Invalidity dossier
US 8340785
Self expanding electrode cuff
Current assignee: Medtronic Inc
Added 9/26/2026, 4:04:54 AM
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Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll search for this specific patent number across the requested sources.
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Let me do a couple more targeted checks on ownership/assignment and any 2026 docket activity.
US Patent 8,340,785 — Analyst Summary
Search scope note: I ran targeted web searches against Google Patents (full text + granted PDF), FreePatentsOnline, Justia, Unified Patents, and general web indexes for CAFC/PTAB activity. I did not have direct PACER/Docket Alarm/CAFC-oral-argument-query access in this session, so the litigation and 2026-appeal findings below carry that limitation. I did not auto-correct the number; everything is reported for 8340785 / US 8,340,785 B2 only.
1. Bibliographic data (verified against granted PDF)
| Field | Value |
|---|---|
| Title | Self Expanding Electrode Cuff |
| Patent number | US 8,340,785 B2 |
| Application no. | 12/114,352 |
| Filing date | May 2, 2008 |
| Priority date | May 2, 2008 (no earlier domestic/foreign priority) |
| Date of patent (issue) | December 25, 2012 |
| Assignee (original & current) | Medtronic, Inc., Minneapolis, MN |
| Inventors | Eric H. Bonde (Minnetonka, MN); Roy L. Testerman (New Hope, MN); Timothy P. Herbert (Maple Grove, MN); Mark A. Christopherson (Shoreview, MN); Jesse D. Geroy (North Saint Paul, MN) |
| Prior publication | US 2009/0276024 A1, Nov. 5, 2009 |
| Examiner / attorney | Carl H. Layno (primary); Deborah Malamud (asst.); Dicke, Billig & Czaja PLLC |
| Classification | A61N 1/08 (Int. Cl. per PDF); A61N 1/0551, A61N 1/0556, A61N 1/0558 (CPC, cuff/peripheral-nerve electrodes) |
| Term adjustment | +847 days under 35 U.S.C. §154(b) ("subject to any disclaimer") |
| Google Patents status | "Active, expires 2031‑04‑16" — the source itself flags legal status/expiration dates as assumptions, not legal conclusions |
| Claims | 10 total; only Claim 1 is independent |
| Related U.S. | Continuation 13/718,544 → US 2013/0123895 A1 (status: abandoned) |
Foreign family (PCT/US2009/042543, filed 2009‑05‑01): WO 2009/135140 A1, EP 2310083 B1, JP 5571655 B2, CN 102105193 A, AU 2009242502 A1, CA 2722984 A1.
(Note: a co-pending Medtronic application, PCT/US2009/042539 → EP 2310082, also bears the title "Self expanding electrode cuff" with the same inventors and 2008‑05‑02 priority. That is a sibling filing, not this patent; note it literally per the source as EP 2310082.)
2. Abstract (verbatim)
"An expandable electrode cuff of an implantable stimulation system that includes a base member, a first flange member extending from a proximal end along a first side wall of the base member to a first distal end, and a second flange member extending from a proximal end along a second side wall of the base member to a second distal end. The first flange member extends over both a top wall of the base member and the second flange member, and the second flange member extends over the top wall to form a lumen. The electrode cuff is capable of being advanced between a first position corresponding to both flange members extending over the top wall, a second position corresponding to the first flange member not extending over the top wall and the second flange member extending over the top wall, and a third position corresponding to both of the flange members not extending over the top wall."
3. Independent claim — plain-language overview
Claim 1 (the sole independent claim)
An expandable electrode cuff (a nerve-wrap carrying stimulation electrodes) made of these parts:
- A base member with a first side wall and a second side wall that face each other, plus a top wall and bottom wall that face each other; the bottom wall spans from the first side wall to the second side wall.
- A first flange member (an outer wrap arm) having a proximal end and a first distal end.
- A second flange member (an inner wrap arm carrying the electrodes) that starts at a proximal end on the second side wall and ends at a second distal end. It is tapered — the proximal end has a first thickness substantially greater than the thinner second distal end.
- A third flange member starting at a proximal end on the first side wall and ending at a third distal end. The third distal end sits above the first side wall but does not extend over the top wall. It is also tapered (thicker at the proximal end than at the third distal end).
- Unitary construction: the third flange member, the second flange member, and the base member are one single unitary molded piece.
- Fixed first flange / biased assembly: the first flange's proximal end is fixedly engaged against the third flange member (i.e., bonded to it — the FIG. 10–12 embodiment), and the first flange is biased (spring-memory) to run from the third flange, over both the top wall and the second flange member. The second flange is likewise biased to arch over the top wall so that its distal end rests above, and in releasable contact with, the third distal end.
- Resulting lumen: the third flange and second flange together define a lumen (the nerve channel), with the first flange overlapping both the second and third flange members (a closed outer wrap that prevents gaps as the nerve swells).
- Proportionality limitation: the cross-sectional length of each of the first and second flange members is substantially greater than the cross-sectional length of the third flange member.
Practical reading: a self-closing, self-expanding molded cuff with a short inner locating flange (third), a long electrode-bearing inner flange (second), and a long outer overlapping flange (first) bonded to the short flange. The overlaps/taper/spring memory let the cuff be peeled open for placement and let it re-expand around a swelling nerve without creating an open gap that would let the nerve escape or stimulation current leak.
4. Dependent claims at a glance
| Claim | Adds |
|---|---|
| 2 | Three operable states: (a) both flanges over top wall, first flange running opposite the second and overlapping substantially its entire length; (b) only the second flange over the top wall; (c) neither flange over the top wall. |
| 3 | Expansion range: first lumen diameter at initial placement → larger second diameter after placement (swelling accommodation), expressed as measured distances of the distal ends above the reference walls. |
| 4 | Taper quantified: first thickness at least one order of magnitude greater than the second thickness. |
| 5 | "Means for pulling" one or both flanges under the nerve (supported by the sutures 537 / holes 539 of FIG. 17 and the tabs 645 / holes 639 of FIG. 18). |
| 6 | Incorporates the whole implantable stimulation system: IPG + stimulation lead (body with proximal/distal ends) + connector at the lead proximal end, with the cuff at the lead distal end. |
| 7 | The releasable-contact point between the second and third distal ends lies laterally of the first side wall. |
| 8 | Second and third flange members are memory-based material, shape-biased to form the lumen with the distal ends in releasable contact before nerve engagement. |
| 9 | First flange length configured to overlap substantially the entire length of the second flange. |
| 10 | A portion of the base member (including parts of both side walls) extends generally outward/away from the proximal ends of the third and second flanges respectively. |
Note: the pre-grant publication US 2009/0276024 A1 and the Canadian counterpart CA 2722984 A1 contain differently numbered and different-scope claims (e.g., an independent claims 1, 12 and a system claim 22 in CA 2722984 A1). Those are not the granted US claim set; do not conflate them with claims 1–10 above.
5. Technical substance worth flagging from the specification
- Field: obstructive sleep apnea (OSA) therapy via hypoglossal nerve / genioglossus stimulation using cuff electrodes.
- Stated design problem: cuff must hug the nerve (to avoid fibrous-tissue build-up and stimulation-current leakage to adjacent nerves/muscles) yet must not strangulate the nerve when it swells post-implant.
- Stated physiological constraint: ≈25 mmHg is quoted as the approximate pressure that may be applied to the nerve without restricting blood flow.
- Materials taught: polyurethane, silicone, or blends; silicone durometer ≈40A–70A; flange thickness ≈0.005–0.025 in (nominally 0.0075 in for ≈85A polyurethane); proximal ends ≈0.025–0.030 in; distal ends ≈0.001–0.010 in (0.005 in in one embodiment); lumen ID 0.050–0.400 in (nominally ≈0.140 in). Polyurethane is described as formed with "memory" biasing flanges toward the fully engaged position.
- Incorporated-by-reference: U.S. Pat. No. 6,572,543 (Christopherson et al.).
6. Litigation, PTAB, and CAFC 2026 docket status
Finding: I located no 2026 CAFC docket entry, no Federal Circuit appeal, and no PTAB (IPR/PGR) proceeding naming U.S. Patent 8,340,785.
What I did find (and what it is not):
- No district-court complaint asserting the '785 patent surfaced in searches. Closest hits were unrelated Medtronic litigations involving different patent numbers (e.g., Medtronic v. Axonics concerning 8,036,756 / 8,626,314 / 9,463,324 / 9,821,112 / 8,738,148 / 8,457,758 / 7,774,069; NuVasive/Medtronic IPRs; Medtronic v. Robert Bosch). Those numbers should not be mapped onto 8,340,785.
- One search hit referencing "8,340,785" was a Brazilian state commercial-registry filing (JUCISRS) listing a company registration number — a false positive with no patent relationship.
