Invalidity dossier
US 7041106
Interphalangeal fusion pin
Current assignee: Biomet Manufacturing LLC
Added 10/1/2026, 4:14:43 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 authoritative records on this patent number.
Let me check specifically for litigation or CAFC docket activity involving this patent number.
US 7,041,106 — verified against the authoritative full text
I searched for this specific number and found no litigation or appellate activity. Details below, with the caveat that patent-number searches return many false hits for other "…106" patents (e.g., 6,703,106; 7,030,106; RE43,106; 7,612,058) — those are different patents and I have not conflated them.
Bibliographic data
| Field | Value |
|---|---|
| Title | Interphalangeal fusion pin |
| Patent number | US 7,041,106 B1 |
| Application no. | 09/882,320 |
| Filing date | 2001-06-15 |
| Priority date | 2001-06-15 (no earlier priority shown in the record) |
| Issue/publication date | 2006-05-09 |
| Inventors | Andrew Carver; Lowell S. Weil, Sr.; Tim Lessek; William S. Pietrzak |
| Original assignee | Biomet, Inc. (Warsaw, IN) |
| Current assignee | Biomet Manufacturing LLC (after change of name from Biomet Manufacturing Corp.) |
| Claims | 27 (independent: 1, 15, 18, 20, 24) |
| Status | Expired – Lifetime; adjusted expiration 2022-02-03; 12th-year maintenance fee paid 2017-10-26 |
| Classifications | A61B 17/7291; A61F 2/4225; A61F 2002/4228; A61F 2002/4243; A61F 2210/0004 (bioabsorbable) |
Sources: Google Patents https://patents.google.com/patent/US7041106/en ; uspto.report https://uspto.report/patent/grant/[7,041,106](/patent/7041106) . The assignment record (Reel/Frame 012203/0829, signed 2001-02-01 to 2001-02-12) names Carver, Weil Sr., Lessek and Pietrzak as assignors to Biomet, Inc. One third-party aggregation page (radaris) lists only three inventors and omits Weil — the patent front page and assignment record control.
Abstract (as issued)
"A device is described for joining a first phalange to a second adjacent phalange, such as the proximal phalange to the intermediate phalange at the proximal interphalangeal joint. The device is a substantially elongated member comprised of a resorbable material, such as, but not limited to polylactic acid, polyglycolic acid, and combinations thereof. The member has a first end portion, a middle portion, and second end portion spaced and opposed from the first end portion. The middle portion has a curvature such that an angle is formed between the first end portion and the second end portion, wherein the angle is substantially anatomically correct with respect to the particular joint, such as the proximal interphalangeal joint."
Specification highlights: the blank is a resorbable cylinder with threads on one end (for the proximal phalange) and shouldered/ribbed/helical structure on the other (for the intermediate phalange); the anatomically correct PIP angle is stated as "about 172.5 degrees," and the bend is imparted by heating-and-bending or "cold working," or the part can be injection molded in one step. Preferred material is Biomet's LACTOSORB® (82% L-lactic acid / 18% glycolic acid). Notably, the specification emphasizes that because the material is resorbable/thermoplastic, the surgeon can re-adjust the angle intra-operatively — a point the claims, not the abstract, actually capture.
Independent claims in plain language
- Claim 1 — Method of inserting a device into two adjacent phalanges to fuse them: provide a monolithic, substantially elongated member of resorbable material; connect a first end portion to the first phalange and a second (opposed) end portion to the second phalange; and adjust the middle portion from a fixed angle to a second fixed angle between the two end portions. The recitation is grammatically awkward (the "adjusting" element restates "a middle portion having a fixed angle"), but the gist is angle re-adjustment of a monolithic resorbable pin across a joint.
- Claim 15 — Operative-procedure method: drill a bore in the distal end of the first phalange; drill a bore in the proximal end of the second phalange; provide a resorbable elongated member with first/middle/second portions; the middle portion has a bend formed during the operative procedure by a user so the ends sit at a fixed angle toward one another; then insert the device into both bores.
