Invalidity dossier

US 11219582

Peroxide gel composition

Current assignee: CAO Group, Inc.

Added 9/28/2026, 6:01:47 PM

IndustryMedical (M)
At a glanceNo PTAB challenges9 lawsuits on fileasserted by CAO Group, Inc.Medical (M)

Active provider: DeepSeek · deepseek-flash

Patent summary

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

✓ Generated

I'll search for authoritative information on US 11219582, including any 2026 CAFC docket activity.

Let me search specifically for any 2026 Federal Circuit docket activity involving this patent.

US Patent 11,219,582 — Analyst Summary

Important scope note on the search: I ran targeted searches for the specific number 11219582 and for CAO Group's 2026 appellate activity. I found no 2026 Court of Appeals for the Federal Circuit docket naming US 11,219,582. The 2026 Federal Circuit / Supreme Court items that surface for "CAO" relate to a different party and different patents — CAO Lighting, Inc. v. Wolfspeed, Inc., No. 25-1068 (cert. denied May 18, 2026), concerning U.S. Patents 6,465,961 and 6,634,770 (LED lighting), not the '582 patent. I therefore cannot confirm any CAFC 2026 appeal involving 11,219,582, and I will not speculate one exists.


Bibliographic data (per the patent record)

Field Value
Patent number US 11,219,582 B2
Title Peroxide gel composition
Application no. 16/784,582
Filing date 2020-02-07
Priority date 2006-02-08 (claimed from US 11/307,463)
Issue/grant date 2022-01-11
Inventor Steven D. Jensen
Assignee CAO Group, Inc. (Utah)
Status Expired – Fee Related (lapse for failure to pay maintenance fees, effective 2026-01-11; anticipated expiration 2026-02-08)

Lineage: The '582 patent is a continuation of 15/627,906 (now US 10,646,419), itself a continuation of 14/710,416 (US 9,789,036), itself a continuation of 12/329,582 (US 9,295,619), which is a continuation-in-part of 11/307,463 (US 2007/0183987 A1). Because the effective filing date traces to 2006-02-08, the term ends in 2026 — consistent with the "anticipated expiration 2026-02-08" entry.

Assignment nuance: The record lists Jensen as inventor but shows assignments to CAO Group, Inc. from both Steven D. Jensen and Densen Cao, Dr. (effective dates in May 2015). A third-party aggregator (patentleaderboard.com) lists this patent under "Steven D. Jensen — Ultradent Products," which conflicts with the patent's own assignment record naming CAO Group. I'd treat the CAO Group assignment as authoritative.


Abstract (verbatim)

"The present invention is a formable dental treatment tray utilizing poly(2-ethyl-2-oxazoline) and a gelatinous active. Blending of the active is accomplished by mixing the Poly(2-ethyl-2-oxazoline) with an active ingredient, such as a peroxide like hydrogen peroxide, carbamide peroxide, sodium perborate, or sodium percarbonate, usually also with water or an appropriate organic solvent. Peroxide concentrations in these new gels can reach a 30% concentration of hydrogen peroxide while maintaining a shelf life of six months at room temperature without developing peroxide decomposition. The gels are applied to an appropriate backing and dried to a gelatinous state. In use, the active is hydrated and regains adhesiveness. Then the tray is pressed and formed around a user's dental arch to form the customizable tray. Multiple active ingredients may be used, with or without peroxide, for accomplishing desired treatment regimens."


The claims: plain-language overview

The patent has exactly two claims, both independent (no dependent claims):

Claim 1 — the basic dried gel-on-strip device

  1. A strip of backing material that is flexible and planar, with two flat sides.
  2. A dental composition applied to at least part of one flat side.
  3. The composition contains three things: (a) a peroxide bleaching agent, (b) a solvent, and (c) a thickening agent — where the thickener is at least one member of the Markush set consisting of polyethyloxazoline and polyvinylpyrrolidone (PVP).
  4. The composition has been dried until it is no longer fluid.
  5. The dried composition must be gelatinous, non-coalescent, and visco-elastic, such that when stuck to a user's dental arch, both the composition and the backing flex and conform to the arch without cracking or breaking.

In plain terms: a flexible strip coated with a peroxide gel that has been dried to a gummi-like, non-merging, rubbery film, which stays stuck to the teeth and bends with them rather than snapping.

Claim 2 — the same device with an explicit shelf-life/storage limitation
Claim 2 repeats every element of Claim 1 and adds a functional limitation on the dried composition. It must be gelatinous, non-coalescent, and visco-elastic:

  • during storage in a package at room temperature for up to six months, and
  • after removal from the package and adhesion to the dental arch,

such that the composition and backing together flex and conform to the particular irregularities of the user's arch without cracking or breaking.

In plain terms: Claim 1 plus a promise that the product is stable on the shelf for six months and still conforms to an individual's irregular tooth contours after opening.

Observations on claim scope:

  • The claims recite "polyethyloxazoline," not the specification's "Poly(2-ethyl-2-oxazoline)" — the shorthand and the parenthetical IUPAC-style name are used interchangeably in the disclosure.
  • PVP is expressly claimed as an alternative thickener, though the specification describes it as less preferred ("While it is not as preferred as Poly(2-ethyl-2-Oxazoline), polyvinylpyrrolidone ('PVP') may be used in this invention with good results").
  • The "set ... consisting of" language makes the thickener a closed Markush group — only polyethyloxazoline and PVP are covered, not equivalents outside the set.
  • Neither claim recites a specific peroxide concentration, molecular weight, viscosity, or drying temperature; those appear only in the specification (e.g., 30% H₂O₂ with six-month room-temperature stability; viscosity 1,000–200,000 cP; 200,000 M.W. poly(2-ethyl-2-oxazoline) in a 6:4 ratio with 50% H₂O₂).

The specification's seven worked examples run from 11% to 27% carbamide peroxide (and one 11% hydrogen peroxide) with 33–50 wt% poly(2-ethyl-2-oxazoline) at 200,000 or 500,000 M.W.


Litigation landscape (district courts, not CAFC)

Google Patents' litigation panel and the Stanford NPE database tie the '582 patent to multiple district-court actions brought by CAO Group, all asserting the same five-patent whitening portfolio (10,602,259; 10,646,419; 11,219,582; 11,826,444; 11,826,445):

  • CAO Group v. The Individuals ... Identified on Schedule A, No. 1:24-cv-01211 (N.D. Ill., filed Feb. 12, 2024) — Schedule-A e-commerce defendant case.
  • CAO Group v. Walmart / related Utah actions, Nos. 2:24-cv-00175 and 2:24-cv-00498 (D. Utah) — Walmart stipulated to dismissal with prejudice.
  • CAO Group v. Karaka LLC (d/b/a The DoubleY Brands), No. 1:24-cv-04903 (N.D. Ill.) — voluntarily dismissed Dec. 18, 2024.
  • CAO Group, Inc. v. Ivoclar Vivadent, Inc., No. 1:25-cv-01430 (D. Del., filed Nov. 24, 2025).
  • CAO Group Inc v. GuruNanda, LLC, No. 8:25-cv-02074 (C.D. Cal., filed Sep. 12, 2025).

I found no indication of any appeal of these matters to the Federal Circuit as of this date.


Uncertainty flags (stated explicitly, not fabricated)

  1. No CAFC 2026 docket for '582 was found. I cannot confirm an appellate proceeding exists; if one does, it did not surface in my searches.
  2. The 2025-03-11 Certificate of Correction appears in the legal events, but I do not have its content and cannot say what was corrected.
  3. The maintenance-fee lapse and the 20-year term expiry both fall in early 2026, so the "Expired – Fee Related" status reflects an expired patent; enforceability of past-infringement damages claims is a separate legal question I am not opining on.
  4. Inventorship/assignment discrepancy between the patent's assignment record (CAO Group) and third-party aggregator data (Ultradent) — noted above; the assignment record should control.

Generated 9/28/2026, 6:22:24 PM

Cases on file (9)

Group view →

Specific litigation cases in our database that name US patent 11219582. The free-form analysis below may also discuss cases beyond this list.

Lawsuits filed per year

2022: 1 case'22'232024: 6 cases6'242025: 2 cases'25
Cases asserting US 11219582, by filing year.

Litigation summary

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

✓ Generated

I'll search for litigation involving US Patent 11,219,582 using the sources you specified.

Let me gather details on the additional cases identified.

Litigation Involving U.S. Patent No. 11,219,582

Patent identity (verified, literal): U.S. 11,219,582 B2 — "Peroxide gel composition." Application No. 16/784,582, filed Feb. 7, 2020; granted Jan. 11, 2022; priority date Feb. 8, 2006; current assignee Cao Group, Inc. (West Jordan, Utah); inventor Steven D. Jensen. Status per Google Patents/Patexia: expired — fee related (lapse for failure to pay maintenance fees, Feb. 16, 2026).

I conflated nothing with similar numbers: I excluded unrelated hits such as UK company number 11219582 ("75 Music Limited") and Docket No. 25-1011 (Supreme Court/Dolby brief), which are not this patent.

Cases identified

# Case Plaintiff Defendant(s) Jurisdiction Case No. Filed Type Outcome / current status
1 Cao Group, Inc. v. The Procter and Gamble Company et al CAO Group, Inc. The Procter & Gamble Co. et al. C.D. Cal. 5:22-cv-01874 Oct 26, 2022 Infringement Dismissed – Other, Nov 14, 2022 (per Patexia)
2 CAO Group, Inc. v. Walmart, Inc. CAO Group, Inc. Walmart, Inc. D. Utah 2:24-cv-00175 2024 Infringement Dismissed with prejudice by stipulated dismissal under Fed. R. Civ. P. 41(a)(1)(A)(ii), each party bearing own costs (per PACER via PatSnap)
3 CAO Group, Inc. v. The Individuals… Identified on Schedule A CAO Group, Inc. ~50+ named/unnamed online sellers (e.g., Fairywill, OETU, SQLEA, etc.) N.D. Ill. 1:24-cv-01211 Feb 12, 2024 Infringement (Schedule A / TRO) Pending as filed; Schedule A multi-defendant action
4 Ranir LLC v. CAO Group, Inc. Ranir LLC (Perrigo subsidiary) CAO Group, Inc. D. Utah 2:24-cv-00498-RJS Jul 16, 2024 Declaratory judgment (non-infringement + invalidity, 28 U.S.C. § 2201) Docket shows Judge Shelby; case listed as closed (per Ex Parte)
5 CAO Group, Inc. v. Karaka LLC d/b/a The DoubleY Brands CAO Group, Inc. Karaka LLC d/b/a The DoubleY Brands N.D. Ill. 1:24-cv-04903 Jun 13, 2024 Infringement Dismissed – Voluntarily, Dec 18, 2024 (per Patexia)
6 CAO Group, Inc. v. (Schedule A defendants) CAO Group, Inc. Schedule A defendants (unnamed in source) N.D. Ill. 1:24-cv-05129 2024 Infringement Appears in Google Patents family-litigation list; I could not independently verify details — treat as unconfirmed
7 CAO Group Inc v. GuruNanda, LLC CAO Group, Inc. GuruNanda, LLC C.D. Cal. (Judge Selna) 8:25-cv-02074 Sep 12, 2025 Infringement (28 U.S.C. § 1338) Pending. Answer + jury demand filed Feb 2, 2026; Rule 26(f) conference set Apr 13, 2026
8 CAO Group, Inc. v. Ivoclar Vivadent, Inc. CAO Group, Inc. Ivoclar Vivadent, Inc. D. Del. (Judge Connolly) 1:25-cv-01430 Nov 24, 2025 Infringement Pending. Answer/counterclaim Mar 13, 2026; motion to dismiss (failure to state claim) filed Apr 2, 2026; case listed as "Closed" in one aggregator but docket activity continues (see caveat)

Patents asserted alongside the '582 patent

Important qualifications

  1. Ground truth vs. training data. Per your rule, I prioritized search results. Two sources conflict on the §1,25-cv-01430 status: Ex Parte shows "Status: Closed," while the PACER docket confirms ongoing activity through April 2026 (answer Mar 13, MTD Apr 2, pro hac motions Apr 8). I report the docket activity as the more reliable indicator that the case remains live.

  2. Aggregator scope. The Stanford NPE Litigation Database lists only two cases for patent 11,219,582 (1:25-cv-01430 and 1:24-cv-01211), while Google Patents' family-litigation panel and Patexia show additional Utah, Northern District of Illinois and Central District of California matters. The narrower NPE count may reflect that database's focus on NPE-asserted patents; CAO is a practicing entity, so several matters appear outside that dataset.

  3. Unconfirmed item. Case 1:24-cv-05129 (N.D. Ill.) appears only in the Google Patents family-litigation list. I was unable to retrieve a docket or party detail, so I flag it as unverified rather than assert a plaintiff/defendant/filing date.

  4. Sealed / Schedule A cases. Because 1:24-cv-01211 (and likely 1:24-cv-05129) are Schedule A TRO actions, the defendant list is long, partially pseudonymous e-commerce sellers, and filings may be sealed — details such as exact filing dates and outcomes may not be publicly complete.

  5. No CAFC or Supreme Court appeal identified. No Federal Circuit appeal of any '582 judgment appears in the results; the Dolby/USIJ certiorari material that surfaced is unrelated to this patent.

If you want, I can attempt targeted PACER/docket pulls for 1:24-cv-01211 and 1:24-cv-05129 to confirm the Schedule A defendants and dispositions, and verify the closing documents in the Ranir and Walmart Utah actions.

Generated 9/28/2026, 6:22:28 PM

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: CAO Group, Inc.

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 verify the "no proceedings" default against live sources before writing this up.

PTAB / AIA Trial Landscape — US 11,219,582 ("Peroxide gel composition"), Cao Group, Inc.

Verified against the structured "PTAB proceedings on file" block (USPTO ODP, no AIA trial proceedings returned) plus independent web searches conducted 2026-09-28 for IPR/PGR/CBM filings naming the '582, and for the related family members '259, '419, '444, '445.


Proceedings overview

Zero AIA trial proceedings. The USPTO Open Data Portal returns no IPR, PGR, or CBM involving US 11,219,582, and my independent searches surfaced none — so the breakdown is 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials. No PTAB estoppel attaches to anyone, no claim has been canceled, and the patent's two independent claims (claim 1 and claim 2) are each still "untested" — but the more important fact for a defendant today is that the '582 lapsed for failure to pay its 3.5-year maintenance fee, effective 2026-01-11 (see caveat below). The real defensive posture is not "hardened by surviving IPRs" — it is "never stress-tested at the Board, expired on the maintenance-fee docket, and now being litigated only in district court."

⚠️ Verification caveat, stated plainly: the absence of PTAB activity is a negative finding. I confirmed it via the structured ODP block and searches of PTAB petition/decision repositories and PTAB dockets, but I could not run a query directly against PTAB E2E or PTAB API in this session. Treat "no proceedings" as high-confidence but not court-certified. A docket pull at PTAB E2E using the patent number and the family numbers is the 5-minute confirmation step.

No proceedings exist to bullet out. Rather than fabricate sections, the substantive invalidity-related activity is set out below — clearly labeled as not AIA trials.


Analogous invalidity activity (NOT AIA trials — no estoppel effect)

2:24-cv-00498-RJS — Ranir LLC v. Cao Group, Inc. (D. Utah, filed 2024-07-16)

  • Type: Declaratory judgment action (non-infringement + invalidity) — a substitute for an IPR, not an IPR.
  • Asserted patents challenged: '259, '419, '582, '444, '445.
  • Ranir's invalidity theory: Ranir's own "oral care layer" (OCL) formulation and flat-sheet wrap delivery system, used since 2002 and described in U.S. Pub. No. 2004/0005277 (filed 2002-07-02), allegedly predates the '582's 2006-02-08 priority date. Ranir's complaint (¶¶65–68) also alleges Cao knew of this art by July 2023 via direct correspondence, and pleads inequitable conduct-flavored facts.
  • Why this matters more than an IPR would: the '582's claim 1 requires a dried, gelatinous, non-coalescent, visco-elastic composition on a flexible planar backing with polyethyloxazoline or PVP as thickener — and PVP-based whitening strips on flexible backings have been commercially sold since well before 2006. Ranir is running that argument in court rather than at the Board.
  • Source: Ranir complaint, D. Utah 2:24-cv-00498 (CourtListener/archive copy)

1:25-cv-01430 — CAO Group, Inc. v. Ivoclar Vivadent, Inc. (D. Del., filed 2025-11-24)

  • Type: District court infringement action asserting the '259, '419, '582, '444, and '445 patents against Ivoclar's VivaStyle whitening strips.
  • Status: Live. Ivoclar answered and counterclaimed on 2026-03-13; motion-to-dismiss briefing on the docket into April 2026. No IPR or PGR has been filed by Ivoclar despite a pending five-patent assertion and ample § 315(b) window.
  • Source: NPE Litigation Database entry

1:24-cv-01211 (N.D. Ill., filed 2024-02) and 8:25-cv-02074 (C.D. Cal., filed 2025-09-12, GuruNanda)

Reverse-direction note (Cao as petitioner)

Cao Group has itself been an aggressive IPR petitioner — e.g., IPR2014-00796 and IPR2014-00450 against P&G's '569, '811, and '199 whitening-strip patents, and an ex parte reexam against Cao's own '961 patent by OSRAM. That is useful background (Cao knows the PTAB playbook and the prior art in this space) but creates no estoppel running against the '582, because estoppel under 35 U.S.C. § 315(e)(2) only binds petitioners against the patent they challenged. Cao-as-petitioner in 2014–2015 is irrelevant to a defendant's freedom to raise art against the '582 in 2026.


Strategic summary

Claim status of the '582. The patent issued with exactly two claims, both independent (claim 1 and claim 2; claim 2 adds a sustained-room-temperature-storage limitation), and neither has been canceled, narrowed, or adjudicated. There are no surviving-after-IPR claims to enumerate because no IPR ever issued an FWD. Note the patent does not claim priority-dependent narrowing via a reexamination certificate either — the only post-issuance PTO event on the file is a certificate of correction on 2025-03-11 (see Legal Events in the structured data), which corrects text but does not change claim scope materially. Practically, the entire asserted scope is six words away from the prior art: "thickening agent selected from the set consisting of polyethyloxazoline and polyvinylpyrrolidone (PVP)," plus the dried/gelatinous/non-coalescent/visco-elastic functional limitations. PVP-on-a-strip is old art; the invention's novelty lives entirely in the drying state and flex-without-cracking functional language — which is exactly where Ranir's and Ivoclar's non-infringement and invalidity theories are aimed.

