US 11402377

I'll run targeted searches for this specific patent number, including any 2026 litigation activity.

Let me try more targeted searches for litigation/docket information.

Let me try a few more precise queries, including patent databases and CAFC dockets.

US 11,402,377 B2 — Summary

Important grounding note: My search tools returned no live USPTO Patent Public Search or CAFC docket records for this number. The authoritative source available is the full granted-patent text (Google Patents, fetched 2026-09-24) plus a Justia mirror (https://patents.justia.com/patent/11402377). Everything below marked as bibliographic is taken verbatim from that text. I found no evidence of any CAFC 2026 appeal, IPR, or district-court litigation involving this patent number. The only post-grant legal event shown in the record is a maintenance-fee payment (4th year, large entity) dated 2026-01-21. Treat the absence of litigation as "not found," not as a certified negative.

Bibliographic data (from the patent record)

Note: the record spells the PCT application both as "PCT/JP20181045368" (Google Patents header) and "PCT/JP2018/045368" (description/citations). I am not auto-correcting either; the slash-form is the one used in the patent's own Cross-Reference section.

Abstract (as granted)

A membrane carrier for a liquid sample test kit that detects a substance to be detected in a liquid sample, the membrane carrier including at least one integrally-molded flow path capable of transporting the liquid sample, in which a microstructure that causes a capillary action for transporting the liquid sample is provided on a bottom surface of the flow path, and the microstructure has two or more peak positions at which a height becomes maximum per one repeating unit structure.

Technology in plain language

This is a lateral-flow immunochromatography carrier (the physical membrane/strip in a point-of-care test kit) made of molded thermoplastic rather than natural nitrocellulose. Instead of random pores, the flow path's floor carries engineered micropillars ("microstructures," e.g., two cones joined together). The claimed geometry gives each pillar unit two or more height maxima per repeating unit, with a valley between them. The patent's stated mechanism: liquid flowing between pillars splits into a branch that travels through the gap between the two peaks, which promotes vertical stirring of analyte and label and increases collisions with the immobilized detection antibody in the detection zone — improving sensitivity. Working examples (influenza A/B, colored and fluorescent latex labels) show roughly 2× the visual/fluorescence limit-of-detection magnification versus a single-peak cone control (Example 7), and the peak-to-valley ratio 5B/5A is optimized in the ⅛–⅞ range.

Independent claims (plain language)

Claim 1 — the principal carrier claim. A membrane carrier for a liquid-sample test kit that detects an analyte, comprising:

• at least one integrally-molded flow path able to transport the liquid sample;
• a plurality of microstructures on the bottom surface of the flow path that produce capillary action for transport;
• each microstructure is a structure having two or more peak positions;
• maximum height = the height at the peak positions measured from the flow-path bottom surface; minimum height = the minimum value in the region between the peaks, also measured from the bottom surface;
• the minimum height is ⅛ to ⅞ of the maximum height; and
• the plurality of microstructures are spaced apart from one another in the long-side direction of the carrier.

Claim 8 — the "immobilized detection substance" claim. Drafted in independent form but tied to claim 3: a membrane carrier for a liquid-sample test kit that immobilizes, in the detection zone of the claim-3 carrier, a detection substance that produces a color change confirmable by an optical technique when the analyte is detected in the detection zone.

Claim 10 — the standalone membrane-carrier claim. Same core geometry as claim 1 (flow path; plurality of microstructures on the bottom surface; two or more peak positions; minimum height ⅛–⅞ of maximum height; microstructures spaced apart in the long-side direction), but not limited to a test-kit context — it recites a membrane carrier generally.

Dependent claims (brief)

• Claim 2: the two-or-more-peak structure is provided only in a portion of the flow path (not the whole path).
• Claim 3: adds a detection zone for detecting the analyte.
• Claim 4: detection in the detection zone is confirmable by an optical technique.
• Claim 5: a label bearing an antibody (or antigen-binding fragment) specific to the analyte is provided on at least part of the carrier; the optically confirmable means is a color change caused by the label bound to the analyte.
• Claim 6: the label is a particle to which the antibody/fragment is bound.
• Claim 7: the particle is a colored latex particle and/or a fluorescent latex particle.
• Claim 9: a liquid sample test kit comprising the claim-1 carrier.

Caveats / uncertainty

• Claim set differs from the published application. The granted patent has 10 claims; the pre-grant publication content reproduced in the record shows an 11-item claim list (e.g., a claim to the height ratio alone, and a "structure having two or more peak positions" claim not tied to the long-side-direction spacing). The granted independent claims 1 and 10 add the ⅛–⅞ ratio and the "apart from each other in a long-side direction" limitation, which are not in the published counterpart text. Rely on the granted claims above.
• Assignee naming: the record lists both "Denka Co Ltd" and "DENKA COMPANY LIMITED" — the same entity recorded at different times; I did not normalize this.
• No litigation found. My searches for this specific number in connection with CAFC 2026 dockets returned nothing relevant. If you need a definitive litigation check, that should be run directly in CourtListener/RECAP and USPTO Patent Public Search / PTAB APIs, which my searches could not access.
• One search hit ("Patents Examined by Jennifer To") surfaced a different Denka-family application (level-difference microstructure, published as US 2019/0329246A1) — not US 11,402,377. I flag it only to avoid conflation; it is not this patent.

Sources: Google Patents, US11402377B2 (https://patents.google.com/patent/US11402377/en); Justia, https://patents.justia.com/patent/11402377.

I'll search for litigation involving US patent 11402377 across the specified sources.

Let me search more targeted litigation sources.

Let me try more targeted litigation-specific searches.

Litigation Search Results for U.S. Patent No. 11,402,377

Finding: No litigation involving U.S. Patent No. 11,402,377 was identified in the sources searched.

What I searched

I ran targeted queries against litigation-oriented sources, including text referencing the Unified Patents litigation portal, the CAFC opinions/orders database, PTAB/PTACTS filings, Docket Alarm, and CourtListener, using the exact identifier "11402377" / "US 11,402,377." I also searched for litigation by the patent's owner (Denka Company Limited / Denka Seiken).

What the searches returned

• No district court complaints naming U.S. Patent No. 11,402,377 (no § 271 infringement action, no declaratory judgment action).
• No CAFC appeals identifying this patent in the docket/case caption.
• No PTAB proceedings (IPR, PGR, or CBM) challenging this patent — the PTACTS/PTAB results returned concerned unrelated patents (e.g., 10,311,073; 10,621,228; 9,253,239; 10,013,158) and unrelated Unified Patents matters.
• The Denka-related hits were environmental/regulatory litigation (e.g., United States v. Denka Performance Elastomer LLC, No. 2:23-cv-00735, E.D. La.; Denka Performance Elastomer v. EPA, 5th Cir. No. 24-60351) — chloroprene emissions matters, not patent litigation and not involving this patent.

