US 10041865

I'll search for authoritative information on this specific patent number, including any litigation activity.

Search-scope caveat up front

I ran targeted web searches for the exact string 10041865 / 10,041,865 against patent-data mirrors and general web indexes, plus queries aimed at Federal Circuit and district-court dockets for this patent. I did not have direct credentialed access to USPTO Patent Center, PTAB/PTACTS, PACER, or the CAFC docket system in this session, so the litigation findings below are "no evidence found," not a certified negative. I did not auto-correct any identifier: everything below refers literally to US 10,041,865 B2.

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1. Bibliographic summary (US 10,041,865 B2)

Abstract (as issued): "Assemblies for storing, handling, transporting, viewing, evaluating, and/or shipping corneal tissue are provided. The assemblies may include a viewing chamber and a corneal tissue carrier removably coupled to an inner portion of the viewing chamber. The assemblies may further include a corneal tissue sample disposed within the corneal tissue carrier. Methods of processing a corneal tissue sample and administering the corneal tissue sample to a subject are also provided."

Commercial context: assignee's own press release (visiongift.org, Aug 1/7, 2018) describes the patent as covering its "Patient Ready DMEK™" / Endothelial Delivery System (EDS™) — a Straiko modified Jones tube held in a standard corneal viewing chamber, with pre-stripped, pre-punched, pre-stained and pre-loaded DMEK grafts evaluated in the carrier.

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2. Plain-language overview of the independent claims

Claim 1 — "An assembly for storing and evaluating corneal tissue" (apparatus):
Two components working together: (i) a viewing chamber made of a body plus a lid, and (ii) a corneal tissue carrier that is removably coupled to an inner portion of the body of that chamber. In plain terms: instead of a loose graft floating in a bottle of preservation fluid, the graft rides inside a small transparent tube/carrier that is itself clipped inside a standard viewing chamber — so the tissue stays put, stays immersed, and can be inspected in situ without being extracted.

Claim 18 — "A corneal tissue sample assembly" (apparatus, chamber-free):
A carrier having an inner cavity and two openings, one at each end, plus two caps or plugs — the first removably coupled at the first opening, the second at the second opening. This is the stand-alone shipping/handling configuration that does not require a viewing chamber. Dependent claims (19–22 per the claim listing) add a corneal tissue sample, a stained sample, and fluid/preservation fluid substantially immersing the sample.

Claim 23 — "A method of processing a corneal tissue sample":
Three steps: (1) obtain a corneal tissue sample; (2) dispose it in the inner cavity of a corneal tissue carrier; (3) couple that carrier to an inner portion of a viewing chamber. Dependent claims add filling with fluid to immerse the sample (24), evaluating the sample within the carrier/chamber (25), evaluating via slit-lamp biomicroscopy, specular microscopy, light microscopy and/or OCT (26), and determining ECD and/or estimating % endothelial cell loss (27).

Key dependent-claim subject matter worth noting (as listed for the granted patent): stained sample (3, 20); first/second openings and caps/plugs that either permit or block fluid passage (4–11); fluid/preservation fluid immersion (12–13); a plurality of arms on the chamber body's inner surface that removably couple the carrier (14); at least a portion of chamber and carrier substantially transparent so the sample is visible (15); carrier is a Straiko modified Jones tube (16); carrier length about 38 mm (17).

Note on the '109 publication vs. the granted patent: the pre-grant publication US 2018/0143109 A1 included a claim directed to the viewing chamber being "a KROLMAN™ viewing chamber," with the Straiko-tube and 38 mm recitations shifted one number later. In the granted-patent claim listing I retrieved, claim 16 is the Straiko modified Jones tube and claim 17 is the ~38 mm length. That is consistent with the KROLMAN-specific claim having been cancelled/renumbered during prosecution — but I did not retrieve the paper prosecution history to confirm, so treat this as an inference.

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3. Litigation / post-grant activity (as requested)

• CAFC 2026 dockets: I found no Court of Appeals for the Federal Circuit docket, opinion, Rule 36 judgment, or briefing referring to US 10,041,865. My searches were for the patent number and for ophthalmic/eye-bank subject matter; nothing surfaced.
• District court: I found no complaint, § 290 notice, docket entry, or damages/injunction opinion naming US 10,041,865 as an asserted patent.
• One item worth flagging with low confidence: a Justia page for the sibling patent US 10,481,051 B2 displayed the line "Ex Parte Reexamination Request for U.S. Pat. No. 10,041,865 dated Mar. 14, 2019 for US 90/014,279." This suggests an ex parte reexamination request may have been filed against the '865 patent in March 2019. I could not verify (a) that this line belongs to the '865 patent rather than a similarly numbered document, (b) whether the request was granted or denied, (c) any resulting reexamination certificate, or (d) whether any claim survived unchanged. Because the request's outcome is unknown, the assertion that the '865 patent is currently "Active" should be read as the routine maintenance-fee status shown by Google/USPTO data, not as confirmation that all original claims are intact. Unresolved — do not rely on this item without pulling the reexam file wrapper.

Honest statement of uncertainty: I cannot tell you with authoritative confidence whether this patent has ever been litigated, licensed under dispute, or subjected to an adversarial validity challenge with a recorded outcome. My search returned no evidence of CAFC 2026 activity, but absence of search results is not proof of absence.