- The '785 patent appears in third-party citation lists (e.g., it is cited in the background/description of EP 4,003,158 B1), which shows it is treated as prior art/context in the sleep-disordered-breathing neuromodulation space (Inspire Medical Systems, Boston Scientific Neuromodulation, Alfred E. Mann Foundation, Invicta Medical appear in its citing/cited family lists). Prior-art citation is not litigation.
Uncertainty statement: absence of results in my searches is not proof that no action exists. A recently filed (2026) appeal or a sealed/not-yet-indexed proceeding could exist. A definitive check requires direct queries to the CAFC docket system and USPTO Patent Trial and Appeal Board / PatentCenter for Patent 8,340,785 — which I could not execute as an authenticated database query in this session.
7. Confidence and caveats
- Bibliographic fields, abstract, claim set (10 claims, claim 1 independent), and family data: high confidence — corroborated by the granted-PDF front page and Google Patents full text supplied as authoritative.
- "Active, expires 2031‑04‑16": reported as the source states it, but Google Patents expressly labels legal status and expiry as assumptions. The 2031 date is consistent with a May 2, 2028 base expiry plus the 847-day §154(b) adjustment (≈Sept. 2008 → April 2031 range), but treat it as non-authoritative.
- Claim 1 appears to read primarily on the FIG. 10–12 embodiment (first flange bonded to a short third flange, with the base/second/third as one molded piece) rather than the FIG. 3–5 embodiment which the text describes as "a single, unitary molded piece" including both flanges. That is a literal reading of the claim language ("fixedly engaged against the third flange member"); I flag it as an observation, not a legal conclusion on claim scope or validity.
Generated 9/28/2026, 3:22:23 PM
Cases on file (0)
Specific litigation cases in our database that name US patent 8340785. The free-form analysis below may also discuss cases beyond this list.
No cases on file mention this patent. Upload a CSV or add a case manually in Admin → Manage litigation cases.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll search for litigation involving US patent 8340785 across patent litigation databases.
Let me search more targeted litigation sources and specific case databases.
Let me search additional litigation-specific databases.
Litigation Search Results for U.S. Patent No. 8,340,785
Bottom line: Based on my searches, I found no publicly documented litigation (district court, ITC Section 337, or CAFC appeal) involving U.S. Patent No. 8,340,785. I must be candid that this is a negative finding qualified by real search limitations, explained below.
Patent identification (as verified, not corrected)
- Patent: US 8,340,785 B2 — "Self expanding electrode cuff"
- Inventors: Eric H. Bonde; Roy L. Testerman; Timothy P. Herbert; Mark A. Christopherson; Jesse D. Geroy
- Assignee/Owner: Medtronic, Inc.
- Application No.: 12/114,352 — filed May 2, 2008; granted Dec. 25, 2012
- Family: US 2009/0276024 A1 (pre-grant pub.); continuation US 13/718,544 (abandoned, pub. US 2013/0123895 A1); foreign counterparts EP 2310083, JP 5571655, CN 102105193, AU 2009242502, CA 2722984, and PCT WO 2009/135140
What the searches actually returned
Every hit referencing the '785 patent number was either a patent-document page or a citation, not a litigation record:
| Source | What it contained | Litigation? |
|---|---|---|
| Google Patents (US8340785) | Full patent text; "Cited By" list; family data | No |
| Unified Patents Portal (US-20080103570-A1 page) | Lists "US-8340785-B2 – Self Expanding Electrode Cuff" merely as a related patent in Medtronic's portfolio | No |
| FreePatentsOnline / Patent Encyclopedia | The continuation application text (US 2013/0123895) | No |
| PTAB/EPO/PCT documents (e.g., EP4003158B1, US9227053, JP5575113) | The '785 patent cited as prior art/background | No |
| A Brazilian state corporate registry (JUCIS-RS) | An unrelated registration number "8340785" for a cooperative — not this patent | N/A |
Notably, the "Cited By (48)" and "Families Citing this family (30)" tables on the patent page — the places where a litigation-driven citation (e.g., an IPR or an invalidity contention) would typically appear — contain only other patents and patent applications, with no litigation or PTAB case identifiers keyed to the '785 patent.
Important qualifications
- I was cut off before completing the full planned search set. My final two targeted queries — one for docket-level records ("8,340,785"/"8340785" on Docket Alarm) and one for a possible Medtronic v. Inspire Medical Systems nerve-cuff suit — did not return results before my search budget was exhausted. Those are exactly the queries most likely to surface a niche case, so the negative result is not fully conclusive.
- PACER and CAFC dockets require authenticated access and are not fully indexed by general web search; a filing that exists but was never picked up by a public aggregator could be missed.
- RPX/Unified litigation-portal case lists were not directly retrievable in a usable form for this patent number.
- This patent is a medical-device / neuromodulation patent held by a large operating company (Medtronic) in the hypoglossal-nerve-stimulation space. Such patents are frequently never asserted; the absence of litigation here is consistent with that pattern.
Requested case table
Because no case was identified, the table is empty:
| Plaintiff(s) | Defendant(s) | Jurisdiction | Case No. | Filing Date | Outcome/Status |
|---|---|---|---|---|---|
| — none found — | — | — | — | — | — |
Recommendation for definitive confirmation
To close the gap with certainty, the following should be run directly (I could not complete them):
- Unified Patents litigation search for "8340785" at
portal.unifiedpatents.com/litigation(district-court and PTAB case lists) - Docket Alarm / PACER docket search on the patent number
- USPTO PTAB search (IPR/PGR/CBM) — the patent's adjusted expiration of April 16, 2031 confirms it remained in force well into the AIA era, so a post-grant challenge is possible even if no district-court suit exists
- RPX Insight and Lex Machina patent-litigation modules
If you'd like, I can run those specific queries and report back — but on the evidence gathered so far, no litigation involving U.S. Patent No. 8,340,785 is known.
Generated 9/28/2026, 3:22:13 PM
Proceedings on file (0)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.
PTAB challenges
AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.
I'll verify the structured block's "no proceedings" finding against public sources before drafting.
Proceedings overview
Zero AIA trial proceedings. The structured PTAB block (USPTO Open Data Portal ingest) reports no AIA trial proceedings on file for US 8,340,785 — no IPR, no PGR, no CBM — and web search surfaced nothing contradicting that. Independent corroboration: RPX's patent page for US 8,340,785 B2 states "0 Petitions" (https://insight.rpxcorp.com/patent/[US8340785B2](/patent/US8340785B2)). Breakdown by status is therefore 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials.
Bottom-line defensive posture: all 10 claims (claim 1 independent; claims 2–10 dependent) stand untested and fully intact — no claim of US 8,340,785 has ever been canceled, narrowed, or even construed by the Board. That cuts both ways for a defendant: you cannot point to a dead claim to kill a demand letter, but you also inherit no § 315(e)(2) estoppel and a blank Board record — no prior petitioner has spent the money to map this cuff design against prior art, so the invalidity work is still entirely yours to do from scratch. Note also who the patent owner is: Medtronic, Inc. (a large, practicing medtech), not a troll — the "well-asserted patents eventually attract IPRs" heuristic is weakened here because the owner's posture has been licensing/commercial rather than wide-scale assertion.
No proceedings to enumerate
Because the canonical list is empty, the per-proceeding template ("most-impactful first") has nothing to populate. Do not accept any secondary source that appears to show an IPR against "the '785 patent" without checking the number digit-for-digit — see the trap table below.
Do-not-confuse table (three unrelated "'785 patents" that generate false hits)
| Authority | Number | Owner / context | Why it surfaces |
|---|---|---|---|
| Oren Technologies | US 9,440,785 | Proppant Express v. Oren, IPR2018-00733, FWD 2019-09-12, appeal Notice filed 2019-11-11 | Same last three digits; heavy web footprint, including a "Notice of Appeal" PDF |
| Sandbox Logistics | US 7,xxx,785 | Sandbox v. Grit Energy (fracking container claim construction) | District-court '785 hits with no PTAB tie |
| Halozyme / Merck | US 8,343,487 | PGR2025-00009 exhibit | Numerically adjacent; irrelevant to this patent |
(The Google Patents record for US 8,340,785 also cross-references US 9,227,053, "Self expanding electrode cuff," also Medtronic, priority 2008-05-02 — a separate patent in the same family. I found no evidence of PTAB proceedings against the '785 patent itself; I did not complete a verified check on '053, so treat any suggestion of IPRs on family members as an open lead, not a finding.)
Strategic summary
Claim status. US 8,340,785 issued 2012-12-25 with a 10-claim set. Claim 1 recites the three-flange, single-unitary-molded-piece cuff with the first flange "fixedly engaged against the third flange member" and the second flange biased into "releasable contact with" the third distal end; claims 2–10 add the three-position (fully engaged / intermediate open / fully open) transitions, the swelling-accommodation distance relationships, the ≥1-order-of-magnitude thickness ratio, the "means for pulling" limitation, the IPG/lead environment, the § 112-style memory-material limitation, and the base-portion geometry. CANCELED: none. SUSTAINED: none (nothing was ever challenged). UNTESTED: claims 1–10 — the entire patent. Any statement that a claim of this patent has been invalidated is wrong.
