US 9358086

I'll verify the litigation/docket angle with targeted searches before summarizing.

Let me check for any litigation or PTAB activity specifically involving this patent and its owners.

Search posture / caveats

I could not query the USPTO PatentCenter/PAIR or CAFC docket systems directly — I only have general web search, which is not an authoritative docket source. I also found no evidence of any CAFC 2026 appeal, PTAB proceeding (IPR/PGR), or district-court case specifically naming U.S. Patent No. 9,358,086. Searches surfaced dental-mouthpiece litigation involving related parties (Innerlite, Inc. v. Zirc Dental Products, C.D. Cal. No. 2:13-cv-07501, and Solmetex, LLC v. Ascentcare Dental Products, Inc., W.D. Mich. No. 1:24-cv-00954), but those matters appear to involve other patents in the same family (e.g., U.S. 6,974,321) rather than the '086 patent itself. Treat any litigation/2026-docket statement as unconfirmed.

The bibliographic data below comes from the patent document itself and matches FreePatentsOnline and Google Patents listings.

Bibliographic summary — US 9,358,086 B2

Abstract (verbatim): "An intraoral device includes a flexible body having an upper front flap including evacuation holes and a upper edge; an upper rear flap forming an upper pocket with the upper front flap and including internal channels and a upper edge separated from the upper edge of the upper front flap to form an upper pocket opening, the internal channels terminating in grooves along the upper edge; a lower front flap including evacuation holes and a lower edge; a lower rear flap forming a lower pocket with the lower front flap and including internal channels and a lower edge separated from the lower edge of the lower front flap to form an lower pocket opening, the internal channels terminating in grooves along the lower edge."

Note the abstract omits the vacuum/non-vacuum functional limitation that appears in the claims.

Plain-language overview of the independent claims

Claim 1 — the device. A one-piece flexible intraoral body with four flaps: an upper front flap and an upper rear flap that together form an "upper pocket," and a lower front flap and lower rear flap forming a "lower pocket." The front flaps carry evacuation (suction) holes. The rear flaps have internal channels, and the rear flap edge is spaced from the corresponding front flap edge to create a pocket opening; the channels end in grooves along that rear-flap edge. The functional hook: when no vacuum is applied the pocket openings sit open, but under vacuum the openings substantially seal shut — so fluid is drawn in through the front-flap evacuation holes and through the grooves (which act as fluid inlets), then through the channels in the rear flaps. In other words, the seal is achieved by vacuum-induced collapse of the flaps against tissue rather than by a rigid seal.

Claim 9 — method of use. A method of using the claim 1 device: (a) insert it so the upper flap edges contact the roof/upper mouth and the lower flap edges contact the tongue; (b) apply vacuum so the pocket openings substantially seal closed and the grooves along the rear-flap edges become fluid inlets; and (c) aspirate fluid from the mouth through the front-flap evacuation holes and into the channels via the grooves.

Claim 10 — the device (broader/second species). Same four-flap pocket architecture, but the front flaps are recited with only an edge (no evacuation holes required), and the rear flaps are recited as "including grooves along the [upper/lower] edge." The vacuum/non-vacuum sealing behavior is again recited, with aspiration occurring through the grooves, which become fluid inlets in the rear flaps for drawing fluid into the device. Claim 10 is essentially the "grooves-only" inlet variant.

Dependent claims worth flagging:

• Cl. 2: holes in front flaps, not in rear flaps (specification explains this prevents three-way-syringe spray from passing through the device into the throat).
• Cl. 3: grooves are at the intersection of the rear-flap edges and internal channels, not in the front flaps.
• Cl. 4: channels are vertical. Cl. 5: channels form corresponding external ridges. Cl. 6: evacuation holes aligned with the channels.
• Cl. 7: recites a horizontally/longitudinally extending spine with upper and lower internal evacuation channels above/below it. Cl. 8: upper and lower portions vertically symmetrical about the spine (enabling left/right-side use of the same device).
• Cl. 11 (dep. from 1) and Cl. 12 (dep. from 10): the rear-flap profile is the same as the front-flap profile except for the grooves.

Drafting observations (analyst note, not legal advice): claim 8 recites "the spine" although claim 1 (from which it depends) does not itself recite a spine — a potential antecedent-basis vulnerability. Claim 10 is drafted independently of claim 1 and drops the evacuation-hole requirement, which broadens the groove-as-inlet concept but also removes a limitation that the specification ties to spray-blocking benefit.

What I cannot confirm

• Any CAFC 2026 docket entry, appeal number, or PTAB case involving US 9,358,086 — not found in searchable sources.
• Current ownership beyond the recorded Zyris, Inc. change-of-name; Google notes assignee listings "may be inaccurate."
• Whether the 2024 maintenance-fee lapse has been petitioned for revival; the record shows expiration effective 2024-06-07 with no later revival event in the data I have.

I'll run targeted searches on patent litigation databases for this specific patent number.

Let me run more targeted searches on litigation databases and specific party names.

Let me try more specific search angles on the parties and litigation databases.

Answer: No litigation naming U.S. Patent No. 9,358,086 found

I ran multiple targeted queries against litigation-oriented sources (patent-litigation aggregator pages, PTAB petition documents, docket-alarm-indexed and Justia/CourtListener dockets, and party-name searches). I found no case — district court, ITC, CAFC, or PTAB (IPR/PGR) — in which U.S. Patent No. 9,358,086 is identified as an asserted or challenged patent. I must flag the search limitations honestly: I could not query PACER, the Unified Patents litigation case-list portal, or Docket Alarm's search interface directly (those require subscription/authenticated access), so my negative finding rests on open-web indexing only, which for a low-profile, non-practicing-entity dental patent is thin but not obviously incomplete.

Because the tool returned no dockets for this number, I am reporting no known litigation rather than fabricating case data. Per your instruction, I did not fold in results for other patent numbers.

Related matters I did find — none of which involve the '086 patent

To be explicit and avoid confusion, here are the dental-mouthpiece disputes my searches surfaced, with a clear statement of why each is not a '086 case:

Why the absence is plausible

The '086 patent's architecture (the four-flap, vacuum-collapse "pocket" design with grooves as secondary inlets, claims 1/9/10) is a narrow improvement over the earlier Hirsch/Innerlite family that was actually litigated ('321, '973, '627, '308). The commercially active Zyris enforcement activity appears to have targeted the earlier, broader claims. In addition, the patent lapsed for non-payment of maintenance fees effective 2024-06-07 (recorded 2024-07-15), which would make it an unattractive assertion target and is consistent with its never having been asserted.

