Invalidity dossier
US 11402368
Added 9/24/2026, 3:39:59 PM
Active provider: DeepSeek · deepseek-v4-flash
Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll search for authoritative information on this patent, including any litigation activity.
US Patent 11,402,368 — Summary
Important caveat up front: my searches returned no record of any litigation, PTAB proceeding, or CAFC 2026 appeal involving US 11,402,368. Searches on the number plus "litigation," "CAFC," and "docket" produced no relevant hits, and the "11402368"-adjacent results were unrelated patents/applications (e.g., a D. Del. case about a different "'023 patent," an "'904 patent," and unrelated file histories). I cannot confirm from authoritative sources that this patent has ever been asserted or appealed. Treat "no litigation found" as absence of evidence, not proof of non-existence — I was unable to query PACER/CAFC dockets directly.
Bibliographic data (from the patent record)
| Field | Value |
|---|---|
| Patent number | US 11,402,368 B2 |
| Title | Biological sample analyzer and biological sample analysis method |
| Application no. | US 15/772,196 (national stage of PCT/JP2015/082903) |
| PCT publication | WO 2017/090087 A1 |
| Pre-grant publication | US 2018/0313813 A1 (2018-11-01) |
| Priority / filing date | 2015-11-24 (PCT filing date; no earlier priority claimed) |
| Issue (grant) date | 2022-08-02 |
| Inventors | Michiru Fujioka; Nobuyuki Isoshima; Wataru Sato |
| Original assignee | Hitachi High-Technologies Corporation |
| Current assignee | Hitachi High-Tech Corporation (recorded as a name change, effective 2020-02-12, recorded 2020-04-14) |
| Status / term | Active; adjusted expiration 2036-11-20; 4th-year maintenance fee recorded paid 2026-01-21 |
| Claims | 12 (2 independent: claims 1 and 11) |
| Representative CPC | G01N 33/48721 (nanopore analysis), C12Q 1/6816, B82Y 15/00, C12Q 2565/631 |
| Attorney/agent of record | Crowell & Moring LLP |
| Family | JP 6498314 B2; CN 109073625 B (2020-03-17); GB 2558482 B (2021-11-17); WO 2017/090087 A1 (Ceased) |
Source: https://patents.google.com/patent/US11402368/en and https://uspto.report/patent/grant/11,402,368
Abstract (as granted)
"A biological sample analyzer using a nanopore, said analyzer comprising: a first chamber that storing a solvent; a baseboard provided with a nanopore through which a biological sample passes; a second chamber which is positioned adjacently to the first chamber via the baseboard and stores the solvent; a first electrode formed in the first chamber; a second electrode formed in the second chamber; a detector detecting the biological sample which has passed through the nanopore; and a stirrer stirring the solvent in the first chamber."
Note: the abstract still recites a "stirrer," but the granted independent claims do not — they recite a heater/cooler pair producing Bénard convection as the mechanism. This is a notable abstract-vs-claims mismatch.
Independent claim 1 — plain language (apparatus)
A nanopore-based biological sample analyzer with:
- first chamber holding solvent;
- baseboard containing the nanopore the sample passes through;
- heater on the lower surface of the baseboard;
- cooler on the upper surface of the first chamber;
- second chamber adjacent to the first via the baseboard, also holding solvent;
- a biological-sample guider moving the sample from chamber 1 → chamber 2;
- a detector sensing the sample passing through the nanopore;
where:
- the guider directs the sample to the nanopore by Bénard convection in the first chamber's solvent;
- the detector is configured to measure pass-through frequency through the nanopore; and
- "a high temperature part of the Benard convection is 42° C. or less."
Independent claim 11 — plain language (method)
A nanopore analysis method: (a) guiding a sample from a solvent-filled first chamber to an adjacent solvent-filled second chamber through the nanopore; (b) detecting, with a detector, the sample passing through the nanopore; where guidance to the nanopore is by Bénard convection in the first chamber driven by a heater on the lower surface of the first chamber and a cooler on the upper surface of the first chamber; the detector measures pass-through frequency; and the Bénard convection's high-temperature part is 42 °C or less.
Dependents (brief)
- 2 – controller that controls the Bénard-convection guidance based on the detector output.
- 3 – guidance controlled by the Rayleigh-number relation 5 < Ra_L < 1,710, with Ra_L = gβ(T₁−T₂)L³/(να); T₁ = upper first-chamber solution temp, T₂ = lower second-chamber solution temp.
- 4 – controller sets the timing of Bénard guidance from detector output.
- 5 – convection triggered when pass-through frequency ≤ a predetermined value.
- 6 – rounded outer periphery of the second chamber's inner bottom surface.
- 7 – solvent melting point < 0 °C.
- 8 / 9 – first temperature sensor at the first chamber's upper portion / second temperature sensor at its lower portion.
- 10 – guider has first electrode in chamber 1 near the inflow path and second electrode in chamber 2 directly across from the nanopore.
- 12 – method counterpart of claim 10's electrode placement.
Points of uncertainty / internal inconsistencies worth flagging
- Heater location differs between the two independents. Claim 1 says the heater is on the lower surface of the baseboard; claim 11 says the heater is on the lower surface of the first chamber. Relatedly, the description places the heater both below the nanopore baseboard (Fig. 2) and below the second chamber (Fig. 4, heater 401) — the claim language may or may not read on both embodiments.
- "42 °C or less" has no express antecedent I could locate in the supplied description text. The description discusses a ~10 °C temperature difference producing Bénard cells and turbulence onset "in the vicinity of 17 °C," but I did not find "42 °C" in the specification text provided. I cannot confirm the written-description support for this limitation from the material available to me.
- Claim 3's numeric range is in tension with the description. Claim 3 caps Ra_L at 1,710, whereas the specification states that "when the Rayleigh number Ra_L is equal to or greater than 1,710, a Benard cell is formed and the convection occurs" — i.e., the spec describes 1,710 as the onset threshold, not an upper bound. This is an apparent inconsistency between claim and description.
- No "stirrer" element in the granted independents, despite the abstract, title-of-record references, and reference numeral 118 ("stirrer") throughout the specification. The granted claims recite only the heater/cooler/Bénard-convection arrangement.
Prior art of record (for context)
Cited/relevant references include US 2005/0074782 A1 (Univ. of Michigan — biochemical reactions in a convective flow field), US 2011/0162963 A1 (Electronic Bio Sciences — increasing polymer/nanopore interactions), US 2013/0264206 A1 (Samsung — biomolecule detection with multiple electrodes), JP 2014-519823 A (Oxford Nanopore), WO 2014/165168 A1 (Arizona Board of Regents — translocation control), WO 2014/208184 A1 / US 2016/0153960 A1 (Hitachi High-Technologies — analysis device), US 2015/0060276 A1 (Peking Univ.), and JP 2015-206737 A (Hitachi High-Tech — analysis equipment). Non-patent literature: Belkin et al., ACS Nano 7:6816–6824 (2013) (locally heated solid-state nanopores); He et al., ACS Nano 7:538–546 (2012) (thermophoretic manipulation of DNA translocation); Nicoli et al., Nano Lett. 14:6917–6925 (2014) (solid-state plasmonic nanopores). The He and Belkin thermophoresis papers are the closest conceptual neighbors to the claimed temperature-gradient transport.
If you need docket-level confirmation of litigation or appeal activity, that would require a direct PACER / CAFC docket query, which my searches did not surface — I'd recommend verifying there rather than relying on the negative result above.
Generated 9/29/2026, 10:11:38 PM
Cases on file (0)
Specific litigation cases in our database that name US patent 11402368. The free-form analysis below may also discuss cases beyond this list.
No cases on file mention this patent. Upload a CSV or add a case manually in Admin → Manage litigation cases.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll search for litigation involving US patent 11402368.
Let me run more targeted searches on litigation databases.
Answer: No litigation found for U.S. Patent No. 11,402,368
Based on my searches — including targeted queries against patent-litigation aggregators (RPX Insight, CourtListener, PACER Monitor, Unified Patents-style results, Justia, and general web) — I found no record of any litigation, ITC investigation, or PTAB proceeding involving U.S. Patent No. 11,402,368 ("Biological sample analyzer and biological sample analysis method," Hitachi High-Tech Corporation).
I cannot provide the requested case list because, as far as the available sources show, there are no cases to list. No plaintiff, defendant, docket number, filing date, or outcome exists for this patent in what I could retrieve.
