US 9671318

I'll verify against live sources, then summarize from the authoritative patent text provided.

US 9,671,318 B1 — "Specimen collector"

Verification status: Confirmed against the full granted text (Google Patents, fetched 2026-09-24) and cross-checked against Espacenet bibliographic data and the USPTO/Google patent PDF. No live source I retrieved contradicts the granted text. One minor discrepancy noted below.

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Bibliographic data

Sources: https://patents.google.com/patent/US9671318/en ; https://worldwide.espacenet.com/publicationDetails/biblio?CC=US&NR=[9671318B1](/patent/9671318B1)&KC=B1&FT=D ; https://patentimages.storage.googleapis.com/a8/17/01/49bd13d6befa45/US9671318.pdf

Minor discrepancies (interpreted literally, not auto-corrected):

• Google Patents lists the inventors as "Scott Bedoe; Taylor Ling; James Burgess" while the printed face of the patent lists them in the order "Scott Bedoe; Taylor Ling; James Burgess" — consistent. Espacenet orders them "BURGESS JAMES; BEDOE SCOTT; LING TAYLOR," which is a formatting difference only.
• The legal-events record shows the inventors' assignment effective 2015-11-30, i.e., two days before the 2015-12-02 filing date — a routine pre-filing assignment execution date.
• A Unified Patents portal entry lists a "2015-12-01" date associated with US-9671318-B1; the granted text and USPTO record both give 2015-12-02. I treat 2015-12-02 as authoritative.
• Apparent typographical errors inside the specification (quoted as printed, not corrected): "The outlet port 210 is disposed 'downstream'…" (should read 212), and the method-of-manufacture paragraph says "inserting the sleeve into the tray" (the assembly logic implies the reverse). Claim 12 recites "collecting the specimen from the first tray."

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Abstract (as printed)

"A specimen collector includes a sleeve with one or more interior walls defining a substantially hollow interior cavity. The sleeve further includes an inlet port in fluid communication with the interior cavity and an outlet port in fluid communication with the interior cavity. The sleeve further includes a first side aperture and a second side aperture. The specimen collector also includes a tray slidable within the interior cavity of the sleeve. The tray includes a first specimen well and a second specimen well that alternately may be placed into fluidic communication with the inlet and outlet ports."

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Plain-language overview of the independent claims

Claim 1 (apparatus — the core claim). A specimen collector made of two cooperating parts:

1. a sleeve whose interior wall(s) bound a hollow cavity, and which carries (a) an inlet port open to the cavity, (b) an outlet port open to the cavity, and (c) two side apertures; and
2. a tray that slides inside the cavity and has two specimen wells.
   The tray is movable between a first position, where the first well is in fluidic communication with both the inlet and outlet ports, and a second position, where the second well is instead in that fluidic communication. In essence: a two-chamber shuttle trap that swaps one well into the suction path while the other sits out of it, so a specimen can be retrieved without breaking the suction line.

Claim 10 (method — assembly/provision). A method that consists of providing the same sleeve (cavity, inlet port, outlet port, first and second side apertures) and providing the same slidable two-well tray movable between the first and second positions. This is a "provide the components" claim — it recites no active collecting or suction step.

Claim 12 (method — method of use). A method that: provides the collector of claim 1; applies suction to the outlet port and recovers bodily fluids through the inlet port; upon retention of a specimen in the first well, slides the tray to the second position; and then collects the specimen from the first tray. This is the actual clinical-use claim — the sequence of suction, capture, shuttling the tray, and retrieving the trapped specimen.

Dependent claims of note: 2 and 3 (the inactive well sits exterior to the interior cavity); 4 (inlet/outlet in substantial axial alignment); 5 (side apertures in substantial axial alignment); 6 (wells distributed axially along the tray's central axis); 7 (wells have a porous surface); 8 (each well has a removable screen with a fluid-permeable region); 9 (an orientation surface on the sleeve interior wall maintaining a single rotational orientation of the tray); 11 (placing an end cap on the tray — appended to the claim-10 provision method); 13 and 14 (dependent on claim 12 — sliding exposes the first well exteriorly, and a second specimen is received in the second well followed by sliding back).

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Litigation and PTAB check — what I found and what I did not

• I found no US district court action, PTAB proceeding, or CAFC appeal in 2026 (or any year) asserting or referencing US 9,671,318. Searches for "US9671318 litigation 2026 docket" returned only unrelated matters (Netlist/Micron, VB Assets v. Google, Samsung/XiFi, Agilent v. Axion, Droplets, Wave Sense) — none of which named this patent number. Per your instruction, I am not substituting results for similar-looking numbers.
• Caveat on completeness: I do not have direct, query-able PACER, PTAB (PTAB E2E), or CAFC docket access in this session; I can only run open-web searches. So "no results" here is a tentative negative, not a certification that no such proceeding exists. If you need a defensible litigation clearance, this should be re-run against Docket Navigator, LexMachina, or PACER directly.
• Related-art context that did surface: US 11,821,820 B2 ("Specimen collector including multiple specimen wells," EnTellect Medical Holdings, priority 2020-07-22) appears in the "Cited By" list of the '318 patent family listing and recites a housing with inlet/outlet ports plus first and second specimen wells on a slideable tray — i.e., a later patent in the same technical space. U.S. Patent No. 9,671,318 is also cited on the face of Stryker design patents (e.g., USD930850S1, "Specimen collection tray"). Google Patents lists 15 "Cited By" entries and 66–70 "Citations" (the count differs between the two tables on the page: 66 vs. 70).

Exemplary prior art cited on the face of the '318 patent (relevant if you are assessing validity): US 3,855,997 (Sterile specimen trap, Cinco Medical); US 6,375,625 B1 (In-line specimen trap and method therefor, Scion Valley); US 7,244,236 B2 (Specimen trap with strainer, M D Technologies); US 8,088,079 B2 (Polyp trap, U.S. Endoscopy Group); US 2011/0106029 A1 (Polyp trap, Garren); and the applicant's own US 2015/0359949 A1 (Polyp Filter, Medline Industries, priority 2014-06-17). The single non-patent citation is Yeager, Anna et al., Design U.S. Appl. No. 29/494,106, filed 2014-06-17.

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Uncertainty statement

High confidence on title, inventors, assignee, filing/issue dates, application number, claim count, and claim text — all taken directly from the granted patent text. Moderate confidence on the current chain of title (based on the Google Patents legal-events listing, which is an aggregation and not a legal conclusion). Low confidence / negative finding only on the absence of 2026 litigation, for the access reasons explained above.

I'll research litigation involving US patent 9671318 using multiple searches.

Initial searches didn't surface litigation. Let me try more targeted sources.

Bottom line

I could not identify any litigation — district court or Federal Circuit — involving U.S. Patent No. 9,671,318 ("Specimen collector," Medline Industries, LP, filed 2015‑12‑02, granted 2017‑06‑06, current assignee Medline Industries, LP). I also found no PTAB proceeding (IPR/PGR/CBM) challenging the '318 patent. On the record available to me, the patent appears to have been asserted in no lawsuit.

Treat this as a qualified negative, not a certified one — see the caveats at the end.

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What the searches actually returned

Notably, the Google Patents page for US 9,671,318 lists "Cited By" entries (Stryker, Huronmed, EnTellect Medical Holdings, Keymed, etc.) and "Families Citing this family" entries (A C Hoogerheide, Multi4 AB, Atlanta Scientific). Again, these are citations, not litigation. In particular:

• US 11,821,820 B2 — "Specimen collector including multiple specimen wells," assigned to EnTellect Medical Holdings, cites the '318 patent. This is a citation relationship in a related technical field, not a case, pleading, or judgment.
• Multi4 AB's SE 542926 C2 ("A tissue specimen collector comprising a rack…") and NL 2021759 B1 are foreign family-citing publications, not litigations.

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Litigation that exists but is UNRELATED to the '318 patent

My searches did surface substantial Medline patent litigation — but none of it asserts the '318 patent. I am flagging these expressly so they are not mistaken for '318 cases:

None of these complaints, IPR petitions, or decisions identifies U.S. 9,671,318 as an asserted patent.

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Caveats you should weigh before relying on this

1. Strict-number discipline was applied. Searches for "9,671,318" returned near-misses (e.g., 5,673,318; 8,673,318; D930,850; patent numbers in unrelated Turkish/Chinese academic records). I did not treat these as '318 litigation.
2. Tool limitations. I could not query PACER, Docket Navigator, or Lex Machina directly; Unified Patents' portal is a web application that did not return a machine-readable result for this number. My negative is therefore based on open-web indexing, which can lag or omit newer filings and non-indexed complaints.
3. Post-grant proceedings vs. litigation. A patent can be challenged via PTAB without any district court case. I found no IPR/PGR for the '318 patent, but IPR filings are only reliably confirmed through the PTAB's own PTRC/PatentsView APIs.
4. "Anticipated expiration 2035‑12‑02" (per Google Patents' legal-status assumption) means the patent remains within its enforceable term, so a future assertion case is possible even though none appears today.

Recommended verification before you rely on this in a diligence or clearance opinion: run a full-text PACER docket search on "9,671,318" and a PatentsView/PTAB API query for post-grant proceedings naming the patent, ideally via Docket Navigator or Lex Machina, which index complaint exhibits and infringement contentions that open-web search does not.

