US 11353382

I'll search for this specific patent number across USPTO and CAFC sources.

Let me now check for any CAFC litigation activity in 2026 involving this patent.

US Patent 11,353,382 — Verification Summary

Sourcing note: I could not directly query USPTO Patent Center / Patent Public Search or the CAFC docket system through open search, so the details below are grounded in the authoritative full text supplied for US11353382B2 plus corroborating secondary records (Google Patents, Justia, patents-review.com, uspto.report, iprdb.com). Where sources conflict, I flag it rather than resolve it.

Bibliographic Data

Expiration discrepancy (flagged, not reconciled): Google Patents lists "2036-03-30 Anticipated expiration," whereas patents-review.com lists an "Adjusted expiration: 2040-04-08." These cannot both be right and I have not verified which applies.

Assignee nuance: Google Patents lists current assignee as Roche Molecular Systems, Inc. But the assignment records shown on the same page indicate a two-step chain: Roche Diagnostics GmbH received assignments from Dick, Fischer, Schmelzer and Trapp (2022-04-13), then assigned to Roche Molecular Systems, Inc. (2022-04-13); Stephen G. Will separately assigned to Roche Molecular Systems, Inc. (2022-04-13). So both Roche entities appear in the chain of title.

Abstract (as issued)

A multi-layer plasma separation card comprising (a) a first layer including a sample receiving member with (i) a top planar surface for applying or receiving a blood sample, adapted to permit contact of the blood sample with a separating member, and (ii) a bottom planar surface adapted to contact said separating member; (b) a second layer including at least three separating members, each adapted to permit the passage of plasma to an absorptive member and comprising a top planar surface for receiving the blood sample and a bottom planar shield-shaped surface adapted to contact the absorptive member; and (c) a third layer including at least two absorptive members for absorbing plasma from the bottom planar surface of each corresponding separating member, plus a backing member supporting the absorptive members, each absorptive member comprising a removable absorptive element having a top planar surface adapted to contact the bottom planar surface of the separating member, detachably fixed to the third layer.

Note: the abstract says "at least three separating members," while granted claim 1 recites "at least two." This is an abstract-to-claims mismatch in the issued document; I report both literally.

Plain-Language Overview of the Independent Claim

Claim 1 is the only independent claim, and it is a method claim (all of claims 2–12 depend from it). Its three steps:

1. Provide the card (three-layer stack).

   • First layer (spotting/top layer): a sample receiving member whose top planar surface has an opening for applying/receiving a whole blood sample; the receiving member is adapted to let the blood contact a separating membrane; its bottom planar surface contacts the separating member.
   • Second layer (separation layer): at least two separating members, each (i) allowing plasma to pass through to an absorptive member, (ii) composed of a poly-sulfone material (a material limitation new to the claim language versus the earlier generic "plasma separation membrane" description), and (iii) having a top planar shield-shaped surface for receiving blood and a bottom planar shield-shaped surface for contacting the absorptive member.
   • Third layer (collection layer): at least two absorptive members that absorb plasma from the bottom planar surface of each corresponding separating member, plus a backing member supporting them. Each absorptive member is made of a plasma collection fleece or material, or a plasma collection material not dissolvable in water or buffer-containing solutions. Each includes a removable absorptive element with a planar surface contacting the separating member's bottom surface, and that element is detachably fixed to the third layer.

2. Apply the whole blood sample onto the first layer's sample receiving member.

3. Let the components pass down through the first, second and third layers so plasma separates from the other blood components and is absorbed onto the third layer's absorptive element (driven by capillary action per the specification).

Representative dependent claims (informative, not independent): handle strip adjacent to the absorptive element (claim 2); at least two fixing/anchor elements (claim 3); sample-port size smaller than separating/absorptive surface (claim 4); 10–1000 µL sample (claim 5), with a narrower 100–1000 µL range in claim 8; cotton-linter fleece of 300–420 µm average thickness (claim 6); perforated borders on the absorptive members (claim 7); steps performed over 3–4 hours (claim 9); and an added drying step (claims 10–11), with the perforated borders enabling tweezer removal/transfer to a vessel (claim 12). Notably, the dependent claims that recite specific structures (fleece thickness, perforated borders) matter because claim 1 itself is broad.

CAFC 2026 Docket Search

No 2026 Court of Appeals for the Federal Circuit docket activity involving US 11,353,382 was located. Targeted searches for the patent number together with "Federal Circuit," "appeal," and "Roche Molecular Systems" returned no matching CAFC appeal, and no PTAB post-grant proceeding (IPR/PGR) referencing this patent surfaced either. Results that did appear involved unrelated patents and parties (e.g., Enanta v. Pfizer over U.S. 11,358,953; Contour IP v. GoPro; Ollnova v. ecobee) and are not results for 11,353,382 — I am excluding them per your instruction not to return similar numbers.

Uncertainty statement: The absence of a 2026 CAFC docket in my searches is not proof that none exists. Federal Circuit dockets are not fully indexed by general web search, and I could not query the court's docket system or Docket Navigator directly. If you need a definitive litigation/PTAB answer, that should be confirmed against PACER/CM-ECF, the CAFC docket, and the PTAB Patent Trial and Appeal Board End-to-End (PTAB E2E) system directly. I also could not independently confirm the current maintenance-fee status or the correct expiration date from a primary USPTO source.

I'll research litigation involving US Patent 11,353,382 across patent litigation databases.

Let me search more targeted litigation databases.

Let me search directly on litigation-specific databases.

Litigation Search: US Patent No. 11,353,382

Bottom line: I found no litigation involving US Patent No. 11,353,382.

I searched patent-litigation-oriented sources (Unified Patents litigation portal, Docket Alarm/Docket Navigator-derived records, RPX Insight, CourtListener/Justia, and general web/CAFC/PACER-indexed results) for the literal number 11353382 / 11,353,382 / "the '382 patent" and could not identify any district court case, ITC investigation, PTAB proceeding, or Federal Circuit appeal in which this patent is the asserted or challenged patent.

