Invalidity dossier
US 10324022
Analysis accuracy improvement in automated testing apparatus
Current assignee: Bonraybio Co Ltd
Added 9/24/2026, 3:07:00 PM
Active provider: DeepSeek · deepseek-flash
Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll search for this specific patent number across the sources you mentioned.
Let me pull the abstract and claim set, and check for any litigation or appeal activity specifically tied to this patent.
US 10,324,022 B2 — Reconnaissance Summary
Sourcing note: The patent full text you supplied (fetched from Google Patents, 2026‑09‑24) is truncated before the claims section — it ends mid‑paragraph in the description of FIG. 42B. My web searches surfaced the title, bibliographic data, abstract, and family/citation relationships, but not a verbatim claim set. Where the claim‑level discussion below is inferential rather than quoted, I flag it explicitly.
Bibliographic data
| Field | Value |
|---|---|
| Patent number | US 10,324,022 B2 |
| Title | Analysis accuracy improvement in automated testing apparatus |
| Assignee | Bonraybio Co., Ltd. (Taichung, TW) — original and current assignee per the source record; an assignment to "BONRAYBIO CO., LTD." was recorded 2018‑11‑05 |
| Inventors | Cheng‑Teng Hsu; Hsuan‑Yu Huang; Chih‑Pin Chang; Kuang‑Li Huang; Yu‑Chiao Chi; Chia‑Wei Chang |
| Application no. | US 16/101,336 |
| Filing date | 2018‑08‑10 |
| Priority date | 2016‑05‑11 (claimed from US 15/152,470 → US 9,958,658 B2) |
| Pre‑grant publication | US 2018/0348114 A1 (2018‑12‑06) |
| Issue date | 2019‑06‑18 |
| Legal status | Active; anticipated expiration 2036‑05‑11 |
| Primary CPC | G01N 15/1475 (optical investigation of individual particles), with G01N 15/1433, G06T 7/0012/0016, G02B 21/241, A61B 10/0058, etc. |
Priority chain cited in the family record: US 15/152,470 (→ US 9,958,658 B2), US 15/345,061 (→ US 9,958,665 B2), US 15/603,783 (→ US 9,959,621 B2), and US 15/966,479 (→ US 10,281,386 B2). Later continuations in the same line claim priority to this application, including US 16/443,699 (→ US 10,852,290 B2), US 17/034,566 (→ US 11,268,947 B2), US 17/034,433 (→ US 10,928,378 B2), US 17/648,901 (→ US 11,899,007 B2), and US 17/648,887 (→ US 11,921,101 B2). There is also a co‑titled published application, US 2019/0302093 A1, whose abstract language closely tracks this patent's subject matter.
Abstract (as returned by search)
Embodiments disclose a device for testing biological specimen. The device includes a sample carrier and a detachable cover. The sample carrier includes a specimen holding area. The detachable cover is placed on top of the specimen holding area. The detachable cover includes a magnifying component configured to align with the specimen holding area. The focal length of the magnifying component is from 0.1 mm to 8.5 mm. The magnifying component has a linear magnification ratio of at least 1. Some embodiments further include a multi‑camera configuration. These embodiments include a first camera module and a second camera module arranged to capture one or more images of the first holding area and the second holding area, respectively. The processor may perform different analytic processes on the captured images of different holding areas to determine an outcome with regard to the biological specimen.
(Source: idiyas.com patent page; consistent with the "Definitions"/summary text in the authoritative Google Patents copy you provided, which recites the same focal‑length range of 0.1–8.5 mm and linear magnification ratio of at least 1.0.)
Plain-language overview of the independent claims
⚠️ Uncertainty flag: I do not have the verbatim granted claims in front of me. What follows is a reconstruction of the likely independent claims from the specification's stated inventive aspects and the abstract. It should be verified against the actual claim set (e.g., USPTO Patent Public Search / PatentCenter for application 16/101,336) before being relied upon.
The specification frames the invention around several distinct "aspects," each of which reads like the basis for a respective independent claim:
Apparatus with a multi‑holding‑area carrier and two camera modules. A casing with an opening; a receiving mechanism accepting a carrier inserted through the opening; the carrier has a first holding area and a second holding area that carry or have been exposed to the biological specimen. A first camera module images the first holding area, a second camera module images the second holding area. A processor on a main circuit board performs a first analytic process on the first area's images and a second, different analytic process on the second area's images, then determines an outcome regarding the specimen based on both results. The receiving mechanism, both camera modules, and the circuit board are all enclosed within the casing. (FIG. 22; FIG. 29 carriers.)
Adaptive algorithm selection based on imagery. A receiving mechanism, a carrier with a holding area, a camera module capturing multiple images of the holding area, and a processor that adaptively selects — based on the captured images — an analytical algorithm suitable for a motion property of the specimen, then performs the corresponding analytic processes to generate a result.
Visual‑cue‑driven operation / specimen verification. An apparatus where the processor identifies a visual cue in the captured imagery of the holding area (e.g., the shape of the holding area, a graphic pattern, visual indicia, a 1‑D barcode, or a multi‑dimensional pattern code such as a QR code), and selectively performs a set of analytic processes depending on the identification result. Variants cover using the cue to verify that the holding area actually carries the specimen, and to authenticate the carrier.
Image stitching via a positioning mechanism. A camera captures a first image and a second image of the holding area; a positioning mechanism adjusts the relative location of carrier to camera; the processor identifies an edge of the first image, causes the positioning mechanism to reposition so that an edge of the second image aligns with the identified edge, and performs analytic processes on a combined image to determine specimen properties.
Focus‑motor‑derived volumetric measurement. A camera module with a focusing motor; the processor determines, based on the operation of the focusing motor, a volumetric property of the holding area, performs analytic processes on the captured imagery, and adjusts the resulting specimen property based on that determined volumetric property.
Device/method aspects from the earlier priority family (as described in the present specification): a device comprising a sample carrier with a specimen holding area plus a detachable cover bearing a magnifying component aligned to the holding area, focal length 0.1–8.5 mm and linear magnification ratio ≥ 1.0; and method claims directed to testing sperm (obtaining the device, applying sperm specimen, recording video/image, determining sperm count from frame(s), and determining sperm motility), including waiting for liquefaction, aligning a mobile device's camera, illuminating the holding area, extracting frames, identifying sperms, computing count from identified sperms and recorded area, analyzing sperm shapes for morphology, tracking traces and speeds for motility, etc.
The "analysis accuracy improvement" theme in the title is carried by the FIG. 33–42 subject matter in the specification: dividing captured imagery into segments (e.g., 0.05 mm × 0.05 mm squares), scoring each segment's focus level (variance, sum‑modulus‑difference, energy‑of‑Laplacian, gradient‑magnitude maximization), keeping only segments passing a minimum focus threshold as candidate segments, then applying a normalcy requirement (e.g., within two standard deviations of the mean sperm count across candidate segments) before counting. This segment‑selection/normalcy logic is a strong candidate for one or more independent claims, though I cannot confirm that from the material available.
CAFC 2026 docket check
I searched specifically for Court of Appeals for the Federal Circuit docket activity involving 10324022 and for Bonraybio litigation generally. I found no results indicating any CAFC 2026 appeal, IPR appeal, or district‑court action naming US 10,324,022. The only Bonraybio‑related prosecution activity surfaced was before the USPTO (four pending office actions at the company level, on applications 17/815,484, 18/431,908, 18/455,458 and 18/047,242 — none of which is this patent). I did not retrieve a CAFC docket record for this patent, and I cannot rule out pending or unindexed proceedings from the negative search result alone. Treat "no CAFC 2026 activity found" as absence of evidence, not evidence of absence.
Caveats
- The granted claim text was not in the authoritative source you supplied (truncated), so the claim summaries above are reconstructions from the specification, not quotes.
- No search result contradicted the Google Patents data you provided; the search results were consistent with it.
- One search hit for a "DE 10324022 A1" (PERI GmbH formwork support) is an unrelated German document that merely happens to share the numeric string; it is not this patent.
Generated 9/30/2026, 12:03:39 AM
Cases on file (0)
Specific litigation cases in our database that name US patent 10324022. 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 10324022 across patent litigation sources.
Let me search more targeted litigation databases and sources.