If you'd like, I can next pull prosecution-history detail (e.g., the file wrapper and any terminal disclaimers) or compare the '318 claims against the EnTellect and Stryker citations as a freedom-to-operate starting point.

I'll verify the structured "no PTAB activity" block against live sources before reporting.

Let me run a couple more targeted checks — including whether any litigation in this space produced an IPR against the '318 patent.

PTAB / AIA Trial Proceedings — US 9,671,318 B1 ("Specimen collector," Medline Industries, LP)

Source of the proceedings list: the structured "PTAB proceedings on file" block supplied in this prompt, derived from the USPTO Open Data Portal (ODP) API. I treated that block as canonical and then attempted to falsify it by open-web search. I could not falsify it.

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Proceedings overview

There are zero AIA trial proceedings on file for US 9,671,318 — no IPR, no PGR, no CBM, no derivation proceeding — so the breakdown is 0 active / 0 claims-invalidated / 0 claims-sustained / 0 settled / 0 institution-denied; the bottom line for a defendant is that all 14 claims (independent claims 1, 10, 12 and dependents 2–9, 11, 13–14) stand untested and un-narrowed at the Board, which cuts both ways: the patent has not been hardened by a win, but neither has it been weakened, and because no IPR was ever filed there is no § 315(e)(2) estoppel fencing off the prior-art grounds identified in the prior-art section.

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No proceeding entries to report

The canonical structured data returns no AIA trial proceedings for this patent. Accordingly, there is no proceeding number, panel, institution decision, Final Written Decision, settlement, or appeal to report — and per your constraint, I will not invent proceeding numbers to fill the template.

I searched specifically for one and found none. Searches on "9671318" inter partes review PTAB petition, Medline "9,671,318" IPR PTAB challenge specimen collector, and "IPR2024"/"IPR2025" Medline specimen collector polyp trap petition instituted returned only: (a) the patent's own bibliographic and citation records; (b) the EnTellect Medical Holdings US 11,821,820 patent, which cites the '318 patent; and (c) Medline/Bard IPR activity on entirely different patents (see the non-proceedings table below). No hit named U.S. 9,671,318 as a challenged patent.

Caveat on completeness (same limitation flagged in the prior "Litigation summary" section): I have no direct query access to PTAB E2E/P-TACTS or the ODP trial-proceedings API in this session; I can only run open-web searches and rely on the structured block you supplied. Treat "zero proceedings" as a qualified negative — high confidence, given the ODP block plus three independent search formulations agreeing, but not a certified clearance. Verify at:

• PTAB Case Tracking (P-TACTS): https://ptacs.uspto.gov/ptacts-ui/
• USPTO Patent Trial and Appeal Board statistics/decisions: https://www.uspto.gov/patents/ptab
• CourtListener full-text search for the patent number: https://www.courtlistener.com/?q=%229671318%22

Corroborating negative signal: the earlier "Litigation summary" section found no district court or Federal Circuit case asserting the '318 patent either. The absence of an IPR is consistent with the absence of a suit — in the ordinary course, IPRs are filed by defendants served with an infringement complaint, and there is no complaint on record to trigger one.

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Adjacent Medline IPRs — NOT proceedings on the '318 patent (do not confuse these)

These are real, publicly documented AIA proceedings involving the same patent owner (Medline) on catheter-tray patents, surfaced by my searches. They are listed solely to prevent misattribution and to supply pattern signals. None of them concerns US 9,671,318.

Why this matters to a '318 defendant (pattern signals, not holdings): Medline is a practiced PTAB litigant on the patent-owner side — it has defended a multi-patent IPR barrage, prevailed on several claims at the Board, and litigated the resulting appeals through the Federal Circuit. If the '318 patent is ever challenged, the realistic expectation is a well-funded, sophisticated patent-owner defense, not a default adverse judgment. Conversely, Medline is also a frequent PTAB petitioner against Bard (the IPR 2015-005xx series appears in the references of Medline's later filings), so it is fully fluent in PTAB procedure on both sides of the caption.

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Strategic summary

Claim status — everything is UNTESTED. No claim of US 9,671,318 has been canceled, confirmed, or construed by the Board, because no petition has ever been filed. That means the full claim set remains live: independent claim 1 (sleeve with inlet port, outlet port, and first/second side apertures + tray slidable within the cavity carrying first and second specimen wells, movable between first and second positions), independent claim 10 (the "providing a sleeve … providing a tray" assembly claim), and independent claim 12 (the method-of-use claim reciting applying suction to the outlet port, recovering bodily fluids through the inlet port, sliding the tray to the second position upon retention of a specimen in the first well, and collecting the specimen). Dependents 2–9, 11, 13 and 14 are likewise untested. Critically, there is also no reexamination or reissue narrowing the claims on the public record, and no certificate of correction affecting claim scope that I found.

Estoppel landscape — a clean slate for a defendant. Because no IPR was ever instituted, the § 315(e)(2) estoppel bar has never attached to anyone. Practically:

• A defendant is not restricted to art that someone else "raised or reasonably could have raised" in an IPR — that limitation applies only to the petitioner in an instituted proceeding and its privies/real parties in interest, and there is no such petitioner.
• All of the § 103 attack lines mapped in the prior-art section remain fully available in district court: principally US 8,088,079 B2 (U.S. Endoscopy Group — housing in the suction line, sidewall aperture, sliding perforated collection tray, and express teaching of swapping trays to keep the procedure running) combined with US 3,855,997 A (Cinco Medical — selectively alignable members alternately connecting a fluid conduit and a suction conduit) and/or US 5,256,160 A (Mectra — medical device valving mechanism), with US 2011/0106029 A1 (Garren) and US 7,488,312 B2 (Rogers) supplying the removable-screen/porous-surface limitations of claims 7 and 8.
• Because estoppel never attached, a defendant also retains the option of filing a fresh IPR (subject to the usual § 314(a)/§ 325(d) discretion and the Fintiv-type considerations) without the risk that a failed petition has already burned its grounds.
• Timing caveat: the § 315(b) one-year clock has not started for anyone, since (on the record in the prior sections) no complaint alleging infringement of the '318 patent has been served. PGR is unavailable (the 9-month post-grant window from the 2017-06-06 issue date closed in 2017), and CBM is unavailable (AIA § 18 sunset and, independently, this is not a financial-services patent). IPR is the only realistic AIA-trial avenue, and it is currently open to any first mover.

Pattern signals — no troll, no aggregator, no serial petitioner. There is no repeat petitioner against this patent (zero petitions of any kind); no defensive aggregator (RPX, Unified Patents, AST, LOT Network, OIN) anywhere in the assignment chain, per the earlier ownership analysis — so this is not a Unified Patents-funded "kill the troll" campaign; and no indication that the patent owner has ever appealed anything about this patent to the Federal Circuit (there is nothing to appeal). The contrasting data point is that Medline has litigated and appealed other patents vigorously. The overall profile is a dormant, unasserted, un-challenged operating-company patent within a large MedSurg portfolio whose anticipated expiration is 2035-12-02 and whose 4th- and 8th-year maintenance fees are paid — i.e., the patent is alive, maintained, and available to be asserted whenever Medline chooses.

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Recommended next steps

1. State the absence plainly in any opinion you write: "No IPR, PGR, or CBM proceeding has been filed against U.S. 9,671,318; as of 2026-09-29 the patent has never been challenged at the PTAB, and no district court or Federal Circuit decision construing or invalidating any claim exists." Confirm by running the patent number through PTACTS (https://ptacts.uspto.gov/ptacts-ui/) and, if you have a subscription, Docket Navigator / Lex Machina and the PTAB API at https://developer.uspto.gov/api-catalog — the ODP block is the canonical source here, but a diligence-grade opinion should be re-run against those.
2. There is no FWD to link to and no claim-level disposition to quote. Do not represent otherwise in a demand-letter response or an invalidity contentions chart. The only quotable validity-related dispositions in this technology family are the Bard/Medline FWDs and the 2021 Federal Circuit decision on the catheter-tray patents (Nos. 20-1900 et al.) — cite them, if at all, only as context, and label them as unrelated patents.
3. If you are the defendant, the operative advantage is the open estoppel field. Build your invalidity case now, before any IPR is filed by someone else, because (a) the § 315(e)(2) bar cannot be used against you, and (b) the strongest § 103 combination (US 8,088,079 as primary, with a selective-flow reference as secondary, plus the motivation supplied by US 8,088,079's own tray-swap teaching) is still available on both the district-court and PTAB tracks. Note the prior-art section's finding that no reference anticipates any claim — this is an obviousness case, not an anticipation case, so the § 103 motivation/rational-articulation work is where the case will be won or lost.
4. If you are the patent owner or a licensor, the clean PTAB record is a genuine asset: the claims have never been narrowed by the Board, and there is no estoppel-driven constraint on how you characterize them. The prior-art section's Findings 1–3 identify where a future petitioner would likely aim (claims 1, 4, 5, 6 and 12 via US 8,088,079-based combinations), which is the map to pre-emptively address.
5. Reconciliation flag (carried forward from the prior-art section, unresolved): the task header previously stated 2026-04-26 while this session's date is 2026-09-29. I have dated this report 2026-09-29. No PTAB determination above turns on the discrepancy — there are no proceedings either way — but any opinion letter should be dated to the actual date of signature.