Estoppel landscape. With no IPR/PGR/CBM ever instituted, § 315(e)(2) estoppel does not exist against anyone — no petitioner or privy is barred from anything, and, more importantly for a present defendant, no prior-art ground has been "used up" at the Board. You are free to run § 102 and § 103 on any reference set, including the references the examiner already considered (the printed art on the face of the patent, e.g., Naples, Bullara, Tanagho, and the Schwartz 2001 hypoglossal-stimulation publication) and the Goodall et al. IEEE paper cited in the sibling European prosecution. Statutory paths still open: IPR is available; PGR is not (the application was filed 2008-05-02, well before the 2011-03-16 AIA effective date); CBM is not (the program sunset on 2020-09-16, and a nerve-cuff electrode would in any event likely qualify as a technological invention). Ex parte reexamination under § 302 remains a non-AIA fallback. Two clocks matter: § 315(b) bars a petition more than one year after service of a complaint on you or a privy, and § 315(a)(1) bars a petition filed by a party that already filed a DJ action of invalidity.
Pattern signals. No repeated-petitioner pattern, no patent-owner appeal pattern, no defensive aggregator (no Unified Patents or similar) in the chain — because there is no chain. The relevant pattern is the one that isn't there: a 2008-priority Medtronic cuff patent, in force until roughly 2031-04-16 per the adjusted-term status, that has gone 14 years post-grant without a single AIA challenge. Combined with the family history (EP 2310083 lapsed in 2016; continuation US 13/718,544 published as US 2013/0123895 A1 and went abandoned), the signal is a narrow, design-specific cuff patent whose enforcement has not been aggressive enough to draw a petition. If you are receiving a demand today, you are likely one of the first to be asked to design around it — which means your invalidity investigation is leaderless, but so is your opponent's playbook.
Recommended next steps
- Confirm the empty docket yourself, live. Run the patent number in PTAB E2E / the Board's public search (https://ptacts.uspto.gov/ptacts/) and in USPTO Patent Center (https://patentcenter.uspto.gov/) for application 12/114,352. Check Patent Center's transaction history for any ex parte reexamination or supplemental-examination certificate — I found no reexamination evidence in the public legal-status record, but I did not verify that against the official file. Anything found there is a continuation of the "no AIA trial" story, not a contradiction of it.
- Verify the family. Confirm whether any IPR/PGR exists against US 9,227,053 ("Self expanding electrode cuff," Medtronic, same 2008-05-02 priority). If a demand letter asserts the commercial cuff product, it may assert both patents; a proceeding on '053 would give you a shared invalidity record and a possible estoppel lever, and my searches did not resolve this.
- Since there are no FWDs to rely on, build the invalidity case in district court or prepare an IPR. With no Board precedent construing the claim-1 limitations — particularly "fixedly engaged against the third flange member," "releasable contact," and the "cross-sectional length ... substantially greater" limitation — expect the § 112 indefiniteness and claim-construction fights to be genuinely open. That is favorable for a defendant at the pleading stage.
- If you file an IPR, budget for discretionary denial. Any 2026 filing will be judged under current Director practice, including the workload-management guidance in the USPTO's 2025-03-26 "Interim Processes for PTAB Workload Management" memo and the Director's 2025-10-17 open letter on reinstating § 314/§ 324 institution discretion, plus Fintiv-style analysis against your parallel litigation. With no competing petition, § 325(d) and General Plastic are non-issues — the ordinary two-year, § 315(b) one-year clock is the real risk.
- Watch for the patent simply expiring out of relevance: adjusted expiration is on file as 2031-04-16, so this is not a § 101/eligibility throwaway or a near-term expiration defense.
Rule-of-thumb takeaway: "No PTAB activity" is a real signal only when paired with an active assertion campaign. Here there is no PTAB activity and no evidence I could find of the '785 patent being asserted. If you hold a demand letter, it may be the first real test of this patent — treat its claims as fully live, all 10 of them.
Generated 9/28/2026, 3:22:35 PM
Ownership chain (1)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
? · Assignment
Eric H. Bonde; Roy L. Testerman; Timothy P. Herbert; Mark A. Christopherson; Jesse D. GeroyMedtronic, Inc.
standard employee invention assignment
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
I'll search for assignment records and ownership-chain evidence for this patent.
Let me try to locate the specific assignment recordation data.
Let me attempt one more targeted search for the recordation data.
Assignment & Ownership Analysis — U.S. Patent No. 8,340,785 B2
Critical methodological caveat up front: My tools could not retrieve the structured reel/frame records from the USPTO Assignment Center (assignmentcenter.uspto.gov / assignment.uspto.gov) for this patent — the database is behind a dynamic search interface that my search tooling cannot query or scrape. I therefore cannot report reel/frame numbers, execution dates, recording dates, or the correspondent of record for the original inventor→assignee assignment, and I will not fabricate them. What follows is built from the authoritative patent text supplied in this task, the Google Patents bibliographic/legal-events data, the Unified Patents portal entry, and foreign-register (EPO/RVO) assignee data. Where I am inferring rather than reading a record, I say so.
Inventors
| # | Inventor | Employer at filing (determinable?) | Basis |
|---|---|---|---|
| 1 | Eric H. Bonde | Medtronic, Inc. (inferred — see note) | Sole-assignment context; appears on later Medtronic filings |
| 2 | Roy L. Testerman | Medtronic, Inc. (inferred) | PatentLeaderboard lists 22 Medtronic patents, including '785 and '053 |
| 3 | Timothy P. Herbert | Medtronic, Inc. (inferred) | Named on the '785 and related '053 family |
| 4 | Mark A. Christopherson | Medtronic, Inc. (inferred) | Named as "Christopherson et al." on U.S. Pat. 6,572,543, the Medtronic system incorporated by reference at col. 1 of the '785 spec |
| 5 | Jesse D. Geroy | Medtronic, Inc. (inferred) | Named on the '785 and related '053 family |
Pattern flags:
- All five appear to be Medtronic personnel at filing; the specification itself cites Medtronic's own earlier work (U.S. Pat. 6,572,543 to Christopherson et al., "incorporated herein by reference in its entirety") and describes an implantable stimulation system with an implantable pulse generator — i.e., this is a captive corporate R&D filing, not an inventor-owned filing. There is no evidence of all inventors departing the original assignee within 12 months of the 2008-05-02 filing.
- Continuity of employment evidence: Bonde and Testerman re-appear as co-inventors on the related Medtronic patent U.S. 9,227,053 B2 ("Self expanding electrode cuff," granted 2016-01-05), and Bonde appears on a much later Medtronic filing (EP 3,675,950, priority 2017-08-29). This is anti-signal evidence against a "fire-sale precursor" reading — key inventors stayed with the assignee for years after filing.
- Unverified lead (do not treat as fact): Public reporting associates the name Timothy P. Herbert with the founding of Inspire Medical Systems (a Minneapolis hypoglossal-nerve-stimulation company that commercialized this therapy area). I could not confirm this with the sources available to me and flag it only as a name collision worth independent verification — if confirmed, it would be a notable inventor-retention/spin-out narrative, not an ownership-chain event, since the '785 patent never left Medtronic (below).
Original assignee
- Entity on the issued patent: Medtronic, Inc. (a Minnesota corporation; current/record assignee per Google Patents and the Unified Patents portal entry, which lists "Medtronic Inc" as assignee of US-8340785-B2).
- Line of business: The world's largest medical-device company; cardiac rhythm management, neuromodulation, diabetes, and surgical technologies. The '785 claims sit in Medtronic's neurostimulation / hypoglossal-nerve-stimulation portfolio (CPC A61N 1/0556 "Cuff electrodes"; A61N 1/0558 "Anchoring or fixation means").
- Product embodying the claims: Medtronic ran a hypoglossal nerve stimulation (HGNS) program for obstructive sleep apnea. I could not verify in the available sources that Medtronic ever commercially shipped a product practicing the '785 claims under its own brand; the therapy area ultimately reached market through Inspire Medical Systems (which the '785 patent family is cited against, e.g., Inspire's WO 2019/032890 "Cuff electrode"). Treat "did Medtronic ship it?" as unresolved.
- Current status: Operating — a going-concern, actively expanding med-tech company. Not acquired, dissolved, or in bankruptcy. No bankruptcy-style fire-sale risk exists in this chain.
Assignment timeline
Finding: the ownership chain contains only the original assignment. I could not retrieve the recordation metadata.
- 2008-05-02 (filed) — Reel/frame: not retrievable via available tools
- Conveyance: Assignment (inventors → corporation) — the canonical path for a captive Medtronic filing; I am inferring the record exists because the patent issued with Medtronic as assignee, but I did not read the reel/frame
- Assignor: Bonde; Testerman; Herbert; Christopherson; Geroy (individually)
- Assignee: Medtronic, Inc.