Caveats on what I could not verify

• No authenticated PACER/Unified Patents/Docket Alarm query was possible, so I cannot rule out a sealed, low-visibility, or very recently filed case.
• I found no record of a petition to revive the '086 patent after the 2024 lapse.
• If you need a definitive negative, the authoritative check is a PACER docket search plus the Unified Patents portal at the URL you cited (portal.unifiedpatents.com/litigation/caselist), searched by patent number "9358086," and a PTAB search in the USPTO PTAB End-to-End system. I could reach neither portal programmatically here.

Bottom line: on the evidence retrievable, there is no known litigation involving U.S. Patent No. 9,358,086.

I'll verify the structured data with targeted searches before stating conclusions.

PTAB proceedings on file — verification note

I ran the structured ODP block as the canonical source and then tried to corroborate or expand it with web searches (Google Patents / FreePatentsOnline / Justia, P-TACTS document hits, docket aggregators, and law-firm press releases). The canonical block returns zero AIA trial proceedings, and I found nothing in the open web to contradict it. I could not query PTAB E2E or P-TACTS' case-search UI directly from here, so treat the negative as strong but not docket-verified. No proceeding numbers are invented below — there are none to report.

Proceedings overview

Total AIA trial proceedings against US 9,358,086: 0. Breakdown: 0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 institution denials. The bottom-line defensive posture is not "the patent survived two IPRs and is hardened" — it is stronger than that in one respect and weaker in another: the patent was never tested at the Board at all, and it is dead by operation of the fee statute. Claims 1–12 remain textually intact and completely untested, but the patent expired on 2024-06-07 for failure to pay the 8th-year maintenance fee, so a defendant's primary posture is statutory expiration (35 U.S.C. §§ 41(b), 42; 37 C.F.R. § 1.362), not IPR invalidity.

Per-proceeding entries

None

No Inter Partes Review, Post-Grant Review, or Covered Business Method review naming U.S. Patent No. 9,358,086 appears in the ODP structured data or in any searchable public source. Because there is no proceeding, there is no:

• Type / Filed / Status / Judge panel — n/a (no APJ panel has ever been assigned).
• Petition grounds — n/a (no art has ever been asserted at the Board against this patent).
• Institution decision — n/a.
• Final Written Decision — none has ever issued; no claim of this patent has been canceled, confirmed, or construed by the Board.
• Settlement / termination — n/a.
• Appeal — n/a; no FWD exists to appeal, so there is no CAFC docket number to report.
• Defensive value — an IPR-based defense is unnecessary. The § 286 damages tail is the whole fight.

Adjacent activity I found — expressly NOT proceedings on this patent. To avoid confusion when a demand letter or docket sheet crosses your desk, these PTAB matters surfaced in the same technical space and involve overlapping parties/competitors, but none names the '086 patent:

• IPR2025-01057 — Ascentcare challenge to U.S. Patent No. 11,589,970 (Nguyen / Solmetex-side family; petition cites "Hirsch" as prior art). Source: P-TACTS petition document at https://ptacts.uspto.gov/ptacts/public-informations/petitions/1558083/.
• Petitions challenging U.S. Patent No. 12,011,329 and related Solmetex intraoral-isolation patents. Source: https://ptacts.uspto.gov/ptacts/public-informations/petitions/1558007/.
• A W.D. Mich. matter referencing U.S. Patent No. 6,974,321 ("owned by Zyris Inc. … expired on March 1, 2019") — a different Hirsch/Innerlite patent. Source: https://ptacts.uspto.gov/ptacts/public-informations/petitions/1557962/.

If you are being asserted the '086 patent, none of the above gives you § 315(e)(2) estoppel protection or an adverse FWD to cite. They are context, not precedent for your case.

Strategic summary

Claim status: all 12 claims UNTESTED; all 12 claims EXPIRED. Claims 1–12 of the '086 patent were never subject to an AIA trial. There is no cancelation certificate, no certificate of correction narrowing them, and no Board construction to lean on. That cuts both ways: a plaintiff can still assert the claims on paper, but the patent is unenforceable for any act on or after 2024-06-07. Note the accurate nuance: the lapse was recorded 2024-07-15 with an effective expiration date of 2024-06-07, and the record shows no later revival event or petition for revival in the data I have — that last point is unconfirmed and worth a PAIR/PatentCenter check, because a successful unintentional-delay revival petition under 37 C.F.R. § 1.137 would resurrect the tail. Two-thousand-word caution: revival petitions are granted, so do not assume the lapse is permanent until you have pulled the file wrapper.

Estoppel landscape: essentially none, and it does not matter here. Because no petition ever reached an FWD on this patent, § 315(e)(2) bars nobody. Every prior-art ground is theoretically available to a defendant — including grounds that would otherwise be barred. But the more important practical limit is § 315(b): an IPR petition is time-barred if filed more than one year after service of a complaint alleging infringement of the patent. And because the patent is expired, an IPR is a poor use of budget: the Board can still review an expired patent, but there is no reason for the patent owner to amend, and the resulting FWD would only clean up the pre-expiration damages window. The efficient move is a Rule 12 motion / summary judgment on expiration plus a § 286 accounting cut-off, not a PTAB petition.

Pattern signals: none pointing at this patent. No repeat petitioner, no patent-owner appeal activity, no defensive aggregator (Unified Patents and similar appear in the dental/medical-device PTAB record generally, but I found no Unified challenge to the '086 patent). The real signal is structural: this patent's value was allowed to lapse for non-payment of a maintenance fee in 2024 while the family's foreign rights also went inactive (EP 3145442 B1 "Not-in-force"; CA 2949997 C "Expired – Fee Related"; AU 2015264006 B2 "Ceased"), and the related continuation US 9,532,858 B2 lapsed the same way. A portfolio that is abandoned rather than litigated or defended is the story — the owner (Zyris) redirected its prosecution spend toward later filings (e.g., the 2020–2021 "Dental mouthpieces" family). The absence of any IPR here is therefore not the usual "well-asserted patents eventually attract IPRs" failure mode; it is the signature of a patent that was never worth attacking because it was never worth maintaining.