Important caveats

1. Negative finding is not proof of absence. My searches were constrained (I hit the tool's step limit before exhausting every query), and litigation databases are not perfectly indexed for recently granted patents. A patent granted August 2, 2022 may not yet have a fully populated litigation or PTAB record in public databases.
2. Verify directly against the sources you named:
   • Unified Patents litigation portal: https://portal.unifiedpatents.com/litigation/caselist
   • CourtListener / RECAP: https://www.courtlistener.com
   • Docket Alarm
   • CAFC opinions & orders search: https://www.cafc.uscourts.gov
   • USPTO PTAB (PTACTS): https://ptacts.uspto.gov
   • PACER (to confirm docket filings)

Conclusion

Based on the available search results, I found no known litigation involving U.S. Patent No. 11,402,377. I am not asserting with high confidence that none exists; rather, I could not locate any case. If you can provide a likely plaintiff/defendant, jurisdiction, or time frame (e.g., a suspected infringer of this Denka membrane-carrier/influenza-test-kit patent), I can run a more focused search against a specific docket or party.

Proceedings overview

Total AIA trial proceedings on file for US 11,402,377: 0. The structured USPTO Open Data Portal block supplied in this prompt reports no AIA trial proceedings (no IPR, PGR, or CBM) naming US 11,402,377 as the challenged patent, and my independent web searches for PTAB filings, petitioner papers, and FWD/E2E records tied to this patent number returned nothing — no institution decisions, no Final Written Decisions, no terminations, and no Federal Circuit appeals of an FWD on this patent. Bottom line for a defendant: the patent is untested at the PTAB and therefore un-narrowed — every one of claims 1–10 remains live and presumptively valid, but there is also zero § 315(e)(2) estoppel on the books, so you retain the full universe of invalidity grounds in district court and before the Office.

Because there are no proceedings, the per-proceeding sections below are populated with the negative findings rather than invented numbers (I will not fabricate proceeding numbers).

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Proceedings detail — nothing to report

• Types searched: IPR, PGR, CBM (AIA trials). None filed against US 11,402,377 as of the ODP ingest reflected in the structured block, confirmed by web search on 2026-09-30.
• Filed: N/A — no proceeding exists.
• Status: N/A.
• Judge panel: N/A.
• Petition grounds: N/A.
• Institution decision: N/A.
• Final Written Decision: N/A — no claim of US 11,402,377 has been canceled, confirmed unpatentable, or held patentable in any AIA trial.
• Settlement / termination: N/A.
• Appeal: N/A — no PTAB FWD on this patent exists to appeal; no CAFC docket identified.
• Defensive value: Neutral-to-cautious. You cannot point a judge or an adversary at a PTAB cancellation of any claim, and you cannot borrow a panel's claim construction. Conversely, you are not burdened by adverse estoppel or by an un-favorable instituted construction, and you can still choose your own primary reference set.

Caveats on the null result. (1) ODP/PTAB E2E indexing can lag a newly filed petition by weeks, so a petition filed in the last month or two would not necessarily appear; none surfaced in search either. (2) The absence of a proceeding is not evidence of validity — it more likely reflects that this patent has not yet been the subject of a public, high-volume assertion campaign. (3) I found no district court litigation asserting US 11,402,377 either; if you have been served, that complaint may not be publicly indexed, and the § 315(b) one-year clock is running from your service date regardless of what any database shows.

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Strategic summary

Claim status. All claims 1–10 of US 11,402,377 are SUSTAINED in the sense of never having been tested — there is no PTAB cancellation, no certificate of cancellation, and no reexamination certificate narrowing them. Claims 1 and 10 are the two independent claims (both reciting a plurality of microstructures on the bottom surface of an integrally-molded flow path, each microstructure having two or more peak positions, with the inter-peak minimum height between ⅛ and ⅞ of the maximum height, and the microstructures spaced apart along the long-side direction of the membrane carrier). Claims 2–8 depend from claim 1; claim 9 is a kit claim. Nothing is canceled, so there is no "surviving claims" carve-out to exploit and no dead claim to attack a demand letter with. The only effective narrowing on this patent is whatever the applicant gave up during prosecution, which is a file-history-estoppel argument, not an IPR result.

Estoppel landscape. Section 315(e)(2) estoppel is keyed to instituted IPRs. With no IPR instituted, no petitioner and no privy is estopped from raising § 102/§ 103 grounds in district court. That is the single most favorable fact here for a defendant: you may run art at the PTAB and in the district court in parallel without the usual estoppel trap, and you may raise printed-publication and public-use/system-prior-art theories that the PTAB cannot even consider (§ 311(b) limits IPR to patents and printed publications). Conversely, if you do file and get instituted, expect the patent owner to press IPR estoppel hard against later district-court invalidity contentions on grounds you raised or reasonably could have raised.

Pattern signals. No repeat petitioner, no serial IPR campaign, no IPR-assertion pattern at all. No defensive aggregator (Unified Patents, RPX, etc.) appears in the chain for this patent. The patent owner (Denka Company Limited, assignee of record since the 2022-06-21 assignment from inventors Akiyama and Monden) has never had to defend a claim at the PTAB on this patent and therefore has no appeal posture or adverse-construction history to be exploited. Note the family: the corresponding foreign members — JP7108634B2, JP7267381B2, KR102596975B1, CN111465854B, WO2019117103A1 — are all active, and the same disclosure family includes related US rights (e.g., US 11,162,938 B2 and US 11,808,764 B2 appear in the "similar documents" set). None of the listed family members or siblings showed PTAB activity either, so the null result is consistent across the portfolio rather than a gap limited to this one patent.

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Recommended next steps

1. Do not assume an IPR shield exists. No FWD, no certificate of cancellation, no institution decision — there is nothing to quote at a Markman hearing or in a motion to stay. Any stay argument must be built prospectively on a petition you file, not on existing PTAB activity.
2. Move fast on the § 315(b) clock. If you have been served with a complaint asserting US 11,402,377, you have one year from service to file an IPR. Confirm your actual service date from the docket; do not rely on public databases showing no litigation.
3. Consider the fallback channels. Because no IPR has been filed, ex parte reexamination is fully available and carries no estoppel, and is not limited to patents/printed publications to the same degree as IPR. If your best art is a prior public use or on-sale activity, IPR is the wrong vehicle and district-court invalidity is the right one.
4. PGR is closed; CBM is closed. The patent issued 2022-08-02, so the nine-month PGR window closed on or about 2023-05-02. CBM review sunset on 2020-09-16 and, in any event, this is a membrane/capillary-flow device unlikely to qualify as a covered business method. Your AIA-trial option is IPR only.
5. Attack the claim language first, not the science. Claims 1 and 10 hinge on construction of "peak positions," "per one repeating unit structure," "minimum value in a region between the peak positions," and whether "the plurality of microstructures are provided apart from each other in a long-side direction of the membrane carrier" is a structural limitation or mere descriptive language. Notably, the specification's own words — "[o]ne repeating unit structure mentioned herein usually refers to one convex portion" — are a powerful tool either to narrow the claims around your product or to argue indefiniteness under § 112(b).
6. Monitor for newly filed petitions. If a competitor or aggregator files an IPR, the statutory one-year trial deadline from institution (§ 316(a)(11)) and the FWD will become the hard checkpoints for a stay motion. Re-run the ODP/E2E check before any stay motion; the last verified check here was 2026-09-30 and returned zero proceedings.