What the patent is (for context)

• Patent: US 11,353,382 B2, "Plasma separation card"
• Current assignee: Roche Molecular Systems, Inc.
• Inventors: Siegfried Dick; Markus Fischer; Alexander Schmelzer; Andreas Trapp; Stephen G. Will
• Application: US 16/843,130, filed 2020-04-08; granted 2022-06-07
• Priority: 2015-03-31; a continuation of US 10,663,379 (Ser. No. 15/085,882)
• Family members: EP3278105B1, JP6787920B2, CN107430114B, ES2903175T3, WO2016156376A1

Important caveats about the search

1. A distinct "'382 patent" appeared in the results and must NOT be confused with this one. An RPX Insight litigation document (https://insight.rpxcorp.com/litigation_documents/14305429) refers to infringement of a "'382 patent" with a February 2021 notice letter and a complaint dated July 8, 2021. That cannot be US 11,353,382, because this patent did not issue until June 7, 2022. The "'382" reference there is to a different patent number (e.g., an earlier-issued patent ending in 382). Per the instruction to interpret identifiers literally and to avoid returning similar numbers, I am not reporting that as litigation against US 11,353,382.
2. The patent's own record shows no litigation activity. The Google Patents "legal events/status" for US 11,353,382 lists only routine prosecution and assignment events (assignment to Roche Molecular Systems, grant, and anticipated expiration 2036-03-30). It does not list any district court, PTAB, or other litigation-related events, which such records typically surface when a patent is asserted.
3. Enforcement context (inference, not litigation): Roche Molecular Systems has been a defendant in unrelated patent suits (e.g., Enzo Life Sciences v. Roche Molecular Systems, D. Del./Fed. Cir.; Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, 563 U.S. 776 (2011)). None of these involve US 11,353,382, and I mention them only so they are not mistaken for litigation on this patent.

Status summary

Confidence and limitations

I have moderate-to-high confidence that no litigation has been publicly filed on US 11,353,382, based on (a) the absence of litigation events in the patent's official record and (b) the absence of any matching case in the litigation databases searched. However, I could not run a query directly inside a subscription litigation database (e.g., Docket Navigator, Lex Machina, RPX) with a live session, and I did not complete exhaustive CAFC/PACER docket-by-docket verification before the search budget was exhausted. Over the life of the patent (issuing in 2022 and expiring ~2036), it is possible a very recent or non-publicly-indexed case exists that these searches did not surface. If you need a litigation-grade clearance opinion, that should be confirmed by a direct Docket Navigator / Lex Machina / PACER search on the exact patent number 11,353,382.

I'll verify the structured block's "no PTAB activity" finding against live sources before writing the report.

Let me cross-check the PTAB trial docket sources directly, including any Roche-versus-competitor plasma-separation disputes.

One more check on the parent patent and any related-family PTAB activity.

PTAB / AIA Trial Report — US Patent No. 11,353,382 ("Plasma separation card")

Canonical source for the proceedings list: the structured "PTAB proceedings on file" block supplied in the prompt (USPTO Open Data Portal ingest). That block returned no AIA trial proceedings. All four web searches I ran (PTAB E2E / PTACTS-indexed documents, Docket Alarm PTAB docket pages, CourtListener, and general web) returned no IPR, PGR, or CBM naming U.S. Patent No. 11,353,382 as the challenged patent, and no proceeding naming its parent, U.S. Patent No. 10,663,379, either.

Proceedings overview

Zero AIA trial proceedings. Total count: 0 — 0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 with institution denied. Bottom line for a defendant: the patent is completely untested at the PTAB, and nothing about it has been narrowed or canceled. There is no IPR number to cite, no Final Written Decision to quote, and no claim of US 11,353,382 that has been canceled. That cuts against a would-be challenger looking for a ready-made invalidity template, but it also means no estoppel attaches to anyone — a first petitioner gets a clean § 102/§ 103 run at all 12 claims with no § 315(e)(2) baggage.

No proceedings to detail

The template calls for one section per proceeding. There are none, so I will not manufacture sections. Instead, here is the verification trail and the false-positive list, because a "no results" answer is only as good as the searches behind it.

What I checked and what came back empty:

False positives you must not import into a brief:

1. 19-71134 / [11353382] — West Ventures, L.P. v. CIR (9th Cir.). The bracketed [11353382] in my search hit is a Ninth Circuit CM/ECF docket-entry number, not a patent number. It is a tax case (Commissioner of Internal Revenue). Nothing to do with this patent.
2. The Therasense / Abbott "'382 patent" (US 4,545,382, Higgins). A CourtListener opinion PDF (https://storage.courtlistener.com/harvard_pdf/[8715680](/patent/8715680).pdf) repeatedly refers to a "'382 patent," and a related passage calls it the "'382/ '636 patent." That is US 4,545,382 (Higgins et al., glucose-sensor art at issue in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011)) — a different patent, a different decade, a different field. Do not confuse it with US 11,353,382.
3. Roche-adjacent PTAB cases that are not this patent. Roche Molecular Systems / Roche Sequencing / Ariosa have been parties to DNA-sample-preparation IPRs (e.g., the Ravgen v. Roche/Ariosa matters around IPR2021-01577 and the Ravgen '277 patent, and the older Qiagen/NeuMoDx v. Roche IPRs on PCR patents such as 7,998,708, 8,323,900, 8,709,787, 8,415,103). Those involve Roche's molecular-diagnostics portfolio generally, not the plasma separation card family, and Roche's posture there (largely as patent owner in the Ravgen matters) says nothing about the patentability of 11,353,382.
4. US 11,738,124 (IPR2025-01374, Terumo BCT). This surfaced in search results because it is a plasma patent (plasma apheresis, predicated on a "system and method for collecting plasma"). It is unrelated to 11,353,382 — different owner, different claim scope, different art.

Strategic summary

Claim status of US 11,353,382: every claim is UNTESTED. The patent has 12 claims (claims 1–12, of which claim 1 is the sole independent claim — a method claim for separating plasma from a whole blood sample, and claims 2–12 depend from it, with claim 8 depending from claim 5 and claim 12 depending from claim 7). None has been canceled, disclaimed via statutory disclaimer, amended via a PTAB motion to amend, or adjudicated unpatentable by the Board. There is likewise no reexamination certificate. Practically, this means the claim set as issued on 2022-06-07 is the claim set you must address.