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4. Known gaps and uncertainties

1. Full claim set not verified. The Google Patents full-text page I used was truncated inside the Detailed Description and did not include the claims section. The claim text summarized above comes from a third-party mirror (Justia) that lists claims numbered at least through 27, with an ellipsis suggesting additional claims (possibly including a further independent method claim, e.g., a method of administering the tissue to a subject, which is described in the specification). I therefore cannot state a verified total claim count.
2. Current assignee legal name. A recorded "change of name" exists (reel 063693/0435, recorded 2023-02-24), but I did not retrieve the new legal name on that reel. Google Patents continues to list "Lions VisionGift" as current assignee.
3. Examiner / cited art. The patent's cited references include a June 22, 2014 YouTube video ("Assembly of Straiko DMEK Jones Tube," Devers Eye Institute Cornea Service) — relevant context for any invalidity analysis, but I did not retrieve the full list of record.
4. No certified negative on litigation. As noted, I used web search rather than direct PACER/CAFC/USPTO-file-wrapper queries.

5. Sources cited

• Full patent text (authoritative for this analysis): https://patents.google.com/patent/US10041865/en
• Claim listing as issued / assignment and fee history: https://patents.justia.com/patent/10041865 and https://patents.justia.com/assignee/lions-visiongift
• Pre-grant publication claims (US 2018/0143109 A1): https://patents.justia.com/patent/20180143109
• Sibling parent patent US 10,481,051 B2 (app. 15/660,004): https://patentimages.storage.googleapis.com/79/93/2d/418d86a9e1974f/US10481051.pdf
• Assignee press release on issuance: https://www.visiongift.org/lions-visiongifts-focus-on-research-and-innovation-once-again-pays-off-with-the-issuing-of-a-technology-patent-from-the-u-s-patent-and-trademark-office/

Bottom line: US 10,041,865 is a Lions VisionGift patent, sole inventor Khoa D. Tran, filed Jan 18, 2018 as a continuation (priority Oct 13, 2016), issued Aug 7, 2018, covering a corneal tissue carrier removably held inside a viewing chamber plus cap/plug variants and a corresponding processing method. I found no evidence of any CAFC 2026 appeal or district-court litigation involving it; the only post-grant adverse event hinted at in my searches is a 2019 ex parte reexamination request whose identity and outcome I could not confirm.

I'll search for litigation involving US patent 10041865 across patent litigation databases.

Let me search more specific litigation databases and court records.

Let me check a few more specialized sources for any litigation records.

Litigation Search Report — U.S. Patent No. 10,041,865

Patent identified (as literally recited): U.S. Patent No. 10,041,865 B2 ("the '865 patent"), titled "Corneal tissue sample assemblies and related methods of use." Inventor: Khoa D. Tran. Original/current assignee: Lions Visiongift. Application No. 15/874,789, filed Jan. 18, 2018; granted Aug. 7, 2018; priority date Oct. 13, 2016 (via U.S. App. Ser. No. 15/660,004 and Provisional 62/407,930); anticipated expiration 2037-07-26.

Known Litigation

No litigation involving U.S. Patent No. 10,041,865 was found.

I searched the requested and related sources, including:

• Unified Patents litigation portal (portal.unifiedpatents.com/litigation/caselist) — no entry for the '865 patent
• General patent-litigation web searches and PACER/Docket Alarm–indexed results
• CAFC / District-court docket references
• Assignee-focused search ("Lions Visiongift" infringement suits)

No district court complaints, declaratory-judgment actions, ITC investigations, or PTAB proceedings (IPR/PGR) asserting or challenging the '865 patent surfaced.

Important caveats

• I was unable to retrieve a direct, confirmatory hit from the specific databases named (Unified Patents caselist, PACER, CourtListener) before my search budget was exhausted. The absence of results is therefore based on negative search returns, not on a database-confirmed "zero litigation" query.
• Assignee context: Lions Visiongift is a 501(c)(3) non-profit eye bank (Portland, OR). Non-profit eye banks historically assert patents rarely, which is consistent with the absence of litigation, but this is contextual reasoning, not evidence.

Do not confuse with similar numbers

• U.S. 10,481,051 B2 — a separate Lions Visiongift patent with the same title ("Corneal tissue sample assemblies and related methods of use"), same Oct. 13, 2016 priority family. This is a distinct patent number and is not the subject of this request.
• The search results also surfaced unrelated "…865" references (e.g., Regeneron v. Formycon's " '865 patent" for FYB203/EYLEA, and " '065/'769" patents in the Lupin ANDA matter). Those involve different patents and different technology (biologics/ophthalmics) and must not be attributed to U.S. 10,041,865.

Bottom line

If you need a database-confirmed negative, I'd recommend a direct Docket Navigator or Lex Machina query on patent number 10041865, plus a PACER party search for "Lions Visiongift" — those would provide authenticated "zero results" confirmation that free web search cannot.

I'll verify the PTAB record for US 10041865 using the structured data as the baseline and web search to check for anything not yet indexed.

Let me run additional targeted checks against PTAB, litigation dockets, and the Federal Circuit.

Let me do two final confirmation checks — one on the patent's litigation/docket footprint and one on PTAB E2E-style records.

Proceedings overview

Total AIA trial proceedings on file for US 10041865: zero. The structured USPTO Open Data Portal block supplied for this patent returns no IPR, PGR, or CBM proceeding, and independent web checks (PTAB/PTActs records, Justia patent page, Google Patents "Legal Events," and general PTAB/court searches) surfaced no petition, institution decision, Final Written Decision, or Federal Circuit appeal naming this patent. Breakdown: active 0 / claims invalidated 0 / claims sustained 0 / settled 0 / institution denied 0.

Bottom line for a defendant: There is no PTAB kill shot to point to. The patent is untested at the PTAB, not "hardened." That cuts both ways: the Patent Owner cannot hand you an FWD/§ 315(e)(2) estoppel narrative, but you also get a clean slate — no petitioner has yet framed the early date-of-invention, objective-indicia, or § 112 record that would tell you how the Board reads the claims. The absence of IPRs is not evidence of validity; it is consistent with a patent that is being asserted rarely (or not at all) in litigation. As of the last data ingest, Lions VisionGift has not been shown to be an active serial litigant on this family.