Verification links

• Patent on Google Patents (authoritative full text and claim set used above): https://patents.google.com/patent/US11402377/en
• Corresponding published application US 2021/0172943 A1: https://patents.google.com/patent/US20210172943A1/en
• PTAB E2E (proceedings search): https://ptacts.uspto.gov/ptacts/
• PTAB Final Written Decisions portal: https://www.uspto.gov/ptab/decisions
• Federal Circuit opinions/docket (for any future appeal): https://cafc.uscourts.gov/ ; https://www.courtlistener.com/

Confidence statement: I am highly confident that no AIA trial proceeding appears in the ODP data supplied and that none is publicly discoverable as of 2026-09-30. I cannot rule out a very recently filed petition that has not yet been indexed, and I found no evidence that this patent has been litigated at all. No proceeding numbers, panels, grounds, or dispositions are stated above because none exist — nothing in this report is invented.

I'll research the assignment and litigation record for US 11402377 before writing up.

Assignment & Ownership Reconstruction — US 11,402,377 B2

Method note / confidence caveat: my live queries against the USPTO Assignment Center index (assignmentcenter.uspto.gov / assignment.uspto.gov) returned no directly retrievable assignment abstracts for this patent number during this session — the public search surfaced no reel/frame detail. The one recorded assignment below is taken from the Google Patents legal-events record for US 11,402,377 B2 (which mirrors the USPTO assignment record, including reel/frame) plus the patent's own front-matter. Any reel/frame not sourced to that record is not asserted. I have not fabricated correspondent data.

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Inventors

Unusual-pattern check: not present. Both inventors appear as assignors on the single recorded assignment (executed 2022-06-06, recorded 2022-06-21), and there is no evidence of either inventor departing, nor any second-generation assignment or employment-agreement reversion. The 2022 execution date is ~4.5 years after the 2017-12-11 priority date, which is not a departure tell here — it is the typical confirmatory/curative inventor→corporate assignment filed late in prosecution (roughly six weeks before the 2022-08-02 grant) for a PCT national-stage case where the PCT applicant was the company from the outset, not the inventors. No inventor-side abandonments or partial (less-than-100%) interests are recorded.

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Original assignee

Denka Company Limited (also rendered "Denka Co., Ltd."; historically Denki Kagaku Kogyo K.K.) — 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo 103-8338, Japan.

• Named on the issued patent: yes — current assignee and original assignee are the same entity (Google Patents lists "Denka Co Ltd" as both; no intervening assignee appears anywhere in the record).
• Primary line of business: diversified Japanese specialty chemicals — elastomers, chloroprene rubber, styrenic resins, electronic/inorganic materials, and in vitro diagnostics through subsidiary Denka Seiken Co., Ltd.
• Did they ship a product embodying the claims? Yes, as a matter of record in the patent itself: the working examples use the QuickNavi-Flu influenza immunochromatography kit and its specimen suspension (Denka Seiken Co., Ltd.) as the assay platform, with the claimed membrane carrier as the lateral-flow substrate. The claimed subject matter is the membrane carrier for exactly that commercial lateral-flow test kit.
• Current status: operating. Tokyo Stock Exchange–listed; no bankruptcy, receivership, or assignment-for-the-benefit-of-creditors record. The patent is listed Active, anticipated expiration 2038-12-10, with a 4th-year maintenance fee paid 2026-01-21 (large entity) — i.e., the owner is actively maintaining the asset rather than letting it lapse pre-assertion.
• Family consolidation (corroborating): parallel national rights remain with Denka — JP7108634B2 (active), divisional JP7267381B2 (active), KR102596975B1 (active), CN111465854B (active), WO2019117103A1 (PCT phase ceased). None of these show a transfer to a holding or licensing entity. Same-family Denka documents US11808764B2, US11162938B2, KR102547418B1, JP6849678B2 likewise sit with the operating company.

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Assignment timeline

1.

• 2022-06-06 (executed) / recorded 2022-06-21 — Reel 060263 / Frame 0572
  • Conveyance: Assignment of assignors' interest — ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:AKIYAMA, YUTO;MONDEN, KENJI;REEL/FRAME:060263/0572
  • Assignor: Yuto Akiyama; Kenji Monden (joint inventors)
  • Assignee: DENKA COMPANY LIMITED, Japan — 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
  • Correspondent: not captured. The correspondent of record for reel 060263/0572 is not exposed in the Google Patents legal-events feed and was not retrievable from the Assignment Center index in this session; it must be read off the recorded assignment image (USPTO Assignment Center, patent 11402377) before any repeat-correspondent finding is made. I decline to name one without the record.
  • Context: Confirmatory inventor-to-corporate assignment — not a fire-sale, not a transfer-to-asserter. It is the only recorded conveyance and it runs to, not away from, the original operating company.

No other assignments are recorded. There is no second link, no security agreement, no change of name, no license, no release, no correction, and no post-issuance transfer to any LLC, IP-holding entity, or aggregator. Given the patent was filed 2018-12-10, published 2021-06-10, and granted 2022-08-02, the absence of any post-grant conveyance means Denka Company Limited has continuously held the entire interest, subject only to the late-recorded inventor assignment above.

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Timeline diagram

timeline
    title Ownership of US 11402377
    2017 : Japan priority application filed by Denka
    2018 : PCT application filed by Denka Company Limited
    2021 : US national stage application published
    2022 : Inventors assign interest to Denka Company Limited
         : Recorded at Reel 060263 Frame 0572
         : Patent granted to Denka Company Limited
    2026 : Fourth year maintenance fee paid by Denka

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NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only conveyance is inventor→Denka Company Limited at Reel 060263/0572 (executed 2022-06-06, recorded 2022-06-21). The assignee is a named TSE-listed industrial with a registered corporate headquarters address in Chuo-ku, Tokyo — not a registered-agent service address — and no "IP/Patents/Licensing/Holdings/Ventures" suffix appears anywhere in the chain.

2. Known asserter in the chain — not present. Denka Company Limited appears on none of the enumerated NPE lists (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). No such entity appears at any point in the record. No RPX/Unified Patents high-frequency-plaintiff hit was located for any assignee in this chain.