Estoppel landscape is clean — for everyone. Because no IPR or PGR was ever instituted, § 315(e)(2) estoppel bars no one. A defendant today can raise any § 102/§ 103 ground, including art that a prior petitioner might have raised. There is no SAS-type partial-institution residue, no adverse final written decision to inherit, and no estoppel gap to exploit. Conversely, a defendant gets no benefit from someone else's work — there is no FWD whose obviousness findings can be repurposed.

Procedural posture / pattern signals. No petitioner, no patent owner, and no defensive aggregator (e.g., Unified Patents) appears anywhere in the chain for this patent. Roche Molecular Systems is the current assignee and the original assignee; the 2022-04-13 reclassification events in the patent record are intra-Roche assignments (Roche Diagnostics GmbH and individual inventors assigning to Roche Molecular Systems, Inc.), not adversary activity. Roche has litigated its molecular-diagnostics patents elsewhere, and it has been a defendant in unrelated suits, but nothing indicates it has asserted the plasma separation card family — which is consistent with the litigation section's finding that there is no case law on 11,353,382 either.

Two timing observations that matter for challenge planning:

• The PGR window is closed. § 321(c) requires a PGR petition within 9 months of grant. The '382 patent granted 2022-06-07, so the PGR window closed 2023-09-07 (9 months post-grant). PGR is not a live option. (The application's 2016 filing and 2015 priority date place it squarely in the AIA regime, so pre-AIA-only avenues are not a workaround.)
• IPR remains available for the life of the patent. IPRs have no post-grant deadline; the only brake is the § 315(b) one-year bar running from service of a complaint alleging infringement. With no litigation identified (per the litigation section), no § 315(b) clock is running, and there is no § 325(d) or Fintiv overlap to argue. A petition filed today would face a clean, no-parallel-litigation discretionary-denial posture — the most favorable Fintiv facts a petitioner can have. The patent's anticipated expiration is 2036-03-30, so the IPR runway is long.

One structural caution for challengers: the '382 patent is a continuation of US 10,663,379 (Ser. No. 15/085,882, filed 2016-03-30), sharing the 2015-03-31 priority. Invalidating the '382 patent would not, by itself, invalidate the parent, and vice versa. Any challenge program should decide up front whether to attack the family (both the '379 and the '382) in parallel, because the same prior art will likely be dispositive against both. Note also that the '382's claim 1 recites method steps (applying blood, allowing components to pass through, plasma absorbed onto the absorptive element), whereas the '379 is a device claim — so the obviousness case is not identical across the two, and the method-step limitations (claim 9's "3-4 hours," claim 10's drying step) are potential distinguishers.

Recommended next steps

Because there is no PTAB activity on this patent, the defensive posture is: challenge from scratch or don't challenge at all.

1. Say it plainly in any opinion or client memo. There is no PTAB activity on US 11,353,382 — no IPR, no PGR, no CBM. Do not allow a paralegal or junior attorney to populate an invalidity chart with a 11353382-looking hit; the [11353382] search hit is a Ninth Circuit docket-entry number and the Therasense "'382 patent" is US 4,545,382. Both are already flagged above.

2. If you intend to file an IPR, do it on your own timetable, not the § 315(b) clock's. Confirm the absence of a served complaint (which would start a one-year bar) before relying on the "clean Fintiv" conclusion. If a complaint has been served and is simply not yet in the public databases, the § 315(b) date is the operative deadline and the Fintiv analysis changes materially.

3. Build the prior-art case against the '382 in parallel with the '379. The two share a specification and a 2015-03-31 priority date, but the '382 claims are method claims and the '379 claims are apparatus claims. The patents' own background discussion identifies the closest art already: EP 1096254 B1 (capillary pathway with obstructions) and US 2012/0088227 (stacked separating and absorptive members) are both cited on the face of the patent as background, and the applicant distinguished McClernon and McClernon (20th Annual DART Conference, Maui/Hawaii, 2015-12-06 to 2015-12-10). Whatever you intend to assert, the applicant's own characterizations of these references are admissions worth mining — and the DART conference publication's December 2015 date sits after the 2015-03-31 priority date, so check whether it is even prior art before building on it. The twelve examiner citations in the patent's "Citations" list are the natural starting point for § 102/§ 103 combinations.

4. Check the foreign counterparts on their own clocks. The same family includes EP3278105B1, JP6787920B2, CN107430114B, and WO2016156376A1. An EPO opposition (9 months from grant) and any national-stage invalidation actions run on independent timelines and are not governed by the PTAB analysis above. I have not verified the EP grant date or whether the EPO opposition period is open — that requires a direct check of the EPO Register for EP3278105, and I will not guess at it.

5. Re-run the check before filing. A "zero" finding is time-stamped. The USPTO ODP ingest can lag newly filed petitions, and petitions are typically not public until the Board mails a Notice of Filing Date Accorded. If a defendant or aggregator filed recently, it may not yet be indexed. The authoritative live check is the PTAB's Patent Trial and Appeal Board End-to-End (PTAB E2E) system and the Patent Center for application 16/843,130, filtered on patent number 11,353,382 — a direct docket search there on the day you file is the only way to convert this "no activity found" into a clean "no activity exists" representation.

Confidence: High that no PTAB proceeding has been publicly indexed against US 11,353,382 as of 2026-09-29, supported by the canonical ODP block plus four independent web searches returning no match. I did not run a query in a live PTAB E2E session and did not docket-verify, so if you need a litigation-grade or filing-grade negative, confirm directly in PTAB E2E before relying on it. I have named no proceeding numbers because none exist for this patent; every case number cited above is expressly identified as belonging to a different patent.

I'll research the assignment chain for US 11,353,382.

I hit my search-step limit before I could retrieve primary-source reel/frame data from the USPTO Assignment Center. I'll report what is verifiable from the authoritative full text supplied, flag the gaps precisely, and will not invent reel/frame numbers or correspondent names.

Inventors

Pattern note: the two-track assignment — four inventors to Roche Diagnostics GmbH, one inventor directly to Roche Molecular Systems — is a cross-entity inventorship signature, not a fire-sale signature. It indicates the work was done by a German Roche Diagnostics group and a US Roche Molecular Systems group, then consolidated. There is no evidence of inventors departing the original assignee within 12 months of filing; the assignments were recorded roughly six years after the 2016-03-30 parent filing, which is consistent with routine recordation at/near grant rather than distress. (Employer attributions above are inferences from the assignor names in the assignment records plus the DE-country EP priority; I did not obtain employment confirmations.)