- Correspondent: not retrievable — cannot state the attorney/firm of record
- Context: standard employee invention assignment (initial vesting in employer)
- ~2009-05-01 — Reel/frame: not retrievable
- 2012-12-18 — Reel/frame: not retrievable
- Continuation US 13/718,544 filed (published US 2013/0123895 A1), same inventive entity, Medtronic as assignee
- Context: prosecution-family continuation, later abandoned (Google Patents "Family Applications" table marks 13/718,544 "Abandoned")
- No post-issuance assignment to any third party appears in any source I could consult.
Per your instruction, because the only transaction of record is the original assignment and I cannot surface additional links, I stop the chain analysis at the original assignee — Medtronic still owns the patent. (Google Patents lists the patent as Active, adjusted expiration 2031-04-16, "Current Assignee: Medtronic Inc" — consistent with no transfer ever having occurred.)
Timeline diagram
timeline
title Ownership of US 8340785
2008 : Filed by five Medtronic inventors
: Rights assigned to Medtronic Inc
2009 : Foreign family filed by Medtronic
2012 : Patent US 8340785 granted
: Continuation filed and later abandoned
2031 : Adjusted expiry remains with Medtronic
NPE / troll-pattern signals
| # | Signal | Call | Evidence / basis |
|---|---|---|---|
| 1 | Shell-entity transfer | Not present | No assignment from Medtronic to any licensing-only LLC appears in any consulted source. Current assignee remains Medtronic, Inc. No "IP/Holdings/Ventures" successor in the chain. |
| 2 | Known asserter in the chain | Not present | Current and sole assignee is Medtronic — an operating company, not on any Acacia / Marathon / IV / Wi-LAN / Conversant / Vringo / Pendrell / Round Rock list I can check. No licensing-only entity appears. |
| 3 | Repeat correspondent across the chain | Unclear | I could not retrieve the correspondent of record for the original assignment, so I cannot assess recurrence. Note the prosecution correspondent for Medtronic's Minneapolis filings is commonly captured under Medtronic's internal patent-ops docketing or outside firms such as Shumaker & Sieffert, P.A. (Woodbury, MN) on modern Medtronic recordations (e.g., reel 066993/0200) — but these are other Medtronic applications, not this patent, and prove nothing about the '785 chain. No NPE recurrence finding is supportable here. |
| 4 | Cascading transfers | Not present | No sequence of chained LLC transfers exists — zero post-issuance transfers. No shared correspondent address or common principals to point to. |
| 5 | Pre-litigation transfer | Not present | No assignment within 6 months before any suit, because no suit naming the '785 patent was found (consistent with the prior litigation section of this analysis, which returned no cases). |
| 6 | Bankruptcy fire-sale | Not present | Medtronic has never been in Chapter 7/11; no IP sale-out of this patent is evidenced. |
| 7 | Privateering | Not present | This is the inverse scenario that the litigation search would have surfaced — an operating company transferring to an NPE to sue competitors. No transfer occurred, and no NPE assertion campaign tied to '785 was found. |
| 8 | Defensive aggregator termination | Not present | The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates at the original operating assignee. |
Additional observation (not a scored signal): the patent's 48-item "Cited By" list is populated entirely by other patents/applications (mostly Inspire Medical Systems and Boston Scientific Neuromodulation) — the pattern you'd expect for a widely cited foundational operating-company patent, not an assertion vehicle. The prior-art date of 2008-05-02 and the 2031-04-16 expiry place it squarely in the AIA era, so a PTAB post-grant challenge (IPR/PGR) would have been legally available — yet none keyed to '785 appears in the sources I saw.
Verdict
Insufficient data (only the original assignment is evidenced).
Justification: the only ownership event I can substantiate is the original inventor→Medtronic, Inc. assignment associated with application 12/114,352 (filed 2008-05-02; granted 2012-12-25), with a later Medtronic continuation 13/718,544 (2012-12-18, since abandoned) and Medtronic-held foreign counterparts (EP 2310083, JP 5571655, etc.). There is no recorded transfer to an NPE, no cascade, no defensive-aggregator termination, and no litigation — but because I could not read the Assignment Center's reel/frame metadata (no reel, frame, execution/recording dates, or correspondent retrievable), I cannot certify a complete chain. On the evidence available, the patent sits with its original operating-company assignee and was never transferred — the strongest negative NPE finding this dataset supports, though formally "insufficient data" given the un-retrieved recordation details.
Verification link (run this to close the gap): USPTO Assignment Center search for patent 8,340,785 — https://assignment.uspto.gov/patent/index.html (and the dynamic portal at https://assignmentcenter.uspto.gov/). Also review Google Patents legal events at https://patents.google.com/patent/[US8340785B2](/patent/US8340785B2)/en.
Cross-reference with previously generated sections
This is consistent with the prior litigation section's negative finding. Note one minor discrepancy between sources that I do not treat as material: the Unified Patents portal entry tags US-8340785-B2 with the date string "2008-05-01," while the patent's priority/filing date is 2008-05-02; Google Patents and the EPO register both use 2008-05-02. I flag it only as a source-indexing artifact, not a corrected date.
Open items I could not resolve (stated plainly rather than guessed)
- Reel/frame, execution date, recording date, and correspondent of record for the original assignment.
- Whether Medtronic ever shipped a product practicing the '785 claims, versus the therapy reaching market via Inspire Medical Systems.
- Confirmation of the reported Herbert → Inspire Medical Systems link.
Generated 9/28/2026, 3:23:18 PM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll search for the citation record of US 8,340,785 to identify its cited prior art references.
I have the front-page reference list. Let me retrieve the complete list and details on the most relevant nerve-cuff references.
Prior-Art Analysis — U.S. Patent No. 8,340,785 B2
1. Patent identified (literal, not corrected)
| Field | Value |
|---|---|
| Patent No. | US 8,340,785 B2 |
| Title | Self expanding electrode cuff |
| Inventors | Eric H. Bonde; Roy L. Testerman; Timothy P. Herbert; Mark A. Christopherson; Jesse D. Geroy |
| Assignee | Medtronic, Inc. |
| App. No. / Filing | 12/114,352 — filed May 2, 2008 |
| Priority / Granted | May 2, 2008 / Dec. 25, 2012 |
| Claims | 10 (1 independent) |
| Adjusted expiration | Apr. 16, 2031 |
Note on scope/verification: I was unable to complete a direct authenticated USPTO PatentCenter / Patent Public Search query before my search budget was exhausted. The reference list below is taken from the "References Cited" (56) block printed on the face of US 8,340,785 B2 (Google Patents/Justia mirror the same USPTO record, and both reproduce the front page). Where the scanned front page is internally inconsistent, I flag it rather than silently correcting it (per your literal-interpretation rule). Descriptions of what each reference discloses are given with a confidence qualifier; I did not individually open all ~60 references, so treat the "disclosure" column as a triage aid, not a verified quotation.
Critical framing point: the references below are the backward citations (art of record considered by the examiner during prosecution of 12/114,352). Because the application was filed May 2, 2008, pre‑AIA 35 U.S.C. § 102 governs. Every cited U.S. patent issued before May 2, 2007 and therefore qualifies as a §102(b) statutory bar. The "Cited By (48)" / "Families Citing this family (30)" tables are forward citations (later patents citing the '785) and are not prior art to the '785 — I discuss them separately in §6.
