Invalidity dossier

US 11402330

Method for measuring optical signal detector performance

Current assignee: Gen Probe Inc

Added 9/24/2026, 5:43:31 PM

At a glanceNo PTAB challengesNo litigation on fileOptical Technology

Active provider: DeepSeek · deepseek-v4-flash

Patent summary

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

✓ Generated

I'll search for authoritative records on this specific patent number before summarizing.

Now let me check for any litigation or CAFC docket activity involving this patent.

Let me retrieve the actual claim set for US 11402330 to ground the claim summary.

Bottom line first

I could not find any CAFC 2026 docket activity, or any litigation at all, naming U.S. Patent No. 11402330. A targeted search for a 2026 Federal Circuit appeal returned zero results, and broader litigation searches surfaced only unrelated older Gen-Probe/Hologic matters (e.g., Gen-Probe Inc. v. Becton Dickinson, S.D. Cal. 2009; Enzo Life Sciences v. Hologic/Roche). I also could not directly query USPTO PatentCenter/PAIR in this session, so the bibliographic data below comes from the authoritative full patent text supplied to me (Google Patents record for US11402330B2, fetched 2026‑09‑24), not from a live USPTO query. Treat "no litigation found" as a search result, not a negative legal conclusion.


Bibliographic record for US 11402330 B2

Field Value (as recorded)
Patent number US 11402330 B2
Title Method for measuring optical signal detector performance
Application number US 16/937,905
Filing date 2020‑07‑24
Publication (grant) date 2022‑08‑02
Earliest priority date (stated as an assumption) 2015‑12‑31
Anticipated expiration (stated) 2036‑12‑23
Inventors David Opalsky; Srajan Raghuwanshi; James Bui
Assignee Google lists "Gen Probe Inc" as both original and current assignee; the USPTO reassignment record of 2022‑05‑31 is to "GEN‑PROBE INCORPORATED" (assignment of interest from Bui, Opalsky, Raghuwanshi)
Other collateral record 2020‑10‑15: security interest granted to BANK OF AMERICA, N.A., as collateral agent (assignors include Gen-Probe Incorporated, Hologic, Inc., and others)
Status Active
Earlier publication of the same application US 2020/0355610 A1, published 2020‑11‑12
Later continuation claiming priority to this filing US 17/840,388 (filed 2022‑06‑14) → US 11726041 B2
Classifications G01N 21/645; G01N 21/274 (calibration/drift correction); G01N 21/0332 (temperature-controlled cuvettes); G01N 2201/12723 (self-check capacity) among others

Uncertainty note: the supplied full text does not render a verbatim Abstract block (the fetched page omits it). I am therefore not quoting the official abstract; the overview below is drawn from the specification.


What the patent is about

The patent addresses a practical failure mode in automated nucleic-acid assay instruments: a fluorometer can fail or degrade mid-run, silently corrupting real-time amplification readings. Historically, fluorometer function was only checked during instrument shutdown and maintenance, which is incompatible with continuous high-throughput operation. US 11402330 claims in-situ self-check methods that use features already present on the instrument's receptacle carrier — a non-fluorescent surface portion (e.g., aluminum) and a recess/void (e.g., an empty receptacle station) — rather than external calibration standards.

The technical logic is a two-point optical sanity check per detection channel:

  • Non-fluorescent surface in the detection zone → a small but non-zero amount of light should be scattered/reflected back; expected range is stated as >0, e.g. 5–5800 RFU (dye-specific examples: FAM 5–600 RFU; HEX 200–5800 RFU; ROX 5–550 RFU).
  • Recess/void in the detection zone → essentially no light should return; expected range includes zero, e.g. 0–2260 RFU (dye-specific examples: FAM 0–300 RFU; HEX 0–2260 RFU; ROX 0–300 RFU).

A reading outside the expected range indicates a failure status or deteriorated performance status for that channel. The hardware context is a rotary incubator (carousel with upper disk 244 / lower disk 256, non-radial outer spokes 264 carrying surface portions 250a–250e) with up to six signal detectors 400, each having five detection channels (LED source 405, photodiode sensor 423, dichroic beam splitter 440). The self-check is performed by relative motion of carrier and detector (carrier moving past a stationary detector in the illustrated embodiment), so it can occur during normal assay operation.

Distinguishable sibling disclosures that should not be merged with this patent:

  • US 10739263 — "System for measuring optical signal detector performance" (apparatus counterpart).
  • US 11726041 — continuation from US 17/840,388, published as US 2022/0364988 ("Method of analyzing a sample").
  • US 2018/0180544 A1 (Li, Opalsky, Heinz, Hagen) — a different Gen-Probe family that self-checks using fluorescent reference standards (fluorescent plastic disks) rather than the non-fluorescent surfaces/voids of this patent. Do not cite it as the same invention.

Independent claims — plain-language overview

Caveat on grounding: the authoritative text I was given contains the specification and the summary-of-invention passages but is truncated before the granted claim set, so I could not verify the verbatim wording or the exact count/numbering of the independent claims of US 11402330 B2. Because the title is "Method for measuring optical signal detector performance," the independent claims are method claims; the apparatus ("assay instrument"), "system," and "method of analyzing a sample" passages in the supplied text read as summary/embodiment language that is largely co-extensive with the sibling patents. I flag this as an explicit uncertainty rather than asserting a claim set I have not verified.

Parsing the method subject matter disclosed, the independent claims appear to cover:

  1. A method for measuring optical signal detector (fluorometer) performance — align a first non-fluorescent surface portion with a first detection zone; direct light from the detector onto that surface; measure a first characteristic (intensity) at the first sensor; position a first void/recess in the detection zone; direct light into the void; measure a second characteristic at the first sensor; and determine an operational performance status of the detector from at least one (in embodiments, both) of the first and second characteristics — by testing whether each falls within a predetermined non-fluorescent-surface range and a predetermined void/recess range respectively.

  2. A method of analyzing a sample — position the carrier so a portion of a first receptacle is in the detection zone; illuminate it; measure a third intensity; determine a characteristic of the sample (presence, or quantity, of a particular analyte) from that intensity — combined with the same non-fluorescent-surface and recess self-check steps to validate the detector reading.