Original assignee

Roche Molecular Systems, Inc. — named as both original and current assignee on the issued patent (Google Patents legal events, and per the assignment chain the ultimate recipient of all five inventor interests).

• Product embodying the claims: Yes, with moderate confidence. Roche commercialized a cobas® Plasma Separation Card (PSC) for HIV-1 viral load specimen collection, and the patent's own Examples tie the card to the COBAS® AmpliPrep/COBAS® TaqMan® HIV Test v2.0 (CAP/CTM), Cobas® 4800, and Cobas® 6800/8800 platforms (Tables 1–2, FIG. 10). Roche's specimen pre-extraction workflow described in Example 2 is the commercial use case. I did not independently verify the current catalog/SKU status of the PSC product in 2026.
• Primary line of business: in-vitro diagnostics / molecular diagnostics (PCR-based nucleic acid testing). Roche Molecular Systems, Inc. is the Roche Diagnostics US molecular diagnostics entity (Branchburg, NJ / Pleasanton, CA); its German affiliate Roche Diagnostics GmbH is at Sandhofer Strasse 116, 68305 Mannheim.
• Current status: operating. Roche is publicly listed (SIX: RO / ROG); no bankruptcy, dissolution, or acquisition of the assignee is indicated. No Chapter 7/11 proceeding was found.

Assignment timeline

Important limitation — read first. The authoritative text supplied for US11353382B2 contains Google Patents' "legal events" list, which surfaces assignee, assignor, and date but no reel/frame, no execution date, and no correspondent. My attempts to pull the underlying Assignment Center records (assignmentcenter.uspto.gov / assignment.uspto.gov) were cut off by the search-step limit. Accordingly:

• Reel/frame: NOT RETRIEVED — reported as unknown rather than guessed.
• Correspondent of record: NOT RETRIEVED.
• Execution dates: not shown in the record I hold; the dates below are the recorded/assignment-event dates as listed (2022-04-13), not necessarily execution dates.

Every numbered entry below is grounded in the legal-events list in the supplied full text; entries I could not ground are omitted rather than reconstructed.

• Executed date not captured / recorded 2022-04-13 — Reel not retrieved

  • Conveyance: Assignment (per Google Patents "Assigned to … reassignment" event; conveyance type not further specified in the record)
  • Assignor: Dick, Siegfried; Fischer, Markus; Schmelzer, Alexander; Trapp, Andreas
  • Assignee: Roche Diagnostics GmbH
  • Correspondent: not retrieved — cannot assess recurrence
  • Context: internal corporate consolidation — original inventor-to-employer assignment into the German Roche Diagnostics entity.

• Executed date not captured / recorded 2022-04-13 — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: Roche Diagnostics GmbH
  • Assignee: Roche Molecular Systems, Inc.
  • Correspondent: not retrieved
  • Context: internal reorg / intra-group transfer — Roche Diagnostics GmbH passes the four German inventors' interests to the ultimate Roche Molecular Systems entity.

• Executed date not captured / recorded 2022-04-13 — Reel not retrieved

  • Conveyance: Assignment
  • Assignor: Will, Stephen G.
  • Assignee: Roche Molecular Systems, Inc.
  • Correspondent: not retrieved
  • Context: inventor-to-employer assignment directly into the ultimate assignee; completes the five-inventor chain of title.

No other recorded assignments exist in the record I hold. There is no post-issuance transfer, no security interest, no license recordation, and no change-of-name record. All three events are same-day (2022-04-13), two months before the 2022-06-07 grant.

Cross-reference: Google Patents' event log lists no litigation, PTAB, or adverse legal events — only the three assignment events, the grant, and the anticipated-expiration entry. This is consistent with the earlier litigation-section finding of no litigation on this patent and is a reinforcing (not independent) data point.

Timeline diagram

timeline
    title Ownership of US 11353382
    2015 : Priority application filed
    2016 : Parent application filed
    2020 : Continuation application filed
    2022 : Patent US 11353382 granted
    2022 : Inventors assign to Roche Diagnostics GmbH
         : Roche Diagnostics GmbH assigns to Roche Molecular Systems
         : Will assigns to Roche Molecular Systems

NPE / troll-pattern signals

1. Shell-entity transfer — not present. No assignee anywhere in the chain bears an "IP / Patents / Licensing / Holdings / Ventures" suffix, and no single-purpose LLC appears. The chain runs Roche Diagnostics GmbH → Roche Molecular Systems, Inc., both operating diagnostic entities (recorded 2022-04-13). No registered-agent service address is involved; addresses of record are Roche operating addresses.

2. Known asserter in the chain — not present. Neither Roche Diagnostics GmbH nor Roche Molecular Systems, Inc. appears on any NPE list (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). No Unified Patents / RPX high-frequency-plaintiff listing for either entity was found.

3. Repeat correspondent across the chain — unclear / not assessable. I could not retrieve the correspondent of record for any of the three 2022-04-13 recordings. Because recurrence is the signal and I have zero correspondent data points, this must be marked unclear, not "not present." This is the single most important gap in this analysis: with three same-day recordings by one corporate family, a recurring corporate-law/docketing correspondent is the expected benign finding, but I cannot state it as fact.

4. Cascading transfers — not present. The chain contains a single intra-group hop (Roche Diagnostics GmbH → Roche Molecular Systems, Inc.) and is confined to one corporate family on one day. There are no chained unrelated LLCs, no shared registered-agent addresses, and no <24-month cascade of successive assignees.

5. Pre-litigation transfer — not present. There is no infringement suit naming this patent at all (see the earlier litigation section), so no assignment can be "pre-litigation." The 2022-04-13 assignments precede the 2022-06-07 grant, consistent with recordation at grant, not with venue/standing engineering.

6. Bankruptcy fire-sale — not present. No Chapter 7/11 filing by either assignee; Roche is a going concern. No sold-in-bankruptcy event in the record.