Let me run additional targeted searches to confirm whether any litigation exists.
Litigation Search Report — U.S. Patent No. 10,324,022
Bottom line
No litigation involving U.S. Patent No. 10,324,022 was found. Based on multiple targeted searches of patent-litigation aggregators, PTAB/CAFC sources, and the patent owner's own public disclosures, I could not identify any district court action, PTAB proceeding, ITC investigation, or Federal Circuit appeal in which this specific patent was asserted or challenged.
What I searched
I ran searches across litigation-oriented and general sources, including attempts directed at Unified Patents' portal (portal.unifiedpatents.com/litigation/caselist), Docket Alarm, Justia-style docket references, and general web queries combining the patent number with litigation terms ("litigation," "lawsuit," "defendant," "complaint," "district court," "infringement"). I also searched for the assignee (Bonraybio Co., Ltd.) combined with litigation terms, and for the patent's title ("Analysis accuracy improvement in automated testing apparatus") combined with "lawsuit."
Results and their significance
No case records surfaced. No docket entries, complaint documents, case captions, or PACER/CAFC references tying this patent number to any proceeding appeared. Searches for the number returned only the patent's own bibliographic record and its technology/company context — not litigation.
The patent's Google Patents page shows no litigation events. The authoritative patent text provided lists prosecution and family events (assignments, priority claims, grants) but contains no "Litigation" or "PTAB" section — consistent with no asserted/challenged history for the '022 patent itself.
Owner is a Taiwanese diagnostics company (Bonraybio Co., Ltd.), and its public filings describe an IP-enforcement posture but identify no litigation. Bonraybio's published ESG/IP-management disclosure states that it maintains "a list of intellectual property disputes and infringement litigation" and may take legal action if products are suspected of infringing its patents. This is generic corporate policy language, not evidence that any case involving the '022 patent (or any Bonraybio patent) actually exists. Its investor materials instead emphasize a growing patent portfolio (reported as 93 granted patents out of 111 filed worldwide as of Q4 2025) rather than enforcement activity.
No PTAB challenge to the '022 patent was found. Unified Patents materials that appeared in results referenced unrelated patents (e.g., 8,953,816; 10,621,228; 9,069,648; 8,793,336) and other parties — none involving 10,324,022.
Caveats and confidence
- Confidence: moderate-to-high that no litigation exists, but this is a negative finding and I was limited to web-search tooling rather than direct access to PACER, Docket Navigator, or the Unified Patents database. I could not confirm some databases returned zero results versus being inaccessible.
- Do not treat this as a legal conclusion. A definitive check would require querying PACER (all districts), the PTAB API, the ITC EDIS, and Docket Navigator/Lexis on the exact patent number.
- Distinguish the patent numbering. Search hits referencing "DE 10324022" (a German formwork patent) are not the same identifier and were excluded. Likewise, U.S. patent family members such as 9,958,658 / 9,958,665 / 9,959,621 / 10,281,386 / 10,852,290 / 10,928,378 / 11,268,947 / 11,899,007 / 11,921,101 are different patents; should any of those be litigated, that would not itself constitute litigation of the '022 patent.
Recommended verification steps
If you need a certified negative or positive, run the exact string "10,324,022" (and "10324022") against:
- PACER Case Locator — nationwide district court search;
- PTAB (USPTO Patent Trial and Appeal Board) API / PTAB Center — IPR, PGR, CBM;
- USITC EDIS — Section 337 investigations;
- CAFC docket search for any appeal referencing the patent;
- Commercial litigation databases (Docket Navigator, Lexis Patent Litigation, Westlaw Litigation Analytics).
If you would like, I can draft those specific queries (including wildcard variants) for each database so the search can be run and documented.
Generated 9/30/2026, 12:03:53 AM
Proceedings on file (0)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
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.
PTAB Proceedings — US 10,324,022 B2 ("Analysis accuracy improvement in automated testing apparatus")
Proceedings overview
Zero. The canonical "PTAB proceedings on file" block supplied in this prompt — sourced from the USPTO Open Data Portal (ODP) AIA-trial feed — returns no inter partes review, post-grant review, or covered business method review naming US 10,324,022, and my independent web searches (Google Patents family/citation pages, PTAB-related docket aggregators, PTAB petition document repositories surfaced via ptacts.uspto.gov, and general litigation queries for the assignee) surfaced no petition, institution decision, final written decision, or appeal involving this patent or its direct family members. Breakdown by status, therefore:
| Status | Count |
|---|---|
| Active (instituted, pre-FWD) | 0 |
| Claims invalidated | 0 |
| Claims sustained | 0 |
| Settled / terminated | 0 |
| Institution denied | 0 |
| Total AIA trials ever filed | 0 |
Bottom-line defensive posture: there is no IPR-based shortcut and no IPR-based landmine. A defendant today cannot cite a prior FWD canceling claims 1–5, and equally cannot rely on petitioner-side estoppel or on a PTAB record of claim construction. Conversely, the patent owner has never had to defend these claims in an adversarial PTAB forum, so the claims remain untested and un-narrowed — they carry their full originally-granted scope, and any invalidity challenge would have to be built from scratch (IPR, PGR-not-available, or district-court § 282). "Zero IPRs" here means clean slate, not hardened patent.
⚠️ Caveat on certainty: the source you supplied renders the patent text only through the description of FIG. 42B — the claim set is truncated and I could not verify claim numbering from the authoritative copy. I therefore do not state which claims exist, how many there are, or which are independent. Any statement mapping invalidity risk to specific claim numbers would be fabrication. The "no proceedings" finding, by contrast, is a negative result from the structured feed plus multiple corroborating negative searches.
Per-proceeding detail
Not applicable — no proceedings to report. I will not invent proceeding numbers, panels, or dispositions.
Two notes on things I explicitly checked and did not find, so the negative is not overread:
- No CAFC appeal. Because there is no FWD, there is no appeal to the Federal Circuit from this patent. My earlier reconnaissance also found no CAFC 2026 docket activity naming US 10,324,022. This is consistent: no PTAB trial → no PTAB appeal.
- No known district-court assertion. My searches did not surface a complaint asserting US 10,324,022. That is an absence-of-evidence result, not proof of non-assertion — Docket Alarm, CourtListener, and PACER coverage of non-published settlements and of foreign-forum disputes (e.g., Taiwan IP Court, where a Taiwanese patent owner would most naturally sue) is incomplete. If you have a demand letter in hand, that is evidence of assertion my searches did not reach.
Strategic summary
Claim status across 10324022. All claims are UNTESTED. None canceled, none sustained, none construed. Practically, this matters more than it first appears: US 10,324,022 issued 2019-06-18 from an application filed 2018-08-10 that claims priority to 2016-05-11, with anticipated expiration 2036-05-11 — roughly nine and a half years of remaining term as of today (2026-09-30). A patent with ~9.5 years left, an active legal status, an untested claim set, and a commercially growing owner is a more dangerous assertion target than a narrowed one, not less. Note also the unusually deep continuation practice: the family includes US 9,958,658, US 9,958,665, US 9,959,621, US 10,281,386, and — downstream of this patent — US 10,852,290, US 11,268,947, US 10,928,378, US 11,899,007, and US 11,921,101. An adverse invalidity ruling on 10324022 would not end the family's leverage; the owner has repeatedly refiled. Invalidity work on 10324022 should be scoped against the whole continuation set, because the "analysis accuracy improvement" segment-selection and normalcy subject matter described at FIG. 33–36 recurs across the line.
Estoppel landscape. § 315(e)(2) estoppel is entirely inapplicable — no petitioner has ever completed an IPR against this patent, so no third party is barred from raising any ground. For a defendant today, the entire prior-art universe remains available: § 102 anticipation, § 103 obviousness, printed publications, public-use/on-sale, and — because the owner is a Taiwanese company with documented product commercialization (LensHooke semen-quality analyzer line; FDA 510(k) K221810 covering the LensHooke CA0/CA1 Sperm Separation Devices) — prior public use and sale evidence is worth affirmative investigation. Note the priority date of 2016-05-11 is what your art must predate; the 2018-08-10 filing date is not the operative date if the priority chain holds.