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No proceedings to itemize

Because the canonical list is empty, there is no proceeding block to render. Per the operating rules, I will not manufacture proceeding numbers, panels, or decisions that do not exist. To the extent a petition was filed very recently and is not yet indexed by ODP, my web checks did not surface it — but I cannot rule out a filing made after the most recent ingest, so treat this as "none on file as of ingest, re-verify before relying on it."

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Strategic summary

Claim status. All 27 claims stand as originally issued — none canceled, none narrowed, none disclaimed. Independent claim 1 (viewing chamber + body + lid, corneal tissue carrier removably coupled to an inner portion of the body), independent claim 18 (carrier + first cap/plug + second cap/plug), and independent claim 23 (method: obtaining a corneal tissue sample, disposing it in an inner cavity of a carrier, coupling the carrier to an inner portion of a viewing chamber) are the assertion targets. Claims 2–17 depend from claim 1; 19–22 from claim 18; 24–27 from claim 23. Every claim is currently "untested" rather than "sustained" — there is a difference, and you should not let an FWD-free record be characterized as surviving review. Note that the published application (US 2018/0143109 A1) shows a slightly different claim set (e.g., claim 16 reciting a "KROLMAN™ viewing chamber") than the patent as granted, so use the granted claim text as the operative scope.

Estoppel landscape. With no IPR/PGR ever instituted, § 315(e)(2) estoppel attaches to nobody. There is no petitioner-privity chain, no estoppel-based restriction on which prior-art combinations a defendant can raise in district court, and no "reasonably could have raised" floor to work around. Conversely, the Patent Owner has not had to defend these claims at the Board, so there is no PTAB claim-construction precedent binding anyone — you would be litigating claim scope (e.g., what "removably coupled to an inner portion," "about 38 mm," and "inhibits passage of the corneal tissue sample" mean) from scratch, likely before a district court under Phillips.

Pattern signals. No serial-petitioner pattern (no petitioner has filed anything). No defensive aggregator (Unified Patents or similar) appears anywhere in the record for this patent. No PTAB-to-CAFC appeal activity. The Patent Owner, Lions VisionGift (now associated with Lions World Vision Institute), presents publicly as a nonprofit eye bank that licenses the "Patient Ready DMEK™" technology selectively rather than as an enforcement-driven NPE — which is a plausible explanation for the thin assertion history, though it does not affect your legal position.

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Recommended next steps

• If you are a defendant being asserted against: you have a genuinely open § 102/§ 103 runway. With no estoppel and no prior PTAB constructions, an IPR petition is available on any art you can find, and it will be a first-instance proceeding — the Board will have no prior record to defer to. Because the priority chain is U.S. provisional 62/407,930 (2016-10-13) → Ser. No. 15/660,004 (2017-07-26) → Ser. No. 15/874,789 (2018-01-18, the continuation that issued), verify conception/reduction-to-practice dates against your best art, since DMEK preloading practice (Straiko modified Jones tube use, Krolman chamber evaluation) was published well before the 2016 priority date (e.g., Tran KD et al., Cornea 2017;36:484-490, and the Schallhorn et al. Cornea 2016;35:377-382 work cited in the specification). Public-use/on-sale and printed-publication art from the eye-banking literature is worth a full prior-art search.
• Trial-stage milestones: none applicable — no trial has been instituted, so there is no 1-year § 316(a)(11) FWD clock, no institution-decision deadline, and no hearing date to track. If you file, the ordinary IPR timeline applies: institution decision within 6 months of the petition's filing date, FWD due within 12 months of institution.
• If you are relying on the PTAB record to defend: say it plainly to your client and the court — there is no PTAB activity on US 10041865. Do not represent that the claims "survived" IPR or that any claim has been invalidated. Whether the patent has been litigated at all is unconfirmed on the record I could reach; the absence of PTAB challenges is a neutral data point, not proof of strength or weakness.

Verification links (none of which currently show a proceeding for this patent):

• Google Patents — https://patents.google.com/patent/US10041865/en (no PTAB/review events listed)
• USPTO PTAB Decisions search — https://developer.uspto.gov/ptab-web/#/search/decisions
• PTAB E2E / PTActs public portal — https://ptacts.uspto.gov/ptacts/
• Justia patent page — https://patents.justia.com/patent/[10041865](/patent/10041865)

Caveat: My confirmation rests on the ODP structured data plus public web sources reachable in this session. I did not obtain a live PTAB E2E docket dump for this patent number. If a petition is filed between the last ingest and now, it would not appear in the above. Re-run the ODP "PTAB proceedings" endpoint immediately before relying on this in a filing or client memo.

I'll research the assignment record and associated legal events for US 10041865 before reconstructing the chain.

US 10041865 — Ownership & Assignment Reconstruction

Patent: US 10041865 B2 — Corneal tissue sample assemblies and related methods of use
Inventor of record: Khoa D. Tran
App. No.: 15/874,789 (continuation of 15/660,004; priority to prov. 62/407,930)
Filing date: 2018‑01‑18 · Issue date: 2018‑08‑07 · Anticipated expiration: 2037‑07‑26 · Status: Active

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Inventors

Unusual patterns: None. Single-inventor patent; no evidence of inventors departing the original assignee near filing; the inventor's identity and the assignee's research program (DMEK graft processing) are consistent throughout LVG's publications. No "fire‑sale precursor" pattern.

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Original assignee

Lions VisionGift (styled "Lions VisionGift"; operating brand "VisionGift"; abbreviated LVG).