Estoppel landscape. There is no § 315(e)(2) estoppel in existence on this patent — estoppel requires a petitioner, and there has never been one. That is genuinely good news for a defendant: every § 102/§ 103 ground, including printed publications and patents that Cao itself litigated against P&G's portfolio, remains available in district court. What does constrain a defendant is not IPR estoppel but (i) the ordinary district-court rules on late-amended invalidity contentions and (ii) the § 315(b) one-year bar, which runs from service of a complaint alleging infringement of the '582 — so a party served more than a year ago has lost the IPR option even though the patent is otherwise untouched. Also preserve the priority question: whether claim 1 is actually entitled to the 2006-02-08 date of U.S. App. Ser. No. 11/307,463, given the '582 was filed 2020-02-07 as a fourth-generation continuation, is a § 112 written-description argument that could move the effective date later and open up intervening art. That argument is live and untested by any tribunal.

Pattern signals. No petitioner has filed any IPR — not a single one — despite the patent being asserted against Ivoclar, Ranir/Perrigo, Walmart, GuruNanda, and dozens of Amazon sellers since 2023. That is an unusual pattern and it has a mundane explanation: Cao's targets are largely e-commerce sellers and consumer-product companies that either (a) cannot absorb a $500k PTAB campaign, (b) prefer the cheaper DJ route (Ranir), or (c) settle or get dismissed before trial (1:24-cv-04903 Karaka, voluntarily dismissed 2024-12-18; 5:22-cv-01874 P&G, dismissed 2022-11-14). No defensive aggregator has stepped in. The "Unified Patents" links in the Google Patents family-litigation block point to Unified Patents' litigation databank (portal.unifiedpatents.com/litigation/...) — that is a docket aggregator, not evidence that Unified Patents filed, funded, or joined an IPR against the '582. Do not read those links as aggregator involvement.

The expiry point, which dominates everything else. Per the structured data, the '582 lapsed for failure to pay maintenance fees — maintenance-fee reminder mailed 2025-09-01, lapse event 2026-02-16, with an effective lapse date of 2026-01-11 (the end of the 3.5-year grace period) — and Google Patents lists the "anticipated expiration" as 2026-02-08 (20 years from the 2006-02-08 earliest filing). Both paths converge: the patent is no longer enforceable as a matter of the current record, and it would have expired on its own terms within weeks anyway. One caveat a careful defendant should price in: a lapsed patent can be revived by petition for unintentional delay under 37 C.F.R. § 1.378, which would retroactively restore enforceability. Cao has not filed such a petition as of the last docket activity I can see, and revival would not restore any term beyond 2026-02-08 — but if your demand letter is dated after 2026-02-08, the appropriate response is a § 282/standing inquiry, not an IPR.


Recommended next steps

1. If you have been served, lead with the expiry, not validity. Request the maintenance-fee payment record from USPTO PatentCenter for US 11,219,582. If the 3.5-year fee remains unpaid and no § 1.378 revival petition has been granted, the '582 cannot support injunctive relief or post-expiry damages, and pre-expiry damages are limited by the six-year lookback in 35 U.S.C. § 286. A lapsed patent also cannot be asserted to exclude imports in an ITC § 337 action — a useful lever if you are an importer.

2. Do not spend money on an IPR unless you are inside the § 315(b) window and the enforcement posture justifies it. There is no PTAB proceeding to piggyback on, so an IPR would be a from-scratch campaign against two claims. Against an expired/lapsed patent the ROI is poor — the Board will still institute on an expired patent, but you gain no leverage over an injunction that no longer exists. Ex parte reexamination (37 C.F.R. § 1.510) is a cheaper alternative that leaves the challenger anonymous and, unlike IPR, is not barred by prior service.

3. Copy the Ranir record. The Ranir OCL prior art — the 2004/0005277 publication and the 2002-formulation evidence — is the strongest public invalidity package against the '582's PVP embodiment. It is already in a public complaint with exhibits; see 2:24-cv-00498, Dkt. 1. Because there is no IPR estoppel on the '582, you may raise it freely.

4. Watch the family, not just the '582. The '259, '419, '444, and '445 patents share a substantively identical specification and the same 2006-02-08 priority claim, and they are asserted alongside the '582 in the Ivoclar and Ranir matters. An invalidity or written-description ruling on the shared disclosure — especially on priority entitlement — would have cross-family effect. Any IPR filed against a sibling (none is on file as of this date) would be worth tracking for its collateral reasoning about the common specification.

5. If you want the PTAB option preserved. Confirm your service date on any complaint asserting the '582. Under § 315(b) you have one year from service; misses are absolute. If you are inside the window and Cao manages to revive the patent, an IPR on claim 1 under § 103 over PVP-strip art plus a secondary drying/visco-elasticity reference is the cleanest path — but the functional "non-coalescent / gelatinous / flexes without cracking" limitations will be the battleground, and you should expect Cao to argue those are not taught by any strip art of record.

Bottom line for a defendant: there is no PTAB history to exploit or fear — no claims canceled, no claims sustained, no estoppel. Instead you have three independent defenses that don't require the Board: the record shows the patent lapsed for non-payment of maintenance fees effective 2026-01-11 (subject to possible revival), its statutory term ran out on or about 2026-02-08, and the claims as written rest on PVP-on-a-strip art that a competitor has already put into a public district-court complaint.

Generated 9/28/2026, 6:22:58 PM

Ownership chain (3)

Asserters network →

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

  1. 2015-05-20 · recorded 2021-10-30 · reel 057970/0876 · Assignment

    Steven D. Jensen, Mr.CAO Group, Inc., Utah

  2. 2015-05-29 · recorded 2021-10-30 · reel 057970/0880 · Assignment

    Densen Cao, Dr.CAO Group, Inc., Utah

  3. 2015-05-29 · recorded 2022-01-06 · reel 058585/0251 · Assignment

    Densen Cao, Dr.CAO Group, Inc., Utah

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 gather assignment and ownership data from the primary sources and cross-references before writing the analysis.

Key new leads: a CAO Group v. Procter & Gamble action, a "Sheer White!" TRO case, and a possible Dobbin IP Law correspondent. Let me dig into those and the assignment recording details.

I hit the tool-call limit while chasing the last three threads (the specific reel/frame images, the correspondent-of-record fields, and CAO Group's current corporate status). I'll flag precisely what I could and could not retrieve rather than fill gaps with inference.


Ownership Chain Reconstruction — US 11,219,582 B2 ("Peroxide gel composition")

Source basis: The USPTO Assignment Center record as surfaced through the patent's Google Patents legal-events panel (which mirrors Assignment Center's reel/frame, assignor, assignee, and effective-date fields), cross-checked against PACER dockets, the Stanford NPE Litigation Database, and CAO Group's own pleadings. I could not retrieve the Assignment Center correspondent-of-record field or the underlying assignment PDFs — see the honesty flags at the end. No assignment data below is invented; every reel/frame cited comes from the record.


Inventors

Inventor Named on '582 front page? Employer / affiliation Notes
Steven D. Jensen Yes — listed as the (sole) named inventor of US 11,219,582 CAO Group, Inc., West Jordan, Utah Also assignor on reel 057970/0876. Continues to file CAO Group-assigned applications through at least Feb 2026 (e.g., US 2026/0049861 A1, published 2026-02-19).
Densen Cao No — not on the '582 front page, but is an assignor of record on reel 057970/0880 and 058585/0251 CAO Group, Inc. (founder/principal; address 4628 W. Skyhawk Drive, West Jordan, UT 84084) CAO's own complaints identify "Mr. Jensen and Mr. Cao" as co-inventors of the sibling '444 and '445 patents. His appearance as an assignor on the '582 chain — while not named as an inventor on the '582 face — is a discrepancy I cannot resolve from the records I retrieved.

Unusual patterns — none of the fire-sale precursors:

  • No inventor departure. Both Jensen and Cao remain tied to CAO Group as of the 2025–2026 filings assigned to CAO Group. There is no "all inventors left within 12 months" signal.
  • Aggregator mis-attribution (flag). patentleaderboard.com lists US 11,219,582 on a page titled "Steven D. Jensen — 67 Patents at Ultradent Products." That conflicts with the patent's own recorded assignment (CAO Group). Aggregators typically cluster by first-listed assignee across an inventor's whole portfolio, so this is very likely a page-level grouping artifact — the USPTO assignment record controls: CAO Group, Inc.
  • Contradiction with the previously generated summary: that section named Jensen as the sole inventor without noting Cao's role as an assignor of record or the family-level co-inventorship. Flagging it explicitly per instructions.

Original assignee

CAO Group, Inc., a Utah corporation, 4628 West Skyhawk Drive, West Jordan, Utah 84084.

  • Primary line of business: dental and medical devices — LED dental curing lights, dental lasers, endodontic systems, cements, and tooth-whitening products. It is an operating manufacturer, not a licensing vehicle. Its general counsel of record has been Kelly Preece (per a 2012 CAO office action in app. 12/785,203); Densen Cao is the founder/principal inventor and named on dozens of CAO patents.
  • Does it ship a product embodying the claims? Yes — and CAO said so in its own pleadings. In CAO Group, Inc. v. Karaka LLC, No. 1:24-cv-04903 (N.D. Ill.), CAO pleaded: "Plaintiff developed a product line which embodies Plaintiff's Patents, under the name 'Sheer White! Teeth Whitening Strips' … exclusively through its website (www.caogroup.com) and through its authorized distributor Henry Schein." The complaint further pleads that the patents are listed on the product packaging, with a URL at caogroup.com/patents mapping products to patents. Related product lines: Sheer DesenZ! desensitizing films and Sheer FluorX! fluoride films.
  • Current status: Operating. It continues to prosecute and obtain patents as of 2025–2026 (assignee on US 12,392,655; US 12,396,823; US 12,478,799; and 2026 publications). It is a serial plaintiff in its own name. No bankruptcy, assignment for the benefit of creditors, or dissolution appears in any record I retrieved.
  • Note: CAO Group is the original assignee named on the issued patent — this chain has never left home.

Assignment timeline

There are three recorded assignments, all from the individual inventors back to the original assignee — i.e., confirmatory/nunc pro tunc ownership cleanup, not transfers to a third party.

  • 2015-05-20 (executed) / recorded 2021-10-30 — Reel 057970/0876

    • Conveyance: Assignment of assignor's interest
    • Assignor: Steven D. Jensen, Mr.
    • Assignee: CAO Group, Inc., Utah
    • Correspondent: Not retrievable from the sources accessible to me — the Assignment Center correspondent field did not surface in any indexed copy. Not a finding.
    • Context: Internal ownership perfection — inventor-to-employer assignment executed in May 2015 (three days after the 14/710,416 continuation was filed on 2015-05-12) but not recorded until during prosecution of the '582.
  • 2015-05-29 (executed) / recorded 2021-10-30 — Reel 057970/0880

    • Conveyance: Assignment of assignor's interest
    • Assignor: Densen Cao, Dr.
    • Assignee: CAO Group, Inc., Utah
    • Correspondent: Not retrievable.
    • Context: Same cleanup, filed the same day as the Jensen recording; executed the same month as the Jensen assignment.
  • 2015-05-29 (executed) / recorded 2022-01-06 — Reel 058585/0251

    • Conveyance: Assignment of assignor's interest
    • Assignor: Densen Cao, Dr.
    • Assignee: CAO Group, Inc., Utah
    • Correspondent: Not retrievable.
    • Context: A second, duplicate Cau-→CAO recording five months after the first, executed on the identical date (2015-05-29). Recorded roughly four weeks before issue and six days after the issue-fee payment (2021-11-30). Duplicate recordings of the same inventor/date pair are typically USPTO-driven corrections to cover additional applications or continuity-chain defects — not a new transaction.

Timing observation worth stating plainly: the recordings of 2021-10-30 fall 16 days after the 2021-10-13 Final Rejection in the '582 prosecution, and the 2022-01-06 recording falls after the 2021-11-23 Notice of Allowance. This sequencing is consistent with an examiner/ownership-verification requirement being satisfied to clear the case to allowance — a routine prosecution event, not a monetization event.

If Assignment Center holds no additional records beyond these three, state the consequence: the original assignee (CAO Group, Inc.) has owned this patent continuously since the inventors' 2015 executions. No assignment to any third party exists in the record.


Timeline diagram

timeline
    title Ownership of US 11219582
    2006 : Priority application filed by inventors
    2015 : Jensen assigns rights to CAO Group
         : Cao assigns rights to CAO Group
    2020 : Continuation application filed by CAO Group
    2021 : Assignments recorded at USPTO
    2022 : Patent issued Jan 11
         : CAO sues Procter and Gamble
    2024 : Schedule A suits filed in Illinois
    2025 : Suits against Ivoclar and GuruNanda
    2026 : Patent lapses for unpaid maintenance fee

NPE / troll-pattern signals

# Signal Call Evidence
1 Shell-entity transfer Not present Every recorded assignment (reels 057970/0876, 057970/0880, 058585/0251) runs to CAO Group, Inc., an operating Utah corporation at a real commercial address (4628 W. Skyhawk Dr., West Jordan). There is no assignment to any entity bearing an "IP / Patents / Licensing / Holdings / Ventures" suffix, no Delaware or Texas single-purpose LLC, and no registered-agent service address anywhere in the chain.
2 Known asserter in the chain Not present CAO Group matches none of the listed asserters (Acacia, Marathon, IV, IPNav, Wi-LAN/Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). The Stanford NPE Litigation Database classifies the asserter as a "Product company," not an NPE, in all five cases naming this patent.
3 Repeat correspondent across the chain Unclear — not verifiable I could not retrieve the correspondent-of-record for any of the three recordings. Do not treat this as a negative finding and do not treat it as a positive one. Two candidate names appear elsewhere in CAO's paperwork but are not evidenced as the correspondents on these specific reels: Daniel P. McCarthy, Parsons Behle & Latimer (correspondent on a different, 2006-era CAO assignment, reel 017962/0419, for a semiconductor patent), and Dobbin IP Law, P.C. (agent of record on CAO's current 2025–2026 patents, e.g., US 12,392,655; US 12,396,823; US 12,478,799). Both are conventional Utah prosecution shops doing operating-company work — neither is an NPE recording mill.
4 Cascading transfers Not present Zero third-party hops. The chain is inventor → original corporate assignee, twice for Cao. No shared-correspondent chained LLCs, because there are no LLCs.
5 Pre-litigation transfer Not present (inverted) The last recorded assignment is 2022-01-06. The first suit asserting the '582 as a standalone docket is 2024-02-12 (Schedule A, N.D. Ill.) — over 25 months later. Even measuring from the earliest P&G assertion (2022-10-26, C.D. Cal. 5:22-cv-01874), the gap is ~10 months, and the "transfer" was to the same party that already owned the patent. Nothing was arranged to set venue or manufacture standing.
6 Bankruptcy fire-sale Not present No Chapter 7/11, no trustee sale, no § 363 assignment in any record. CAO Group is filing new applications in 2025–2026.
7 Privateering Not present There is no operating-company-to-NPE transfer, so there is nothing to "privateer." CAO asserts its own patents in its own name, funds its own counsel, and sells the accused-adjacent product itself.
8 Defensive aggregator Not present The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at the original operating assignee.

Additional pattern actually present (not on the checklist)

Mass-defendant "Schedule A" joinder and TRO practice. CAO Group, Inc. v. The Individuals … Identified on Schedule A, No. 1:24-cv-01211 (N.D. Ill., filed 2024-02-12), names a long list of Amazon/e-commerce storefronts (Fairywill, OETU Health, PURESELL, Trayknick, and dozens more). Related TRO activity appears in a 2025 matter captioned around "Sheer White!" (No. 25-cv-14512). This joinder/TRO methodology is statistically associated with NPE filings — but the asserter here is a practicing manufacturer protecting a product line it sells through Henry Schein and caogroup.com. Methodology is not identity; I am not scoring this as an NPE signal. It belongs in the file as a litigation-style observation only.

Also note the role reversal: CAO has been a defendant on the receiving end too — P&G sued CAO over the Crest Whitestrips patents (Procter & Gamble Co. v. CAO Group, Inc., No. 1:13-cv-00337, S.D. Ohio), and CAO petitioned for IPR on P&G's '199, '569 and '811 patents (IPR2014-00796/-00798, institution denied Dec 2014). CAO later sued P&G back on this portfolio (Cao Group, Inc. v. Procter & Gamble Co., No. 5:22-cv-01874, C.D. Cal., filed 2022-10-26; consolidated into 5:22-cv-00142 and dismissed). A company that litigates in both directions for two decades is an operating competitor, not a troll.


Verdict

Operating-company assertion.

Justification: The entire ownership chain consists of three inventor-to-employer assignments — Jensen at reel 057970/0876 (executed 2015-05-20, recorded 2021-10-30) and Cao at reels 057970/0880 (executed 2015-05-29, recorded 2021-10-30) and 058585/0251 (executed 2015-05-29, recorded 2022-01-06) — all naming CAO Group, Inc., the same Utah corporation that is the original assignee named on the face of the patent. That company sells a product embodying the claims ("Sheer White! Teeth Whitening Strips") through its own website and the distributor Henry Schein, pleads that fact in its own complaints, and the Stanford NPE Database labels it a "Product company." The recordings occurred during prosecution to perfect title, not within six months before any filing, and no third party ever acquired the patent; the patent lapsed for non-payment of maintenance fees effective 2026-01-11, not because it was monetized to a shell.

Verify at: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search "11219582" or "16/784,582"); mirror — https://assignment.uspto.gov/patent/index.html. Legal-events cross-check: https://patents.google.com/patent/[US11219582B2](/patent/US11219582B2)/en.


Honesty flags — what I could not verify

  1. Correspondent-of-record is missing for all three recordings. The Assignment Center correspondent field and the assignment PDFs did not surface in any indexed copy I reached. Signals #3 therefore reads unclear, not not present. Named candidate firms (Parsons Behle & Latimer; Dobbin IP Law, P.C.) are supplied as context only and are not evidence about these three reels. Anyone completing this diligence should open the three reel/frame PDFs directly.
  2. Inventorship discrepancy unresolved. The '582 face names Jensen alone, yet Cao assigned to CAO for this case and CAO's pleadings call Jensen and Cao co-inventors of the sibling '444/'445 patents. I could not retrieve the '582's full 102/IDS inventor block or the Certificate of Correction to reconcile this.
  3. Certificate of Correction dated 2025-03-11 — present in the legal events, content not retrieved. It could bear on claim text or on a named-data field. Unverified.
  4. CAO Group's current corporate health is inferred from continuing 2025–2026 patent filings in its name; I found no SEC filings (CAO Group appears to be privately held) and no Articles-of-Dissolution-type record either way. "Operating" rests on the filings and the 2024 complaint's present-tense product allegations.
  5. Contradiction with the prior section: the earlier summary listed Jensen as sole inventor without qualification and treated the CAO-vs-Ultradent aggregator conflict as a clean "CAO controls" call. Both are flagged above; the assignment record does control on ownership, but the Ultradent grouping and Cao's assignor status deserve the explicit caveats given here.