Recommended next steps

1. Confirm the expiration is final before you build a defense on it. Pull the file wrapper in USPTO PatentCenter (https://patentcenter.uspto.gov) for application 14/285,248 and app/patent number 9,358,086, and confirm (a) no § 1.137 revival petition is pending or granted, and (b) the terminal disclaimer filed against US 9,532,858 has no ongoing effect. The Google Patents legal-events trail I have ends at the 2024-08-06 "Lapsed due to failure to pay maintenance fee, effective 20240607" entry with nothing after it.
2. Do not spend on an IPR. With no FWD and no estoppel against anyone, an IPR buys you nothing that expiration does not already give you, and it resets a clock you do not need. Redirect the budget to (i) a § 286 damages-window analysis (a complaint filed today reaches back to roughly 2020-09-28, which is pre-expiration and therefore live), and (ii) an on-sale/public-use and pre-2014 catalog-art investigation, which is where any residual past-damages defense actually lives.
3. If you do face a demand citing claims 1–12, your response should quote the disposition record verbatim: no PTAB proceeding exists, no claim has been adjudicated, and the patent expired 2024-06-07. The absence of any PTAB activity is itself the argument — you can state plainly that the patent has never been tested and the owner let it lapse, and there is no contrary FWD or CAFC opinion for the other side to wave at you.
4. Authoritative sources to cite if you need to show the negative. PTAB E2E (https://ptab.uspto.gov), P-TACTS (https://ptacts.uspto.gov), the USPTO PTAB decisions portal at https://developer.uspto.gov/ptab-web/#/search/decisions, and CourtListener (https://www.courtlistener.com) for any CAFC appeal — there is no appeal to find for this patent, and a certification to that effect is defensible.

Confidence and limits. High confidence that no AIA trial proceeding names US 9,358,086 in the ODP data. Moderate-high confidence from corroborating searches. I did not have direct E2E/P-TACTS case-search access, so I cannot categorically exclude a very recently filed petition that neither ODP nor the web has indexed — if this matters for a filing deadline, verify through E2E directly. Everything about claim text and claim scope in this section derives from the patent document supplied above.

I'll verify what I can from public sources before reconstructing the record. Let me run several targeted searches.

Let me check the prosecution/assignment correspondent and the litigation history.

Assignment-chain reconstruction — US 9,358,086 B2

Source status. I could not open the USPTO Assignment Center query UI directly (it is a JavaScript application that my search tooling cannot render). The reel/frame data below therefore comes from the Google Patents "Legal Events" record for the patent document, which mirrors the Assignment Center records, and is corroborated by the assignee blocks printed on the face of the patent and its family members. I found no correspondent-of-record name in any retrievable source for these two reels — see the caveats in each entry and in signal #3. Search the reels yourself at https://assignmentcenter.uspto.gov/ (query by patent number 9358086), or the indexed mirror at https://assignment.uspto.gov/patent/index.html.

Per the project rules, the patent text itself is authoritative where it conflicts with search results; no conflict arose here.

Inventors

Notes / patterns:

• The '086 is a single-inventor patent. Nearly every earlier member of this family (e.g., US D495,799; US 8,734,152; US 6,974,321) names James A. Hirsch and Thomas R. Hirsch, and some name Hirsch + Hirsch as co-inventors. The '086 dropping to one inventor is consistent with a late-cycle improvement filing by the founding group, not with a change in inventive entity.
• No inventor-departure signal. Public company history states the founding team was Jim Hirsch, his wife Sandi Hirsch, and his brother Tom Hirsch, who started the company in 2001. Jim Hirsch is still publicly listed as "Founder & Board Member" of the successor entity as of the 2018 rebrand (Zyris). This is the opposite of the "all inventors gone within 12 months" fire-sale tell.
• Thomas R. Hirsch is listed on related Innerlite patents (e.g., D615,203, Malibu CA; US 8,734,152, Santa Barbara CA) but is not an inventor on the '086 — worth noting only because he is a family/portfolio principal, not a sign of transfer activity.

Original assignee

Innerlite, Inc., Santa Barbara, California (assignee block on the face of US 9,358,086; also the "Applicant" of record, app. 14/285,248).

• Business: operating dental-device manufacturer. Innerlite commercialized the Isolite illuminated dental isolation system — a mouthpiece-based retractor/evacuator/illuminator — i.e., the assignee is a product company, not a holding vehicle.
• Did it ship a product embodying the claims? Yes, to a high degree of commercial certainty. The claimed four-flap mouthpiece with front-flap evacuation holes, rear-flap channels and edge grooves is the architecture Zyris/Isolite still markets ("mouthpieces," "Posterior Mouthpiece," "Anterior Mouthpiece," sold in 6+ sizes) as the "heart" of the Isolite systems. The patent's own prosecution history cites a Zyris/Solmetex-adjacent competitive landscape ("Isolation vs. IsoDry," Frias RDH).
• Current status: the original corporate entity was not acquired or dissolved — it was renamed. The 2018-03-23 recorded event is a Change of Name from Innerlite, Inc. → Zyris, Inc., effective 2017-09-08. The company's own communications confirm Isolite Systems "has not been bought or sold" and the Zyris name is an outgrowth of the same organization (https://www.zyris.com/isolite-systems-is-becoming-zyris/). Zyris remains an operating manufacturer (Santa Barbara address used in trade directories: 6868A Cortona Drive, Santa Barbara, CA 93117), with a live product store and a 2020 exclusive-distribution agreement with Henry Schein (investor.henryschein.com/node/22301). Zyris is also still filing (e.g., EP 4259036 A4, "Dental mouthpieces," priority 2020-12-14, listed among citing/related documents).
• Name-collision caveat (do not conflate): a search surfaced a Florida entity, "INNERLITE LLC," document #L25000456371, registered agent Austin S. Devaney, 3129 Eagle Boulevard C, Orlando, FL 32804 (2026 FL annual report). This is not the Santa Barbara "Innerlite, Inc." that owns the '086. It is a distinct, apparently unrelated LLC and is not part of this chain.

Assignment timeline

Two recorded post-filing events exist for US 9,358,086. Both are benign; neither is an arm's-length sale.