• Entity type / business: 501(c)(3) nonprofit eye bank, founded 1975 by the Lions Clubs of Oregon. HQ: 2201 SE 11th Ave., Portland, OR 97214; satellite: 27‑43 Wormwood St., Suite 100, Boston, MA ("Lions VisionGift East"). FDA‑registered and Eye Bank Association of America (EBAA)‑accredited. Line of business: recovery, processing, evaluation, and distribution of donor ocular tissue for corneal transplantation, research, and surgical training.
• Product embodying the claims: Yes. LVG commercializes the claimed assembly under its Patient Ready DMEK® / EDS™ (Endothelial Delivery System) processing program — a Straiko modified Jones tube tissue carrier held in a standard corneal viewing chamber, with the graft pre‑loaded, pre‑stained and pre‑punched, and evaluated by slit‑lamp and specular microscopy while still inside the carrier. LVG charges a pass‑through processing fee for EDS. This is a direct commercial implementation of the claimed "viewing chamber + corneal tissue carrier + corneal tissue sample" assembly.
• Current status: Operating. Active 501(c)(3) with ongoing operations in Portland and Boston (reporting activity through 2025). No bankruptcy, acquisition, or dissolution found. Note: LVG separately holds a patented e‑beam corneal preservation method (reported in CRST Europe, Feb. 2021) — a different family from US 10041865.

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Assignment timeline

Finding: No post‑issuance assignment is recorded for US 10041865. The Google Patents legal‑events record for this patent lists only prosecution events — Application filed by Lions Visiongift (2018‑01‑18), Priority to US15/874,789, Publication of US20180143109A1 (2018‑05‑24), Application granted / Publication of US10041865B2 (2018‑08‑07), Status: Active, Anticipated expiration 2037‑07‑26 — with no assignment, security agreement, merger, change‑of‑name, license, or release entries, and with "Current Assignee" identical to "Original Assignee" (Lions Visiongift).

That means:

• The only ownership instrument reflected in the public record is the initial inventor→Lions VisionGift assignment made at filing (no reel/frame for a post‑issuance transfer exists).
• There is no recorded chain — no shell LLC, no intermediary, no asserter.

Reel/frame disclosure and verification: I could not retrieve a specific reel/frame number for even the initial assignment; the Assignment Center screen was not directly accessible in this session, and Google Patents does not surface the reel/frame for the original filing assignment. Per the Assignment Center's own published guidance, recording a document does not always auto‑populate the assignment field, so an unlisted assignment cannot be entirely excluded — but no evidence of any transfer away from Lions VisionGift exists. Verify directly at https://assignmentcenter.uspto.gov/ (legacy index: https://assignment.uspto.gov/patent/index.html) using patent number 10041865.

Because there is no post‑issuance assignment chain, the timeline below is a prosecution/ownership-event chain only (no conveyancing links).

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Timeline diagram

timeline
    title Ownership of US 10041865
    2016 : Priority provisional filed
    2017 : Parent application filed
    2018 : Continuation application filed
         : Patent issued to Lions VisionGift
    2037 : Anticipated expiration

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NPE / troll-pattern signals

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Verdict

Insufficient data — only the original assignment exists.

Justification: The record shows a single ownership event — the original inventor→assignee interest to Lions VisionGift at filing — with no post‑issuance assignment, security interest, or transfer of any kind (Google Patents legal events for US 10041865, filed 2018‑01‑18, issued 2018‑08‑07; current assignee identical to original assignee). Every NPE/privateering signal (1–8) is not present, and the sole owner is an operating 501(c)(3) eye bank that commercializes the claimed assembly as its Patient Ready DMEK® / EDS™ product line — an operating‑entity profile, not an NPE profile. The verdict is "Insufficient data" rather than "Operating‑company assertion" only because that category requires evidence of the owner suing actual competitors, and no litigation naming this patent was found; if forced to characterize the chain affirmatively, it is plain operating‑nonprofit ownership with no monetization‑entity overlay.

Verification link: https://assignmentcenter.uspto.gov/ (search patent 10041865; legacy: https://assignment.uspto.gov/patent/index.html).

Caveat: I could not open the Assignment Center record directly in this session, so the "no post‑issuance assignment" finding rests on the Google Patents legal‑events record and the identity of original and current assignee. No reel/frame numbers should be inferred — none were found.

I'll search for the specific patent number and its cited prior art references.

Prior-Art Analysis — U.S. Patent No. 10,041,865 B2

Important methodological caveat up front. I was able to reach the patent record and the "Referenced Cited" (face-of-patent citation) data, but I was not able to pull the complete machine-readable (56) reference table — i.e., the full "Patent Citations" grid on Google Patents or the USPTO Patent Public Search "References Cited" field. Everything below distinguishes (a) confirmed citation data from (b) references I could identify from the specification/claim text and (c) items I could not verify in this session. I have not invented titles or subject matter for any reference I could not confirm. Where I lack verified content for a cited reference, I say so explicitly and give a conditional §102 analysis rather than a fabricated one.

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1. Record verification (literal identifiers)

Contradiction check against the previously generated litigation section: none. That section correctly flagged US 10,481,051 B2 as a separate Lions Visiongift patent with the same title and the same Oct. 13, 2016 priority family — the search results confirm this (Google Patents family table lists "US15/874,789 Continuation US10041865B2 … Corneal tissue sample assemblies and related methods of use" and cross-lists US20180106704A1 and US10481051B2). It is not the subject of this analysis and its citations are not the '865 citations.

Priority-law note that governs the whole analysis: because the effective filing date is Oct. 13, 2016, this is an AIA patent — prior art is measured under 35 U.S.C. §102(a)(1) (patented, described in a printed publication, in public use/on sale, or otherwise available to the public before Oct. 13, 2016) and §102(a)(2) (U.S. patents/applications effectively filed before that date), subject to the §102(b)(1)/(b)(2) exceptions.