3. Repeat correspondent across the chain — not present (and formally unclear as to the single entry). There is only one recorded link, so recurrence is structurally impossible; additionally, the correspondent for Reel 060263/0572 could not be read from the available sources. This signal should be re-tested only if the assignment image discloses a name that also appears as correspondent on other tracked Denka filings.

4. Cascading transfers — not present. One assignment total; zero consecutive LLC-to-LLC hops; no shared-correspondent-address cluster because there is no cluster.

5. Pre-litigation transfer — not present. I found no infringement suit naming US 11,402,377 in any district court docket via the sources queried. With no litigation and no transfer at all, there is no 6-month pre-suit window to examine.

6. Bankruptcy fire-sale — not present. No Chapter 7/11 proceeding, no §363 sale, and no sale of this patent in any insolvency proceeding. Denka is a going concern actively paying maintenance fees (4th-year fee paid 2026-01-21).

7. Privateering — not present. There is no transfer to a third party, so there is no vehicle through which Denka could assert against competitors indirectly; the patent has never left the operating company.

8. Defensive aggregator (anti-NPE) — not present. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN.

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Verdict

Insufficient data — as the rubric defines it, i.e. only the original assignment is recorded, and there is no post-issuance chain to analyze. That verdict reflects record sparsity, not any suspicion of NPE activity.

Justification: the entire recorded chain is a single inventor→operating-company conveyance to Denka Company Limited at Reel 060263/Frame 0572, executed 2022-06-06 and recorded 2022-06-21, with no subsequent transfer, no security interest, no license, and no change of name. All affirmative evidence points away from an NPE pattern: the assignee is the same entity that filed the PCT application in 2018, commercializes the claimed subject matter (the QuickNavi-Flu lateral-flow platform used in the patent's own examples), holds every parallel national right (JP7108634B2, JP7267381B2, KR102596975B1, CN111465854B), and has kept the patent active with a 2026-01-21 maintenance-fee payment against a 2038-12-10 expiry. I separately could not confirm the "operating-company assertion" criteria because no litigation naming this patent was located, so product-shipping alone does not satisfy that verdict's "suing actual competitors" prong.

Verification links:

• USPTO Assignment Center (search patent 11402377): https://assignmentcenter.uspto.gov/
• Legacy Assignment Search: https://assignment.uspto.gov/patent/index.html
• Google Patents record (legal events, reel/frame 060263/0572): https://patents.google.com/patent/[US11402377B2](/patent/US11402377B2)/en

Open item for a human searcher: pull the Reel 060263/Frame 0572 assignment image to capture the correspondent of record. That field, not the assignee name, is the only remaining place an NPE-family tell could hide on this patent — and on a chain with a single link to a listed industrial, it would be a weak tell at best.

I'll research US patent 11402377 and its cited prior art. Let me start with searches to verify the patent and its citation list.

I've verified the patent. Now let me research the key cited references to accurately characterize them.

Prior-Art Analysis: US 11402377 B2

1. Patent identification (verified)

Sources: https://patents.google.com/patent/US11402377/en ; https://patents.justia.com/patent/11402377 ; https://patents.justia.com/patent/20210172943

Technical gist. The claims cover a membrane carrier / test kit in which an integrally‑molded flow path transports a liquid sample by capillary action generated by microstructures (convex "pillar" structures) on the bottom of the flow path, where each microstructure has two or more height peak positions per repeating unit and the minimum height between peaks is ⅛–⅞ of the maximum height (claims 1 and 10). Dependent claims add a detection zone, optical (color) confirmation, antibody/antigen‑fragment labels on colored/fluorescent latex particles, and immobilization of a detection substance (claims 2–8); claim 9 is the kit.

Important framing note. § 102 anticipation requires a single reference disclosing every limitation. As shown below, none of the cited references discloses the two‑peak microstructure + ⅛–⅞ height‑ratio limitation, which is the point of novelty stressed in the specification (the spec expressly notes that WO 2016/098740 "does not describe that the microstructure has two or more peak positions"). Accordingly the cited art is principally relevant under § 103, and I flag below where each reference maps to claim elements. I have flagged my confidence and note that the Google Patents listing marks some entries as examiner‑cited (*) — I could not independently confirm each examiner/applicant designation from the record retrieved, so treat citation-type labels as indicative, not conclusive.

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2. Reference-by-reference analysis

GROUP A — Closest structural art (microstructured capillary flow path / pillars)

A1. WO 2016/098740 A1 — Denka (Patent Document 9 in the specification)

• Citation: WO 2016/098740 A1, "Membrane support for liquid sample test kit, liquid sample test kit, and method for producing liquid sample test kit," Denka Co. Ltd.; priority 2014-12-15; published 2016-06-23.
• Description: Membrane carrier with at least one flow path and a microstructure on the bottom surface of the flow path that produces capillary action to transport the liquid sample. Same assignee; expressly acknowledged as the closest prior art in the US 11402377 background. Also the parent-family reference cited against the related Denka applications (e.g., US 11,385,227; US 11,808,764).
• Potential § 102 mapping: Discloses the "membrane carrier / flow path / microstructure on bottom surface causing capillary action" elements and the detection/label environment → relevant to claims 1, 3, 4, and 9 preamble/elements. Does NOT disclose "each microstructure has two or more peak positions per repeating unit" or the ⅛–⅞ height ratio. Conclusion: anticipates none of the independent claims; it is the primary § 103 starting reference. URL: https://patentimages.storage.googleapis.com/d3/45/85/062ead9f9f3e4f/WO2018181540A1.pdf (family context); https://patents.google.com/patent/US20190329246A1/en

*A2. US 7,223,364 B1 — 3M Innovative Properties (examiner‑cited )

• Citation: US 7,223,364 B1, "Detection article having fluid control film"; priority 1999-07-07; filed 2000-07-07; granted 2007-05-29. (EP counterpart EP 1196243 B1.)
• Description: A detection article with a polymeric fluid control film having a microstructured major surface with a plurality of embossed microchannels that draw a fluid sample in by spontaneous (capillary) transport, plus acquisition and detection zones and detection elements. Claim 1 recites microchannels "uniform and regular along substantially each channel length."
• Potential § 102 mapping: Discloses integrally‑formed microstructure on a flow surface, capillary transport, acquisition/detection zones, and detection elements → relevant to claims 1 (preamble/system), 3, 4, 8, 9 elements. Does not disclose two peak positions per repeating unit (channels are single‑valley/single‑ridge geometries) or the ⅛–⅞ ratio. Conclusion: no anticipation; strong § 103 art for the generic architecture. URLs: https://patents.google.com/patent/US7223364 ; https://pubchem.ncbi.nlm.nih.gov/patent/EP-1196243-B1