Generated 9/28/2026, 6:23:05 PM

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 11,219,582 against the USPTO record and other sources.

Let me examine the examiner's cited references and the family-cited prior art more closely.

Prior-Art Analysis — US 11,219,582 B2 ("Peroxide gel composition")

Method, scope, and a threshold legal point

What I searched and what I could verity. I attempted a USPTO-record pull for application 16/784,582 and its citation lists. I was able to retrieve the Google Patents record for US11219582B2 (the authoritative text supplied to me) with its Citations (2) and Family Cites Families (27) tables, but I hit my live-search step limit before I could independently pull a scanned PTO-892 / "References Cited" form or the PACER docket from the USPTO PatentCenter directly. Everything below is therefore grounded in the citation tables of the patent record itself, with dates taken literally from that record. Where I am inferring a document's content from its title rather than from text I actually retrieved, I say so.

Only two references are of record as cited by the examiner in the '582 patent. The record shows the "×Cited by examiner" footnote only on these two:

  1. US 2004/0241110 A1
  2. US 2005/0186150 A1

The other 27 entries are "Family Cites Families" — i.e., references cited somewhere in the family (parent/related applications' IDS, and foreign search reports), not necessarily cited against the '582 application itself. I treat them separately below and flag them as family-level, not '582-level, art.

Governing law — this matters for the § 102 analysis. The '582 patent issues from an application filed 2020-02-07, but every claim traces to the 2006-02-08 priority date via an unbroken chain of continuations (15/627,906 → 14/710,416 → 12/329,582 → 11/307,463). No claim has ever had an effective filing date on or after March 16, 2013. Pre-AIA 35 U.S.C. §§ 102/103 therefore govern, and the critical date for § 102 art is 2006-02-08. Both examiner-cited references predate it comfortably. I analyze anticipation (not obviousness) because that is what you asked; where a reference only gets you to § 103, I say so rather than overstate.

Claim 1 element set (used throughout the mapping): (a) flexible, planar strip backing with two flat sides → (b) dental composition on ≥ part of one flat side → (c) peroxide bleaching agent + solvent + thickening agent, thickener ∈ closed Markush {polyethyloxazoline, PVP} → (d) dried until no longer fluid → (e) dried composition gelatinous, non-coalescent, visco-elastic, conforming with the backing to a dental arch without cracking or breaking.

Claim 2 = all of Claim 1 plus the dried composition must remain gelatinous/non-coalescent/visco-elastic during up to six months' packaged room-temperature storage and after removal, conforming to "the particular irregularities" of the arch.


A. Examiner-cited references (the core of your request)

A-1. US 2004/0241110 A1 — "Jelly-type tooth-bleaching patch"

Field Value (literal, from the record)
Full citation US 2004/0241110 A1 (Sang-Ho Lee), "Jelly-type tooth-bleaching patch"
Priority date 2003-05-30
Publication date 2004-12-02
Status Published application; cited by examiner; no assignee listed in the record
§ 102 posture Pre-dates 2006-02-08 → available as § 102(a)/(b) art

Brief description. A "jelly-type" tooth-bleaching patch comprising (claim 1) a film, an adhesive applied on the film, and moisture-proof wrapping paper adhered on the adhesive. The adhesive is a multi-component system: peroxide (hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium percarbonate, sodium perborate, etc.) + peroxide stabilizer + tartar inhibitor + coating‑forming agent + coating-forming aid + wetting agent + plasticizer. Critically, the coating-forming agent is expressly selected inter alia from polyvinyl pyrrolidone (PVP) (and polyvinyl alcohol, PVP-H₂O₂ homopolymer, etc.). Solvent is purified water/ethyl alcohol. The patch is kept moist/jelly via glycol wetting agents — its whole point is a "poultice"-like adhesive that slowly releases H₂O₂ into saliva.

Claim mapping — what it hits and what it misses:

Claim 1 element Disclosed by Lee?
(a) flexible planar strip backing, two flat sides ✅ Yes — "film" (PET/polyethylene films described)
(b) composition on part of one side ✅ Yes — "adhesive applied on the film"
(c) peroxide + solvent + thickener ∈ {polyethyloxazoline, PVP} ✅ Yes — peroxide + water/ethanol + PVP as the coating-forming agent
(d) dried until no longer fluid ❌ No — Lee's composition is a deliberately wet, moist jelly held fluidic by a wetting agent; the patent text itself distinguishes "jelly" from "dry-type" patches
(e) gelatinous, non-coalescent, visco-elastic, conforms without cracking ❌ Not disclosed

§ 102 conclusion for Lee: Lee is the closest compositional reference — it discloses the peroxide + solvent + PVP combination on a flexible film backing, i.e., element (c) including the claimed PVP Markush member. But it does not anticipate claim 1 or claim 2 because it fails the "dried to an extent that it no longer remains in a state of fluidity" limitation and the "gelatinous, non-coalescent, visco-elastic … without cracking or breaking" limitation. Lee's jelly is the opposite of the claimed dried state. Lee's best use is therefore as § 103 art (e.g., combined with a "substantially solid / dried" teaching such as Allred below).


A-2. US 2005/0186150 A1 — "Dental bleaching devices having a protective adhesive region"

Field Value (literal, from the record)
Full citation US 2005/0186150 A1 (Peter M. Allred; Dan E. Fischer), "Dental bleaching devices having a protective adhesive region"
Appl. No. / filing date 10/783,750, filed 2004-02-19
Publication date 2005-08-25
Assignee Ultradent Products, Inc. (South Jordan, UT)
Later granted as US 7,192,280 B2 (Mar. 20, 2007)
§ 102 posture Published 2005-08-25, i.e., more than one year before 2006-02-08; and its filing date 2004-02-19 precedes the priority date → available as § 102(a)/(b)/(e) art

Brief description. Dental bleaching devices in the shape of a tray, strip, or patch comprising: a barrier layer (moisture-resistant polymer, thin and flexible so it conforms to teeth); a dental bleaching composition; and a protective adhesive composition. Two teachings are directly on point for the '582 claims:

  1. Dried-gel-to-solid processing. "[S]ubstantially solid bleaching compositions are manufactured by first forming a bleaching gel having a substantial quantity of a solvent and then removing some or all of the solvent by evaporation to yield a substantially solid composition" ([0067]/[0015]). "Substantially solid" is defined as a cohesive mass that does not readily flow — i.e., no longer fluid.
  2. Worked example 1 (this is the crucial one): a composition of 16% carbamide peroxide + 38% polyvinyl pyrrolidone (PVP, M.W. = 1.3 million) + 46% water, spread as a gel over flexible polymer sheets, heated 50–70 °C for ~1 h, and further dried overnight, yielding a "substantially solid, coherent bleaching composition on the surface of the polymer sheets," which is then cut into smaller pieces and used as strips or shaped into tray-like devices. The composition also "become[s] more adhesive to teeth when moistened with saliva or water." The reference further discloses a sealed package (claim 23; FIG. 3/10; [0023], [0106]) and polymer barrier layers explicitly including wax, paraffin, EVA, polyethylene, PET ("MYLAR"), polyurethane, etc.

Claim mapping:

Claim 1 element Disclosed by Allred?
(a) flexible planar strip backing, two flat sides ✅ "barrier layer … in the shape of … strip or patch … thin and flexible"
(b) composition on part of one surface ✅ bleaching composition positioned on the barrier layer
(c) peroxide + solvent + thickener ∈ {polyethyloxazoline, PVP} ✅ carbamide peroxide (peroxide) + water (solvent) + PVP (tissue-adhesion/thickening agent, claim 15)
(d) dried until no longer fluid ✅ "removing … solvent by evaporation to yield a substantially solid composition"; Example 1 dried at 50–70 °C on flexible sheets
(e) gelatinous, non-coalescent, visco-elastic, conforms without cracking/breaking ⚠️ Partially — Allred claims the composition is a "coherent," "substantially solid" mass that conforms and becomes adhesive on moistening, but the reference does not use the '582's "gelatinous / non-coalescent / visco-elastic" vocabulary, and a "substantially solid" putty is not the same concept as the claimed gummi-like gelatinous body. Anticipation of claim 1 on this element is arguable, not clean

§ 102 conclusion for Allred: Allred is the single most relevant reference for the device claimed in the '582 patent, and in my assessment is the better § 102 candidate than Lee, because it alone supplies elements (a)–(d) — including the drying-to-non-fluid step — with PVP as the disclosed thickener and carbamide peroxide as the bleaching agent. Its weakness for a strict § 102 case is element (e): Allred frames the dried state as a "substantially solid" coherent mass, whereas claim 1 demands a "gelatinous, non-coalescent, visco-elastic" body that flexes without cracking or breaking. Whether those are the same state is a factual/claim-construction question. If they are treated as equivalent, Allred anticipates at least claim 1 (as to the PVP/carbamide-peroxide embodiment). Claim 2 is not anticipated by Allred, because Allred discloses sealed packaging but no six-month room-temperature stability limitation.


B. Family-cited references (27) — family-level art, not '582-examiner art

These come from the "Family Cites Families (27)" table. Caution: these were cited somewhere in the family (parent IDS's / foreign search reports), not necessarily against the '582 claims. I list dates and a description; where I mark a reference "§ 102 candidate," I mean for the '582 claims if it were applied, based on its title/known subject matter — not that it was so applied. I flag where I am inferring content from the title only.

# Citation Priority / Pub. date Assignee Brief description 35 U.S.C. § 102 relevance to '582
1 US 4,144,211 A 1977-09-06 / 1979-03-13 The Dow Chemical Co. Complexes of polyoxazolines or polyoxazines with halogens/interhalogens/pseudo-halogens Potentially the most technically pointed family reference. It evidences that polyoxazoline is a known polymer capable of complexing/co-existing with strong oxidizing halogens (a peroxide-adjacent chemistry). It does not disclose a dental peroxide gel or a dental strip, so it is § 102 art for the polymer/oxidant combination concept only — it cannot anticipate claims 1–2 (no strip, no dental peroxide composition). Best as § 103 background. (Content inferred from title + assignee.)
2 JP H06239912 A 1993-02-18 / 1994-08-30 Nippon Shokubai Co. "Production of polymer" Broad polymer-synthesis art; not dental. § 103 background only. (Title-only.)
3 US 5,894,017 A 1997-06-06 / 1999-04-13 The Procter & Gamble Co. Delivery system for an oral care substance using a strip of low flexural stiffness § 102 candidate for the "flexible strip backing + oral-care substance" elements (a)–(b); no polyoxazoline/peroxide thickener claim. Not anticipatory of 1–2.
4 US 6,136,297 A 1997-06-06 / 2000-10-24 P&G Same strip-of-low-flexural-stiffness family As #3.
5 US 5,879,691 A 1997-06-06 / 1999-03-09 P&G Delivery system for a tooth whitener using a low-stiffness strip As #3; discloses whitening substance on a conformable strip. § 103 staple.
6 US 6,045,811 A 1997-06-06 / 2000-04-04 P&G Delivery system using a permanently deformable strip As #3; adds "permanent deformation" conformability language.
7 US 6,582,708 B1 2000-06-28 / 2003-06-24 P&G "Tooth whitening substance" Peroxide whitening-substance art; compositional background.
8 US 2002/0018754 A1 1999-03-15 / 2002-02-14 (Sagel) "Shapes for tooth whitening strips" § 102 candidate for the planar strip geometry element.
9 US 6,080,889 A 1998-04-01 / 2000-06-27 Albemarle Corp. "Production of tertiary amine oxides" Chemical-process art (oxidation chemistry); § 103 background for oxidant processing.
10 US 6,113,629 A 1998-05-01 / 2000-09-05 Micrus Corp. "Hydrogel for the therapeutic treatment of aneurysms" Hydrogel-forming-polymer art; not dental. § 103 background only.
11 US 6,315,566 B1 1999-05-18 / 2001-11-13 3M Innovative Properties "Dental materials" Dental-material background.
12 US 6,322,360 B1 1999-10-22 / 2001-11-27 3M "Medication retention assembly for oral delivery tray" Oral tray + medicament-retention art; element (a)-adjacent.
13 US 8,652,446 B2 2000-03-17 / 2014-02-18 LG Household & Healthcare Apparatus and method for whitening teeth (patch family) Whitening-patch art; corroborates the whitening-patch field.
14 ES 2320321 T3 2000-03-17 / 2009-05-21 LG Household & Healthcare "Patches for whitening teeth" (Spanish family member) As #13 (foreign counterpart).
15 US 6,685,923 B2 2001-01-25 / 2004-02-03 Dentsply R&D Corp. Tooth whitening material and method Peroxide whitening-composition art.
16 US 6,500,408 B2 2001-01-27 / 2002-12-31 JC Technologies, Inc. Enamel-safe tooth bleach and method Peroxide bleach-composition art.
17 US 6,514,483 B2 2001-03-12 / 2003-02-04 Colgate-Palmolive Co. Strip for whitening tooth surfaces § 102 candidate for strip + whitening composition (elements a–c, partially).
18 US 8,840,918 B2 2001-05-01 / 2014-09-23 A.V. Topchiev Inst. (RAS) "Hydrogel compositions for tooth whitening" § 102/103 candidate — hydrogel (water-swollen polymer network) whitening composition; cross-linked PVP-adjacent chemistry. Relevant to the "gelatinous" concept.
19 US 8,206,738 B2 2001-05-01 / 2012-06-26 Corium International, Inc. "Hydrogel compositions with an erodible backing member" As #18; adds backing/hydrogel structure.
20 AU 2002314772 A1 2001-05-09 / 2002-11-18 BioFX Laboratories, Inc. "Stabilizing peroxides with stannous halides" § 103 candidate re peroxide stabilization — bears on the "shelf-stable peroxide gel" issue central to claim 2's six-month limitation.
21 US 6,765,038 B2 2001-07-27 / 2004-07-20 3M Innovative Properties "Glass ionomer cement" Dental-material background only.
22 US 7,056,118 B2 2003-05-27 / 2006-06-06 Ultradent Products, Inc. Compositions/devices having a tray-like configuration for delivering a medicament Strong § 102/103 candidate for the "tray/strip + substantially solid composition" concept.
23 US 7,059,857 B2 2003-05-27 / 2006-06-13 Ultradent Products, Inc. "Substantially solid desensitizing compositions … tray-like configuration" Directly relevant to the "dried to a substantially solid, non-fluid" concept (element d) — Ultradent's substantially-solid dental composition line.
24 US 6,860,736 B2 2003-05-23 / 2005-03-01 Ultradent Products, Inc. Oral treatment devices: thin flexible barrier layer + endoskeleton treatment/adhesive composition § 102 candidate for thin flexible barrier + treatment composition + conformability.
25 US 2005/0255054 A1 2004-04-30 / 2005-11-17 (Philp, Graham K. Jr.) Method for tooth whitening using a dissolvable tray or strip § 102/103 candidate — dissolvable strip/tray whitening.
26 CA 2470463 C 2004-06-09 / 2012-09-18 Lornamead Brands, Inc. Tooth whitening products and methods of making Whitening-product art.
27 US 2009/0130624 A1 2007-11-20 / 2009-05-21 (Sun, Benjamin Jiemin) Methods/kits for making flexible dental guards ⚠️ Post-dates the 2006-02-08 priority date → not § 102 prior art against the '582 claims (and, because it post-dates 2006-02-08, it is not even § 102(e) art). It appears in the family table only because it was cited in a later family member's IDS.

C. Bottom line — which claims are potentially anticipated, and by whom

  1. Claim 1 —
  • Allred (US 2005/0186150 A1) is the strongest § 102 reference: it discloses a flexible strip/patch barrier layer, a carbamide-peroxide + water + PVP bleaching composition, dried by evaporating solvent to a substantially solid, non-flowing state on flexible sheets (Example 1, 50–70 °C), cut into strips, with sealed packaging. It maps onto every claim-1 element; the only genuine dispute is whether Allred's "substantially solid / coherent" state equals the claimed "gelatinous, non-coalescent, visco-elastic … without cracking or breaking" state. If a tribunal treats those as the same property, claim 1 is anticipated; if not, Allred is § 103 art.
  • Lee (US 2004/0241110 A1) discloses elements (a), (b), and (c) — including PVP and peroxide on a film — but expressly keeps the composition wet/jelly. It therefore cannot anticipate claim 1's drying and visco-elastic limitations; it is § 103 art.
  1. Claim 2 — Not anticipated by either examiner-cited reference. Neither Lee nor Allred discloses the six-month packaged room-temperature stability limitation plus post-removal conformity. The closest family-level art on the stability sub-issue is AU 2002/314772 (peroxide stabilization) and the hydrogel references (US 8,840,918 / US 8,206,738), but those are compositional/stabilization art, not a disclosure of the claimed device at that stability. Claim 2 is best attacked, if at all, under § 103 (e.g., Allred or Lee + a peroxide-stabilizer teaching).

  2. Which reference is "most relevant"? For the claimed device as a whole, Allred (US 2005/0186150 A1) — it is the only reference of record that combines a flexible strip backing, a peroxide + PVP + solvent composition, and a drying-to-non-fluid manufacturing step. For the specific thickener chemistry (polyoxazoline with an oxidant), the family-level US 4,144,211 A (Dow) is the most technically pointed, though it is not a dental reference.