7. Privateering — not present. No transfer to an NPE asserting on Roche's behalf. The patent stayed inside the Roche corporate family. Roche does enforce diagnostics patents against competitors in other matters (e.g., the long-running Enzo Life Sciences v. Roche Molecular Systems litigation), but that is unrelated to this patent and does not involve any privateer of this chain — I raise it only so it is not mistaken for privateering of the '382 chain.

8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at Roche Molecular Systems, Inc., an operating company.

On the "no-IPR" data point: the earlier failure to find any PTAB proceeding against this patent is not an anti-NPE signal; it is simply the absence of a challenge. I note it to avoid over-reading an absence.

Verdict

Defensive / non-asserting — with an explicit definitional caveat: the chain does not terminate at a defensive aggregator (RPX/AST/LOT/Unified). It terminates at an operating original assignee, Roche Molecular Systems, Inc., which ships a product embodying the claims and has not asserted the patent. That is the practical substance of "non-asserting," so of the five available labels this is the closest fit; the alternative labels all fail on their stated criteria — there are no NPE signals to support either NPE verdict, and "Operating-company assertion" requires an actual suit, which does not exist.

Justification: All three recorded assignments are same-day (2022-04-13) intra-group recordings — Dick/Fischer/Schmelzer/Trapp → Roche Diagnostics GmbH, Roche Diagnostics GmbH → Roche Molecular Systems, Inc., and Will → Roche Molecular Systems, Inc. — moving the five inventor interests into a single operating assignee two months before the 2022-06-07 grant. Every NPE signal except "repeat correspondent" resolves to not present, and "repeat correspondent" is unclear only because I could not retrieve correspondent or reel/frame data before exhausting my search budget. This is a routine corporate chain of title, not an assertion vehicle.

Verification and residual gaps: Confirm the three recordings directly at the USPTO Assignment Center (https://assignmentcenter.uspto.gov/ — search patent number 11353382; mirrored at https://assignment.uspto.gov/patent/index.html) to capture reel/frame, execution dates, and correspondent of record — the three fields I could not obtain. The earlier-generated sections flagged two unresolved items that remain unresolved here and should be reconciled in the same pass: (a) the continuation vs. division characterization of the US 15/085,882 parent (specification says continuation; Google's "Related Parent Applications" says division), and (b) the expiration discrepancy ("2036-03-30 anticipated expiration" per Google vs. "2040-04-08 adjusted expiration" per patents-review.com).

I'll research the prior art citations for US 11,353,382. Let me search for the full citation list, since the provided patent text truncates it.

I have the full citation list. Let me research the key references in detail to accurately describe them and assess §102 relevance.

Prior-Art Analysis — US 11,353,382 B2 ("Plasma separation card")

Sourcing note and scope

I was asked to pull the prior-art citations for the specific number 11,353,382. I anchored this on the USPTO-sourced full text already supplied for US11353382B2 plus the Google Patents rendering of the same document (which mirrors the USPTO face record) at https://patents.google.com/patent/US11353382/en, and corroborated select references against their own pages. I did not open USPTO Patent Center / Patent Public Search directly, so where the face record itself is internally inconsistent I flag it rather than resolve it.

Per the instruction to interpret identifiers literally: everything below is keyed to the number 11,353,382 only. I excluded hits for other numbers ending in "382" (an RPX document referencing an unrelated "'382" patent appears in searches and is not this patent).

Internal discrepancy flagged (do not silently reconcile): the copy of the patent supplied to me lists the citation block as "Citations (12)," while the Google Patents rendering of the same page lists "Patent Citations (13)." The extra entry in the 13-item rendering is US 5,516,487 A (Isolab) — the U.S. counterpart of WO 95/35497 A1 (Isolab), both of the same disclosure. I list all 13 below and note which ones the "12"-count version appears to merge.

Governing law: earliest priority is 2015-03-31 (US provisional 62/141,089); the application chain was filed 2016/2020. This is an AIA case, so 35 U.S.C. §102(a)(1) (patented/published/described before the effective filing date) and §102(a)(2) (U.S. patents, U.S. application publications, and PCT applications designating the U.S. having an earlier effective filing date) apply, with §103 for combinations.

A. Anchor record (brief — builds on the prior summary, not repeated)

US 11,353,382 B2 · App. US 16/843,130 · filed 2020-04-08 · granted 2022-06-07 · priority 2015-03-31 · assignee Roche Molecular Systems, Inc. · 12 claims, claim 1 the sole independent (method) claim.

B. Complete list of patent citations of US 11,353,382 (the examiner/IDS references)

Note on #2/#3: US 5,516,487 A and WO 95/35497 A1 are family members of the same Isolab disclosure. Their separate listing is the most likely explanation for the 12-vs-13 count discrepancy in the face record.

C. Non-patent literature cited in the specification (not in the citation table)

These are the references the applicant expressly discussed in the Background, which is a distinct (and often more probative) set than the IDS citations:

1. EP 1,096,254 B1 — device for separating hematocrit from whole blood via an inlet port, reaction region and capillary pathway with cell-retaining obstructions. §102(a)(1) art.
2. U.S. Published Patent Application No. 2012/0088227 — same document as citation #10 above (device with stacked separating + absorptive members). §102(a)(1) art. This is the applicant's own identification of the closest prior art.
3. McClernon and McClernon, 20th Annual DART Conference, Maui/Hawaii, USA, Dec. 6–10, 2015 — described in the specification as a separation-membrane + plasma-collection-pad device that is "easier to handle" but risks cross-contamination. Timing check: this presentation postdates the 2015-03-31 priority date, so on its face it is not §102 prior art (see note in Section E).

D. §102 analysis, reference by reference

Threshold legal points I am applying:

• Anticipation under §102 requires a single reference disclosing every element of the claim, arranged as in the claim, enabled.
• A dependent claim carries all limitations of the claim from which it depends. Therefore, if claim 1 is not anticipated by a reference, that reference cannot anticipate claims 2–12 either — even if it separately shows, e.g., a handle or a fleece. This is decisive here.

Claim 1 — what a single reference must show to anticipate

(a) first layer / sample-receiving member, top planar surface with an opening, bottom planar surface contacting the separating member; (b) at least two separating members composed of a poly-sulfone material, each with a top planar shield-shaped surface and a bottom planar shield-shaped surface; (c) at least two absorptive members each composed of a plasma-collection fleece/material (or water/buffer-insoluble collection material), each a removable absorptive element detachably fixed to the third layer, plus a backing member; and method steps (2)–(3).

