board
Case No. IPR2025-00820
Patent Challenged U.S. Patent No. 11,648,090 — claims 1–11
Petition Filing Date April 14, 2025
Status Instituted; pending. Patent Owner Response filed February 20, 2026.

This is a post-grant proceeding, not district-court litigation, but it directly targets the '090 patent. Grounds asserted: (1) claims 1–2, 4–5, 8–11 obvious over Tadros in view of Porter, Kalili, and Texin 990R; (2) claims 1–11 obvious over the same combination further in view of Wen; (3) claims 1–6, 8–11 obvious over Kalili in view of Porter, Wen, and Texin 990R. ClearCorrect is represented by Finnegan (lead counsel Charles T. Collins-Chase); Align by Wilson Sonsini.

This IPR is part of a coordinated set (IPR2025-00818 through -00821) covering Align's '613, '384, '090, and '091 patents.

Sources: https://ai-lab.exparte.com/case/ptab/IPR2025-00820/doc/1 ; https://www.docketalarm.com/cases/PTAB/IPR2025-00820/ClearCorrect_Operating_LLC_v._Align_Technology_Inc/ ; https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557675](/patent/1557675)/download-documents


3. Potential / related matter — ITC Section 337 investigation (unconfirmed as to the '090 patent)

Align's SEC disclosure states that on September 23, 2025, it filed a Section 337 complaint at the U.S. International Trade Commission alleging unlawful importation/sale of clear aligners infringing patents "related to multilayer materials for clear aligners" and "bite ramp" and "power ridge" features. The ITC instituted the investigation on December 19, 2025; it remains pending.

Because the '090 patent is one of Align's "multilayer materials" patents, it is plausible — but not confirmed by the sources I retrieved — that the '090 patent is asserted in that ITC action. The specific asserted patent numbers were not identified in the available excerpt, so I flag this as unverified rather than asserting it.

Source: https://aligntech.gcs-web.com/node/28181/html


Summary

  • One district-court case directly asserts U.S. 11,648,090: Align Technology, Inc. v. ClearCorrect Operating, LLC, et al., No. 6:24-cv-00187-ADA-DTG (W.D. Tex., filed April 11, 2024) — went to a jury verdict reported July 7, 2026 (four asserted patents held infringed-but-invalid; ClearCorrect antitrust counterclaims rejected; whether '090 was among the invalidated patents is unconfirmed).
  • One PTAB proceeding directly challenges it: IPR2025-00820 (ClearCorrect v. Align), filed April 14, 2025, instituted, claims 1–11 challenged — currently pending (Patent Owner Response filed Feb. 20, 2026).
  • A related ITC Section 337 action exists involving Align's multilayer-materials patents, but I could not confirm the '090 patent is among those asserted.

Note on dates: The system date provided is September 30, 2026, while the case prompt states April 26, 2026. I have reported post–April 2026 events (the July 2026 jury verdict) because they appear in the retrieved search results, which I am instructed to treat as current ground truth.

No other litigation asserting or challenging U.S. 11,648,090 was found.

Generated 9/30/2026, 4:04:19 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: ClearCorrect Operating, LLC

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 reconcile the contradiction between the structured ODP block ("no AIA trials on file") and the previously-generated section (which identifies IPR2025-00820), then verify via live sources.

Strong results. Now let me pin down whether any other IPR has ever targeted the '090 patent, the outcome of the March 2026 RPI motion, and any post-verdict developments.

Now let me check for post-verdict developments, any oral hearing/FWD status, and whether any other party (e.g., Angelalign, 3M, Bay) ever petitioned against the '090 patent.

PTAB / AIA Trial Landscape — US 11,648,090 B2 ("Multilayer polymer sheets")

⚠️ Reconciliation of sources (read first). The structured "PTAB proceedings on file" block states the USPTO ODP returns no AIA trial proceedings for this patent. That block is contradicted by the live record and appears stale or unindexed. A full IPR on this patent is pending and was instituted on 2025-11-06: IPR2025-00820, ClearCorrect Operating, LLC v. Align Technology, Inc. Everything below is sourced to the actual PTAB papers. I also note: the Google Patents header that says "Petitioner: Unified Patents PTAB Data" is a data-attribution string, not the petitioner — the real petitioner is ClearCorrect. Do not repeat that error.

Prior-section corrections: (1) The earlier summary's reference to IPR2022-01214 as a Bay Materials/Align matter is mis-attributed — IPR2022-01214 is 3M Company v. Bay Materials, LLC on U.S. 10,946,630 (Bay's own patent; FWD 2024-01-16, Paper 77). It is relevant only as evidence Align uses in the '090 IPR, not as a proceeding on the '090 patent. (2) The earlier summary's "current date = 2026-04-26" conflicts with today's date of 2026-09-30; I use 2026-09-30.


Proceedings overview

One AIA trial has ever been filed against US 11,648,090: IPR2025-00820 — status instituted and active; 0 claims canceled, 0 claims sustained, 0 settlements, 0 institution denials (the denial of institution was sought by Patent Owner on discretionary/RPI grounds and was refused, both by the Director and on Director Review).

Defensive posture: the patent is neither PTAB-hardened nor PTAB-killed. Nothing has been canceled, so you cannot say "claim 1 is dead"; but nothing has been affirmed patentable either, so Align cannot yet claim PTAB vindication. The single most useful fact for a defendant today is that all 11 claims are under challenge in a live IPR with a Final Written Decision due on or about 2026-11-06/2026-11-08, and that a W.D. Tex. jury found the asserted claims invalid on 2026-07-02 (subject to JMOL/appeal). The IPR record — petition, institution decision, and Align's response — is a ready-made invalidity roadmap for anyone else being asserted against.


IPR2025-00820 — ClearCorrect Operating, LLC v. Align Technology, Inc.

  • Type: Inter Partes Review (35 U.S.C. §§ 311–319)
  • Filed: 2025-04-14 (Petition, Paper 1; filing date accorded 2025-05-08, Paper 5)
  • Status: Instituted / Active (verbatim per docket: "Institution Decision Grant," Paper 17, 2025-11-06). Plain English: trial is running; no FWD yet; no termination.
  • Judge panel: Neil T. Powell, Kristina M. Kalan, and Christopher L. Ogden (caption of Paper 31, 2026-03-26; Kalan authored). Caveat: I retrieved the caption of the March 2026 order, not the face of the 2025-11-06 institution decision; I have not independently confirmed that the institution panel was composed identically, though PTAB practice makes that the norm.
  • Parties' counsel: Petitioner — Finnegan, Henderson, Farabow, Garrett & Dunner (Kathleen A. Daley, Charles T. Collins-Chase, Xirui Zhang, Anthony J. Berlenbach, Luke J. McCammon, Melanie M. Magdun, Kyle W. Howarth). Patent Owner — Wilson Sonsini Goodrich & Rosati (Michael T. Rosato, Matthew A. Argenti, Patrick M. Medley).
  • Petition grounds — all § 103 obviousness, claims 1–11 (the entire claim set; claim 1 is the sole independent claim):
    • Ground 1 — claims 1–2, 4–5, 8–11 over Tadros (US 2005/0100853) in view of Porter (2007 Plastics Technology article on Eastman Tritan copolyester), Kalili (US 2011/0020761), and the Texin 990R datasheet.
    • Ground 2 — claims 1–11 over Tadros + Porter + Kalili + Texin 990R, further in view of Wen (WO 2006/096558) (adds the multi-sublayer teaching aimed at claims 3, 6, 7).
    • Ground 3 — claims 1–6, 8–11 over Kalili + Porter + Wen + Texin 990R (drops Tadros).
    • No § 102 anticipation ground and no § 112 ground was pleaded.
    • Provenance note: the claim-by-ground mapping above is drawn from a third-party summary of the petition; it is consistent with Align's Patent Owner Response and the institution decision as to the reference set (Tadros / Porter / Kalili / Texin 990R / Wen), but treat the exact claim groupings as derived, not verbatim-from-the-Board.
  • Institution decision: Granted, 2025-11-06 (Paper 17). Reasoning, in substance: at the threshold stage Petitioner and Dr. Osswald made a sufficient showing that a POSITA would have been motivated to (a) replace Tadros's BPA-containing polycarbonate hard layer with Tritan copolyester (Porter) while preserving Tritan's properties via adhesive lamination, and (b) use Texin 990R for the soft layers (Kalili's express disclosure of Texin 990R for aligner soft layers), with a reasonable expectation of success. The panel expressly rejected Align's preliminary arguments, including that Texin 990R is "far softer than Tadros's materials," and cited In re Mouttet for the proposition that "even if better alternatives exist in the prior art, that does not make Petitioner's proposed combination inapt for obviousness." Procedurally, institution came after referral from the Director (Director Discretionary Decision: Refer, Paper 14, 2025-08-29), which denied Align's § 314(a)/§ 325(d)/Fintiv discretionary-denial request — including Align's § 325(d) arguments that Wen and the asserted combinations were never before the Examiner.
  • Final Written Decision: None issued as of 2026-09-30. The Board's projected FWD due date is 2026-11-08 (stated in the 2025-08-29 Director referral decision); the statutory § 316(a)(11) one-year clock from the 2025-11-06 institution runs to approximately 2026-11-06. Caveat: I could not retrieve a paper confirming the exact due date or an oral-hearing date; the two dates above differ by two days and should be confirmed on P-TACTS.
  • Settlement / termination: None. No termination, no joint stipulation to terminate. (Contrast: Align's briefs note ClearCorrect previously settled with Align after earlier litigation — that has no bearing on this IPR.)
  • Key procedural events:
    • 2025-05-08 — Filing date accorded (Paper 5).
    • 2025-08-08 — Petitioner's Opposition to Patent Owner's Request for Discretionary Denial (Paper 10); PO reply authorized 2025-08-18/20.
    • 2025-09-10 — Board authorizes a 5-page Petitioner reply and PO sur-reply to PO's preliminary response (reply by 2025-09-17; sur-reply by 2025-09-24).
    • 2025-08-29 — Director Discretionary Decision referring the petitions to the Board (discretionary denial not appropriate). (Decision filed in the -00819/-00817 family and applied across -00817 through -00821.)
    • 2025-11-06 — Institution granted (Paper 17).
    • 2025-11-20 — Align files Request for Director Review of the institution decision (Paper 19), arguing among other things that institution should be vacated in light of the Director's 2025-10-17 Open Letter on "extraordinarily high institution rates," and that all real parties in interest were not named — specifically Bay Materials, LLC (a Straumann affiliate) — invoking the de-designation of SharkNinja and the newly *precedential Corning Optical RPI framework.
    • 2026-02-20 — Patent Owner Response (Paper 27), requesting the Board reject all three grounds and affirm patentability. Themes: (i) Petitioner's "exercise in contradictions" on predictability; (ii) hindsight-driven combinations "discouraged, not motivated"; (iii) strong objective indicia — unexpected results of SmartTrack/ST30 over the best prior-art material, commercial success, widespread industry adoption, and copying by ClearCorrect/Bay Materials (Zendura FLX); (iv) the RPI defect (Bay Materials unnamed).
    • 2026-03-03 — Director denies Director Review in all five cases (Paper 29, signed by Under Secretary/Director John A. Squires).
    • 2026-03-11 — Align requests authorization to move to vacate the institution decision and terminate each of -00818 through -00821 on the RPI ground.
    • 2026-03-26 — Board denies Patent Owner's filing request (Paper 31, 37 C.F.R. § 42.5); no termination motion was permitted.
    • Anticipated/next: Petitioner's Reply and Patent Owner's Sur-reply, then FWD due ~2026-11.
    • Note: the previously-generated section lists the PO Response as due 2026-02-13 after a stipulation; the paper on the docket is dated 2026-02-20. I report the docket date; the due-date detail is unverified.
  • Appeal: None. No FWD exists, so no § 319 CAFC appeal is possible yet. The appeal window would open on issuance of the FWD (60 days, Fed. R. App. P. 4(a)(1)(B) as applied via 35 U.S.C. § 319 / 37 C.F.R. § 90.3), i.e., roughly January 2027 — after today's date. No Federal Circuit docket exists for the '090 patent. Do not conflate the 2026-07-07 CAFC decision in Dental Monitoring SAS v. Align Technology, Inc. (deep-learning dental image analysis; U.S. 11,049,248 and 10,755,409 → § 101 ineligible; Law360) with this patent.
  • Defensive value: The patent has survived the discretionary-denial gauntlet — a meaningful negative signal, because Align threw § 314(a), § 325(d)/Advanced Bionics, Fintiv, and RPI arguments at the Board and lost every one, including on Director Review. A defendant hoping to knock out a parallel IPR on discretionary grounds will face a Board and Director that have already refused to do so here. Conversely, the substantive record is all upside for an accused infringer: the institution decision found Petitioner "currently appears to have the better position" on the Tritan substitution, and Align's entire response rests on objective indicia rather than a clean non-obviousness showing. Anyone served with a demand letter on the '090 patent should treat IPR2025-00820's papers as a pre-built § 103 case — while recognizing they must file independently (see estoppel below).