- Claim 18 — Method of inserting the device during an operative procedure: provide a substantially rigid elongated resorbable member; engage first and second end portions in the two phalanges; form the middle portion to have a fixed curvature and adjust a fixed angle during the operative procedure. (Claim 18 does not depend from claim 15 — it is separately independent.)
- Claim 20 — Apparatus: a substantially single-piece elongated cylindrical member with first and second ends joined by a middle portion; a helical thread on the first end such that twisting advances the member into one phalange; and a barb extending from the second end that engages the other phalange to assist in holding the member there. (Dependent claims 21–22 add that the middle portion is deformable by the user during implantation, or is produced at a first angle and later deformed to a second angle; claim 23 recites the resorbable material.)
- Claim 24 — Operative-procedure method with a resorbable device: form bores in both phalanges; provide a thread on the first end and a barb on the second end; determine an appropriate angle during the operative procedure; form that angle in the device; thread the first end into the first bore; push the barbed second end into the second bore. (Claim 25 adds that the angle is anatomically appropriate; claims 26–27 add a substantially elongated cylinder and "forming the device material.")
Uncertainty / flags
- No CAFC or PTAB activity found for this patent. My searches returned no Federal Circuit 2026 appeal, no IPR/PGR, and no district-court complaint identifying U.S. 7,041,106. Hit titles like "the '704 patent"(Valtrus v. Google, N.D. Cal.) and the Treace v. Zimmer Biomet / Stryker litigation concern entirely different patents. I cannot affirmatively state the patent was never litigated — only that I found no record of it, and I am not asserting one.
- Citation-list anomaly (reported literally, not corrected): the eight "Patent Citations" listed for this patent include US 6,011,497 (Seagate Technology, "Location dependent maximum transition run length code…") — a magnetic-recording coding patent with no apparent relation to bone fixation. This looks like a database artifact in the Google Patents citation table, but I am flagging it as it appears rather than editorializing it away.
- Claim-text irregularities are reproduced literally: claim 2 reads "further comprising comprising"; claim 27 reads only "forming the device material." These appear to be as-issued/OCR artifacts of record, not my errors.
- Term status is as listed by the databases ("Expired – Lifetime," adjusted expiration 2022-02-03); that is a database status field, not a legal conclusion.
Generated 10/1/2026, 4:32:04 AM
Cases on file (0)
Specific litigation cases in our database that name US patent 7041106. 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 7041106.
Let me search more targeted litigation databases for this specific patent.
Let me check dedicated patent litigation databases for this specific patent.
Litigation Search Results — U.S. Patent No. 7,041,106
Bottom line: I found no record of any litigation involving U.S. Patent No. 7,041,106 ("Interphalangeal fusion pin," Carver et al., assigned to Biomet, Inc. / Biomet Manufacturing LLC).
To be explicit about what that means and its limits: based on the sources I was able to reach, I cannot identify a single district court case, ITC investigation, or Federal Circuit appeal in which US 7,041,106 was asserted as a patent-in-suit, challenged, or otherwise at issue. I am not going to invent a case caption, docket number, or filing date to fill that gap.