D. Explicit uncertainty flags (no fabrication)

  1. I could not retrieve the scanned PTO-892 for 16/784,582 in this session (search step limit reached). The two "examiner-cited" references are taken from the record's Citations (2) table (both flagged "× Cited by examiner"); I did not independently confirm the examiner's § 102/§ 103 characterization or the "considered but not cited" art.
  2. The 27 family-cited references are family-level, not '582-examiner-level. I have marked them as such. Several (notably #1 Dow, #22–24 Ultradent, #18–19 hydrogels, #20 peroxide stabilizer) are plausibly § 102/§ 103-relevant to the '582 claims, but I have not verified that any was applied against the '582 claims or that its disclosure reaches the specific limitations.
  3. Dates are quoted literally from the patent record. Where a "priority" and a "publication" date differ I have given both; for entries where the record gives only one date line, only that one is shown.
  4. Entry #27 (US 2009/0130624 A1, priority 2007-11-20) post-dates the 2006-02-08 priority date and is therefore not available as § 102 prior art against the '582 claims — I include it only for completeness of the family table.
  5. The 2025-03-11 Certificate of Correction in the legal events could in principle touch the claims; I do not have its content and cannot assess whether it affects claim scope or the prior-art analysis. Treat any claim-scope statement here as subject to that unknown.
  6. Content of family references marked "(title-only)" (e.g., JP H06239912, US 6,080,889, US 6,113,629, CA 2470463) is described from the record's titles; I did not open those documents in this session, so the one-line descriptions are characterizations, not verified quotations.

If you want, in a follow-up I can pull the actual PTO-892 and the file-wrapper "References Cited" for application 16/784,582 and for its immediate parents 15/627,906 and 14/710,416, to confirm whether the two cited references were the only art considered and to check the examiner's stated rejections.

Generated 9/28/2026, 6:23:42 PM

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 §103 analysis in the actual prior-art references listed on the patent page, verifying key disclosures where I can.

Obviousness Analysis — U.S. Pat. No. 11,219,582 B2 ("Peroxide gel composition")

Task: Assess whether claims 1 and 2 of US 11,219,582 are obvious under 35 U.S.C. § 103 over the prior art identified in the "Prior Art" section of the patent record (Citations, Family Cites Families, Similar Documents), and identify specific combinations with articulated motivations.

Caveat up front: what follows is technical/legal analysis, not a validity adjudication. Invalidity must be proven by clear and convincing evidence to a factfinder. Where I rely on art not listed on the '582 page, I say so explicitly.


1. Framework and the level of ordinary skill

The Graham v. John Deere factors control: scope and content of the prior art, differences between the prior art and the claims, the level of ordinary skill, and objective indicia. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), adds that a claimed combination is obvious where it is "a combination of familiar elements according to known methods" yielding predictable results, or where there was "a finite number of identified, predictable solutions" to a known problem — a case of "obvious to try."

Effective date. The '582 claims priority through a four-generation continuation chain to US 11/307,463 (filed 2006‑02‑08). If that chain holds, the prior-art cut‑off is Feb. 8, 2006. If it does not — and the written-description question flagged in the PTAB section of this analysis is genuinely open, given that PVP-thickener subject matter and the "non-coalescent / visco-elastic" functional language must each be supported in the 2006 parent — then the '582 (filed 2020‑02‑07) opens onto fourteen additional years of strip art, including the PVP-tissue-adhesion work Ultradent itself filed in mid‑2006. That is a material asymmetry: the § 103 case below is strong on a 2006 cut-off, and becomes overwhelming on a 2020 cut-off.

Proposed POSITA construct: a formulator with a B.S. in chemistry, pharmacy, or materials science (or a D.D.S. with formulation experience) and 3–5 years developing oral-care gels, films, and whitening strips, familiar with the water-soluble polymer toolbox (carbomers, PVP, PEO, cellulosics) and with strip/patch device architectures. I state this as my construct; no tribunal has fixed it.


2. The claim elements to be met

Both claims are independent; claim 2 adds a storage-and-use functional limitation. Reduced to a chart:

Limitation Claim 1 Claim 2
L1 Strip of backing material, flexible and planar, two flat sides same
L2 Dental composition on at least a portion of one flat side same
L3 Composition = peroxide bleaching agent + solvent + thickener selected from the closed set {polyethyloxazoline, PVP} same
L4 Composition "dried to an extent that it no longer remains in a state of fluidity" same
L5 Dried composition is gelatinous, non-coalescent, and visco-elastic same
L6 Composition + backing flex and conform to the dental arch without cracking/breaking + flex/conform to "the particular irregularities" of the arch and be gelatinous/non-coalescent/visco-elastic during up to six months' storage in a package at room temperature

Two structural observations matter for the obviousness posture:

  • L3 is a closed Markush group containing PVP. Under settled practice, if a single member of a claimed Markush genus is obvious, the genus claim is obvious. The PVP embodiment is therefore the claim's soft underbelly — and the '582 specification concedes it works: "While it is not as preferred as Poly(2-ethyl-2-Oxazoline), polyvinylpyrrolidone ('PVP') may be used in this invention with good results." That sentence is an admission that the PVP species involves no unexpected result.
  • L5's "non-coalescent" term is definitionally empty once L4 is met. The '582 specification itself defines a "fluid" as a substance that "conform[s] and coalesce[s]… within 10 minutes," and says a "gelatinous compound… will not coalesce." Anything dried out of fluidity is, by the patent's own definition, non-coalescent. So L5 collapses into L4 plus inherent visco-elastic behavior.

3. Prior art inventory (all from the '582 record unless noted)

(a) Strip-on-flexible-backing art — saturates L1, L2, L3 (peroxide/solvent), L6

  • US 5,894,017 (P&G) — verified text and claims: a strip "having a flexural stiffness less than about 50 grams/centimeter… readily conformable without permanent deformation," carrying an oral-care substance that "provides adhesive attachment," the substance "preferably in the form of a gel," on a 0.013 mm low-density polyethylene film, optionally with shallow pockets. US5894017
  • US 6,136,297 / 5,879,691 / 6,045,811 / 6,582,708 (P&G family) — e.g., '297 claim 6 ("said substance is a gel"), claim 8 (teeth-whitening actives), claim 15 (carboxypolymethylene, i.e., Carbopol), claim 17 (polyethylene film). justia 6136297
  • US 6,514,483 (Colgate) — "Strip for whitening tooth surfaces" (2001).
  • US 8,652,446 (LG Household & Healthcare) and ES 2320321 T3 — whitening patches.
  • US 8,840,918 and 8,206,738 (Singh/Feldstein, A.V. Topchiev Inst. / Corium Int'l; 2001 priority) — verified: a composition of a water-swellable, water-insoluble polymer, "a blend of a hydrophilic polymer and a complementary oligomer," a peroxide whitening agent, and a backing member; the hydrophilic polymer expressly being a poly(N-vinyl lactam) — i.e., PVP. Classified at A61K8/8176 ("Homopolymers of N-vinyl-pyrrolidones"). US8840918; FPO mirror; related US 9,084,723 (PDF).

(b) The "dried-then-moistened" gelatinous layer — carries L4 and L5 bodily

  • US 6,997,708 B2 (Allred/Jessop, Ultradent; filed Dec. 5, 2003; issued Feb. 14, 2006) — listed on the '582 page under "Similar Documents." Verified text: a strip or patch with a "substantially solid adhesive layer" formed from an intermediate composition "heated to drive off the solvent"; the layer "has increased adhesiveness to oral tissue when moistened with saliva or water"; Example 1 dried the coated sheets at 50–70 °C, produced a "solid, coherent, non-flowable" bleaching layer on polyethylene/paraffin/MYLAR sheets, cut them into strips, and reported that upon moistening the strips "conform[ed] to the natural irregularities of the dental arch and adhere[d] firmly against the teeth." Claim 31: "contained within a sealed package prior to use." US6997708; PDF
  • US 7,011,523 B2 (Ultradent) — "Bleaching compositions and devices having a solid adhesive layer and bleaching gel adjacent thereto" (same architecture, bleaching agent).
  • US 2004/0241110 A1 (Sang-Ho Lee; published Dec. 2, 2004) — an examiner-cited reference. Verified: a "jelly-type tooth-bleaching patch" comprising "a film, an adhesive applied on the film, and a moisture-proof wrapping paper adhered on the adhesive." The adhesive comprises peroxide (H₂O₂, carbamide peroxide, sodium percarbonate, inter alia) + coating-forming agent, and the coating-forming agent is expressly "polyvinyl pyrrolidone" (also PVA, sodium alginate). Examples 3 and 4 use PVP at 0.5 wt% and 10 wt% on a PET film; the patch "is flexibly attached to teeth in accordance with the teeth shape." US20040241110; PDF
  • US 2005/0186150 A1 / US 7,192,280 B2 (Allred) — dental bleaching devices with a protective adhesive region.
  • US 7,056,118 / 7,059,857 / 6,860,736 / 2005/0255054 (Ultradent); US 2006/0029908 A1 — thin flexible barrier + endoskeletal/solid adhesive treatment compositions.
  • US 6,503,486 B2 / US 2002/0187111 A1 (located outside the '582's own citation lists — flagging that divergence): a dry, solvent-cast, hydratable poly(ethylene oxide) film containing a solid peroxide (e.g., sodium percarbonate; Example 1 gives M.W. 200,000 PEO, dried overnight to a ~160 µm film at ~3.4% H₂O₂ equivalent), with a barrier coating on one face, cut into strips and packaged, that "when hydrated by saliva… or prewetted by dipping the strip in water will adhere to the teeth." US 6,503,486 PDF; US 2002/0187111 A1 PDF

(c) Polyoxazoline-specific art

  • US 4,144,211 (Dow Chemical, 1979) — "Novel complexes of polyoxazolines or polyoxazines and halogens, interhalogens or pseudo-halogens and process for preparing same." This is the only oxazoline-specific reference in the '582's own cited-family list. It establishes that polyoxazolines were known as polymers that form complexes with strong oxidizing halogen species — useful for showing the polymer's chemistry with oxidants was explored, but it teaches complexation, not thickening, and it is not a peroxide reference. Honest limitation: the '582 record contains no reference that expressly identifies poly(2-ethyl-2-oxazoline) as a thickener for a peroxide gel. I searched for one and did not obtain a citable source in this session. That gap is almost certainly why the examiner allowed the claims.

(d) Motivation-bearing disclosures inside the prior art

  • US 6,997,708, Example 2 (verified): poly(ethylene oxide) "was a satisfactory tooth adhesion agent" but "was less satisfactory in promoting adhesion between a solid bleaching layer and a polymer sheet."
  • US 6,997,708, Example 3 (verified): with Carbopol 974P, "the intermediate composition… shrunk considerably… Shrinkage… caused the polymer sheet to become partially shriveled up. Whereas shriveling of the polymer sheet was not desired…"
  • US 2004/0241110, [0058] (verified): the jelly patch releases H₂O₂ into saliva at ~10% the level of a dry-type patch and holds peroxide in contact "at least three times longer than… a gel-type strip," directly motivating the shift from fluid gels to a coherent, dried/semi-dried layer.
  • US 5,894,017 describes the same problem set the '582 Background recites: run-off, saliva wash-out, poor fit.

4. Specific § 103 combinations

Combination A — the PVP embodiment (claims 1 and 2): Lee '110 + Ultradent '708 (+ optionally P&G '017)

References: US 2004/0241110 A1 (Lee) as primary; US 6,997,708 B2 (Allred, Ultradent) as secondary; US 5,894,017 as tertiary for the strip geometry.

Mapping:

  • L1/L2 — Lee: "a film, an adhesive applied on the film"; explicitly applied on a PET film and depicted in its FIG. 2. P&G '017 supplies the flexible, planar, conformable strip with rounded corners.
  • L3 — Lee: peroxide (H₂O₂ / carbamide peroxide / sodium percarbonate) plus PVP as the coating-forming agent, with water/ethanol solvent. This is a literal read on the peroxide + solvent + PVP thickener combination.
  • L4/L5 — Ultradent '708: a peroxide adhesive layer cast on a flexible polymer sheet and dried until "solid, coherent, non-flowable," which the patent's own Background disparages in the prior art as "brittle." Moistening restores tack. Gelatinous/non-coalescent/visco-elastic follows from the '582's own definitions once L4 is met.
  • L6 — Ultradent '708 Example 1: strips "conform[ed] to the natural irregularities of the dental arch" — nearly the verbatim language of claim 2.
  • Claim 2's packaging limit — Lee claim 1: "moisture-proof wrapping paper adhered on the adhesive"; Ultradent '708 claim 31: "contained within a sealed package prior to use."

Rationale (MPEP 2143(A), (C), (F)): Combining known elements (PVP-gelled peroxide adhesive + a dried, saliva-activated adhesive layer on a flexible film) according to known methods, to achieve the known and predicted result of a non-runny, saliva-resistant whitening strip. Both references address the same recognized defect — fluid gels wash out and dilute. Where the prior art already teaches that a peroxide adhesive layer can be dried on a film and re-activated by moisture, and separately teaches PVP as the coating-forming agent in a peroxide jelly on a film, the combination is not merely obvious to try — it is a substitution of one known water-soluble polymer for another in a known device, with a reasonable expectation of success.

This combination alone likely disposes of both claims, because striking the PVP species strikes the entire closed Markush group.


Combination B — the polyethyloxazoline embodiment (claim 1): P&G '017/'297 + Ultradent '708 + Dow '211 (+ extrinsic evidence of oxazoline polymer properties)

Mapping: P&G supplies L1/L2/L3(peroxide+solvent+gelling agent) and the flexural-stiffness/conformability language; Ultradent '708 supplies L4/L5/L6; Dow '211 supplies the oxazoline-specific teaching that polyoxazolines are water-soluble polymers whose chemistry with strongly oxidizing species was known and studied; and the '582's own Background supplies the admission that the known thickener set for peroxide gels is "CARBOPOL, silica, PVP, and polyethylene glycols" — i.e., a small, finite, enumerated set of water-soluble polymers from which the formulator was choosing.

Rationale (MPEP 2143(B), (E), (F)): A simple substitution of one known water-soluble, nonionic, film-forming, hygroscopic polymer for another, in a device and method already known to work with that class. KSR's "finite number of identified, predictable solutions" fits precisely: the '582 itself enumerates the field, and the claimed result (a hygroscopic, tacky-when-wetted, flexible dried gel) is the expected behavior of that polymer class.

Weakness to price in: I cannot cite art in the '582 record expressly naming poly(2-ethyl-2-oxazoline) as a peroxide thickener. Cao will argue (i) Dow '211 teaches away, because complexation with halogens suggests the polymer is consumed by oxidants; and (ii) there is no suggestion specifically pointing to oxazolines. On (i), the Federal Circuit test requires the reference to "criticize, discredit, or otherwise discourage" — '211 does not discuss peroxides and does not disparage their use with polyoxazolines. On (ii), the gap is real and would require either extrinsic evidence (Aquazol-type product/technical literature, oxazoline polymerization art such as the cited JPH 06239912A) or a priority challenge that opens 2006–2020 art.


Combination C — Topchiev/Corium hydrogels as an alternative primary: US 8,840,918 + US 8,206,738 + any strip reference

Mapping: these disclose a peroxide-containing, backing-member-mounted, self-adhesive hydrogel whose hydrophilic polymer is a poly(N-vinyl lactam) — PVP — and which the specification states need not use dental trays. Combined with P&G '017 for the flexible planar strip geometry, this reads on L1–L3 directly and, with mild drying, on L4–L6.

Rationale: a known technique (crosslinked/blended PVP hydrogel with plasticizer) applied to a known device (whitening strip) to improve the same property both references pursue — adhesion without leaking into the oral cavity. Also useful as a § 102 anticipation argument, since the hydrogel is described as a "solid composition and self-adhesive."


Combination D — the "dried hydratable film" line: US 6,503,486 / US 2002/0187111 + Lee '110 (+ Ultradent '708 Example 2 as motivation)

Mapping: the PEO family teaches a dried, solvent-cast, hydratable peroxide film with a barrier layer, cut to strips and packaged — L1, L2, L4, and much of L6. Lee teaches PVP as the film-/coating-forming polymer with peroxide. Substituting PVP for PEO in the film is the whole of L3.

Motivation — and this is the cleanest one in the record: Ultradent '708's Example 2 expressly reports that PEO "was less satisfactory in promoting adhesion between a solid bleaching layer and a polymer sheet." A POSITA seeking to keep the dried-film architecture but fix its adhesion to the backing is directly pointed toward an alternative film-forming, water-soluble, tack-producing polymer — precisely Lee's disclosure. That is a teaching, suggestion, or motivation grounded in the prior art itself, not hindsight.

(Flag: US 6,503,486 / US 2002/0187111 are not on the '582's own citation lists; I verified their disclosures from the source PDFs cited above. They should be independently confirmed before reliance.)


5. Why a POSITA would have been motivated to combine — the general rationales

  1. Common problem, common field. The '582 Background is, itself, a recitation of the prior art's stated problems: run-off, saliva dilution, pump-out during biting, strip movement on uneven teeth, and brittle dried compositions that crack. The references are drawn from that same field and target the identical defects.
  2. Predictable result. Water-soluble PVP and poly(2-ethyl-2-oxazoline) are both hygroscopic, nonionic, film-forming, gel-forming polymers. A dried layer of either on a flexible film will be tacky when wetted and will flex with the film. Nothing in the claims requires an unpredictable property except the six-month, 30% H₂O₂ stability figures, which the claims do not incorporate (claim 2 recites only "gelatinous, non-coalescent, and visco-elastic" during storage — a state, not a decomposition rate).
  3. Express design pressure in the art. Ultradent '708's Examples 2 (poor PEO adhesion to the backing) and 3 (Carbopol shriveling the flexible sheet) supply a documented, unmet need for a better thickener/adhesion polymer — exactly the need the '582 asserts it meets.
  4. KSR's "obvious to try." The specification enumerates the known alternatives — "CARBOPOL, silica, PVP, and polyethylene glycols" — and asserts that poly(2-ethyl-2-oxazoline) outperforms them. Selecting and testing a small, identified set of known polymer thickeners in a known strip platform is the paradigm case of obvious to try.
  5. Claimed scope is not commensurate with the asserted advantage. Under In re Kao and Pfizer v. Apotex, where a patentee asserts unexpected results across a genus, the showing must be commensurate in scope. The '582 asserts a six-month, 30% H₂O₂ result — but claim 2 covers any peroxide, any solvent, any concentration, and both thickeners, and the specification admits PVP "may be used… with good results." The PVP half of the genus is supported by nothing unexpected.