Result: none of the 13 cited references, standing alone, discloses the full combination. The specific triad of (i) poly-sulfone separating members, (ii) shield-shaped top and bottom planar surfaces, and (iii) ≥2 detachable plasma-collection-fleece absorptive elements is not shown in a single one of them. Accordingly:

• No claim of US 11,353,382 — independent claim 1 or any of dependent claims 2–12 — is anticipated under §102 by any cited reference on the present record. Because anticipation of a dependent claim presupposes anticipation of its base claim, the §102 answer for claims 2–12 is likewise "none."

Reference-by-reference: closest mapping and correct statutory basis

Bottom line on §102: The examiner's citation set is, on its face, a §103 obviousness art collection plus background art, not a set of §102 anticipatory references. No single cited document contains all limitations of claim 1, and therefore none anticipates claims 2–12 by derivation.

E. Most relevant prior art (ranked) and honesty about the DART/conference reference

1. US 2012/0088227 A1 (Roche Molecular Systems) — the closest single item, and the applicant's own admitted closest prior art. It already discloses a stacked separating + absorptive structure with removable fixation, a handle, and a backing member. The '382 claims appear designed to patent around and improve on this reference.
2. WO 2016/025726 A1 (Vivebio, LLC) — highly material on the multi-spot card concept (multi-region membrane array, separable collection membranes, folded/desiccated format). Its §102(a)(2) availability turns on whether it is entitled to its 2014-08-13 provisional date and names a different inventive entity (it does — Vivebio/Murray et al.), which is exactly the §102(a)(2) scenario.
3. US 2006/0188392 A1 (Arkray) — the cleanest match to the poly-sulfone separating-membrane limitation and to the blood-supply/development architecture.
4. US 6,106,732 A (Binax) and Isolab US 5,516,487/WO 95/35497 — material to the absorptive collection element.
5. WO 2015/022410 A1 (GE) — material to nucleic-acid stabilization/collection.

Important timing observation (builds on the prior summary): The specification cites McClernon & McClernon, 20th Annual DART Conference, Dec. 6–10, 2015 as describing a separation-membrane + plasma-collection-pad device. That date is after the '382 priority date of 2015-03-31, so on the face of the record that conference disclosure is not §102 prior art to this patent. Notably, the Vivebio WO 2016/025726 (#12) names MCCLERNON, Daniel R. and MCCLERNON, Anita among its inventors — i.e., the DART presenters and the Vivebio applicants appear to be the same group, which is why the Vivebio application (effective 2014-08-13) is the operative §102(a)(2) counterpart of that disclosure rather than the later talk.

F. Contradictions and uncertainties I am not resolving

1. Citation count: face record shows "Citations (12)" in the copy supplied to me vs. "Patent Citations (13)" on the Google Patents rendering. Most probable cause is the separate listing of the Isolab family pair (US 5,516,487 A and WO 95/35497 A1). Reported literally; not reconciled.
2. Dates convention: the table's "priority/filing" column uses the priority date shown on the face record (e.g., US 5,552,276 = 1993-03-18). For §102(a)(2) analysis the legally operative date is the effective filing date, which I have noted only where it changes the answer (items 12 and 13).
3. Verification depth: I retrieved substantive text for references #7, #10, #12 and the non-patent items, but could not retrieve full text for #1 (Mochida), #4 (Cleator), #5 (Amrad), #6 (Binax), #8/#9 (PTS), #11 (GE) or #13 (Axxin) within the search budget. Their descriptions above are based on titles/known content and are flagged as lower-confidence; the §102/§103 classification, however, does not turn on those details because none supplies the missing claim-1 elements.
4. No evidence of any §102 rejection: nothing in the supplied record shows that the examiner actually entered a §102 anticipation rejection over any of these items. Treat §103/§102(a)(2)–availability as the operative framework unless the full prosecution history says otherwise.

Net answer to the question asked: On the specific number 11,353,382, the cited prior art is a §103-oriented set; no single cited reference anticipates claim 1, and consequently none anticipates claims 2–12. The most probative references to develop further are US 2012/0088227 A1, WO 2016/025726 A1, and US 2006/0188392 A1.

I'll research the prior art references cited in this patent to ground the § 103 analysis.

Let me research the remaining prior art citations and the membrane technology.

Obviousness Analysis — U.S. Patent No. 11,353,382 ("Plasma Separation Card")

Under 35 U.S.C. § 103; AIA version (effective filing/priority 2015‑03‑31)

Scope note / built on prior sections. This analysis builds on the earlier Verification and Litigation summaries (do not repeat): the '382 patent issued 2022‑06‑07 on application US 16/843,130, is a continuation of US 10,663,379 (Ser. No. 15/085,882), claims priority to US provisional 62/141,089 (2015‑03‑31) and EP 16155284 (2016‑02‑11), is assigned to Roche Molecular Systems, Inc., and has 12 claims, with claim 1 the sole independent claim (a method claim). No litigation or PTAB activity was found. I rely on that framing and now analyze the prior-art citations listed on the patent page.

1. Legal framework and evidentiary basis

Under Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), I consider: (a) scope and content of the prior art; (b) differences between the prior art and the claims; (c) level of ordinary skill; and (d) secondary considerations. Where a claimed element is "known" and used "according to its established function," it is obvious to combine it (KSR, 550 U.S. at 417). MPEP §§ 2141–2144.03 govern the written analysis; MPEP § 2144.04 addresses "obvious to try."

Statutory-date check (important):

Flag. The specification (Background) discusses the McClernon/McClernon DART presentation on a "separation membrane and plasma collection pad." Because the conference postdates the 2015‑03‑31 priority date, this disclosure is not available as prior art under § 102(a)(1)/(a)(2) and cannot be used in the § 103 combination. I note it only because the patent owner's own characterization of it ("there is still a risk of cross-contamination when removing the plasma collection pad") defines the problem the claims purport to solve.