What I searched and what came back
| Query target | Result |
|---|---|
7041106 patent litigation |
No patent case; the "7041106" hits were unrelated (a Brazilian state court case number 7041106-35.2017.8.22.0001, Norwegian census tract codes, a Lithuanian company notice). |
"7041106" patent lawsuit |
Same — no US patent litigation. |
"7,041,106" Biomet patent infringement complaint |
Returned Biomet-related patent suits, but for other patents (e.g., AOS v. Biomet, 2:14-cv-06354, asserting U.S. 8,702,707 and 8,092,454; Puget/Hudson Surgical v. Biomet, 3:10-cv-00465 and 3:17-cv-00502, asserting U.S. 6,726,541 and 8,182,822; Bonutti Skeletal v. Zimmer Biomet). None involved the '106 patent. |
Biomet "interphalangeal fusion pin" patent lawsuit defendant |
Only patent-office and patent-classification pages for the '106 patent itself — no litigation. |
| Unified Patents / docketalarm / courtlistener queries | No case tying "7,041,106" to a docket. |
"interphalangeal fusion pin" Biomet patent asserted infringement |
Only the Google Patents/USPTO/report pages and sibling-art listing pages. |
What the record does show about the '106 patent
- Patent: US 7,041,106 B1, "Interphalangeal fusion pin." Application 09/882,320, filed June 15, 2001; granted May 9, 2006. Inventors: Andrew Carver, Lowell S. Weil, Sr., Tim Lessek, William S. Pietrzak. Original assignee Biomet, Inc. (Warsaw, IN); current assignee Biomet Manufacturing LLC.
- Status: Expired – Lifetime, with adjusted expiration February 3, 2022. Maintenance fees were paid through the 12th year (fees paid in 2009, 2013, and 2017), so the patent was in force for its full term.
- Only "legal-proceeding" style references located for this patent are prosecution/validity events, not litigation:
- It is cited as prior art ("Y" category) in the international search report for WO 2010/029246 A1 (Memometal Technologies / PCT/FR2009/051658).
- It is listed as a cited-reference (cited by examiner) on later patents such as U.S. 10,898,243 (Arrowhead) and U.S. 8,715,326 (Champagne). These are examiner citations, not adversary proceedings.
- I found no IPR, PGR, or reexamination of the '106 patent in the materials reviewed.
Important caveats
- Coverage limits. I was unable to fully execute queries against the Unified Patents litigation caselist (
portal.unifiedpatents.com/litigation/caselist) and PACER/RPX docket databases before exhausting my search budget. Those are the authoritative places to confirm a negative. - No evidence ≠ proof of none. A patent can be involved in litigation in ways that never use the full number in easily indexed text (e.g., included in a multi-patent complaint or a counterclaim), and district court complaints are not consistently indexed by patent number in every free database.
- Ownership is relevant. Because the patent has been held by Biomet/Biomet Manufacturing (now part of Zimmer Biomet) and has been expired since 2022 (effective 2022-02-03), it is not a plausible candidate for recent assertion activity, though it could theoretically have been asserted during its 2006–2022 term.
Recommended next steps if you need a definitive negative
- Search Unified Patents' litigation caselist and RPX Insight by patent number 7,041,106.
- Run a PACER / Docket Alarm / CourtListener docket search on
"7,041,106"and"7041106". - Search Lex Machina or Westlaw Litigation Analytics filtered to US Patent 7,041,106.
- Check Zimmer Biomet's 10-K litigation disclosures and Biomet's historical litigation dockets for any assertion of the '106 patent, including cases filed in N.D. Ind. (Biomet's home venue) against hammer-toe implant competitors (e.g., Wright Medical, Arthrex, Nextremity).
If you'd like, I can draft the specific search strings/list of dockets to pull from PACER and Unified Patents so you can complete the confirmation.
Generated 10/1/2026, 4:32:11 AM
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.
PTAB / AIA Trial Activity — US 7,041,106 ("Interphalangeal fusion pin")
Proceedings overview
Zero AIA trial proceedings on file. The canonical structured block supplied in this task states that the USPTO Open Data Portal (ODP) returns no AIA trial proceedings for US 7,041,106 as of the most recent ingest, and my independent web searches surfaced no IPR, PGR, or CBM petition, institution decision, final written decision, or appeal naming this patent. Breakdown: 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denied. Defensive posture: the patent is untested at the PTAB, so there is no claim-level invalidation record to lean on — but the far more important defensive fact is that the patent expired on 2022-02-03 (Google Patents legal-status: "Expired – Lifetime," adjusted expiration 2022-02-03; 12th-year maintenance fee paid 2017-10-26). An expired patent cannot support injunctive relief, and damages exposure is confined to pre-expiration infringement within the 35 U.S.C. § 286 six-year lookback.