I'll verify the assignment records against live sources, focusing on the correspondent-of-record data that Google Patents doesn't surface.

Inventors

Basis for the employer inference (not a verified fact): all three inventors executed an "ASSIGNMENT OF ASSIGNORS INTEREST" in favor of Medline Industries, Inc. with an execution date of 2015-11-30 — two days before the 2015-12-02 filing — which is the signature pattern of an employee invention-assignment agreement. All three reside in Lake County, Illinois, within commuting distance of Medline's Mundelein, IL headquarters. No employment agreement, W-2, or deponent testimony is in the record, so I am not asserting employment as a documented fact.

Unusual patterns — none detected. Specifically, there is no evidence any inventor departed the assignee within 12 months of filing, no co-inventor with a distinct (e.g., non-employee) assignor entity, and no re-assignment or reversion by an individual inventor. The pre-filing execution date (2015-11-30) is routine and consistent with an in-house capture program, not a portent of a fire-sale. The previously generated "Patent summary" already flagged the "effective 2015-11-30 vs. filed 2015-12-02" gap; this section confirms that gap is explained by the execution/recording distinction and is benign.

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Original assignee

Medline Industries, Inc. (Northfield / Mundelein, Illinois), a corporation of Illinois — assignee of record on the issued patent via Reel 037193/Frame 0170.

• Primary line of business: Medline is the largest privately held (now publicly listed) US manufacturer and distributor of medical-surgical products — exam gloves, gowns, sterilization wraps, wound care, specimen-collection and endoscopy consumables, and OR/patient-care products. This patent sits inside that consumables portfolio, not in a licensing arm.
• Did it ship a product embodying the claims? Yes — with high commercial confidence, but no in-record proof. The '318 patent claims a two-well sliding specimen collector (a polyp trap) for use in-line in a polypectomy suction circuit. Medline's own cited prior publication, US 2015/0359949 A1 ("Polyp Filter," filed 2014-06-17, Medline Industries, Inc.), plus the companion design application of (Yeager, Design U.S. Appl. No. 29/494,106, filed 2014-06-17) — the patent's only non-patent citation — show Medline was actively commercializing polyp-collection hardware in this exact window. That is strong circumstantial evidence of a shipped product line. I have not verified a specific SKU/catalog number, so treat "ships a product embodying the claims" as likely but unverified.
• Current status: Operating, and now publicly traded (moderate-to-high confidence). Medline Industries, Inc. converted to Medline Industries, LP (Delaware) effective 2021-09-07. That conversion coincided with the October 21, 2021 financing recorded at the USPTO (see timeline) — the acquisition/recapitalization of Medline by a private-equity consortium. Medline's registration statement on file at SEC CIK 2046386 (Exhibit 10.26, the Notes Security Agreement, publicly available at sec.gov) confirms the corporate structure: Medline Intermediate, LP (Holdings) and Medline Borrower, LP (successor by merger to Mozart Debt Merger Sub Inc.), with Medline Inc. as the parent. I identify no dissolution, insolvency, Chapter 7, or Chapter 11 event for the original assignee — the bankruptcy/fire-sale signal is affirmatively negative.
• Not a holding company. Medline Industries, LP is the operating borrower/grantor under the Credit Agreement and Indenture, not a licensing special-purpose vehicle. Its address of record is One Medline Place, Mundelein, IL 60060.

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Assignment timeline

Scope note: the Google Patents legal-events record for US 9,671,318 contains nine entries, but only five are assignment-type ("AS") records. The other four (FEPP 2016-12-05; STCF 2017-05-17; MAFP 2020-12-07; MAFP 2024-12-06) are fee/status events with no assignor or assignee and are excluded below and noted separately.

Correspondent-of-record — data gap, disclosed up front. The assignment records as served by Google Patents carry no correspondent field. I attempted to retrieve the correspondent attorney/firm for each reel from the USPTO Assignment Center and third-party mirrors; I was unable to retrieve the correspondent for any of the five recordings in this session, and my search budget was exhausted on the attempt. I am therefore not supplying a correspondent name below. See "NPE signal 3" for what this does and does not support.

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1. 2015-11-30 (executed) / recorded 2015-12-02 — Reel 037193/0170

• Conveyance: Assignment — "ASSIGNMENT OF ASSIGNORS INTEREST"
• Assignor: BEDOE, SCOTT; BURGESS, JAMES; LING, TAYLOR (all three named inventors)
• Assignee: MEDLINE INDUSTRIES, INC., Illinois
• Correspondent: not retrievable this session
• Context: Original employee invention assignment. Captured pre-filing (executed 2 days before the 2015-12-02 filing date, recorded the same day as filing). This is the origin link of the entire chain and the only true sale/transfer of title in the record.
• Note: the assignor list in the record order is Bedoe, Burgess, Ling — the same three individuals, differs from the printed inventor order only in sequence.

2. 2021-09-07 (executed) / recorded 2021-10-20 — Reel 058554/0159

• Conveyance: Change of Name — "CHANGE OF NAME; ASSIGNOR:MEDLINE INDUSTRIES, INC."
• Assignor: MEDLINE INDUSTRIES, INC.
• Assignee: MEDLINE INDUSTRIES, LP, Illinois
• Correspondent: not retrievable this session
• Context: Internal corporate reorganization only. A name/entity-form conversion (Inc. → LP) recorded as a change of name, not a conveyance of title to a third party. No change in ultimate beneficial owner is evidenced by this record itself.

3. 2021-10-21 (executed) / recorded 2021-10-21 — Reel 058040/0001

• Conveyance: Security Interest — "SECURITY INTEREST;ASSIGNOR:MEDLINE INDUSTRIES, LP"
• Assignor: MEDLINE INDUSTRIES, LP
• Assignee: BANK OF AMERICA, N.A., Texas — acting as Administrative Agent / Collateral Agent
• Correspondent: not retrievable this session
• Context: Securitization / collateral pledge — not an ownership transfer. This is the grantor-side recording of the Credit Agreement dated October 21, 2021 (Bank of America as Admin/Collateral Agent, Swing Line Lender and L/C Issuer). It appears in the assignment database because IP security agreements are recorded at the USPTO under 35 U.S.C. § 1060; Medline Industries, LP retained title. Corroborated by Medline's SEC registration statement (CIK 2046386) exhibiting the "SECURITY AGREEMENT dated as of October 21, 2021 among THE GRANTORS."

4. 2021-10-21 (executed) / recorded 2021-10-21 — Reel 057927/0091

• Conveyance: Security Interest — "SECURITY INTEREST;ASSIGNOR:MEDLINE INDUSTRIES, LP"
• Assignor: MEDLINE INDUSTRIES, LP
• Assignee: WILMINGTON TRUST, NATIONAL ASSOCIATION, Minnesota — acting as Notes Collateral Agent
• Correspondent: not retrievable this session
• Context: Securitization / bond-collateral pledge — not an ownership transfer. Same-day companion to the Bank of America mechanical-lien recording, securing the noteholders under the Indenture. Again, title stayed with Medline Industries, LP.

5. 2024-03-27 (executed) / recorded 2025-06-20 — Reel 071672/0100

• Conveyance: Security Interest (supplemental) — "PATENT SECURITY AGREEMENT;ASSIGNOR:MEDLINE INDUSTRIES, LP"
• Assignor: MEDLINE INDUSTRIES, LP
• Assignee: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS NOTES COLLATERAL AGENT, Minnesota
• Correspondent: not retrievable this session
• Context: Securitization — incremental/joinder pledge within the existing notes collateral package. Consistent with the "Supplement No. 2, dated as of December 20, 2024" to the October 21, 2021 Security Agreement that appears in Medline's SEC registration-statement exhibit. Note the 13-month gap between execution (2024-03-27) and recording (2025-06-20) — late recording of an IP security-agreement supplement is common and is not an indicator of distress. Important: this record was recorded after the 2025-06-20 IPO window; it does not reflect any transfer of title.

Non-assignment records (excluded from the chain above, listed for completeness): FEPP 2016-12-05 (payor number assigned / large-entity status); STCF 2017-05-17 (patent grant); MAFP 2020-12-07 (4th-year maintenance fee paid); MAFP 2024-12-06 (8th-year maintenance fee paid). Also note the 2035-12-02 anticipated expiration — the patent is live and in force.

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Timeline diagram

timeline
    title Ownership of US 9671318
    2015 : Inventors assign to Medline Industries Inc
         : Application filed 2 Dec
    2016 : Payor number assigned
    2017 : Patent granted 6 Jun
    2020 : Maintenance fee paid 4th year
    2021 : Change of name to Medline Industries LP
         : Security interest to Bank of America
         : Security interest to Wilmington Trust
    2024 : Maintenance fee paid 8th year
    2025 : Notes collateral security agreement recorded

Reading the chain: one true transfer of title (2015 inventors → Medline), one entity-form change (2021), three collateral pledges (2021 ×2, 2024/2025). No third-party purchaser ever enters the chain.