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2. The claims that control the prior-art analysis

For §102 purposes, only the independent claims matter as anticipation targets. They read (per US 2018/0143109 A1, same specification/claims):

• Claim 1 — "An assembly for storing and evaluating corneal tissue, the assembly comprising: a viewing chamber comprising a body and a lid; and a corneal tissue carrier removably coupled to an inner portion of the body of the viewing chamber."
• Claim 19 — "A corneal tissue sample assembly, comprising: (i) a corneal tissue carrier comprising an inner cavity, a first opening disposed at a first end … and a second opening disposed at a second end; (ii) a first cap or plug; and (iii) a second cap or plug, wherein the first cap or plug is removably coupled … at the first opening and the second cap or plug …"

Dependent-claim hooks of interest: 14 (plurality of resilient arms on the inner surface of the body holding the carrier), 15 (substantial transparency of both chamber and carrier), 16 (Krolman chamber), 17 (Straiko modified Jones tube), 18 (carrier length ~38 mm), 6–11 (cap/plug permeable vs. sealing).

Bottom line on the claim architecture: independent claim 1 is broad — "viewing chamber (body + lid)" plus "carrier removably coupled to an inner portion." The novelty hook is the internal, removable coupling (the arms 115), not the existence of a chamber or a tube per se. That framing is important because the '865 specification itself contains applicant statements that a Jones tube "can fit into a KROLMAN™ viewing chamber" and that "as many eye banks use KROLMAN™ viewing chambers, additional modifications to eye banks' procedures may not be required" — i.e., an admission of a known combination that is usable as evidence of what a POSA already knew (and thus strong §103 fuel even if not §102 art).

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3. Cited patent documents (confirmed citation data)

The face-of-patent "Referenced Cited" listing (Justia mirror of the (56) references) shows the following patent documents (source: https://patents.justia.com/patent/10041865). I reproduce them literally and do not auto-correct them:

Honest disclosure: I recognized the citation strings and dates as they appear on the record, but I could not retrieve and read the text of these four documents within this search session. I am therefore not asserting what each discloses. The "brief description" requested cannot be responsibly supplied for P1–P4 without fabrication, which the operating rules forbid. What I can state with confidence is their §102 status and the claim chart they would have to satisfy:

Conditional §102(a)(1) analysis (to be completed against the actual texts):

• P1 (US 6,605,093, Blake, 2003). Qualifies as §102(a)(1) art on its face (granted >1 year before the Oct. 13, 2016 priority). To anticipate claim 1, it must disclose all three elements: (i) an assembly for storing/evaluating corneal tissue, (ii) a viewing chamber having both a body and a lid, and (iii) a tissue carrier removably coupled to an inner portion of the body. If Blake discloses only an implant/lens carrier in a threaded vial — a common configuration in this space — it reaches (i) and (ii) but likely fails (iii) because the carrier is seated in the vial mouth/stopper rather than coupled to an inner portion of the body. Confidence in anticipation of claim 1: LOW–UNKNOWN. As to claim 19, a storage device with a two-ended carrier plus end caps is a closer structural fit; this is the claim I would expect P1 (and P4) to attack first.
• P2 (US 2009/0270876 A1, Hoffmann et al., 2009). §102(a)(1) art on its face. Same claim-chart test as above; no verified disclosure.
• P3 (US 2010/0256651 A1, Jani et al., 2010). §102(a)(1) art on its face. Same test; no verified disclosure.
• P4 (EP 2 533 724 A1, Nov. 2011). §102(a)(1) art on its face (foreign published application). Same test; no verified disclosure.

Two structural inferences I can draw from the citation set itself (these are inferences about prosecution, not about disclosure):

1. The patent portion of the cited art is thin (four documents), while the non-patent literature portion is very large (see §4). That pattern is typical of a case where the applicant's IDS was dominated by scientific literature and the examiner located little close patent art — consistent with the broad, apparatus-level claim 1 issuing over this record.
2. Nothing in the confirmed patent-art list is an obvious single-reference §102 "X" hit against claim 1, because a single document would need to disclose the internally coupled carrier. The likely rejection posture (if any) was §103 over a chamber reference in view of a carrier reference.

Recommended verification step (30 seconds each): open the "Patent Citations" table at https://patents.google.com/patent/US10041865B2/en and confirm (a) whether any further US/foreign patent documents were cited that are missing from the Justia mirror, and (b) whether each entry is flagged cited by applicant vs. cited by examiner. In the USPTO Patent Public Search / PatentCenter "References Cited" view for App. 15/874,789, the same list is authoritative.

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4. Cited non-patent literature (the material art)

The (56) record is dominated by printed publications. Under §102(a)(1) these are prior art only if publicly available before Oct. 13, 2016; several listed items are the inventors' own 2016–2017 work and may fall inside the §102(b)(1)(A) grace-period exception (disclosures made ≤1 year before the effective filing date by the inventor or one who obtained the subject matter from the inventor).

Confirmed citations from the record (as listed):

Additional literature named in the '865 specification body but that does not appear in the Justia "Referenced Cited" snippet (cross-check these against the authoritative (56) list — their presence in the specification, without an IDS entry, would be a prosecution/hygiene flag, and each is independently §102(a)(1) art if published before the priority date):

• Price M O, et al., Int. Ophthalmol. Clin. 50:137–147 (2010)
• Tourtas T, et al., Am. J. Ophthalmol. 153:1082–1090 (2012)
• Schallhorn J M, et al., Cornea 35:377–382 (2016) — highly material: describes injecting DMEK scrolls into a viscoelastic bed and unfurling; explicitly relied on by the '865 to establish the injector-mediated handling step.
• Terry M A, et al., Cornea 34:845–852 (2015) — highly material: the Straiko-injector assembly protocol (Jones tube + French catheter + syringe) that the '865 "corneal tissue carrier" is.
• Veldman P B, et al., Cornea 34:1175–1178 (2015) — DMEK stripping/preparation.
• Tran K D, et al., Cornea 36:484–490 (2017) — attribution flag: this is the inventor's own preprint-adjacent publication on preloading. Published after the Oct. 13, 2016 priority date, it is not §102(a)(1) art; and if it is the inventor's own disclosure it is separately excepted under §102(b)(1)(A) anyway.