Retrieval limitation (honest caveat): I retrieved and verified full text for US 2012/0088227, US 6,106,732, US 5,552,276, WO 1998/001753, and EP 1 096 254. The citation list on the patent page is truncated at US 2006/0063267 A1, and I did not retrieve full text for US 5,948,687 (Cleator), US 2006/0063267, or WO 1995/035497 A1 (Isolab) beyond their bibliographic entries. Conclusions that depend on those three are flagged as provisional.

2. Level of ordinary skill in the art (POSITA)

A POSITA here would hold a bachelor's degree in chemistry, biomedical engineering, or a related field plus about 2–4 years' experience designing lateral/vertical-flow diagnostic devices and blood-sample collection matrices, or equivalent experience. Such a person would be familiar with: (i) asymmetric polysulfone plasma-separation membranes (the patent itself names the Pall Vivid™ membrane, an asymmetric poly-sulfone membrane from Pall Corp.; US11353382, "Definitions"); (ii) cellulosic collection media (Whatman™ 903™, cotton-linter fleeces such as Hahnemühle FP2992/FP2316/ISP7216); (iii) capillary-driven vertical-flow stacks; and (iv) dried-plasma transport/dessication packaging. This is a mature, predictable arts area — a fact that materially supports combinability.

3. Claim 1 mapped to the prior-art references

Claim 1 requires a method with three steps. Steps (2) and (3) — applying whole blood to the sample-receiving member and letting it pass down through the layers so plasma separates and is absorbed — are simply the intended operation of any vertical-flow plasma-separation stack. The structural limitations live in step (1).

4. Grounds of rejection

GROUND 1 — US 2012/0088227 alone (the closest art), optionally in view of the known polysulfone membrane

US 2012/0088227 is, on its face, Roche's own earlier stacked plasma-separation device and discloses nearly every structural element of claim 1:

• A first portion with a separating member having a first surface for applying/receiving the blood sample, adapted to pass plasma but inhibit cells.
• A second portion with an absorptive member and a backing member supporting it; the absorptive member contacts the separating member and draws plasma by capillary pressure — i.e., the "pass the components down through the layers" step.
• The absorptive member is removably fixed to the backing member by a second adhesive element, non-destructively removable — the "detachably fixed … removable absorptive element" requirement.
• A cover member with an opening for applying the blood sample (claim 9) — the "opening in the top planar surface."
• Gripping handles for both the first portion and the absorptive member (claims 5–6) — the "handle" concept of dependent claim 2.
• An arrangement of a plurality of devices on one backing (three devices "in serial arrangement"), i.e., ≥2 separating members and ≥2 absorptive members on one card.
• Claim 15 is a process claim that mirrors claim 1's steps (2)–(3).

Only meaningful difference: the explicit "poly-sulfone" limitation and the "shield-shaped" geometry. Asymmetric polysulfone plasma-separation membranes were known and commercially available (Pall Vivid™; the '382 specification lists it as an off-the-shelf product and describes no new synthesis). Incorporating a known membrane into the 88227 device is "the predictable use of prior art elements according to their established functions" (KSR). The shield shape is an unclaimed-for-function design choice with no demonstrated criticality.

Conclusion: Claim 1 would have been obvious over US 2012/0088227 in view of the admitted, commercially available polysulfone plasma-separation membrane. Claim 1 is, in substance, a method of using a known device for its intended purpose — a classic § 103 scenario (cf. In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997)).

GROUND 2 — US 2012/0088227 + US 6,106,732 (Binax)

Binax supplies the remaining "collection-matrix" and "drying/packaging" teachings:

• A process for separating plasma/serum from whole blood by applying the sample through a receiving hole in a first upper (hydrophobic) layer, letting it flow downwardly through a first hydrophilic layer that retains red cells, into a second hydrophilic "plasma retention" layer — the two-layer vertical-flow method of claim 1 steps (2)–(3).
• The device "may be constructed with multiple whole blood sample-receiving stations" — supporting "≥2" separating/absorptive members.
• The plasma-retention pad is stripped away at the lab and either extracted or assayed — the removable absorptive element.
• The card is sealed in a resealable pouch with a desiccant, "maintain[ing] dryness of the plasma retention pads" during transport — the packing/drying environment reflected in claims 10–11.

Motivation to combine: Both references are in the identical field (capillary-driven, vertical-flow, dried-plasma sample collection for remote/point-of-care analysis). Both seek to (1) avoid centrifugation, (2) produce a stable, transportable dried plasma specimen, and (3) allow the collection pad to be separated and analyzed later. Binax expressly frames the problem the '382 patent solves (variable plasma recovery from dried spots, need for known/stable plasma volume). A POSITA seeking to improve the 88227 card would look directly to Binax's multiple-station architecture, its plasma-retention pad, and its desiccant packaging — creating a reasonable expectation of success because each element performs the same function it performs in its own reference.

Result: Claim 1 (and dependent claims 5, 6, 7, 9–11 by extension) obvious over 88227 + Binax.

GROUND 3 — US 5,552,276 (Mochida) + US 2012/0088227 and/or the polysulfone membrane

US 5,552,276 discloses a multi-layer, vertical-flow diagnostic stack with:

• a liquid-impermeable case having a top opening for introducing the test sample (claim 1(e)) — the "opening in the first-layer top surface";
• a porous membrane disposed below the top porous body;
• an absorption member below the membrane arranged to contact a periphery of the membrane (claim 1(c)) — the "absorptive member below the separating member"; and
• a process (claim 17) of adding sample to the top opening, letting it migrate down and be absorbed.

A POSITA seeking a plasma-separation card would substitute a polysulfone plasma-separation membrane for Mochida's assay/reaction membrane — an obvious substitution of one known porous membrane for another where each operates by capillary flow and size-based retention, with predictable results — and add the removal/handle features of 88227. Mochida also supplies the "case/backing enclosing the layers" concept (the third-layer backing member).

GROUND 4 — WO 1998/001753 A1 (Amrad) + US 6,106,732 + WO 1995/035497 A1 (Isolab)

Amrad discloses a blood-separation module with:

• a planar base member having apertures, and a filter element in/covering each aperture — a "planar base with an opening + filtering membrane over the opening," i.e., the claim's first-layer-opening/separating-member geometry;
• the filter element may be a multi-layer separation membrane (per U.S. 5,240,862) optionally combined with a porous non-woven matrix; and
• adhesive on the base surface so the module is removably attached to a test device and later removed — the detachable/removability theme.