Important disambiguation (results that looked relevant but are NOT this patent)
Several search hits contained the string "023" or "02368," but none relate to U.S. 11,402,368. I flag them so they are not mistaken for this patent's litigation:
| Hit | What it actually is | Relevance to 11,402,368 |
|---|---|---|
| Sonos v. Linkplay (Delaware; IPR2025-00509) | Litigation over U.S. Patent 10,853,023 ("the '023 Patent") | Different patent; unrelated technology |
| Hip-prosthesis decisions citing "the 023 patent" (e.g., Wright Medical / Whiteside art) | U.S. Patent 5,133,023-family femoral implant claims | Different patent |
| Genentech "…the '023 patent to Affymetrix" (D. Del. 09-cv-00627) | An older patent in the 6,xxx series | Different patent |
| Ever Win Int'l v. Magnadyne, C.D. Cal. 2:10-cv-02368 | Case number coincidentally ends in "02368" | Not this patent |
| FrameTech LLC v. Hitachi, Ltd., E.D. Tex. 2:25-cv-00059 | Suit against Hitachi, Ltd. (2025) — but the asserted patent is not identified as 11,402,368 | Does not involve this patent |
Contextual notes (not litigation)
- Assignment/ownership: Originally assigned to Hitachi High-Technologies Corporation (2018), renamed Hitachi High-Tech Corporation (2020). No litigation-related reassignments (e.g., to an NPE) appear in the record.
- Family/foreign counterparts: JP6498314B2, CN109073625B, GB2558482B, WO2017090087A1 — none of these turned up in litigation searches either.
- Forward citation: A later Hitachi family member, JP7638386B2 (2025), cites this family — a prosecution citation, not a lawsuit.
- The patent is a specialized solid-state nanopore instrument patent. Its permissive use profile (a large operating-company appliance patent) makes it less likely to appear in the NPE-driven dockets that dominate litigation aggregators, consistent with the null result.
Caveats (I want to be explicit rather than fabricate)
- I could not directly query the Unified Patents litigation portal or PACER dockets in this session; my conclusion rests on indexed search results. A direct docket search (e.g., Docket Navigator, Lex Machina, PACER, or the Unified Patents Case List) would give a more authoritative negative.
- Patent numbers should be read literally, and I have not auto-corrected any identifier. If you intended a different number (for example U.S. 10,853,023, which is in active litigation between Sonos and Linkplay), the answer would differ substantially.
- Absence of evidence in these sources is not a guarantee of no litigation; a recently filed case might not yet be indexed.
Bottom line: No known litigation is associated with U.S. Patent No. 11,402,368 based on the sources searched. If you need a court-certified negative, I recommend a paid docket search of PACER/Docket Navigator under the patent number, which I was unable to run here.
Generated 9/29/2026, 10:11:35 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.
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.
Proceedings overview
Total AIA trial proceedings on file: 0. The structured "PTAB proceedings on file" block drawn from the USPTO Open Data Portal (ODP) returns no IPR, no PGR, no CBM for U.S. Patent No. 11,402,368 as of the most recent ingest, and my independent web searches (Google Patents family data, PTAB petition document repositories, uspto.report, and general litigation reporting) surfaced no AIA trial proceeding, no Director Review decision, and no Federal Circuit appeal involving this patent. The breakdown is therefore active: 0 / claims invalidated: 0 / claims sustained: 0 / settled: 0 / institution denied: 0 — a null set, not a "0–0 tie."
Bottom line for a defendant: the patent is untested at the PTAB, which cuts both ways. There is no invalidating FWD you can borrow, but also no § 315(e)(2) estoppel constraining your prior-art case — the entire field of art, including the art examined during prosecution and the art Hitachi itself distinguished, remains open to you in district court and in a fresh IPR. This is not a hardened patent; it is simply an unchallenged one. Note also that the claims on their face contain at least one apparent internal inconsistency (see the § 112 hooks below), which typically signals a claim set that has never been stress-tested adversarially.
Because no proceeding exists, the per-proceeding template is inapplicable. In its place, below is the substantive record a defendant actually needs.
Why there is no proceeding (and what that means procedurally)
There is no per-proceeding entry to report, but the reason matters:
- PGR is time-barred. The patent issued 2022-08-02. The 35 U.S.C. § 321(c) nine-month PGR window closed on or about 2023-05-02. PGR is no longer available to anyone.
- CBM is unavailable. Post-SAS/AIUIA and the 2020-09-16 sunset for CBM petitions, this patent — a nanopore biopolymer analysis device — is not a "covered business method" patent in any event. CBM was never a vehicle here.
- IPR is the only live vehicle, and it remains fully available to a party that has not yet been served with a complaint. Watch the 35 U.S.C. § 315(b) one-year bar: it runs from service of a complaint alleging infringement of the '368 patent (or a patent claiming priority to it, per Click-to-Call), and failure to file within one year is absolute.
- No statutory deadline is pending — there is no institution decision deadline, no oral hearing, and no 1-year FWD due date to track, because no trial was ever instituted.
Claim status summary (for the record, absent any PTAB narrowing)
All claims are UNTESTED at the PTAB and stand as issued. The patent has 12 claims:
| Claim | Type | Status |
|---|---|---|
| 1 | Independent (apparatus) | UNTESTED — as issued |
| 2–10 | Dependent (apparatus) | UNTESTED — as issued |
| 11 | Independent (method) | UNTESTED — as issued |
| 12 | Dependent (method) | UNTESTED — as issued |
No claim has been canceled, disclaimed, or held unpatentable by the Board. The only narrowing of record is prosecution history narrowing: the file wrapper shows a non-final action (2020-04-09), another non-final action (2021-06-17), a final rejection (2022-01-07), a new case docketed for examiner consideration (2022-04-11), and allowance (2022-04-28) leading to grant on 2022-08-02. As issued, claims 1 and 11 both carry an unusual, numerically specific limitation not found in the original disclosure narrative — "a high temperature part of the Benard convection is 42° C. or less" — which is the classic signature of an after-final amendment added for patentability over cited art. I cannot confirm the exact amendment without the file wrapper, and I flag that as a document to pull immediately (USPTO PatentCenter, application 15/772,196).
Prior art already of record (your starting point, and none of it is estopped)
Because no IPR was filed, no reference is off the table. The '368 patent's face cites:
- US 2005/0074782 A1 (Regents of the University of Michigan) — "Methods of performing biochemical reactions in a convective flow field." This is the most dangerous reference conceptually: it is convection-driven reaction/transport in a fluid chamber. Expect a defendant to build a § 103 combination putting this at the center.
- US 2011/0162963 A1 (Electronic Bio Sciences) — "System and Method for Increasing Polymer/Nanopore Interactions." Directly on the stated problem of the '368 patent (increasing nanopore encounter frequency).
- US 2013/0264206 A1 (Samsung) — the patent's own PTL 2, discussed and distinguished in the specification at col./¶ describing electrode-based field-bias moderation.
- US 2015/0060276 A1 (Peking University) — "Nanopore Control With Pressure and Voltage."
- WO 2014/165168 A1 (Arizona Board of Regents) — "Systems, devices and methods for translocation control."
- WO 2014/208184 A1 / US 2016/0153960 A1 (Hitachi High-Technologies) — "Analysis device" — applicant's own earlier work, useful for § 102(a)(2)/§ 103 and for obviousness-type double patenting adjacency.
- JP 2015-206737 A (Hitachi High-Technologies) — "Analysis equipment."
- JP-T-2014-519823 / US 2014/0262784 A1 (Oxford Nanopore Technologies) — the patent's own PTL 1.
And the examiner-cited non-patent literature, both squarely on point for temperature/thermophoretic transport through nanopores:
- Belkin et al., "Stretching and Controlled Motion of Single-Stranded DNA in Locally Heated Solid-State Nanopores," ACS Nano, vol. 7, pp. 6816–6824 (2013).
- He et al., "Thermophoretic Manipulation of DNA Translocation through Nanopores," ACS Nano, vol. 7, pp. 538–546 (2012).
- Nicoli et al., "DNA Translocations through Solid-State Plasmonic Nanopores," Nano Lett., vol. 14, pp. 6917–6925 (2014) — the patent's own NPL 1.
He et al. and Belkin et al. are temperature-gradient manipulation of DNA at a nanopore. That is uncomfortably close to the '368 patent's core inventive concept, and because no IPR was ever filed on this patent, no petitioner's § 315(e)(2) estoppel attaches to them. They are live ammunition.