Strategic summary

Claim status: 11 challenged, 0 canceled, 0 sustained, 0 untested. IPR2025-00820 attacks the entire claim set (claims 1–11). Claim 1 is the only independent claim; claims 2–3 depend from 1, claims 6–7 depend from 1 and add a fourth layer, and the balance add property limitations. Because there is no partial challenge, there is no narrowing to date and no "surviving claims" list — the patent stands exactly as granted. If the FWD cancels claim 1, the whole patent falls (nothing depends from anything else). The nearest thing to a partial outcome so far is ground coverage: claims 3, 6, and 7 are reached only through Ground 2 (Wen), and claim 7 is reached only by Ground 2 — so the Wen-based sub-layering teaching is the sole vehicle for the four-layer dependents. That is a pressure point to watch in the FWD. There is no claim-level disposition to quote, because no FWD has issued; I will not manufacture one.

Estoppel landscape. Section 315(e)(2) estoppel has not yet attached to anyone — it attaches only on issuance of a final written decision. ClearCorrect (and, per Align's unadjudicated RPI theory, Straumann/Bay Materials if proven privies) will be barred from asserting in the parallel litigation any ground raised or that reasonably could have been raised — i.e., essentially the Tadros/Porter/Kalili/Texin-990R/Wen universe, plus anything else a skilled searcher would have found. A different defendant is not estopped at all, but faces a practical General Plastic-style risk on follow-on petitions and, more importantly, the cost of building its own primary reference: the obviousness theory here is anchored on Tadros as the primary structure and Porter for the Tritan substitution, with Kalili/Texin 990R for the soft layer. A new petitioner should look for materially different primary art and should expect the Board to weigh § 325(d) and General Plastic against a me-too filing. Note also that the same prior-art grounds are in play in W.D. Tex., where a jury already found the claims invalid.

Pattern signals. (1) ClearCorrect is a mass filer here, not a one-shot challenger. It filed a coordinated wave on the same day: IPR2025-00814 through -00821, covering Align's 10,791,936 (-00817), 10,973,613 (-00818), 11,154,384 (-00819), 11,648,090 (-00820), and 11,648,091 (-00821), plus -00814/-00815/-00816 on three other Align patents (referred to as the '217, '879, and '456 patents). Align moved to have all five post-'819 cases captioned together; the Board denied that courtesy caption (Paper 31) but treats the papers as parallel. (2) No defensive aggregator is in the chain. Unified Patents appears nowhere except as the attribution string Google uses for its PTAB data; there is no Unified- or RPX-style petitioner. (3) The patent owner litigates PTAB aggressively: Align filed a discretionary-denial request with a § 325(d) Advanced Bionics attack, a Director Review request, and an attempted termination motion on RPI/[Corning] grounds — and lost all three. Expect the same posture in the FWD and in any appeal. (4) This is a reprisal of a long-running war: Align's briefs recount ClearCorrect filing 26 ex parte reexamination requests (2015–2017), plus IPR2016-00270 and IPR2017-01829, against Align's portfolio — Align characterizes those earlier campaigns as having canceled only one claim. Those proceedings targeted other Align patents, not the '090 patent, so they carry no estoppel here. (5) Related parallel front: Align filed an ITC § 337 action against Angelalign (instituted 2025-12-19) asserting, among other things, multilayer-material patents for clear aligners; evidentiary hearing was held 2026-07-20–24, with the CALJ's initial determination due 2026-11-20. That is a separate forum but confirms Align is actively enforcing this family.

The district-court overlay. In W.D. Tex. 6:24-cv-00187 (Align v. ClearCorrect, Judge Albright), four patents were asserted, including US 11,648,090. Per Law360 and Align's own Form 10-Q reporting, a jury verdict on 2026-07-02 found the defendants infringed the asserted claims of four Align patents but those claims invalid, while rejecting ClearCorrect's antitrust counterclaims. Flagging this carefully: a jury invalidity verdict does not terminate an instituted IPR, is subject to JMOL/JPML and appellate review, and I have no confirmation of any post-trial ruling, judgment entry, or CAFC appeal. It nonetheless materially changes settlement leverage — an accused infringer now has both a live IPR and an on-paper district-court invalidity judgment against the same claims.


Recommended next steps

  1. Get the FWD the day it issues — target the window 2026-11-01 to 2026-11-15. Pull it from P-TACTS / PTAB E2E: https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557676](/patent/1557676) (P-TACTS public information page) and the case docket: https://www.docketalarm.com/cases/PTAB/IPR2025-00820/ClearCorrect_Operating_LLC_v._Align_Technology_Inc/. Read it at claim-level granularity — specifically whether claim 1 survives, and whether claims 3, 6, and 7 (reached only through the Wen-based Ground 2) fare differently from the rest.
  2. Diary the appeal window now. If the FWD issues ~2026-11-06, a § 319 notice of appeal is due ~2027-01-05. If either side appeals, the CAFC docket (not the '090 patent's current absence of one) becomes the thing to track on CourtListener. Today there is no CAFC appeal touching the '090 patent — do not let anyone tell you otherwise; the only 2026 Align-related CAFC item is Dental Monitoring.
  3. If you are a defendant being asserted on the '090 patent today, the argument architecture writes itself: (a) the institution decision's finding that Petitioner "appears to have the better position" on substituting Tritan for Tadros's polycarbonate, and its holding that "better alternatives exist in the prior art" does not defeat obviousness (In re Mouttet); (b) the W.D. Tex. 2026-07-02 jury invalidity verdict — verify the judgment and its appellate status before citing it as preclusive; and (c) the 11-month-thin objective-indicia record Align has staked its case on (SmartTrack/ST30 nexus, copying by ClearCorrect/Bay, industry adoption). Attack nexus directly: the earlier 3M v. Bay Materials (IPR2022-01214, FWD 2024-01-16) record shows Align's own objective-indicia theory is being recycled — 3M argued there that Zendura FLX lacked nexus to Bay's '630 claims, and Align now uses Bay's opposite arguments from that same case to prove copying.
  4. Do not file a me-too IPR without a distinct primary reference. ClearCorrect already occupies Tadros/Porter/Kalili/Texin 990R/Wen. A second petitioner gets no benefit from ClearCorrect's estoppel but inherits § 325(d) and General Plastic exposure; the practical alternative is to litigate the art in the district court (or via ex parte reexam, which the 2024–2026 filing trend shows is surging precisely because of PTAB discretionary risk).
  5. Correct the record internally. If your docketing system is fed by an ODP pull for this patent, it is currently showing zero AIA trials. That is wrong, and it is the kind of gap that misses a FWD or a § 315(e)(2) estoppel trigger entirely.

Generated 9/30/2026, 4:05:08 AM

Ownership chain (5)

Asserters network →

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

  1. 2022-05-01 · recorded 2022-09-15 · Assignment

    Chunhua Li; Yan ChenAlign Technology, Inc.

    chain-of-title cleanup

  2. ? · recorded 2022-09-15 · Assignment

    Craig PehlertCovestro LLC

    employment-contract assignment

  3. ? · recorded 2022-09-15 · Assignment

    Dr. Heinz Pudleiner; Klaus Meyer; Joerg NickelCOVESTRO DEUTSCHLAND AKTIENGESELLSCHAFT

    employment-contract assignment

  4. ? · recorded 2022-09-15 · Assignment

    Covestro Deutschland Aktiengesellschaft; Covestro LLCAlign Technology, Inc.

    co-owner consolidation

  5. ? · recorded 2023-05-19 · Confirmatory Assignment

    COVESTRO LLC; COVESTRO DEUTSCHLAND AKTIENGESELLSCHAFTAlign Technology, Inc.

    confirmatory

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 attempt to pull the actual recorded assignment data (reel/frame, correspondents) before writing the sections.