2014-10-07 (executed) / recorded 2014-10-13 — Reel 033939/0332

• Conveyance: Assignment ("ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
• Assignor: Hirsch, James A.
• Assignee: Innerlite, Inc. (California)
• Correspondent: not retrievable from the sources I could access. For context only, the attorney/agent firm of record on an earlier Innerlite filing (US D495,799) was Procopio, Cory, Hargreaves & Savitch LLP, San Diego, CA — I could not confirm Procopio as the correspondent on reel 033939/0332, so treat this as an unverified lead, not a finding.
• Context: routine inventor-to-company assignment captured weeks before the 2015-11-26 pre-grant publication of US 2015/0335409 A1 — standard operating-company housekeeping.

2017-09-08 (effective) / recorded 2018-03-23 — Reel 045692/0285

• Conveyance: Change of Name ("CHANGE OF NAME; ASSIGNOR: INNERLITE, INC.")
• Assignor: Innerlite, Inc.
• Assignee: Zyris, Inc. (California)
• Correspondent: not retrievable (same limitation as above). No recurrence can be claimed.
• Context: internal reorg / change of name only — the same legal entity rebranding; no consideration, no third-party purchaser.

No other recorded assignments were found. In particular I found no security agreement, no license recordation, no release, and no correction for this patent, and no transfer to any entity other than the two above. The child continuation US 15/169,367 → US 9,532,858 B2 is a new application, not an ownership transaction (it would carry its own parallel assignment record, presumably the same chain).

Timeline diagram

timeline
    title Ownership of US 9358086
    2014 : Filed by Innerlite Inc
         : Inventor assignment recorded
    2016 : Patent issued
    2017 : Name change to Zyris effective
    2018 : Name change recorded
    2024 : Patent lapsed for unpaid fee

NPE / troll-pattern signals

Additional observation that cuts against NPE characterization: the patent lapsed for non-payment of maintenance fees effective 2024-06-07 (lapse recorded 2024-07-15; "PATENT EXPIRED FOR FAILURE TO PAY MAINTENANCE FEES"). An entity building an assertion program does not let its patent go abandoned for a routine maintenance fee. The '086 is now expired and in the public domain.

Verdict

Operating-company assertion.

The chain is a two-step housekeeping sequence — inventor assignment to Innerlite, Inc. (Reel 033939/0332, executed 2014-10-07) followed by a pure Change of Name to Zyris, Inc. (Reel 045692/0285, effective 2017-09-08, recorded 2018-03-23) — with zero intervening sale, LLC transfer, security interest, or aggregator purchase, and no NPE-list assignee anywhere in it. The beneficiary is a genuine dental-device manufacturer whose Isolite mouthpieces embody the claimed subject matter and whose corporate predecessor asserted the family against a competitor (Innerlite v. Zirc Dental Products, C.D. Cal. 2013).

Two honest limitations on that verdict: (a) I found no suit naming the '086 patent itself, so "assertion" applies at the corporate/portfolio level, not to this patent specifically; and (b) the patent is now expired for nonpayment of maintenance fees (2024-06-07), so there is no live assertion to characterize. Awarding anything stronger than "not an NPE chain" is not supportable on the record I retrieved.

Verification link: https://assignmentcenter.uspto.gov/ (enter patent 9358086); mirrored listings at https://assignment.uspto.gov/patent/index.html and Google Patents legal events at https://patents.google.com/patent/US9358086/en.

I'll verify the patent and its cited prior art against live sources before analyzing.

Let me verify several key cited references directly.

1. Target confirmation and scope

Target: U.S. Patent No. 9,358,086 B2 — "Intraoral device and method of use." App. No. 14/285,248; filed 2014-05-22; issued 2016-06-07; inventor James A. Hirsch (Santa Barbara, CA); original assignee Innerlite, Inc., now Zyris, Inc. 12 claims (independent claims 1, 9, 10). Pre-grant pub. US 2015/0335409 A1 (2015-11-26). PTA of 97 days noted on the face of the patent.
Grounding: https://patents.google.com/patent/[US9358086](/patent/US9358086)/en ; https://www.freepatentsonline.com/9358086.html ; front page of US 9,358,086 (patentimages PDF).

Scope note / method. I could not query USPTO PatentCenter, PAIR, or the examiner's PTO-892 directly — I have web search only. Everything below is built from (a) the citation list embedded in the patent record you supplied (listed there as "Citations (71)" / "Patent Citations (89)"), and (b) live verification of the most important references via Google Patents / FreePatentsOnline / PTAB exhibits. Where I am describing a reference I could not open directly, I say so.

Identifier discipline. All numbers are reproduced literally as they appear in the citation data (e.g., "US 20140212840A1," "US1122086A," "US20110311942A1"). I have not normalized or "corrected" any of them.

2. Legal framework that governs the § 102 analysis

• Effective filing date: 2014-05-22. The '086 claims no earlier domestic benefit and no foreign priority, so AIA (post-March 16, 2013) § 102 applies.
• Practical consequence: essentially every cited reference that published/issued before 2014-05-22 is available under § 102(a)(1) ("patented, described in a printed publication… or otherwise available to the public before the effective filing date").
• Exception — the Incept 2014 published applications and the Incept patent. US 2014/0212837–841 A1 published 2014-07-31 and US 8,911,232 issued 2014-12-16 — both after the '086 filing date. These are therefore § 102(a)(2) art only (U.S. applications/patents naming another inventor and "effectively filed" before 2014-05-22; the Incept family claims 2012-12-07 priority, and app. 14/100,323 was filed 2013-12-09, so the § 102(a)(2) date is met).
• Common-ownership caveat. US 6,974,321 and the rest of the Hirsch/Innerlite family are the applicant's own earlier work. Common ownership can defeat § 102(a)(2) art under § 102(b)(2)(C), but it does not remove them as § 102(a)(1) art — they issued years before 2014-05-22 and were public. So Hirsch's own earlier patents remain fully citable.
• Antecedent-basis issue carried forward. Dependent claim 8 recites "the spine" although claim 1 (its parent) does not recite a spine; claim 7 introduces it. Flagged as a drafting vulnerability, not a prior-art issue.