Combined with Binax (multiple stations, plasma-retention pad, desiccant pouch) and Isolab's absorbent paper for liquid sampling (typical of the Whatman 903-type collection matrix), Ground 4 reaches claim 1's collection-member limitations. Caveat: my substantive review of WO 1995/035497 A1 was limited to its bibliographic entry; this ground is included for completeness and should be confirmed against full text before being relied upon.

5. Why a POSITA would have been motivated to combine (the "reason to combine")

The references supply express and inherent motivations:

1. Same field, same problem, same mechanism. All of 88227, Binax, Mochida, Amrad, and EP 1 096 254 are directed to separating plasma/serum from whole blood using capillary-driven vertical (or capillary-pathway) flow without a centrifuge, for transport to a remote lab. That is the '382 patent's own field.
2. Same purpose → predictable combination. Each claimed element (a top layer with an opening, a polysulfone separating membrane, a removable collection pad, a backing layer, dessication) performs in the combination the identical function it performs in its own reference. KSR, 550 U.S. at 417.
3. The patent owner's own admissions. The '382 Background states the 88227-style device with a separation membrane + plasma-collection pad "described by McClernon" is "easier to handle" — i.e., the device architecture is admitted prior art, and the stated deficiency is only "a risk of cross-contamination when removing the plasma collection pad" and that the pad "can be easily removed" and be "sufficiently stable." These are addressed by known expedients — 88227's second adhesive "predetermined breaking zone" and gripping handles (anti-contamination) and a plasma stabilizer in the pad (known fleece chemistry).
4. Design incentives in the art. WHO's 2013–2015 emphasis on HIV viral-load testing in resource-limited settings (recited in the '382 Background) created a well-documented demand for cheap, ambient-stable, transportable plasma cards with multiple test spots — supplying the "market pressure/design incentive" KSR recognizes as a motivation.
5. Beyond "obvious to try." Because the components are from a predictable arts area with a finite number of known materials (polysulfone membranes, cotton-linter/Whatman fleeces, adhesive peel zones), the substitution of one for another is an obvious design choice, not merely "obvious to try."

6. Dependent claims (2–12)

None of claims 2–12 adds an element with a patentable, unexpected functional relationship beyond the express teachings of 88227 and Binax.

7. Counterarguments and secondary considerations (patent owner's likely rebuttal)

A rigorous analysis must state where the § 103 case is weaker:

1. "Poly-sulfone" limitation. This is the most claim-narrowing structural term and likely a prosecution amendment. If the applicant added it to overcome 88227 (which does not literally recite polysulfone), the patent owner will argue 88227 teaches away or is silent. Rebuttal: the '382 specification itself concedes polysulfone membranes were commercially available off-the-shelf ("Vivid™ Membrane (available from Pall Corp.)") and describes no criticality; a known material chosen for its known properties is obvious (KSR; MPEP 2144.03).
2. "Shield-shaped" geometry. Recited in claim 1 only for the second layer. No data tie the shape to an unexpected result in claim 1, so it is a design choice. However, a patent owner may argue the shield shape enables the "easy transfer into tubes" advantage recited in the specification (¶ on absorptive members). Rebuttal: that advantage is asserted for the absorptive element, which claim 1 does not require to be shield-shaped, and Section 112 written-description/commensurability limits the argument.
3. Secondary considerations. The '382 Examples show (i) LOD values (Table 1: 502–613 cp/mL HIV on CAP/CTM and c4800; HBV/HCV LODs), (ii) linearity R² = 0.98–0.99 over 400–2×10⁷ cp/mL (Table 2), and (iii) 16‑week/40 °C specimen stability with and without stabilizer (FIG. 10). Rebuttable: (a) These results are largely attributable to the known Vivid polysulfone membrane and to the plasma stabilizer, and the stabilizer is not a claim limitation — so the stability data are not commensurate with claim scope (In re Kao; In re Hiniker). (b) The specification itself states the "delta mean log titer ≤ 0.3" requirement is a stability requirement defined by the experimenter, not an unexpected property. (c) No evidence of copying, unexpected results, or industry praise attributable to the claimed combination was located; the commercial "plasma separation card" success (if any) is not shown to be caused by the claim-1 elements over the 88227 device.
4. Common ownership nuance (not a saving grace). US 2012/0088227 is Roche-owned, as is the '382 patent. AIA 35 U.S.C. § 102(b)(2)(C) can disqualify a § 102(a)(2) disclosure only. Because 88227 published 2012 — more than one year before the 2015‑03‑31 priority — it is a § 102(a)(1) printed publication and the grace-period/common-ownership exceptions do not remove it. It remains prior art. (I frame this as the correct statutory treatment; the ultimate common-ownership posture should be confirmed against the assignment records.)

8. Bottom line

Assessment: On the record supplied, claim 1 is most likely obvious under § 103 over US 2012/0088227 (the closest art) in view of an admitted, commercially available asymmetric polysulfone plasma-separation membrane, and further in view of US 6,106,732 for the multi-station/drying/dessication features. Claim 1 is functionally a method of using a known multi-layer plasma-separation device for its intended purpose, with the only literal structural additions (polysulfone material, "shield-shaped" geometry, and ≥2 members) being predictable selections from a finite set of known options in a mature art. Dependent claims 2–12 likewise appear obvious in view of the same references and routine design choices, with the specimen-stability data on which the owner would rely being not commensurate with the claims because the plasma stabilizer responsible for that stability is unclaimed.

Confidence and limitations: Moderate-to-high for Grounds 1–3 (full text retrieved and verified for 88227, Binax, Mochida, Amrad, and EP 1 096 254). Lower for Ground 4 and for any conclusion relying on US 5,948,687, US 2006/0063267, and WO 1995/035497 A1, whose full texts I could not retrieve before the search limit. The strongest confirmation step would be to check the 15/085,882/16/843,130 file wrapper for the amendment that introduced "poly-sulfone" and the examiner's cited art, which I could not access directly (USPTO Patent Center/Patent Public Search). Absent that, the analysis above should be treated as a well-grounded preliminary obviousness opinion, not a final clearance.