2. U.S. Patent Documents cited on the face of US 8,340,785
(citations and dates exactly as printed on the front page)
| # | Citation | Date | Brief description / field | Potentially anticipates any '785 claim? |
|---|---|---|---|---|
| 1 | US 3,654,933 A — Hagfors | 4/1972 | Early implantable/body electrode art (specific teaching not verified) | No |
| 2 | US 3,774,618 A — Avery | 11/1973 | Early implantable electrode art (not verified) | No |
| 3 | US 4,374,527 A — Iversen | 2/1983 | Body-implant/prosthetic device art (not verified) | No |
| 4 | US 4,979,462 A — Borkan et al. | 4/1983 | As printed, the number and date are internally inconsistent (a 4,979,xxx patent issued ~1991, not 1983). The April-1983 Borkan reference is likely US 4,379,462. Flagged, not corrected. | No |
| 5 | US 4,512,351 A — "Poindorf" | 4/1985 | Lead/electrode art; probable typo for Pohndorf | No |
| 6 | US 4,573,481 A — Bullara | 3/1986 | Spiral/self-curling nerve-electrode cuff (resilient sheet wrapped around nerve) — high confidence this is nerve-cuff art | Closest art group (see §3) |
| 7 | US 4,602,624 A — Naples et al. | 7/1986 | Nerve cuff electrode — self-curling dielectric sheet forming a helical cuff about a nerve (Case Western) | Closest art group (see §3) |
| 8 | US 4,628,614 A — Thompson | 12/1986 | Electrical connector/lead art | No |
| 9 | US 4,649,936 A — Ungar et al. | 3/1987 | Self-curling / coiled sleeve electrode art (moderate confidence) | Possible §103 combination |
| 10 | US 4,838,272 A — Lieber | 6/1989 | Electrode assembly/cuff art (moderate confidence) | Possible §103 combination |
| 11 | US 4,940,065 A — Tanagho et al. | 7/1990 | Neural/electrode stimulation device art | No |
| 12 | US 4,967,755 A — "Poindorf" (Pohndorf) | 11/1990 | Body-implantable lead art | No |
| 13 | US 5,038,781 A — Lynch | 8/1991 | Implantable electrode art | No |
| 14 | US 5,095,905 A — Klepinski | 3/1992 | Medical electrical lead/electrode art | No |
| 15 | US 5,158,080 A — Kallok | 10/1992 | Cardiac/nerve stimulation apparatus | No |
| 16 | US 5,238,006 A — Markowitz | 8/1993 | Neuro/electrode art | No |
| 17 | US 5,265,624 A — Bowman | 11/1993 | Implantable lead art | No |
| 18 | US 5,282,468 A — Klepinski | 2/1994 | Medical electrical lead art | No |
| 19 | US 5,324,322 A — Grill, Jr. et al. | 6/1994 | Nerve-cuff electrode modeling/stimulation art | No |
| 20 | US 5,344,438 A — Testerman et al. | 9/1994 | Nerve/electrode cuff art (inventor overlap with '785) | Possible §103 combination |
| 21 | US 5,351,394 A — Weinberg | 10/1994 | Electrode/lead manufacture art | No |
| 22 | US 5,398,596 A — Fond et al. | 3/1995 | Endocardial/body-electrode art | No |
| 23 | US 5,400,784 A — Durand et al. | 3/1995 | Nerve-cuff electrode (selective nerve stimulation) | Possible §103 combination |
| 24 | US 5,487,756 A — Kallesoe et al. | 1/1996 | Self-curling nerve cuff electrode (resilient sheet) | Closest art group (see §3) |
| 25 | US 5,505,201 A — Grill, Jr. et al. | 4/1996 | Cuff-electrode / stimulation art | No |
| 26 | US 5,531,778 A — Maschino | 7/1996 | Cuff/electrode art | No |
| 27 | US 5,591,216 A — Testerman et al. | 1/1997 | Sleep-apnea / nerve-stimulation electrode art (inventor overlap) | Possible §103 combination |
| 28 | US 5,634,462 A — Tyler et al. | 6/1997 | Implantable electrode/lead art | No |
| 29 | US 5,741,319 A — Woloszko et al. | 4/1998 | Nerve-cuff/electrode art | No |
| 30 | US 5,824,027 A — Hoffer et al. | 10/1998 | Nerve-cuff electrode with electrodes for selective stimulation | Possible §103 combination |
| 31 | US 5,919,220 A — Stieglitz et al. | 7/1999 | Micro-electrode/cuff art | No |
| 32 | US 5,938,586 A — Woloszko et al. | 8/1999 | Electrode/nerve art | No |
| 33 | US 6,066,165 A — Racz | 5/2000 | Epidural/lead art | No |
| 34 | US 6,093,197 A — Bakula et al. | 7/2000 | Nerve/electrode lead art | No |
| 35 | US 6,366,815 B1 — Haugland | 4/2002 | Nerve-cuff electrode (multielectrode) | Possible §103 combination |
| 36 | US 6,456,865 B1 — Tyler et al. | 9/2002 | Electrode/nerve art | No |
| 37 | US 6,572,543 B1 — "Christophenson" (Christopherson) et al. | 6/2003 | Implantable stimulation system for sleep apnea / hypoglossal nerve — expressly incorporated by reference in the '785 and used as the '785's own system context | No (it is the system, not the cuff) |
| 38 | US 6,587,725 B1 — Durand et al. | 7/2003 | Nerve-cuff electrode / selective stimulation | Possible §103 combination |
| 39 | US 6,600,956 — Maschino et al. | 7/2003 | Cuff/electrode art | No |
| 40 | US 6,907,293 — Grill | 6/2005 | Nerve-cuff / stimulation art | No |
| 41 | US 6,907,295 — Gross | 6/2005 | Nerve stimulation art | No |
| 42 | US 7,054,692 — Whitehurst et al. | 5/2006 | Implantable stimulation lead/electrode art | No |
| 43 | US 7,065,410 — Bardy | 6/2006 | Implantable cardiac device art | No |
| 44 | US 7,082,336 — Ransbury et al. | 7/2006 | Implantable intravascular device art | No |
| 45 | US 7,155,278 — (assignee/inventor truncated in the source I retrieved) | 12/2006 | Implantable stimulation/lead art | No |
Foreign patent document of record: EP 0865800 — 9/1998 — nerve-cuff electrode art (the same EP 0865800 appears in the EPO search report for related family EP 0865800A3, which lists Kallesoe US 5,487,756, Testerman US 5,344,438, Naples US 4,602,624, Loeb US 4,590,946, Medtronic EP 0723788, Durand US 5,400,784 — i.e., the classic self-curling nerve-cuff cluster).
Non-patent literature of record: A. Schwartz et al., "Therapeutic Electrical Stimulation of the Hypoglossal Nerve in Obstructive Sleep Apnea," Arch Otolaryngol Head Neck Surg., vol. 127, Oct. 2001, pp. 1216–1223. This is the clinical/method background for hypoglossal-nerve stimulation, not a structural cuff reference; it cannot anticipate any claim.
3. § 102 anticipation analysis — the references that actually matter
Anticipation under §102 requires a single reference disclosing every element of the claim, arranged as in the claim. Claim 1 is a narrow, structurally specific apparatus claim requiring, in combination:
- a base member with first/second side walls and top/bottom walls;
- a first (outer) flange whose proximal end is fixedly engaged against the third flange member and which is biased to extend over the top wall and over the second flange;
- a second flange extending from the second side wall, tapered (thicker proximal, thinner distal);
- a third flange extending from the first side wall, distal end positioned above the first side wall but not over the top wall, tapered;
- second + third flanges + base formed as a single unitary molded piece;
- the second flange biased over the top wall so its distal end sits spaced above and in releasable contact with the third distal end to form a lumen;
- the first flange overlapping both the second and third flanges; and
- cross-sectional length of the first and second flanges substantially greater than that of the third flange.
Result of the review: None of the cited references anticipates claim 1 (or claims 2–10) under §102. This is consistent with the fact that the examiner allowed the claims over this art. The most relevant references each disclose at most one or two of the eight elements:
| Reference | What it discloses toward claim 1 | Why it does not anticipate |
|---|---|---|
| US 4,602,624 (Naples) — nerve cuff, self-curling helical sheet | A resilient, self-biased sheet that curls into an overlapping, closed cuff about a nerve (i.e., element 6's "biasing to form a lumen" and element 7's "overlap") | Single-piece spiral sheet; no base member with four walls, no discrete first/second/third flanges, no tapered two-thickness flanges, no first flange "fixedly engaged against" a third flange |
| US 4,573,481 (Bullara) — spiral nerve electrode | Overlapping spiral electrode cuff about a nerve (overlap; self-closing bias) | Same gaps as Naples; single spiral, not the three-flange molded assembly |
| US 5,487,756 (Kallesoe) — self-curling nerve cuff | Resilient cuff that curls around a nerve; may include multiple layers of a spiraled sheet | No base + first/second/third flange architecture; no tapered thickness limitation; no "releasable contact" between second and third distal ends |
| US 5,344,438 (Testerman) / US 5,591,216 (Testerman) | Cuff/nerve electrodes, sleep-apnea nerve stimulation context | Cuff structures differ; no two-part outer/inner flange with unitary-molded base + third flange |
| US 5,400,784 (Durand) / US 5,824,027 (Hoffer) / US 6,366,815 (Haugland) / US 6,587,725 (Durand) / US 5,741,319 (Woloszko) | Multi-electrode nerve-cuff designs for selective stimulation | Disclose cuff bodies with electrodes, but not the claimed flange-over-flange closure architecture or the taper |
| US 6,572,543 (Christopherson) | The entire implantable sleep-apnea stimulation system (IPG, lead, sensor) that the '785 expressly incorporates | It is the host system; it does not disclose the expandable three-flange cuff at all — and it is cited for the system context, not as cuff art |
Best §102 framing: No single cited reference discloses the "first flange fixed to a third flange, biased over both the top wall and the second flange, with a tapered second flange in releasable contact with a tapered third flange, the base + second + third flanges being one unitary molded piece" combination. The manifold's only realistic attack vector is §103 (obviousness) via a combination such as Naples/Bullara/Kallesoe (self-curling, overlapping, biased cuff) + a tapered/dual-flange cuff reference + Testerman/Christopherson (hypoglossal-nerve context) — and even that combination is a stretch against element 8 (relative cross-sectional lengths) and the "fixedly engaged / unitary molded" recitations.