3. Bottom line up front

No single cited reference anticipates claim 1 as a whole. The claimed combination — (i) an upper/lower front flap carrying evacuation holes, (ii) a rear flap forming a pocket with the front flap and containing internal channels that terminate in grooves along the rear-flap edge, the two edges being separated to form a pocket opening, and (iii) the vacuum/non-vacuum sealing behavior where the pocket openings "substantially seal closed" and the grooves "become fluid inlets" — is not disclosed in one reference.

The closest three references, and what each is missing:

Claim 10 (the "grooves-only" independent claim, no evacuation holes required) is the broadest and most exposed claim, and is the one most plausibly reached by Black '280 alone or Black + Incept '232.

4. Tier 1 — references with genuine § 102/§ 103 bearing on claims 1, 9, 10

4.1 US 8,911,232 B2 — Incept, Inc. (Nguyen, Pham)

• Full citation: Nguyen, Thien; Pham, Tam Thanh. "Intraoral dental suction and isolation system." US 8,911,232 B2. App. 14/100,323; filed 2013-12-09; provisional 61/734,939 filed 2012-12-07; pre-grant pub. US 2014/0162209 A1 (2014-06-12); issued 2014-12-16. Assignee Incept, Inc. Foreign counterparts: EP 2903557 B8, WO 2015/088577 A1.
• Description: A one-piece flexible silicone mouthpiece with a main body portion comprising an enclosed pocket defined by an anterior wall, a posterior wall, and a side wall, the side wall perforated as a mesh, with additional perforations on the walls; a stability bar; a slit along the anterior wall's longitudinal axis; and an internal bridge protruding from the posterior wall with crests and troughs that hold the anterior and posterior walls apart during suction. The superior and inferior sides are formed identically, permitting the piece to be flipped/reversed.
• § 102 relevance: § 102(a)(2). Bears on claim 1 (flexible body, flap-like walls, evacuation holes, upper/lower symmetry as in claim 8) and claim 10 (pocket formed by opposed walls). The "crests on the interior surface to prevent collapse under suction" teaching is the same problem the '086 solves with the spine (claim 7). Gap: no front/rear flap pair whose edges are separated to form a pocket opening, and no grooves at a rear-flap edge that become fluid inlets. Not a clean anticipation; very strong § 103 art.
• URL: https://patents.google.com/patent/US8911232

4.2 US 8,029,280 B2 — Black / Van Ryn

• Full citation: Black, Brian P.; Van Ryn, John D. "Intra-oral device and method." US 8,029,280 B2. App. 12/284,900; filed 2008-09-26; provisional 61/126,294 filed 2008-05-02; pub. US 2009/0274991 A1 (2009-11-05); issued 2011-10-04. Divisional: US 8,292,620 B2; also pub. US 2011/0311942 A1.
• Description: A unitary, flexible tongue shield aspirator having a first layer with a proximal flap (tongue retractor) and a second layer spaced apart by a plurality of walls, the walls defining an axial passageway and forming at least one upper channel extending at an angle from the passageway to a top edge of the second layer and at least one lower channel extending to the bottom edge, so as to place the passageway in fluid communication with the oral cavity; plus bite member, bite grip, and HVE evacuation tube.
• § 102 relevance: § 102(a)(1) (patented >1 year before). This is the single closest disclosure to "internal channels terminating in grooves along the [rear flap] edge" (claims 1 and 10) and to claim 4 (channels that run to the edge; "at an angle"). Bears on claim 10 most directly, since claim 10 requires only grooves along the rear-flap edge and vacuum-induced inlet behavior. Gap: Black's channels open at the layer's top/bottom edge but the layered structure is not a front/rear flap pair defining a pocket opening that seals under vacuum; Black also lacks front-flap evacuation holes recited in claims 1/2.
• URL: https://patents.google.com/patent/US8029280

4.3 US 6,974,321 B2 — Innerlite, Inc. (Hirsch et al.)

• Full citation: Hirsch, James A.; Hirsch, Thomas R. "Intraoral device." US 6,974,321 B2. App. 10/375,230; filed 2003-02-27; issued 2005-12-13. Assignee Innerlite, Inc.
• Description: A one-piece flexible injection-molded body with upper front and rear flaps and lower front and rear flaps; the upper edges of the front flaps and lower edges of the lower flaps are sealed by the patient's mouth to form upper and lower evacuation channels; evacuation holes in the flaps communicate with the channels; a connection section runs outside the mouth to a vacuum source. A flexible bite piece is vertically compressible and longitudinally/laterally displaceable.
• § 102 relevance: § 102(a)(1). Recites essentially the entire claim 1 preamble architecture — four flaps, pockets/gaps between front and rear flaps, evacuation holes communicating with channels (claims 1, 2, 4, 7, 8). Gap: no internal channels within the rear flaps terminating in grooves along the rear-flap edge, and no vacuum-state sealing of the pocket openings. Because it predates the '086 by ~9 years, the § 102(b)(2)(C) common-ownership exception is unavailable. This is the most consequential § 103 starting point in combination with Black or Incept.
• URL: https://patents.google.com/patent/[US6974321B2](/patent/US6974321B2)

4.4 US 2014/0212840 A1 — Incept, Inc. (Nguyen, Pham)

• Full citation: "Intraoral device with slit." US 2014/0212840 A1. App. 14/228,057; filed 2014-03-27; priority 2012-12-07; pub. 2014-07-31.
• Description: Same Incept mouthpiece family as '232 — pocket with anterior wall (slit), posterior wall, side wall, mesh/perforations, stability bar, internal bridge.
• § 102 relevance: § 102(a)(2) only (published after the '086 filing). Bears on claims 1, 2, 7, 10 under the same analysis as '232; the slit/anterior-wall emphasis adds nothing beyond '232.
• Sibling § 102(a)(2) art (same family, filed 2014-03-27, pub. 2014-07-31): US 2014/0212837 A1 ("with mesh"), US 2014/0212838 A1 ("with bridge"), US 2014/0212839 A1 ("with stability bar"), US 2014/0212841 A1 ("with detachable mouth prop"); and US 9,788,924 B2 ("Intraoral device with bridge"). Relevant to claims 1, 7, 10.
• URL: https://patents.google.com/patent/US20140212840

4.5 US 6,213,772 B1 — Drident, L.L.C. (Costello)

• Full citation: "Oral isolation device with evacuation chambers." US 6,213,772 B1. Filed 1999-04-14; issued 2001-04-10.
• § 102 relevance: § 102(a)(1). Discloses an intraoral isolation device built around discrete evacuation chambers — bears on the "pocket/upper and lower evacuation channel" concept underlying claims 1 and 7. Gap: chambers are not formed by front/rear flap edges with grooves.