§ 112 hooks visible on the face of the claims
I flag these as investigative leads, not as adjudicated defects:
- Claim 1 vs. claim 11 locate the heater differently. Claim 1 requires "a heater disposed on a lower surface of the baseboard" and "a cooler disposed on an upper surface of the first chamber." Claim 11 requires "a heater disposed on a lower surface of the first chamber and a cooler disposed on an upper surface of the first chamber." The apparatus claim puts the heater on the baseboard; the method claim puts it on the first chamber. If the specification's FIG. 2 embodiment (heater 201 below nanopore baseboard 103) is the only disclosure, claim 11's "lower surface of the first chamber" heater may raise written-description/enablement questions under § 112(a). Compare carefully against FIG. 4, where heater 401 is installed "downward the sample outflow section 105" — i.e., also not on the first chamber's lower surface.
- Claim 3's Rayleigh-number range is internally odd. Claim 3 recites guidance "controlled by"
5 < Ra_L < 1,710. The specification expressly teaches that "when the Rayleigh number Ra_L is equal to or greater than 1,710, a Benard cell is formed and the convection occurs," with stable cellular convection up to ~10× the critical value. A lower bound of 5 is not explained by, and appears directionally inconsistent with, the disclosed critical value. Claim 3's T1/T2 definitions ("solution temperature of the upper portion of the first chamber" / "solution temperature of the lower portion of the second chamber") also straddle two different chambers, while the specification's L is defined as the distance between the high-temperature part (T1) and low-temperature part (T2) — itself undefined as to which chamber. This is a genuine indefiniteness/§ 112(b) argument to develop. - The "42° C. or less" upper bound in claims 1 and 11 has no threshold rationale I can locate in the specification — the disclosure discusses temperature differences (e.g., ~10 °C, ~17 °C) but does not derive 42 °C. Expect a defendant to probe written description for that specific number, which strongly suggests it was lifted from a comparative example or an examiner's suggestion during the 2021–2022 prosecution.
Strategic summary
Claim landscape. All 12 claims of the '368 patent are untested and stand as issued. There is no PTAB proceeding to point to, no canceled claim to cite, and no FWD to hand a court. The patent's real narrowing has been prosecution-driven, not PTAB-driven: the granted claims are materially narrower than the disclosure's broad "stirrer in the first chamber" concept, and the added limits (Benard convection specifically; a 42 °C cap; claim 3's Ra_L band) give a defendant significant room to argue non-infringement by designing around the temperature-gradient requirement and to argue invalidity over the convection-driven transport art already on the face of the patent.
Estoppel landscape. This is the most favorable feature of the current posture for a defendant. Because no party has ever filed an IPR or PGR against this patent, the § 315(e)(2) estoppel bar is empty. No prior-art ground — whether it was before the examiner (Belkin, He, Nicoli, Michigan, Electronic Bio Sciences, Samsung, Peking University, Arizona State, Oxford Nanopore, Hitachi's own JP 2015-206737 and WO 2014/208184) or never submitted — is foreclosed. A defendant retains the complete universe: § 102 anticipation, § 103 obviousness in any combination, and § 112 grounds in district court. There is also no estoppel-creating petitioner to be in privity with, and no Sotera-style stipulation in play. If you file an IPR, you choose the art; the only cost is the § 315(b) clock and the estoppel you yourself create.
Pattern signals. None. There is no multi-petition pattern against this patent, no serial filing, no defensive aggregator (no Unified Patents, RPX, or similar) anywhere in the chain. The patent owner, Hitachi High-Tech Corporation, is a large operating entity — not a non-practicing assertion vehicle — and its family is globally maintained and active (JP 6498314 B2, CN 109073625 B, GB 2558482 B, WO 2017/090087 A1), with continued prosecution in the same space (e.g., JP 7638386 B2, granted 2025-03-03, "Biological sample analyzer"). Hitachi has shown no appetite to take this patent to the Board or to the Federal Circuit. That absence of PTAB traffic on a granted, family-maintained, long-expiry patent is itself a signal: the patent has not been asserted in a way that provoked third-party challenge.
One anomaly worth your attention. The structured block states ODP shows no proceedings. I independently located no proceedings either. But note that the terms "Benard convention," "43" in claim 1's lineage, and the 42 °C figure appear nowhere in the specification's own reasoning — only the post-issuance/narrowing claim language carries them. Pull the file wrapper (application 15/772,196) before you finalize any invalidity or claim-construction position; the after-final amendment that produced the 42 °C limit is the single most probative document for both § 112 and file-wrapper-estoppel purposes.
Recommended next steps
- Pull the file wrapper. USPTO PatentCenter, application 15/772,196 — retrieve the 2021-06-17 non-final action, the 2022-01-07 final rejection, any after-final response or RCE (docket entry 2022-04-11), and the examiner's reasons for allowance (2022-04-28). Identify exactly which claim language was added to overcome which reference. This drives both file-wrapper estoppel and any § 112 written-description argument.
- Cite the absence of PTAB activity affirmatively. In any IPR petition you file, there is no need to navigate around an existing FWD or a parallel Board proceeding; you have a clean slate and a clean § 315(b) timeline. Confirm filing well inside one year of any complaint service.
- Bench-test the § 112 arguments on claim 3 and claim 11. The heater-location conflict between claim 1 ("lower surface of the baseboard") and claim 11 ("lower surface of the first chamber"), and claim 3's
5 < Ra_L < 1,710bracket against the specification's 1,710 critical value, are the cheapest early-win theories available against this claim set. An IPR on § 112 is not available (IPR is limited to § 102/§ 103), so these belong in a district court invalidity contention or in a SAS-era PGR — which is, however, now time-barred. Practically, § 112 goes to district court. - Build the obviousness case around He et al. (2012) and Belkin et al. (2013). Both were before the examiner, both involve temperature-driven control of DNA at a solid-state nanopore, and neither is protected by any estoppel. Combine with US 2005/0074782 (Michigan, convective flow field) for the convection-chamber element.
- Monitor for future activity. There is nothing to put on a docket watch today — no institution deadline, hearing, or FWD date. But keep an eye on the family's continued prosecution (JP 7638386 B2 issued 2025-03-03) and on whether Hitachi asserts the '368 patent, since an assertion would both start your § 315(b) clock and create the first real opportunity for IPR traffic on this patent.
Sources checked: Google Patents, US 11402368 B2 (https://patents.google.com/patent/US11402368/en); USPTO PatentCenter (application 15/772,196); USPTO PTAB E2E / PTAB petition document repository (no '368 filings located); uspto.report/patent/grant/11,402,368; FreePatentsOnline US 2018/0313813 A1. No PTAB Final Written Decision and no Federal Circuit opinion exists for this patent, so none is cited — I have not fabricated a proceeding number, a panel, or a disposition, and I note explicitly that I could not confirm the precise after-final amendment language from the materials available to me and would need the file wrapper to state it definitively.
Generated 9/29/2026, 10:12:01 PM
Ownership chain (2)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
2018-03-16 · recorded 2018-04-30 · reel 045669/0209 · Assignment
FUJIOKA, Michiru; ISOSHIMA, Nobuyuki; SATO, WataruHITACHI HIGH-TECHNOLOGIES CORPORATION
routine acquisition
? · recorded 2020-04-14 · reel 052398/0249 · Change of Name
HITACHI HIGH-TECHNOLOGIES CORPORATIONHITACHI HIGH-TECHNOLOGIES CORPORATION
change of name only
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.
I'll research the assignment record before writing. Let me run parallel searches.
Inventors
| Inventor | Presumed employer at filing | Evidence / notes |
|---|---|---|
| Michiru Fujioka | Hitachi High-Technologies Corporation (Japan) | Named as assignor on Reel 045669/0209; assignment executed 2018‑03‑15 |
| Nobuyuki Isoshima | Hitachi High-Technologies Corporation (Japan) | Named as assignor on Reel 045669/0209; assignment executed 2018‑03‑15 or 2018‑03‑16 |
| Wataru Sato | Hitachi High-Technologies Corporation (Japan) | Named as assignor on Reel 045669/0209; assignment executed 2018‑03‑15 or 2018‑03‑16 |
Pattern check — no fire-sale precursor observed. All three inventors executed the assignment to the corporate applicant within a two-day window (2018‑03‑15/16), i.e., as a single batch immediately preceding U.S. national-stage entry (the 30-month PCT deadline was 2018‑05‑24). That is normal foreign-applicant practice, not a distressed hand-off. The record contains no evidence that any inventor departed the assignee, and none of the three is recorded as an assignor on any subsequent conveyance. I could not independently verify their current employment (no Assignment‑Center person-level index is exposed here), so I flag that as not determinable rather than "no departure."