Good — I found the underlying assignment instruments in the IPR prosecution-history exhibits. Let me verify the assertion context and any additional recorded transfers.

US 11,648,090 — Assignment / Chain-of-Title Reconstruction

Method and data-integrity note (read first): I could not execute a live query against the USPTO Assignment Center or the legacy assignment.uspto.gov index with the tools available to me. I therefore cannot report reel/frame numbers or the recorded "correspondent" fields, and I will not invent them. What follows is built from (a) the Google Patents legal-events ledger for US 11,648,090 (which is itself derived from USPTO assignment recordation data), and (b) the underlying assignment instruments themselves, which were filed into the record as Exhibit 1017 (Prosecution History of U.S. Application 17/858,825) in IPR2025-00820 and are publicly retrievable via Docket Alarm. Where a field is unverified I say so explicitly.


Inventors

All six are named on the '090 patent, and all six executed assignments. Two are Align people; four are Covestro (formerly Bayer MaterialScience) people — i.e., this is a joint-development inventive entity across two unrelated companies, which is itself the structural fact that drives the entire chain of title.

Inventor Address of record (per assignment instrument) Employer at filing (determinable) Assignment executed to
Chunhua Li 19688 Vicksburg Dr., Cupertino, CA 95014 Align Technology, Inc. Align Technology, Inc.
Yan Chen 10461 Pineville Ave., Cupertino, CA 95014 Align Technology, Inc. Align Technology, Inc.
Dr. Heinz Pudleiner Bethelstr. 39, 47800 Krefeld, Germany Covestro Deutschland AG (Bayer MaterialScience heritage; Covestro carve-out from Bayer completed 2015) Covestro Deutschland AG
Klaus Meyer Kamillenstr. 40, 41539 Dormagen, Germany Covestro Deutschland AG Covestro Deutschland AG
Joerg Nickel Krokusweg 2, 41539 Dormagen, Germany Covestro Deutschland AG Covestro Deutschland AG
Craig Pehlert 29 St. Ann's Avenue, Lenox, MA 01240 (signed at Sheffield, MA) Covestro LLC (Pittsburgh, PA; a Delaware LLC) Covestro LLC

Pattern notes (evidence-based):

  • No inventor-departure / fire-sale pattern. Chunhua Li is a repeat Align inventor and remains one years later — she is named as an inventor on Align's later bite-ramp patents (US 11,154,616 / 11,155,996) asserted in Align v. Angelalign, E.D. Tex. 2:25-cv-00804. That is the opposite of the "all inventors departed within 12 months" tell you flagged as a fire-sale precursor.
  • The Covestro inventors assigned under express employment-contract obligations, not by negotiated purchase. The Pudleiner/Meyer/Nickel instrument recites: "in accordance with the obligations in our employment contract with COVESTRO DEUTSCHLAND AKTIENGESELLSCHAFT… we do hereby sell, assign and transfer unto said COVESTRO DEUTSCHLAND AKTIENGESELLSCHAFT." The Pehlert instrument is identical in form as to COVESTRO LLC.
  • Timing anomaly worth flagging (change of name not separately recorded): the 2012 parent was filed while these German inventors worked for Bayer MaterialScience AG; the recorded 2022 instruments recite employment contracts with Covestro Deutschland AG (the post-2015 spun-off successor). There is no separately recorded "Change of Name" conveyance for Bayer MaterialScience → Covestro in the '090 ledger as surfaced by Google Patents. I am not asserting the chain is defective — the Covestro entities recorded the assignment as successors — but a title examiner should note the absence of a recorded name-change instrument on the face of this chain.

Original assignee

Align Technology, Inc. — a Delaware corporation, address of record 2560 Orchard Parkway, San Jose, CA 95131 (per the assignment instruments; Align also appears post-issue with its Tempe, AZ address in press releases).

  • Primary line of business: design, manufacture and sale of the Invisalign® clear-aligner system, iTero intraoral scanners, and digital orthodontic software. Publicly traded (Nasdaq: ALGN).
  • Does it ship a product embodying the claims? Yes — affirmatively pleaded by Align itself. Align's own complaint in Align Technology, Inc. v. Angelalign Technology Inc., E.D. Tex. 2:25-cv-00804 (¶¶15–16) states that the '384 and '091 Patents relate to Align's proprietary multilayer material called SmartTrack™, describing it as "a new, three-layer material… two polyurethane outer layers… and a co-polyester inner layer." The '090 and '091 are the same-family continuations claiming the same three-layer soft/hard/soft structure with numerical property windows (see the previously generated summary, claim 1). The commercial product is SmartTrack, the aligner material used across the Invisalign system.
  • Current status: Operating, solvent, no bankruptcy. Recent public filings show active IP enforcement worldwide (10-Q disclosures; 2025 ITC complaint against Angelalign; 2026 press releases on China/UPC wins).

Assignment timeline

⚠️ Reel/frame numbers, execution dates and recorded correspondents are marked "NOT RETRIEVED" — see the method note. Recording dates below are from the Google Patents legal-events ledger and the instruments are corroborated by IPR2025-00820 Exhibit 1017. Do not treat the bracketed placeholders as data.

1. Executed 2022-05-01 (instrument face date "5-1-2022"; notarial acknowledgment recital references May 16, 2012) / recorded 2022-09-15 — Reel NOT RETRIEVED/NOT RETRIEVED

  • Conveyance: Assignment (inventor → assignee)
  • Assignor: Chunhua Li; Yan Chen
  • Assignee: ALIGN TECHNOLOGY, INC., a Delaware corporation, 2560 Orchard Parkway, San Jose, CA 95131
  • Correspondent: NOT RETRIEVED. (Filed under a separate docket format, "Assignment Attorney Docket No.: 83289-831160 (022900US)" — a different docket series from the WSGR prosecution docket 22773-826.xxx, indicating a different firm handled this inventor assignment than handled prosecution. That is an inference from the docket format, not a verified correspondent.)
  • Context: Confirmatory/re-executed inventor assignment covering the 2012 parent (13/470,681), executed and recorded as part of a family-wide chain-of-title cleanup timed to the continuation filings in 2021–2022.

2. Executed 2022 (exact date NOT RETRIEVED) / recorded 2022-09-15 — Reel NOT RETRIEVED/NOT RETRIEVED

  • Conveyance: Assignment (employee invention obligation)
  • Assignor: Craig Pehlert
  • Assignee: COVESTRO LLC, Pittsburgh, Pennsylvania, a Delaware limited liability company
  • Correspondent: NOT RETRIEVED.
  • Context: Ordinary employment-contract invention assignment by a supplier-side co-inventor to his employer.

3. Executed 2022 (exact date NOT RETRIEVED) / recorded 2022-09-15 — Reel NOT RETRIEVED/NOT RETRIEVED

  • Conveyance: Assignment (employee invention obligation)
  • Assignor: Dr. Heinz Pudleiner; Klaus Meyer; Joerg Nickel
  • Assignee: COVESTRO DEUTSCHLAND AKTIENGESELLSCHAFT, Leverkusen, Germany, a German corporation
  • Correspondent: NOT RETRIEVED.
  • Context: Same — employment-contract invention assignment by the three German co-inventors.

4. Executed 2022 (exact date NOT RETRIEVED) / recorded 2022-09-15 — Reel NOT RETRIEVED/NOT RETRIEVED

  • Conveyance: Assignment (co-owner consolidation / transfer to commercializing party)
  • Assignor: Covestro Deutschland Aktiengesellschaft (Assignor 1) and Covestro LLC (Assignor 2)
  • Assignee: ALIGN TECHNOLOGY INC., Delaware corporation, 2560 Orchard Parkway, San Jose, CA 95131
  • Correspondent: NOT RETRIEVED.
  • Context: Co-owner buy-in / consolidation of title in the operating company. The instrument recites that the application "names inventors from Assignor 1, Assignor 2 and Assignee… These inventors have assigned their invention to their respective company," and that the Covestro entities "assign their respective state to Assignee and Assignee accepts such assignment." Critically, the instrument covers 13/470,681, 15/132,171, and a then-unfiled divisional (docket 22773-826.401) — a portfolio-level, family-wide conveyance, not a single-patent transfer.

5. Executed 2023 (exact date NOT RETRIEVED) / recorded 2023-05-19 — Reel NOT RETRIEVED/NOT RETRIEVED

  • Conveyance: Confirmatory Assignment
  • Assignor: COVESTRO LLC; COVESTRO DEUTSCHLAND AKTIENGESELLSCHAFT
  • Assignee: ALIGN TECHNOLOGY, INC.
  • Correspondent: NOT RETRIEVED.
  • Context: Confirmatory only — a belt-and-suspenders re-recordation of link 4, filed three days after the '090 issued (2023-05-16). Consistent with a large operating company cleaning up standing before enforcement. It conveys no new consideration and no new party into the chain.

Net result of the chain: Li + Chen → Align and Covestro inventors → Covestro entities → Align, all landing at one assignee, Align Technology, Inc., with a confirmatory re-recording in 2023. No assignment out of Align appears anywhere in the record.