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NPE / troll-pattern signals

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Verdict

Operating-company assertion — driven by Reel 037193/0170 (inventors → Medline Industries, Inc., executed 2015-11-30, recorded 2015-12-02) and the complete absence of any downstream third-party purchaser. Medline Industries, LP is a large operating medical-supply manufacturer that retains full title; the only later recordings are a change of name (Reel 058554/0159) and three security interests in favour of Bank of America and Wilmington Trust (Reels 058040/0001, 057927/0091, 071672/0100) that never transfer ownership. No NPE signal is present — not one of the eight markers fires on positive evidence.

Definitional caveat, stated plainly: the verdict category I've selected presupposes that the operating-company owner is suing actual competitors on the claims. That prong is not met for the '318 patent — the earlier sections of this analysis found no assertion of US 9,671,318. Medline is a habitual patent plaintiff (the Bard catheter-tray campaign), so it is unambiguously an operating-company patent enforcer, but it has not enforced this patent on the record available. If your framework requires a strict "assertion on these claims" test, the accurate label would be operating-company ownership, not currently asserting — a category the supplied five-option list does not contain. I flag the mismatch rather than distort the facts.

Verification link: https://assignmentcenter.uspto.gov/ (search by patent number 9671318 or application 14/957,137; the five reels above are 037193/0170, 058554/0159, 058040/0001, 057927/0091, 071672/0100). Legal-events mirror: https://patents.google.com/patent/US9671318/en#legalEvents

Two open items for a diligence-grade version of this memo: (1) retrieve the correspondent of record for each reel at the Assignment Center — this is the single field most likely to fill signal 3; (2) confirm whether a release/reassignment of the 2021 security interests was ever recorded (none appears in the Google Patents event list, which would mean the BofA and Wilmington Trust liens remain of record on the patent even though Medline owns it) — a lien search against the USPTO assignment database, not just a patent-number lookup, is required for that.

One contradiction to carry forward: the earlier "Prior art" section noted this task's header date (2026-04-26) conflicts with the session date (2026-09-29) and with a PureWick complaint dated 2026-05-11. That date conflict is unrelated to the assignment record and affects nothing above, but it should be reconciled before any output is dated.

I'll ground this on the authoritative citation lists in the patent text, then verify the most technically significant references against live sources before doing the § 102 analysis.

Prior-Art Analysis — US 9,671,318 B1 ("Specimen collector," Medline Industries, LP)

Built on the prior sections. This section assumes the bibliographic, litigation, PTAB, and assignment findings already produced. Two carry-forwards matter here: (a) the earlier prior-art section (not reproduced in my context) concluded that no cited reference anticipates any claim, and that the strongest § 103 combination runs US 8,088,079 B2 as primary with a selective-flow reference secondary; my independent element-by-element re-derivation below agrees and strengthens that finding; and (b) the date discrepancy (this task header says 2026‑04‑26; the litigation/PTAB sections are dated 2026‑09‑29) is still unresolved — I date this report 2026‑04‑26 per the current task header and flag that the report date should be fixed to the actual signature date.

Number discipline. Every reference below was matched on its literal number as it appears on the face of the '318 patent. I specifically rejected near-misses that search surfaced — 5,671,318 / 8,671,318 (different patents), US D930,850, and unrelated Turkish/Chinese academic hits. Where a search result contradicted my training data, I used the search result.

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1. The statutory frame — and the trap in it

US 9,671,318 was filed 2015‑12‑02, i.e. after the AIA's 2013‑03‑16 change, so AIA 35 U.S.C. § 102(a)(1)–(2) governs. The consequence for a citation-by-citation analysis is that "cited on the face of the patent" does not equal "prior art," and the publication dates in Google's citation tables are frequently the priority date rather than the publication date. Three corrections are required:

Everything else on the face has a publication date before 2015‑12‑02 and is available under § 102(a)(1) as a patent or printed publication.

Provenance caveat. The scraped citation tables disagree on count (66 vs. 70) — already flagged in the patent-summary section. I analyze the union, i.e. the 70-row "Patent Citations (70)" table plus the 1 non-patent citation. The asterisk markers that Google uses to distinguish "cited by examiner" from "cited by third party" survived the scrape inconsistently (asterisks appear on only US 3,788,484, US 4,376,053, US 5,256,160 and US 5,387,339 in the 66-row table, and on none in the 70-row table). I therefore do not rely on examiner-vs-third-party provenance anywhere below; that should be read off the printed patent or the file wrapper.

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2. The claim-1 element matrix used throughout

Anticipation under § 102 requires every element in one reference, arranged as claimed. I decomposed the independent claims as follows and used these IDs in every row below:

E4 + E6 + E7 in combination are the inventive core — a shuttle tray carrying two wells that alternately presents one well into, and withdraws the other from, the suction path — and, as shown below, no cited reference discloses that combination.

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3. Tier 1 — the closest cited art (verified against full text / claim text)

These five references are where any § 102 or § 103 case will be fought. I retrieved and read the operative disclosure of each.

3.1 US 8,088,079 B2 — "Polyp trap" — U.S. Endoscopy Group, Inc. — filed/priority 2006‑02‑10; granted 2012‑01‑03. (Closest art overall.)

Disclosure (verified): "A polyp trap for use in collecting tissue samples. The device includes a collection container and a removable tray. The collection container has an inlet port, a sidewall aperture, and an exit port. The removable tray has a first end and a second end. The tray is sized for movement within the sidewall aperture between an inserted position forming a seal with the collection container and a withdrawn position remote from the collection container. The tray has a perforated bottom surface such that fluids traveling under suction from the inlet port to the outlet port pass through the tray." The container is a six-sided hollow clear-plastic body with two protruding conical ports 24, 26 through a top surface; FIG. 2 shows the tray fully withdrawn. Later embodiments add a valve at the inlet (FIG. 9), instrument access (FIG. 10), irrigation (FIG. 11), and an internal light source (FIGS. 12–13).
§ 102 verdict — anticipates nothing. Mapping: E1 ✔ (a "collection container" — but whether a six-sided container reads on a "sleeve" is a claim-construction argument, not a clean disclosure); E2/E3 ✔; E4 ✖ — the '079 container has one sidewall aperture, and the claim requires first and second side apertures in substantial axial alignment; E5 ✔; E6 ✖ — a single perforated tray, not first and second specimen wells; E7 ✖ — the tray moves between inserted and withdrawn position with respect to the container, but the claim requires well 1 and well 2 to be alternately placed into communication with the inlet and outlet. The '079 tray has no second well to swap in; withdrawing it simply breaks suction. E11, E14 ✖.
Claim-level targets: the only reference with a sidewall-opening + slidably removable perforated tray in a suction line — i.e. the primary § 103 reference against claims 1, 4, 5, 10, 12, and the base for the combination the prior section identified. Its own FIG. 2 "fully withdrawn" teaching supplies part of the motivation for a multi-position tray; the remaining gap (second well + second aperture + alternating positions) is where a petitioner must find secondary teaching.

3.2 US 7,244,236 B2 — "Specimen trap with strainer" — M.D. Technologies, Inc. — provisional 2003‑05‑16; filed 2004‑05‑17; granted 2007‑07‑17.

Disclosure (verified): container forming a chamber; strainer fixed in the chamber with a porous surface; a cap rotatable relative to the container; a dividing element with radially extending dividers 71 forming a plurality of specimen compartments 75; "the cap is rotatable with respect to container 12 to align one specimen compartment 75 with field tube connection passage 52 for collection of one independent specimen, without the specimen entering and contaminating adjacent specimen compartments"; indices on the container surface indicate compartment position. Product of the multi-specimen ambition.
§ 102 verdict — anticipates nothing. E1–E3 ✔ (container/chamber + first and second tube connections); E4 ✖ (no side apertures; the container is closed by the cap); E5/E6 ✖ — the compartments are statically fixed inside the container and defined by a divider on the strainer; selection is by rotating the CAP, not by sliding a well-carrying tray through a sleeve. There is no slidable tray at all, so E7's "tray movable between a first position … and a second position" is unmet, as are E8, E10, E11, E14. E12 ✔/partially (porous strainer surface) — but claim 7 depends from claim 1 and cannot be anticipated without claim 1.
Claim-level targets: the single most damaging reference on the "collect multiple specimens without stopping the procedure" motivation, and the reference that the '318 specification's own background paragraph about "a rotatable cap that allows a user to selectively deposit a specimen in various ones of the multiple chambers" is describing. It also supports claim 7/8 obviousness (porous surface; independent specimen isolation) and helps with a claim 9 obviousness argument (rotational indexing/alignment).

3.3 US 3,855,997 A — "Sterile specimen trap" — Cinco Medical Health Supply Co. — filed 1973‑07‑11; granted 1974‑12‑24.

Disclosure (verified): "closure means … formed of two independent cover members, at least one of which is angularly movable relative to the other … Each member has a pair of openings formed in it which may be aligned by movement of one of the members a certain angular distance about their central axis to allow the interior of the container to communicate, through these openings, with both the fluid conduit and the suction conduit." The adapter cap carries fluid specimen conduit 18 and suction conduit 20; the trap never opens to ambient.
§ 102 verdict — anticipates nothing. This is the selective-alignment teaching, not a well-shuttling teaching: the selector is a relatively rotatable disc pair, there is no slidable tray (E5), no wells (E6), no side apertures (E4), and the single container interior collects everything. Relevant only to E7's functional idea of "port openings alternately brought into and out of alignment with the flow path."
Claim-level targets: secondary reference in a § 103 combination against claim 1 E4/E7, and independently against claim 9 (relative-rotation alignment) if the combination is argued.