Pattern signals. (1) No repeat petitioner, because there are no petitioners at all. (2) No defensive aggregator — nothing in the record connects Unified Patents, Unified Patents LLC, or any similar entity to this patent; that is unsurprising given the narrow life-sciences/particle-analysis subject matter, which falls well outside the aggregators' typical target set. (3) No aggressive PTAB-appeal posture by the patent owner, simply because the owner has never been in front of the Board on this patent. The owner's only visible post-grant USPTO activity is ordinary prosecution: four pending office actions at the company level (applications 17/815,484; 18/431,908; 18/455,458; 18/047,242) — none of which is this patent and none of which is an AIA trial.
Read on the signal. The absence of IPRs is weak evidence here, not strong. IPRs cluster around patents that are actually asserted, and Bonraybio's public posture — a Taiwanese-listed biotech (TWSE 6955, listed 2024-12-06) growing revenue ~37% year-over-year in 2025 — suggests a company using patents as brand/regulatory moat markers in male-fertility diagnostics rather than as litigation ammunition. The absence is best read as "nobody has tried yet," not "everybody tried and failed."
Recommended next steps
If you are a defendant and were hoping for a canceled claim to point at: there is none. You cannot cite a final written decision, because no FWD exists. Your defenses must be built independently:
- Verify the claim set first. The authoritative text I was given is truncated at the FIG. 42B description, so I could not confirm claim numbering or scope. Pull the granted claims from USPTO Patent Public Search or PatentCenter for application 16/101,336, and the full text at https://patents.google.com/patent/US10324022B2/en, before any validity opinion. Do not accept the claim summaries in my earlier reconnaissance section as quotes — they were reconstructions from the specification.
- Scope validity work against the real target. The title-driven subject matter — dividing captured imagery into segments (e.g., 0.05 mm × 0.05 mm squares), scoring focus per segment (variance; sum-modulus-difference; energy of Laplacian; gradient-magnitude maximization), thresholding candidates, then applying a normalcy filter (e.g., within two standard deviations of mean cell count) — sits squarely in well-trodden computer-vision art. The specification itself at FIG. 16 and FIG. 18 recites standard adaptive-thresholding binarization, distance transform, ellipse fitting, 2-D Kalman filtering, and JPDAF tracking. That is a § 103 evidentiary opportunity, not a § 102 one.
- If you intend to file an IPR: the statutory frame is available to you in full — 35 U.S.C. § 311–319, 37 C.F.R. § 42.100 et seq., with institution required within 6 months of the petition's filing and an FWD due within 12 months of institution (§ 316(a)(11)). Note two § 315 bars to check before filing: (a) § 315(b)'s one-year bar runs from service of a complaint alleging infringement of this patent; if a complaint has been served on you or a privy, the clock is running and my searches did not surface the date. (b) § 315(a)(1) bars an IPR if you previously filed a civil action challenging validity.
- Do not file a PGR. This patent's effective filing date traces to 2016-05-11 — well before 2013-03-16 — so post-grant review is unavailable regardless of when the patent issued. CBM is likewise unavailable (the patent is not a "covered business method" patent, and the CBM program has sunset).
- Watch the family, not just this patent. Because validity work against 10324022 can be neutralized by the owner asserting a sibling (US 10,852,290; US 11,268,947; US 10,928,378; US 11,899,007; US 11,921,101), a defensible strategy maps prior art across the continuation chain so the same art can be deployed against whichever member gets asserted.
If a proceeding is filed and the ODP feed has not yet indexed it: re-run the query rather than trusting this document. The PTAB's own filing systems (PTAB E2E, PTAB public petitions, and the USPTO PTAB Decisions page) are the primary sources; CourtListener and the Federal Circuit docket cover any resulting appeal. This report is a snapshot as of 2026-09-30 and reflects a negative result that can be superseded by a single petition filing at any time.
Generated 9/30/2026, 12:04:02 AM
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 for US 10,324,022. Let me run several targeted searches.
Let me dig deeper into assignment records and the corporate status of Bonraybio.
Let me search for the specific reel/frame number and any additional assignments or litigation.
Assignment Reconstruction — US 10,324,022 B2
Sourcing note (read first): The authoritative Google Patents legal‑events record supplied in the base material shows exactly one recorded conveyance for this patent — the original inventor‑to‑company assignment, recorded 2018‑11‑05. My searches did not surface a verbatim USPTO Assignment Center entry (reel/frame, execution date, or correspondent) for application 16/101,336; the Assignment Center interface is not fully indexable by the search tools available in this session. I have therefore left reel/frame, execution date, and correspondent fields explicitly marked as not retrieved rather than reconstructing them. Everything else below is grounded in the identifiable record.
Inventors
All six named inventors appear, on the available evidence, to have been Bonraybio personnel at the time of filing — this is a company‑invented, single‑assignee portfolio, not an acquired or inventor‑held asset.
| Inventor | Role / employer at filing (as determinable) |
|---|---|
| Cheng‑Teng Hsu (徐振騰) | Founder, Chairman & General Manager (CEO) of Bonraybio. Ph.D., Chemistry, National Chung Hsing University; former co‑founder and VP of R&D at Bionime Corp (華廣生技), a Taiwanese blood‑glucose‑meter maker. Listed as inventor on the family's other members. |
| Hsuan‑Yu Huang | Bonraybio‑listed inventor; PatentLeaderboard credits him with 16 US patents assigned to Bonraybio, first granted 2017, most recent May 2025. |
| Chih‑Pin Chang | Bonraybio inventor. |
| Kuang‑Li Huang | Bonraybio inventor. |
| Yu‑Chiao Chi | Bonraybio inventor. |
| Chia‑Wei Chang | Bonraybio inventor. |
Unusual‑pattern check — no fire‑sale precursor signals:
- The lead inventor is the CEO and remains CEO. Bonraybio investor‑conference materials from 2026 still list 徐振騰 as Chairman/General Manager. There is no inventor‑departure pattern.
- The inventor team is stable across the whole family. The same founder‑team names recur on Bonraybio continuations (US 10,852,290; US 10,928,378; US 11,268,947; US 11,899,007; US 11,921,101) and on the co‑pending publication US 2022/0163507 A1 — i.e., the patent‑generating team is still inside the company, still filing into 2025.
- No evidence of any inventor assigning away from the company, and no evidence of the "all inventors exit within 12 months" pattern.
Original assignee
BONRAYBIO CO., LTD. (邦睿生技股份有限公司), Taichung, Taiwan — named as both original and current assignee. Corporate registration no. 42686138; incorporated 2016‑01‑12; ~117 employees.
- Primary business: development and sale of a "Male Infertility Total Solution" — the LensHooke® brand of portable AI sperm‑quality analyzers (X1 PRO, X12 PRO, X3 PRO), test cassettes/consumables (CS1, CS3), sperm DNA‑fragmentation kits (R10/R11), and sperm selectors (CA0/CA1). Revenue is dominated by export (Americas ~29%, Europe ~20%, Asia ~45% in FY2023).
- Did they ship a product embodying the claims? — Yes, affirmatively. The patent's own product concepts (miniaturized high‑pixel microscope lens module, multi‑camera carrier, magnifying cover, segmented/autofocus image analysis) map directly onto the shipped X‑series analyzers and CS‑series consumables. The company reported to TWSE that it has been running the LensHooke product line commercially since ~2017, with distribution in 50+ countries.
- Current status: operating and profitable, publicly listed. Bonraybio moved from Taiwan's emerging stock board (興櫃, ticker 6955) — debut 2023‑07‑25 — to the TWSE Innovation Board (創新板) with a listing date of 2024‑12‑06. FY2025 net income before tax NT$104.8M (EPS 4.13); H1‑2026 income before tax NT$60.7M (EPS 2.11). This is not a distressed or dissolving entity.
- No bankruptcy, no liquidation, no acquisition. I found no Chapter 7/11 analog, no merger, and no change‑of‑name transaction in the record relevant to this patent.
⚠️ Note on the 同花顺 "终止上市 2024‑12‑06" field: this is the emerging‑board registration terminating on the date the company moved up to the TWSE Innovation Board — not a delisting. The TWSE company page confirms "Listing Date 2024/12/06."
Assignment timeline
Only one conveyance is recorded against this patent.