Timeline diagram

timeline
    title Ownership of US 11648090
    2012 : Parent application filed
         : Align and Covestro named as co inventors
    2022 : Li and Chen assign to Align Technology
         : Covestro inventors assign to Covestro entities
         : Covestro entities assign their rights to Align
         : All four recordings entered on one date
    2023 : Confirmatory assignment from Covestro to Align
         : Patent issues as US 11648090
    2024 : Align sues ClearCorrect in W D Texas
    2025 : ClearCorrect petitions for IPR

NPE / troll-pattern signals

# Signal Call Evidence
1 Shell-entity transfer Not present Every assignee in the chain is an operating or manufacturing entity: Align Technology, Inc. (Delaware corp. at 2560 Orchard Parkway, San Jose — a real HQ), Covestro LLC (Pittsburgh, PA), Covestro Deutschland AG (Leverkusen). No "IP / Holdings / Ventures / Licensing" suffix appears anywhere in the '090 ledger.
2 Known asserter in the chain Not present Current assignee Align Technology, Inc. matches no entry on the Acacia / Marathon / IV / IPNav / Wi-LAN / Conversant / Vringo / Pendrell / Round Rock / Spangenberg lists. Same for Covestro. Align is the defendant-side counterparty to Unified Patents' IPR and to ClearCorrect's petition — i.e., Align is the operating company being challenged, not an NPE petitioner.
3 Repeat correspondent across the chain Cannot be assessed — not retrieved I was unable to retrieve recorded correspondents (the single most probative field for this signal). What is verifiable is that the prosecution correspondence address of record for 17/858,825 is "Align Technology, Inc. / WSGR, 650 Page Mill Road, Palo Alto, CA 94304" (Wilson Sonsini Goodrich & Rosati), with Garrett T. Potter, Reg. No. 76,602, Customer No. 107046, as filer on the 2022-07-06 filing (docket 22773-826.310). I make no finding — a single law firm prosecuting a family for an operating company is normal, and I have not established recordation correspondents. Re-run this field against Assignment Center to close it out.
4 Cascading transfers Not present Four recordings on 2022-09-15 all run in one direction (inventors → their employers → Align) and terminate at Align; there is no chain of LLC-to-LLC hops, no shared registered-agent addresses among nominal strangers, and no second hop after the 2023 confirmatory filing. The 2022 cluster is a single-date chain-of-title cleanup for a continuation family, not a cascade.
5 Pre-litigation transfer Not present Assignments recorded 2022-09-15 and 2023-05-19. The first suit asserting this patent is W.D. Tex. 6:24-cv-00187, filed on/around 2024-03-01 — roughly 19 months after the operative transfer, and after Align already owned the portfolio. The transfers pre-date the patent's own issuance (2023-05-16) in most instances, which is inconsistent with a transfer arranged to enable suit.
6 Bankruptcy fire-sale Not present No Chapter 7/11 proceeding involving Align or Covestro appears in the record. Both are solvent: Align is a Nasdaq-listed medical device company actively filing suits (2024 WDTX; 2025 E.D. Tex. v. Angelalign; 2025 ITC complaint); Covestro AG is a listed German polymer producer.
7 Privateering Not present — inverse pattern The economically natural "privateer" move here would be for Covestro (a materials supplier to Align's competitors, including Bay Materials/Zendura supply chains) to retain rights and assert them against Align or Align's rivals. Instead, Covestro assigned its rights in to Align (link 4, recorded 2022-09-15) and re-confirmed it (link 5, 2023-05-19). The chain consolidated into the practising entity.
8 Defensive aggregator Not present Chain does not terminate at RPX, AST, LOT, Unified Patents or OIN. It terminates at Align, which is actively asserting the patent. (Note the inversion: Unified Patents filed IPR2025-00820 as Petitioner against Align — a defensive-aggregator posture directed at this patent, not ownership of it.)

Verdict

Operating-company assertion

Justification (2–3 sentences): The chain of title runs from the six co-inventors through their respective employers (Covestro LLC and Covestro Deutschland AG) and consolidates entirely into Align Technology, Inc. by recorded assignment on 2022-09-15, with a confirmatory assignment from both Covestro entities to Align recorded 2023-05-19 — after which no assignee other than Align ever appears. Align is a solvent Nasdaq-listed entity that ships the practising product: its own pleadings state the sibling patent US 11,648,091 covers SmartTrack™, "a new, three-layer material… two polyurethane outer layers… and a co-polyester inner layer," which is precisely the claim-1 structure at issue. Align asserts the '090 against direct commercial competitors — accused claims 1–3, 5, 9–10 in W.D. Tex. 6:24-cv-00187 against ClearCorrect's ClearQuartz/Zendura FLX aligners, and the same multilayer family against Angelalign in E.D. Tex. 2:25-cv-00804 and at the ITC — which is the textbook operating-company assertion posture, not NPE conduct.

Verification links:


Open items / flags for the next analyst

  1. Two fields remain genuinely unverified and should be pulled directly from Assignment Center: (a) the reel/frame for each of the five recordings above, and (b) the recorded correspondent of record for each. Signal #3 (repeat correspondent) cannot be scored until (b) is retrieved. I deliberately left placeholders rather than guessing.
  2. Contradiction with the prior section, flagged explicitly as required: the previously generated summary says the task date was April 26, 2026, whereas this task states 2026-09-30. The prior section also reported a July 2, 2026 W.D. Tex. jury verdict in 6:24-cv-00187 (infringement found, claims held invalid, antitrust counterclaims rejected). Current searches surface an Align 10-Q stating "The jury found that the Defendants infringed the asserted claims of four of Align's patents" — directionally consistent with that verdict but I could not independently confirm the invalid-claims portion or the date. Treat the verdict as reported, not verified.
  3. New assertion of record not in the prior section: Align has also asserted the multilayer-material family against Angelalign — E.D. Tex. 2:25-cv-00804 (complaint filed 2025-08-18, Judge Gilstrap) asserting the '384, '091, '977, '616, '996 patents, plus an ITC complaint filed 2025-09-23 (instituted 2025-12-19) directed to "patents related to multilayer materials for clear aligners" and bite-ramp/power-ridge features. This reinforces the "operating-company assertion" verdict and supplies additional product-embodiment evidence.
  4. No CAFC appeal specific to the '090 was identified — consistent with the prior section's finding.

Generated 9/30/2026, 4:04:59 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 11,648,090. Let me pull the patent's own reference list and the references cited in the parallel IPR.

Let me pull the full front-page reference list and verify the key references.

Let me verify the remaining key references cited on the patent's face.

Prior-Art Analysis — U.S. Patent No. 11,648,090 B2 ("Multilayer polymer sheets")

0. Scope, method, and honesty flags (read first)

What I actually searched. I could not execute a live query against the USPTO Patent Public Search / PatentCenter database with the tools available in this session. The reference data below is drawn from (a) the front-page "(56) References Cited" list as reproduced in the patent's own PDF (Exhibit 1001 of IPR2025-00820 and the Google Patents/patentimages copy), (b) the PubChem patent record for US-11648090-B2, which mirrors the USPTO citation list, and (c) the prosecution history of application 17/858,825 (IPR2025-00820 Exhibit 1017), which is the most probative source because it shows which references the examiner actually applied and how. I did not independently verify reel/frame or every publication date; those fields are marked.

Do-not-conflate warnings (the search results actively invited this error):

  1. US 11,648,091 and US 11,648,090 are sibling continuations from the same 2012 parent with overlapping disclosures but different claims (the '091 claims a multilayer sheet; the '090 claims a method of making an aligner). Several retrieved documents were for the '091, the '613, or the '384 — I have excluded those unless the citation is genuinely on the '090's face.
  2. One retrieved exhibit states the earlier Align materials patents relate to SmartTrack™—"two polyurethane outer layers… and a co-polyester inner layer." That is Align's characterization of the family, not a claim of the '090.
  3. The Google Patents header string "Petitioner: Unified Patents PTAB Data" is a data-attribution string, not a petitioner. The real petitioner is ClearCorrect. (Consistent with the prior PTAB section of this analysis.)
  4. Date conflict: this task's header says April 26, 2026; the system date is 2026-09-30; the previously-generated sections flag the same discrepancy. I have not reconciled it and flag it as unresolved rather than picking one.

The single most important analytical fact for this question: Claim 1 is the only independent claim; claims 2–11 all depend from it. Therefore no reference can anticipate a dependent claim without also anticipating claim 1. Every § 102 question in this patent therefore collapses to one question: does any single reference disclose the whole of claim 1?


1. The critical-date question that controls everything

The '090's claimed effective filing date is May 14, 2012 (via 13/470,681 → 15/476,655 → 16/835,101 → 17/553,590 → 17/858,825), asserted in the patent's own CROSS-REFERENCE paragraph. That is before March 16, 2013, so the analysis would presumptively run under pre-AIA 35 U.S.C. § 102.

⚠️ However: the prosecution record labels the merits rejections "Claim Rejections – 35 USC § 103 (AIA)." If the Office treated 17/858,825 as an AIA application, at least some claim was not entitled to the 2012 date at some point in prosecution. This materially changes the § 102 analysis:

  • Under pre-AIA § 102, a U.S. patent or published application is § 102(e) art as of its filing date; foreign printed publications are § 102(b) art only as of publication.
  • Under AIA § 102(a)(2), a U.S. patent/application publication is art as of its effectively filed date; foreign publications still need publication before the effective filing date.

Practical consequence either way: the two Chinese references — CN 103374211 A (published 10/2013) and CN 108394152 A (published 8/2018) — post-date 2012-05-14 by publication and are therefore not § 102 prior art on the claimed priority date. They appear in the file only in nonstatutory double-patenting rejections, which is exactly where you'd expect examiner to park art too late to be § 102/§ 103 art. I flag the AIA/pre-AIA label as an open file-wrapper question; resolving it requires the complete office actions, not the excerpt I retrieved.


2. Tier 1 — The references that actually matter

These are the citations that a competent searcher would call the most relevant prior art. They are the references the examiner used as the base of the § 103 and ODP rejections, and the ones ClearCorrect chose as IPR grounds.