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5. §102 mapping — claim-by-claim summary

Key legal point for the record: dependent claims 16 and 17 recite the very commercial products named in the specification (Krolman chamber; Straiko modified Jones tube). Those products are, on the face of the '865's own text, pre-existing third-party/eye-bank devices. This is the classic §102(a)(1) public-use / otherwise-available-to-the-public exposure for the narrow claims, and the reason claim 1 was drafted at the broad "body + lid + removably coupled carrier" level rather than at the product level.

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6. Related documents that are family members / forward citations, NOT prior art

Do not treat these as §102 art:

• US 2018/0106704 A1 — the parent application publication (15/660,004). Same family.
• US 2018/0143109 A1 — the '865's own pre-grant publication.
• US 10,481,051 B2 — same-family Lions Visiongift patent, same title, same Oct. 13, 2016 priority.
• US 11,094,064 B2 — forward citation: lists "10041865 | August 7, 2018 | Tran" in its Referenced Cited table. The '865 is prior art to it, not the reverse.
• US 2021/0045863 A1 ("Corneal Graft Assemblies for Improved Surgical Operations") — forward citation of US10041865B2.
• WO 2023/239870 A1, EP 4 039 475, US 10,627,649, US 8,621,521, US 10,969,412, US 7,992,906, US 4,334,736, US 4,054,646, EP 1 981 437 B1, WO 2005/013850, WO 2004/034129, WO 2003/009789, EP 3 244 855 B1, WO 98/53774, US 5,632,757, US 5,658,303, US 4,198,132, WO 94/17851 — these surfaced in my searches but belong to unrelated patent families (intraocular lenses, femtosecond lasers, ophthalmic imaging, absorbent articles, 3D bioprinting, etc.). They are not citations of the '865 and must not be attributed to it.

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7. Bottom line

1. Patent art on the face of the '865 is sparse and only four documents: US 6,605,093 (Blake, 2003‑08‑12), US 2009/0270876 A1 (Hoffmann et al., 2009‑10‑29), US 2010/0256651 A1 (Jani et al., 2010‑10‑07), and EP 2 533 724 A1 (2011‑11). All four are §102(a)(1)-eligible on their dates.
2. I could not verify the disclosures of those four references in this session, and I am not supplying invented summaries of them. Their §102 viability turns on whether any one of them discloses a tissue carrier removably coupled to an inner portion of a lidded body (claim 1) or a two-ended carrier with first and second caps/plugs (claim 19).
3. The denser, and probably more dangerous, art is the cited non-patent literature — especially Parekh et al. 2016, Terry et al. 2015, Schallhorn et al. 2016, Holiman et al. 2015, and Majmudar 2016 — plus the EBAA Medical Standards, which supply the "storing and evaluating" motivation recited in claim 1. Watch the §102(b)(1)(A) grace-period exception for the inventor's own 2016–2017 publications (Tran et al., Cornea 36:484–490, 2017).
4. No single confirmed reference anticipates claim 1. The distinguishing feature appears to be claim 14 (resilient arms on the inner surface of the body releasably holding the carrier); claims 16–17 (Krolman chamber; Straiko modified Jones tube) are the narrow claims most exposed to §102(a)(1) public-use art.
5. To close the gaps, pull the authoritative list directly: https://patents.google.com/patent/US10041865B2/en ("Patent Citations" table) and the PatentCenter "References Cited" for App. 15/874,789. If you want, I can then run the per-reference §102 element-by-element chart against claims 1 and 19 using the actual texts — which is the step I could not complete here without fabricating content.

I'll analyze the obviousness of US 10,041,865. First, let me verify the actual claim language and identify prior art references, since the claims section wasn't included in the provided full text.

Let me retrieve the actual claim set and the cited prior-art references for the '865 patent.

Let me retrieve the exact granted claims of the '865 patent and confirm the key prior-art references cited on its face.

Obviousness Analysis — U.S. Patent No. 10,041,865 B2

("Corneal tissue sample assemblies and related methods of use") under 35 U.S.C. § 103

Analysis date shown as April 26, 2026. Builds on the earlier litigation section; no contradiction found between that section and the technical record here (the earlier note that U.S. 10,481,051 B2 is a same-title, same-priority sibling is consistent with the family data retrieved below).

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0. Important scope caveats (read first)

• The provided full text of the '865 patent does not include a claims section. The Google Patents scrape supplied above ends within the Detailed Description. I therefore reconstructed the claims from the published family members and secondary sources (Justia, FreePatentsOnline, Google Patents family pages). The granted claim set of the '865 patent itself could not be independently re-verified in this session, so all claim language below should be treated as representative and re-confirmed against the printed patent (US10041865B2, cols. 1–2 of claims) before being relied on.
• The claim text I could retrieve comes from the closely related publications US 2018/0143109 A1 (the '865's own publication) and US 2018/0106704 A1 (a same-family publication). These share one specification, so the representative claims below are highly likely, but not certain, to match the '865 grant. Flagged as a potential discrepancy: the "claim 1…claim 26" set quoted below is labeled "patent/20180106704" in the source, not "20180143109." Verify numbering.
• "Prior Art section of this page": no discrete prior-art list was supplied in the user message. I have grounded this analysis on (a) the references cited on the face of / in the body of the '865 patent (its own Background section), and (b) the admitted prior art the '865 specification expressly names (the Straiko modified Jones tube, Jones tube, KROLMAN™ viewing chamber, OPTISOL™-GS). Where I rely on a reference not literally named in the patent, I say so.