4.6 US 5,827,061 A — Goodman

• Full citation: Goodman, Phillip M. "Dental bite block with aspirator tips." US 5,827,061 A. Filed 1997-05-02; issued 1998-10-27.
• § 102 relevance: § 102(a)(1). Bite block with integrated aspirator tips — bears on the bite-piece/vacuum integration and fluid-inlet concept in claims 1 and 9 (method). It is one of the references marked as examiner-cited in the record.

4.7 US 5,127,411 A — Schoolman

• Full citation: Schoolman, Arnold. "Oral appliance for removing aerosols produced during dentistry." US 5,127,411 A. Filed 1988-10-12; issued 1992-07-07.
• § 102 relevance: § 102(a)(1). Background/apparatus art for hands-free intraoral evacuation of aerosols and fluids — claims 1 and 9 contextually; no pocket/flap/groove structure.

4.8 US 5,890,899 A — Sclafani / Intellitech

• Full citation: "Dental isolator." US 5,890,899 A. Filed 1997-06-27; issued 1999-04-06.
• § 102 relevance: § 102(a)(1). Dental isolation device; claim 1 environmental context.

5. Tier 2 — secondary references (principally § 103 / claim-element context)

6. Tier 3 — remaining citations (cumulative / background; no independent § 102 weight against claims 1/9/10)

7. Non-patent literature cited

1. Frias RDH, Mark, "Izolation vs. IsoDry," July 3, 2011, accessed Jan. 7, 2016 at http://markrdh.com/?p=147, 6 pages. A practitioner comparison of two commercial isolation mouthpieces. Available under § 102(a)(1) (dated 2011). Potentially relevant as prior public use / printed publication evidence describing an actual commercial device with an isolating mouthpiece — but on its face it is a comparative product review, not a structural disclosure of the claimed rear-flap grooves, so its § 102 weight against claims 1/10 is limited without the underlying product literature.
2. International Search Report and Written Opinion of PCT/US2009/000903, European Patent Office, July 22, 2009, 8 pages.
3. International Search Report and Written Opinion of PCT/US2015/032219, Korean Intellectual Property Office, Sept. 8, 2015, 16 pages — this is the ISR for the '086's own PCT counterpart (WO 2015/179785 A1).

8. Claim-by-claim § 102 map (most-relevant references only)

9. What I could not confirm / caveats

• I could not open PatentCenter/PAIR to retrieve the examiner's PTO-892 (Form 892) and its "cited by examiner" vs "cited by third party" designations. The Google Patents data marks only a handful with an examiner asterisk (e.g., US 2,937,445; US 5,827,061; US 6,022,214; US 6,974,321; US 8,911,232). Whether a given reference was the examiner's or the applicant's citation does not change its § 102 status, but it does affect how the record reads.
• Some descriptions in Tier 3 are title/date-grounded rather than full-text-verified. I verified full-text descriptions for the Tier 1 references (Incept, Black, Hirsch/Innerlite) and for US 8,911,232; for the bulk of the pre-1990 citations I am relying on titles, assignees, and dates.
• No new contradiction with the previously generated sections. That section flagged the Incept/Innerlite/Solmetex litigation picture as unconfirmed as to the '086 itself. Consistent with that, my searches surfaced PTAB proceedings IPR2025-01057 / IPR2025-01059 / IPR2025-01104 (Ascentcare Dental Products v. Solmetex, LLC), in which Black US 8,029,280, Hirsch US 6,974,321 / US 6,575,746, and Nguyen US 8,911,232 are being used as prior art against Solmetex patents (e.g., US 12,290,418). Those proceedings are not about the '086 — the '086 expired for fee non-payment effective 2024-06-07 — but they confirm that the same reference set cited during '086 prosecution is now the central invalidity arsenal in the Solmetex dispute. Treat the specific IPR/patent-number mapping as search-derived, not docket-verified.
• One record inconsistency worth noting: the front page of US 9,358,086 lists a much shorter "References Cited" set than the 71–89 entries aggregated on Google Patents; Google's larger list mixes examiner citations, third-party citations, and family citations. The analysis above uses the fuller supplied list, per your instruction.

I'll ground the key prior-art references before analyzing.

Let me check whether the closest Hirsch-family references already disclose the ridge/channel/groove structure.

Obviousness Analysis — U.S. Patent No. 9,358,086 B2 under 35 U.S.C. § 103

Scope note: The instructions direct me to use the Prior Art section of the patent page. That section lists 71–89 cited references (examiner-cited and third-party) plus 3 non-patent citations. I have quoted below only from references whose text I actually retrieved and verified. Where I am inferring a disclosure from a reference's abstract/summary rather than its full text, I say so. I have not read the full specifications of Black, Costello ('772), Goodman ('061), Kanas ('362), Sullivan ('718), Feltham ('086), or Costello, and I flag that limitation where it matters.

1. Governing framework and threshold dates

• Effective filing date: 2014-05-22. The '086 claims no earlier priority (the family table shows a single, self-referential "Priority Applications" entry for 14/285,248). The 1998 Innerlite/Hirsch family (U.S. 6,022,214 → 6,974,321 → 8,297,973) is therefore not in the '086's chain — a significant self-inflicted wound, because it makes that family available as prior art.
• AIA applies. Filed after 2014-03-16-adjacent boundary (post–March 16, 2013), no pre-AIA priority claim → § 102(a)(1)/(a)(2) as amended, and AIA § 103.
• Grace period does not save the inventor's own disclosures. Hirsch's own publications (e.g., US 2009/0246728 A1, published 2009-10-01) are more than one year before the effective filing date, so the § 102(b)(1)(A) exception is unavailable. The inventor's own earlier work is prior art against the '086.
• AIA § 102(a)(2) reach for the Incept references. US 2014/0212840 A1 (published 2014-07-31) and US 8,911,232 B2 (issued 2014-12-16) both post-date the '086's filing but claim benefit of provisional 61/734,939 (2012-12-07). They are § 102(a)(2) art as of their effective filing dates for subject matter carried in the provisional. The '086's own "Citations" list confirms both were before the examiner.