Claim-by-claim §102 bottom line:
| Claim | Subject | §102 anticipated by any cited ref? |
|---|---|---|
| 1 | Three-flange expandable cuff | No |
| 2 | Three-position advancement | No |
| 3 | Two-diameter expansion range | No |
| 4 | 1st thickness ≥ one order of magnitude > 2nd | No |
| 5 | Means for pulling flange under nerve | No |
| 6 | System (IPG + lead + connector + cuff at distal end) | No (Christopherson '543 discloses the system but not the claimed cuff) |
| 7 | Releasable contact located laterally of first side wall | No |
| 8 | Memory-based material biasing to a closed lumen | No (Naples/Bullara/Kallesoe approach this concept, but not the claimed structure) |
| 9 | First flange overlaps substantially entire second flange | No |
| 10 | Base portion extending outward away from flange proximal ends | No |
4. Additional art considered in the family (flagged)
The granted EP counterpart EP 2310083 B1 expressly states (at [0006]): "US 7,248,930 and US 2006/030919 disclose examples of cuff electrodes configured to be positioned about a nerve." Those two references are therefore part of the family's considered art even though they do not appear in the US front-page list. I could not verify their exact disclosures within this session — flagged for verification. They, too, appear to be generic cuff-electrode art and would not anticipate the three-flange unitary-molded claim.
5. Related family = NOT prior art
The following share the May 2, 2008 priority date and are the same inventive family, so they are excluded from the prior-art analysis (they cannot be §102 art against their own family):
- US 2013/0123895 A1 — continuation app. 13/718,544 (abandoned) of the '785.
- US 2011/0147046 A1 → US 9,227,053 B2 — app. 12/990,702 (from PCT/US2009/042539), titled "Self expanding electrode cuff," disclosing the re-closable-opening / biased overlapping flange embodiments. (Note: the '785 and the '053 are sibling, not parent/child, filings — a point worth keeping straight if either is asserted.)
- Foreign counterparts: EP 2310083, EP 2310082, JP 5571655, CN 102105193, AU 2009242502, CA 2722984, WO 2009/135140.
6. Forward citations (not prior art, but probative)
The 48 "Cited By" documents are later patents/Applications that cite the '785 — evidence the '785 is regarded as foundational cuff art. Notable ones: US 10,981,000 B2 (Alfred E. Mann Foundation, "Self-expanding nerve cuff electrode"), US 11,833,348 and US 12,194,290 (Alfred E. Mann, multi-application nerve cuffs), US 12,350,489, US 12,576,267, WO 2019/032890 (Inspire Medical, "Cuff electrode"), and DE 10 2018 213120 A1 (Neuroloop). These cannot anticipate the '785.
7. Bottom line
- US 8,340,785 B2 is confirmed literally; it is a Medtronic hypoglossal-nerve cuff patent (app. 12/114,352, filed 5/2/2008, granted 12/25/2012).
- Its prior art of record is a large (~45 U.S. patents + EP 0865800 + one journal article) body of mostly general implantable-electrode and nerve-cuff art.
- No cited reference anticipates any of claims 1–10 under §102. The closest references (Naples US 4,602,624; Bullara US 4,573,481; Kallesoe US 5,487,756; and the Testerman cuff patents) disclose self-curling, overlapping, biased nerve cuffs but lack the '785's specific base member + tapered second flange + tapered third flange (unitary molded with the base) + outer first flange fixedly engaged to the third flange, overlapping both, all with the claimed relative cross-sectional lengths.
- The realistic invalidity theory is §103, not §102.
- Qualifications/caveats: (a) I could not complete a direct authenticated USPTO PatentCenter query; (b) I did not open the full text of all ~45 references, so the "description" column is a triage estimate and should be verified against each reference's specification; (c) the front-page scan contains at least three internal inconsistencies (item 4 "4,979,462 / 4/1983"; "Poindorf" vs. Pohndorf; "Christophenson" vs. Christopherson) that I have flagged rather than corrected, per your literal-interpretation rule.
Would you like me to (i) pull and verify the full disclosure of the specific closest references (Naples '624, Bullara '481, Kallesoe '756, Testerman '438/'216, Durand '784/'725, Haugland '815), and/or (ii) run an authenticated USPTO PatentCenter/Patent Public Search confirmation of the complete "References Cited" list for 12/114,352?
Generated 9/28/2026, 3:23:14 PM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll pull the prior-art references for the '785 patent before analyzing.
Let me pull the full cited-references list and the key cuff-electrode references.
Obviousness Analysis — U.S. Patent No. 8,340,785 B2
"Self expanding electrode cuff" · Bonde, Testerman, Herbert, Christopherson, Geroy · Medtronic, Inc. · App. 12/114,352 filed 2008‑05‑02 · granted 2012‑12‑25 · 10 claims (1 independent)
Note on scope of this section: Per the instruction, I use the prior‑art results surfaced for this page. I was able to retrieve only part of the (56) "References Cited" list — the front page of the granted patent shows the US patent list through US 5,938,586, then truncates (the "6,066,165 A 5/2…" entry is cut off mid‑line). The full "Citations (82)" table on Google Patents did not render in my retrievals. Accordingly, combinations below are built from (a) the references I could positively confirm as cited on the face of the patent, (b) references cited during prosecution of the EP counterpart (EP 2310083), and (c) the non‑patent literature listed in the patent and in progeny. This is not an exhaustive invalidity search, and the ~50 unretrieved front‑page citations could contain art that is closer than what I discuss.
1. Governing framework and the prior‑art window
| Item | Value |
|---|---|
| Statute | Pre‑AIA 35 U.S.C. §§ 102/103 (application filed 2008‑05‑02, before 2013‑03‑16) |
| Critical date | 2008‑05‑02 (priority + filing; no earlier priority claimed) |
| Prior art eligible | 102(b) art published/patented before 2008‑05‑02; 102(a)/(e) art before that date; 102(e) subject to the pre‑AIA 103(c) common‑ownership carve‑out |
| Standard | Graham v. John Deere, 383 U.S. 1 (1966); KSR Int'l v. Teleflex, 550 U.S. 398 (2007); MPEP §§ 2141–2144 |
| Family | PCT/US2009/042543 → WO 2009/135140; EP 2310083 B1; JP 5571655 B2; CN 102105193 A; AU 2009242502 A1; CA 2722984 A1; continuation US 13/718,544 (abandoned, US 2013/0123895 A1) |
Important family caveat — do not use as art: the sibling Medtronic filing published as US 2011/0147046 A1 / CA 2722982 A1 (same 2008‑05‑02 priority, Medtronic, same subject matter) shares inventorship/ownership with the '785 patent. Under pre‑AIA § 103(c) a commonly owned 102(e) reference is not prior art for obviousness. Any analysis that leans on the sibling disclosure should be discarded; I do not use it below.
2. Claim 1, decomposed into limitation groups
Claim 1 is the only independent claim. Its structural requirements, labeled for the chart in §5:
- L1 Expandable electrode cuff of an implantable stimulation system
- L2 Base member: first side wall, second side wall, top wall, bottom wall; side walls opposed; bottom wall spanning first→second side wall
- L3 First flange member (proximal end + first distal end)
- L4 Second flange member, proximal end extending from the second side wall, tapered — proximal thickness substantially greater than distal thickness
- L5 Third flange member, proximal end extending from the first side wall, third distal end positioned above the first side wall without extending over the top wall, also tapered
- L6 Third flange + second flange + base member = single unitary molded piece
- L7 First flange proximal end fixedly engaged against the third flange; first flange biased to extend from the third flange over both the top wall and the second flange
- L8 Second flange biased over the top wall so its distal end is spaced above, and in releasable contact with, the third distal end — the second and third flanges form a lumen
- L9 First flange overlapping both second and third flanges
- L10 Cross‑sectional length of each of the first and second flanges substantially greater than that of the third flange
Dependent claims add: 3‑position articulation (2), diameter change accommodating nerve growth/swelling (3), "at least one order of magnitude" taper ratio (4), means for pulling a flange under the nerve (5), system with IPG/lead/connector (6), lateral contact point (7), memory‑based material (8), full‑length overlap (9), flared base/side‑wall extension (10).
3. Person having ordinary skill in the art (POSITA)
A POSITA at the 2008 critical date would be a biomedical engineer or neurophysiologist (B.S. + 2–5 years, or M.S./Ph.D. + 0–3 years) with experience designing chronically implantable, elastomeric nerve cuff electrodes and leads — i.e., familiar with the split‑cylinder and self‑curling cuff families, silicone/polyurethane dip‑molding and bonding, silicone durometer selection, and the clinical problem of perineural fibrosis, nerve swelling, and cuff‑induced ischemia. This is a mature, well‑populated, highly predictable art: by 2008 the field had a ~40‑year literature on cuff geometry (Bullara '481; Naples '624; Hoffer '027) and a ~20‑year literature on hypoglossal stimulation for OSA (Schwartz 2001, listed in the patent itself).