3.4 US 2011/0106029 A1 — "Polyp trap" — Garren et al. — filed 2010‑11‑02 (provisional 61/257,200); published 2011‑05‑05; abandoned.

Disclosure (verified from the published claims and description): a body portion and a sealing top portion; a suction entrance passageway in the top; a removable tissue collection basket in the body with a bottom wall having a plurality of small drainage openings; a removable screen in the body below the basket; a suction discharge passageway below the screen; hinge connection between top and bottom; a stop limiting opening; vacuum-sealing ridges. The specification expressly describes "two separate sites that are capable of collecting samples, the basket 24 and the screen 26. This double collection or fail safe is unique to present [sic] trap." Its background cites US 4,643,197, US 2006/0189950 and US 2007/0191731 — the first of which (US 4,643,197 A, E-Z-Em, granted 1987‑02‑17) is itself one of the 70 citations against the '318 patent, a useful cross-link showing how tightly the examiner's art cluster overlaps.
§ 102 verdict — anticipates nothing. E12/E13 ✔ (removable basket/screen with drainage openings and a secondary screen) — this is the best honest disclosure of claims 7 and 8's subject matter in the cited set. But E4, E5, E6, E7 all ✖: it is a clamshell container, not a sleeve with two axially aligned side apertures and a slidable two-well tray. Its two "sites" are stacked vertically in one flow path, not alternate positions of a single movable well.
Claim-level targets: § 103 secondary reference for claims 7 and 8 (and to a degree 6), and a § 103 motivation reference for "facilitate retrieval of multiple specimens" (its stated object). Note its status as an abandoned application — it is still § 102(a)(1) printed-publication art as of its 2011‑05‑05 publication.

3.5 US 6,375,625 B1 — "In-line specimen trap and method therefor" — Scion Valley, Inc. — filed 2000‑10‑18; granted 2002‑04‑23.

Disclosure (title/abstract-level, per search; I did not retrieve full text): an in-line trap for a suction line. I flag this as not full-text verified.
§ 102 verdict — anticipates nothing. On the title/abstract-level record this is the single-chamber in-line trap archetype — precisely the prior art the '318 specification describes in its background as requiring disassembly and disconnection (and thus a delay) to remove a specimen between collections. It cannot disclose E4, E6 or E7 (two wells, two apertures, alternating positions). Note the '318 background's port geometry, "inlet and outlet ports that are in axial alignment with the suction line," is effectively a description of this class of device.
Claim-level targets: § 103 background/primary-alternative reference against claim 1 and against claim 4 (E9, axial alignment) — the '625-type in-line trap is where the axial-alignment limitation of claim 4 will be met, which makes claim 4 the most likely dependent claim to fall in a § 103 combination.

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4. Tier 2 — references that supply one claim element (multi-sample capture, porous/removable collection members, filters in a suction path)

None of these discloses E4 + E6 + E7 together; none anticipates claim 1 or, derivatively, any claim depending from it. They are mapped to the limitation each would be cited for.

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5. Tier 3 — general suction/filter/trap and non-analogous art (no independent anticipation value)

Every one of these is a § 102(a)(1) patent or publication except where noted. Each is listed with the single disclosure for which it might plausibly be cited, and all share the same § 102 verdict: none discloses E4 (first and second side apertures) + E6 (two wells on the tray) + E7 (alternate positioning) in a single reference, so none anticipates any of claims 1–14.

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6. Tier 4 — design patents on the face (ornamental only; no § 102 anticipation of a utility claim)

Design patents are § 102 art for what they disclose, but ornamentation of a container/cup/filter housing does not disclose the functional limitations E4/E6/E7. All are § 102(a)(1) except USD755922S1 (§ 102(a)(2) only).

§ 102 verdict for all 13: anticipates nothing — no design disclosure addresses a slidable two-well tray or the two side apertures of a sleeve.

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7. The single non-patent citation

Yeager, Anna et al., Design U.S. Appl. No. 29/494,106, filed 2014‑06‑17.
This is a design application, cited as an NPL reference. It is § 102(a)(1) art as of its filing only if it became publicly available (design applications are generally unpublished until grant), so its prior-art date is the grant/publication date, not 2014‑06‑17. Inference, moderate confidence: the publication "USD771832S1 — Lid and screen assembly of a sample collection container with screen — 2014‑06‑17 — Medline Industries, Inc. — 2016‑11‑15" that surfaced in the Cited By list of Garren US 2011/0106029 matches the filing date and subject matter, suggesting the 29/494,106 design issued as USD771,832 S1 — i.e. Medline's own design, which would make its § 102 relevance nominal (and its disclosure ornamental). I flag this as an inference requiring confirmation from the design patent's own face; do not treat it as established.

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8. What is not prior art: the "Cited By" list (a misuse warning)

The '318 page's Cited By (15) and Cited By (30) entries — US 10,471,188; US 11,318,242; US 12,350,418 (Stryker); US 11,682, US 11,684,924 / US 2020/0188921 (Huronmed); US 11,821,820 B2 (EnTellect Medical Holdings, priority 2020‑07‑22); US D919,799 / D930,850 / D956,967 / D983,367 / D996,640 / D1,031,076 / D1,039,168 / D1,069,161 / D1,117,812 (Stryker designs); USD964,553 (Keymed); US 11,471,796 (Sherwood); US D959,658 / D1,019,941 / D1,050,427 / D1,120,315 (Stryker); US 2021/0162101; US 2023/0381400; US 11,759,563; US 12,296,087; US 12,290,626 — all post-date the '318 filing date and cannot be § 102 prior art against it. They are forward citations (evidence of the patent's technical significance and of the crowdedness of the field), not prior art. Likewise the "Families Citing this family" entries (NL 2,021,759 B1 — A C Hoogerheide; SE 542,926 C2 — Multi4 AB; WO 2020/242607 A1 — Atlanta Scientific) are later, foreign documents, not prior art.

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9. Bottom line — § 102

No reference cited on the face of US 9,671,318 anticipates any of claims 1–14. Anticipation fails uniformly at the same three limitations, in every reference:

• E4 — first and second side apertures in the sleeve. US 8,088,079 has exactly one sidewall aperture; US 7,244,236 and US 2011/0106029 have none (clamshell/rotatable caps); US 3,855,997 has none.
• E6 — first and second specimen wells on the tray. Only US 7,244,236 and US 7,244,236's relatives disclose multiple specimen compartments, and those are fixed inside the container, not on a sliding tray.
• E7 — a tray movable between a first position and a second position in which different wells are alternately in communication with the inlet and outlet ports. No reference discloses a single sliding member that swaps one collection well into the suction path while withdrawing the other. US 8,088,079 slides to break the path; US 7,244,236 rotates to index compartments; US 3,855,997 rotates openings into alignment.

Because claims 2–9 and 11 depend from claim 1 and claims 10 and 12 incorporate the same structural recitation, the same negative result carries to the entire claim set — including the method-of-use claim 12, for which the M1/M2/M3 steps (suction → recover → slide the tray to the second position → collect) cannot be met by any reference that lacks the slidable two-well tray.

The closest single reference is US 8,088,079 B2, and even it is missing E4, E6 and E7. This is an obviousness case, not an anticipation case — consistent with the prior-art section's finding.

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10. § 103 map (carried forward and refined)

If you are charting invalidity, the work is in the motivation and the secondary teachings:

The weakness in every one of these rows is the same: the art teaches breaking suction (US 8,088,079) or stopping to index (US 7,244,236), whereas claim 1's E7 and claim 12's M2 are directed to continuing the procedure across the swap. Expect the patent owner to press exactly there.

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11. Gaps, confidence, and what to re-run

Confidence levels:

• High — Tier 1 (US 8,088,079; US 3,855,997; US 7,244,236; US 2011/0106029) and all citation dates/number identifications: I retrieved the operative disclosure or the published claims myself. The conclusion that no reference anticipates is high confidence.
• Moderate — Tier 2 classifications, based on titles, abstracts, and family relationships rather than full-text review. US 6,375,625 B1, US 7,488,312 B2, US 5,256,160 A, US 7,758,515 B2 and the SenoRx family are the ones most likely to be cited for an element I have characterized from title alone; each should be full-text reviewed before being used in an invalidity contention or an FTO opinion.
• Low / inference only — (i) the correlation of the Yeager NPL citation (Design Appl. 29/494,106) with USD771,832 S1; (ii) the application of the § 102(b)(2)(C) common-ownership exception to US 2015/0359949 A1 (it turns on the ownership record as of 2015‑12‑02, which the assignment section reconstructed from aggregated data, not from the Assignment Center itself); (iii) the examiner-vs-third-party provenance of each citation, given the inconsistent asterisk markers in the scraped tables.
• Carried-forward caveat — the prior sections' qualified negatives on litigation and PTAB activity rest on open-web indexing only; nothing in this section depends on them, but an opinion letter should re-run both.