A threshold § 102 problem that may moot much of the § 103 analysis. US 2009/0246728 A1 (Hirsch et al., "Intraoral Device," pub. 2009-10-01) states, at [0007]:

"The body includes an upper front flap including an upper edge, an upper rear flap including an upper edge separated from the upper edge of the upper front flap by a gap, a lower front flap including a lower edge, and a lower rear flap including a lower edge separated from the lower edge of the lower front flap by a gap. The upper edges of the front flaps are configured to be sealed by an upper part of a patient's mouth and form an upper evacuation channel when the body is disposed within the patient's mouth… One or more evacuation holes in at least one of the upper flaps are in communication with the upper evacuation channel…"

US 6,974,321 B2 and US 8,075,310 B2 carry the same summary language ("An intraoral device includes a one-piece, flexible, injection molded body made of a single homogeneous material. The body includes upper front and rear flaps, and lower front and rear flaps…"). The '086's specification uses the same reference numerals for the same elements (device 200, front flaps 310/330, rear flaps 320/340, evacuation holes 410, spine 365), and third-party IPR briefing describes Hirsch's FIG. 19A as "an intraoral device 200 including front flaps 310, 330 … evacuation holes 410" and quotes Hirsch's spine 365 as "a light pipe and a separator for an upper internal evacuation channel and a lower internal evacuation channel."

If the full text of US 6,974,321 / US 2009/0246728 also describes the rear-flap ridges 412, internal channels 414, and edge grooves 416 (same numerals), claim 1 is anticipated under § 102, not merely obvious under § 103. I could not verify that from the text I retrieved, and I will not assert it. But a searcher or challenger should read the '321 and '728 specifications in full before doing anything else — this is the highest-value single check in the whole analysis.

The remainder of this memo assumes, conservatively, that the grooves-at-the-rear-flap-edge are the point of novelty, and analyzes them as a § 103 question.

2. Level of ordinary skill

For context, in the co-pending Incept/Ascentcare–Solmetex IPR proceedings (IPR2025-01057, IPR2025-01104), the petitioner proposed a PHOSITA with "at least a B.S. degree in mechanical engineering or a related field with at least two years' experience designing medical devices." That proposal is not binding on the '086, but it is a reasonable and defensible level for this field, and it is a level at which the combination of known anti-collapse and known inlet features is squarely within ordinary skill.

3. The prior-art landscape as it bears on the claims

4. Ground 1 — Hirsch '321 (or '728) + Black → claims 1–9, 11

Where Hirsch stops. Hirsch discloses the four-flap architecture, the edge gap, the tissue-sealing of the edges to form an evacuation channel, the evacuation holes, and the spine. It does not, in the text I retrieved, disclose the rear flaps having internal channels terminating in grooves along the rear-flap edge.

Where Black supplies the missing elements. Black's tongue shield aspirator has two layers separated by spaced transverse walls, with channels formed between consecutive walls, perforations in the layer, and — critically — an express statement of purpose: the walls "prevent the anterior and posterior layers from collapsing under suction," while fluids pass through the gaps. That is precisely the problem the '086's ridges/channels/grooves address. The '086's own specification concedes that the prior art already had upper/lower internal evacuation channels and that the claimed improvement merely "allow[s] the upper internal evacuation channel … and lower internal evacuation channel … to be smaller than was possible in the past because of the improved communication … caused by the evacuation holes 410, ridges 412/channels 414, and V-shaped grooves 416." A device whose advance is more efficient communication between the suction channel and the mouth is an optimization, and optimization along a known axis is the paradigm case for obviousness under KSR.

Motivation to combine (articulated).

1. Both references are in the same field and address the same problem (hands-free intraoral evacuation with tissue isolation); both are classified in A61C 17/06 / 17/10 territory, and Black was cited by the '086's own examiner.
2. Black teaches the desirability of the modification in terms ("prevent the … layers from collapsing under suction"). A PHOSITA modifying Hirsch to prevent Hirsch's flexible front and rear flaps from being drawn together under high-volume suction would naturally adopt Black's internal, channel-defining anti-collapse structure.
3. The grooves at the flap edge follow from the combination plus ordinary skill: once channels are formed in the rear flap and the opposite edges are sealed by tissue (which Hirsch expressly discloses creating "a substantial seal along upper edges 370, 380"), the channel becomes dead-ended at the edge unless an inlet is left open there. Cutting the channel through the sealed edge as a V/U notch is the obvious, minimal way to keep the inlet open. That is also exactly what Nelson teaches at a lower level of generality (apertures at "the lowermost and rearmost portions" of the lingual member, "where the saliva tends to pool or collect") and what the general saliva-ejector art teaches (edge/lateral vents to prevent tissue occlusion — cf. US 2009/0136895, "Evacuation Tips having Lateral Vents," listed in the page's Similar Documents).
4. The result is predictable — improved suction at the margins of the isolated field — and the '086's specification offers no data suggesting anything unexpected.

Claim 9 (method) falls with claim 1: Hirsch's own disclosure is framed in method terms ("the intraoral device 20 will now be described generally in use. The patient opens his or her mouth …a health care provider inserts the device …"), and Nelson frames its apertures functionally ("In operation, lingual member 106 is connected to a vacuum source … saliva that pools in the patient's mouth is collected through apertures 116"). The claimed step of applying vacuum so that the pockets seal and the grooves become inlets is the inherent consequence of Hirsch's disclosed tissue-sealing plus the edge grooves.

Claim 11 (rear-flap profile identical to front-flap profile "except for the grooves") is directly met by the '086's own admission that "the front flaps 310, 330 and the rear flaps 320, 340 (minus V-shaped grooves 416) respectively define envelopes that are the same and aligned with each other" — the design choice is stated as such in the specification, and Black likewise discloses an "anterior layer that corresponds in size and shape to a posterior layer."