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1. Governing law and framework

• 35 U.S.C. § 103 (AIA version applies — the '865 has an effective filing date of Oct. 13, 2016, via continuation Ser. No. 15/660,004 (filed Jul. 26, 2017) and provisional 62/407,930 (filed Oct. 13, 2016)).
• Graham v. John Deere, 383 U.S. 1 (1966): scope/content of prior art; differences; PHOSITA level; secondary considerations.
• KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007): combination of known elements, each performing its known function, is likely obvious; predictable variation and "obvious to try" are relevant; a motivation can come from the problem to be solved, design incentives, market demand, or common sense — not only from the references' text.
• In re Keller / In re Merck: a reference must be read for what it fairly teaches; it need not be physically combinable as printed.
• All asserted references must qualify under § 102(a)(1) (patented, described in a printed publication, or in public use before the effective filing date) or § 102(a)(2) (earlier-effective U.S. application publication).

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2. Person of ordinary skill in the art ("PHOSITA")

A PHOSITA for this art is a person with a bachelor's degree in biomedical/mechanical engineering, ophthalmic device design, or a life-science field, or an ophthalmologist/eye-bank technician, with ~2–4 years of experience handling and processing corneal tissue (Descemet membrane endothelial keratoplasty, "DMEK") and designing/procuring the associated carriers and viewing chambers — including familiarity with Eye Bank Association of America (EBAA) Medical Standards (2016) requiring slit-lamp and specular-microscopy evaluation of eye-bank-prepared grafts. This person knows the off-the-shelf Straiko modified Jones tube, the KROLMAN™ viewing chamber, and OPTISOL™-GS storage medium.

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3. Representative claim scope (reconstructed)

The common inventive core across all independent claims is therefore narrow: a fluid-filled viewing chamber (body + lid) that holds a clear corneal tissue carrier (a tube) in which a rolled corneal graft sits, so the graft can be imaged through both the tube and the chamber.

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4. Prior art references (all qualifying § 102(a)(1) unless noted)

Not prior art: Tran KD et al., Cornea 2017; 36:484–490 — published after the Oct. 13, 2016 priority date and authored by the inventor and co-workers, so it is neither § 102(a)(1) nor § 102(a)(2) art. The prosecution-facing "prior art" is the fully pre-Tran record above.

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5. The differences over the art are small; the combination is a predictable arrangement

Claim 1 differs from KROLMAN-149 in a single respect: KROLMAN-149 cradles a whole corneoscleral disc on the prongs, whereas claim 1 places a corneal tissue carrier (tube) in the chamber and couples the carrier to the inner portion. Everything else in claim 1 — clear body, lid, preservation fluid, inner portion capable of supporting a specimen, imaging capability — is disclosed by KROLMAN-149.

Claims 17 & 18 (arms; transparency) read directly on KROLMAN-149's radial prong basket and clear PMMA construction, and on KROLMAN-809's prong geometry. The only variation is dimensioning the prong spacing to retain a ~35 mm × ~5.8 mm glass tube (the '865's own admitted tube dimensions) instead of a 17–22 mm disc — a matter of routine dimensioning for the size of the article to be held, not an inventive step. In re Rose, 220 F.2d 459 (CCPA 1955) (change of size is obvious absent a new/unexpected result).

Claim 5 (first opening → fluid communication) is met by any open-ended tube; the tube's open distal lumen and the prongs' inter-prosthetic gaps (KROLMAN-809) put the interior in fluid communication with the chamber.

Claims 9 & 14 (caps/plugs that keep the graft in but pass fluid) are taught by TISSUE-CONTAINER's "adaptor configured to prevent migration of the corneal tissue graft out of the interior region of the tissue container," and by GRAFT-ASSEMBLY's capped/sealed holding member. The motivation is concrete: the '865's own shipping study reports a graft falling out of the tube (50.4% ECL) — an express, recognized reason to add a retaining cap.

Claims 2 & 16 (sample in cavity; preservation fluid) are the very point of GRAFT-ASSEMBLY (a rolled, preformed graft held in refrigerated storage with fluid) and of the admitted Straiko-tube practice.

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6. Specific § 103 grounds (combinations and motivations)

Ground A — KROLMAN-149 + STRAIKO/TERRY-2015 (optionally + SCHALLHORN-2016) ⇒ claims 1, 2, 5, 16, 17, 18

Proposed combination: modify the Krolman viewing chamber (or equivalently use it as-is) by placing the known Straiko modified Jones tube (admitted prior art) — containing a scrolled DMEK graft in OPTISOL™-GS — in the chamber's prong cradle.

Motivation (KSR-recognized):

1. Same field, same problem. Both references address storing/protecting corneal endothelium in a fluid-filled sterile container; the claimed combination uses each element for its known function (chamber = sterile fluid reservoir + imaging window; tube = convenient, atraumatic carrier/injector for a scrolled graft).
2. Regulatory driver. EBAA 2016 Medical Standards required slit-lamp + specular evaluation of every eye-bank-prepared graft. A graft already loaded in a glass injector cannot readily be re-inspected; the chamber's viewing windows plus the tube's transparency solve exactly that problem. This is a problem-driven motivation squarely within KSR.
3. Predictable result. Transparent tube inside a transparent chamber yields an inspectable, immersed specimen — the ordinary, expected consequence of the known elements' known properties.
4. No new cooperation. The tube and chamber do not cooperate in any unexpected way; the tube merely rests where the cornea formerly rested. KSR ("familiar elements according to known methods").

Ground B — TISSUE-CONTAINER (US 2009/0270982) + GRAFT-ASSEMBLY (US 8,673,002 / EP 1 981 437) ⇒ claims 1, 2, 5, 16

Proposed combination: an open-ended tubular tissue container that receives a rolled graft inside a transport member chamber holding transplant medium (TISSUE-CONTAINER), used with the preformed-rolled, pre-loaded graft concept (GRAFT-ASSEMBLY).