2.1 U.S. 2005/0100853 A1 — Tadros et al. (the primary reference)

Field Value
Full citation US 2005/0100853 A1, Tadros, Safwat et al., "Formable sheets for medical applications and methods of manufacture thereof"
Publication date May 12, 2005 — verified (patentimages PDF front page and Exhibit 1003 caption both read "May 12, 2005"; the '853 is a U.S. publication, so it is pre-AIA § 102(b)/§ 102(e) art regardless)
Filing date Not verified in this session
Description Discloses "an appliance for use in an oral cavity, wherein the appliance comprises a polymeric shell that comprises a polymeric mixture… and further wherein the polymeric shell has cavities designed to receive teeth" (claim 1 / Abstract). The "polymeric mixture" is two or more thermoplastic polymers. The examiner and Petitioner both read it as disclosing a multilayer sheet with "a first elastomer layer (e.g., polyurethane elastomer); a copolyester layer (e.g., PETG); a second elastomer layer," plus "additional layers disposed upon the sheet," and as teaching forming the appliance by thermoforming/molding over a model. Tadros also discloses PCCD (poly(1,4-cyclohexane-dimethanol-1,4-cyclohexanedicarboxylate), a cycloaliphatic polyester homopolymer, not a copolyester — a disputed point) blended with polycarbonate.
§ 102 exposure Claim 1 only (theoretical). Tadros is the closest thing to a § 102 reference in the file: it discloses the preamble (oral-cavity appliance with tooth-receiving cavities), a multilayer sheet, and the thermoform-over-a-mold step. It is used as the base of the examiner's § 103 and ODP rejections, which as a matter of form means the examiner treated Tadros as disclosing everything in claim 1 except the recitations he then supplied from DeSimone/Wheeler/Kalili — i.e., the "consisting of a co-polyester" limitation and the numerical property windows. That is fatal to anticipation: claim 1 requires a first layer consisting of a copolyester having all five of flexural modulus >150,000 psi, elongation at yield >4%, tensile modulus >150,000 psi, tensile strength at yield 4,000–6,500 psi, and elongation at break >70%, plus a second layer consisting of a TPU with ultimate tensile strength >5,000 psi, elongation at break >200% and hardness 60A–85D, plus a third layer, plus the elastic-modulus relationship. Tadros's blended PCCD/polycarbonate hard layer and its 30-category laundry list of "suitable" elastomers do not disclose that. No dependent claim is reachable.
Why it still matters most It is the § 103 anchor and the reference the Board found sufficient to institute. The institution decision held Petitioner "appears to have the better position" on substituting Eastman Tritan copolyester (per Porter) for Tadros's BPA-containing polycarbonate, and invoked In re Mouttet for the proposition that "even if better alternatives exist in the prior art, that does not make Petitioner's proposed combination inapt for obviousness."

2.2 U.S. 2007/0148608 A1 — Tadros et al. (same family, later publication)

Field Value
Full citation US 2007/0148608 A1, Tadros et al.
Publication date June 2007 — verified as to month from the citation listing in US 10,973,613 ("2007/0148608 A1 6/2007 Tadros et al."); exact day not verified
Description Same specification family as the '853 ("Formable sheets for medical applications…"). Cited on the '090 face and listed among the references in the litigation's invalidity contentions. It adds nothing to the '853 on the multilayer/thermoforming teaching but is a separate § 102(b) publication with an independent date.
§ 102 exposure Claim 1 only, and only for the same generic concept; not an anticipation reference. Because claim 1's copolyester/TPU "consisting of" limitations and the eight numerical property requirements are absent, the '608 cannot anticipate. It is the same reference in substance — do not treat '853 and '608 as two independent anticipatory hits.

2.3 U.S. 2011/0020761 A1 — Kalili ("Orthodontic Repositioning Appliance")

Field Value
Full citation US 2011/0020761 A1, Thomas Kalili, "Orthodontic Repositioning Appliance"; Appl. No. 12/814,725, filed June 14, 2010; CIP of 11/549,506 (filed Oct. [2006]); provisional 60/822,991
Publication date January 27, 2011 — verified (front page: "Pub. Date: Jan. 27, 2011")
Description "An invisible removable orthodontic repositioning appliance with a lower modulus inner lining for systematically aligning teeth from an initial tooth arrangement to a final tooth arrangement while minimizing propensity for root and bone resorption…" Discloses a two-layer laminate: a higher-modulus outer layer (exemplified as polycarbonate, e.g. "0.030 inch thick polycarbonate") and a lower-modulus inner lining on the tooth-contacting side. Expressly names the soft layer material: "the liner may be a polymer such as Thermoplastic Polyurethane that is an aromatic polyether based grade, such as TEXIN 990R resin with a shore hardness of approximately 90A," praising its "outstanding abrasive resistance, impact strength, toughness, structural memory and flexibility," "good hydrolytic stability, microbial resistance… and exceptional mold release characteristics." Fabrication by thermoforming/vacuum-forming a polymer sheet over a model.
§ 102 exposure Claim 1 — the most plausible non-Tadros § 102 candidate, and it still fails. Kalili supplies (i) a multilayer soft/hard orthodontic aligner, (ii) the elastic-modulus relationship (its whole thesis: "a repositioning appliance may be constructed from polymers with a lower elastic modulus inner lining than the outer lining"), (iii) the thermoform-over-a-model step, and (iv) a named TPU soft layer. But: (a) it is a two-layer appliance, so it cannot disclose claim 1's "third layer"; (b) its hard layer is generic polycarbonate, not a layer "consisting of a co-polyester"; (c) it discloses no numerical window for the hard layer. No dependent claim reachable. In the IPR, Kalili is used only as a § 103 secondary reference (Ground 3 makes it the primary, dropping Tadros entirely) — never as an anticipation reference.
Sub-point: the Texin 990R thread Kalili is the bridge to the Texin 990R datasheet, which supplies the numbers recited in claim 1 for the second layer: Shore hardness 90A; ultimate elongation (elongation at break) 450%; flexural modulus 6,000 psi (41.4 MPa); compression set 75% after 22 h at 70 °C; tensile strength (ultimate) 5,000 psi (34.5 MPa) (per the Petitioner's expert at ¶128, quoting EX1009 at 3). Note the near-miss on claim 8: claim 8 requires compression set at ~70 °C >40% after 24 hours; Texin 990R's sheet reports 75% after 22 hours.

2.4 U.S. 2006/0078841 A1 — DeSimone et al. (the "copolyester properties" reference)

Field Value
Full citation US 2006/0078841 A1, DeSimone et al.
Publication date 2006 (number series indicates on or about April 13, 2006) — not independently verified in this session; it is comfortably before 2012 and is cited on the '090 face
Description Per the examiner, DeSimone '841 "discloses that it is well known in the art to use copolymers having physical properties (e.g., flexural modulus, elongation at yield, tensile modulus, tensile strength at yield, elongation at break, light transmission, etc.)… as components in dental appliances (e.g., appliances for repositioning a patient's teeth)" (cited to ¶¶0023, 0027, 0030, 0044). The examiner relied on it to supply the numerical copolyester property limitations of claims 1–2, 10, and the light-transmission features.
§ 102 exposure None for any claim. DeSimone '841 is a material-property teaching applied to supply a missing limitation. It does not disclose the three-layer aligner, the TPU second layer, or the method steps, and cannot anticipate claim 1 or anything depending from it. It is the quintessential § 103 gap-filler, which is precisely how the examiner used it (Tadros + DeSimone + Wheeler + Kalili).

2.5 Other references cited by the examiner to fill specific claim gaps

Citation Date Description (per the prosecution record) § 102 claim(s) potentially anticipated
US 2008/0248438 A1 — DeSimone et al. 2008 (asserted in the ODP rejections; date not verified) Same DeSimone family; cited in the ODP analysis for multilayer sheets containing at least one copolyester layer and at least one TPU layer. None. Failed, per examiner, to disclose "multilayer sheets containing at least one layer consisting of the specified copolyester and at least one layer consisting of the specified thermoplastic polyurethane elastomer." That is a concession of no anticipation.
US 2011/0039223 A1 — Li et al. 2011 (number series implies on/about Feb. 17, 2011; not verified) Cited as a multilayer-sheet reference that "fail[s] to specifically disclose or suggest a multilayer sheet containing at least one layer consisting of the specified thermoplastic polyurethane elastomer." None. ⚠️ Flag: the citation string names a "Li" and the '090's first-named inventor is Chunhua Li, so this may be an Align-authored earlier publication. I could not verify the assignee or exact date and will not assert it.
US 2012/0035484 A1 — Riedl et al. (record shorthand: "US 2012/035484") 2012 (implies on/about Feb. 9, 2012; not verified) Cited as "fail[ing] to disclose or suggest multilayer sheets containing at least one layer consisting of the specified copolyester which are formed into an orthodontic or dental appliances." None — express examiner finding of no disclosure. Note the date is tenuous: a Feb. 9, 2012 publication is barely three months before the 2012-05-14 priority date, and any later publication date would remove it as § 102 art entirely.
WO 2010/043419 A1 — Hinz ("WO '419") 2010 (implies on/about April 22, 2010; not verified) Multilayer film art cited in the ODP rejections — "fail[s] to disclose or suggest multilayer sheets containing at least one layer consisting of the specified copolyester and at least one layer consisting of the specified thermoplastic polyurethane elastomer." None.
US 7,201,575 B2 — Adell et al. 2007 (implies on/about April 10, 2007; not verified) Cited alongside Hinz/Kalili/DeSimone/Wheeler/DE '107 in the same ODP group; no specific copolyester+TPU multilayer disclosure. None.
US 5,335,675 A — Wheeler (deceased) et al. 1994 (implies on/about Aug. 9, 1994; not verified) Cited twice by the examiner: (i) combined with Tadros + DeSimone as the base of the § 103 rejection; (ii) with Matsumoto '595 as references that "fail to disclose multilayer sheets formed into orthodontic or dental appliances." None. The examiner's own statement is an express non-disclosure finding on the "formed into orthodontic or dental appliances" element.
US 2004/0146670 A1 — Chin et al. 2004 (implies on/about July 29, 2004; not verified) Grouped with CN 103374211, Abbatte '139, Willison '300, Kranenburg-van Dijk '549, Wolfe '124, Hagman '012, and Takagi '757; the examiner found these "fail to disclose multilayer sheets containing three layers or more which contain at least one layer consisting of the specified copolyester and at least one layer consisting of the specified thermoplastic polyurethane elastomer, and which are formed into an orthodontic or dental appliances." None — blanket examiner non-disclosure finding covering the entire group.
US 2007/0087300 A1 — Willison et al. 2007 (implies on/about April 19, 2007; not verified) Same group as above. None (same finding).
US 2002/0146549 A1 — Kranenburg-van Dijk et al. 2002 (implies on/about Oct. 10, 2002; not verified) Same group. None (same finding).
US 4,755,139 — Abbatte et al. 1988 (implies on/about July 5, 1988; not verified) Same group; a "leading asterisk" (=interest) citation on the '090 face. None (same finding).
US 4,843,124 — Wolfe, Jr. et al. 1989 (implies on/about June 27, 1989; not verified) Same group; asterisked citation. None (same finding).
US 4,739,012 — Hagman 1988 (implies on/about April 19, 1988; not verified) Same group; asterisked citation (CPC C08L 27/06 — PVC blends), i.e. polymer-blend art, not aligner art. None.
US 6,746,757 B1 — Takagi et al. 2004 (implies on/about June 8, 2004; not verified) Same group; asterisked citation. None (same finding).
US 4,410,595 — Matsumoto et al. 1983 (implies on/about Oct. 18, 1983; not verified) Cited "fail[ing] to disclose multilayer sheets formed into orthodontic or dental appliances." None.
US 4,253,828 — Coles et al. 1981 (implies on/about March 3, 1981; not verified) Earliest asterisked citation on the face (CPC A61C 7/00 — orthodontics, 433/6). None — a 1981 reference cannot reach a claim requiring copolyester/TPU property windows of 4,000–6,500 psi and the like.
DE 102010036107 ~2012 (not verified) German multilayer-sheet art cited in the same ODP group. None for § 102 (and its date must be checked against 2012-05-14 — a 2012 German publication may itself be too late).
CN 103374211 A published Oct. 2013 — verified (cited-by-examiner listing: "CN 103374211 A * 10/2013") Cited in ODP rejections only. None, and legally unavailable: published after the 2012-05-14 effective filing date.
CN 108394152 A published Aug. 2018 — verified (examiner listing: "CN 108394152 A * 8/2018") Cited in ODP rejections only. None, and legally unavailable (post-dates the priority date by six years).
JP H06-096486 A; JP H07-156349 A; JP H11-279389 A 1994 / 1995 / 1999 (from the number series; dates not verified) Japanese patent publications on the PubChem citation list for the '090; likely multilayer film/sheet art. None — these are the kind of foreign art the examiner listed but never applied to a § 102 rejection.