- Executed 2018‑??‑?? (not retrieved) / recorded 2018‑11‑05 — Reel/frame: not retrieved
- Conveyance: Assignment of assignors' interest (original inventor→company assignment; Google Patents legal event labels it "ASSIGNMENT OF ASSIGNORS INTEREST")
- Assignor: CHANG, Chia‑Wei; CHANG, Chih‑Pin; CHI, Yu‑Chiao; HSU, Cheng‑Teng; HUANG, Hsuan‑Yu; HUANG, Kuang‑Li (all six named inventors)
- Assignee: BONRAYBIO CO., LTD.
- Correspondent: not retrieved — cannot be assessed for recurrence. ⚠️ Per the task brief, recurrence of a single recording attorney across multiple links is the tell; with only one link in the chain this signal is not assessable here, not "absent."
- Context: Routine original‑assignment perfection. Filed 2018‑08‑10; recorded roughly three months later, and ~7 months before the 2019‑06‑18 grant. Nothing about the timing suggests a transfer arranged for assertion.
No post‑issuance assignments of any kind are recorded. No security agreements, no releases, no licences of record, no change‑of‑name reels, no transfer to any IP‑holding or licensing entity. Google Patents still reports the current assignee as Bonraybio Co Ltd, and independent patent‑owner aggregators (ipqwery/onscope) likewise list the owner as "Bonraybio Co., Ltd. (Taiwan, Province of China)" with status "In Force."
Family consistency: The priority chain (US 15/152,470 → US 9,958,658; US 15/345,061 → US 9,958,665; US 15/603,783 → US 9,995/9,621; US 15/966,479 → US 10,281,386) and the downstream continuations all list Bonraybio as assignee. The foreign siblings — TWI699532B and CN110408513B, both claiming priority from this application — are likewise Bonraybio properties (Taiwan and China filings, 2019‑04). There is no split ownership and no offshore holding vehicle in the chain.
Timeline diagram
timeline
title Ownership of US 10324022
2016 : Bonraybio incorporated in Taichung
: Earliest priority application filed
2018 : Continuation filed 10 Aug
: Inventors assign to Bonraybio 5 Nov
2019 : Patent granted 18 Jun
2023 : Bonraybio debuts on Taiwan emerging board
2024 : Bonraybio moves to TWSE Innovation Board
2026 : Still owned by Bonraybio
NPE / troll‑pattern signals
| # | Signal | Call | Basis |
|---|---|---|---|
| 1 | Shell‑entity transfer | Not present | The only recorded conveyance is inventors → Bonraybio Co., Ltd. (2018‑11‑05). Bonraybio is an identified Taiwanese operating company with a registration number, a physical Taichung address, 117 employees, and a public listing. No "IP / Holdings / Licensing / Ventures" entity appears anywhere. |
| 2 | Known asserter in the chain | Not present | No assignee in the chain matches any entity on the Acacia / Marathon / IV / IPNav / Wi‑LAN / Conversant / Vringo / Pendrell / Round Rock / Spangenberg lists, or any elevated on a Unified Patents or RPX high‑frequency‑plaintiff list. The single assignee is a product company. |
| 3 | Repeat correspondent across the chain | Unclear — not assessable | Only one recorded link exists, so recurrence cannot be tested. The correspondent on that link was not retrievable in this session. Flagging as "unclear" rather than "not present," since a one‑appearance sample cannot establish the absence of recurrence. |
| 4 | Cascading transfers | Not present | Zero post‑issuance transfers; no chained LLCs; no shared correspondent addresses; no common‑principal pattern. The chain length is one. |
| 5 | Pre‑litigation transfer | Not present | No infringement action naming US 10,324,022 was found (consistent with the CAFC/docket check in the summary section). The sole assignment (recorded 2018‑11‑05) predates issuance and there is no litigation to which it could be pre‑litigation. |
| 6 | Bankruptcy fire‑sale | Not present | Assignee is a going concern with rising earnings (FY2024 net income before tax NT$68.4M → FY2025 NT$104.8M) and declared dividends (2025: NT$1.50 cash + NT$1.50 stock). No Kodak/Nortel/Polaroid‑style event. |
| 7 | Privateering | Not present | No transfer to any third‑party NPE asserting on Bonraybio's behalf. Bonraybio retains and enforces its own IP as a practising entity. |
| 8 | Defensive aggregator | Not present | Chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. The patent has not been neutralised — it remains with a practising manufacturer. |
Verdict
Insufficient data — but with an important clarification: the insufficiency is procedural, not substantive. Under the rubric, "Insufficient data" covers the case of "only the original assignment," which is exactly what the record contains: a single inventor→company conveyance recorded 2018‑11‑05, with no post‑issuance transfers, and no litigation to test the assertion prong of "operating‑company assertion."
Substantively, the evidence points strongly away from any NPE characterisation: the sole assignee is Bonraybio Co., Ltd., a listed Taiwanese medical‑device manufacturer (TWSE Innovation Board, ticker 6955, listed 2024‑12‑06) that ships the LensHooke® X‑series sperm analyzers and CS‑series cassettes embodying the claims into 50+ countries, employs ~117 people, and generated NT$104.8M pre‑tax income in FY2025; the lead inventor is the founder‑CEO and remains so; and the family continues to grow through Bonraybio continuations filed as recently as 2025. No signal among the eight enumerated NPE/troll indicators is present. Because the chain never left the operating company, there is simply no NPE chain to score — hence no confidence‑graded NPE verdict is warranted, and no assignment evidence supports one.
Verification link: https://assignmentcenter.uspto.gov/ — search by patent number 10324022 to retrieve the reel/frame, execution date, and correspondent that I could not pull in this session. Cross‑check the sibling records for US 15/966,479 (→ US 10,281,386) and US 16/443,699 (→ US 10,852,290) to confirm the same single‑assignee pattern holds across the family.
Caveats and open items
- Reel/frame, execution date, and correspondent were not retrieved. I have deliberately not invented them. The single most useful field for NPE detection — the recording attorney — remains unverified for this patent.
- The "recorded 2018‑11‑05" date is a Google Patents legal‑event date, not a confirmed Assignment Center recording date; it is almost certainly the same event, but treat it as one source.
- No litigation found is absence of evidence. I did not locate any district‑court or CAFC proceeding naming this patent, which is consistent with — but not proof of — there being none.
- Ownership may sit at a subsidiary level. Bonraybio's annual report refers to "本公司及子公司" (the company and its subsidiaries) and notes a 2018 China market entity. The US patent record nonetheless names the Taiwan parent as assignee; if any intra‑group licence or holding arrangement exists, it is undocumented in the US assignment record.
- One search hit for a "DE 10324022 A1" (PERI GmbH formwork support) shares only the numeric string and is unrelated to this patent — flagged here to prevent a future mis‑link.
Generated 9/30/2026, 12:04:26 AM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll search for the patent's prior-art citations, focusing specifically on US 10,324,022.
The generic searches are surfacing unrelated hits (including the recurring German "DE 10324022 A1"). Let me target the citation tables directly.
Let me try to reach the patent's own front-page "References Cited" data and the Google Patents citation tables.
Prior-Art Reconnaissance — US 10,324,022 B2
Status: PARTIAL. My tool budget was exhausted before I could retrieve the authoritative "(56) References Cited" face of US 10,324,022 B2 itself. Below I report exactly what I did retrieve, what it is attached to, and where I am inferring rather than quoting. I am not going to present a reconstructed citation list as if it were the patent's own.
1. What the search actually returned
I could not obtain the front-page reference list of US 10,324,022 B2. Every search I ran returned one of four things instead:
- "Cited By" tables (art that cites this patent family) — not prior art against it.
- Citation tables belonging to other documents that merely display US 10,324,022 in a family/related-applications table.
- Family members and continuations of the same Bonraybio priority chain.
- Unrelated numeric collisions — see the contamination warning below.
I did not obtain a verbatim quote of the patent's own §102 reference list. The claim-level §102 mapping in Section 4 is therefore inferential, and I flag it as such.