Common limitations threading through the disclosed independent/dependent subject matter:

  • Relative movement between carrier and detector among at least three positions: (i) receptacle portion in the detection zone, (ii) non-fluorescent surface portion in the detection zone, (iii) recess in the detection zone; plus a fourth position for a second non-fluorescent surface portion where a second detection channel is present.
  • The carrier may be a carousel with first and second spaced disks, the second disk facing the fluorometer and carrying the non-fluorescent surface portion and defining the recess opening; concentric inner/outer rings joined by a spoke bearing the surface portion.
  • Multiple non-fluorescent surface portions may be linearly aligned and coplanar, each comprising an aluminum surface.
  • Movement variants: carrier moves / detector stationary; carrier stationary / detector moves; or both move. (The specification cross-references U.S. Pat. No. 7,794,659 for relative-motion arrangements.)
  • A second fluorometer with its own third non-fluorescent surface portion and second recess may be independently self-checked on the same carrier pass.
  • The "system" framing in the supplied text also recites a controller determining operational status from (i) a measured characteristic with a non-fluorescent surface portion in the zone and (ii) a measured characteristic with a void in the zone, where operational status is proper / failure / deteriorated performance.

Caveats and open items

  • Verbatim claims, abstract, and claim count for US11402330B2 were not independently verified in this session; the supplied full text cuts off inside the description. Anyone relying on claim scope should pull the granted claims from USPTO PatentCenter or the Google Patents claims tab.
  • No CAFC 2026 docket or district-court case naming 11402330 was found. Absence of results is not proof of absence; the searches were web-index based, and I could not query PACER, CourtListener dockets exhaustively, or USPTO PTAB/assignment feeds directly.
  • Priority date is expressly labeled an assumption in the source record (2015‑12‑31), as is the 2036‑12‑23 expiration. The 2015‑12‑31 priority implies a parent filing near 2016‑12‑23, consistent with the stated expiration, but I have not verified the parent application number.
  • The "RFU" ranges in the source text are internally inconsistent in places (e.g., "5 to 600," "200 to 5800," "5 to 550" for non-fluorescent surfaces versus a general "5‑5800 RFU"), and the fetched text contains apparent OCR artifacts including a stray "Relative Fluorescen Units" spelling and "no‑zero" for "non‑zero." I have preserved the numbers literally rather than normalizing them.

If you want, I can next attempt to pull the exact granted claim text and confirm the independence/dependency structure, or check the sibling US 11726041 and US 10739263 for claim-scope overlap with this patent.

Generated 9/29/2026, 1:22:35 PM

Cases on file (0)

Specific litigation cases in our database that name US patent 11402330. 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.

✓ Generated

I'll research litigation specifically involving US Patent 11402330. Let me run targeted searches.

The initial searches returned mostly prosecution-history noise. Let me search more specifically using litigation databases and the patent's parties.

Let me run a few final targeted searches to be thorough before drawing a conclusion.

Generated 9/29/2026, 1:22:19 PM

Proceedings on file (0)

All PTAB activity →

AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.

No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.

PTAB challenges

AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.

✓ Generated

I'll start by verifying the structured "no proceedings" signal against public sources, and check for related patents/continuations that might have drawn PTAB activity.

Let me run a few more targeted searches to make sure I'm not missing anything — including the related continuation and any Gen-Probe/Hologic PTAB activity.

Let me do a final round of verification searches on the patent number directly and on any Unified Patents activity.

PTAB Proceedings Report — U.S. Patent No. 11,402,330 B2

"Method for measuring optical signal detector performance"
Patent Owner / Current Assignee: Gen-Probe Incorporated (Hologic subsidiary)
Priority date: 2015-12-31 · Filed: 2020-07-24 · Issued: 2022-08-02 · Anticipated expiration: 2036-12-23
Continuation: US 11,726,041 B2 (from US 17/840,388, priority claim 2022-06-14)


Proceedings overview

Total AIA trial proceedings on file: 0 (zero). The USPTO Open Data Portal shows no IPR, PGR, or CBM proceedings against US 11,402,330 as of the most recent ingest, giving a breakdown of 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denied. In plain terms, all claims of the patent remain untested and intact at the PTAB, so a defendant cannot point to any prior panel holding that narrowed or killed a claim; the defensive posture is "no PTAB ammunition exists yet — you would be the first petitioner, and you would have to build the invalidity case from scratch, on your own dime and on your own clock."

I verified this against public sources. Targeted web searches for the patent number, for Gen-Probe/Hologic PTAB challenges to fluorometer/optical-detector patents, and for Unified Patents activity in this space surfaced no petition, no institution decision, no Final Written Decision, no termination, and no Federal Circuit appeal involving US 11,402,330 or its continuation US 11,726,041. I could not access PTAB E2E or Docket Alarm directly within this session, so treat the "zero" as high-confidence but not E2E-confirmed; the ODP structured data is the canonical source and it is silent.


Proceedings

None to report. Because there are no proceedings, the per-proceeding template (type / filing date / panel / grounds / institution / FWD / settlement / appeal / defensive value) has no entries to populate. I am not going to invent proceeding numbers, panels, or dispositions — the constraints of this task forbid it, and fabricated IPR numbers are exactly the kind of error that gets a defendant sanctioned for citing non-existent art records.

Two points that look like PTAB history but are not proceedings against this patent — do not confuse them:

  1. Inter partes reexaminations of older Gen-Probe patents. USPTO records show third-party (Roche Diagnostics) requests for inter partes reexamination on Gen-Probe patents such as US 7,524,652 and US 7,482,143 (control nos. 95/002,232 and 95/002,383, with Office Actions in 2014), plus a long Gen-Probe v. Becton, Dickinson litigation (S.D. Cal. Nos. 09-cv-2319, 10-cv-0602). These involve different patents, different technology, and a pre-AIA reexamination regime. They are not AIA trials and have no estoppel effect on US 11,402,330.

  2. The Enzo/Hologic dispute over US 6,221,581 and the Panther/Panther Fusion accused products. That litigation put Hologic on the defensive side of an assertion; it generated no PTAB proceeding on US 11,402,330 (which did not exist until 2022).


Strategic summary

Claim status. Every claim of US 11,402,330 is UNTESTED. Nothing has been canceled, nothing has been confirmed in a Final Written Decision, and no claim has been the subject of an institution decision. The claims as issued on 2022-08-02 are the claims you would face in litigation, in their original scope and original numbering. For a defendant, this cuts both ways: the Patent Owner cannot point to a PTAB win to argue "hardened" claims, but you also get no free claim-construction or invalidity roadmap from a prior panel's work.

Estoppel landscape. § 315(e)(2) estoppel is a non-issue here because no petitioner has ever been before the Board on this patent. There is no class of privies barred from raising grounds, and there is no "could have raised" shadow cutting off prior art. Every § 102/§ 103 ground is theoretically available to a first petitioner — subject only to the § 325(d)/Fintiv-type discretionary and § 315(b) one-year-bar considerations in your specific litigation posture. This is the cleanest possible estoppel slate: if you want to file, nothing procedural from a prior IPR blocks you.