Original assignee
- Entity named on the issued patent: Hitachi High‑Technologies Corporation (original assignee; renamed Hitachi High‑Tech Corporation, effective 2020‑02‑12).
- Primary line of business: operating industrial/analytical-instrument company — electron microscopes, analytical instruments (spectrophotometers, analyzers), semiconductor manufacturing/inspection equipment, LCD inspection equipment, and in vitro diagnostic systems and services. This is a large, publicly known operating group, not a licensing vehicle.
- Product embodying the claims: unverified. I could not confirm from the sources available that a commercial nanopore sequencer reading on granted claim 1 ever shipped. The patent's technical field is a solid-state nanopore instrument; the family's continuation of prosecution (JP 7638386 B2, 2025, Hitachi High‑Tech) suggests the company is still investing in the area, but investment ≠ a product in commerce. Do not treat "ships a product" as established.
- Current status: operating / going concern. Two independent corroborations: (a) the 4th‑year maintenance fee for large entity was paid 2026‑01‑21 (fee code M1551), and (b) the same corporate owner files and prosecutes later members of this family. I saw no dissolution, bankruptcy, or receivership record.
- Group-level ownership note (medium confidence, flag for verification): Hitachi High‑Technologies became a wholly owned/consolidated Hitachi group subsidiary following Hitachi, Ltd.'s tender offer completed in early 2020 — temporally consistent with the name change recorded at Reel 052398/0249. This is a share-level change; it produced no patent reassignment and does not break the chain of title. I could not confirm it from an SEC filing in this session.
Assignment timeline
Two recorded assignments exist. (I was unable to open the Assignment Center UI directly in this session — the reel/frame values below are the ones the authoritative patent record itself reports from the USPTO assignment database, rendered in the Google Patents legal‑events table. Correspondent-of-record fields were not retrievable; see the caveat under signal 3.)
2018‑03‑15 / 2018‑03‑16 (executed) / recorded 2018‑04‑30 — Reel 045669 / 0209
- Conveyance: Assignment — Assignment of assignors' interest (inventor-to-applicant)
- Assignor: FUJIOKA, Michiru; ISOSHIMA, Nobuyuki; SATO, Wataru (signing dates 2018‑03‑15 to 2018‑03‑16)
- Assignee: HITACHI HIGH‑TECHNOLOGIES CORPORATION (Japan)
- Correspondent: not retrieved — the recording correspondent field did not surface in any source I could reach. Note the prosecution agent of record on the patent face is Crowell & Moring LLP (per the bibliographic section generated earlier); a U.S. agent handling national-stage filings is the normal recorder for a Japanese applicant, but I cannot confirm the recorder identity. No recurrence to flag.
- Context: routine acquisition — the standard inventor→corporate-applicant assignment filed on U.S. national-stage entry of PCT/JP2015/082903. Not a fire-sale, not a transfer to an asserter.
- Same date, Reel 045669 context: an entity-status (FEPP) event was also recorded — status set to undiscounted / large entity. Relevant because it contradicts a "micro-entity shell parked the patent" theory.
2020‑02‑12 (effective) / recorded 2020‑04‑14 — Reel 052398 / 0249
- Conveyance: Change of Name (not a transfer of ownership)
- Assignor: HITACHI HIGH‑TECHNOLOGIES CORPORATION
- Assignee: HITACHI HIGH‑TECH CORPORATION
- Correspondent: not retrieved (same limitation as above).
- Context: internal corporate reorganisation — purely the company's own renaming (日立ハイテクノロジーズ → 日立ハイテク, English "Hitachi High‑Tech Corporation," head office moved to Toranomon, Minato‑ku, Tokyo) with no change in beneficial ownership. I independently corroborated the rename and its 2020‑02‑12 effective date against the company's own customer notice and Japan's corporate-number registry (houjin-bangou), which shows a name change and head-office change both dated 令和2年2月12日 (2020‑02‑12).
No other recorded conveyances. The record shows no Security Agreement, Merger, License, Release, Correction, or further Assignment. Nothing after 2020‑04‑14 — which means the patent has sat with the same operating-company owner through grant (2022‑08‑02) and to date.
Timeline diagram
timeline
title Ownership of US 11402368
2015 : PCT filed by Hitachi High-Technologies
2018 : Inventors assign interest to Hitachi High-Technologies
: Recorded Reel 045669 frame 0209
2020 : Company renamed Hitachi High-Tech
: Recorded Reel 052398 frame 0249
2022 : US 11402368 granted
2026 : Fourth year maintenance fee paid
NPE / troll-pattern signals
- Shell-entity transfer — NOT PRESENT. No "IP / Holdings / Licensing / Ventures" assignee ever appears. The only assignee in the chain is Hitachi High‑Tech Corporation (Reel 052398/0249), a Japanese operating company at a verified corporate address (1‑17‑1 Toranomon, Minato‑ku, Tokyo). No registered-agent service address, no single-purpose LLC, and the entity is self-evidently not single-purpose.
- Known asserter in the chain — NOT PRESENT. Neither Hitachi High‑Technologies nor Hitachi High‑Tech appears on the Acacia, Marathon, Intellectual Ventures, IPNav, Wi‑LAN, Mosaid/Conversant, Vringo, Pendrell, Round Rock, MPHJ, or Spangenberg rosters, and no such entity appears anywhere in the recorded chain. (Context, not a signal: other Hitachi affiliates have historically asserted their own patents — e.g., Hitachi Maxell's 2017‑era handset suits — but those are separate companies asserting their own operating patents, and no such assertion touches US 11,402,368.)
- Repeat correspondent across the chain — UNCLEAR (not determinable). The recording-correspondent field is the one datum I could not pull: neither the Assignment Center UI nor the Assignment Search index would resolve in this session, so I have no correspondent name or firm for either Reel 045669/0209 or Reel 052398/0249 and therefore no recurrence to test. What I can say is that both recordings are of a type that a Japanese applicant's ordinary U.S. prosecution agent handles (inventor assignment at national-stage entry; then a name-change recordation), and the patent face lists Crowell & Moring LLP as agent of record. That is a large general-practice IP firm used by operating companies; a single appearance is not a finding under the stated rule. Action item: pull the correspondent from the Assignment Center detail pages for both reels — it is cheap to verify and is the one field that could change this analysis if it turns out to recur on an NPE family.
- Cascading transfers — NOT PRESENT. Two events spaced ~2 years apart, one of which is a pure change of name; no chained LLCs, no shared-address assignees, no common principals.
- Pre-litigation transfer — NOT PRESENT. Per the earlier litigation section, no suit naming this patent was found at all, so the trigger condition cannot be met. There is also no transfer of any kind within 6 months of any date — the last recorded conveyance was 2020‑04‑14, six years ago.
- Bankruptcy fire-sale — NOT PRESENT. No Chapter 7/11 record for either assignee surfaced; the owner paid its 4th‑year maintenance fee on 2026‑01‑21 as a large entity, which is inconsistent with a distressed or abandoned portfolio.
- Privateering — NOT PRESENT / no evidence. Nothing in the chain moves rights to a third party that could assert on Hitachi's behalf; the patent never leaves the Hitachi group, and no funding/licensing intermediary appears.
- Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at the original operating-company assignee.
Verdict
Insufficient data (construed precisely: the record contains only the original inventor-to-company assignment plus a change-of-name, i.e., no ownership transfer to evaluate for NPE behaviour).
Justification: the sole substantive conveyance is the inventors' assignment to Hitachi High‑Technologies Corporation at Reel 045669/0209 (executed 2018‑03‑16, recorded 2018‑04‑30) — a routine national-stage filing step for a Japanese corporate applicant, acknowledged as a large/undiscounted entity — and the only later entry is a change of name only at Reel 052398/0249 (effective 2020‑02‑12, recorded 2020‑04‑14). No LLC, no asserter, no security interest, no post‑grant transfer; the patent remains with a going-concern operating company that paid its 4th‑year fee in 2026. There is accordingly no NPE chain to grade — the honest answer is "original owner still owns it," not "chain arranged for assertion." The one open item that could add colour is signal 3, the recording correspondent, which I could not retrieve; if you need it, verify at the USPTO Assignment Center search (https://assignmentcenter.uspto.gov/, mirrored at https://assignment.uspto.gov/patent/index.html) by searching patent number 11402368 or application 15/772,196, and read the correspondent fields on Reel 045669/0209 and Reel 052398/0249.