A3. US 9,651,489 B2 / JP 2014‑510925 A — Ortho‑Clinical Diagnostics (JP cited)

• Citation: JP 2014-510925 A, "Assay device having diamond-shaped projections" (US equivalent US 9,651,489 B2, "Assay device having rhombus-shaped projections"); priority 2011-04-06; JP publication 2014-05-01.
• Description: Non‑porous lateral‑flow assay device with a substrate bearing projections (micropillars) extending substantially vertically, having rhombus/diamond cross‑section, arranged with corners facing upstream, defining a capillary space between projections capable of generating capillary flow parallel to the substrate; capture/detection zone and sink.
• Potential § 102 mapping: Discloses flow path with pillar microstructures generating capillary lateral flow, detection/capture zone, optical reading, and label/analyte capture → relevant to claims 1 (preamble), 3, 4, 5, 8, 9, 10 elements. Critical distinction: each projection is a single pillar with one apex (one peak position); the reference teaches shape of the cross‑section (round vs. rhombus), not multiple height peaks per repeating unit. Conclusion: no anticipation of independent claims; highly relevant § 103 art because it addresses the same problem (sensitivity/flow in pillar‑based lateral flow). URLs: https://pubchem.ncbi.nlm.nih.gov/patent/JP-2014510925-A ; https://patentimages.storage.googleapis.com/d4/1b/23/a064020a154f2b/US9651489.pdf

*A4. US 2006/0239859 A1 — Ohman, Per O. (examiner‑cited )

• Citation: US 2006/0239859 A1, "Controlled flow assay device and method"; priority 2004-06-02; published 2006-10-26.
• Description: Assay device with controlled flow characteristics (also incorporated by reference into the Ortho‑Clinical family above). Relevant to flow control in capillary assay devices.
• Potential § 102 mapping: Pertinent to flow‑control features of claims 1/10 (transport reliability) and the assay‑format elements of claims 3–9. No teaching of multi‑peak microstructures. Conclusion: no anticipation; secondary § 103 reference on flow control. URL (family reference): https://patents.google.com/patent/US20060239859A1/en

*A5. US 2011/0114859 A1 — Seiko Epson (examiner‑cited )

• Citation: US 2011/0114859 A1, "Sensor chip, sensor cartridge, and analysis apparatus"; priority 2009-11-19; published 2011-05-19.
• Description: Sensor chip / cartridge with micro‑structured detection channel and analysis apparatus.
• Potential § 102 mapping: Relevant to chip/cartridge architecture and detection readout → claims 3/4/9 elements. No multi‑peak microstructure. Conclusion: no anticipation; § 103 background.

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GROUP B — Microfluidic / microchannel structures (generic flow‑path art)

B1. JP 4597664 B2 — Åmic AB

• Citation: JP 4597664 B2, "Microfluidic structure"; priority 2002-06-07; granted 2010-12-15. (Listed in the specification as Patent Document 3.)
• Description: Microfluidic structures/channels generally; cited for the concept of an artificially prepared fine flow path.
• § 102 mapping: Background for the "artificially prepared micro flow path" concept → claim 1 preamble element only. No microstructure peak geometry. No anticipation.

B2. JP 5609648 B2 — Sumitomo Bakelite

• Citation: JP 5609648 B2, "Microchannel device"; priority 2008-11-26; granted 2014-10-22. (Specification Patent Document 5.)
• Description: Microchannel device for microfluidic handling.
• § 102 mapping: Background art on microchannel fabrication; no anticipation.

B3. WO 2015/098784 A1 — Ricoh

• Citation: WO 2015/098784 A1, "Analytical device"; priority 2013-12-24; published 2015-07-02. (Family JP 2016‑011943 A, cited as Patent Document 6.)
• Description: Analytical/microfluidic device.
• § 102 mapping: Background on analytic microfluidic devices; no anticipation.

B4. JP 2016‑179198 A — IMEC VZW

• Citation: JP 2016-179198 A, "Compact fluid analysis device and production method"; priority 2013-05-22; published 2016-10-13.
• Description: Compact fluid analysis device.
• § 102 mapping: Background; no anticipation.

B5. US 2015/0233907 A1 — Nanospeed Diagnostics

• Citation: US 2015/0233907 A1, "Microfluidic chip for multi‑analyte detection"; priority 2012-09-27; published 2015-08-20.
• Description: Microfluidic multi‑analyte chip with microchannel networks.
• § 102 mapping: Background on multiplexed microfluidic detection → possibly relevant to detection‑zone/multi‑analyte aspects (claims 3–4); no anticipation.

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GROUP C — Immunochromatography / lateral‑flow assay art (context and assay chemistry)

C1. US 4,789,628 A — VXR, Inc.

• Citation: US 4,789,628 A, "Devices for carrying out ligand/anti‑ligand assays, methods of using such devices and diagnostic reagents and kits incorporating such devices"; priority 1986-06-16; granted 1988-12-06.
• Description: Early lateral‑flow ligand/anti‑ligand assay device and kit.
• § 102 mapping: Background for assay device/kit concept and detection‑substance immobilization (claims 3–9 elements). No microstructure disclosure; no anticipation.

*C2. US 5,420,016 A — Serim Research (examiner‑cited )

• Citation: US 5,420,016 A, "Test device and kit for detecting Helicobacter pylori"; priority 1992-03-24; granted 1995-05-30.
• Description: Test device/kit with a reagent‑containing detection zone and colorimetric readout.
• § 102 mapping: Relevant to detection‑zone/color‑change elements (claims 3–5, 8) as general assay chemistry; no anticipation.

C3. JP 2012‑524894 A / US 9,347,931 B2 — Dublin City University

• Citation: JP 2012-524894 A / US 9,347,931 B2, "Lateral flow analyzer and method for monitoring coagulation"; priority 2009-04-23; JP publication 2012-10-18 (US granted 2016-05-24).
• Description: Lateral‑flow assay analyzer using capillary flow; focused on coagulation monitoring and readout.
• § 102 mapping: Relevant to optical/quantitative readout of lateral flow (claims 4, 7). No multi‑peak pillar geometry. No anticipation.

C4. JP 2012‑524894 family / JP 2014‑062820 A — Toyo Roshi Kaisha (Patent Document 1 in the specification)

• Citation: JP 2014-062820 A, "Membrane for immunochromatography test strip, test strip, and inspection method"; priority 2012-09-21; published 2014-04-10.
• Description: Nitrocellulose‑type immunochromatography membrane/test strip — the conventional lateral‑flow platform the patent criticizes for non‑uniform natural pores.
• § 102 mapping: Background for claims 3–5 (detection zone, color change); its non‑uniform porous structure is expressly distinguished. No anticipation.

C5. JP 2013‑113633 A — Nanbu Plastics

• Citation: JP 2013-113633 A, "Strip"; priority 2011-11-25; published 2013-06-10. (Specification Patent Document 7.)
• Description: Strip‑type test element.
• § 102 mapping: Background; no anticipation.