Pattern signals. No repeat-petitioner pattern exists (there are no petitioners at all). Gen-Probe/Hologic has not been aggressive in PTAB appeals on this patent, because there was nothing to appeal. There is no defensive aggregator (e.g., Unified Patents) in the chain — no evidence that this patent has been targeted by a crowd-funded validity challenge. The low PTAB activity is consistent with the artifact's profile: it is a process/instrument-diagnostics patent (self-check methodology using non-fluorescent aluminum spoke surfaces and recesses to validate fluorometer performance), owned by a large, sophisticated operating company that tends to assert its diagnostic IP in district court rather than at the Board, and relatively young (issued 2022-08-02). Its absence from PTAB is not the classic "troll patent attracting IPRs" signal — but it also means the technology has not been stress-tested by an adversarial validity challenge.


Recommended next steps

There is no PTAB activity on US 11,402,330 — say so plainly, and price the risk accordingly.

  • Do not build a defense on an FWD that does not exist. There is no opinion to cite, no canceled claim to rely on, and no § 315(e)(2) estoppel to invoke. If a demand letter or complaint asserts claims of US 11,402,330, you cannot shortcut invalidity by pointing to a prior PTAB outcome.
  • Treat yourself as the first prospective petitioner. The clean estoppel slate (no § 315(e)(2) bar, no prior panel findings to inherit or rebut) means an IPR/PGR is procedurally available, but you would bear the full cost of building the invalidity case — prior-art search, expert declaration, and claim-construction analysis — with no prior petition or POPR to borrow from. Note the § 315(b) one-year bar from service of a complaint if you are already in litigation, and the § 311(c) constraint that IPR grounds are limited to patents and printed publications (which fits a patent whose novelty turns on instrument structure and methodology, so pre-issuance printed art and the prior-generation Panther/Tigris instrument documentation are the natural hunting grounds).
  • Watch the continuation. US 11,726,041 B2 claims priority to the same 2015-12-31 family. A validity challenge to US 11,402,330 that is not coordinated with the continuation can be mooted by the Patent Owner pivoting to the continuation claims. Any IPR strategy should map both patents together.
  • Confirm on PTAB E2E before committing. Because I could not open PTAB E2E or Docket Alarm directly, run one final docket check on PTAB E2E and Docket Alarm's PTAB index for both US 11,402,330 and US 11,726,041, plus the Federal Circuit docket and CourtListener, before you file or respond to a demand. If anything appears that the ODP ingest has not yet captured, it would change the analysis above, and it should be verified at the claim level before anyone relies on it.

Verification note: this report reflects the structured "PTAB proceedings on file" block in the prompt (no AIA trial proceedings indexed) plus public web searches conducted 2026-09-29 that surfaced no petition, institution, FWD, termination, or CAFC appeal for US 11,402,330 or US 11,726,041. No proceeding numbers, panels, or dispositions have been inferred or fabricated.

Generated 9/29/2026, 1:22:34 PM

Ownership chain (5)

Asserters network →

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

  1. 2015-10-13 · reel 036855/0468 · Security Agreement

    Hologic, Inc.; Biolucent, LLC; Cytyc Corporation; Cytyc Surgical Products, LLC; Direct Radiography Corporation; Gen-Probe Inc.; Gen-Probe Prodesse, Inc.; Suros Surgical Systems, Inc.Bank of America, N.A.

    securitization

  2. 2020-10-15 · Security Agreement

    HOLOGIC, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.Bank of America, N.A., as Collateral Agent

    securitization

  3. ? · recorded 2022-05-31 · Assignment

    BUI, James; OPALSKY, David; RAGHUWANSHI, SrajanGEN-PROBE INCORPORATED

  4. ? · reel 036307/0199 · Security Agreement

    Hologic, Inc.; Biolucent, LLC; Cytyc Corporation; and othersBank of America, N.A., as Collateral Agent

    securitization

  5. ? · reel 028810/0745 · Release

    Goldman Sachs Bank USA, as Collateral Agent—

    securitization

Assignment history

Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.

✓ Generated

I'll research the assignment record for US 11402330 before reconstructing the chain.

Let me dig for the specific assignment records.

I ran targeted searches against Google Patents legal events, patent-assignment indexes (PlainSite mirror of USPTO records), PTAB dockets, and Hologic SEC exhibits. Here is what the record actually supports — and where it runs out.


Inventors

Inventor Address of record Employer at filing
David Opalsky San Diego, CA Gen-Probe Incorporated / Hologic, Inc.
Srajan Raghuwanshi (not stated on face) Gen-Probe Incorporated / Hologic, Inc. (inferred)
James Bui (not stated on face) Gen-Probe Incorporated / Hologic, Inc. (inferred)

Notes on pattern:

  • All three inventors appear on the face of US 11,402,330 as assignors to GEN-PROBE INCORPORATED in the assignment recorded 2022-05-31 (Google Patents legal events, this patent). There is no evidence of any inventor departing Gen-Probe/Hologic within 12 months of filing — the classic pre-fire-sale tell is absent, and no data source I retrieved contradicts this. I could not independently confirm employment dates for Raghuwanshi or Bui, so the employer attribution for those two is an inference from the assignment, not a verified fact.
  • Opalsky is a repeat Gen-Probe/Hologic inventor: he is also the first-named inventor of US 11,761,026 B2 (Diagnostic system and method, Gen-Probe Incorporated, application 17/842,535). That is an ordinary large-corporate-portfolio pattern, not a signal.
  • Unusual-but-benign item: the inventor→company assignment was recorded on 2022-05-31, roughly 22 months after the 2020-07-24 filing date and only ~14 days before the family continuation US 17/840,388 was filed (2022-06-14, later granted as US 11,726,041 B2). This is consistent with a confirmatory/family-level housekeeping filing rather than a real-time transfer of rights.

Original assignee

Gen-Probe Incorporated (listed as "Gen Probe Inc" in the Google Patents current-assignee field; "GEN-PROBE INCORPORATED" in the 2022-05-31 assignment), San Diego, CA.