Re-run before relying on this in a diligence or clearance opinion:

1. USPTO Patent Public Search / PatentCenter for application 14/957,137 — confirm the face-of-patent citation list, the examiner/third-party markers, and whether an IDS or a PTO‑892 supplies additional art not aggregated by Google (this is the single highest-value check).
2. Full-text retrieval of US 6,375,625, US 7,488,312, US 5,256,160, US 7,758,515, US 7,572,236, US 7,981,051, US 8,465,439 and US 9,220,485 — the eight Tier 2 references I could not read.
3. Assignment Center confirmation of the Medline ownership record as of 2015‑12‑02 (required to lock down the § 102(b)(2)(C) point on US 2015/0359949 A1).
4. Reconcile the report date (2026‑04‑26 per this task header vs. 2026‑09‑29 in the litigation/PTAB sections) and confirm which controls the opinion.

No prior-art reference cited on the face of US 9,671,318 discloses the first and second side apertures, the first and second specimen wells on a slidable tray, and the alternating first/second position fluidic communication in a single reference. The prior art resides in the § 103 combination space, centered on US 8,088,079 B2.

I'll verify the key prior-art disclosures I intend to rely on for the motivation-to-combine analysis, since § 103 hinges on what those references actually teach.

Key motivation evidence verified. Let me check the remaining secondary references and the legal standard I'll apply.

Two final verification checks: the MPEP "duplication of parts" rationales I want to invoke, and the Garren reference's screen disclosure.

Obviousness Analysis Under 35 U.S.C. § 103 — US 9,671,318 B1 ("Specimen collector," Medline Industries, LP)

This section builds on, and does not repeat, the previously generated "Patent summary," "Litigation summary," "PTAB challenges," "Assignment history," and "Prior art" sections. The prior-art section established the reference set, the § 102 element-by-element testing, and the finding that no cited reference anticipates any claim of the '318 patent. This section takes that finding as its premise and does the § 103 work: which combinations, what motivation, and how strong.

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0. Date reconciliation flag (carried forward, unresolved)

The task header states the current date as April 26, 2026. My session context and the previously generated sections use 2026-09-29. I have dated this analysis 2026-09-29 and have not altered any date in the evidentiary record. Nothing in the § 103 analysis turns on the discrepancy — every reference relied on below predates the 2015-12-02 effective filing date by years, so § 102(a)(1) status is unaffected either way. But any opinion letter must be dated to the actual date of signature, and the two dates should be reconciled before issuance.

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1. Governing framework and method applied

The '318 application was filed 2015-12-02, after the AIA cutover, so AIA 35 U.S.C. § 103 governs. The inquiry is the four Graham factors: (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 (Graham v. John Deere, 383 U.S. 1, 17–18 (1966)). The strict teaching–suggestion–motivation test is not the exclusive route: KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), recognized additional rationales, codified at MPEP § 2143 and in the 2007/2010 KSR Guidelines (72 FR 57526; https://www.govinfo.gov/content/pkg/FR-2010-09-01/html/2010-21646.htm). The six non-TSM rationales I apply below are: (1) combining prior-art elements by known methods for predictable results; (2) simple substitution of one known element for another; (3) using a known technique to improve a similar device in the same way; (4) applying a known technique to a known device ready for improvement; (5) "obvious to try" — a finite number of identified, predictable solutions; (6) design incentives/market forces prompting predictable variation.

Critical procedural caveat: every rationale must be explicitly tied to the facts, and MPEP § 2144.04 rationales (duplication, change in shape, making integral) must never be applied as per se rules. See In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995) ("reliance on per se rules of obviousness is legally incorrect"); Ex Parte Granneman, 68 U.S.P.Q.2d 1219 (BPAI 2003). I flag where I am invoking those rationales and why the facts support them, and where a tribunal could properly reject them. Source for the MPEP text: https://www.uspto.gov/web/offices/pac/mpep/mpep-2100.pdf · https://www.bitlaw.com/source/mpep/2144-04.html

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2. The person of ordinary skill in the art (POSITA) — Graham factor (c)

No party has litigated this patent, so there is no judicially adopted POSITA definition. Based on the field (endoscopic accessories, polyp traps, suction specimen-collection), the claimed subject matter, and the prior art of record, a defensible definition is:

A person with a bachelor's degree in mechanical engineering, biomedical engineering, or a related field, plus 2–4 years of experience designing single-use disposable medical devices for fluid handling or suction-based specimen collection, or equivalent practical experience in the endoscopy accessory industry; familiar with the design of in-line suction traps, luer/tubing port geometry, molded-plastic part design, living-hinge and snap-fit closures, and the sterility/vacuum-integrity constraints of disposable traps.

This is a predictable, mature mechanical arts field — the KSR "predictable results" rationales apply with force (In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009), declining to cabin KSR to unpredictable arts). The '318 specification is itself entirely mechanical: molded plastic, snap-fits, gaskets, screen meshes, keyed orientations. There is no unpredictable biology or chemistry in the claims.

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3. Claim 1 element chart against the primary combination

3.1 The claim-1 element set (from the prior-art section, § 1)

(a) sleeve with interior wall(s) defining a substantially hollow interior cavity; (b) inlet port in fluidic communication with the cavity; (c) outlet port in fluidic communication with the cavity; (d) first and second side apertures; (e) a tray slidable within the interior cavity; (f) the tray comprising first and second specimen wells; (g) the tray movable between a first position (first well in fluidic communication with inlet and outlet ports) and a second position (second well in that communication).

3.2 Primary combination A: US 8,088,079 B2 (primary) + US 5,256,160 A (secondary), optionally + US 2011/0106029 A1 or US 7,488,312 B2

Reading the chart: 8,088,079 supplies elements (a), (b), (c), (e), (g)-functionally, and (7)–(8); US 5,256,160 supplies the explicit "member movable between an open position and a closed position to alternately establish/eliminate fluid communication" mechanism. The residual differences are (i) the second side aperture, (ii) two wells on one tray rather than two interchangeable collectors, and (iii) the linear shuttle rather than removal/replacement.

3.3 Primary combination B: US 8,088,079 B2 + US 3,855,997 A (Cinco Medical)

US 3,855,997 is arguably the cleaner secondary reference on element (g) because it is the same device type facing the same problem — selectively establishing and eliminating communication between a specimen-trapping container's interior and the fluid/suction conduits. Verified text: the closure means is "formed of two independent cover members, at least one of which is angularly movable relative to the other about a central axis common to both," each with "a pair of openings formed in it which may be aligned by movement of one of the members … to allow the interior of the container to communicate, through these openings, with both the fluid conduit and the suction conduit," and — "alternately…" — movable "until the openings are brought back to their original, misaligned positions, thereby positively sealing the interior." That is a literal teaching of an element movable between a first position (communication established) and a second position (communication eliminated), in a specimen trap. Sources: https://patents.google.com/patent/[US3855997A](/patent/US3855997A) · https://patentimages.storage.googleapis.com/05/a5/0f/9a05afa5699461/US3855997.pdf

Combination B is my preferred primary § 103 vehicle for claim 1, because 8,088,079 already supplies the sliding perforated collector and 3,855,997 supplies the bivalve/misalignable selective-communication concept without importing an unrelated mechanism. Combination A (Mectra) is the better vehicle for the motivation prong (see § 4.4).

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4. Motivation to combine — the heart of the case

This is where the '318 patent is most exposed, because US 8,088,079 states the '318 patent's own stated advantage as its own object. The verified passage (bracketed numerals as printed):

"If multiple polyp samples are required, a second tray can be used to allow the endoscopic procedure to proceed without interruption while the polyp is removed from the first tray."

and:

"Further, once polyp removal begins, use of the plug tray [100] and removable tray [14] can be alternated to allow for uninterrupted multiple polyp removal."

Sources: https://patents.google.com/patent/US20070191731 · https://patents.google.com/patent/US8088079

Compare the '318 specification's own selling point: "a polypectomy procedure does not need to be paused during removal of a specimen 102 from the tray 300… a first user may remove a first specimen… while a second user continues to perform the polypectomy procedure, drawing a second specimen… into the tray 300." The problem is identical and the prior art already announced the solution. The only difference is how the second collector is carried: 8,088,079 alternates two discrete collectors through one aperture; the '318 claim uses one tray carrying two wells through the cavity.

4.1 KSR Rationale (4) — known technique applied to a known device ready for improvement

8,088,079 expressly identifies the device as ready for improvement in exactly the claimed direction ("If multiple polyp samples are required, a second tray can be used… without interruption"), and even discloses a second body (the plug tray 100) that is alternately inserted through the same aperture. The '318 claim merely consolidates the alternation onto a single carriage. This is textbook rationale (4).

4.2 KSR Rationale (3) — known technique to improve a similar device in the same way

Mounting two collecting receptacles on a single linearly indexable carriage is a known technique in fluid-handling and laboratory apparatus (a rack/magazine indexing each receptacle into a flow path). Applying it to 8,088,079's removable tray to eliminate the withdrawal-and-reinsertion step is the same technique used for the same purpose.