5. Ground 2 — Incept '232 / '840 + Hirsch → claims 1, 10 (and 8)

Claim 10 is the broader, "grooves-only" species (front flaps recited with edges but no evacuation holes; aspiration "through the grooves"). It maps almost element-for-element onto Incept '840:

• "flexible body" + "upper front flap … upper edge" ↔ '840 cl. 1 anterior wall / posterior wall / side wall forming a pocket.
• "upper rear flap … forming an upper pocket" ↔ '840 cl. 1 "main body portion configured as a pocket."
• "grooves along the [upper/lower] edge" ↔ '840 [0021] "longitudinal, open slit 170 … may assist in capture and suction of water, saliva and debris."
• "in a non-vacuum state the pocket opening … open and in a vacuum state … substantially sealed closed" ↔ '840's flexible/resilient pocket walls under suction, and '232's bridge structure that "keep[s] the anterior wall separated from the posterior wall during suction" (i.e., the pocket walls collapse under vacuum absent anti-collapse structure).

Hirsch supplies the two-part flap geometry, the edge-to-edge gap, the vertical symmetry, and the spine with upper/lower evacuation channels. Motivation: Incept's own specification states the pocket walls collapse under suction and that the bridge/slit are there to preserve the flow path — the same problem Hirsch's flap geometry creates and the same problem the '086 claims to solve. Combining a known edge-referenced inlet (Incept) with a known flap-edge gap (Hirsch) is the predictable use of known elements to preserve suction at a sealed margin.

Claim 8 (vertical symmetry) is the cleanest dependent-claim obviousness finding available: Incept '840 [0015] states the superior and inferior sides "may be formed identically, which may allow for the mouthpiece to change orientation such that the superior side may appear as the inferior side and vice versa." That is the claim-8 concept almost verbatim, and it is disclosed as a deliberate design objective (ambidextrous placement), not an accident.

6. Ground 3 — Hirsch + Nelson + Black → all dependents

7. Where the patent owner has real arguments

I want to be candid that this is not a clean kill on the § 103 theory alone:

1. No single reference discloses the full combination. The specific triplet — (i) internal channels within the rear flap, (ii) terminating in grooves along the rear-flap edge, (iii) with the vacuum-induced sealing of the pocket opening as the operative inlet-enabling condition — is not shown together in anything I retrieved. The § 103 case rests on combination, and combination cases live or die on the articulated motivation.
2. Possible teaching away. Hirsch affirmatively relies on the flap edges sealing against the palate and tongue to create the evacuation channel. A patent owner will argue that a PHOSITA would not have cut inlets through the very edge whose sealing is functionally required. The rebuttal is that the '086 itself does both (seals at the edge, and cuts grooves at the edge), and that the sealing claimed is "substantial," not total — but the tension is real and worth briefing carefully.
3. Secondary considerations are thin in both directions. There is no record of unexpected results, and the specification offers no comparative data. Notably, the patent expired for failure to pay maintenance fees effective 2024-06-07, and the WO, AU, EP and CA family members are recorded as ceased/not-in-force. That is at best weak, non-dispositive evidence of diminished commercial significance and would be attacked as irrelevant (the assignee, Zyris, continued selling the Isolite line). I would not lead with it.
4. Prosecution history may cut the other way. The '086's Google Patents legal-events record shows only notices of allowance (2016-02-11, 2016-03-23) and no rejection entries. Google Patents does not reproduce the full file wrapper, so I cannot confirm whether any § 103 rejection was made and overcome, and what the examiner's stated reasons for allowance were. That record is the single most important thing to read before finalizing an invalidity position — an examiner's stated reason for allowance on the grooves would be examined-estoppel-adjacent ammunition for the patent owner.

8. Cross-reference / contradiction check against the earlier section

• No contradiction: the earlier section's statement that no IPR/PTAB proceeding names US 9,358,086 is consistent with what I found. The PTAB materials I located (IPR2025-01057, IPR2025-01104, and petitions bearing artifacts 1557962 / 1558007 / 1558083) are the Ascentcare Dental Products v. Solmetex family of proceedings over related mouthpiece patents (the '969, '418, '232, '970), not the '086.
• New and materially useful finding: those petitions repeatedly assert Hirsch as the archetypal prior-art mouthpiece — "In 2001 (EX1018). Hirsch taught a suction connector, a bite block …, a wide main body …, a narrow neck …, and a cheek retractor," and they cite Hirsch's FIG. 19A device 200 with flaps 310/330, holes 410, and spine 365. That is the '086's own disclosure architecture. It confirms that in the real-world litigation posture, the Hirsch family is the reference the industry treats as the primary prior art against 200-series mouthpieces.
• Caution on one identifier: one PTAB document refers to "the '686 Patent" (a bridge-structure patent with claims quoted at "7:30-32"). I have not equated that with US 9,358,086 — the quoted subject matter (a bridge structure with wave-shaped crests and troughs) does not match the '086's claims (four flaps, rear-flap channels and edge grooves). Do not conflate "'686" with "'086."

9. Bottom line

• Claims 1, 4, 5, 6, 7, 8, 9, 10, 11, 12 are, in my assessment, obvious over US 6,974,321 B2 (or US 2009/0246728 A1) in view of US 8,029,280 B2 / US 2011/0311942 A1 (Black), and further in view of US 2014/0212840 A1 (Incept "slit") and US 4,259,067 (Nelson). Claim 7 (spine) and claim 8 (symmetry) are the weakest claims in the set — claim 7's element is disclosed by Hirsch's own spine 365, and claim 8's element is disclosed nearly verbatim in Incept '840 [0015].
• Claims 2 and 3 are design choices supported by stated rationales in the specification itself, with Black and Nelson supplying the single-layer and edge-inlet alternatives.
• The strongest invalidity theory may not be § 103 at all. If US 6,974,321 B2 or US 2009/0246728 A1 discloses the rear-flap ridges 412, internal channels 414, and edge grooves 416 under the same reference numerals (as the shared 200-series numbering strongly suggests), claim 1 is anticipated under § 102, and the § 103 analysis becomes secondary. That check should be performed first, against the full text of those two documents, plus the Korean IPO International Search Report and Written Opinion on PCT/US2015/032219 (cited on the '086 page, NPL item 3) — the ISR/WO for this very family.

Confidence: Moderate for the claim-1-combination conclusion; high for claims 7, 8 and 11/12; low-to-moderate for claims 2, 3 and 5, which depend on reference text I did not read in full. I have not verified the full text of Black, Costello '772, Goodman '061, Kanas '362, Sullivan '718, or Feltham '086, and I have not verified the '086's complete prosecution history.