2. ⚠️ Contradiction / contamination flag (repeat of the earlier section)
The German document DE 10324022 A1 (PERI GmbH, formwork support, published 2004‑12‑16) resurfaced again in this search round — twice — whenever I queried the bare string 10324022. This is not US 10,324,022. It is an unrelated German formwork patent that shares the numeric string. Any citation list that appears to include "DE 10324022" as prior art for this patent should be treated as a text-matching artifact. This confirms, rather than contradicts, the warning recorded in the previously generated summary.
No search result contradicted the Google Patents bibliographic data supplied in the authoritative source.
3. References I did retrieve, with provenance labels
Table A — Five-item citation list surfaced on the Bonraybio cartridge-family page
Provenance caveat: these five appeared under a "Patent Citations (5)" heading on a Google Patents page for a Bonraybio-family cartridge document (WO 2015/020884 lineage), not on the US 10,324,022 page itself. They are topically apt for this patent's apparatus claims, but I cannot confirm they sit on the US 10,324,022 face.
| # | Full citation | Date | Brief description |
|---|---|---|---|
| A1 | US 2004/0165778 A1 — Cartlidge, Andrew G. et al., "Semiconductor imaging system methodology" | Pub. 2004‑08‑26 (filed from a 2001‑07‑06 priority) | Solid-state/semiconductor imaging system and methodology; background art for camera-module + image-sensor capture. |
| A2 | US 2009/0130745 A1 — Handylab, Inc., "Integrated apparatus for performing nucleic acid extraction and diagnostic testing on multiple biological samples" | Pub. 2009‑05‑21 | Microfluidic cartridge with multiple reaction/processing zones and optical detection — i.e., a single carrier with multiple analysis regions read optically. |
| A3 | US 8,105,849 B2 — Board of Regents, The University of Texas System, "Integration of fluids and reagents into self-contained cartridges containing sensor elements" | Granted 2012‑01‑31 | Self-contained assay cartridge integrating fluidics, reagents and sensor elements; one-piece disposable diagnostic carrier. |
| A4 | US 2012/0045786 A1 — Stith, Curtis W. et al., "Opto-fluidic microscope diagnostic system" | Pub. 2012‑02‑23 | Opto-fluidic microscope for automated imaging/counting of cells in a fluidic channel — close to the "automated testing apparatus with magnifying optics" concept. |
| A5 | US 2012/0218379 A1 — The Regents of the University of California (Ozcan et al.), "Incoherent lensfree cell holography and microscopy on a chip" | Pub. 2012‑08‑30 | Lens-free on-chip holographic microscopy, incl. cell counting/characterization without a conventional objective. |
Table B — References on the sibling US 9,958,665 B2 front page
Provenance caveat: this is the §(56) face of US 9,958,665 B2 ("Testing equipment with magnifying function"), a sibling in the same 2016‑05‑11 priority family. It is not confirmed to be the §(56) face of US 10,324,022. Because the two share an examiner art unit and a common specification lineage, overlap is likely but unverified.
U.S. patent documents (as printed, with OCR column-alignment risk flagged):
| Full citation | Date as printed | Description |
|---|---|---|
| US 3,656,840 A — Smith et al. | 4/1972 | Early optical/analytical instrument art |
| US 5,021,651 A — Ishikawa | 6/1991 | Optical measurement instrument |
| US 5,267,087 A — Weidemann | 11/1993 | Cited in CPC class A61B 10/0012 (semen/sample collection) |
| US 5,280,389 A — Kunikane et al. | 1/1994 | Class 359/385 — compound microscope optics |
| US 5,572,370 A — Cho | 11/1996 | Optical/microscope element |
| US 5,894,346 A — Gu‑pin et al. | 4/1999 | Optical instrument |
| US 8,460,942 B2 — Kislev et al. | 6/2013 | Optical imaging/illumination apparatus |
| US 8,516,390 B2 — Ozcan et al. | printed "12/2014" ⚠️ | Lens-free/on-chip microscopy of cells and particles |
| US 9,322,767 B2 — Ehrenkranz | 4/2016 | Analyte testing device / personal diagnostic instrument |
| US 2002/0044347 A1 — Steenblik et al. | 4/2002 | Class G02B 21/0008 — microscope optics |
| US 2002/0048819 A1 — Alley | 4/2002 | Analytical/sample apparatus |
| US 2004/0263810 A1 — Kirchner et al. | 12/2004 | Class G03F 7/70233 — high-NA optical projection imaging |
| US 2009/0251751 A1 — Kuhlmann et al. | 10/2009 | Class G02B 25/552 — lens/magnifier device |
| US 2012/0148141 A1 — Ozcan et al. | 6/2012 | Class 359/15 — on-chip holographic/lens-free microscopy |
⚠️ The OCR of this table interleaves two columns; the date "12/2014" beside US 8,516,390 B2 does not match my recollection of that patent's issue date. Treat the dates in Table B as printed-with-risk and verify each against the actual front page.
Foreign patent documents in the same Table B: CN 2269833 Y (12/1997); CN 201535752 U (7/2010); CN 202088642 U (12/2011); CN 101952762 B (11/2012); CN 202974876 U (6/2013); CN 102236011 B (10/2013); CN 203232198 U (10/2013); TW M491168 U (12/2014); TW M491840 U (12/2014); WO 2009/053927 A2 (4/2009); WO 2014/099629 A1 (6/2014); WO 2015/020884 A1 (2/2015); WO 2015/087232 A1 (6/2015).
Other publications listed: European Search Report dated 2017‑10‑16 (European Application); International Search Report and Written Opinion dated 2017‑09‑08.
4. §102 anticipation analysis — with explicit claim-mapping caveat
Blocker: as recorded in the previously generated summary, the authoritative Google Patents text you supplied is truncated before the claims. I still do not have the verbatim granted claims of US 10,324,022. I therefore cannot name claim numbers. I map instead to the reconstructed independent-claim themes from the prior section, by letter.
| Reference | Claim theme potentially implicated | §102 analysis |
|---|---|---|
| US 2004/0165778 A1 (Cartlidge) | (1) multi-camera apparatus | Unlikely §102 anticipation. Discloses imaging hardware/methodology, not a cassette with two holding areas each read by a dedicated camera module plus a processor performing two different analytic processes and combining them. At most §103 background. |
| US 2009/0130745 A1 (Handylab) | (1) carrier with first + second holding areas analyzed differently | Strongest §102 candidate among Table A for theme (1). A microfluidic cartridge with multiple distinct processing/analysis zones read by an optical detector reads on "carrier with first holding area and second holding area," and could be argued to anticipate the multi-region architecture if the reference discloses distinct analytic processes per zone and a combined outcome. Verify whether it discloses two separate camera modules (the patent requires a first camera module and second camera module, which is the narrow point of distinction). |
| US 8,105,849 B2 (UT System) | (1) disposable carrier + integrated sensor elements | Partial §102 exposure to any claim reciting a self-contained disposable cartridge integrating fluid handling and detection. Does not, on its face, teach the two-camera / two-distinct-analytic-process limitation. |
| US 2012/0045786 A1 (Stith, opto-fluidic microscope) | (1), (2), (4); and the FIG. 16 sperm-counting method | Meaningful §102 risk against the counting/imaging claims. Automated opto-fluidic microscopy of cells in a channel anticipates the general concept of "receiving mechanism + camera + automated cell determination." Its weakness against theme (1) is the absence of a two-holding-area/two-camera configuration. |
| US 2012/0218379 A1 (Ozcan, lensfree holography) | FIG. 16–18 analytics (cell count, trajectory/motility-style characterization) | §103 risk rather than clean §102. On-chip lensless imaging with automated cell counting/characterization. If a claim recites only "camera module captures images of holding area; processor performs analytic process to determine a property of the biological specimen," this reference is directly on point. Note Ozcan art appears twice in the Table B list as well (US 8,516,390 B2; US 2012/0148141 A1), indicating the examiner treated Ozcan as the central §102/§103 reference for the on-chip microscopy aspects. |
| US 9,322,767 B2 (Ehrenkranz) | (3) visual-cue-driven / specimen-verification operation; (§ 102(a)(1)) | Notable for theme (3). A personal analyte-testing instrument with a reader interpreting a test strip's visual indication. Directly relevant to claims reciting a processor that identifies a visual indicia on a carrier and selectively performs analytic processes. |
| WO 2014/099629 A1 and WO 2015/020884 A1 | (6) device with magnifying cover | Both were cited on the sibling's face; WO 2015/020884 is a Bonraybio-lineage cartridge document. If either discloses a magnifying component aligned over a specimen holding area with the recited focal-length range (0.1–8.5 mm) and linear magnification ratio ≥ 1.0, it would be the most dangerous §102 art for the device claims. I could not verify the focal-length disclosure. |
| TW M491168 U / TW M491840 U / CN 201535752 U / CN 202974876 U | (6) magnifying test device | Utility-model counterparts in the same technical space; worth checking for the specific numeric ranges. |
Critically: what is not prior art
The entire Bonraybio sibling set — US 9,958,658 B2, US 9,958,665 B2, US 9,959,621 B2, US 10,281,386 B2 — and the later continuations (US 10,852,290 B2, US 11,268,947 B2, US 10,928,378 B2, US 11,899,007 B2, US 11,921,101 B2) all claim the same 2016‑05‑11 priority date as US 10,324,022. They are therefore not available as §102(a)(2)/§102(e) prior art against it. Their text may be cited as evidence of what the common specification discloses, but not as anticipating references. This is the single most important structural point in the file.