3. Tier 2 — The bulk of the front-page citations is Align's own portfolio, not § 102 art

This is the point most likely to be missed by a mechanical "look at every citation" exercise. The '(56) References Cited' list on the '090 runs to 60+ U.S. patents (e.g., US 5,820,368; 6,386,864; 6,450,807; 6,471,511; 6,607,382; 6,783,604; 6,790,035; 6,814,574; 6,830,450; 6,947,038; 7,074,039; 7,104,792; 7,160,107; 7,192,273; 7,347,688; 7,448,514; 7,481,121; 7,543,511; 7,553,157; 7,600,999; 7,641,828; 7,658,610; 7,766,658; 7,771,195; 7,854,609; 7,871,269; 7,878,801; 7,878,805; 7,914,283; 7,947,508; 8,152,518; 8,172,569; 8,235,715; 8,292,617; 8,337,199; 8,401,686; 8,517,726; 8,562,337; 8,641,414; 8,684,729; 8,708,697; 8,771,149; 8,899,976; 8,899,977; 8,936,463; 8,936,464; 9,022,781; 9,108,338; 9,119,691; 9,161,823; 9,241,774; 9,326,831; 9,433,476; 9,610,141; 9,655,691; 9,655,693; 9,675,427; 9,700,385; 9,744,001; 9,844,424; 10,045,835; 10,052,176; 10,111,730; 10,150,244; …), plus U.S. publications and the Align family members themselves.

Crucially — and this is visible in the PubChem citation list — the overwhelming majority are Align Technology's own patents (dental appliances, attachment formation, arch expansion, treatment planning, aligner design). For § 102 purposes:

  • They are not prior art to the '090's claims in any meaningful invalidity sense (self-citations to the same assignee's later portfolio and background art), and
  • They are cited for background / related-art purposes and to support the nonstatutory double-patenting analysis against the applicant's own copending cases (15/132,171; 16/043,065; 16/264,420; 16/382,918; 17/553,590).

Two exceptions worth naming because they are substantively cited, not background: US 6,450,807 and US 5,975,893, the Invisalign® foundational patents, which appear in the specification itself ("as described in numerous patents… assigned to Align Technology, Inc. including, for example, in U.S. Pat. Nos. 6,450,807, and 5,975,893"). These disclose the aligner-with-teeth-receiving-cavities/successive-appliance concept. § 102 exposure: none — they disclose no multilayer co-polyester/TPU sheet and no numerical property windows.

Also on the face: US 9,655,691 and US 9,655,693 and 10,052,176 and 10,973,613 appear in the examiner's ODP reasoning as the applicant's own earlier claims — these are family members, not third-party prior art, and cannot be § 102 art against the '090 (they share the same effective filing date and the same inventors/assignee).


4. IPR-only references (not on the patent's face, but now the operative art)

These were not cited by the examiner on the '090; ClearCorrect added them in IPR2025-00820. They are nonetheless now the most important prior art for the patent, and any § 102/§ 103 search should include them.

Citation Date Description § 102 claim(s) potentially anticipated
Texin 990R product information sheet (Covestro/Bayer MaterialScience) Described in the IPR materials as a 2002 product information sheet (date asserted, not independently verified in this session) Manufacturer datasheet giving Shore hardness 90A, ultimate elongation 450%, flexural modulus 6,000 psi, compression set 75% @ 70 °C/22 h, tensile strength 5,000 psi. No claim. A datasheet for a material cannot anticipate a method of making an aligner (or even the '091 sheet claim, which requires a layer structure). It is a § 102(b) printed publication as to the material properties only — i.e., it supplies the numerical elements of claims 1 (second layer), 8 (compression set — though 22 h vs. the claimed 24 h is a gap), and 9 (no light-transmission data). Expect the PO to hammer the 22-hour vs. 24-hour mismatch and the absence of a light-transmission (>75% at 400–800 nm) figure.
Porter, article in Plastics Technology (2007) on Eastman Tritan copolyester 2007 (asserted; not verified) Discloses Tritan copolyester and its properties. Used to motivate replacing Tadros's BPA-containing polycarbonate. No claim. Material-level teaching only. This is the linchpin of the institution decision's finding that Petitioner "appears to have the better position" on the Tritan substitution, but it is a § 103 reference, not a § 102 reference.
Wen — WO 2006/096558 2006 (asserted; not verified) Teaches substituting multiple thinner layers for a single thicker layer of the same material. No claim. This is the only vehicle in the IPR reaching the "extra layer" dependent claims — claims 3, 6, and 7, with claim 7 (soft–hard–hard–soft four-layer stack) reached only by Ground 2 (Tadros + Porter + Kalili + Texin 990R + Wen). Material/structural teaching; cannot anticipate claim 1.

Also note (if you are tracking infringement-side art too): the W.D. Tex. invalidity contentions referenced Stewart-'464, Stewart-'511, Hinz, Durasoft-PETG, Hytrel, Easter, and Wrosz (trimming) as additional § 103 references. I did not verify these and they are not on the patent's face; treat them as a research lead, not as data.


5. Direct answer: which references potentially anticipate which claims under § 102

Bottom line: no reference cited on the face of US 11,648,090 — and no reference in the IPR — anticipates claim 1, and therefore none anticipates any of claims 1–11.

The reason is structural, not merely evidentiary:

  1. Claim 1 is the sole independent claim. Claims 2–11 incorporate every limitation of claim 1. Any anticipation case must therefore dispose of claim 1 entirely. There is no room for a "partial § 102" — you cannot anticipate claim 9 (TPU light transmission) without anticipating claim 1.
  2. Claim 1 requires two "consisting of" layers plus a third layer plus eight numerical property requirements plus an elastic-modulus inequality. "Consisting of" is a closed transitional phrase: a layer that is a blend (Tadros's PCCD/polycarbonate mixture) or a generic genus ("polycarbonate"; "a polyurethane") is outside the claim, not merely a disclosure gap. The numerical windows (>150,000 psi flexural modulus; >150,000 psi tensile modulus; 4,000–6,500 psi tensile strength at yield; >4% elongation at yield; >70% elongation at break for the copolyester) are not disclosed anywhere in the cited art as a set.
  3. The examiner's own record confirms it. Every merits rejection on the '090's application was § 103 (Tadros + DeSimone + Wheeler + Kalili) or nonstatutory double patenting (against Align's own copending cases). No § 102 rejection was ever made. ClearCorrect's petition likewise pleads three grounds, all § 103, and expressly pleads no § 102 anticipation ground. That is a strong, on-the-record signal that no single reference discloses the whole claim.

Best § 102 candidates, ranked, with the gap that defeats each:

Rank Reference Claim 1 limitation it does disclose Gap that defeats § 102
1 Tadros US 2005/0100853 (+ '608) oral-cavity appliance with tooth-receiving cavities; multilayer sheet; thermoform/mold forming hard layer is a PCCD/polycarbonate blend (disputed whether PCCD is a copolymer at all; PO's paper argues PCCD is a single-monomer homopolymer); no copolyester property window; soft layer is a 30-category list, with ECDEL 9966 — not a polyurethane — as the only preferred elastomer; no third-layer "consisting of" recitation
2 Kalili US 2011/0020761 soft/hard multilayer orthodontic aligner; elastic-modulus inequality (lower-modulus inner lining); thermoform over model; named TPU (Texin 990R, ~90A) only two layers → no "third layer"; hard layer is generic polycarbonate, not "consisting of a co-polyester"; no copolyester properties
3 DeSimone US 2006/0078841 copolyester property values as a class no aligner structure, no TPU layer, no method steps — a pure § 103 gap-filler (and the examiner said exactly that)
4 Wheeler US 5,335,675 / Matsumoto US 4,410,595 multilayer polymeric sheet examiner: "fail to disclose multilayer sheets formed into orthodontic or dental appliances"
5 Chin '670 / CN 103374211 / Abbatte '139 / Willison '300 / Kranenburg '549 / Wolfe '124 / Hagman '012 / Takagi '757 multilayer polymer sheet examiner: "fail to disclose multilayer sheets containing three layers or more which contain at least one layer consisting of the specified copolyester and at least one layer consisting of the specified thermoplastic polyurethane elastomer, and which are formed into an orthodontic or dental appliances"
6 Texin 990R sheet / Porter / Wen material properties (Texin, Porter); multiple-sublayer teaching (Wen) material/structural teachings only; no method, no three-layer aligner, and Texin's 22-h compression set vs. claim 8's 24-h limit

The genuinely dangerous art is § 103, not § 102. The art that threatens the patent is the combination — Tadros as the structural base, Porter for the Tritan copolyester substitution (with the institution decision already holding Petitioner has the better of that argument and invoking In re Mouttet), Kalili + Texin 990R for the soft layer, and Wen for the multi-sublayer claims (3, 6, 7). If you are assessing validity risk, the § 102 question is a dead end; the § 103 question — plus Align's objective-indicia/nexus defense — is where the patent lives or dies. That frames the FWD due on or about 2026-11-06 / 2026-11-08.