Contradictions / caveats to carry forward (nothing conflicts with the prior sections, but two boundaries matter):
- The earlier summary lists "Attorney/agent of record: Crowell & Moring LLP." That is the prosecution agent on the patent face — it is not necessarily the Assignment Center recording correspondent, which is a distinct field. I have not equated the two, and I could not retrieve either correspondent from the assignment database in this session.
- The earlier summary's "no litigation found" conclusion is load-bearing for signals 5 and 6 here; if a suit is subsequently found, signal 5 would still be not present (the last recorded assignment predates any conceivable filing by ~6 years), so the verdict would not flip.
- The 2036‑11‑20 adjusted expiration implies a PTA award of roughly one year beyond the 2035‑11‑24 twenty-year date — consistent with a normally prosecuted large-entity application, not a continuation-shell strategy.
- Per the earlier sections' internal-inconsistency flags (no "stirrer" in the granted independents; the "42 °C" limitation and the Ra_L = 1,710 cap lacking clean description support): these are validity/prosecution issues, not ownership issues, and they do not bear on the NPE assessment above.
Generated 9/29/2026, 10:12:15 PM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll verify the citation details for US 11,402,368's prior-art references before mapping them to claims.
Now let me verify the remaining cited references.
Prior-Art Analysis for U.S. Patent No. 11,402,368
Scope / search discipline. I searched specifically for US 11,402,368 ("Biological sample analyzer and biological sample analysis method," Hitachi High‑Tech Corporation). No results for other numbers are substituted. The authoritative prior-art-of-record set is the "Patent Citations (10)" and "Non-Patent Citations (5)" lists on the face of the patent (as fetched from https://patents.google.com/patent/US11402368/en). Identifiers are reproduced literally as they appear; e.g., "JP‑T‑2014‑519823" (used in the specification as "PTL 1") and "JP2014519823A" are the same document in two notations, and "US‑A‑2013/0264206" ("PTL 2") = "US20130264206A1." I have not normalized/corrected any ID.
Important analytical frame. Being "cited on the face" is not the same as being applied under § 102. For a single reference to anticipate, it must disclose every limitation of a given claim. The novel hook of this patent is the combination: (a) two solvent chambers separated by a nanopore baseboard, (b) a heater below / cooler above producing Bénard convection, (c) that convection itself serving as the biological-sample guider, (d) detection of the sample with a detector configured to measure pass-through frequency, and (e) a thermal cap of "42 °C or less." As analyzed below, no cited reference anticipates claims 1 or 11, and none anticipates any dependent claim as a whole; several are strong § 103 candidates.
1. The ten patent citations of record
| # | Full citation | Priority / Filing | Publication | Assignee | Brief description | § 102 verdict |
|---|---|---|---|---|---|---|
| 1 | US 2005/0074782 A1 (granted as US 7,537,890 B2, 2009‑05‑26) | 2003‑10‑03 | 2005‑04‑07 | The Regents of the University of Michigan (Krishnan, Ugaz, Burns) | Runs biochemical reactions (PCR) in a Rayleigh–Bénard convection cell; heat source at/near the bottom, cooling source at/near the top; temperature differential ≥5 °C (pref. ≥10 °C) establishes a convection cell; expressly recites the Rayleigh number Ra = gα(T₂−T₁)h³/(νκ). | No anticipation of any claim. Lacks the nanopore, baseboard, two-chamber nanopore cell, and any detector. Closest art on the convection element (claims 1, 3, 11) — § 103 core. |
| 2 | US 2011/0162963 A1 (granted as US 8,283,157 B2, 2012‑10‑09) | 2008‑06‑18 | 2011‑07‑07 | Electronic Bio Sciences, LLC | Long, thin analyte chamber with a nanopore in an "interaction region"; electrodes on either side generate an electrophoretic force that drives target molecules toward the nanopore to increase the number of molecules interacting per unit time; pore-blocking current sensor reads the analyte. | No anticipation. Solves the same problem (nanopore capture/frequency) but by electrophoresis, not convection; no heater/cooler/Bénard limitation; no "42 °C" cap. Relevant § 103 art for the guider/detector elements of claims 1 and 11. |
| 3 | JP 2014‑519823 A (spec's "PTL 1") | 2011‑05‑27 | 2014‑08‑21 | オックスフォード ナノポール テクノロジーズ リミテッド (Oxford Nanopore Technologies Ltd) | "Joining method." The patent itself characterizes PTL 1 as binding analytes to membranes where detectors are present (hydrophobic linker/cholesterol-tagged DNA captured at the membrane), reducing required analyte. | No anticipation. Different delivery mechanism (membrane binding), requires linker pretreatment, no thermal convection, no pass-through-frequency measurement. Addressed and distinguished in the patent's own Background. |
| 4 | US 2014/0262784 A1 | 2011‑05‑27 | 2014‑09‑18 | Oxford Nanopore Technologies Limited | "Coupling method" — same family/priority as item 3; coupling of a polymer (e.g., via a molecular motor) for controlled passage into a nanopore. | No anticipation. No convection/heater/cooler; no pass-through-frequency detector as claimed. |
| 5 | US 2015/0060276 A1 | 2012‑03‑13 | 2015‑03‑05 | Peking University (with President and Fellows of Harvard College; Golovchenko et al.) | Nanopore in a solid‑state membrane separating first (cis) and second (trans) reservoirs; a pressure source plus a voltage source across the nanopore; tunes translocation speed/capture and traps or reverses molecules. | No anticipation. Discloses the two-reservoir + two-electrode + nanopore architecture only, and drives the analyte with pressure/voltage, not convection. Relevant to claim 1/11 architecture; no thermal limitations. |
| 6 | US 2013/0264206 A1 (spec's "PTL 2"; granted as US 9,382,575) | 2012‑04‑09 | 2013‑10‑10 | Samsung Electronics Co., Ltd. | Nanopore device with a reservoir; first electrode in front of the nanopore device, second electrode inside the reservoir (nanopore between them), plus an added third electrode adjacent the nanopore to induce the target biomolecule toward the nanopore and to moderate electric-field bias; blocking-current sensing. | No anticipation of claims 1/11 (no convection/heater/cooler/42 °C). Closest art to claim 10 / claim 12 — the in‑chamber electrode placement (first electrode on the cis side; second electrode in the reservoir across the nanopore). |
| 7 | WO 2014/165168 A1 (US pub. US 2016/0025702 A1) | 2013‑03‑13 | 2014‑10‑09 | Arizona Board of Regents (on behalf of Arizona State University) | First and second compartments separated by a partition containing an orifice (nanopore); a first electrode pair in the two compartments; a functionalized second electrode pair at the orifice with a tunnel gap; aims to concentrate/trap analytes to raise effective concentration at the detector. | No anticipation. Two-compartment + electrode-pair + detection architecture resembles claims 1/11, but there is no thermal convection guider and no pass-through-frequency/42 °C teaching. Relevant § 103 art. |
| 8 | WO 2014/208184 A1 | 2013‑06‑28 | 2014‑12‑31 | 株式会社 日立ハイテクノロジーズ (Hitachi High‑Technologies) | "Analysis device" — Hitachi's own earlier nanopore analysis platform (two chambers/electrodes/detection). | No anticipation. No convection/heater/cooler guiding, no pass-through-frequency trigger. Same-assignee background art. |
| 9 | US 2016/0153960 A1 | 2013‑06‑28 | 2016‑06‑02 | Hitachi High‑Technologies Corporation | "Analysis device" — U.S. counterpart of item 8. | No anticipation. Same reasoning as item 8. |
| 10 | JP 2015‑206737 A | 2014‑04‑23 | 2015‑11‑19 | 株式会社日立ハイテクノロジーズ (Hitachi High‑Tech) | "Analysis equipment" — further Hitachi nanopore instrumentation disclosure. | No anticipation. No teaching of Bénard convection as the sample guider, no 42 °C cap. |
Note on provenance: in the front-page list only US 2005/0074782 A1 carries the "*" (cited by examiner) marker; the remainder appear as applicant/IDS‑type citations with no asterisk. So most of the above are art the applicant brought to the examiner's attention rather than art the examiner independently located.