4.3 KSR Rationale (5) — "obvious to try" over a finite set of identified, predictable solutions

The '318 specification itself treats the number and arrangement of wells as a menu of interchangeable options:

"In other approaches (not shown), the tray includes three or more specimen wells, which may be aligned along a central longitudinal axis of the tray or may be otherwise configured as appropriate. For example, the wells may be distributed radially about an annular tray. In this alternative approach, the circular tray is rotatably slidable through the interior cavity 208 of the sleeve 200."

This is an applicant admission that the claimed axial two-well arrangement is one of a small, identified, predictable set (two, three, or more wells; linear or radial; sliding or rotating). Under KSR and MPEP § 2144.05, where the prior art discloses a range or set and the claim lies within it, a prima facie case exists absent criticality evidence. There is no criticality showing anywhere in the '318 record: the only numeric values (20.2 mm sleeve ID, 21 mm cavity depth, 10 mm well depth, 0.5 mm pore size, 15 mm central-region thickness) are described with the phrase "for example" / "approximately," and no data link them to any unexpected result.

4.4 Rationale (6) — design incentives/market forces, and the one-hand-operation motive

US 5,256,160 supplies an express, quotable market/ergonomic incentive that maps onto a '318-touted benefit:

"the provision of a combination sample trap and a valve mechanism… the valve mechanism may be held securely in one hand and operated by the thumb of that hand… leaving the other hand free to perform other functions" — and the mechanism must be "low-cost disposable."

Compare the '318 specification: "a user may slide the tray 300 from one position to another position with one hand, keeping the user's other hand free to remove a specimen 102 from the tray 300." The prior art already articulated the ergonomic rationale for a one-hand-actuable, disposable trap-and-selector combination. Sources: https://patentimages.storage.googleapis.com/3d/b3/cf/511e642229ff33/US5256160.pdf

4.5 Rationale (2) — simple substitution of one known element for another

Substituting a sliding carriage with two collectors for 8,088,079's two discretely inserted collectors is a substitution of one known element (plural collectors alternately placed in the flow path) for another (a single carrier indexing them), with a predictable result (the same alternating workflow with fewer hand movements). Nothing in 8,088,079's principle of operation changes: the fluid still enters port 24, passes through a perforated collecting surface, and exits port 26 under suction.

4.6 MPEP § 2144.04 rationales (used with care)

• Duplication of parts (In re Harza, 274 F.2d 669 (CCPA 1960)): adding a second identical well to the same tray is a duplication. However, I flag the Granneman/Ochiai limitation — this rationale cannot be applied as a per se rule, and the stronger argument is not "duplication is always obvious" but rather "8,088,079 already taught plural collectors and their alternation, so no new principle is introduced." That is a rationale-(1)/(4) argument, not a naked duplication argument. A tribunal should be expected to demand this framing.
• Making integral (In re Larson, 340 F.2d 965 (CCPA 1965)): consolidating 8,088,079's two alternately-inserted bodies into one integral tray is "a matter of obvious engineering choice."
• Changes in shape (In re Dailey, 357 F.2d 669 (CCPA 1966)): the cup/funnel well geometry (claimed only in dependent claim 7's "porous surface" form) is a configuration matter.

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5. Reasonable expectation of success (rationale (5) requires it)

The combination would work predictably because:

1. The primary reference already works this way. 8,088,079's tray is already a sliding, sealing, perforated collector traversing an aperture, with a disclosed seal/wiper effect on withdrawal; a second well on the same carriage does not alter the sealing interface geometry.
2. The switching function is already reduced to practice in the same field. 3,855,997's misalignable covers establish and eliminate communication in a specimen trap with a positive seal; 5,256,160's rotor does the same for a disposable sample-trap valve.
3. The "second aperture" is a trivial mechanical consequence. For a tray to slide through the cavity so that one well exits while the other enters, the sleeve needs an opposed opening. The '318 specification's own description confirms this is what the apertures are: they are "dimensioned so as to permit a tray… to slide within the interior cavity," they are "in substantial axial alignment," and "the distance between the first and second side apertures 214, 216 defines a depth of the interior cavity 208." In other words, the sleeve of claim 1 is a tube with two opposed openings — a through-passage. Supplying the exit opening opposite 8,088,079's aperture 16 is routine in view of the stated desire to shuttle rather than withdraw. (See § 11, construction risk, for the double-edged nature of this point.)
4. No unpredictable physics is involved — vacuum integrity, gravity drainage, and mesh retention are all documented in the primary reference.
5. Corroborating (but NOT prior art) evidence of the art's trajectory: the STERIS eTrap® instructions for use (issued October 2019) instruct: "Always insert the extra strainer into the eTrap® upon removal of the first strainer… The process of removing and replacing the specimen retrieval strainers in tandem (as needed), prevents loss of suction and allows the availability to retrieve additional polyps" (https://imda.moh.gov.vn/documents/10182/85748240/upload_00004055_1783931451409.pdf). ⚠️ This document post-dates the '318 filing date and is NOT available as § 102/§ 103 prior art. I cite it only as commercial-context corroboration that the '318's asserted advantage was the industry's recognized design objective; a court should exclude it from the prior-art record, and I do not rely on it.

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6. Dependent claims 2–9 and 11

Note on the central tray region. The '318 specification's impermeable central tray region 310 — which "serves to prevent fluid communication between the inlet portion 210 and the outlet port 212" — is not recited in any claim. That matters: the most arguably novel architectural feature the patent describes (an indexable intervening blank that blocks the suction path mid-stroke) is unclaimed and therefore cannot save the claims from obviousness. Corroborating that container-partitioning for the same purpose was known: US 8,088,079's own claims 14/16 recite "a dam extending inward from a container sidewall between said inlet port and said outlet port, wherein said dam partially separates said container into multiple compartments." (Source: https://insight.rpxcorp.com/patent/[US8088079B2](/patent/US8088079B2))

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7. Independent claims 10, 12, 13, 14

Claim 10 ("providing a sleeve… providing a tray…") is a pure provision claim with no active step — no suction, no collection, no sliding. If claim 1's apparatus is obvious, claim 10 adds nothing patentable; there is no separate inventive concept to assess. It rises or falls with claim 1. Its only arguable non-obviousness would come from a construction that "providing" imports a method of making, which the language does not support.

Claim 12 (method of use) recites: providing the collector; applying suction to the outlet port and recovering bodily fluids through the inlet port; upon retention of a specimen in the first well, sliding the tray to the second position; and collecting the specimen from the first tray. Every step is disclosed or rendered obvious by 8,088,079's use disclosure, which describes: connecting the inlet tube to the endoscope; pulling suction; suctioning the polyp into the tray where "a polyp of any significant diameter will be trapped"; then removing the tray to recover it; then using "a second tray… to allow the endoscopic procedure to proceed without interruption." The only delta is "sliding the tray to the second position" versus removing and inserting a replacement. Given (i) 8,088,079's express second-tray/plug-tray alternation teaching and (ii) 8,088,079's teaching that the tray is already a sliding element that "forms a seal" in the inserted position and wipes on withdrawal, sliding a two-well tray one increment to index the second well is an obvious mechanization of a disclosed workflow. Method claims whose steps are the natural and disclosed manner of using an obvious apparatus are obvious as a matter of law.

⚠️ Two issues to flag on claim 12 (outside § 103 but material to any opinion):

• The claim recites "collecting the specimen from the first tray." Literally there is one tray with two wells; the phrase is a drafting error (the prior-art section flagged it; the specification and claim 13 both treat "the first specimen well" as the object of removal). A court would likely construe "first tray" as the first specimen well, but a defendant could alternatively press a § 112(b) indefiniteness argument. Either way, the § 103 analysis should be run on the construed scope — the first well — and on that construction claim 12 is obvious for the reasons above.
• Similarly, the specification's statement that "the outlet port 210 is disposed 'downstream'" is a typo for 212 (flagged in the patent summary). Harmless to validity.

Claims 13 and 14 are the method-side counterparts of claims 2/3 and the shuttle-back step:

• Claim 13 ("sliding the tray to dispose the second specimen well in fluidic communication… disposes at least a portion of the first specimen well and the received specimen exterior to the interior cavity") — the same design consequence as claim 2: the spent well must be reachable. 8,088,079's "withdrawn position remote from said collection container" teaches removal of the spent collector from the container. Obvious.
• Claim 14 (receiving a second specimen in the second well; sliding back) — directly prefigured by 8,088,079's alternation teaching ("use of the plug tray and removable tray can be alternated to allow for uninterrupted multiple polyp removal"). This is the single strongest obviousness mapping in the entire patent. Very strong.

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8. Alternative combinations (for redundancy in an invalidity contention)

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9. Rebuttal analysis — where Medline wins, and whether it holds

R1. "No reference discloses two wells on a single slidable tray." True, and it is the strongest non-obviousness point. But it is a difference in arrangement of old elements, not a new principle; the number and carriage of collectors is exactly the kind of "design choice" KSR and MPEP § 2144.04 address, and 8,088,079 supplies the reason (multiple samples without interrupting the procedure) and the mechanism (alternating collectors). Under KSR, a narrow structural difference that achieves a prior-art-announced workflow is a weak basis for patentability. Assessment: does not overcome the prima facie case, but it is the argument to lead with, and it will narrow claim 1 if it succeeds partially.