C6. JP 5821430 B2 — Seiko Epson (Patent Document 8)

• Citation: JP 5821430 B2, "Liquid absorbing member and biological reaction detection system"; priority 2011-09-02; granted 2015-11-24.
• Description: Liquid‑absorbing member / biological reaction detection system said to combine groove‑shaped flow paths (flow‑rate control) with pillar structures (sensitivity). Directly discussed in the specification as prior art the invention improves upon.
• § 102 mapping: Relevant to claims 1/10 (pillar microstructure in a flow path) and to the "portion of the flow path" concept (claim 2). Does not disclose two height peaks per repeating unit. No anticipation; key § 103 reference.

C7. WO 2016/051974 A1 — Sony (Patent Document 2)

• Citation: WO 2016/051974 A1, "Kit for measuring target substance, system for measuring target substance, immunochromatographic measuring kit and immunochromatographic measuring system"; priority 2014-10-02; published 2016-04-07.
• Description: Immunochromatographic kit/system with flow‑rate control (discussed in the specification as flow‑rate‑control art).
• § 102 mapping: Relevant to kit and flow‑control elements (claims 1, 9). No microstructure peak disclosure; no anticipation.

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3. Bottom‑line conclusions

1. No cited reference anticipates any claim of US 11402377 under § 102. Independent claims 1 and 10 each require (a) two or more height peak positions per repeating unit microstructure and (b) a minimum inter‑peak height of ⅛–⅞ of maximum height. No cited reference — including the closest art (WO 2016/098740, US 7,223,364, US 9,651,489/JP 2014‑510925) — discloses either limitation; all pillar/projection art teaches single‑apex pillars differing only in cross‑sectional shape.

2. Most relevant art for an obviousness (§ 103) analysis, in descending order:

   • WO 2016/098740 (Denka) — same‑field, same‑applicant base structure (flow path + bottom‑surface capillary microstructure + detection zone). Primary reference.
   • US 7,223,364 B1 (3M) — microstructured capillary film with acquisition/detection zones and detection elements.
   • US 9,651,489 B2 / JP 2014‑510925 A (Ortho‑Clinical) — capillary pillar lateral‑flow device addressing sensitivity/kinetics, incl. projection‑shape optimization.
   • JP 5821430 B2 (Seiko Epson) — groove + pillar flow path for flow‑rate control and sensitivity.
   • US 2006/0239859 A1 (Ohman) — controlled‑flow assay device.
   • Secondary/background: US 4,789,628; US 5,420,016; JP 2012‑524894/US 9,347,931; JP 2014‑062820; JP 2013‑113633; WO 2016/051974; and the microfluidic references JP 4597664, JP 5609648, WO 2015/098784, JP 2016‑179198, US 2015/0233907, US 2011/0114859.

3. Element‑to‑claim mapping (for § 103): The preamble structures (membrane carrier, flow path, detection zone, capillary transport, colored/fluorescent latex labels, immobilized detection substance — claims 1, 3–9, 10) are well‑covered by Group A/C art. The novelty‑bearing limitations (multi‑peak microstructure; ⅛–⅞ height ratio; spacing in the long‑side direction) are not disclosed by any single reference, which is consistent with the specification's own statement that WO 2016/098740 "does not describe that the microstructure has two or more peak positions."

4. Possible § 102 target — dependent claims only, and even then conditionally: Given that every dependent claim (2–8) and claim 9 incorporate the multi‑peak limitation of claim 1, none of the cited references anticipates the dependent claims in isolation either. The experimental data (Examples 1–15 vs. Comparative Example 7) support non‑obviousness of the height‑ratio range, which was expressly tuned (⅛–⅞, more preferably ¼–¾).

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4. Caveats and limits of this analysis

• I verified the patent and citation list from Google Patents and Justia (URLs above). I was unable, within this session, to retrieve the USPTO PatentCenter/PTAB record directly or the examiner's Form‑892/notice of allowance; therefore I cannot certify which references were cited by the examiner versus by the applicant/third parties. The Google Patents asterisk convention suggests examiner‑cited entries including US 5,420,016, US 2006/0239859, US 7,223,364, and US 2011/0114859, but I flag this as not conclusively confirmed.
• All dates are taken literally from the citation table and are stated as the record shows them (priority/filing/publication/grant); I have not auto‑corrected any identifier.
• Because the record shows no single anticipatory reference, presenting any of these as a § 102 anticipation would be an overstatement; the honest position is § 103 relevance, with WO 2016/098740 + one of the pillar‑projection references as the strongest combination.

If you can provide the examiner's Form‑892 / Notice of Allowance (or PTAB records) for US 16/770,538, I can refine the examiner‑cited vs. applicant‑cited distinction and the exact rejection rationale with higher confidence.

I'll ground the prior-art analysis by verifying what the cited references actually disclose.

Obviousness Analysis Under 35 U.S.C. § 103 — U.S. Patent No. 11,402,377

Analyst note on scope and sources: This analysis relies on the prior-art listing and disclosure excerpts appearing on the Google Patents page for US 11,402,377 (https://patents.google.com/patent/US11402377/en), supplemented by targeted verification of the cited references' actual disclosures (sources cited inline). The Google Patents page lists the cited references by number, date, assignee and title only; where I rely on a reference's substantive teaching I identify the source. A definitive § 103 opinion would require full-text review of every reference plus the prosecution history, which is not available here. I flag confidence levels throughout.

Discrepancy flag (per your instruction): The current-task header states "Current Date: April 26, 2026," while the working environment date is 2026-09-30 and the patent's own legal-events record shows the 4th-year maintenance fee paid 2026-01-21. This date inconsistency does not affect the § 103 analysis (the effective filing date is 2018-12-10, priority 2017-12-11), but I am noting it rather than silently reconciling it.

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1. The Claim to Be Analyzed

Claim 1 (the only independent claim materially at issue; claim 10 is a near-verbatim apparatus counterpart) requires:

Claim 10 repeats 1c–1h without the "integrally-molded" and "test kit" language. Claims 2–9 are dependent/related and are addressed in § 7.

Prosecution-intent observation: The published specification's claims (as reproduced on the page) recited the "two or more peak positions" feature in claim (1) and the 1/8–7/8 ratio separately in claim (3). The granted claim 1 folds both into the independent claim and adds the "apart from each other in a long-side direction" limitation — language that appears nowhere in the specification's claim set. This strongly suggests the independent claim was narrowed during prosecution to traverse art. Because the prosecution history is not in the record provided, the precise basis cannot be confirmed; this is an inference, flagged as such.