Caveat on what I searched: queries run against PTAB decision repositories, USPTO PTACTS petition documents, Docket Alarm PTAB records, and general web sources returned only look-alike patent numbers — IPR2017-00809 (U.S. Pat. 6,703,106), IPR2019-00219 (U.S. Pat. 7,020,106, Uniloc), and various '106-suffixed patents in other families. None of these is US 7,041,106. I could not perform an exhaustive docket-by-docket litigation check, so the absence of PTAB activity below is based on the ODP structured data plus negative search results, not on a certified PTAB E2E docket pull.
Proceedings
No proceedings to report. Because there are no proceeding numbers in the structured data and no proceeding numbers surfaced by search, I am not creating placeholder entries — inventing IPR/CBM numbers is exactly the failure mode you asked me to avoid.
Strategic summary
Claim status: all 27 claims are UNTESTED. Claims 1–14 (method claims keyed to a monolithic resorbable elongated member with a middle portion "adjust[ed] … to a second fixed angle"), claims 15–19 (operative-procedure method, including intra-operative bending at claim 15 and heat/bend/cool at claim 19), claims 20–23 (apparatus with a helical thread on one end and a barb on the other), and claims 24–27 (method of forming the angle during the operative procedure and pushing the barbed end into the second phalange) have never been construed by the PTAB and have never been canceled or confirmed in an AIA trial. There is likewise no certificate of correction, disclaimer, or reexamination record noted in the structured data that would narrow the claims. Any assertion of this patent today therefore rests on claims whose validity has never been administratively tested — a double-edged fact: it means no free invalidity win, but also that no estoppel has been generated and no petitioner has ever laid down a road map.
Estoppel landscape: clean slate. Because no IPR/PGR was ever instituted, 35 U.S.C. § 315(e)(2) estoppel has never attached to anyone with respect to this patent. A defendant today faces no estoppel bar and no residual-art restrictions; every § 102/§ 103 ground built on patents and printed publications is available, and there is no prior petitioner whose grounds you must avoid or improve upon. The entire prior-art space is open. Practically, the richest vein is likely the pre-2001 resorbable-fixation art (PLLA/PGA pins, e.g., the LACTOSORB®-era literature the specification itself describes) combined with the angled-intramedullary-pin art cited on the face of the patent (US 3,681,786; US 5,047,059; US 5,092,896; US 5,984,970; US 6,017,366; US 6,319,284; US 6,386,877) — none of which the record shows was ever deployed in an AIA challenge.
Pattern signals. There is no repeat-petitioner signature, no defensive-aggregator footprint (no Unified Patents or similar filing), and no patent-owner PTAB-appeal history to analyze, because there is no PTAB history at all. The patent was filed 2001-06-15, granted 2006-05-09, and assigned to Biomet, Inc., later Biomet Manufacturing Corp./LLC (reel/frame chain: 019043/0792; 019287/0413; 030656/0702; security interest at 020362/0001 released via 037155/0133). The absence of any IPR against a commercially significant hammertoe-arthrodesis patent across the entire 2012–2022 AIA era — while competitors (Wright Medical, Stryker/Memometal, Nextremity, Arrowhead, Extremity Medical, Paragon 28) raced to build out the very same space and litigated heavily against each other — is itself a signal that this patent was not viewed as a priority clearing target, quite possibly because it was approaching expiration.
Recommended next steps
- Do not assume PTAB ammunition exists. There is none. Ask the asserting party for its infringement contentions and a claim chart, then build your invalidity case from scratch under §§ 102/103 — there is no FWD to cite and no canceled claim to point at. If you were hoping to say "claims 1–5 have been canceled," you cannot; that would be a fabrication.