  • Line of business: molecular diagnostics — nucleic acid tests and the automated instrument platforms that run them (target capture, TMA, chemiluminescent/fluorescent detection).
  • Shipped a product embodying the claims: Yes. The patent's own specification describes the incubator/rotary-carousel/fluorometer architecture of the TIGRIS® and PANTHER® systems, and expressly names them ("Exemplary assay instruments include the Tigris® and Panther® systems sold by Hologic, Inc., Bedford, Mass."). FDA 510(k) records show Aptima Combo 2 and Aptima Trichomonas assays cleared for the Panther and Tigris systems. So the claimed fluorometer/self-check architecture is a real, commercially shipped diagnostic instrument line.
  • Current status: Operating. Gen-Probe Incorporated is a wholly owned subsidiary of Hologic, Inc. (NASDAQ: HOLX), which acquired Gen-Probe in 2012 (approximately $3.7B — I state the figure with moderate confidence). Not dissolved, not in bankruptcy. Gen-Probe's patent assets sit inside Hologic's Bank of America credit facility collateral pool (see below).

Assignment timeline

Critical sourcing caveat up front: I could retrieve the legal events for this patent (from the authoritative patent text provided, plus corroborating Hologic SEC exhibits and a PlainSite mirror of USPTO records), but I could not open USPTO Assignment Center record pages in this session. Reel/frame numbers and correspondent-of-record names for the two records that touch this patent are therefore not retrieved. I am not going to invent them. Two reel/frames that appear in the Hologic enterprise lien filings are cited below but are not verified as recorded against US 11,402,330 specifically.

2022-05-31 (execution date not separately shown) / recorded 2022-05-31 — Reel not retrieved

  • Conveyance: Assignment of Assignors' Interest (original inventor assignment)
  • Assignor: BUI, James; OPALSKY, David; RAGHUWANSHI, Srajan
  • Assignee: GEN-PROBE INCORPORATED
  • Correspondent: not retrieved
  • Context: original inventor-to-employer assignment, recorded late (≈22 months post-filing, 2 months pre-grant); routine housekeeping, not an acquisition or reorg.

2020-10-15 / recorded 2020-10-15 — Reel not retrieved

  • Conveyance: Security Agreement (security interest only — not a transfer of title)
  • Assignor: HOLOGIC, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.
  • Assignee: BANK OF AMERICA, N.A., as Collateral Agent
  • Correspondent: not retrieved
  • Context: securitization / collateral. This is the recording of the Hologic group's patent-security grant under its Bank of America credit facility. It is a lien, and the "assignor" list is a group of Hologic grantor entities — it is not a link in the ownership chain.

Background lien records surfaced (Hologic enterprise level, NOT verified for this patent):

  • Reel 036307/0199 — Bank of America, N.A. as collateral agent, Security Agreement, assignors Hologic, Inc.; Biolucent, LLC; Cytyc Corporation; and others (surfaced on a Hologic-family Google Patents assignment block). Likely the 2015 grant, superseding an earlier Goldman Sachs lien.
  • Reel 028810/0745 — Security Interest Release by Goldman Sachs Bank USA as collateral agent, effective 2015-05-29 (surfaced on the same Hologic-family record).
  • Reel 035820/0239 — instrument confirming the security-interest release (same source).
  • Reel 044727/0529 — appeared in the same assignment block; purpose not determinable from the snippets retrieved.
  • Patent Assignment 036855/0468 — Hologic, Inc.; Biolucent, LLC; Cytyc Corporation; Cytyc Surgical Products, LLC; Direct Radiography Corporation; Gen-Probe Inc.; Gen-Probe Prodesse, Inc.; Suros Surgical Systems, Inc. → Bank of America, N.A.; paperwork executed 2015-10-13 (PlainSite mirror of the USPTO record).

Context for all five of the above: securitization/collateral under the Hologic group's Amended and Restated Credit and Guaranty Agreement (originally 2015-05-29; restated 2017-10-03; amended 2018 and 2021), with Bank of America as administrative/collateral agent. SEC Exhibit filings confirm Gen-Probe entities are named borrowers/guarantors and grantors thereunder.

No ownership transfer other than the original inventor assignment is recorded for US 11,402,330. That is itself the finding.


Timeline diagram

timeline
    title Ownership of US 11402330
    2015 : Family priority date
         : Hologic grants lien to Bank of America
    2016 : Parent non-provisional filed
    2020 : Continuation filed by Gen-Probe
         : Blanket lien rerecorded to BofA
    2022 : Inventors assign to Gen-Probe
         : US 11402330 granted

(2008–2016 parent-filing inference: the patent's anticipated expiration is stated as 2036-12-23, which is consistent with a parent non-provisional filed 2016-12-23; the 2015-12-31 priority date is to an earlier provisional. I flag this as an inference from the expiration field, not a record I retrieved.)


NPE / troll-pattern signals

  1. Shell-entity transfer — not present. The only non-inventor assignee of record is Bank of America, N.A. as collateral agent, and that recording is a security interest, not a title transfer. Ownership sits with Gen-Probe Incorporated, an operating diagnostics manufacturer. No "IP/Holdings/Ventures/Licensing" LLC appears anywhere in the record.

  2. Known asserter in the chain — not present. Neither Gen-Probe Incorporated nor Hologic, Inc. appears on the RPX, Unified Patents, or Patent Progress high-frequency plaintiff lists; both are operating life-sciences companies. Gen-Probe has asserted its own patents as a plaintiff — e.g., Gen-Probe Inc. v. Becton, Dickinson & Co., S.D. Cal. (asserting the '256, '255, '652, '143, '892, '200 and other patents against BD's Viper XTR and ProbeTec systems) — but that is textbook operating-company assertion against a direct competitor, not NPE conduct. No asserter-syndicate entity (Acacia, Marathon, IV, Wi-LAN/Conversant, Vringo, Pendrell, Round Rock, Spangenberg, etc.) appears in this chain.

  3. Repeat correspondent across the chain — unclear (data gap). Correspondent-of-record names for the two recordings tied to this patent were not retrievable in this session, so recurrence can neither be established nor excluded. This is the single most important unresolved item; if you are running this check in-house, the two records to pull correspondent data for are the 2020-10-15 Bank of America collateral record and the 2022-05-31 Gen-Probe inventor assignment.

  4. Cascading transfers — not present. There is exactly one ownership conveyance in the entire record (inventors → Gen-Probe, 2022-05-31). No chained LLCs, no sub-24-month transfer cascade, no shared correspondent addresses to compare.

  5. Pre-litigation transfer — not present. No litigation naming US 11,402,330 was identified (consistent with the earlier litigation summary in this analysis, which found only prosecution-history noise). The only dated transfer precedes the grant and post-dates the filing — the opposite of a venue- or standing-engineering transfer.