Likewise, everything appearing in a "Cited By" table — including WO 2016/138120 A1 (Nanoscopia, "Sample analysis methods with spectral information"), the CN 11xxxxx sperm-detection documents, and JP 2022534852 — is post-dating art and cannot anticipate.
5. What I could not establish
- The verbatim granted claims of US 10,324,022 B2 (source text truncated pre-claims). Without them, no claim-number-level §102 mapping is defensible.
- Confirmation that Tables A and B are actually printed on US 10,324,022's own front page, as opposed to its siblings'.
- Whether any retrieved reference discloses the numerically specific limitations the patent leans on (focal length 0.1–8.5 mm; linear magnification ratio ≥ 1.0; 0.05 mm × 0.05 mm segment size; the two-standard-deviation normalcy requirement).
6. Recommended next steps to close the gap
- Pull the granted claims and the (56) face from USPTO Patent Public Search / PatentCenter for application 16/101,336 — this is the authoritative record and would resolve both open items in one step.
- Pull the US 2018/0348114 A1 pre-grant publication's citation list (it is the same application, and its FPO/Justia pages are usually rendered with a clean "(56) References Cited" table).
- Pull the file wrapper / IFW for 16/101,336 to capture any examiner-cited art added after publication, including Form PTO‑892 references.
- Cross-check the Table B dates (especially US 8,516,390 B2) against the actual patent face before relying on them.
Generated 9/30/2026, 12:04:25 AM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll ground this analysis in the actual prior-art landscape before reasoning. Let me run targeted searches.
Now let me pin down the specific "analysis accuracy improvement" prior art: region-based focus selection, multi-camera readers, and cue-based assay identification.
Obviousness Analysis under 35 U.S.C. § 103 — US 10,324,022 B2
"Analysis accuracy improvement in automated testing apparatus" — Bonraybio Co., Ltd.
0. Scope, sourcing, and two threshold flags
0.1 — The "Prior Art section of this page" did not contain a reference list. The page supplied to me contains the patent's full text (truncated mid‑description of FIG. 42B, i.e., before the claims), a bibliographic/priority table, a CPC list, and a "Prior art keywords" field (specimen, holding area, segments, sperm, carrier) with a prior‑art date of 2016‑05‑11. There was no enumerated prior‑art reference list. I therefore grounded this analysis by searching the relevant art, and every reference below is cited with its identifier and date so you can verify it. Where I could not confirm a date or a passage, I say so rather than assume it.
0.2 — I do not have the verbatim granted claims. This is carried forward from the reconnaissance section and it materially limits the analysis. What follows is a § 103 analysis keyed to claim concepts rather than quoted claim language. I treat three sources as authoritative for those concepts:
- the specification's "Definitions"/inventive‑aspect paragraphs and abstract (verbatim, your supplied text);
- the dependent/independent claim set of sibling US 9,958,665 B2 (same priority chain — US 15/345,061 — same specification; verbatim, retrieved during search). This is the best available proxy for the claim architecture of the 10,324,022 family; e.g., US 9,958,665 cl. 1 recites "a magnifying component … wherein the focal length of the magnifying component is from 0.1 mm to 8.5 mm, and the magnifying component has a linear magnification ratio of at least 1.0" plus "a base component … insertion port … camera component …" and "a supplemental lens placed below the camera component, a linear magnification ratio of an optical system including the magnifying component and the supplemental lens is at least 1.0." US 10,324,022's "Definitions" section recites the same ranges.
- the FIG. 33–42 disclosure (segments, focus levels, normalcy thresholds), which is not in the earlier claim set and appears to be the "accuracy improvement" novelty the title advertises.
0.3 — Critical priority question you must resolve. US 10,324,022 was filed 2018‑08‑10 as a continuation claiming priority to 2016‑05‑11. Any claim limitation not supported by the 2016‑05‑11 parent (US 15/152,470) receives an effective filing date of 2018‑08‑10. This matters enormously here because the FIG. 33–42 "analysis accuracy improvement" material looks like later‑added subject matter, and the obviousness calculus changes if that is the operative date. Flagged, not resolved.
0.4 — Governing statute. Filed 2018 with a 2016 priority → AIA § 102/§ 103 apply. I therefore rely on art that is (a) a § 102(a)(1) printed publication/patent before the critical date, or (b) a § 102(a)(2) U.S. patent/published application effectively filed before the critical date and not disqualified by the common‑ownership exception of § 102(b)(2)(C).
0.5 — A disqualification you should not overlook. The Bonraybio family itself — US 9,958,658 B2, US 9,958,665 B2, US 9,959,621 B2, US 10,281,386 B2 — is commonly owned and shares the same six inventors as US 10,324,022. Under AIA § 102(b)(2)(C) that common ownership/disclosure exception likely removes them as § 102(a)(2) art. Do not build an obviousness case on Bonraybio's own patents. Everything below is third‑party art.
1. Level of ordinary skill in the art (POSITA)
A bachelor's degree in electrical, optical, mechanical, or biomedical engineering (or computer science), or equivalent, plus 2–3 years of experience designing point‑of‑care/at‑home optical diagnostic instruments. The POSITA is conversant with (i) compact optical design and smartphone camera modules, (ii) digital image processing — adaptive thresholding, binarization, segmentation, morphological denoising, object tracking, and (iii) focus‑quality/autofocus metrics. This is a POSITA who routinely combines a flow‑assay chemist's strip with an engineer's camera. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420–21 (2007) (POSITA is a person of ordinary creativity, not an automaton).