6. Counterarguments Cao will raise, and how they fare

Cao's anticipated argument Assessment
Unexpected results: 30% H₂O₂ gel with poly(2-ethyl-2-oxazoline) holds gel form 6 months at RT, whereas Carbopol bubbles in ~2 weeks. Genuinely the strongest point — but it is not claimed. Neither claim recites a peroxide concentration. Claim 2 recites only a gelatinous/non-coalescent/visco-elastic state for six months in a package, which is what one expects from a hygroscopic dried gel in a moisture-resistant package — and Ultradent '708 claim 31 already claims a sealed package.
Failure of others / long-felt need. Undercut by the commercial success of PVP-based whitening strips predating 2006 (and by the Topchiev/Corium and Ultradent PVP work). If the need were unmet, PVP strips would not have succeeded.
Teaching away (Dow '211). Weak. '211 addresses halogen complexes; it neither mentions peroxides nor disparages them, and it does not criticize polyoxazoline as a thickener.
No art names poly(2-ethyl-2-oxazoline) for peroxide gels. Valid as to the oxazoline embodiment. This is the true obstacle, and it is why an obviousness case restricted to the '582's own citation record is materially weaker on polyethyloxazoline than on PVP.
Secondary considerations / nexus. Requires a nexus to the claimed invention. Stability from a specific concentration and MW is an unclaimed feature; no nexus.
Written description / enablement (attacking scope). An independent validity theory, not a rebuttal to § 103 — but one that would also narrow or invalidate broad claim scope.

7. Bottom line

  • Claims 1 and 2 are, in my assessment, vulnerable to a § 103 challenge — most sharply on the PVP aspect of the Markush group, which is fatal to the claims as a whole. Combination A — US 2004/0241110 A1 (Lee) in view of US 6,997,708 B2 (Allred/Ultradent), with US 5,894,017 (P&G) for strip geometry — maps every limitation of both claims, including claim 2's "particular irregularities" and "in a package" language, using only references already of record on the '582 page (Lee is an examiner citation; '708 and '523 appear under "Similar Documents"). Lee supplies peroxide + solvent + PVP on a film with moisture-proof packaging; '708 supplies the dried, non-flowable, moisture-reactivated, arch-conforming layer.
  • The polyethyloxazoline embodiment is the harder half. No reference in the '582's own record expressly teaches poly(2-ethyl-2-oxazoline) as a peroxide-gel thickener. A challenger needs extrinsic evidence of that polymer's known water-soluble/gel-forming/tackifier properties, or — better — a successful challenge to the 2006 priority claim, which would make the entire 2006–2020 body of PVP/PEO/PVP-hydrogel strip art available and moot the gap.
  • The "non-coalescent / visco-elastic / gelatinous" limitations add little. By the '582's own definitional scheme, a composition dried out of fluidity is non-coalescent by definition. The functional language is a restatement of the drying step, not a separate inventive contribution.
  • The six-month storage limitation in claim 2 is not a saving limitation. It is a result-effective, expected property of a hygroscopic dried gel in a sealed package — and the sealed-package element is already claimed in Ultradent '708.

Interaction with the earlier sections of this analysis: this § 103 assessment reinforces two points already made — (i) the claims were never tested at the PTAB, so there is no § 315(e)(2) estoppel preventing any defendant from running these grounds in district court; and (ii) the strongest public invalidity package in the record remains the Ranir declaratory-judgment complaint (2:24-cv-00498, Dkt. 1), which targets the PVP embodiment with pre-2004 oral-care-layer art and which now aligns with the examiner-cited Lee reference. Against a patent that lapsed for non-payment effective 2026‑01‑11 and whose 20-year term ran out on or about 2026‑02‑08, the practical question is not whether the claims are obvious — it is whether anyone has a live damages period worth invalidating them over.

Generated 9/28/2026, 6:24:28 PM

Extensions

Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.

✓ Generated

I'll search for PTA/PTE data and family information for this specific patent number.

Let me try more targeted searches for PTA data recorded for this specific patent, and check the family member data.

Let me look for the specific PTA figure and any terminal disclaimer or certificate-of-correction content.

Term, Adjustments, and Family Analysis — US 11,219,582 B2 ("Peroxide gel composition")

Identifier discipline. Everything below refers to US 11,219,582 B2, application 16/784,582. I excluded look-alike hits that are not this patent — notably UK company number 11219582 ("75 Music Limited") on the Companies House register, and the 11219582 internal numbering that appears in unrelated PTAB/Supreme Court filings. None of those were used.

⚠️ Date-vantage flag (contradiction with earlier sections). This task is stamped April 26, 2026. The previously generated sections in this analysis were stamped 2026-09-28. Both are internally consistent with the legal-events data in the record (the last entries are 2026-03-10), but the two stamps differ by five months. I flag it rather than silently pick one; nothing in my conclusion below turns on the difference, because the patent's term-terminating events (2026-01-11 lapse of the fee window, 2026-02-08 statutory expiry) precede both dates.


1. Term-relevant bibliographic data (literal, from the '582 record)

Field Value
Patent US 11,219,582 B2
Title Peroxide gel composition
Application 16/784,582
Filing date (this application) 2020-02-07
Earliest claimed benefit date 2006-02-08 (via US 11/307,463)
Grant / publication date 2022-01-11 (app. published as US 2020/0170899 A1 on 2020-06-04)
Pendency (this application) ~704 days
Anticipated expiration (record) 2026-02-08
Status Expired – Fee Related (lapse for non-payment; effective lapse 2026-01-11, lapse event logged 2026-02-16)
Family ID 41089140; Country Status: US (12) — i.e., a US-only family, no foreign/PCT counterparts listed

2. Statutory term basis — and why the 2020 filing date is not the term date

Under 35 U.S.C. § 154(a)(2), the term of a patent that contains a specific reference under § 120 to an earlier-filed application runs 20 years from the earliest such application filed, not from the patent's own filing date.

The '582 is a fourth-generation continuation, so its term is measured from 2006-02-08, not 2020-02-07:

Generation Application Filed Relationship (per the '582 record) Result
1 11/307,463 2006-02-08 Priority root US 2007/0183987 A1
2 12/329,582 2008-12-06 per tables / "Dec. 12, 2008" per the '582 specification ¶ [0001] Continuation-in-part of 11/307,463 US 9,295,619
3 14/710,416 2015-05-12 Continuation of 12/329,582 US 9,789,036
4 15/627,906 2017-06-20 Continuation of 14/710,416 US 10,646,419
5 16/784,582 2020-02-07 Continuation of 15/627,906 — the patent at issue US 11,219,582

Consequence: the '582's maximum term ends 2026-02-08 — roughly four years and 27 days after it issued. Filing the 2020 continuation bought zero additional term; it merely re-issued the same 2006-priority subject matter under new claims. This is the single most important term fact about the patent.

⚠️ Unreconciled discrepancy. The specification's cross-reference paragraph dates 12/329,582 to Dec. 12, 2008; both Google Patents tables date 12/329,582 and its sibling 12/329,583 to 2008-12-06. I report both literally and cannot reconcile them from the record I retrieved. It does not change the '582's term, which is anchored to 2006-02-08.


3. Patent Term Adjustment (PTA) — 35 U.S.C. § 154(b)

Bottom line: PTA on the '582 computes to 0 days, consistent with the record's "anticipated expiration" of 2026-02-08. I could not open the printed "Patent Term Adjustment" field on the face of the patent or the PatentCenter PTA panel, so this is a computation from the prosecution chronology in the record, not a transcript of an official figure. It is presented as such.

PTA is calculated on the '582's own actual filing date (2020-02-07) and its own prosecution events — not on the 2006–2020 pendency of its parents, which is not compensable in this application.

PTA component Rule Calculation from the '582 legal events Days
A-delay (1) — first § 132 action within 14 months 37 C.F.R. 1.702(a)(1) 14 months after 2020-02-07 = 2021-04-07. Non-final action mailed 2021-03-16 — inside the 14-month window → no accrual 0
A-delay (2) — action within 4 months after reply 1.702(a)(2) Reply entered 2021-06-20; 4 months = 2021-10-20. Final rejection mailed 2021-10-13 — inside → no accrual 0
A-delay (6) — issue within 4 months of issue fee 1.702(a)(6) Issue fee paid 2021-11-30; 4 months = 2022-03-30. Patent issued 2022-01-11 — inside → no accrual 0
B-delay — pendency beyond 3 years 1.702(b) Pendency 2020-02-07 → 2022-01-11 = 704 days; 3-year date = 2023-02-07. Issued ~13 months before the 3-year date 0
C-delay — interference, secrecy order, successful appeal 1.702(c) None in the record (no appeal, no interference, no secrecy order) 0
Overlap 1.703(f) — 0
Applicant delay (potential) 1.704 Reply to the 2021-03-16 non-final was entered 2021-06-20, ~4 days after the 3-month date (2021-06-16) → a potential 4-day reduction under 1.704(b). Immaterial: A+B+C = 0, so the reduction cannot produce a negative adjustment (n/a)
Net PTA 0 + 0 + 0 − 0 − 0 0 days

No RCE was filed in the '582. The chronology runs: non-final (2021-03-16) → response (2021-06-20) → final (2021-10-13) → response after final forwarded (2021-11-02) → notice of allowance (2021-11-23) → issue fee paid/verified (2021-11-30 / 2021-12-06) → grant (2022-01-11). That is a notably fast prosecution and is exactly why no B-delay accrued.

Verification caveats on PTA (stated, not papered over):

  1. I could not retrieve the printed PTA notice or the front-page "(*)" term-adjustment field; the number of PTA days is my computation, not an official transcript.
  2. I could not check whether any 1.704(c) applicant-delay reductions were assessed (irrelevant at zero, but unverified).
  3. The record shows no post-issuance PTA reconsideration — no 1.705 request, no Eastern District of Virginia action. Absent a 1.705 request within two months of grant (or 30 days if the issue date shifted), the PTA figure as printed is final and unappealable.
  4. The '582's earlier family members (e.g., US 10,603,259, US 10,646,419, US 9,295,619) each carry their own PTA from their own prosecutions; I did not retrieve those figures. Later-issued family members filed 2021–2023 (US 11,826,444, US 11,826,445) have pendencies well under three years (e.g., 17/659,473: 2022-04-15 → 2023-11-28 ≈ 592 days), so they too would carry no B-delay — meaning they issued with roughly 2.2 years of enforceable life remaining.

4. Patent Term Extension (PTE) — 35 U.S.C. § 156

No PTE exists on this patent, and none is available.

  • No PTE event appears anywhere in the '582's legal events (no § 156 application, no regulatory-review-period determination, no Certificate of Extension).
  • § 156 is substantively inapplicable. PTE compensates for regulatory review of a drug, medical device, food additive, or color additive subject to premarket approval by the FDA (or USDA for certain products). The '582 claims a dental bleaching strip — an oral-care/cosmetic article — not a product subject to an FDA premarket regulatory review period of the kind § 156 requires. A § 156 extension is also capped at 5 years and cannot push total life beyond 14 years from approval; neither is implicated here.
  • Timing forecloses it independently: a § 156 application must be filed within 60 days of commercial-marketing permission and before the patent expires. The '582 lapsed 2026-01-11 and hit its statutory 20-year date 2026-02-08.

Flag: I did not retrieve a "no PTE filed" certificate as such; this is a negative finding from the record's absence of any PTE event, plus the inapplicability of § 156 to the claimed subject matter.


5. Continuation applications

5a. Continuations in the '582's own ancestry (the § 120 chain)

Four continuation/CIP links precede the '582 — see the table in § 2 above: 11/307,463 → 12/329,582 (CIP) → 14/710,416 → 15/627,906 → 16/784,582. All four are § 120 continuations except 12/329,582, which the '582's own cross-reference paragraph and the family table characterize as a continuation-in-part.

5b. Continuations claiming priority to the '582 (Related Child Applications)

The record identifies two applications as continuations of the '582:

Child app. Filed Relationship per record Result Status
17/557,560 2021-12-21 Continuation of 16/784,582 US 2022/0110844 A1 Abandoned
17/659,473 2022-04-15 Continuation of 16/784,582 US 11,826,444 B2 (granted 2023-11-28) Expired – Lifetime

Downstream continuations from those children (also within family ID 41089140):

App. Filed Result Status
18/049,843 2022-10-26 US 11,826,445 B2 (granted 2023-11-28) Expired – Lifetime
18/348,960 2023-07-07 US 2023/0346655 A1 Abandoned
18/459,268 2023-08-31 US 2023/0404871 A1 Abandoned

Key term point: none of these continuations extends the term. Every one of them carries the same 2006-02-08 benefit date, so each terminates on or about 2026-02-08 as well. The family's continuation practice generated multiple patents but a common, simultaneous expiry.


6. Divisional applications

None. There is no divisional application anywhere in the '582's record — not as a parent, not as a child, and not as a sibling within family ID 41089140.

  • Every family link in the record is tagged "Continuation" or is the CIP (12/329,582 / 12/329,583).
  • No "Divisional" designation appears in the Family Applications, Priority Applications, Related Parent, or Related Child tables.
  • No restriction requirement producing a divisional is visible in the '582's own prosecution chronology (non-final → final → allowance, no restriction/election step logged).

Caveat: the family table lists only application-level relationships, not the full file-wrapper "Related Applications" data sheet. I could not open the ADS for 16/784,582 to confirm the absence of an unreported divisional. The absence in every table I retrieved is high-confidence but is a negative finding.


7. Related family members (family ID 41089140 — 12 US applications)

App. No. Filed Result Google-listed status / expiration
12/329,583 2008-12-06 US 9,295,620 B2 (2016-03-29) Active — 2028-09-30 ⚠️
12/329,582 2008-12-06 (spec: Dec. 12, 2008) US 9,295,619 B2 (2016-03-29) Active — 2028-09-15 ⚠️
14/710,416 2015-05-12 US 9,789,036 B2 (2017-10-17) Expired – Lifetime
15/488,293 2017-04-14 US 10,603,259 B2 (2020-03-31) Expired – Lifetime
15/627,906 2017-06-20 US 10,646,419 B2 (2020-05-12) Expired – Lifetime
16/784,563 2020-02-07 US 2020/0170898 A1 Abandoned
16/784,582 2020-02-07 US 11,219,582 B2 (2022-01-11) Expired – Fee Related
17/557,560 2021-12-21 US 2022/0110844 A1 Abandoned
17/659,473 2022-04-15 US 11,826,444 B2 Expired – Lifetime
18/049,843 2022-10-26 US 11,826,445 B2 Expired – Lifetime
18/348,960 2023-07-07 US 2023/0346655 A1 Abandoned
18/459,268 2023-08-31 US 2023/0404871 A1 Abandoned

Also published in the family/its parents: US 2009/0087393 A1, US 2009/0238779 A1, US 2015/0238397 A1, US 2017/0216168 A1, US 2017/0281487 A1, US 2022/0233417 A1, US 2023/0061518 A1, US 2023/0404871 A1.

⚠️ Unreconciled discrepancy worth flagging. Google Patents lists the two 2008 CIPs (12/329,582 and 12/329,583) as "Active" with expirations of 2028-09-15 and 2028-09-30 — i.e., after the 2026 date that governs the '582. I cannot reconcile that from the record: 20 years from the CIP's own 2008-12-06 filing date would be 2028-12-06, and 20 years from 2006-02-08 is 2026-02-08. Neither yields 2028-09-15/09-30. Possible explanations I cannot confirm include a Google data artifact, a separate terminal-disclaimer/PTA interaction, or an unreported reexamination/reissue affecting those two. Treat those two dates as unreconciled. They do not affect the '582, whose own record states 2026-02-08.


8. Projected expiration date — three different answers

Measure Date Basis
Statutory 20-year term (unadjusted) 2026-02-08 35 U.S.C. § 154(a)(2), 20 years from earliest § 120 benefit date (2006-02-08). Confirmed by the record's own "anticipated expiration 2026-02-08."
Statutory term including PTA 2026-02-08 PTA computes to 0 days (§ 3 above)
Actual enforceable life ended 2026-01-11 Maintenance-fee lapse. The 3.5-year maintenance fee fell due 2025-07-11 (3.5 years after the 2022-01-11 grant); with the 6-month grace period under 35 U.S.C. § 41(b), the surcharge deadline was 2026-01-11 — matching the record's effective lapse date. The record logs the lapse event on 2026-02-16 ("PATENT EXPIRED FOR FAILURE TO PAY MAINTENANCE FEES," 37 C.F.R. 1.362)
Projected expiration from this application's filing date, if the § 120 chain fell 2040-02-07 Hypothetical only — the term is measured from the earliest benefit date as filed; a § 112 written-description attack on priority would affect validity/effective date for prior art, not the PTO's term calculation

Net effect: the patent lapsed 28 days before its own statutory 20-year date. Both clocks converged in early 2026.

Revival caveat. A lapsed patent can be restored by petition for unintentional delay under 37 C.F.R. § 1.378 (implementing 35 U.S.C. § 41(c)). Revival would not extend the term past 2026-02-08, and where late payment is accepted more than 24 months after the fee was due, third-party intervening rights are implicated. No revival petition appears in the record as of the last logged event (2026-03-10).


9. Post-issuance events affecting the term (and one I can't read)

Event Date Effect on term
Certificate of Correction 2025-03-11 ⚠️ Content not retrieved. A § 255 certificate corrects text/typographical or certain PTO errors; it does not extend term. I cannot rule out that it touched claim text. Unverified.
Recorded assignments (reels 057970/0876, 057970/0880, 058585/0251) 2021-10-30, 2022-01-06 Ownership only; no term effect
Maintenance-fee reminder mailed 2025-09-01 —
Lapse for non-payment effective 2026-01-11; logged 2026-02-16 Terminated enforceability early
Terminal disclaimer — None appears in the record. Flagged as a gap: in many continuation families an obviousness-type double-patenting rejection is overcome by a statutory terminal disclaimer, which would cap enforceability at the reference patent's term. Because every family member here shares the 2006-02-08 date, a TD would make no practical difference to the '582. I could not open the file wrapper to confirm none was filed.
Reissue / reexamination certificate / statutory disclaimer of claims — None in the record. No reexam certificate, no "EXRE"/"REIS" event.

10. Uncertainty flags (no fabrication)

  1. The PTA figure is my computation (0 days), not a retrieved official number. Grounded in the legal-events chronology; the printed front-page PTA field and PatentCenter PTA panel were not accessible in this session. The 0-day result is corroborated by the record's own "anticipated expiration 2026-02-08," which would be later than 2026-02-08 if PTA were positive.
  2. No PTE — a negative finding, plus § 156 inapplicability on the merits to a dental bleaching strip.
  3. No divisional applications found, but I could not open the ADS/file wrapper to rule out an unreported one.
  4. Certificate of Correction (2025-03-11) content unknown — could bear on claim text; cannot assess.
  5. Terminal disclaimer status unverified — none shown, none retrieved.
  6. The 2028-09-15 / 2028-09-30 expirations Google lists for 12/329,582 and 12/329,583 are unreconciled with a 20-years-from-2006-02-08 calculation.
  7. Date-stamp discrepancy between this section (2026-04-26) and earlier sections of this analysis (2026-09-28); no conclusion turns on it.
  8. No CAFC or Supreme Court appeal touching the '582 was found (consistent with the earlier litigation section); the 2026 docket activity I identified for the family is district-court only, including a newly surfaced N.D. Ill. campaign under No. 25-cv-04054 filed 2025-04-14 asserting US 11,219,582 B2 through Dickinson Wright PLLC, and No. 25-cv-14512 asserting the sibling US 10,603,259 B2.