  6. Bankruptcy fire-sale — not present. Hologic, Inc. is a NASDAQ-listed going concern (HOLX) with an active credit facility; Gen-Probe is not and has not been a debtor in bankruptcy. No Chapter 7/11 sale of this patent.

  7. Privateering — not present. The patent has never left the Hologic corporate family. There is no transfer to a third-party assertion vehicle, no SEC disclosure of such a transfer, and no EFF/Patent Progress coverage of one.

  8. Defensive aggregator — not present. The chain terminates at Gen-Probe Incorporated, not at RPX, AST, LOT Network, Unified Patents, or OIN. The patent has not been neutralized — it is a live, active asset (status: Active; anticipated expiration 2036-12-23) inside an operating company's portfolio.

One unresolved, tangential item (flagged, not a finding): a PTAB petition exhibit contains 2017 Delaware infringement contentions in which Hologic was the accused party on US 6,221,581 — a patent of Gen-Probe origin (target-capture technology), covering Hologic's Progensa/Aptima/Procleix/Panther Fusion products, served by Farnan LLP on 2017-08-31. I could not confirm the identity of the plaintiff or how it came to hold that patent, and US 6,221,581 is not in the US 11,402,330 family. I raise it only because it suggests the Gen-Probe-origin portfolio has been on the receiving end of an assertion at least once; do not read it as a signal about this patent.


Verdict

Insufficient data.

The record for US 11,402,330 contains only the original inventor→Gen-Probe assignment (recorded 2022-05-31) plus a Bank of America collateral security interest (recorded 2020-10-15, assignors = Hologic group grantor entities). There is no post-issuance ownership chain to analyze, which is the definitional trigger for this verdict — but it is important to say clearly that the absence of a chain is not the absence of information: every affirmative data point retrieved shows ordinary, clean operating-company ownership with zero of the eight NPE indicators present. If you want this upgraded to a definitive "operating-company" call, the two things to pull are (a) the correspondent-of-record for both recordings, to close Signal 3, and (b) confirmation that no Hologic-family entity has asserted US 11,402,330 or its sibling US 11,726,041 B2 in litigation.

Verify at USPTO Assignment Center, searching patent number 11402330: https://assignmentcenter.uspto.gov/ (same underlying records as https://assignment.uspto.gov/patent/index.html).

Note on the "uspto" search-URL caution: because I could not load the Assignment Center pages in this session, everything above regarding reel/frame numbers and correspondents is either cited to a corroborating secondary source (PlainSite mirror, Hologic SEC exhibits) or explicitly marked "not retrieved." Treat the unmarked reel/frame entries as Hologic-enterprise-level records that likely encumber this patent, pending confirmation on the face of the Assignment Center record.

Generated 9/29/2026, 1:23:15 PM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I'll research the prior art citations for US Patent 11402330. Let me run several targeted searches.

Let me look for the specific "References Cited" / patent citations list for US11402330.

Let me try to retrieve the citation list directly from patent databases.

Prior-Art Analysis — US Patent 11,402,330 B2

1. Patent identification (as requested, searched literally as "11402330")

Field Value
Patent number US 11,402,330 B2
Title Method for measuring optical signal detector performance
Application no. US 16/937,905
Filing date 2020-07-24
Priority date 2015-12-31 (provisional 62/274,027)
Granted 2022-08-02
Inventors David Opalsky; Srajan Raghuwanshi; James Bui
Assignee Gen-Probe Incorporated
Pre-grant pub. US 2020/0355610 A1
Anticipated expiration 2036-12-23

Source: Google Patents, https://patents.google.com/patent/US11402330/en (fetched per the supplied full text).


2. Important scope limitation on this answer — please read

I was unable to retrieve the authoritative front-page "References Cited" (USPTO form 56 / PTO-892) list for US 11,402,330 in the searches available to me. Searches for the citation list returned unrelated documents (European search reports for fibre-optic power-monitoring patents such as EP 1 691 495 A1, US 6,108,074, WO 98/14766, EP 2 680 464 A1, and PTAB petitions on unrelated optical-transceiver patents). Those are not citations in US 11,402,330 and I am deliberately not presenting them as such.

Per the operating rules, I will not fabricate citation numbers, dates, or examiner references. Below I separate (A) references affirmatively documented in the patent's own text, (B) same-family documents (which are not §102 prior art), and (C) what remains to be verified against the USPTO file.


3. References affirmatively identified in the US 11,402,330 record

A. U.S. Pat. No. 7,794,659 B2 — expressly incorporated by reference

Field Value
Citation U.S. Pat. No. 7,794,659 B2 (Gen-Probe Incorporated)
Title "Signal measuring system having a movable signal measuring device"
Filing / priority 2005-03-10
Publication / issue 2010-09-14
Description Discloses a signal measuring system in which a signal measuring device (e.g., fluorometer) and a receptacle carrier are movable relative to each other so the detector can be brought into operative (optical) relation with each receptacle.
Status in the '330 Expressly incorporated by reference. The '330 specification states: "receptacle carrier 242 and signal detector 400 can be configured to move relative to each other as described in U.S. Pat. No. 7,794,659, issued Sep. 14, 2010, which is incorporated by reference herein."
§102 analysis Timing-wise it qualifies as prior art (issued 2010, more than one year before the 2015-12-31 priority date, so §102(a)(1)/pre-AIA §102(b) eligible). However, because it is expressly incorporated into the '330, it functions as part of the patent's own disclosure (admitted art / background) rather than as third-party anticipating art. Its disclosure of relative carrier/detector movement corresponds to the "movable relative to each other" limitations of the instrument claims and the corresponding method claims (the positioning steps); it does not appear to disclose the core self-check features (non-fluorescent surface portion / recess/void test positions and the predetermined intensity-range comparisons), so it would not anticipate the claims on its face.

B. Evidence of the patent family (context only — NOT prior art)

The '330 states it is a continuation of U.S. App. Ser. No. 16/219,388, filed Dec. 13, 2018, which is a continuation of U.S. App. Ser. No. 15/389,897, filed Dec. 23, 2016 (now U.S. Pat. No. 10,190,084), which claims benefit of U.S. Provisional App. No. 62/274,027, filed Dec. 31, 2015. Google Patents also records a later continuation, US 17/840,388 (US 11,726,041 B2), and siblings US 10,739,263 B2 ("System for measuring optical signal detector performance"), US 2020/0355610 A1, and JP 7320480 B2.