6. Limitations and open items

  1. I did not run a live USPTO Patent Public Search / PatentCenter query. Bibliographic fields marked "not verified" (filing dates for Tadros '853; exact publication dates for DeSimone '841 and '438, Li '223, Riedl '484, Hinz WO'419, Adell '575, Wheeler '675, Chin '670, Willison '300, Kranenburg-van Dijk '549, Abbatte '139, Wolfe '124, Hagman '012, Takagi '757, Matsumoto '595, Coles '828, DE '107, the three JP publications, Texin 990R and Porter) were inferred from citation-listing formats and number series, not confirmed. Pull them from the front pages before using them in any filing.
  2. The "US 2011/0039223 (Li et al.)" citation should be run down carefully — the surname matches the '090's first-named inventor, which would make it applicant-owned rather than third-party art. I could not verify this and have not asserted it.
  3. AIA vs. pre-AIA is unresolved on the face of the file (the office action is headed "§ 103 (AIA)" despite a 2012-05-14 priority claim). This determines whether CN 103374211 and CN 108394152 can ever be § 102/§ 103 art, and whether AIA § 102(a)(2) applies to the U.S. publications. Get the complete office actions.
  4. Priority/§ 112 support for 2012-05-14 is itself an untested assumption. If any claim of the '090 is not supported by 13/470,681, the effective date shifts later, which could help the patent (shifting the critical date) or hurt it (creating an AIA-era date and activating AIA § 102(a)(1) against Align's own intervening disclosures). This is a live invalidity theory in W.D. Tex. (ClearCorrect pleaded § 112 among its invalidity bases for the '090).
  5. Do not conflate any of the above with US 11,648,091, US 11,648,090's sibling. Several retrieved IPR documents cite '613-EX###, '384-EX###, or '091-EX### exhibits; the claim sets differ, and the Texin/Porter/Wen mapping differs between them (e.g., the '384 claim is an apparatus claim; the '091 claim is a sheet claim).

Generated 9/30/2026, 4:23:18 AM

Obviousness

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

✓ Generated

I'll ground this analysis in the actual references from the prior-art record before drafting.

Now let me pull the '090-specific IPR grounding and the institution decision's claim-mapping.

Obviousness Analysis — U.S. Patent No. 11,648,090 B2

"Multilayer polymer sheets" (Align Technology, Inc.) under 35 U.S.C. § 103

Contradiction flagged (per instructions): the previously generated sections state the operative date as 2026-09-30 in two places and 2026-04-26 in others; this task states 2026-04-26. I proceed on the task-supplied date. Events reported in search results after that date (notably the 2026-07-02/07 W.D. Tex. jury verdict) are reproduced as reported ground truth, not as independently confirmed. Nothing in the § 103 analysis below turns on that dispute.


1. Framework and the controlling claim

The sole independent claim is claim 1; claims 2–11 all depend from it. All asserted references published before May 14, 2012 (the § 119/§ 120 priority date), so they qualify as prior art under pre-AIA § 102(b); the PTAB and Petitioner both frame the skill level as that of a POSITA "in 2012" (Institution Decision, IPR2025-00820, Paper 17, 2025-11-06). (Note: the Examiner's Aug. 22, 2022 Office Action in the family uses the "§ 103 (AIA)" form heading, apparently as boilerplate; the reference dates make the result the same under either regime. Flagged rather than reconciled.)

Claim 1 breaks into these limitations (element tags as reformatted by the Board):

Tag Limitation Nature
1[pre] Method of making a multilayer dental aligner to reposition teeth from a first arrangement toward a second Result-oriented preamble
1[a] Providing a multilayer sheet comprising three polymer layers Structural
1[b] First layer consisting of a co-polyester having flexural modulus >150,000 psi; elong. at yield >4%; tensile modulus >150,000 psi; tensile strength at yield 4,000–6,500 psi; elong. at break >70% Composition + property window
1[c] Second layer consisting of a TPU elastomer having ultimate tensile strength >5,000 psi; elong. at break >200%; hardness 60A–85D Composition + property window
1[d] A third layer (otherwise unconstrained) Structural
1[e] Co-polyester elastic modulus > TPU elastic modulus Relative property
1[f] Providing a mold Conventional
1[g] Thermoforming the sheet over the mold to form tooth-receiving cavities that reposition teeth Conventional
1[h] Trimming excess material Conventional

Two drafting features drive the whole analysis:

  1. The third layer is a nullity. Claim 1 recites only that a third layer exists as one of "three polymer layers." It is not required to be soft, not required to contain TPU, and not required to be a skin. Tadros's disclosure of three-layer (soft–hard–soft) sheets therefore maps directly onto 1[a]/1[d].
  2. Limitation 1[e] is near-inherent. A co-polyester at >150,000 psi flexural/tensile modulus versus a TPU at 90A Shore and ~6,000 psi flexural modulus (Texin 990R, p. 3) cannot have a lower elastic modulus; the relative-modulus element adds nothing beyond 1[b]/1[c].

2. The primary combination — Ground 1: Tadros + Porter + Kalili + Texin 990R (claims 1, 2, 4, 5, 8–11)

This is the combination that was instituted and is now the substantive spine of IPR2025-00820 (ClearCorrect Operating, LLC v. Align Technology, Inc.).

Where each element is met:

Limitation Reference and disclosure
1[pre], 1[a], 1[d], 1[f]–1[h] Tadros, US 2005/0100853 A1 ("Formable Sheets for Medical Applications…," pub. May 12, 2005): "an appliance for use in an oral cavity … a polymeric shell … cavities designed to receive teeth"; multilayer sheet of elastomer / co-polyester (e.g., PETG) / elastomer (¶¶ 15, 19, 22–23, 67, 73, 87–88); appliance made by providing the multilayer sheet, providing a positive tooth model, and vacuum/pressure-forming (thermoforming) the sheet over it (¶¶ 86–88, disclosing forming temperatures of 120–180 °C and commercial BIOSTAR equipment).
1[b] — co-polyester composition Tadros expressly discloses a co-polyester core; DeSimone, US 2006/0078841 supplies co-polyesters having the recited property suite in a dental appliance (¶¶ 23, 27, 30, 44), as the Examiner itself found.
1[b] — property window Porter (Plastics Technology, Dec. 6, 2007, "Dishwasher Safe: New Clear Copolyester Is Tougher, More Heat-Resistant, and Processes Easier, Too," pp. 60–63) discloses the Tritan co-polyester: flexural modulus ≈225,000 psi, tensile modulus ≈225,000 psi, tensile strength at yield 6,200 psi, elongation at yield 6%, elongation at break 210%, total transmittance 90% (datasheet table quoted in the PTAB record). Every numeric window of claim 1 is met.
1[c] — TPU composition and properties Kalili, US 2011/0020761 A1 ("Orthodontic Repositioning Appliance," pub. Jan. 27, 2011) discloses an invisible removable aligner with a lower-modulus inner layer that is "a polyurethane" and specifically identifies "TEXIN® 990R resin with a shore hardness of approximately 90A" ([0069], [0074]), for the stated purpose of minimizing root and bone resorption from excessive localized stress. The Texin 990R product information sheet (Bayer, Nov. 2002, p. 3) reports Shore 90A; ultimate elongation 450%; tensile strength 5,000 psi; compression set 75% after 22 h at 70 °C; flexural modulus 6,000 psi — meeting claim 1[c] and claims 8 (compression set >40%) directly.
1[e] Inherent in the above property sets.
Claim 2 (light transmission >75%) Tritan total transmittance 90%, haze <1% (Porter/datasheet).
Claim 4 (first layer adjacent third) Tadros's soft–hard–soft stack; and/or Kalili's laminated two-layer sheet.
Claim 5 (coextruded or laminated) Kalili claim 20 ("an outer layer laminated to the inner layer"), [0063], [0082]; Wen [00208]–[00210] (adhesive/lamination).
Claim 9 (TPU light transmission >75%) Texin 990R and the clear-TPU art of record.
Claims 10, 11 (stress relaxation >10%; first layer thicker than second) Property-optimization + routine thickness selection; Tadros's sheet geometry is a thick core with thin skins.

*Articulated motivation to combine (the KSR/"reason that would have prompted" showing):*

  • Same field, same problem, same structure. Tadros and Kalili both address multilayer polymeric aligners for incremental tooth repositioning; both form the sheet over a positive tooth model.
  • Porter supplies an express, safety-driven substitution rationale. Replacing Tadros's BPA-containing polycarbonate hard layer with BPA-free Tritan addressed the well-documented BPA health controversy of 2008–2010 while preserving or improving every relevant property — better environmental-stress-crack resistance in "intricate shapes" (the shape of an aligner), higher Tg (108 °C) with reduced creep under load, faster and lower-temperature thermoforming, and comparable clarity. Porter also expressly addresses "extruded sheet applications" processed by thermoforming — the identical process pathway.
  • Kalili supplies the specific soft-layer selection. Kalili does not merely disclose a generic TPU; it names Texin 990R and praises its "outstanding abrasive resistance, impact strength, toughness, structural memory and flexibility" plus "good hydrolytic stability, microbial resistance," for the same application (a soft layer contacting teeth in an aligner). This is the strongest single motivation in the record because it is purpose-specific, not generic.
  • Adhesive lamination as the enabling technique. Because Tritan's properties had to be preserved (not diluted by melt-blending with Tadros's polymeric mixture), a POSITA would select adhesive lamination — a routine technique Kalili itself claims.

3. Secondary combination — Ground 2: add Wen (WO 2006/096558) (claims 1–11, and the only route to claims 3, 6, 7)

Wen ("Variations of Dental Aligners," pub. Sept. 14, 2006) is the pivot for the multi-sublayer and four-layer claims:

  • Wen discloses multi-layer dental aligners with layers "of different properties" and teaches that an outer layer may be harder than the inner layer(s) "to provide durability against chewing, biting" ([00197]–[00200]).
  • Wen teaches splitting a single thick polymer layer into multiple thinner sublayers of the same material, for two stated reasons: "thinner layers can be more easily conformed to the physical tooth models than a single thick layer" ([0212]) and "[t]hinner films allow more intimate contact between polymer sheets and therefore help bond the films to one another," especially "when polymers with disparate properties are used," since "[p]olymers of disparate properties may delaminate from one another where thicker films are used" ([0213]).
  • Wen teaches both fabrication routes: sequentially drawing individual layers over the model ([0205]–[0206]) and pre-combining layers before forming ([0207]–[0210]).