2. Non-patent literature (5 records)
| Ref | Full citation | Date | Brief description | § 102 relevance |
|---|---|---|---|---|
| Belkin et al. | "Stretching and Controlled Motion of Single‑Stranded DNA in Locally Heated Solid‑State Nanopores," ACS Nano 7:6816‑6824 | 2013‑07‑22 | Local heating of a solid‑state nanopore creates a temperature gradient that stretches and controls ssDNA motion through the pore. | Closest NPL to the thermal-gradient transport concept behind claims 1/11. No anticipation: it is local heating/thermophoresis, not Bénard convection; no heater-below/cooler-above cell; no pass-through-frequency measurement; no 42 °C cap. |
| He et al. | "Thermophoretic Manipulation of DNA Translocation through Nanopores," ACS Nano 7:538‑546 | 2012‑12‑02 | A temperature gradient across a nanopore drives thermophoresis to manipulate DNA translocation. | Strong § 103 neighbor to the "temperature-difference moves the sample at the pore" idea; no anticipation (thermophoresis ≠ Bénard convection; no frequency-triggered stirring; no 42 °C). |
| Nicoli et al. (spec's "NPL 1") | "DNA Translocations through Solid‑State Plasmonic Nanopores," Nano Letters 14:6917‑6925 | 2014 | Conductive thin film near the nanopore + laser‑induced plasmons/near‑field and local heating to increase DNA pass‑through efficiency. | Disclosed and expressly distinguished in the patent's Background (needs E‑beam lithography structure + laser optics; causes temperature rise/noise). No anticipation of claims 1/11. |
| ISR | International Search Report (PCT/ISA/210), PCT/JP2015/082903 | 2016‑02‑16 | Search report for the application that issued as this patent. | Procedural; not art. |
| Written Opinion | Japanese‑language Written Opinion (PCT/ISA/237), PCT/JP2015/082903 | 2016‑02‑16 | Written opinion on patentability. | Procedural; not art. |
Additional family-level citations (listed under "Family Cites Families," i.e., art cited in sibling family members JP 6498314 B2 / CN 109073625 B / GB 2558482 B, not necessarily in the US IDS):
- US 2009/0277792 A1 — "Method for concentrating charged particles and apparatus thereof" (National Chung Cheng University), 2009‑11‑12 — charged‑particle concentration; tangential to the delivery problem, no anticipation.
- WO 2012/142174 A1 — "Site specific chemically modified nanopore devices" (Electronic Biosciences Inc.), 2012‑10‑18 — chemically modified pores; no anticipation.
3. Ranked "most relevant" prior art
- US 2005/0074782 A1 (Univ. of Michigan) — the single most relevant reference. It is the only cited document that supplies both the heater-below/cooler-above arrangement and the Rayleigh–Bénard convection mechanism and the Rayleigh-number relation (claim 3's formula). It cannot anticipate (no nanopore, no two-chamber nanopore cell, no pass-through-frequency detector, no 42 °C limit), but it is the natural § 103 primary reference against the convection core of claims 1, 3, and 11.
- He et al. (ACS Nano 2012) and Belkin et al. (ACS Nano 2013) — closest NPL; tie temperature gradients to nanopore translocation (thermophoresis / local heating). The strongest § 103 combination candidates with item 1.
- US 2011/0162963 A1 (Electronic Bio Sciences) — frames the identical technical problem ("increase the number of molecules interacting with the nanopore per unit time") and shows electrode-driven guiding + blocking-current detection (claims 1, 11).
- US 2013/0264206 A1 (Samsung) — closest to the electrode-placement limitations of claims 10 and 12 (cis electrode + reservoir electrode with the nanopore between them).
- WO 2014/165168 A1 (Arizona State) — two-compartment/nanopore/electrode-pair architecture plus explicit analyte concentration at the detector.
- Nicoli et al. (Nano Lett. 2014) — plasmonic/local-heating delivery; distinguished in the patent.
- US 2015/0060276 A1 (Peking Univ.), WO 2014/208184 A1 / US 2016/0153960 A1 and JP 2015‑206737 A (Hitachi), and the two Oxford Nanopore documents (items 3–4) — background architecture and alternative delivery mechanisms.
4. Claim-by-claim § 102 conclusion
- Claim 1 (independent, apparatus): No cited reference discloses, in one document, the first chamber + nanopore baseboard with a heater on the baseboard's lower surface + cooler on the first chamber's upper surface + second chamber + guider that guides by Bénard convection + detector configured to measure pass-through frequency + "high temperature part of the Benard convection is 42 °C or less." Not anticipated. Strongly vulnerable on § 103 if items 1 + 3/5 (or items 1 + NPL He/Belkin) are combined — but note the specification itself provides no express antecedent for "42 °C," which cuts in favor of validity on written description/enablement while also making the numerical cap hard to attack with the cited art.
- Claim 3 (dependent, 5 < Ra_L < 1,710): While US 2005/0074782 discloses the Rayleigh-number relation itself, claim 3 incorporates every limitation of claim 1, so no anticipation. (Also flag the internal tension carried over from the earlier section: the spec describes Ra_L ≥ 1,710 as the onset of a Bénard cell, whereas claim 3 caps Ra_L below 1,710 — an apparent claim/description inconsistency.)
- Claim 6 (rounded second‑chamber inner bottom): No cited reference discloses. Not anticipated.
- Claim 7 (solvent melting point < 0 °C): No cited reference expressly discloses. Not anticipated.
- Claims 8 / 9 (upper/lower temperature sensors): US 2005/0074782 mentions thermometers/probes generally, but claims 8/9 depend on claim 1, so not anticipated; at most § 103.
- Claim 10 (first electrode near the first chamber's inflow path; second electrode directly across from the nanopore): US 2013/0264206 A1 (Samsung) is the closest — first electrode in front of the nanopore device, second electrode inside the reservoir with the nanopore between them. Even so, claim 10 inherits all of claim 1, so no anticipation; this is the claim where the cited art is most threatening.
- Claim 11 (independent, method) / claim 12: Same analysis as claims 1 and 10. Not anticipated. (Note the cross-claim discrepancy flagged previously: claim 1 places the heater on the lower surface of the baseboard, while claim 11 places it on the lower surface of the first chamber — a distinction that matters when mapping any single reference against both independents.)
5. Caveats
- No § 102 rejection I can confirm. The prosecution events in the record (non‑final actions 2020‑04‑09 and 2021‑06‑17; response 2021‑09‑20; final rejection 2022‑01‑07; then allowance 2022‑04‑28) show that art was applied, but the record supplied to me does not identify which reference(s) formed the § 102/§ 103 grounds. I will not guess which citation was applied.
- Verification limits. I confirmed bibliographic/content details for US 2005/0074782 A1, US 2011/0162963 A1, US 2013/0264206 A1, US 2015/0060276 A1, and WO 2014/165168 A1 via live retrieval. For JP 2014‑519823 A, US 2014/0262784 A1, WO 2014/208184 A1, US 2016/0153960 A1, and JP 2015‑206737 A I relied on the patent's own front‑page citation data (priority/publication dates, assignee, title) rather than independent confirmation; those dates are quoted literally from the authoritative patent text.
- Terminology fidelity. "JP‑T‑2014‑519823" / "JP2014519823A," "US‑A‑2013/0264206" / "US20130264206A1," and "WO2014208184A1" / "US20160153960A1" (family) are the same documents in different notations; I have not altered any identifier.
- Nature of the "closest" art. All of the truly relevant art converges on delivery of analyte to a nanopore (electrophoretic, pressure, thermophoretic, local-heating, membrane-binding), yet none recites Bénard convection as the guider, and none recites a ≤42 °C convection cap. That gap is where this patent's novelty principally resides — and, correspondingly, where the written-description support for "42 °C" is thinnest.
Generated 9/29/2026, 10:12:26 PM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll research the prior art of record to ground this obviousness analysis.
Let me gather details on the remaining key references.
Obviousness Analysis — U.S. Patent No. 11,402,368 B2 under 35 U.S.C. § 103
Note on the two dates supplied in the prompt: the task header says "Current Date: April 26, 2026," while the session clock reads 2026-09-29. Neither changes the analysis — all prior art relied on here predates the 2015-11-24 filing date by years. Flagging it only because you asked me not to silently reconcile inconsistencies.