§102 significance: none. These all share the 2015-12-31 priority date. Under AIA §102(b)(2) (and pre-AIA §103(c) practice), same-family/same-owner documents are excepted from being prior art against one another for anticipation. They must not be cited as §102 art against the '330. Note: US 10,739,263 and US 11,726,041 are frequently mis-flagged by automated tools as "citations"; they are family members, not art.

C. Related-family references observed (needs verification against the '330 file)

  • EP 2 348 321 A2/A3 (Gen-Probe Incorporated) — "System and methods to perform assays for detecting or quantifying analytes within samples," filed 10.03.2006, priority US 659,874 P (2005-03-10), published A2 27.07.2011. This is the European sibling of the US 7,794,659 family and describes the incubator/signal-detector architecture (temperature-controlled chamber, signal detector in operative position with a receptacle). Relevant background art for the assay-instrument claims, but its disclosure does not appear to reach the non-fluorescent-surface/recess self-check.
  • US 2004/0033518 A1 (Wittmer et al.), 19 February 2004 — appears as a "Y" reference in the European search report for the related Gen-Probe family (EP 11001533.6). Flagged here only as a family-level search-report reference; I have not confirmed it is cited in US 11,402,330.

4. What still needs to be done (and why I am not guessing)

To complete a rigorous §102 anticipation chart, the following must be pulled from the actual USPTO file (PatentCenter / Global Dossier for application 16/937,905) and the printed front page of US 11,402,330:

  1. The complete "References Cited" list (U.S. patent documents, foreign documents, and non-patent literature) with examiner/Applicant designations.
  2. The Information Disclosure Statements (IDS/SB-08) filed 2020–2022 and any PTO-892 notices.
  3. Any office actions / PTAB proceedings for the '330 family to identify the references the examiner actually relied on.

I could not obtain these in this session, and I will not invent patent numbers or dates to fill the gap.

5. Preliminary §102 mapping on the verified record

  • Claims directed to relative movement between the carrier and the fluorometer/detector (positioning steps in the method claims; "movable relative to each other" in the instrument/system claims): U.S. 7,794,659 (via express incorporation) is the closest antecedent. Timing qualifies it as prior art, but it is incorporated, and it does not disclose the self-check test positions → anticipated on its face: none.
  • Claims directed to the non-fluorescent surface portion in the detection zone + predetermined non-fluorescent-surface intensity range (e.g., 5–5800 RFU), and the recess/void in the detection zone + predetermined recess intensity range (e.g., 0–2260 RFU): I found no verified prior-art reference in this session that discloses this combination. On the retrieved record, this appears to be the point of novelty; I cannot name a specific anticipatory reference without reviewing the front-page citations.
  • EP 2 348 321 / US 2004/0033518: background showing assay instruments with incubators and movable carriers and signal detectors; to be treated as §102/§103 candidates only after confirming their appearance in the '330 file and comparing element-by-element.

6. Contradiction / correction flag relative to prior generated sections

No contradiction with the previously generated litigation summary was observed — that section's conclusion (litigation-specific research returned prosecution-history noise) is consistent with what I found here: the harvested material is dominated by prosecution/citation artifacts from other patents, not from US 11,402,330. The one substantive factual point to carry forward is the express incorporation-by-reference of U.S. Pat. No. 7,794,659, which is the single most defensible "prior-art" item grounded in the patent's own text.

Bottom line: The only prior-art reference I can state with high confidence from the authoritative record is U.S. Pat. No. 7,794,659 B2 (issued 2010-09-14), expressly incorporated by reference, plus the EP 2 348 321 sibling as background. The full "References Cited" list for US 11,402,330 requires direct retrieval from USPTO PatentCenter (application 16/937,905), which I was not able to complete here; I recommend not treating any other enumerated reference as an official citation of the '330 without that confirmation.

Generated 9/29/2026, 1:22:52 PM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

I'll research the prior art cited in US11402330's prosecution and family before building the obviousness analysis.

Obviousness Analysis — US 11,402,330 B2 under 35 U.S.C. § 103

0. Two threshold flags before the analysis

(a) The "Prior Art section" of the page was not carried into my context. The only prior work product I received is the Litigation summary. The prior-art inputs I actually have for this page are (i) the Google Patents bibliographic block, and (ii) the full patent text. From that block, the operative prior-art framing is:

  • Prior art date: 2015-12-31 (the § 102 effective filing date; the '330 claims benefit of provisional 62/274,027 filed Dec 31, 2015, via PCT/US2016/068384, filed Dec 23, 2016, published as WO 2017/117011 A1).
  • Prior art keywords: signal detector; fluorometer; receptacle; optical signal; intensity.

I therefore ran the § 103 analysis against a Dec-31-2015 critical date using those keywords, and I flag below where a reference is one I verified versus one I am inferring.

(b) The patent text supplied to me is truncated mid-sentence — it ends at "…a non-fluorescent material, for example, aluminum, that will generate a sufficient amount of reflected or scattered light that failure." I also do not have the issued claim set; the element chart below uses the verbatim claim-style language from the SUMMARY and Definitions sections, which mirror the claims. I could not verify exact US claim numbering, so I refer to claim groups rather than asserting specific numbers. If the Prior Art section you intended contained a different reference set, this analysis should be re-run against it.


1. What is actually claimed (critical date Dec 31, 2015)

Four independent claim groups:

Group Core elements
Assay instrument first fluorometer / first detection channel (first light source + first sensor), focused at a first detection zone; carrier (a) comprising a first non-fluorescent surface portion, (b) defining a recess, (c) supporting a first receptacle; relative movement among (i) receptacle in zone, (ii) non-fluorescent surface in zone, (iii) recess in zone; controller determines (1) a sample characteristic from the first intensity (receptacle position) and (2) an operational performance status from at least one of the second (surface) and third (recess) intensities
Method of analyzing a sample positioning surface → measure first intensity → positioning recess → measure second intensity → determine status from at least one of them; plus receptacle-position measurement and sample-characteristic determination
System for measuring optical signal detector performance detector + controller determining status from at least one of (i) measured characteristic with non-fluorescent surface in zone and (ii) measured characteristic with void in zone
Method for measuring optical signal detector performance (title claim group) aligning surface with detection zone, measuring; positioning void, measuring; determining status from at least one

Dependent features of note: RFU comparison ranges (non-fluorescent surface: 5–5800 RFU, must be > 0; recess/void: 0–2260 RFU, may include zero); "failure status or deteriorated performance status"; second detection channel/second fluorometer; surfaces linearly aligned and coplanar on a spoke of a carousel; relative-motion variants; aluminum surface.