The level of skill matters here because nearly every element of claim 1 is a mechanical/geometric arrangement in a crowded design space, which lowers the bar for "predictable" under KSR.
4. Prior art positively confirmed as of record
4.1 Confirmed from the face of US 8,340,785 (front page, (56))
| Reference | Relevance (what it teaches) | Confidence |
|---|---|---|
| US 4,602,624 (Naples et al.) — self‑curling spiral cuff | Self‑coiling sheet of elastomeric material biased into a tight spiral; self‑sizing — the coil opens/closes to accommodate a range of nerve diameters; the patent later discusses this as the canonical "self‑curling coil type" cuff | High (known art; described in Tyler '462 and Sahin/Durand 1994) |
| US 4,573,481 (Bullara) — helical/spiral cuff electrode | Self‑coiling sheet electrode; sibling of the Naples design | Medium‑High |
| US 5,344,438 (Testerman et al.) | U‑shaped / semi‑cylindrical non‑conductive body with electrodes in the interior base portion, legs, resilient supports (32, 34) that flex in response to excess tension, and — critically — sutures 40a, 40b passed through leg 30 and drawn under the nerve with forceps until "the nerve is seated in the interior base portion 122" | High (verified from the PDF) |
| US 5,634,462 (Tyler et al.) | Corrugated inter‑fascicular nerve cuff; expressly classifies prior cuffs as "split‑cylinder type or self‑curling coil type"; states self‑curling cuffs "tend to interfere with normal swelling and movement of the nerve. Damage to the nerve fibers can result when the self‑curling cuff lodges too tight around the nerve preventing nutrients, blood and other critical fluid flow" | High (verified from the PDF) |
| US 5,824,027 (Hoffer et al.) | Nerve cuff with a wall band defining a lumen (30), a closure (22) using interdigitating closing elements plus a sealing tube, and open/closed configurations | High |
| US 5,487,756 (Kallesoe et al.) | "Implantable cuff having improved closure" — reopening/reclosing a perineural cuff | High |
| US 5,095,905 / 5,282,468 (Klepinski) | Nerve cuff / electrode closures reused across the cuff literature | High |
| US 5,531,778 (Maschino) | Circumneural electrode assembly with wrap‑around geometry | Medium |
| US 5,741,319 / 5,938,586 (Woloszko et al.) | Medical electrical leads with cuff electrode structures | Medium |
| US 5,591,216 (Testerman et al.) | Related cuff/electrode structure to '438 (same inventor) | Medium |
| EP 0865800 (9/1998) | Foreign cuff/lead art | Medium |
| Schwartz et al., "Therapeutic Electrical Stimulation of the Hypoglossal Nerve in Obstructive Sleep Apnea," Arch Otolaryngol Head Neck Surg. 127:1216‑1223 (Oct. 2001) | Non‑patent literature supplying the clinical motivation: hypoglossal stimulation for OSA and the need for a reliable perineural electrode | High |
4.2 Confirmed from prosecution of the EP counterpart (EP 2310083 B1)
The EP search/opposition document for the same family expressly cites, as examples of "cuff electrodes configured to be positioned about a nerve":
- US 7,248,930 (Woloszko et al., "Medical electrical lead")
- US 2006/0030919 A1
These are the art the EPO considered most pertinent to the same claim set. Any US obviousness theory should address them.
4.3 Other art confirmed in the record (useful for dependent claims / secondary evidence)
- US 6,572,543 (Christopherson et al.) — expressly incorporated by reference in the '785 patent; the Medtronic IPG + stimulation lead + pressure‑sensor OSA system → directly supports claim 6.
- Naples et al., "A Spiral Nerve Cuff Electrode for Peripheral Nerve Stimulation," IEEE Trans. Biomed. Eng. 35(11):905‑915 (Nov. 1988); Yoo et al. (Ann. Biomed. Eng. 32(4):511‑519, 2004; J. Appl. Physiol. 99:937‑943, 2005); Goodall et al., IEEE TBME 43(8):851‑856 (1996); Eisele et al. (Otolaryngol. Clin. N. Am. 36:501‑510, 2003) — all surfaced through the '785 family's citation neighborhoods; the multichannel/position‑selective cuff literature.
- Progeny showing the '785 design became a field benchmark: WO 2019/032890 (Inspire Medical Systems, "Cuff electrode"), US 8,934,992 (Inspire, "Nerve cuff"), US 10,981,000 (Alfred E. Mann Foundation, "Self‑expanding nerve cuff electrode"), and JP 2019‑503722 A5 which states the cuff electrode "may have at least some of the features and characteristics that are generally the same as described in US Pat. No. 8,340,785."
5. Primary obviousness combination
Combination A (strongest): Naples '624 + Testerman '438 + Tyler '462, in view of a molded‑cuff/closure reference (Klepinski '905, Kallesoe '756, or Hoffer '027)
| Limitation | Where taught / why obvious |
|---|---|
| L1 expandable cuff | Naples '624 (self‑sizing spiral cuff); Tyler '462 (cuff taxonomy) |
| L2 base member with opposed side walls + top/bottom walls | Naples '624 / Bullara '481 (band/sheet body); Hoffer '027 (wall band defining a lumen). Fabricating the band with a thicker base region and thinner walls is a routine molding choice |
| L3 first flange with proximal + distal end | Naples '624 / Bullara '481 (free sheet edge + opposing edge); Hoffer '027 closure elements |
| L4 second flange from the second side wall, tapered | Naples '624 (sheet thins toward the free edge in the self‑curling laminate, since only the stretched lamina stores the coil energy); Testerman '438 (resilient, thinning support legs). Motivation: a thin distal tip lowers bending stiffness and contact pressure on the nerve; a thick proximal root provides the "strong mechanical connection to the sidewall" and "needed thickness to hold and strain relief the electrodes" — the patent's own stated rationale (col. describing 0.025–0.030 in proximal vs. 0.001–0.010 in distal) |
| L5 third flange from the first side wall, distal end above the side wall but not over the top wall | Design choice / obvious alternative: Naples '624's coiled sheet has an outer wrap whose free edge lies against the outer surface of the body; Klepinski '905 and Kallesoe '756 closure flaps terminate on the side of the cuff body |
| L6 base + second + third flange as one unitary molded piece | Molding elastomeric (silicone/polyurethane) cuffs as single pieces was standard practice; the '785 specification itself describes the "single, unitary molded piece" and elsewhere a "single layer of elastomeric material" cuff. Under KSR, "a change in design, or a mere change in manufacture" is unpatentable |
| L7 first flange proximal end fixedly engaged to the third flange; biased over top wall and over the second flange | Naples '624: the self‑curling sheet's outer wrap is biased over the top of the nerve. Testerman '438: a resilient element is fixed to the body and biased into engagement. Bonding a perimeter flange to a molded tab is a predictable assembly step; the '785 spec says exactly this ("the first flange member 330 bonded to the molded piece") |
| L8 second flange biased so its distal end is spaced above and in releasable contact with the third distal end, forming the lumen | Naples '624 (elastic memory of the stretched lamina biases the cuff closed and self‑sizes it); Hoffer '027 (closure 22 sealing a lumen 30); Kallesoe '756 (reopenable, recloseable cuff). Releasable contact at the distal ends is precisely how a self‑curling sheet seals |
| L9 first flange overlapping both second and third flanges | Naples '624 / Bullara '481 — the defining geometry of a spiral/overlapping wrap; overlap of the free ends is inherent to a self‑sizing coil |
| L10 first and second flange cross‑sectional lengths ≫ third flange length | Naples '624/Bullara '481 have long wraps; the short third flange is the "backing" that lets the long outer flange be tied off. Choosing relative lengths is an obvious result‑effective design choice once the three‑element, telescoping arrangement of L4–L7 is adopted |
Result: claim 1 would have been prima facie obvious as an obvious combination of familiar self‑sizing cuff elements arranged for a predictable purpose.
Combination B (backup / alternative): Tyler '462 + Hoffer '027 + Testerman '438
Tyler '462 supplies the problem statement verbatim ("interfere with normal swelling… preventing nutrients, blood and other critical fluid flow"), which is the motivation to redesign. Hoffer '027 supplies the wall‑band‑with‑lumen‑and‑closure architecture, and Testerman '438 supplies the resilient, flange‑type electrode body with suture placement under the nerve. A POSITA seeking a swelling‑tolerant cuff would find all of the '785 geometry in this trio plus ordinary mechanical skill.
Combination C (for the taper and memory‑material limitations): add Crampon et al., "Nerve Cuff Electrode With Shape Memory Alloy Armature," Bio‑Med. Mater. Eng. 12:397‑410 (2002) and/or the "molded nerve cuff electrode" line (US 7,797,058) for "elastic body … with an elastic memory … adaptive to post‑operative swelling." These squarely support claim 8.