2. Claim concepts decomposed for § 103
Reconstructed claim concepts (labels mine; not quotations of US 10,324,022):
| # | Concept | Support in disclosure |
|---|---|---|
| C‑A | Device (carrier + detachable cover + magnifying component aligned to a specimen‑holding area; focal length 0.1–8.5 mm; linear mag ≥ 1.0) and system with a base having an insertion port and camera, and/or a supplemental lens below the camera; autofocus; collection bottle; colour/pH determination | Definitions; FIGS. 1A–2B, 19–21B; US 9,958,665 cl. 1, 5, 14–20 |
| C‑B | Carrier with first and second holding areas; two camera modules; processor performs a first analytic process on area 1 and a different, second analytic process on area 2 and derives an outcome from both; all enclosed in a casing | FIG. 22, FIG. 29, FIG. 30 |
| C‑C | Visual cue on the carrier (shape of holding area; graphic pattern; visual indicia; 1‑D barcode; multi‑dimensional code such as QR) → processor selectively performs a set of analytic processes; variants: verify specimen presence/readiness; authenticate/authorise the carrier | FIG. 29, 31, 32 |
| C‑D | Divide captured imagery into segments (e.g., 0.05 × 0.05 mm squares); compute a focus level per segment (variance / sum‑modulus‑difference / energy of Laplacian / gradient‑magnitude maximisation); retain only segments passing a minimum focus threshold; then apply a normalcy requirement (e.g., within two standard deviations of the mean cell count across candidate segments) before counting | FIG. 33–36 |
| C‑E | Processor adaptively selects an analytical algorithm based on the captured images / a motion property of the specimen | Definitions |
| C‑F | Camera captures first and second images; positioning mechanism realigns so an edge of the second image aligns with an identified edge of the first; analysis on the combined image | (Specification aspect) |
| C‑G | Processor determines a volumetric property from operation of the focusing motor, and adjusts the specimen property accordingly | (Specification aspect) |
3. The prior art
| Ref. | Date / status | What it discloses (grounded) |
|---|---|---|
| WO 2015/087232 A1 — MES Medical Electronic Systems Ltd. ("Home testing device"), pub. 2015‑06‑18; US priority 61/914,980 of 2013‑12‑12 | § 102(a)(1) | Clip‑on optical adapter over a smartphone; ball lens (~2 mm dia.) between sample and camera entrance aperture, magnifying the image; transparent slide with a ~100 µm depression and a fixed cover slip defining a sample chamber aligned with the lens; illumination optics (two 90° mirrors) back‑illuminating via the phone's own light source; processor computes motile sperm concentration. Family: US 2019/0293545 A1 → US 10,935,484 B2; AU 2014363033 B2; JP 2017‑506324 A; JP 6796340 B2 |
| JP 2017‑506324 A (same PCT/IB2014/066716, published JP text of WO'232) | § 102(a)(1) | Expressly: the processor waits for video stabilisation and "selects, in the stabilised video, the region presenting the clearest view of the sperm cells for analysis" — a 700 × 700‑pixel ROI chosen by computing, per pixel over frames, the maximum gradient of grayscale change, then taking the centroid of all high‑gradient pixels. ¶¶ [0048]–[0051] |
| US 2014/0254004 A1 (Wooder et al.) | § 102(a)(1) | "Test kits for assessing male fertility": sample holder defining an object plane, a lens, a 2‑D sensor and an image plane on a common axis; housing ≤ 100 mm; processing circuitry producing sperm count and/or motility from the image data |
| US 8,046,175 B2 | granted 2011‑10‑25 → § 102(a)(1) | Analytical‑strip reader with an optically readable pattern on the strip carrying "a type, a lot number and an expiration date … as well as reagent calibration data." Claim 1 recites a database sub‑module "for storing algorithms corresponding to various types of analytical strips" and a processing sub‑module "for retrieving the algorithm … corresponding to the type of the analytical strip" and comparing the reaction signal |
| US 8,394,328 B2 / US 2008/0267823 A1 / US 2007/0015286 A1 / US 2010/0068093 A1 (Nipro/Trividia — strip coding) | 2013‑03‑12 / 2008‑10‑30 / 2007‑01‑18 / 2010‑03‑18 → § 102(a)(1) | On‑strip code readable by the meter to identify the test to be performed — expressly "parameters indicating the particular test to be performed"; code may be a bar‑code pattern, a coloured pattern, a distinct contour/perimeter pattern or shape, or an RF/optical character pattern (US 8,394,328, col. on alternative code arrangements & cls. 16–17); codes used "to correlate particular test strips for use only with a specific meter or meter type"; meter detects whether an adequate sample is present |
| US 6,304,684 B1 | granted 2001‑10‑16 → § 102(a)(1) | Automatic focus algorithm evaluates a scanned image and commands an optimal focus position for a Z‑axis lens carriage |
| US 2007/0019883 A1 | pub. 2007‑01‑25 → § 102(a)(1) | Depth map by block‑wise sharpness metric — "uses the sharpness metric to select the sharpest picture block" from a set of blocks |
| Focus‑measure literature: Tenenbaum (1970, Tenengrad); Jarvis, Focus Optimisation Criteria for Computer Image Processing, Microscope 24(2):163–180 (1976); Subbarao & Choi, Focusing techniques, Opt. Eng. 32:2824 (1993); Yeo et al., Autofocusing for tissue microscopy, Image & Vision Computing 11(10):629 (1993); Shen & Chen, Robust Focus Measure for Low‑Contrast Images (NTU) | all pre‑2016 → § 102(a)(1) | The exact families of focus functions recited in US 10,324,022 — variance / normalised variance; Tenengrad gradient magnitude; Laplacian energy; sum‑modulus‑difference/Brenner — are the standard, textbook set, evaluated comparatively in these papers |
| WO 2015/153691 A1 — University of Drexel (tracking a plurality of spermatozoa) | pub. 2015‑10‑15 → § 102(a)(1) | Sperm‑tracking with VCL, VSL, LIN, ALH; expressly: "Limiting motility measurements to confirmed tracks prevents any spurious tracks or measurements caused by erroneous segmentation from affecting the population measurements as a whole" — i.e., rejecting outlying detections so they do not bias population statistics |
| US 7,807,452 B2 (Hamilton Thorne) | 2010‑10‑05 | Cited in the WO'232 ISR as semen‑analysis art |
4. Combinations that render the claim concepts obvious
Combination 1 — C‑A: the carrier/cover/magnifier + base + autofocus architecture
[WO 2015/087232] + [US 2014/0254004] + [US 6,304,684]
WO'232 already discloses nearly every structural element: a detachable/insertable sample holder with a cover slip over a depression (the carrier + cover), a magnifying lens aligned between the sample and the camera (the magnifying component), a base that receives the holder and that fits a mobile device's camera (the insertion port + form‑fitting frame), and back‑illumination. Its ball lens (~2 mm diameter, n ≈ 1.5) has a focal length on the order of 1.5 mm — squarely inside the recited 0.1–8.5 mm range — and necessarily provides a linear magnification ratio ≥ 1.0 (the ball lens exists to magnify). US 2014/0254004 supplies the complementary teaching of a compact (≤ 100 mm) fertility test kit with lens + 2‑D sensor + processing circuitry outputting count/motility. US 6,304,684 supplies automatic focus by evaluating the image and driving a lens carriage, and US 9,958,665‑family/US 10,324,022's own statement that "even a slight deviation of 0.01 mm from the optimal distance can prevent the camera module to capture a clear image" provides the design incentive: a 0.01 mm tolerance is precisely the circumstance in which the POSITA reaches for the known automated‑focus solution.
Motivation: KSR rationale (D)/(F) — applying a known technique (image‑based autofocus) to a known device (a smartphone sperm‑testing adapter) ready for improvement, driven by a recognised, articulated design need. No teaching away.
Combination 2 — C‑C: the visual cue → process selection / verification / authentication
[US 8,046,175] + [US 8,394,328 (or US 2008/0267823)] + [WO 2015/087232]
US 8,046,175 is close to dispositive of the "select analytic process based on a cue on the strip" concept as a claim‑level matter: it claims storing algorithms for different strip types and retrieving the algorithm corresponding to the type read from the optically readable pattern. US 8,394,328 adds that the strip‑borne code may be a bar‑code, a colour pattern, or a distinctive shape/contour, and adds meter‑specific locking — i.e., the authentication/authorisation concept of FIG. 32. The only remaining step is to move this established lateral‑flow‑reader paradigm into the optical sperm‑reader of WO'232, whose processor already decides what to do from what the camera sees.
Motivation: KSR (A)/(C) — combining known elements (strip identifier + algorithm look‑up table) with a known reader (WO'232) to obtain their known, predictable benefit: a single instrument that safely handles multiple assay types and rejects unauthorised or mis‑loaded carriers, eliminating user selection error. US 8,394,328 itself states the goal: "to prevent erroneous results that could have serious consequences for the user." Substituting an image‑based cue (the holding‑area shape, as in FIG. 29) for a conductive or bar‑code cue is a simple substitution of one known identifier for another, yielding predictable results.
Combination 3 — C‑D: the "analysis accuracy improvement" core (segments → focus gating → normalcy gating → count)
[WO 2015/087232 / JP 2017‑506324 ¶0048] + [US 2007/0019883] + [focus‑measure literature] + [WO 2015/153691]
This is the concept most likely to carry the patent, so the combination must be tight:
- Sub‑region focus evaluation is old. US 2007/0019883 selects the sharpest picture block by a block‑wise sharpness metric. The focus‑measure literature supplies exactly the four families the patent recites (variance, sum‑modulus‑difference, Laplacian energy, gradient/tenengrad maximisation) as alternatives of known relative merit — the patent's own list is not a selection invention, it is the standard menu.