POSITA: a B.S. in EE, physics, optics, or BME plus ~3–5 years designing optical detection subsystems for automated clinical analyzers, or equivalent — i.e., someone fluent in fluorometer optical trains, photodiode front-ends, carousel indexing, and instrument self-test/calibration practice.

The crux: every independent claim is satisfied by either the surface measurement or the recess measurement ("at least one of"). Only a subset of dependents requires both.


2. Ground I — Primary: US 2018/0180544 A1 (Li, Opalsky, Heinz, Hagen; Gen-Probe) alone or with US 2016/0363534 A1

US 2018/0180544 A1, "Use of a fluorescent material to detect failure or deteriorated performance of a fluorometer," is a divisional of Ser. No. 13/912,525 (filed June 7, 2013, now US 9,945,780), claiming provisional 61/659,590 (June 14, 2012). It is thus § 102(a)(2) art (published application effectively filed well before Dec 31, 2015). Verified content from the public record:

  • Incubator with a temperature-controlled chamber, a movable receptacle carrier (rotatable carousel), and one or more fixed fluorometers — meets the relative-movement architecture of the '330's independent claims.
  • Reference standards mounted on the carrier and moved into optical communication with a channel; "only one of the two or more fluorescent reference standards can be positioned in optical communication with one of the two or more channels of the fluorometer at a time."
  • The carrier is a circular disk with a plurality of spokes extending outwardly, the standards being located on one or more spokes, and "the spokes may be in a non-radial orientation." This is the identical structural location as the '330's non-fluorescent surface portions 250 on non-radial outer spokes 264.
  • The reference standard may sit closer to or further from the channel than the detection zone — the same h1/h2 distance relationship recited in the '330 dependents.
  • "monitoring the performance of the fluorometer comprises measuring the intensity of the fluorescent emission of the fluorescent reference standard and comparing the measured intensity to a predetermined baseline fluorescent intensity … for that fluorometer."
  • Self-check "occurs in sequence with monitoring the progress of the reaction" — i.e., during a running assay, without shutdown.

The '330's own specification confirms the identity of operation: the self-check is performed by "moving a non-fluorescent surface portion 250 … measuring the optical intensity of light reflected or scattered by the non-fluorescent surface portion 250 and detected by sensor 423, and comparing the measured intensity to an expected, predetermined intensity value range." That is the '544 method with one element substituted.

US 2016/0363534 A1 ("optical signal detection module" with a cover carrying an optical reference material that emits a reference emission detectable by the OMD; drive assembly moving the cover between closed/open positions; "the OMD can include a fluorometer") supplies the express teaching of moving a reference element into and out of the signal-detecting position under motor control, and its background paragraph [0009] states the very problem the '330 recites nearly verbatim ("shutting the instrument down … impractical and non-cost-effective").

Element chart

'330 element '544 / '534 disclosure
First fluorometer, first detection channel, light source + sensor, focused at detection zone '544: two-or-more-channel fluorometer, each channel "a separate light source, an optical focus and filter assembly, and an optical signal detector … configured to focus the light source at a detection zone"
Carrier supporting a receptacle '544: receptacle carrier carrying reaction receptacle vessels
Non-fluorescent surface portion on the carrier Difference — '544 uses a fluorescent reference standard; '534 uses an emitting optical reference material
Recess defined by the carrier Difference — not expressly disclosed; see Ground II
Relative motion among receptacle/surface/recess positions '544: carousel indexing standards and receptacles one-at-a-time into optical communication
Determine sample characteristic from first intensity '544: real-time monitoring of reactions in the receptacles
Determine operational performance status from second (surface) intensity '544: "failure or deteriorated performance" determined from the reference-standard measurement during the assay
Status is failure / deteriorated performance '544: title and claim language — verbatim overlap
(dep.) surface portions coplanar, linearly aligned on a spoke; aluminum '544: standards on linear arrangements on spokes of the carousel disk, non-radial

Result: Ground I reaches every element of the independent assay-instrument, system, and method claims except the "non-fluorescent" character of the surface and the recess/void measurement — and, because the independent claims are satisfied by "at least one of" the two measurements, the recess element is not required to invalidate them.


3. Ground II — The "recess / void" limitation

Even for the dependents that require both measurements, the recess element is obvious for three independent reasons:

  1. Inherency of the physical position. The '330 itself describes the recess as nothing more than "a receptacle station 211 that does not have a MRD 160 received therein, and includes opening 265 defined by lower disk 256." The '330 in turn admits that the 18-station carousel is routinely run "only … loaded with twelve MRDs 160," leaving six empty recesses. In any partially loaded carousel of the '544/'534 type, an empty station necessarily passes through each detection zone every revolution. Acquiring the sensor output at that instant requires no structural change whatsoever.
  2. Routine data-handling / known technique. Reading a dark or background level with nothing in the optical path to establish photodiode offset, amplifier baseline and noise floor is the most elementary calibration step in photometry (and is what the '330 says the recess range is: "zero or significantly small due to noise"). Applying it to a known device is the paradigm of KSR's "combination of familiar elements according to known methods … yield[ing] predictable results." (Leading art in this space — real-time PCR instruments that index a carousel past fixed optics and perform in-run diagnostics, e.g., EP 2 584 342 A1, published Apr. 24, 2013, which claims a method of letting a detector device detect emitted light in a fluorometer / fluorescence spectrometer / real-time PCR instrument and is classified with self-check/offset correction — is consistent with, though I could not verify the specific passage from the search-report snippet I retrieved.)
  3. Express motivation from the disclosure itself. The two measurements probe different failure modes: the surface measurement tests the excitation path and detector response (and yields a non-zero expected value), while the recess measurement tests for an elevated zero-offset (stray light, amplified dark current) that would corrupt every fluorescent reading. Once the surface check exists ('544), a POSITA seeking to fully characterize a channel would add the complementary zero reference as a matter of ordinary engineering — the '330's own test of "RFUrecess … includes zero" is simply a threshold on that baseline.

4. Grounds III–VI — remaining dependents

  • Second detection channel / second fluorometer. Mere duplication of a known element. The '544 discloses a multi-channel fluorometer and two or more fluorometers. Where a claim recites an additional known element performing the same function, "[t]he combination of familiar elements according to known methods is likely obvious" (KSR). No new result attends the second channel.
  • Aluminum / non-fluorescent surface material. The '330 itself states the incubator walls are aluminum and detector housings are "machined aluminum," and describes the reference surface as "made of a non-fluorescent material, for example, aluminum." Selecting a known non-fluorescent, non-photobleaching, readily machinable metal already present in the bill of materials is a design choice (§ 103 obviousness of material selection where no unexpected property is shown).
  • Coplanar / linearly aligned surfaces on a spoke. Directly taught by '544 ("three linear arrangements" of standards on carousel spokes, non-radial orientation) and inherent in any flat disk.
  • Relative-motion variants (carrier movable/detector stationary and vice versa). Admitted prior art: the '330 states the relative movement "can be configured to move relative to each other as described in U.S. Pat. No. 7,794,659, issued Sep. 14, 2010, which is incorporated by reference herein." Incorporation by reference of a specific movement architecture is an admission that the architecture is known and combinable.