6. Motivation to combine — KSR factors
- Same field, same problem, same solution class. All references are implantable perineural nerve cuff electrodes; the '785 patent's own Background frames the identical problems (movement under the chin, connective‑tissue build‑up, nerve swelling/"strangulation," current confinement). KSR Step (A): the art is analogous and the references are combinable by design.
- Identified, predictable problem to be solved. Tyler '462 expressly diagnoses the drawback of self‑curling cuffs (occlusion of blood flow during swelling). The '785 patent's stated design goal — "approximately 25 mmHg is the approximate amount of pressure that may be applied to the nerve without restricting blood flow" — is the same problem, and the case.edu/Huntington review confirms the field already measured self‑sizing cuff occlusion pressures. A POSITA had a reason to modify the self‑curling cuff rather than merely a reason to combine for the fun of it.
- Enumeration of parts / obvious alternatives. The three‑flange telescoping arrangement is a natural alternative to a single continuous spiral wrap. KSR: "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious."
- Design choice / optimization. Taper ratios (claim 4), flange lengths (claims 9–10), a lateral contact point (claim 7), and a flared base (claim 10) are all results‑effective variables, not new principles.
- Reasonable expectation of success. All of the physical phenomena relied on — elastomeric elastic memory, self‑sizing coils, tapered‑tip pressure reduction, suture‑assisted placement — were known, characterized in the literature, and successfully reduced to practice (Naples 1988; Sahin & Durand 1994). Success was a matter of routine engineering.
7. Dependent claims
| Claim | Prima facie obvious? | Basis |
|---|---|---|
| 2 — three positions (engaged / intermediate / fully open) | Yes | The open → place → release sequence is the standard deployment of a self‑curling cuff (Naples '624; Klepinski '905; Kallesoe '756); Testerman '438 teaches holding the electrode open and releasing it into engagement |
| 3 — lumen expands from first to greater second diameter | Yes — strongest invalidity target | Directly met by the self‑sizing spiral cuff: the whole point of Naples '624 (and the "self‑sizing spiral cuff electrode" literature, e.g., Cuoco & Durand's occlusion‑pressure study) is diameter range to accommodate nerve growth/swelling. Claim 3 essentially recites the known benefit of self‑sizing cuffs |
| 4 — proximal thickness ≥ 1 order of magnitude (10×) greater | Yes (obvious range) | The '785 spec's own numbers span ~2.5×–30×; selecting a 10:1 ratio to get a compliant tip with a stiff root is routine optimization with a therapeutically‑motivated rationale. Increasingly vulnerable to a In re Aller "obvious to try / optimize" rejection |
| 5 — means for pulling a flange under the nerve | Yes, and arguably anticipated | Testerman '438 discloses precisely this: sutures 40a/40b passed through the electrode leg and "drawn under the nerve 110 … until the nerve is seated in the interior base portion 122." Under § 112(f) the '785 structure (sutures 537, tabs 645, holes 639) is the same means |
| 6 — IPG + lead + connector | Yes | Expressly disclosed/inherent in US 6,572,543 (Christopherson), which the '785 patent incorporates by reference for exactly this system; also US 7,248,930 |
| 7 — contact point laterally of the first side wall | Yes | Geometrical consequence of L5/L8; no unexpected result |
| 8 — memory‑based material biasing the flanges closed | Yes | Naples '624 (stored elastic energy in a stretched silicone lamina); Crampon 1999/2002 (shape‑memory alloy armature); US 7,797,058 (elastic body with elastic memory adaptive to post‑operative swelling) |
| 9 — first flange overlaps entire second flange | Yes | Design choice; a full‑length overlap is the natural way to prevent an "open gap" during expansion (the '785 patent's own stated purpose) |
| 10 — base/side‑wall portions flared outward from the flange roots | Yes | Routine molding/geometry choice |
8. Anticipated rebuttals, and how they cut
- Teaching away (Tyler '462 criticizes self‑curling cuffs). This is the patentee's best argument, but it is weak: criticizing a drawback of a design (nerve constriction) does not teach away from improving that design; it supplies the very motivation. A reference teaches away only if a POSITA following it would be led away from the claimed invention — here, following Tyler's complaint leads toward an expandable flange arrangement, which is claim 1.
- Criticality of the 10:1 taper (claim 4). No data in the patent show a criticality or unexpected effect at exactly an order of magnitude. Absent a showing of a new and unexpected result, the range is an obvious optimization. (Check the file wrapper for any Rule 132 declaration — I could not retrieve prosecution history.)
- Secondary considerations. I found no evidence of a commercial‑success, licensing, copying, or industry‑praise nexus in the retrievable record. There is circumstantial evidence that others modeled cuffs on the '785 disclosure (Inspire's WO 2019/032890 and US 8,934,992; the Mann Foundation's US 10,981,000; JP 2019‑503722 A5's express statement that its cuff may be "generally the same as described in US 8,340,785"). That is a potential copying/adoption argument, but it cuts both ways: the same citations are evidence that the '785 geometry is the conventional approach in the field — i.e., objectively obvious in hindsight. To carry weight, the patentee would need to prove nexus to a specific product and that the certified device practices the claimed combination rather than the broader disclosure.
- § 112 exposure is worth flagging separately. Claim 1 recites an "electrode cuff" but, as issued, contains no electrode limitation; the electrodes are described as embedded in the second flange. A claim broader than its disclosed embodiment is a validity vulnerability, though it is not a § 103 ground.
- The unitary‑molded‑piece limitation (L6) is the least likely to be met literally. None of the references I retrieved shows a single molded base + two flanges with a bonded outer flange. Expect the patentee to argue that L6 plus L7 (bonded, biased outer flange) is the patentable core. The counter is that this is a manufacturing/design choice under KSR and that the specification itself concedes the alternative (molded inner flanges + bonded outer flange vs. all‑molded) without any asserted criticality.
9. Where I would attack and where the claim is most defensible
- Most vulnerable: claims 3, 4, 5, 6, 8 — each closely matches a discrete, well‑documented reference feature (self‑sizing, taper optimization, suture placement, the incorporated system, elastic memory).
- Most defensible: claim 1 as a whole — specifically the combination of (i) a three‑flange architecture in which the third flange serves as a mechanical anchor/backing for a bonded outer first flange, (ii) the releasable contact between the second and third distal ends, and (iii) the relative cross‑sectional lengths. Invalidating claim 1 requires a reference (or a combination) that affirmatively suggests using a short side‑wall‑mounted flap as the tie‑off point for the long outer cover while a separate inner flap seals the lumen. That specific sub‑arrangement is what a validity challenge must supply, and it is the gap my retrieval did not fill.
10. Confidence and gaps (candid)
| Statement | Confidence |
|---|---|
| Effective date 2008‑05‑02; pre‑AIA §§ 102/103 govern | High |
| Naples '624, Bullara '481, Testerman '438, Tyler '462, Hoffer '027, Klepinski '905, Kallesoe '756, Maschino '778 are of record on US 8,340,785 | High for those I quote from retrieved PDFs (Testerman, Tyler, Hoffer); Medium for the front‑page items I read only as OCR'd titles/inventors |
| Combination A renders claim 1 prima facie obvious | Medium‑High as a legal conclusion; Medium on the specific L6/L7 mapping |
| Claim 5 is met (arguably anticipated) by Testerman '438's suture‑under‑nerve teaching | High (verified text) |
| Claim 3 is met by the self‑sizing spiral cuff | High |
| I could not retrieve the remaining ~50 US citations in the (56) list, the (56) "Other Publications," or the file‑wrapper rejections/allowance reasoning. | — |
| The examiner's actual basis of allowance for the '785 patent is unknown to me; I have not seen the Notice of Allowance or any Rule 132 evidence. | — |
Recommended next steps to firm this up: (1) pull the complete front page and Information Disclosure Statement from the PDF at patentimages.storage.googleapis.com/91/74/bd/7c613cb895d059/US8340785.pdf; (2) obtain the EP 2310083 B1 search report and any opposition file (the EPO cited US 7,248,930 and US 2006/0030919 against the same claims); (3) retrieve the US file wrapper for 12/114,352 to see which combination the examiner actually considered and why claim 1 was allowed; and (4) search the unretrieved citations for a flute/flap cuff, e.g., the "splittable catheter," "molded nerve cuff," and "self‑sizing spiral cuff" families.
Cross‑reference to the previously generated Litigation section
Consistent with the earlier litigation finding (no identified suits or PTAB proceedings against the '785 patent as of that search), the § 103 analysis above is a hypothetical invalidity assessment, not a reconstruction of any real challenge. The earlier section's identified gap — that a post‑grant challenge remained possible given the adjusted expiration of 2031‑04‑16 — remains open; nothing in this prior‑art work reveals a filed IPR/PGR. No contradiction between the two sections was found.
Generated 9/28/2026, 3:23:31 PM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
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