R2. "8,088,079 and 3,855,997 are combinable only by destroying their respective principles of operation." Weak as to 3,855,997 (both are specimen traps that establish and eliminate communication between a container interior and fluid/suction conduits). Stronger as to 5,256,160, whose rotor is a rotary bore device — a defendant should therefore lead with 3,855,997 and use 5,256,160 primarily for the motivation prong (one-hand operation, disposable sample trap + valve) rather than for structural substitution. If the tribunal accepts the "bodily incorporation" attack on the Mectra combination, the 3,855,997 combination survives independently.

R3. "Removing the tray in 8,088,079 breaks suction, so 8,088,079 teaches away from the '318's uninterrupted workflow." This is the most superficially attractive argument and it fails on the reference's own text: 8,088,079 expressly teaches that withdrawal breaks suction and that the plug tray 100 "can be used to maintain a vacuum in the collection container" and that the plug tray and removable tray "can be alternated to allow for uninterrupted multiple polyp removal." The reference does not disparage uninterrupted multi-sample collection; it teaches how to achieve it. A "teaching away" defense requires the reference to criticize, discredit, or otherwise discourage the claimed approach — this one endorses it.

R4. "The outlet port is remote from the tray, and a dam partially separates the outlet from the tray, so 8,088,079 teaches away from putting the well directly in the inlet→outlet flow path." This is a real but limited argument. It is undercut because 8,088,079's own claim language recites "fluids traveling under suction from said inlet port to said outlet port pass through said tray" — i.e., the tray is in the flow path — and because claim 1 of the '318 patent requires only that the well be "in fluidic communication with the inlet and outlet ports," not that it be interposed between them without an intervening dam. Assessment: this argument is aimed at narrowing the claim, not at avoiding it.

R5. Secondary considerations. No objective evidence of non-obviousness is presently available: there is no litigation, no validity record, no adjudicated nexus, no documented industry praise, and no licensing (per the assignment-history section, there is only the 2015 inventor assignment and a same-entity name change; no third-party licenses or royalty-bearing transfers). The specification's assertion that using polypropylene (sleeve) with polycarbonate (tray) "is believed to assist in providing a sealing effect" is (i) unclaimed and (ii) unsupported by any data — "is believed to" is not the kind of evidence that rebuts a prima facie case, and it does not establish criticality for any claimed range. Commercial success of a Medline polyp/specimen-collector product, if it exists, would require a nexus to the claimed two-well-shuttle structure rather than to brand, distribution, price, or the many unclaimed features (magnification portion, translucent sleeve, gasket, formalin-container-sized screens).

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10. Claim-by-claim obviousness assessment

Legend for "Likelihood": a judgment-based calibrated estimate of the probability a fact-finder reaches a § 103 invalid conclusion on the identified combination and record — not a legal opinion, and not a substitute for claim-construction and expert work.

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11. The biggest swing factor — claim construction of "first and second side apertures"

This is the highest-leverage issue in the analysis, and it cuts both ways.

The '318 specification describes the apertures as (i) "dimensioned so as to permit a tray… to slide within the interior cavity," (ii) "in substantial axial alignment," and (iii) such that "the distance between the first and second side apertures 214, 216 defines a depth of the interior cavity 208," with the tray "linearly slidable along a central axis of both the first aperture 214 and the second side aperture 216." That description reads on two opposed openings in the sleeve wall — i.e., a through-passage, with the sleeve functioning as a tube open at both ends.

• If that construction is correct, the "second side aperture" element adds almost nothing over 8,088,079's single aperture plus an opposed exit, and claim 1's non-obviousness rests almost entirely on the two-wells-on-one-tray difference. Claim 1's probability of invalidity rises materially.
• If, instead, a court reads "side apertures" narrowly (e.g., as distinctly framed, ported openings with particular sealing geometry, as the figures may show), the gap to 8,088,079 widens and Medline's position improves.

Caveat: the authoritative text I hold contains no figure data — the Google Patents fetch reproduced the drawing sheets as blank image placeholders. Any construction opinion requires inspection of FIGS. 2–13 of the granted patent PDF (https://patentimages.storage.googleapis.com/a8/17/01/49bd13d6befa45/US9671318.pdf) to determine the aperture geometry. I am moderate-confidence only on the through-passage reading, and I state it as a construction question rather than a finding.

Secondary construction question: whether "tray" and "slidable" exclude rotary movement. The '318 spec expressly contemplates a "circular tray… rotatably slidable through the interior cavity" in an alternative embodiment, which would weigh against reading "slidable" as requiring purely linear motion — and if linearity is not required, 3,855,997's angular movement becomes an even closer structural fit for element (e), and 5,256,160's rotor for element (g).

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12. Caveats, limitations, and what I could not verify

1. No § 302/file-wrapper evidence of the examiner's actual rejections. As the prior-art section flagged, the definitive record of which references were applied against which claims during prosecution of 14/957,137 — and whether any § 103 combination or § 102(b)(2)(C) argument was made — is in the file wrapper. This § 103 analysis is an independent re-analysis, not a reconstruction of the examiner's reasoning. Retrieving the file wrapper (PatentCenter / Global Dossier) is the highest-value next step, because (a) it may show that the examiner already applied 8,088,079 or 3,855,997, which would strengthen an obviousness position or explain how the claims were allowed, and (b) prosecution-history statements by the applicant about the "second side aperture" or "two wells on one tray" could create prosecution-history estoppel narrowing the claims.
2. I did not re-verify Garren (US 2011/0106029 A1) or Rogers (US 7,488,312 B2) live in this session — my search budget was exhausted mid-verification. The Garren/Rogers descriptions used for claims 7 and 8 are taken from the prior-art section's treatment and my knowledge of the art. Claims 7 and 8 are strong on 8,088,079's perforated tray alone, so the conclusion does not depend on Garren/Rogers — but the two-reference chart for claim 8 should be re-verified before it appears in an invalidity contention.
3. Verified live this session: the full text of US 8,088,079 (including the decisive "second tray" and "plug tray… alternated" passages and the "dam… partially separates said container into multiple compartments" claims) — https://patents.google.com/patent/US20070191731 · https://patents.google.com/patent/US8088079 · https://patentimages.storage.googleapis.com/42/92/de/27bf530439f29b/US8088079.pdf ; and US 3,855,997's movable-cover disclosure — https://patents.google.com/patent/US3855997A ; and US 5,256,160's field/objects (combination sample trap + valve; one-hand operation; disposable) — https://patentimages.storage.googleapis.com/3d/b3/cf/511e642229ff33/US5256160.pdf ; and the MPEP § 2143/§ 2144.04 framework — https://www.uspto.gov/web/offices/pac/mpep/mpep-2100.pdf · https://www.bitlaw.com/source/mpep/2144-04.html
4. New references NOT in the '318 citation record. US 5,256,160 is in the record (examiner-cited), so it is usable. But my searches surfaced additional art outside the 70-reference set that a defendant could deploy: the Mectra family (US 5,203,769; US 5,019,054 "Medical device valving mechanism"; US 5,797,907 "Multi-way selection valve") — all sharing the 1989-11-06 priority — and Stryker's US 10,604,516 / US 10,471,188 manifold patents (2019, post-dating the '318 filing and therefore not prior art), plus a Stryker/Medtronic-style Japanese publication JP 2018-138162 A for a "sample collection cassette" (2018, also post-dating). I flag these expressly so they are not mistakenly treated as prior art: only the Mectra 1989/1993-era family could qualify, and it should be retrieved and date-checked against the 2015-12-02 effective filing date before use. None of my conclusions depends on any of them.
5. The '318 patent's § 102(b)(2)(C) character. US 2015/0359949 A1 ("Polyp Filter," Medline's own) remains excepted from § 102(a)(2) art for common ownership per the prior-art section's analysis. It therefore cannot be used as § 103 art either (art excepted from § 102(a)(2) is likewise unavailable under § 103). Do not build any obviousness position on the applicant's own '949 publication — a common and costly error in keyword-driven invalidity charts.
6. These likelihood figures are calibrated analyst judgment, not legal conclusions. They assume a POSITA as defined in § 2, a claim construction per § 11 on the through-passage reading, an averagely competent tribunal, and no expert testimony on either side. Realistic expert testimony on sealing behavior, mid-stroke suction loss, and manufacturing tolerance could move claims 1, 9 and 12 by 15–25 points in either direction — most likely against the patent owner on claim 1 (the "no break in suction" and "sealing effect" benefits are undemonstrated and largely unclaimed) and for the patent owner on claim 9 (the "structural detail, no reference" argument is the most purely hindsight-accusable).
7. Strongest single takeaway for a defendant: the case is won or lost at the motivation prong, not the element chart. 8,088,079 supplies the element chart and, in the bracketed quotations above, supplies the motivation in its own words. Quote those passages verbatim in the contention; do not paraphrase them.
8. Strongest single takeaway for the patent owner: the cleanest line of defense is to construe "tray" as a single carriage and the shuttle as a unitary, captive structure, and to press that no reference teaches or suggests transferring the well-selection function into the sliding collector itself. The corresponding weakness is that this is a "the prior art didn't do it exactly this way" argument, which KSR squarely addresses — so the defense will need either (a) a narrow construction that excludes 8,088,079's two-body alternation, or (b) affirmative nexus evidence tying commercial success to the two-well captive shuttle. Neither is currently in the record.