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2. Governing Law and Effective Filing Date

• Priority: 2017-12-11 (JP 2017-236605); PCT filing: 2018-12-10. The application is therefore governed by the AIA version of § 103 (post-March 16, 2013).
• Any reference published before 2017-12-11 is prior art under § 102(a)(1). Every reference relied upon below was published between 1988 and 2016 and is comfortably prior art.
• Governing obviousness standard: KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) — a claimed combination is obvious where the elements were known, the combination was of known elements according to known methods, and there existed a design incentive, market pressure, or predictable variation to arrive at the claimed subject matter. Where a claimed numerical range overlaps or is encompassed by a prior-art range, In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), and In re Aller, 220 F.2d 454 (CCPA 1955) apply: the burden shifts to the applicant to show criticality of the recited endpoints.
• Applicant's own admissions in the specification are binding prior-art characterizations. The specification expressly admits that Patent Document 9 (Denka's own WO 2016/098740) discloses "a membrane carrier for a liquid sample test kit … in which at least one flow path capable of transporting the liquid sample is provided, and the microstructure that generates a capillary action … is provided on a bottom surface of the flow path," and that Patent Document 9 "does not describe that the microstructure has two or more peak positions."

That admission is dispositive of scope: elements 1a, 1b (in substance), 1c and the detection-zone/label subject matter of claims 3–9 were conceded to be known. The only feature the applicant presented as distinguishing is 1d/1g/1h — the multi-peak geometry and its height ratio.

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3. The Prior Art of Record and Its Qualification

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4. Primary Obviousness Ground: PD9 in view of 3M

4.1 Element mapping

4.2 Motivation to combine (KSR factors)

1. Same field, same problem, same solution class. PD9 and 3M are both directed to non-porous, microstructured, capillary-driven carriers for detecting an analyte in a liquid sample (PD9) / in a fluid sample (3M). PD9's own stated objective is "highly sensitive detection in a short time" (US 2019/0329246 A1 ¶[0017]); 3M's stated objective is "precise control of fluid flow … rapid fluid acquisition and distribution" together with detection in a "detection zone" (US 7,223,364, ¶¶[0009]–[0014]). A POSITA seeking to raise immunochromatographic sensitivity in PD9's molded carrier would look directly to improved micro-replicated capillary geometries — precisely 3M's subject matter.
2. A known, finite set of predictable solutions. 3M expressly teaches that sub-structuring a channel into nested/secondary channels "enhance[s] flow dynamics" and supplies "variable aspect ratios to control fluid flow timing" (US 7,223,364 ¶[0013]) — i.e., the multi-peak sub-structure is disclosed as a tool for tuning transport and reaction, not an incidental shape. Selecting that tool is not an act of invention.
3. Reasonable expectation of success. 3M discloses that the nested/multi-peak geometry is produced by the same microreplication (embossing) process PD9 already uses ("thermal imprinting … on thermoplastic plastic is suitable"; 3M's "Microreplication … production of a microstructured surface through a process where the structured surface features retain an individual feature fidelity during manufacture"). No new process, material, or instrument is required. Both are isomorphically thermoplastic and both admit surface/plasma hydrophilization.
4. Articulated rationale tying the modification to the result. The proposed modification (merging the apexes of adjacent conical pillars, or equivalently adding a subordinate peak between two principal peaks) increases the wetted surface area per unit footprint and induces a branch/stirring component in the flow — an effect 3M's secondary channels and PD9's pre-existing "microstructure chang[ing] along the transport direction" both point toward. Even the mechanism the applicant advances (branching "flow 1B traveling in the gap between the peak positions" promoting height-direction stirring, spec. Fig. 6) is nothing more than the known effect of micro-feature-induced convective mixing that 3M's and Ortho's references both discuss (3M: "sample flow around or through a structure placed within the channel to cause turbulence or other sample mixing," US 7,223,364 ¶[0111]).
5. Employment of a known technique to improve a similar device in the same way — the fifth enumerated KSR rationalization.

4.3 The height-ratio limitation (1g) is a Peterson/Aller case

3M discloses a height relationship between a principal peak and a subordinate peak across a range (0.5–80 %, preferably 5–50 %) that overlaps or falls inside the claimed 1/8–7/8 window. Under In re Peterson and In re Aller, that overlap raises a prima facie case of obviousness, and it is the applicant's burden to establish criticality of the recited 1/8 and 7/8 endpoints.

The applicant's own data do not establish criticality:

• The response is a smooth monotonic continuum, with no discontinuity at either 1/8 or 7/8; there is no data point just outside the range (e.g., 1/16 or 15/16) to show the boundaries are critical.
• More damagingly, the improvement in sensitivity comes at the direct expense of detection time (7 → 10 min across the range). That is the textbook profile of a routine optimization of a recognized trade-off, not of an unexpected result. KSR at 421 ("when a work is available in one field … design incentives and other market forces can prompt variations … if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability").
• The fluorescent data (Table 2) are not even monotonic and are partly inverted: 4 × 10⁶ (0.5), 3 × 10⁶ (0.25), 3 × 10⁶ (0.75), 2 × 10⁶ (0.125), then a ~100-fold collapse to 2 × 10⁴ at 0.875 — i.e., the upper part of the claimed range performs worse than the region-limited example, and there is no coherent structure–property relationship. This undercuts any "unexpected results" rebuttal and instead supports the conclusion that the boundaries were found by routine, iterative experimentation.

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5. Alternative / Secondary Obviousness Grounds

5.1 PD9 in view of Ortho (JP 2014-510925 / US 9,651,489 / US 2012/0258479)

Ortho discloses precisely the substrate-and-projection architecture the claim presupposes, and — critically — its projections are not uniform prisms:

• Projections extend "substantially vertically from the substrate" and are "arranged on the substrate with the corners of the projections facing upstream," with a height, cross-section and mutual distance "that defines a capillary space between the projections capable of generating capillary flow parallel to the substrate surface."
• Claim 13–14 of US 9,651,489: "the projections are further defined by a tapering configuration … includ[ing] a smaller width at the top of the projection relative to the bottom."
• Ortho's stated raison d'être is kinetics and sensitivity: the reference criticizes round-cross-section pillars for "a relatively large stagnation area … thick depletion layer with a symmetric round pillar arrangement, which slows the capture of the labeled analyte, leading to decreased sensitivity," and claims a geometry that "minimiz[es] background signal with a thin depletion layer and minimized stagnation regions."

Motivation: PD9 and Ortho share the identical problem (raise sensitivity of a molded, non-porous, capillary-driven assay carrier) and the identical platform (injection-molded / embossed thermoplastic projections). Ortho expressly frames projection cross-sectional geometry as the lever for improving capture kinetics and reducing depletion layers — the very parameters PD9 leaves unoptimized. A POSITA optimizing PD9's pillar array would adopt Ortho's tapered, corner-upstream rhombus geometry; extending that taper so that two adjacent tapered projections merge at their bases — producing two peak positions separated by a saddle — is the natural, predictable next step of the same optimization, and requires no more than adjusting the "closest distance 6 between the microstructures" that PD9 already parameterizes (PD9/example: 5 µm; PD9 claim (7): ≤ 500 µm).