1. Framework and level of ordinary skill
Governing standard. Because the PCT (PCT/JP2015/082903) was filed 2015-11-24, the AIA applies. Obviousness is assessed under Graham v. John Deere / KSR Int'l v. Teleflex, with each claimed element found in the prior art, an articulated reason to combine, and a reasonable expectation of success. MPEP 2141–2143 and §§ 2144.04 (design incentives / predictable variation) and 2144.05 (ranges and optimization of a result-effective variable) are directly on point for the numerical limits here.
POSITA. I would define the hypothetical person as holding at least a B.S. in bioengineering, biophysics, EE, or applied physics, plus 2–5 years (or an M.S./Ph.D. with less experience) working on solid-state nanopore sensing and/or microfluidic devices — i.e., familiar with (a) nanopore blocking-current detection, (b) cis/trans chambers with trans-membrane electrodes, and (c) heat- and mass-transfer fundamentals including Rayleigh–Bénard convection and the Rayleigh number.
Claim element construction (for mapping only).
- "biological sample guider" — the patent's own spec equates this to electrodes 114/115 + voltage applying means 116 (REFERENCE SIGNS LIST).
- "detector … measure a pass-through frequency" — blocking-current detection; the spec itself says "the frequency per hour is obtained and counted, such that the pass-through frequency is obtained."
- "Benard convection" — textbook Rayleigh–Bénard convection (labeled "Rayleigh-Benard" in the cited art).
- "high temperature part of the Benard convection is 42 °C or less" — an upper bound on the hot region of the convection cell. As flagged in the prior sections, I could not locate "42 °C" in the supplied specification text, so its written-description support is unverified; for this § 103 analysis I treat it as a numerical upper limit on a result-effective variable.
2. The prior art of record, summarized by teaching
| Ref. | Identity | Key teaching relevant to §103 |
|---|---|---|
| PA-1 | US 2005/0074782 A1 (Krishnan, Ugaz, Burns; Univ. of Michigan; granted US 7,537,890 B2) | Expressly performs biological/biochemical reactions in a Rayleigh–Bénard convection cell. Requires "a reaction chamber, reaction solutions … and a heat source (at or near the bottom of the reaction chamber). In some embodiments, a cooling source is also provided at or near the top of the reaction chamber." Supplies the Ra number equation (Ra = gα(T₂−T₁)h³/νκ) and design guidance (chamber height/width, aspect ratio). States the chambers "comprise heating elements, cooling means, probes, thermometers and other devices." |
| PA-2 | US 2011/0162963 A1 (Electronic Bio Sciences; fam. US 8,283,157 B2) | Nanopore sensing system: analyte chamber + second chamber separated by a membrane with a nanopore; first and second electrodes imposing a field that drives analyte toward the nanopore "to increase the number of molecules per unit time that interact with the nanopore"; detection via pore-blocking signals. Critically, it states: "A possible solution would … be to increase the diffusion rate of the target molecules, for example by increasing the temperature of the electrolyte … However, such modifications may not be compatible … and may be very deleterious." |
| PA-3 | US 2013/0264206 A1 (Samsung) — "PTL 2" of the patent | Biomolecule detection apparatus with a plurality of electrodes; biomolecules guided by moderating the bias of the electric field with an added electrode. |
| PA-4 | WO 2014/165168 A1 (Arizona Board of Regents) | Systems/devices/methods for translocation control. |
| PA-5 | US 2015/0060276 A1 (Peking Univ.) | Nanopore control with pressure and voltage. |
| PA-6 | WO 2014/208184 A1 / US 2016/0153960 A1 (Hitachi High-Technologies) | Analysis device (same assignee family). |
| PA-7 | JP 2015-206737 A (Hitachi High-Tech) | Analysis equipment. |
| PA-8 | JP 2014-519823 A (Oxford Nanopore) — "PTL 1" | Analyte delivery/membrane binding (deemed by applicant to require a cholesterol-type linker pretreatment). |
| NPL-1 | He et al., ACS Nano 7(1):538–546 (2013) | Cross-pore thermal gradient: "the cis reservoir is kept at the melting temperature … by an exterior heater, while the trans stays at a lower temperature"; the insulating membrane drops most ΔT across the pore, generating thermophoretic capture and propulsion; reports high capture rate maintained. |
| NPL-2 | Belkin et al., ACS Nano 7(8):6816–6824 (2013) | Local heating of the nanopore volume via a nanometer-scale heater element that can be radiatively switched on and off; thermophoretic force 4–8 pN; promotes single-file translocation at biases as low as 10 mV. |
| NPL-3 | Nicoli et al., Nano Lett. 14(12):6917–6925 (2014) | Solid-state plasmonic nanopores; mechanism "based on plasmon-induced local heating and thermophoresis," used to raise event rates in LiCl buffers "known to suffer from low event rates." |
3. Primary combination — Claim 1 obvious over PA-2 (Electronic Bio Sciences) in view of PA-1 (Krishnan/Michigan)
This is the strongest § 103 case. Claim chart:
| Claim 1 limitation | Where taught |
|---|---|
| first chamber storing solvent | PA-2: "analyte chamber" holding electrolyte |
| baseboard including the nanopore | PA-2: nanopore in a membrane/interaction region |
| second chamber adjacent via the baseboard, storing solvent | PA-2: second chamber/electrode side of the pore |
| biological sample guider chamber-1 → chamber-2 | PA-2: "first and second electrodes … on either side of the interaction region … electrophoretic force that drives the target molecules … toward the nanopore" |
| detector detecting sample passing through the pore | PA-2: "pore blocking signals detected by a current sensor" |
| detector configured to measure pass-through frequency | PA-2: expressly aims to "increase the number of molecules per unit time that interact with the nanopore" — i.e., interaction/pass-through rate |
| guider guides sample to the pore by Bénard convection | PA-1: Rayleigh–Bénard convection in a chamber with heat source at the bottom and cooling source at the top to transport/re-act biological molecules — the "stirrer" the patent itself uses |
| heater disposed on a lower surface of the baseboard | PA-1: heat source "at or near the bottom of the reaction chamber" (the spec's own Fig. 2 places heater 201 on the baseboard's lower face) |
| cooler disposed on an upper surface of the first chamber | PA-1: "a cooling source is also provided at or near the top of the reaction chamber" |
| high-temperature part of the Bénard convection ≤ 42 °C | Not expressly disclosed — see § 7; argued as optimization of a result-effective variable |
Reason to combine (KSR factors all present).
- Same field, same problem. Both are biological-sample analysis devices; both target the identical problem — insufficient arrival of analyte at a detection element. PA-2 states the need verbatim: "a method is needed to increase the number of target molecules within the vicinity of a nanopore without pre-concentrating the sample … and without increasing the absolute number of analyte molecules." U.S. 11,402,368's stated problem is the same: "to increase the pass-through frequency of the biological sample passing through the nanopore."
- Express suggestion in PA-2. PA-2 itself suggests "increasing the temperature of the electrolyte" as a way to raise the molecular arrival rate — a near-express invitation to add thermal transport to a nanopore system. Its caution that this "may be … deleterious" is phrased in the conditional and is not a teaching away; a mere statement of a possible drawback does not defeat obviousness where the reference also proposes the very modification (KSR; MPEP 2145).
- Known technique, known function. PA-1 teaches that Rayleigh–Bénard convection is a simple and inexpensive way to move/react biological molecules in a chamber without a mechanical stirrer — which is precisely the advantage the patent claims ("there is no limitation on electrode installation … and a precision process … is not required"). A POSITA would predictably expect buoyancy-driven convection to replenish the depleted region near the nanopore.
- Predictable art. Rayleigh–Bénard convection is a well-characterized phenomenon with a governing dimensionless number that PA-1 supplies; there is a clear reasonable expectation of success.
4. Alternative/backup combination — NPL-1 (He) or NPL-3 (Nicoli) + PA-1 + a nanopore-sensing base (PA-2 or PA-3)
He et al. is the closest single reference on the thermal-gradient-across-a-nanopore concept and independently discloses most of the physical architecture: cis chamber with a heater, trans chamber with a cooler, a membrane between them — the exact heater/cooler topology of claims 1 and 11. Its difference from the claim is mechanism: He relies on thermophoresis (ΔT dropped across the pore), whereas the claim requires Bénard convection in the bulk first chamber.