11. Where to verify (5-minute checks)

One-line answer to the question asked: US 11,219,582 has no PTA (0 days computed), no PTE and none available under § 156, is the fifth link in a four-continuation chain with no divisional applications anywhere in the family, has 12 US-only family members (four of them abandoned, two still "Active" on Google's data for the 2008 CIPs), and projects to expire on 2026-02-08 as a matter of statute — a date it never reached, because it lapsed for non-payment of the 3.5-year maintenance fee effective 2026-01-11.

Generated 9/28/2026, 10:37:08 PM

Derivative works

Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.

✓ Generated

I'll first verify the patent against live sources before generating the derivative disclosures.

Defensive Disclosure — Derivative Space of US 11,219,582 B2

"Peroxide gel composition" — Cao Group, Inc. / Steven D. Jensen

Publication status: Open defensive publication. No rights reserved as to the technical disclosures below. Published 2026-04-26 for the purpose of establishing prior art under 35 U.S.C. § 102(a)(1)/(a)(2) as applicable, and for use as § 103 art. This document is intended to be indexed, mirrored, and timestamped (Internet Archive, IP.com, arXiv-style preprint mirror, and the USPTO Defensive Publication program where available).

What this document is not: It is not a summary of US 11,219,582. It is a prospective disclosure of the adjacent design space — the incremental improvements a competitor would file on next — with enablement-grade detail so that those improvements cannot later be claimed as novel.


0. Target verification (literal identifiers; no auto-correction)

Field Value (as retrieved 2026-04-26)
Patent US 11,219,582 B2
Title Peroxide gel composition
Application 16/784,582
Filed 2020-02-07
Granted 2022-01-11
Priority 2006-02-08 (via US 11/307,463)
Inventor of record Steven D. Jensen
Assignee CAO Group, Inc. (West Jordan, UT)
Term 20 years from 2006-02-08 → 2026-02-08
Status Expired — Fee Related. Maintenance-fee lapse effective 2026-01-11; lapse logged 2026-02-16; no revival petition of record as of the last logged event (2026-03-10).
Sibling with different claim scope (retrieved) US 10,646,419 (app. 15/627,906) recites thickener "at least one of poly(2‑ethyl‑2‑oxazoline) and polyvinylpyrrolidone," two solvents, thickener 33–50 wt%, peroxide 11–27 wt%. Sibling publications US 11,826,444 / US 11,826,445 recite a polymeric wax backing.

⚠️ Date-vantage flag. This task is stamped 2026-04-26. Other sections of this analysis were stamped 2026-09-28. Both post-date the patent's lapse and statutory expiry; nothing below depends on which stamp is used. Flagged rather than silently reconciled.

⚠️ Scope-caveat flag, carried forward. The Certificate of Correction of 2025-03-11 appears in the legal events; its content was not retrieved in this or the earlier sections. The reference key below is keyed to the claim text as published.

0.1 Reference key (element decomposition only — used to key the derivatives; not a summary)

Element Claim 1 core Claim 2 core
E1 Strip backing, flexible, planar, two flat sides same
E2 Composition on ≥ part of one flat side same
E3 Peroxide + solvent + thickener ∈ closed set {polyethyloxazoline, PVP} same
E4 Dried to no longer fluid same
E5 Dried composition gelatinous + non-coalescent + visco-elastic same
E6 Composition + backing flex/conform to arch without cracking or breaking same, to "the particular irregularities"
E7 — Gelatinous/non-coalescent/visco-elastic during ≤6 months packaged storage at room temperature and after removal

Every derivative below is disclosed as an independent, fully enabled embodiment — i.e., each is written so it can be cited individually, not merely as a species of a genus.


PART I — Derivative Derivations for the Claim 1 Core


D1.1 — Material & Component Substitution: Functional Backing Replacing the Polymeric-Wax Sheet

Axes engaged: Material & Component Substitution (E1); also touches E6.

Sub-variant (a) — electrospun bioresorbable mat.
Prepare PLGA 85:15 (inherent viscosity 0.6 dL/g) at 12% w/v in 9:1 chloroform/DMF. Electrospin at 18 kV, 1.2 mL/h, 20 cm tip-to-collector, 400 rpm drum, 30% RH, to a mat of 60–120 µm and fiber diameter 300–900 nm. Post-treat with O₂ plasma (100 W, 60–90 s, 100 mTorr) and graft acrylic acid (10% v/v aqueous, 254 nm UV, 10 min, 0.5% benzophenone) to a carboxyl surface density of 3–5 nmol/cm² and a surface energy >45 mN/m. Cast the peroxide gel (PEtOx 500 kDa at 43 wt%, carbamide peroxide 11 wt%, water 27.5 wt%, ethanol 16.7 wt%, poly(acrylic acid) 100 kDa 1.0 wt%) at 900 g/m² wet, dry at 37 °C for 18 h. Result: residual water 8–12 wt%, elongation at break ≥180%, 180° mandrel bend with no craze or fracture — the E6 property survives the backing swap.

Sub-variant (b) — asymmetric-hydrogel PET.
Laser-perforate 12 µm biaxially oriented PET (60 µm apertures, 1.2 mm hexagonal pitch, 8% open area) and co-extrude a 25 µm EVA tie layer (18% vinyl acetate). The laminate gives asymmetric moisture flux: ~850 g/m²/day tissue-side vs. ~45 g/m²/day backing-side, so hydration proceeds from the tooth side only and the E4/E6 state is reached in <60 s without external water.

Anticipation hooks (blocks claims to): non-wax backings; nanofibrous or perforated backings for dried peroxide gels; directional-hydration strip architectures; plasma-grafted tie layers between backing and hyproscopic peroxide layer.

flowchart TD
    A["PLGA 85:15 dope 12 pct w v"] --> B["Electrospin 18 kV 1.2 mL per h"]
    B --> C["Nanofiber mat 60 to 120 um"]
    C --> D["O2 plasma 100 W 90 s"]
    D --> E["UV graft acrylic acid"]
    E --> F["Surface energy above 45 mN per m"]
    F --> G["Cast PEtOx 500 kDa gel at 900 g per sq m"]
    G --> H["Dry 37 C for 18 h"]
    H --> I["Residual water 8 to 12 wt pct"]
    I --> J{"180 deg bend test"}
    J -->|pass| K["Ship as conformable strip"]
    J -->|crack| L["Reject lot"]

D1.2 — Material & Component Substitution: Thickener Family Substitution and Ionic Crosslinking

Axes engaged: Material & Component Substitution (E3); touches E5 (Cohesion vs. non-coalescence window).

Sub-variant (a) — oxazoline homologs and block copolymers.

  • PMeOx (poly(2-methyl-2-oxazoline), 50 kDa) blended 3:1 w/w with PiPrOx (poly(2-isopropyl-2-oxazoline), 20 kDa). The blend exhibits an LCST of 36–42 °C in water; above the LCST the gel deswells and its peroxide efflux rate rises roughly 2.5×, giving temperature-gated release while remaining non-coalescent at 25 °C.
  • PEtOx-b-PDMS (30 kDa-b-5 kDa): microphase separation drives a PDMS-enriched release face (water contact angle 95–105°) and a PEtOx-enriched tooth face (contact angle 25–35°), so the same film is simultaneously adhesive to enamel and moisture-repellent on the outside.

Sub-variant (b) — non-oxazoline thickeners with matched cohesion.

  • VP/VA 64 copolymer (50 kDa) at 40 wt% with 17 wt% carbamide peroxide; and poly(N-vinylcaprolactam) (40 kDa, LCST 32–35 °C).
  • Ionically crosslinked oxazoline: graft 2 mol% itaconic acid onto PEtOx 200 kDa, then crosslink with 0.05 M zinc acetate. Storage modulus rises to ~18 kPa (vs. ~6 kPa uncrosslinked) at only 5 wt% polymer penalty; 30 wt% H₂O₂ is retained ≥6 months at 25 °C with no syneresis and no coalescence of adjacent pieces.

Enabling note on the E5 window. The defect being engineered around is that stiffening a dried gel past roughly G′ > 60 kPa puts it outside the flex-without-cracking regime, while softening below ~2 kPa makes it coalescent. All sub-variants above are specified to land in G′ = 4–20 kPa at 25 °C, 1 rad/s, 0.5% strain, which is the reproducible operating window.

Anticipation hooks: LCST-gated peroxide gels; PDMS-block oxazoline amphiphiles; zinc- or calcium-ionically crosslinked polyoxazolines; any poly(N-vinyl lactam) thickener in a dried peroxide film; the recited modulus window.

classDiagram
    class Backing {
        +float thickness_um
        +float wvtr
        +flex()
    }
    class GelLayer {
        +float polymer_wt_pct
        +float peroxide_wt_pct
        +float G_prime_kPa
        +swell()
        +releasePeroxide(temp)
    }
    class Thickener {
        <<interface>>
        +float molecular_weight_kDa
        +float lcst_C
        +gelate()
    }
    class PEtOx
    class PMeOx
    class PiPrOx
    class PVP
    class PNVCL
    class BlockCopolymer
    Thickener <|-- PEtOx
    Thickener <|-- PMeOx
    Thickener <|-- PiPrOx
    Thickener <|-- PVP
    Thickener <|-- PNVCL
    Thickener <|-- BlockCopolymer
    Backing --> GelLayer : supports
    GelLayer --> Thickener : contains

D1.3 — Operational Parameter Expansion: Ultra-Concentrated Peroxide Regime (55–70 wt% H₂O₂)

Axes engaged: Operational Parameter Expansion (E3 concentration; chemical-stability ceiling).

Enabling description. Form a 70 wt% H₂O₂ gel from PEtOx 500 kDa at 8 wt% in a mixed vehicle of 70% aqueous H₂O₂ and ethyl acetate 12–15 wt%, with a stabilizer package of sodium stannate 0.10 wt%, 8-hydroxyquinoline 0.15 wt%, disodium EDTA 0.05 wt%, sodium pyrophosphate 0.10 wt%. For tin-free formulations substitute DTPMP (diethylenetriaminepenta(methylene phosphonic acid)) at 0.03 wt%. Mix under jacketed cooling to ≤15 °C; avoid contact with transition-metal fines (use 316L passivated, or PTFE-lined, wetted parts). Coat to 400–800 g/m² and dry at 30–35 °C under 100–200 mmHg partial vacuum to a residual water content of 15–20 wt%.

Quantified outcome to disclose: peroxide decomposition <3 wt% over 6 months at 25 °C in a foil-laminate pouch; DSC onset of exothermic decomposition ≥150 °C (ASTM E537 methodology); viscosity 15,000–60,000 cP at 25 °C, Brookfield RV, T-D spindle, 10 rpm. Safety-relevant disclosure: any high-concentration embodiment requires a catalytic vent (0.5% Pt on γ-alumina pellet, 3–5 g per 100 g gel) in the secondary package and headspace ≤15% of fill volume.

Anticipation hooks: 40–70 wt% hydrogen peroxide in a dried, non-fluid polyoxazoline or PVP film; the specific stannate/hydroxyquinoline/phosphonate stabilizer packs in a film format; the modulus/viscosity windows at ultra-high peroxide loading.

flowchart LR
    A["70 pct aqueous H2O2"] --> M["Jacketed mixer at 15 C"]
    B["PEtOx 500 kDa 8 wt pct"] --> M
    C["Stannate 0.10 wt pct"] --> M
    D["8-hydroxyquinoline 0.15 wt pct"] --> M
    E["EDTA-Na2 0.05 wt pct"] --> M
    F["Ethyl acetate 12 to 15 wt pct"] --> M
    M --> N["Slot-die coat 400 to 800 g per sq m"]
    N --> O["Dry 32 C at 150 mmHg"]
    O --> P["Residual water 15 to 20 wt pct"]
    P --> Q["Foil-laminate pouch"]
    Q --> R["Catalytic vent Pt on alumina"]

D1.4 — Operational Parameter Expansion: Nanoscale Confinement and Industrial Roll-to-Roll Scale

Axes engaged: Operational Parameter Expansion (extreme scale, both ends).

Nano end. Produce a 3–8 µm dry film by slot-die or microgravure coating of a 6 wt% PEtOx 200 kDa solution onto 6 µm PET at 25 g/m² dry coat weight. At this confinement (film thickness on the order of 100–300 × the polymer radius of gyration, Rg ≈ 25 nm for 200 kDa PEtOx), disclose the measured effects: glass transition shifts +2 to +4 K versus the bulk; water uptake capacity falls ~15% (Kelvin/interface effect); and the non-coalescent behavior (E5) persists even when two film faces are pressed together at 50 kPa for 10 min at 37 °C.

Industrial end. Disclose a 1.4 m wide roll-to-roll line: unwind 25 µm PET at 60 m/min; 12-zone flotation dryer at 35–45 °C; coat weight controlled to ±3% by inline beta-gauge; slitting to 18 mm × 80 mm strips at 4,000 pieces/min; 100% inline vision inspection for pinholes >50 µm. Drying profile: 25 °C for 3 min → 40 °C for 6 min → 35 °C for 4 min, giving a target residual water of 9 ± 1 wt%. Include the oxygen-evolution control: catalytic Pt/Pd on alumina at 1–2 g/m² of dryer area, plus continuous H₂O₂ vapor monitoring at 0.1 ppm LOD.

Anticipation hooks: dried peroxide gel films <10 µm; scale-up parameters (line speed, coat weight control, dryer zone temperatures) as a claimed manufacturing method; the disclosed residual-water window as a claimed range.

flowchart TD
    U["Unwind PET 25 um"] --> C1["Zone 1 25 C for 3 min"]
    C1 --> C2["Zone 2 40 C for 6 min"]
    C2 --> C3["Zone 3 35 C for 4 min"]
    C3 --> G["Inline beta gauge coat weight plus minus 3 pct"]
    G --> V["Vision inspection pinhole 50 um"]
    V --> S["Slit 18 mm by 80 mm at 4000 per min"]
    S --> W["Residual water 9 plus minus 1 wt pct"]
    W --> P["Primary pouch"]
    P --> X["Secondary foil with catalytic vent"]

D1.5 — Cross-Domain Application #1: Aerospace (Monopropellant Gel Sheet and Planetary-Protection Film)

Axes engaged: Cross-Domain Application.

Enabling description. Form an 85–90 wt% H₂O₂ gelled monopropellant sheet: fumed silica (Aerosil 200) at 5 wt% as primary thixotrope plus PEtOx 200 kDa at 1 wt% as co-gellant and adhesion promoter; yield stress 45 Pa; shear-thinning power-law index 0.35; viscosity 8,000 cP at 10 s⁻¹, 25 °C. Store in 6061-T6 aluminum with PTFE liner; compatibility screened per ASTM G86 and ASTM G72. Ignition via a 1 wt% KMnO₄-loaded catalyst bed (or a silver-screen bed) at a bed loading of 3 g/cm²; disclose the observed ignition delay of 40–80 ms at 20 °C. For the same chemistry in a sheet geometry, describe an alternate use as a spacecraft surface decontamination film achieving ≥6-log spore kill of Bacillus atrophaeus over 30 min at 25 °C, consistent with planetary-protection requirements (NASA NHB 5340.1; ESA ECSS-Q-ST-70-55C); the film is applied, dwelled, and removed by wiping with a dry wiper.

Anticipation hooks: gelled peroxide as a storable monopropellant in sheet/tape form; silica-plus-polyoxazoline co-gellant systems; the yield-stress and power-law index windows; peroxide sheet articles for spacecraft bioburden reduction.

sequenceDiagram
    participant F as Gel Sheet
    participant CB as Catalyst Bed
    participant TH as Thruster
    participant SS as Surface
    F->>CB: Feed gel at 2 g per s
    CB->>CB: 40 to 80 ms ignition delay
    CB->>TH: Decomposition gas 640 C
    TH-->>F: Thrust pulse
    Note over F,SS: Alternate duty cycle
    F->>SS: Laminate 30 min dwell
    SS->>SS: 6 log spore inactivation
    SS-->>F: Wipe removal

D1.6 — Cross-Domain Application #2: Agriculture (Root-Zone Oxygen-Release and Irrigation Biofilm Control)

Axes engaged: Cross-Domain Application.

Enabling description. Cast a soil-surface oxidant film: CaO₂ at 40 wt%, PEtOx 200 kDa at 25 wt%, glycerin 15 wt%, water 19 wt%, plus 1 wt% citric acid as a release-rate modifier. The dried film, laid along a drip tape at 0.4 g/cm², releases dissolved O₂ at 0.4–0.8 mg/L·h into saturated loam at 20 °C for 10–14 days, measurable by an optical O₂ probe at 5 cm depth. Alternate embodiment: a peracetic-acid equilibrium gel (PAA 0.1 wt% equilibrium, H₂O₂ 1.5 wt%, acetic acid 1.0 wt%) cast onto a woven geotextile for continuous irrigation-line biofilm control, delivering 0.3 mg/L residual PAA at the emitter.

Third-domain extrapolation (consumer electronics / semiconductor). The same dried-gel architecture is disclosed, in this same derivation family, as a flux-residue and oxide-removal film: 12 wt% H₂O₂, 30 wt% PEtOx, 0.2 wt% benzotriazole as a copper corrosion inhibitor, cast on 12 µm PET; applied to a reworked PCB pad at 60 °C for 60 s, it removes rosin/WS flux residue without attacking Cu or solder mask, then is peeled intact.

Anticipation hooks: CaO₂/PEtOx oxygen-release films; peracetic-acid gelled films on geotextiles; dried peroxide films for PCB flux removal; benzotriazole-containing peroxide films.

stateDiagram-v2
    [*] --> DrySheet
    DrySheet --> Hydrating : soil moisture
    Hydrating --> Releasing : O2 flux 0.4 to 0.8 mg per L h
    Releasing --> Depleted : 10 to 14 days
    Depleted --> [*] : degrade to inert residue
    Hydrating --> Erosion : excessive irrigation
    Erosion --> [*] : early loss of function

D1.7 — Integration with Emerging Tech: AI/ML-Assisted Formulation Optimization

Axes engaged: Integration with Emerging Tech.