5. Motivation to combine (KSR factors) — and why there is no teaching away

  1. Same field, same assignee, same problem statement, overlapping inventor. Both references are Gen-Probe optical-detection/self-check art; David Opalsky is a named inventor on the '544 and on the '330. A POSITA would look directly to the assignee's own reference-standard art. The '330's background paragraph is substantially the '534's background paragraph — evidence of a shared, pre-existing problem formulation, not a new insight.
  2. Identified, admitted need. The '330 recites that fluorometer testing "can only be performed when the instrument is shut down," that shutdowns are "impractical and costly," and "a need exists for … periodically confirming the proper functionality of the signal detector … while the assay is being performed." That is a textbook statement of the problem and the motivation; '544 solves exactly that (self-check in sequence with reaction monitoring).
  3. Predictable substitution (the "non-fluorescent" difference). A POSITA substituting a non-fluorescent reflector/scatterer for a fluorescent standard would expect the same result — a reference intensity in the detection zone comparable against an expected value — while obtaining recognized advantages: no photobleaching (a fluorescent plastic standard's output decays with cumulative excitation, which is precisely the failure mode that makes baseline-comparison schemes drift), no temperature quenching (the '330's reference sits inside a heated incubator), no dye-specific plastic inventory, and lower cost. The '330's own text confirms the expected behavior: an aluminum surface returns "a small, detectable (non-zero) amount of light." Substitution of a known element for a known purpose, with predictable results, is obvious. There is no teaching away: nothing in '544 or '534 disparages non-fluorescent references, and '544's fluorescent standards and '330's aluminum surfaces occupy the same physical real estate (spokes of the carousel), so a POSITA would need no re-architecture.
  4. Obvious to try / finite number of predictable solutions. Once the decision is made to place a reference feature on the carrier, the available design space is small: (a) an emitting (fluorescent) reference, (b) a reflective/scattering (non-fluorescent) reference, or (c) an empty/void reference. A POSITA seeking distinct, complementary failure-mode diagnostics would arrive at (b) and/or (c) with a reasonable expectation of success; the '330's RFU ranges are then merely empirical bounds on those predictable outputs.

6. Rebuttal analysis: secondary considerations and range limitations

  • Ranges (5–5800 RFU; 0–2260 RFU). These are result-effective-variable limits that vary by dye (the specification itself gives FAM 5–600, HEX 200–5800, ROX 5–550, and recess 0–300/0–2260 depending on detector). Optimization of a parameter recognized as affecting the result is within the ordinary skill level (In re Antonie; In re Aller) absent evidence of criticality. Nothing in the specification establishes that values just outside 5800 or 2260 fail; the breadth of the ranges (and their mutual overlap with the specific dye ranges) undercuts a criticality argument.
  • No unexpected results on the record are apparent from the specification; the benefit (in-run self-check) is exactly what the prior art sought.
  • Industry praise / long-felt need could be asserted, but the long-felt need is recited and solved by the prior art references relied upon, so it does not weigh against obviousness.
  • Potential § 112 issues to preserve (not § 103): the Definitions section states "the operational performance status is a proper operational performance status, a failure status, and a deteriorated performance status" — conjunctive phrasing that appears to make the categories mutually exclusive and is potentially indefinite under § 112(b); the SUMMARY's range (5–5800 / 0–2260 RFU) differs from the detailed-description dye-specific ranges; and the specification also uses "Relative Fluorescen Units"/"REU" (transcription errors in the source text I received — verify against the printed patent).

7. Defenses the patent owner will raise (flagged)

Common-ownership disqualification under AIA § 102(b)(2)(C). This is the strongest counter to Grounds I–III. Both US 2018/0180544 A1 and US 2016/0363534 A1 are Gen-Probe applications that published/filed for issuance after Dec 31, 2015; "Gen Probe Inc" is the original assignee on the '330. If they were commonly owned with the '330's application not later than the '330's effective filing date, the applicant can disqualify them as § 102(a)(2) art. A complete invalidity case must therefore also be built on (i) third-party art published before Dec 31, 2015, (ii) the references incorporated by reference in the patent (e.g., US 7,794,659), and (iii) general-knowledge/routine-practice evidence (dark-read calibration practice, carousel indexing, reflective standards) supported by POSITA declaration testimony. Note also that the '330's family members (US 10,739,263; US 2017/0191933; US 2019/0128810; US 11,726,041) are not prior art against the '330 — they share the same priority chain and cannot be used.


8. Conclusion and confidence

Strong obviousness case on the independent claims. US 2018/0180544 A1 discloses, in a Gen-Probe incubator, a fixed multi-channel/multi-fluorometer array and a rotatable carousel carrying reference features on non-radial spokes that are indexed into a detection zone during a running assay, with performance status (failure / deteriorated performance) determined by comparing a measured intensity to a predetermined expected value. The only substantive differences — (i) the reference feature being non-fluorescent rather than fluorescent and (ii) the additional void/recess measurement — are, respectively, a predictable substitution of a known reference element with recognized anti-bleaching/temperature-stability advantages, and the inherent by-product of running a partially loaded carousel plus a routine background/offset reading, further motivated by the complementary failure-mode information it yields. The dependent-claim additions (second channel/fluorometer, aluminum, coplanar spoke geometry, relative-motion variants) are duplication, design choice, and expressly admitted prior art (US 7,794,659).

Confidence: High that a prima facie § 103 rejection can be articulated across all four claim groups. Medium as a litigation-grade invalidity position, contingent on (a) defeating the § 102(b)(2)(C) common-ownership exception with third-party pre-2016 art and POSITA testimony, and (b) confirming the issued claim set and exact element text, which the source text I was given does not contain.

Contradiction flag: the previous Litigation summary section supplies no prior-art references, so nothing here conflicts with it — but the Prior Art section referenced in this task was not present in the materials delivered to me, as noted in § 0(a).

Generated 9/29/2026, 1:23:44 PM

Extensions

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

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