- Combine with PA-1, which supplies the bulk Rayleigh–Bénard convection cell and the heater-below/cooler-above arrangement. Motivation: He reports that raising cis temperature increases capture rate and maintains high capture; Krishnan teaches that a bottom-heated/ top-cooled chamber convects and transports biomolecules; a POSITA seeking still higher pass-through frequency would combine the two transport mechanisms in one chamber.
- NPL-2 (Belkin) further teaches the switchable nanometer-scale heater, i.e., heating that "can be radiatively switched on and off" — the exact control capability needed for the frequency-triggered stirring of claims 4–5.
- NPL-3 (Nicoli) supplies the explicit problem statement — "low event rates" — motivating the whole line of work, and links heating to improved event rates.
5. Dependent claims
| Claim | Obviousness basis |
|---|---|
| 2 (controller based on detector output) | PA-2's current sensor output + NPL-2's on/off-switchable heater; feedback control of a heating element in response to a measured signal is a routine engineering expedient (§ 2144.04). |
| 3 (5 < Ra_L < 1,710, with the Ra formula) | PA-1 supplies the identical Ra formula (Ra = gα(T₂−T₁)h³/νκ) and Ra values. The claimed range is a range of a result-effective variable; ranges in the prior art's disclosed field, or optimized by routine experimentation, are prima facie obvious (In re Aller; In re Woodruff; MPEP 2144.05). ⚠️ Flagged previously and repeated: the spec places Bénard-cell onset at Ra ≥ 1,710, so claim 3's upper bound of 1,710 contradicts the description — the claim arguably excludes the only regime in which its own convection occurs, which weakens it as a distinguishing feature (and raises § 112 concerns). |
| 4 (timing of guidance) | NPL-2's "switched on and off" heater + PA-2's real-time blocking-signal detection → trigger heating at a chosen time. |
| 5 (convection when frequency ≤ threshold) | PA-2's blocking-signal counting + NPL-2's switchable heating, combined with ordinary control logic; the patent concedes this is conventional ("the pass-through frequency … is also measured as … an electrical signal value… when the pass-through frequency is equal to or less than … f_th, a stir operation is performed"). |
| 6 (rounded outer periphery of second chamber's inner bottom) | PA-1's chamber-geometry teaching (cylindrical/oval/doughnut chambers sized for the required ΔT) + routine design; the patent itself admits "efficiency of stirring may be increased by curving the corner portion of the container" — an applicant admission. |
| 7 (solvent melting point < 0 °C) | Routine choice of solvent — the patent's own spec names ethanol/acetone; PA-1/PA-2 use aqueous electrolytes without excluding low-freezing-point solvents. |
| 8 / 9 (temperature sensors upper/lower) | PA-1 expressly recites "probes, thermometers and other devices applicable to the particular reaction" for its convection chamber. Nearly a direct hit. |
| 10 (electrode in chamber 1 near inflow path; electrode in chamber 2 directly across from the nanopore) | PA-2's opposed first/second electrodes on either side of the interaction region; PA-3's plurality of guide electrodes. Optimizing electrode placement relative to the pore is routine design. |
6. Method claims 11–12
Claims 11–12 mirror claims 1 and 10 as method steps. The same combination (§3 or §4) renders them obvious: PA-2/He supply the guiding-through-the-nanopore-by-electrodes step and the detecting step; PA-1 supplies the step of guiding by Bénard convection "based on a heater disposed on a lower surface … and a cooler disposed on an upper surface." Note claim 11 says the heater is on the lower surface of the first chamber, whereas claim 1 says the lower surface of the baseboard — a drafting divergence I flagged earlier. Claim 11's version (heat below, cool above the same chamber) is the textbook Rayleigh–Bénard configuration that PA-1 discloses almost verbatim, making claim 11 arguably the more vulnerable of the two independents.
7. The two limitations that carry the patent — and why they are still vulnerable
(a) "high temperature part of the Benard convection is 42 °C or less."
No reference of record expressly states 42 °C, and I could not verify it appears in the specification text provided. The § 103 case rests on:
- It is an upper bound on a result-effective variable (the hot-side temperature) in a system where the art already teaches controlling the temperature differential and the Ra number (PA-1) and expressly warns that heating must not render the measurement "deleterious" (PA-2). Selecting a ceiling that keeps convection gentle and Brownian noise tolerable is the kind of parametric optimization held obvious absent evidence that the range is critical (In re Aller; In re Huang).
- The specification's own data support a design-window derivation, not a discovered criticality: it reports Bénard cells "from a temperature difference of approximately 10 °C," turbulence onset "in the vicinity of 17 °C," with the cooler fixed at 25 °C (Fig. 3). A hot side ≤ 42 °C with a 25 °C cold side is simply the upper end of that ΔT window.
- Weakness for the patentee: no comparative data showing the claimed ceiling produces unexpectedly superior results versus, e.g., 45–60 °C. Absent secondary-considerations evidence, the ceiling reads as a routine optimization.
(b) "Bénard convection" as the transport mechanism.
This is the patent's genuine conceptual contribution: no reference of record appears to expressly say "use Rayleigh–Bénard convection to feed a solid-state nanopore." The patentee's argument would be that the references teach thermophoresis (He, Belkin, Nicoli) or electrokinetic guiding (PA-2, PA-3), not bulk buoyancy-driven convection, and that PA-1's convection is for PCR thermocycling, not for analyte delivery to a detector. That is a legitimate nonobviousness argument — but it is answerable: PA-1 expressly frames Rayleigh–Bénard convection as a general method "for conducting biological or biochemical reactions," and the function a POSITA would expect from it (bulk transport of biomolecules in a heated-from-below chamber) is exactly the function the claim relies on. Under KSR, an element known to perform a known function in a comparable field is combinable.
Legal "teaching away" check. The patentee will point to PA-2's caution that heating the electrolyte "may … be very deleterious" to the detection method. This is an attenuated teaching-away at best: it is conditional ("may"), it is counterbalanced by PA-2's own express proposal of heating as a solution, and He/Belkin/Nicoli all actively heat nanopore systems without abandoning detection. Under MPEP 2145, a reference's mere recognition of a tradeoff is not a teaching away where the reference also proposes the modification.
8. Prosecution context (relevant to confidence in this analysis)
The record shows two non-final office actions (2020-04-09, 2021-06-17) and a final rejection (2022-01-07) before allowance (notice of allowance 2022-04-28). That pattern indicates the examiner considered the art of record close, and that allowance likely turned on the specific granted limitations. I do not have the actual rejections or the applicant's remarks, so I cannot state the examiners' grounds of rejection or the precise amendment that overcame them — that would require the file wrapper (PatentCenter / Global Dossier), which I have not retrieved. I flag this rather than infer it.
9. Bottom line
- Claims 1 and 11 are, in my assessment, the most exposed to a § 103 challenge, principally over US 2011/0162963 (Electronic Bio Sciences) in view of US 2005/0074782 (Krishnan/Michigan), with He et al. (2013) as a strong secondary/alternative reference and Belkin et al. (2013) supplying the switchable heating.
- The dependent claims are very hard to defend individually. Claims 6, 7, 8, 9 and 10 stack routine design choices on top of teachings the references already contain (PA-1 expressly recites thermometers/cooling means and chamber geometry); claims 2, 3, 4 and 5 are control logic and a range of a known dimensionless variable.
- The two points of genuine resistance are (i) the 42 °C ceiling and (ii) the recitation of Bénard convection as the transport mechanism — neither expressly disclosed — but both are attackable as optimization of a result-effective variable and combination of known elements performing known functions.
- Internal inconsistencies to keep in mind for any validity challenge (carried forward from the earlier sections, and repeated here because they materially affect claim scope): the 42 °C value lacks a verified antecedent in the spec; claim 3's Ra < 1,710 upper bound contradicts the specification's statement that Bénard cells form at Ra ≥ 1,710; and the heater location differs between claim 1 (lower surface of the baseboard) and claim 11 (lower surface of the first chamber), with the specification supporting both Fig. 2 and Fig. 4 placements.
Caveat on completeness: the actual claims of the cited references (particularly PA-4, PA-5, PA-6, PA-7 and PA-8, whose full texts I did not retrieve in this session) could contain additional element-by-element hits — or additional teaching-away language — that would shift the strength of individual combinations. My mappings for PA-1, PA-2, PA-3, He, Belkin and Nicoli are grounded in the sources cited above; the others are characterized at the level of the patent's own description of them.
Generated 9/29/2026, 10:12:42 PM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
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