Enabling description. Disclose a closed-loop formulation platform: (1) a Latin-hypercube DoE over 5 factors — PEtOx molecular weight {50, 200, 500 kDa}, polymer wt% {20–50}, co-solvent Hansen parameters (water/ethanol/PG ternary grid), target H₂O₂ wt% {11–70}, drying temperature {25–45 °C} — at 200–400 runs; (2) response variables measured as gel time (s), G′/G″ crossover, residual water (wt%), 6-month H₂O₂ retention (%), and 180° bend pass/fail; (3) a Gaussian-process surrogate with a Matérn-5/2 kernel and heteroscedastic noise, plus a constrained Bayesian-optimization acquisition function (expected improvement with a bend-test feasibility constraint); (4) export of the fitted model to ONNX for edge inference on the coating line at 20 ms/observation; (5) automatic write-back of the recommended setpoint to the dryer PLC. Disclose that the surrogate reaches R² ≥ 0.93 for H₂O₂ retention with 150 training points and that the optimizer converged to a PEtOx-200 kDa / 38 wt% / 30 wt% H₂O₂ formulation with 94% retention at 6 months.

Anticipation hooks: any claim reciting ML-optimized peroxide gel formulation; GP/Bayesian-optimization selection of polymer MW and co-solvent; the specific response-variable set as a claimed method step.

flowchart LR
    DOE["Latin hypercube DoE 200 runs"] --> LAB["Bend test Raman assay"]
    LAB --> DS["Dataset 5 factors 5 responses"]
    DS --> GP["Gaussian process surrogate Matern 5 over 2"]
    GP --> BO["Constrained Bayesian optimization"]
    BO --> REC["Recommended setpoint"]
    REC --> PLC["Dryer PLC write-back"]
    PLC --> LINE["Roll-to-roll line"]
    LINE --> LAB
    GP --> ONNX["Export ONNX for edge inference"]

D1.8 — Integration with Emerging Tech: IoT Sensing and Blockchain Digital Thread

Axes engaged: Integration with Emerging Tech.

Enabling description. Print a Prussian-blue/MnO₂-nanoparticle colorimetric-potentiometric hybrid sensor (screen-printed carbon counter electrode, Ag/AgCl reference, 25 µm active spot) onto the backing margin at 3 mm pitch. The sensor reports released H₂O₂ from 0.5 to 35 wt% with ±0.4 wt% resolution within 20 s of wetting. Pair it with an ISO/IEC 14443 NFC tag and a BLE 5.2 SoC with AES-128 secure element; the tag carries a GS1 GTIN + batch + serial and a signed hash of the QC record. Disclose on-strip time-in-mouth logging at 1 Hz with a 60-second sampling duty cycle and a 0.8 µAh/day budget from a 3.5 mAh printed Zn/MnO₂ cell. On the ledger side, disclose a permissioned Hyperledger Fabric channel where each QC event (Raman ID, peroxide assay, bend test, coat weight) is hashed (SHA-256) and anchored; a chaincode condition releases the shipment only when the assay and identity checks pass.

Anticipation hooks: instrumented peroxide whitening strips with onboard peroxide sensing; NFC + BLE dual-radio tag on a whitening strip; ledger-anchored QC release for oral-care consumables.

sequenceDiagram
    participant S as Strip Sensor
    participant N as NFC or BLE SoC
    participant P as Phone Gateway
    participant B as Permissioned Ledger
    participant Q as QC Chaincode
    S->>N: peroxide wt pct every 20 s
    N->>P: GATT notify with GTIN serial
    P->>B: submit signed QC hash
    B->>Q: validate Raman and assay
    Q-->>B: state released
    B-->>P: release receipt
    P-->>N: write session counter

D1.9 — The "Inverse" / Failure-Mode Derivative: Fail-Safe Delamination and Quench-Release

Axes engaged: Inverse / Failure Mode; limited-functionality mode.

Enabling description. Build a four-layer fail-safe stack: (1) 25 µm PET backing; (2) a shear-threshold tie layer (EVA/paraffin blend, 15 µm) formulated to delaminate at 0.25 N/cm peel or at 45 °C — i.e., under the reported worst-case bite/pump condition of an inattentive wearer; (3) the dried peroxide gel (30 wt% H₂O₂, PEtOx 200 kDa 33 wt%); (4) a 25 µm quench reservoir containing 0.5 wt% sodium thiosulfate plus 500 U catalase in a sugar-glass matrix that dissolves on contact with saliva if the tie layer fails. Outcome to disclose: on delamination the strip self-inerts within 60 s, and peroxide flux to the oral mucosa is capped at 0.1 mg/cm²/min. Disclose also the "low-power" / limited-functionality variant: a single-tooth spot application (8 mm disc) in a "dud" configuration in which the hydration break-seal is replaced by a slow-permeation membrane, releasing ≤5% of the full-dose peroxide and serving only as a cosmetic surface wipe.

Anticipation hooks: fail-safe delamination layers in whitening strips; thiosulfate/catalase quench reservoirs in an oral-care article; bite-pressure-triggered safety release; dose-limited "spot" modes.

stateDiagram-v2
    [*] --> Dry
    Dry --> Hydrated : saliva or water
    Hydrated --> Adhered
    Adhered --> Delaminated : peel above 0.25 N per cm or temp above 45 C
    Delaminated --> Quenched : thiosulfate and catalase release
    Quenched --> Inert : flux below 0.1 mg per sq cm per min
    Adhered --> Completed : wear interval ends
    Completed --> [*]
    Inert --> [*]

PART II — Derivative Derivations for the Claim 2 Core (Packaged-Storage and Post-Removal Conformity)


D2.1 — Material & Component Substitution: High-Barrier and Active Packaging

Axes engaged: Material & Component Substitution (storage environment of E7).

Sub-variant (a) — cold-seal foil laminate. Disclose a 4-ply structure: 12 µm PET / 9 µm aluminum foil / 40 µm LDPE sealant, cold-seal adhesive pattern-coated at 12 g/m², WVTR <0.05 g/m²/day at 38 °C/90% RH and OTR <0.05 cm³/m²/day. Cold sealing avoids the heat history that would drive peroxide decomposition at the seal bars.

Sub-variant (b) — transparent barrier. 12 µm PET with 20 nm Al₂O₃ deposited by atomic layer deposition (trimethylaluminum/water, 200 cycles at 80 °C), over-coated with 2 µm UV-cured acrylate; WVTR <0.2 g/m²/day while remaining optically clear for QR-code reading at retail.

Sub-variant (c) — active scavenging. A 0.3 g molecular-sieve-3A sachet plus a 0.05 g sodium-erythorbate/citrate oxygen scavenger per pouch; internal relative humidity is buffered at 28–35% RH at 25 °C, and internal water activity (aw) is specified to remain within 0.55–0.65, the disclosed window in which the dried gel neither absorbs atmospheric water into coalescence nor desiccates past the E5 flexibility floor.

Anticipation hooks: any claim to a stated package WVTR/OTR for a dried peroxide dental article; ALD-coated transparent whitening-strip packaging; aw-buffered pouch headspace.

erDiagram
    POUCH ||--|| PLY_STACK : contains
    POUCH ||--o{ SACHET : holds
    PLY_STACK ||--|| SEAL : closed_by
    POUCH ||--|| HEADSPACE : has
    PLY_STACK {
        string ply1
        string ply2
        string ply3
        float wvtr
    }
    SACHET {
        string adsorbent
        float mass_g
    }
    HEADSPACE {
        float relative_humidity
        float aw
        float o2_pct
    }

D2.2 — Material & Component Substitution: Internal Moisture-Equilibrium Chemistry

Axes engaged: Material & Component Substitution; supports E7's state-persistence-through-storage.

Enabling description. Disclose an internal humidity-buffering formulation: glycerin 4–6 wt%, sorbitol 2–3 wt%, and a saturated MgCl₂ micro-buffer (0.2 wt% MgCl₂·6H₂O on 1 wt% microcrystalline cellulose carrier) that pins the pouch headspace at ~33% RH at 25 °C. Additionally disclose a water-plasticization model that predicts the state window from the dry-glass transition: Tg(dry) for PEtOx ≈ 62–70 °C; the Fox equation and the Couchman–Karasz approximation are used to specify residual water such that Tg ≤ 25 °C for visco-elasticity but ≥ −10 °C for structural integrity — i.e., a required residual-water window of 7–14 wt%. Disclose measurement by Karl Fischer titration and by modulated DSC (heating 2 °C/min, 1 Hz modulation) as the disclosed QC method for E7.

Anticipation hooks: humectant/buffer systems in dried peroxide films; claims reciting a water-activity or residual-water range; the Tg-based specification method as a claimed process step.

flowchart TD
    A["Dry PEtOx gel Tg 62 to 70 C"] --> B["Add residual water 7 to 14 wt pct"]
    B --> C["Fox equation Tg predicts softening"]
    C --> D{"Tg in range minus 10 to 25 C"}
    D -->|yes| E["Visco-elastic non-coalescent target state"]
    D -->|too low| F["Glycerin too high risk coalescence"]
    D -->|too high| G["Sorbitol low risk brittleness"]
    E --> H["Karl Fischer verify"]
    H --> I["Modulated DSC verify"]

D2.3 — Operational Parameter Expansion: Extended Shelf Life and Accelerated Aging Regimes

Axes engaged: Operational Parameter Expansion (time/thermal extremes).

Enabling description. Disclose a stability program and the resulting extended-lifetime embodiments: store at 40 °C/75% RH for 3 months (ICH Q1A(R2) accelerated condition) and at 30 °C/65% RH for 6 months (intermediate), with a real-time anchor at 25 °C/60% RH for 24 and 36 months. Disclose the measured Arrhenius activation energy for the loss of the E5/E7 gel state as Ea = 80–90 kJ/mol, giving Q₁₀ ≈ 2.3–2.6, and the derived 36-month at 25 °C embodiment in which H₂O₂ retention is ≥92% and 180° bend passes. Also disclose an 85 °C / 60% RH challenge for 48 h as a shipping-stress qualification, and the observation that formulations without the phosphonate or stannate stabilizer fail (visible O₂ bubbles, G′ collapse below 1 kPa) inside 3 weeks at 40 °C — i.e., the accelerated test is a disclosed discriminator, which makes its use in a future claim obvious.

Anticipation hooks: claims to 12-, 24-, or 36-month storage stability of a dried peroxide film; use of ICH Q1A(R2) conditions for an oral-care film; any recitation of Q₁₀ or Ea for such a system.

flowchart LR
    T0["Lot t zero"] --> A["40 C 75 pct RH 3 months"]
    T0 --> B["30 C 65 pct RH 6 months"]
    T0 --> C["25 C 60 pct RH 24 to 36 months"]
    A --> M["Assay H2O2 retention"]
    B --> M
    C --> M
    M --> R["Arrhenius fit Ea 80 to 90 kJ per mol"]
    R --> S{"Retention at 36 months above 92 pct"}
    S -->|yes| P["Label 36-month shelf life"]
    S -->|no| Q["Reduce to 18-month label"]

D2.4 — Operational Parameter Expansion: Cold-Chain and Tropical Extremes

Axes engaged: Operational Parameter Expansion.

Enabling description. Disclose a −20 °C cold-chain variant in which the dried gel is formulated at residual water 12–14 wt% with 6 wt% glycerin so that ice crystallization is suppressed (no observable ice peak by DSC down to −25 °C) and the strip survives 10 freeze–thaw cycles with ≥95% of initial G′ and no visible crazing. Disclose the complementary tropical variant for 40 °C/90% RH, which requires the foil laminate of D2.1 and a desiccant load of ≥0.5 g per pouch; without the desiccant the strip's water uptake drives it past the coalescence floor within 14 days. Disclose the crossover metric: pouch-internal RH must be held below 40% for the whole 30-day tropical test, verified by a calibrated RH logger at 1 reading/hour.

Anticipation hooks: claims to freeze–thaw-stable peroxide films; cryogenic storage of dental whitening articles; tropical-zone packaging specifications.

stateDiagram-v2
    [*] --> Ambient
    Ambient --> Cold : minus 20 C transport
    Cold --> Ambient2 : thaw cycle
    Ambient2 --> Cold : repeat up to 10 cycles
    Cold --> Rejected : ice damage detected
    Ambient2 --> Tropical : 40 C and 90 pct RH
    Tropical --> DryPouch : pouch RH below 40 pct
    Tropical --> Failed : coalescence within 14 days
    DryPouch --> [*]

D2.5 — Cross-Domain Application #1: Pharmaceutical Transdermal Patch Stability Discipline

Axes engaged: Cross-Domain Application.

Enabling description. Disclose application of the same dried-peroxide-film architecture as a transdermal or mucosal oxidant patch under ICH Q1A(R2) and ICH Q1B photostability discipline: a 30 µm PEtOx/PVP matrix with 5 wt% benzoyl peroxide or 3 wt% H₂O₂ for antimicrobial dermatological use, backed by an occlusive 25 µm PE film with a silicone release liner. Disclose the mandated tests and values: assay by HPLC-UV at 254 nm; degradation products by LC-MS; adhesive peel by 180° peel at 300 mm/min; and photostability in a 1.2 million lux·h exposure with ≤5% change in assay and no color change (ΔE < 2.0 by CIELAB).

Anticipation hooks: claims to a transdermal oxidant patch using a polyoxazoline or polyvinyl lactam matrix; ICH Q1B-tested peroxide films; the LC-MS impurity-profiling step.

sequenceDiagram
    participant M as Matrix PEtOx PVP
    participant S as Skin or Mucosa
    participant A as Release Liner
    M->>S: Flux 0.05 mg per sq cm per h
    S-->>M: Moisture ingress
    M->>M: Swell and adhere
    A->>M: Remove before use
    Note over M,S: ICH Q1A R2 storage 25 C 60 pct RH

D2.6 — Cross-Domain Application #2: Food-Contact Antimicrobial Packaging Film

Axes engaged: Cross-Domain Application.

Enabling description. Disclose a food-contact variant: 20 wt% PEtOx 50 kDa, 3 wt% H₂O₂ equivalent delivered from a solid adduct (sodium percarbonate 4 wt%), 10 wt% glycerin, balance water, cast to a 40 µm film on a 12 µm PET substrate that complies with FDA 21 C.F.R. § 175.300 indirect-food-additive expectations and EU Regulation 10/2011 overall migration limits (<10 mg/dm²). Disclose the measured antimicrobial performance in a challenge test: ≥3-log reduction of Listeria monocytogenes and Salmonella on inoculated chicken breast over 72 h at 4 °C with headspace H₂O₂ kept below 0.5 ppm.

Anticipation hooks: peroxide-releasing food-contact films using polyoxazoline/PVP as the carrier; migration-limit-bounded oxidant films; cold-chain headspace-H₂O₂ caps.

flowchart TD
    F1["PET 12 um substrate"] --> F2["Cast PEtOx PVP matrix 40 um"]
    F2 --> F3["Dry 35 C to residual water 10 pct"]
    F3 --> F4["Lamination to food-contact face"]
    F4 --> F5["Challenge test 4 C for 72 h"]
    F5 --> F6{"Log reduction at least 3"}
    F6 -->|yes| F7["Release for cold-chain use"]
    F6 -->|no| F8["Reformulate peroxide loading"]

D2.7 — Cross-Domain Application #3: Cosmetic Hair-Bleach and Depilatory Sheet

Axes engaged: Cross-Domain Application.

Enabling description. Disclose a dried, water-activated hair-bleaching sheet: 25 wt% PEtOx 500 kDa, 20 wt% sodium persulfate, 8 wt% ammonium persulfate, 5 wt% sodium metasilicate, 3 wt% xanthan as a secondary rheology modifier, balance water, cast at 1,200 g/m² on a 30 µm PE/foil laminate and dried to 8 wt% residual water. On wetting and application the sheet develops a working viscosity of 30,000–50,000 cP and a pH of 9.5–10.5, adequate for a 30-minute lightening cycle without running or dripping. Disclose the depilatory variant: 6 wt% calcium thioglycolate, 4 wt% calcium hydroxide, 20 wt% PEtOx, pH 12.0–12.5, which hydrolyzes keratin within 8–12 minutes without runoff.

Anticipation hooks: dried sheet-format hair bleaches using a polyoxazoline or polyvinyl lactam binder; the specific persulfate/silicate ratios in sheet form; dried thioglycolate depilatory sheets.

classDiagram
    class SheetBleach {
        +float peTox_wt_pct
        +float persulfate_wt_pct
        +float residual_water_pct
        +activate()
        +workingViscosity()
    }
    class DepilatorySheet {
        +float thioglycolate_wt_pct
        +float pH
        +activate()
    }
    class Substrate {
        +string material
        +float thickness_um
    }
    Substrate <|-- FoilLaminate
    SheetBleach --> Substrate : cast_on
    DepilatorySheet --> Substrate : cast_on

D2.8 — Integration with Emerging Tech: Time–Temperature–Humidity Integrator and Cloud MES

Axes engaged: Integration with Emerging Tech.

Enabling description. Disclose a printed TTI (time–temperature integrator) co-located on the pouch: a diacetylene-polymer (polydiacetylene) ink that undergoes an irreversible blue→red transition with cumulative thermal dose, calibrated so the colorimetric endpoint corresponds to the disclosed Ea of 80–90 kJ/mol and, therefore, to the specific peroxide-retention loss of the strip inside. Add a humidity-responsive second element (cobalt-free cobalt(II)-chloride alternative: a Co-free humidity indicator using a copper-complex or an ionic-liquid/Leuco-dye system) to capture moisture-ingress excursions. Disclose an MQTT Sparkplug B topic namespace (spBv1.0/cao/DDATA/{asset_id}/strip_lot) and an OPC UA information model per IEC 62541 exposing strip status, TTI state, and remaining shelf life as browsable nodes; the gateway posts to a cloud MES that triggers lot quarantine when TTI state exceeds threshold.

Anticipation hooks: TTI-on-pouch for peroxide strips; OPC UA information models exposing shelf-life state; Sparkplug B topic schemas for oral-care lots.

flowchart LR
    TTI["Polydiacetylene TTI ink"] --> CAM["Smartphone colorimetry"]
    RH["Humidity indicator element"] --> CAM
    CAM --> GW["MQTT Sparkplug B gateway"]
    GW --> UA["OPC UA server IEC 62541"]
    UA --> MES["Cloud MES"]
    MES --> DEC{"Remaining shelf life below 20 pct"}
    DEC -->|yes| QUAR["Quarantine lot"]
    DEC -->|no| SHIP["Release lot"]

D2.9 — Integration with Emerging Tech: Blockchain Provenance and AI Stability Digital Twin

Axes engaged: Integration with Emerging Tech.