Motivation: TISSUE-CONTAINER already explicitly discloses the claimed architecture — "a transport member defining an interior chamber containing an optical transplant medium and configured to receive the tissue container and adaptor" (claim 14). That is functionally a viewing/transport chamber containing a tissue carrier immersed in medium, i.e., claim 1/2/16 verbatim but for the rigid "lid + inner portion removably coupled" phrasing. GRAFT-ASSEMBLY supplies the express teaching of pre-loading the rolled graft and keeping it ready-for-surgery in refrigerated storage, supplying the "removably coupled" and "sample disposed in the carrier" limitations. The combination would be the ophthalmic-device designer's obvious response to the desire to transport an already-loaded graft.

Ground C — Ground A or B + caps ⇒ claims 9, 14

Add the migration-preventing adaptor/cap of TISSUE-CONTAINER (or the sealing cap of GRAFT-ASSEMBLY). Motivation: the documented risk of a graft escaping the carrier during shipping (the '865 shipping study; ~10% failure rate in the first series), plus the need to keep the medium circulating (mesh/aperature cap). Expectation of success: high — mesh/permeable closures for biological specimens were conventional.

Ground D — TERRY-2015 + SCHALLHORN-2016 + EBAA Standards + KROLMAN-149 ⇒ method claims 19, 20, 22, 23, 26

Motivation: the sequence "obtain graft → load into carrier → store in medium → image by slit-lamp/specular → compute ECD/ECL" is the routine, established eye-bank workflow recited across TERRY-2015, SCHALLHORN-2016, the EBAA standards, and the '865's own conceded practice. Merely adding the step of placing the loaded carrier into the known viewing chamber is an obvious, predictable variation. The method claims add no step that is not a known eye-bank procedure; the only new element is the chamber, addressed in Ground A.

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7. Why these are obvious, not merely aggregated

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8. Anticipation (just to delimit § 103 from § 102)

• US 2009/0270982 A1 is the closest single reference and arguably anticipates the substance of claims 1/2/5/16 if its "transport member … interior chamber … receive the tissue container" is read as the claimed "viewing chamber," and its tissue container as the "carrier." Whether it discloses a "lid" and "removably coupled to an inner portion" (claim 1's wording) determines anticipation vs. obviousness. On the record I retrieved, it discloses a container that receives the carrier rather than coupling to it — so I would plead this reference primarily as § 103 art, with anticipation available as a fallback if the "receive = couple" and "lid" limitations are met.
• KROLMAN-149 alone does not anticipate claim 1 (no tubular carrier; no graft-in-tube), but it supplies nearly every other limitation.

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9. Secondary considerations (Graham factor 4)

Available to the patentee, with nexus caveats:

• Long-felt, recognized need / first-to-solve: The '865's own specification and the Tran 2017 paper state that post-processing evaluation of preloaded tissue was previously impractical ("to the best of our knowledge, this is the first example of practical post-processing evaluation of preloaded tissue for DMEK"). If the claims are limited to the chamber-plus-carrier assembly enabling such evaluation, this can support nonobviousness.
• Commercial success: Lions VisionGift commercialized the "Patient Ready DMEK™" service claiming >1,500 transplants and licensing to other eye banks (visiongift.org press release, Aug. 1, 2018). Nexus is the vulnerability: success arguably flows from the validated processing/loading method and eye-bank service, not necessarily from the assembly claims per se.
• Unexpected results — essentially absent. The '865's data show preloaded grafts had higher ECL than pre-stripped-only grafts (16.8% ± 5.9% vs. 9.3% ± 5.9%, p<0.01) and that ~10% of shipped grafts escaped the carrier. These data show feasibility within acceptable limits and even a design deficiency (grafts falling out — the motivation for the caps), not a surprising technical effect that would rebut obviousness of the assembly. Expect a § 103 challenge to argue there is no unexpected result.
• Copying / industry praise: the WO 2017/214022 background independently describes the same unmet need and the same Straiko-tube-based preloaded workflow, which is evidence that the approach was recognized in the art, not remote from it — cutting against nonobviousness.

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10. Bottom line

On the retrieved record, U.S. 10,041,865 B2 is vulnerable to a § 103 rejection, principally via:

1. KROLMAN-149 (viewing chamber) + Straiko modified Jones tube / TERRY-2015 (admitted carrier) [+ SCHALLHORN-2016, EBAA standards] ⇒ claims 1, 2, 5, 16, 17, 18 and method claims 19, 20, 22, 23, 26; and
2. US 2009/0270982 A1 (tissue container within a transport chamber) + US 8,673,002 / EP 1 981 437 (preformed, pre-loaded rolled graft) ⇒ claims 1, 2, 5, 9, 14, 16.

The stated motivation — enabling mandatory post-processing slit-lamp/specular evaluation of a pre-loaded graft using the clear injector's and chamber's known transparency, while reducing OR time and avoiding graft loss — is a classic problem-driven motivation under KSR. No secondary consideration appears strong, and the specification's own data show an expected (indeed slightly worse) ECL outcome rather than an unexpected effect.

Confidence and open items:

• High confidence on the identity and dates of the prior-art references and on the general claim scope.
• Medium confidence on the exact granted claim wording of the '865 (the claims were reconstructed from family publications; a discrepancy between US 2018/0106704 and US 2018/0143109 claim sets is possible — verify before relying).
• To finalize, pull the printed claims of US10041865B2 and the file history (Examiner's cited art / any 102/103 rejections) to see which references the USPTO actually applied; the prosecution record would materially sharpen this analysis. Consider also a Docket Navigator / Lex Machina confirmation of the "no litigation" finding from the prior section.