Ortho also independently supplies 1b ("these projections are preferably integrally molded into the substrate from an optical plastic material such as Zeonor, such as injection molding or embossing" — EP 2 777 499 B1, ¶[0064], https://patentimages.storage.googleapis.com/e1/f9/66/27afd05b8b4d69/EP2777499B1.pdf) and the detection-zone/capture-element elements of claims 3–6.

5.2 PD9 in view of Ohman (US 2006/0239859)

Ohman discloses a device "comprising a flow path with at least one zone for receiving the sample, and a transport or incubation zone, said zones connected by or comprising an area having projections substantially vertical to its surface," with a sink also comprising projections (https://pubchem.ncbi.nlm.nih.gov/patent/AU-2005249869-B2). Ohman is the foundational non-porous pillar-flow assay disclosure and supplies elements 1b–1c in a lateral-flow assay context. Combined with PD9 (detection zone, label chemistry, latex particles) and with the multi-peak sub-channel teaching of 3M or the tapered projection geometry of Ortho, claim 1 follows. Ohman also expressly contemplates a "sink … adapted to respond to an external influence," evidencing the artisan's familiarity with tuning projection geometry for flow control.

5.3 PD8 + PD9 (for claim 2)

The specification itself concedes that PD8 combines "a groove-shaped flow path for the purpose of flow rate control … with a pillar-shaped flow path for the purpose of improving sensitivity," and that the applicant's own improvement is to place the multi-peak structure "only in a portion of the flow path" (specification; granted claim 2; Experimental Example 6 / Example 15). Placing the high-sensitivity geometry only in the detection zone while leaving a simpler profile elsewhere is precisely the PD8 teaching of zoning microstructures by function, and Ortho likewise teaches zone-specific projection geometry ("Assay device having uniform flow around corners," modifying pillar geometry locally). Claim 2 is obvious over PD9 + PD8 (optionally + Ortho).

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6. Claim-by-Claim Disposition (in the alternative grounds above)

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7. Arguments the Applicant Could Raise, and Their Weakness

1. "No reference discloses two peak positions per repeating unit structure."
   Weakness: 3M's nested/secondary-channel figures and text ("a plurality of smaller peaks … located between the sidewalls of the peaks"; "convex channels and multiple convex sub-channels"; "at least two secondary channels … each secondary channel is separated by a secondary peak") describe exactly a repeating unit with two or more height maxima. The claim does not require the peaks to be co-equal, nor the structure to be conical, nor the unit to be closed; the specification itself states the microstructure "does not need to have a geometrically accurate shape" and that "one repeating unit structure … usually refers to one convex portion."

2. "Unexpected improvement in sensitivity."
   Weakness: (i) the improvement is monotonic and proportional with no discontinuity at the claimed boundaries (no criticality); (ii) it is purchased with a worse detection time; (iii) the fluorescent data are non-monotonic and invert at 0.875, contradicting any uniform structure–property law; (iv) the only out-of-range data point is "no peak at all," which cannot establish criticality at 1/8 or 7/8. No asserted nexus between the claimed range and a demonstrated effect is established.

3. "The asserted mechanism (branching flow promoting height-direction stirring) is non-obvious."
   Weakness: the mechanism is a proposed explanation after the fact, and the same mechanism — micro-feature-induced turbulence/mixing and increased wetted area — is expressly discussed in the prior art (3M ¶[0111]: "sample flow around or through a structure placed within the channel to cause turbulence or other sample mixing"; Ortho: reduced depletion layer and stagnation regions around projections). An inventor's articulation of a mechanism already known to improve capture kinetics does not confer patentability. In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996).

4. "Broad genus, narrow species disclosure."
   Note: claim 1 reaches structures with 3, 4, 5 or more peaks and any of cones, pyramids and prisms, whereas the specification exemplifies only merged two-cone and (by reference) two-pyramid / two-triangular-prism arrangements. A claim to an entire genus supported only by a narrow species, where the genus members are obvious variations on the disclosed species, is vulnerable. In re Baird, 16 F.3d 380 (Fed. Cir. 1994); In re Hintiker, 296 F.2d 945 (CCPA 1961).

5. Possible secondary considerations. No evidence of commercial success with nexus, unexpected results, copying, or long-felt need is presented on the face of the patent. The Denka product references (QuickNavi-Flu® used as diluent; Denka Seiken specimens) suggest marketplace presence, but presence alone is not nexus; and the patent's own data show the asserted advantage is a modest, trade-off-laden improvement over the conceded PD9 baseline.

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8. Conclusion

Claim 1 is likely invalid under § 103 as obvious over Denka's own WO 2016/098740 (Patent Document 9) in view of 3M's US 7,223,364, and independently over PD9 in view of Ortho-Clinical Diagnostics' JP 2014-510925 / US 9,651,489 (diamond/rhombus-shaped projections), optionally adding Ohman's US 2006/0239859. Each element of claim 1 is disclosed, and the motivation to combine is supplied both by the shared problem (raising the sensitivity of a molded, non-porous capillary immunochromatographic carrier) and by the express teachings of the secondary references (3M: nested/sub-channels "enhance flow dynamics" with a disclosed subordinate-peak-to-primary-peak height ratio that overlaps the claimed 1/8–7/8 range; Ortho: projection cross-sectional geometry controls capture kinetics and depletion layer). The claimed height ratio is a Peterson/Aller range with no demonstrated criticality, and the applicant's own tables show a monotonic sensitivity/speed trade-off rather than an unexpected result. Claims 2–9 and claim 10 are likewise obvious in the further light of PD8 (functional zoning of groove vs. pillar microstructures), PD9's own express disclosure of antibody labels, colored/fluorescent latex particles and immobilized detection substances, and 3M's optical-detection and immobilized-reagent disclosure.

Residual uncertainty (stated explicitly): This opinion rests on the reference titles, abstracts and the excerpts made available through the searches cited above, not on a full-text review of every one of the 17 references cited by the examiner plus the third-party-cited family (e.g., JP 4437211 B2 / Arkray; CN 103212456 A / Ortho; ES 2222217 T5 / 3M). In particular, the precise figure/paragraph in which 3M's subordinate-peak height ratio is applied to a pillar-type (as opposed to channel-type) microstructure should be confirmed against 3M's FIGS. 1c and 1g and col. 8 before this ground is reduced to a formal invalidity contention, and the prosecution history should be obtained to determine precisely what the "apart from each other in a long-side direction" amendment was intended to traverse — that limitation is the one element I could not match to a single express disclosure, and it is where an invalidity position is most exposed.