- Selecting the best‑focused sub‑region of a sperm video is disclosed by the art. JP 2017‑506324 ¶0048 (WO'232 family) has the processor select an ROI presenting the clearest view of the sperm by gradient magnitude — the same physical principle as the recited "gradient magnitude maximisation" focus measure, applied to the same specimen.
- Threshold‑gating and discarding unreliable data is disclosed. Drexel WO 2015/153691 expressly discards spurious detections "so that they do not affect the population measurements as a whole" — the identical problem and identical rationale as the FIG. 33–36 normalcy gate.
- The residual arithmetic is routine. Comparing a per‑segment count to the mean of the population and keeping samples within 1–2 standard deviations is textbook outlier rejection with no asserted criticality in the specification.
Motivation: KSR (A)/(D) — "the improvement of one number is a recognized goal of the prior art" (In re Boesch); the prior art in this exact field had already recognised that low‑quality frames/segments and spurious detections degrade CASA counting, and had already deployed both halves of the solution. Combining a known robustness technique (per‑region focus measurement) with a known statistical filter (outlier rejection about a population mean) to improve counting accuracy is the paradigm case of an obvious combination. This is the strongest § 103 position against the patent, and it is why the title limitation is a liability rather than an asset.
Combination 4 — C‑B: two holding areas, two camera modules, two different analytic processes, one combined outcome
[WO 2015/087232 / US 2014/0254004] + [US 8,046,175] + [the specification's own admission]
The specification itself concedes the key motivation: the colourimetric determination (pH/acidity, HCG, LH, fructose) "does necessarily need a magnification" and needs only a colour read of a region, whereas the sperm determination needs a magnified image. It is therefore an express, art‑recognised design choice to use a low‑magnification/colour channel and a high‑magnification/imaging channel for the two job classes. US 8,046,175 already teaches a single reader handling multiple assay types with stored algorithms. Putting two such channels in one casing on one carrier is arranging old elements with each performing its same function, and the benefit (no carrier re‑insertion, no user re‑configuration, faster outcome) is predictable from the specification's own stated advantage.
Motivation: KSR (A)/(B)/(F). Also note the dependent‑claim numbers (first camera ≥ 2 MP, second ≥ 13 MP; second module linear magnification ≥ 4.8×) are result‑effective‑amounts / design choices unsupported by any criticality data.
Combination 5 — C‑G: volumetric property from focusing‑motor operation
[US 6,304,684] + [WO 2015/087232] (and the general machine‑vision art)
Mapping lens/sensor travel to object depth is elementary optics; the autofocus art (US 6,304,684) drives a Z‑axis carriage whose commanded position is known to the processor. Using that known focus position as the depth of the sample chamber (hence volume = field‑of‑view area × depth, which the specification itself recites) to normalise a concentration is the application of a known technique to a known device, with predictable results. Independent claim 14 of US 9,958,665 (autofocus mechanism moving the camera and supplemental lens together) further shows the autofocus architecture was already conventional in the family.
Combination 6 — C‑F: image stitching by edge alignment
[US 2007/0019883] + [panoramic/mosaic stitching art generally]
Capturing overlapping fields, detecting a common edge/feature, repositioning the stage, and analysing the combined image to enlarge the sampling area is the standard panoramic‑mosaic workflow. Motivation: counting accuracy in a concentration measurement scales with sampled area/volume — a recognised goal (KSR (A)).
5. Anticipated rebuttals and where the patent may survive
5.1 — Numerical ranges. Independent‑claim ranges (focal length 0.1–8.5 mm; linear magnification ≥ 1.0; segment size 0.05 × 0.05 mm; normalcy 2σ) are, on this record, ranges without criticality. WO'232's ~2 mm ball lens falls inside the focal‑length range; the segment size and the σ‑multiple are unremarkable. Absent unexpected‑results data under In re Soni, these do not confer patentability.
5.2 — Where a genuine fight exists. If a granted independent claim requires the specific ordered combination — divide into a grid of segments → score each segment with a focus measure → discard segments below a threshold → compute population statistics over the survivors → exclude segments failing a normalcy requirement → count only within survivors — a well‑crafted office action may still not dispose of it cleanly if no single reference frames the pipeline as a counting precondition. My assessment: strong § 103 case, but the pipeline ordering is the feature to attack with a dedicated combination (Combination 3, above), and possibly with the Kanakasabapathy et al., Sci. Transl. Med. 9, eaai7863 (2017‑03‑22) smartphone semen‑analyser paper — but that paper's availability turns entirely on the Priority flag in § 0.3: it post‑dates the 2016‑05‑11 priority and can only be used against claims lacking written‑description support in the parent. Verify before relying on it.
5.3 — § 101 exposure (alternative attack). Several concepts (C‑C "select an algorithm based on the image," C‑E "adaptively select an analytical algorithm suitable for a motion property") are drafted at a level of abstraction that invites Alice/Mayo step‑two scrutiny: organising human activity and mental‑process‑like data comparison. If the claims tie the algorithm selection to no more than a generic processor, this is a live second front.
5.4 — § 112 priority risk. Under § 0.3, if FIG. 33–42 matter is new matter relative to US 15/152,470, then either (a) the claims lose the 2016 date and the intervening art (WO'232's ROI paragraph published 2017‑03‑02 in JP; Kanakasabapathy 2017‑03‑22) becomes available, or (b) the claims are entitled to the earlier date and the intervening art is unavailable. These two outcomes are mutually exclusive and decisive — resolve this before drafting anything.
5.5 — Secondary considerations. No evidence of unexpected results, licensing, or industry praise appears in the record supplied. Earlier work surfaced no litigation naming this patent and no CAFC 2026 docket activity, so there is no established nexus‑bearing objective evidence on this record. Bonraybio's commercial home sperm‑testing product line may supply a nexus argument if asserted — it would need the usual proof that the claimed feature (not the product generally) drove the success.
6. Bottom line
| Concept | Strongest combination | § 103 strength |
|---|---|---|
| C‑A carrier/cover/magnifier + base + autofocus | WO 2015/087232 + US 2014/0254004 + US 6,304,684 | High |
| C‑B two holding areas / two cameras / two processes / combined outcome | WO'232 or US 2014/0254004 + US 8,046,175 + spec's own colour‑vs‑magnification admission | Moderate–High |
| C‑C visual cue → process selection; verification; authentication | US 8,046,175 + US 8,394,328 (or US 2008/0267823) + WO 2015/087232 | High — near claim‑level disclosure of the selection step |
| C‑D segment/focus/normalcy gating (the "accuracy improvement") | JP 2017‑506324 ¶0048 + US 2007/0019883 + focus‑measure literature (Tenenbaum 1970; Jarvis 1976; Subbarao 1993; Yeo 1993) + WO 2015/153691 | Moderate–High — the ordered pipeline is the only real gap |
| C‑E adaptive algorithm by motion property | WO 2015/153691 + US 2014/0254004 | Moderate (also § 101‑exposed) |
| C‑F image stitching by edge alignment | US 2007/0019883 + mosaic art | Moderate |
| C‑G volume from focus‑motor operation | US 6,304,684 + WO 2015/087232 | Moderate–High |
Most probable invalidity theory: a three‑ or four‑reference combination — WO 2015/087232 (or its US 10,935,484 B2 family member) as the primary reference, with US 8,046,175 / US 8,394,328 for the strip‑identified‑algorithm‑selection concept, US 2007/0019883 and the focus‑measure literature for the per‑segment focus gating, and WO 2015/153691 for the statistical rejection of spurious detections — with the KSR rationales of predictable combination, known‑technique‑for‑known‑problem, and recognised design incentive. A declaration from a POSITA tying the FIG. 33 pipeline to standard autofocus and outlier‑rejection practice would be the decisive evidentiary component.
What I cannot tell you with confidence, and would not assert without checking: (1) the verbatim granted claims of US 10,324,022; (2) whether the FIG. 33–42 subject matter is entitled to the 2016‑05‑11 priority date; (3) the effective filing dates of the automatic‑focus references, which govern their § 102(a)(2) availability — the ones I have anchored on are all § 102(a)(1) pre‑2016 publications or pre‑2016 grants for that reason.
Generated 9/30/2026, 12:05:11 AM
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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