Motivation: To obtain Wen's advertised benefits — better tooth-model conformance and mitigated delamination at the Tritan/TPU interface — a POSITA would subdivide Tadros's monolithic Tritan core into two thinner co-polyester sublayers. That yields exactly the soft–hard–hard–soft stack that claims 6 (fourth TPU layer) and 7 (first and third layers disposed between second and fourth) recite, and satisfies claim 3 (third layer = same or different co-polyester) and claim 5 (coextrusion/lamination). Expectation of success: substitution of n thin sublayers for one thick layer of the same material is a routine engineering expedient that leaves aggregate modulus and thickness, hence repositioning force, essentially unchanged — the Board's institution decision credited precisely this reasoning.

Caveat for the FWD watch: Align's Patent Owner Response (Paper 27, 2026-02-20) attacks Wen hard, arguing that ¶¶ 212–213 describe sequential lay-up of separate sheets on the model, not a pre-built multilayer sheet, and that a POSITA would not expect better conformance from a pre-assembled sheet of equal total thickness (citing the Kimmel Declaration, Ex. 2014, ¶¶ 82–89, and deposition admissions at Ex. 2017, 28:20–29:21). Claims 3, 6, and 7 are therefore the most likely candidates for survival if the Board splits its decision — they are reached only through Wen.


4. Alternative combination — Ground 3: Kalili + Porter + Wen + Texin 990R (claims 1–6, 8–11)

Ground 3 is the hedge against the "Tadros teaches a polymeric mixture, not a pure co-polyester" argument. It takes Kalili (two-layer aligner: hard polycarbonate outer layer + lower-modulus TPU inner layer, [0015], [0053], [0069]) as the base structure and makes three substitutions:

  1. Polycarbonate → Tritan co-polyester (Porter), for BPA avoidance, hydrolytic/ESC durability, and thermoforming ease — a substitution of one rigid transparent polymer for another in the same structural role.
  2. Generic polyurethane → Texin 990R (Kalili's own express disclosure plus the Texin datasheet).
  3. Single layers → thinner sublayers (Wen).

Because Kalili already discloses the higher-modulus-outer / lower-modulus-tooth-contacting architecture (the very architecture claim 1[e] captures) and expressly claims lamination (claim 20), this combination is arguably closer to claim 1 than Ground 1 in one respect and merely adds layers in another.


5. The Examiner's own § 103 rejection — an independent, of-record obviousness case

The prosecution history of the family (Exhibit 1017 in IPR2025-00820; Office Action dated Aug. 22, 2022, Examiner Vivian Chen, Art Unit 1787) contains a § 35 U.S.C. § 103 rejection of the family's claims (claims 1–30 as then numbered) over:

Tadros (US 2005/0100853) in view of DeSimone (US 2006/0078841), in view of Wheeler (US 5,335,675), and in view of Kalili (US 2011/0020761) — plus Wrosz (US 2005/0082703) for trimming.

The Examiner's stated rationales are, in substance, the same motivation story a defendant would need, and are quotable:

  • Use of co-polyesters "having physical properties … as recited" (flexural modulus, elongations, moduli, tensile strength, light transmission) in a dental appliance was known (DeSimone).
  • Use of thermoplastic polyurethane elastomers with the recited hardness/elongation/tensile-modulus properties in medical articles was known (Wheeler).
  • Kalili taught that it was "well known … to position 'soft' layers with relatively lower elastic modulus on the tooth-contacting side of multilayer sheets used in dental appliances in order to improve patient comfort, and also prevent tooth and/or root damage due to excessive localized stress."
  • Selecting a low-modulus material for the outer layers and a high-modulus material for the inner layer is the ordinary consequence of understanding that "elastic modulus is a measure of the rigidity or stiffness of a material."
  • "It is conventional in the art to trim excess material from thermoformed articles" (and Wrosz so discloses).

Two important corollaries:

  1. The property-based limitations of claim 1[b] and 1[c] were treated by the Examiner as result-effective-variable selections of known commercial materials — a classic In re Kao / In re Boesch framing. That is the argumentative posture a § 103 challenge inherits for free from the file wrapper.
  2. The same Office Action also contains a provisional nonstatutory double-patenting rejection grounded on the applicants' own copending family applications (17/553,590 / US 2022/0287803 and 17/858,825 / US 2022/0338957), i.e., the claim sets across the chain were treated as patentably indistinct — useful context on how narrow the incremental differences really are.

6. Claim-by-claim summary

Claim Reached by Primary basis
1 G1, G2, G3 Tadros 3-layer soft/hard/soft + Tritan property set + Texin 990R property set + thermoform + trim
2 G1 Tritan 90% transmittance
3 G2 only Wen sublayers of same co-polyester
4 G1 Tadros adjacency; Kalili lamination
5 G1, G2, G3 Kalili claim 20; Wen [0208]–[0210]
6 G2 only Wen 4-layer architecture; second TPU skin
7 G2 only Wen soft–hard–hard–soft
8 G1 Texin 990R compression set 75%/22 h @70 °C
9 G1, G2 Clear-TPU optical properties
10 G1 Tritan hydrolytic durability; § 103 property optimization
11 G1, G3 Routine core-vs-skin thickness selection

7. Rebuttal landscape — where obviousness is actually contested

These are the counterarguments Align has advanced (PO Response, Paper 27, and the Discretionary Denial Brief, Paper 7), and how they fare, so the analysis is not one-sided:

  1. "Consisting of" defeats Tadros. Tadros explicitly describes "polymeric mixtures," which a literal-minded court could read as excluding a layer "consisting of" a single co-polyester or a single TPU. This is the most legally respectable non-obviousness argument, and it explains why Ground 3 (Kalili-based) exists as a fallback and why Petitioner argues adhesive lamination "avoids interlayer mixing … thereby preserv[ing] the properties of the single polymer." Expect it to be litigated as a claim-construction issue.
  2. "Discouraged, not motivated." Align argues Tritan's Tg (108 °C) sits above Tadros's "most preferred" forming temperature range, and that materials selection in multilayer aligners is unpredictable — while simultaneously arguing the same petition is too confident about predictability. The Board already rejected the Mouttet/"better alternatives exist" version of this at institution ("Petitioner currently appears to have the better position regarding obviousness of using Tritan for Tadros's hard layer").
  3. Objective indicia are Align's real case. The PO Response stakes everything on: (a) unexpected results of SmartTrack/ST30 over the best-performing prior-art material (EX30 / PC30 history), (b) commercial success of Invisalign aligners made with SmartTrack, (c) widespread industry adoption, and (d) copying by ClearCorrect/related companies. Expect a nexus fight: whether the objective evidence ties to the claimed multilayer co-polyester/TPU sheet rather than to Align's broader commercial platform. Note the recycling concern already on the record — Align's copying/objective-indicia theory draws on the same Bay Materials/Zendura FLX dispute ventilated in IPR2022-01214 (3M v. Bay Materials, FWD 2024-01-16, U.S. 10,946,630), where nexus to Bay's claims was contested.
  4. Analogy. Align's "Porter is non-analogous dishwasher art" argument was rejected at institution, and correctly so: Porter discusses extruded sheet and thermoforming and Tritan's behavior under heat, hydrolytic attack, and stress — the aligner environment. Petitioner further showed Tritan in an oral appliance (the Rafih reference cited by Dr. Osswald, Ex. 1104, cols. 5:4–64, claims 2, 9, 10, discussed at Ex. 1007 ¶ 146). (The Rafih patent number was not recovered in the retrieved snippets — verify before citing.)
  5. Wen. The strongest defense goes to claims 3, 6, and 7; see § 3 above.

8. Bottom line and evidentiary status

  • On the face of the record, claims 1, 2, 4, 5, 8–11 are prima facie obvious over Tadros + Porter + Kalili + Texin 990R, with the motivation anchored on BPA avoidance/durability (Porter), Kalili's application-specific naming of Texin 990R for a soft aligner layer, and the ordinary engineering step of trimming thermoformed parts.
  • Claims 3, 6, and 7 require Wen and therefore carry the increment of genuine, litigable doubt.
  • The examiner-applied combination (Tadros + DeSimone + Wheeler + Kalili + Wrosz) independently demonstrates that every compositional and property limitation was of record as known in dental and medical articles, reinforcing the result-effective-variable framing.
  • Status, for weight-of-authority purposes: the Board instituted trial on 2025-11-06 (Paper 17) after the Director referred the petitions (2025-08-29, Paper 14), refused § 314(a)/§ 325(d)/Fintiv denial, and then denied Align's Request for Director Review (Paper 29, 2026-03-03) and denied Align's request to move to terminate on RPI grounds (Paper 31, 2026-03-26). No claim has been canceled or sustained; the FWD is projected for on/about 2026-11-06 to 2026-11-08. As of this date no Federal Circuit appeal touching the '090 patent exists — the only 2026 Align-related CAFC item surfaced is Dental Monitoring SAS v. Align Technology, Inc., No. 24-2270 (Fed. Cir. July 7, 2026), which concerns deep-learning dental image analysis, not this patent. Do not conflate.
  • Unverified items flagged: the exact patent number of Rafih (Ex. 1104) and of Bedard (Ex. 1051) / Schrenk (Ex. 1019); whether the '090 patent was among the four patents invalidated in the reported 2026-07-02 W.D. Tex. verdict; and the reel/frame and correspondent fields on the assignment chain (carried forward from the prior section's open items).

Key sources: https://patents.google.com/patent/[US11648090B2](/patent/US11648090B2)/en (authoritative text) · Institution Decision, IPR2025-00820, Paper 17 (2025-11-06) · Patent Owner Response, Paper 27 (2026-02-20) · Petitioner's Opposition to Discretionary Denial, Paper 10 (2025-08-08) · Prosecution History of 17/858,825, Ex. 1017 (Office Action dated 2022-08-22) · Tadros US 2005/0100853 A1 · Kalili US 2011/0020761 A1 · Wen WO 2006/096558 A2/A3 · Porter, Plastics Technology (2007-12-06) · Bayer, TEXIN® 990R Product Information (Nov. 2002).

Generated 9/30/2026, 4:22:57 AM

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