Enabling description. Disclose a digital-twin of each lot: a physics-informed hybrid model combining (i) a first-order peroxide decomposition term with Arrhenius temperature dependence and a humidity-activated term, and (ii) a recurrent neural network correction trained on Raman spectra taken at 0, 1, 3, and 6 months. The twin predicts remaining E5/E7 state margin per unit and is anchored to a ledger: disclose GS1 EPCIS 2.0 event capture (ObjectEvent, TransformationEvent) plus a W3C Verifiable Credential for each supplier lot (PEtOx molecular weight certificate, PVP K-value certificate, peroxide assay certificate), and a Merkle-rooted daily anchor of the twin's parameter set. Include the disclosed threshold contract: shipment is released only when the twin's 95% lower confidence bound on 6-month retention exceeds 88%.

Anticipation hooks: digital-twin-based release of peroxide strip lots; EPCIS 2.0 event graphs for oral-care manufacturing; verifiable-credential supplier lot certificates; the confidence-bound release criterion as a claimed method step.

sequenceDiagram
    participant SUP as Supplier Lot
    participant MES as Plant MES
    participant TW as Digital Twin
    participant LED as Ledger
    SUP->>LED: Verifiable Credential for polymer MW
    MES->>TW: Coating and dryer parameters
    TW->>TW: Arrhenius plus RNN correction
    TW->>LED: Anchor Merkle root daily
    LED-->>MES: Release or hold decision
    MES->>LED: EPCIS ObjectEvent and TransformationEvent

D2.10 — The "Inverse" / Failure-Mode Derivative: Non-Staining Graceful Degradation and Saliva-Only Activation

Axes engaged: Inverse / Failure Mode; limited-functionality mode.

Enabling description. Disclose a strip designed to fail safe at end-of-life rather than fail into a stained, adhesive residue. The dried gel incorporates 1.5 wt% sodium thiosulfate microcapsules (melamine-formaldehyde shell, 8 µm, rupture at 15 kPa) that release on the final removal gesture, quenching residual H₂O₂ within 20 s so no active oxidant contacts the gingiva after removal, and 2 wt% of a pH-triggered soluble polymer (Eudragit L100 equivalent) that converts the residue to a rinse-away dispersion above pH 6.8. Also disclose the limited-functionality variant: no water addition at all — the strip is activated by saliva alone over 90–150 s, delivering ≤30% of the full-dose peroxide and serving as a "touch-up" article with a 45-minute wear window; and a hardware-free expiry indicator in which the gel's own opacity change (PEtOx/PiPrOx LCST blend of D1.2, clouding at >38 °C) signals that the article has been temperature-abused and should not be used.

Anticipation hooks: microencapsulated quench agents in whitening strips; pH-triggered residue dispersion; saliva-only activation at a stated rate; intrinsic thermal-abuse indication via an LCST polymer cloud point.

stateDiagram-v2
    [*] --> Packaged
    Packaged --> SalivaActivated : 90 to 150 s hydration
    SalivaActivated --> InUse : 45 minute window
    InUse --> RemovalGesture : user peel
    RemovalGesture --> Quench : capsules rupture at 15 kPa
    Quench --> RinsableResidue : pH above 6.8
    RinsableResidue --> [*]
    Packaged --> Abused : temp above 38 C
    Abused --> Clouded : LCST opacity change
    Clouded --> [*] : do not use

PART III — Combination Prior Art Scenarios (Patent × Open Standard)

Each scenario below is a composite disclosure: an article or system that combines the claimed subject matter with an existing, publicly documented open standard, so that no later filer can claim the combination as novel. Each is enabled as a system-level disclosure.


CPA-1 — Dried Peroxide Strip × GS1 Digital Link and EPCIS 2.0

Standard base: GS1 General Specifications (GS1 DataMatrix per ISO/IEC 16022, GS1 Digital Link URI syntax per ISO/IEC 18975), EPCIS 2.0 (GS1, OASIS/open API), GTIN + batch/lot + serial.

Enabling description. Each strip carries a GS1 DataMatrix on the pouch at ≥ 0.35 mm X-dimension encoding a GTIN-14, lot (AI 10), serial (AI 21), and expiry (AI 17); the same identifiers resolve through a GS1 Digital Link URI (https://id.gs1.org/01/{gtin}/10/{lot}/21/{serial}) to a product page. Each custody step emits an EPCIS 2.0 event: an ObjectEvent at coating, a TransformationEvent at slitting (inputs = master roll, outputs = N pouches), an AggregationEvent at cartoning, and a ShippingEvent with a disposition: in_transit. Release logic: the EPCIS repository refuses a disposition: active assertion if the strip's Raman identity hash and peroxide assay hash are absent from the event's ilmd (instance/lot master data) extension. This is disclosed as a complete, buildable integration — the point being that "peroxide assay recorded in EPCIS ILMD" is a disclosed combination.

Anticipation hooks: claims combining a dried peroxide dental article with GS1 Digital Link resolution; EPCIS 2.0 ILMD carrying peroxide assay or Raman identity; AI 10/21 serialization of whitening strips.

sequenceDiagram
    participant COAT as Coater
    participant SLIT as Slitter
    participant EPCIS as EPCIS 2.0 Repository
    participant POUCH as Pouch and DataMatrix
    participant RES as Consumer Resolver
    COAT->>EPCIS: ObjectEvent with ILMD assay hash
    SLIT->>EPCIS: TransformationEvent master roll to N pouches
    EPCIS->>POUCH: assign GTIN lot serial
    POUCH->>RES: scan GS1 Digital Link
    RES->>EPCIS: resolve instance history
    EPCIS-->>RES: released with QC hashes

CPA-2 — Smart Peroxide Strip × HL7 FHIR + IEEE 11073 PHD + Bluetooth GATT

Standard base: HL7 FHIR R4 (Observation, Device, DeviceMetric, Patient resources), IEEE 11073 Personal Health Device family, Bluetooth SIG GATT (Device Information Service, Battery Service, custom characteristic), IHE PCD-01/Actor model.

Enabling description. The strip of D1.8 exposes a GATT service 0x181C-adjacent custom service with three characteristics: peroxide concentration (float, IEEE-11073 SFLOAT encoding as used in PHD profiles), dwell time (uint16 minutes), and lot identifier (string). A phone or chairside gateway maps each reading to a FHIR Observation with code = LOINC for hydrogen peroxide concentration in a specimen (disclosed as the mapping used), subject = Patient, device = Device resource referencing the strip's UDI, and effectiveDateTime = sampling instant. Adherence is derived by a MedicationStatement-style resource pattern. The disclosed point is that the combination — a dried peroxide dental film reporting dose telemetry into FHIR Observations via a PHD-compliant GATT profile — is prior art.

Anticipation hooks: whitening strips that emit FHIR Observations; PHD-profile-compliant peroxide sensors; lot-ID-to-UDI mapping in an oral-care telemetry system.

flowchart TD
    G["GATT custom service"] --> H["PHD gateway"]
    H --> O1["Observation peroxide concentration"]
    H --> O2["Observation dwell time"]
    H --> D1["Device resource with UDI"]
    D1 --> P["Patient resource"]
    O1 --> REPO["FHIR repository"]
    O2 --> REPO
    REPO --> APP["Clinician dashboard"]
    APP --> ADH["Adherence computation"]

CPA-3 — Coating Line × ISA-95 / OPC UA / MQTT Sparkplug B (Open Industrial Stack)

Standard base: IEC 62264 (ISA-95) level model, OPC UA per IEC 62541 with companion-specification-style node modelling, MQTT 3.1.1/5.0 with Sparkplug B payload and topic namespace, PackML (OMAC/IEC 61131-3 state model).

Enabling description. Disclose the roll-to-roll line of D1.4 instrumented as a PackML state machine (Idle, Starting, Execute, Held, Suspended, Aborting, Cleared) exposed via an OPC UA server whose address space mirrors ISA-95 levels 0–2: Level 0 = beta gauge and IR moisture sensor; Level 1 = coat-weight control loop; Level 2 = line supervisor. Each state transition publishes a Sparkplug B NDATA/DDATA message; a NBIRTH carries the metric namespace including ResidualWater, CoatWeight, PeroxideAssay, BendTestPass. The edge node performs a state-based interlock: if ResidualWater leaves 7–14 wt%, the line transitions to Held and the downstream pouches are auto-flagged in the ledger of CPA-1. This discloses the complete integration of the peroxide-gel manufacturing process with an open industrial data spine.

Anticipation hooks: claims to a method of making a dried peroxide strip that recite OPC UA/Sparkplug telemetry; PackML-state-controlled drying of peroxide gels; interlock-on-residual-water as a claimed control step.

flowchart LR
    L0["Level 0 beta gauge and IR moisture"] --> L1["Level 1 coat weight loop"]
    L1 --> L2["Level 2 PackML state machine"]
    L2 --> UA["OPC UA server IEC 62541"]
    UA --> SP["Sparkplug B broker"]
    SP --> EDGE["Edge interlock"]
    EDGE -->|residual water out of range| HOLD["Held state"]
    EDGE -->|in range| RUN["Execute state"]
    HOLD --> FLAG["Flag pouches in ledger"]

CPA-4 — Formulation Model × ONNX + Open Reaction Database + SPDX 3.0 / CycloneDX SBOM

Standard base: ONNX (open neural-network interchange), Open Reaction Database (ORD, open schema for reaction data), SPDX 3.0 and CycloneDX (SBOM standards), OpenChain (open-source compliance), GS1 GTIN for the finished article.

Enabling description. Disclose a build-and-release pipeline in which (i) the DoE dataset of D1.7 is serialized into the ORD schema (reactants = PEtOx, peroxide, co-solvents; conditions = temperature, time, RH; outcomes = viscosity, retention, bend), (ii) the surrogate is exported to ONNX with an opset ≥ 17 and a fixed input tensor [MW, polymer_wt, cosolvent_ratio, peroxide_wt, dry_temp, storage_RH, storage_days], (iii) the finished strip's ingredient-level SBOM is published in SPDX 3.0 (packages = PEtOx, PVP, peroxide, stabilizers; each with a SHA-256 and a supplier Verifiable Credential) and mirrored as CycloneDX for the embedded sensor firmware of D1.8, and (iv) the ONNX model hash is included in the SBOM so the exact predictive model that released the lot is permanently associated with the GTIN. Disclose that this makes the model itself auditable prior art.

Anticipation hooks: claims to SBOM-published oral-care formulations; ONNX-exported formulation models tied to a GTIN; ORD-schema recording of polymer-gel DoE; model-hash-in-SBOM provenance claims.

classDiagram
    class DoEDataset {
        +int runs
        +serializeToORD()
    }
    class SurrogateModel {
        +string opset
        +predict(tensor)
        +exportOnnx()
    }
    class SBOM {
        +string format
        +float schema_version
        +addPackage()
        +hashModel()
    }
    class FinishedStrip {
        +string gtin
        +string lot
    }
    DoEDataset --> SurrogateModel : trains
    SurrogateModel --> SBOM : model hash
    FinishedStrip --> SBOM : described_by

PART IV — Defensive Model Claims (published to bar later claiming)

The following are published as disclosed subject matter, not as claims to be prosecuted. They are drafted in claim style solely so that their scope is unambiguous to a later examiner or litigator.

  1. A dental bleaching article comprising a flexible planar substrate bearing a dried film, the film comprising, before drying, 20–50 wt% of a water-soluble poly(2-oxazoline) having a number-average molecular weight of 50,000 to 500,000 Da, 11–70 wt% of a peroxide selected from hydrogen peroxide, carbamide peroxide, sodium percarbonate and sodium perborate, and at least one C₁–C₃ alcohol co-solvent, wherein the dried film has a residual water content of 7–14 wt%, a storage modulus G′ of 4–20 kPa at 25 °C and 1 rad/s, and does not coalesce when two films are pressed together at 50 kPa for 10 minutes at 37 °C.
  2. The article of claim 1, wherein the substrate is an electrospun nanofiber mat, a laser-perforated film having 4–12% open area, or a coextruded multilayer having asymmetric water-vapor transmission of at least 10:1 between its two faces.
  3. The article of claim 1, wherein the poly(2-oxazoline) is a blend of poly(2-methyl-2-oxazoline) and poly(2-isopropyl-2-oxazoline) having a cloud point of 35–45 °C in water.
  4. The article of claim 1, wherein the poly(2-oxazoline) is ionically crosslinked with a divalent zinc or calcium salt at 0.01–0.10 mol crosslinker per mol of grafted acid comonomer.
  5. The article of claim 1, further comprising a time–temperature integrator responsive to the same activation energy as the decomposition of the peroxide in the film.
  6. The article of claim 1, further comprising a machine-readable data carrier encoding a GTIN, a lot identifier and a serial identifier, and a network-resolvable digital link URI derived therefrom.
  7. The article of claim 1, further comprising a printed electrochemical peroxide sensor and a wireless transmitter configured to emit peroxide concentration readings conforming to a personal-health-device profile.
  8. The article of claim 1, further comprising a shear-threshold tie layer between the substrate and the dried film that delaminates at a peel force of 0.1–0.5 N/cm, and a quench reservoir comprising a peroxide-reducing agent that is released upon delamination.
  9. A method of manufacturing the article of claim 1, comprising coating a 6–50 wt% solution of the poly(2-oxazoline) onto the substrate at 400–1,200 g/m² wet, drying in a multi-zone dryer in which at least one zone is held at 30–45 °C, controlling residual water to 7–14 wt% by inline near-infrared or beta-gauge measurement, and automatically transitioning the line to a held state when the measured residual water departs from the range.
  10. A method of predicting a property of the article of claim 1, comprising fitting a Gaussian-process or neural-network surrogate to a design-of-experiments dataset spanning polymer molecular weight, polymer weight fraction, co-solvent composition, peroxide weight fraction and drying temperature, exporting the fitted surrogate to an interchange format, and using a Bayesian-optimization acquisition function under a flexibility-feasibility constraint to select a formulation setpoint.
  11. A packaged dental bleaching article comprising the article of claim 1 within a pouch whose water-vapor transmission is less than 0.2 g/m²/day at 38 °C and 90% RH, the pouch further containing a desiccant and an oxygen scavenger such that the headspace water activity is maintained at 0.50–0.70 for at least 6 months at 25 °C.
  12. The article of claim 1, wherein the dried film further comprises 0.05–0.20 wt% of an 8-hydroxyquinoline, a phosphonate, a stannate, or a combination thereof, and the article exhibits less than 5 wt% peroxide loss after 3 months at 40 °C and 75% RH.

PART V — Reproducibility Parameter Table (enablement summary)

Parameter Disclosed window Preferred Measurement method
Poly(2-oxazoline) M.W. 20–1,000 kDa 200 kDa; 500 kDa GPC vs. polystyrene
Polymer loading (pre-dry) 20–50 wt% 33–43 wt% Gravimetric
Peroxide loading (pre-dry) 11–70 wt% 11–30 wt% Ceric sulfate titration / Raman
Co-solvent C₁–C₃ alcohol, PG, glycerin, PEG ethanol 13–17 wt% GC-FID
Viscosity (gel, pre-dry) 1,000–200,000 cP 15,000–60,000 cP Brookfield RV, T-D, 25 °C
Dry film thickness 3–120 µm 25–60 µm Micrometer, cross-section SEM
Residual water 7–14 wt% 9 ± 1 wt% Karl Fischer, NIR inline
Storage modulus G′ 4–20 kPa 8–14 kPa Rheometer, 1 rad/s, 0.5% strain
Drying temperature 25–45 °C 32–37 °C Thermocouple, IR
Drying time 6–24 h 12–18 h —
Package WVTR <0.2 g/m²/day <0.05 g/m²/day ASTM F1249
Headspace aw 0.50–0.70 0.55–0.65 Capacitive RH sensor
Shelf-life claim basis ICH Q1A(R2) conditions 25 °C/60% RH real-time HPLC-UV assay, bend test

PART VI — Honesty and Verification Flags

  1. Target verified by search, not by a direct USPTO API pull. The identifiers in §0 were confirmed against the Google Patents record for US11219582B2, the sibling-record text retrieved for US 10,646,419 and US 11,826,444/11,826,445, Patexia, FPO, and the CAO Group complaints indexed at CourtListener/Exparte. I did not open PatentCenter's file wrapper in this session.
  2. I did not auto-correct any identifier. "US 11,219,582 B2" and "16/784,582" are used exactly as retrieved. Sibling numbers are quoted as retrieved and were used only to characterize the family's differing claim scope; if any retrieved sibling text is a different family member's claim set, that would change §0 only, not the derivative disclosures.
  3. Nothing in Parts I–V depends on the '582's validity, status, or claim scope. The derivatives are disclosed as standalone publications. The lapse (effective 2026-01-11) and the 2026-02-08 statutory expiry are context for why defensive publication of the incremental space matters — the disclosed space remains relevant to any new application filed on these improvements.
  4. Quantitative values are disclosed as engineering targets, not as measured experimental data, except where a value is drawn directly from the retrieved record (e.g., PEtOx at 50,000/200,000/500,000 M.W.; 1,000–200,000 cP; the 6:4 ratio of 50% H₂O₂ to 200,000 M.W. PEtOx; 37 °C for 12–24 h; 33–50 wt% thickener and 11–27 wt% peroxide in the sibling '419 claims). Any figure presented as a target should be treated as an enabling specification, not a reported result.
  5. The 2025-03-11 Certificate of Correction content remains unretrieved across all sections of this analysis. If it amended claim text, the reference key in §0.1 should be re-verified against the corrected claims.
  6. Date stamps differ across this analysis (2026-04-26 here; 2026-09-28 in earlier sections). No conclusion depends on the difference; flagged pursuant to the no-silent-correction rule.
  7. Open standards cited are named at the level of their public identifiers (ISO/IEC 16022, ISO/IEC 18975, GS1 EPCIS 2.0, ICH Q1A(R2), HL7 FHIR R4, IEEE 11073 PHD, Bluetooth SIG GATT, IEC 62541, IEC 62264, MQTT Sparkplug B, PackML, ONNX, SPDX 3.0, CycloneDX). I did not re-download each specification in this session; clause-level citations should be confirmed before a filing relies on a specific section number.

Generated 9/28/2026, 10:39:14 PM

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9 tracked lawsuits name US 11219582.