- Lead with expiration and the damages clock. The patent expired 2022-02-03. Confirm the expiration date against the PTO PatentCenter fee/reinstatement history and the 12th-year fee record (paid 2017-10-26), then move to dismiss or limit any claim for ongoing or future infringement and for injunctive relief. Any recoverable damages are limited to the six years preceding the complaint under § 286, and only for acts before 2022-02-03.
- If you do file an IPR, note the calendar consequences. The patent is expired, which does not strip IPR eligibility under § 311 (IPR remains available for an expired patent for so long as it can still be asserted for past damages), but the Board may weigh this in any discretionary-denial analysis. A petition would face the statutory 1-year FWD deadline running from institution under § 316(a)(11). Because no prior petition exists, the § 315(b) one-year bar runs from your service date — file within one year of service on your client, and watch § 315(a)(1) if you contemplate a declaratory-judgment action first.
- Check the parallel-art landscape for § 325(d) exposure. Because the Office has never considered an AIA challenge here, § 325(d) ("previously presented art") is unlikely to bite — but confirm which references were actually applied during the 2001–2006 prosecution before you assert that, since the examiner's applied art will control that analysis.
- Verify with a primary-source docket pull before relying on this. I recommend confirming the zero-proceeding result directly on USPTO PTAB E2E / PatentCenter for US 7,041,106 and on CourtListener for any Federal Circuit appeal (CourtListener: https://www.courtlistener.com/?q=%227041106%22). The ODP ingest date lags live filings.
Sources consulted: Google Patents US 7,041,106 (https://patents.google.com/patent/US7041106/en) — usage, claims, family, assignment, and legal-status data; USPTO ODP structured "PTAB proceedings on file" block supplied in this task (canonical, returns none); targeted web searches for IPR/PGR/CBM petitions naming US 7,041,106 (no responsive results). USPTO PTAB E2E is the authoritative next check: https://ptacts.uspto.gov/ptacts/.
Generated 10/1/2026, 4:32:20 AM
Ownership chain (6)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
? · recorded 2001-06-15 · reel 012203/0829 · Assignment
Andrew Carver; Lowell S. Weil, Sr.; Tim Lessek; William S. PietrzakBiomet, Inc.
? · recorded 2007-03-21 · reel 019043/0792 · Assignment
Biomet, Inc.Biomet Manufacturing Corp.
internal reorg
? · recorded 2007-05-15 · reel 019287/0413 · Assignment
Biomet, Inc.Biomet Manufacturing Corp.
internal reorg
? · recorded 2007-12-10 · reel 020362/0001 · Security Agreement
Biomet, Inc.; LVB Acquisition, Inc.Bank of America, N.A., as Administrative Agent for the Secured Parties
securitization
? · recorded 2013-06-21 · reel 030656/0702 · Change of Name
Biomet Manufacturing Corp.Biomet Manufacturing Corp.
change of name only
? · recorded 2015-11-23 · reel 037155/0133 · Release
Bank of America, N.A., as Administrative AgentLVB Acquisition, Inc. and Biomet, Inc.
securitization
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
I'll verify the assignment chain against authoritative sources before writing.
Let me try to pin down the recorded correspondents and confirm the commercialized product lineage.
I've verified the chain against the patent's own legal-events record and cross-checked the corporate history and product lineage. Note up front: the authoritative full text supplies execution dates, recording dates, and reel/frame numbers, but not the recorded correspondents — and I could not retrieve the Assignment Center detail pages (which carry the correspondent-of-record field). I flag that as a data gap rather than guess at attorney names.
Inventors
| Inventor | Likely role/employer at filing | Basis |
|---|---|---|
| Andrew Carver | Outside clinician-inventor; listed address Ross, CA | Third-party inventor index lists Carver with a Ross, CA address; not a Warsaw, IN address |
| Lowell S. Weil, Sr. | Outside clinician-inventor (podiatric foot/ankle surgeon, Illinois) | Name appears in the commercial product name itself — "Weil-Carver Hammertoe Implant" — indicating a surgeon co-inventor; not a Warsaw address |
| Tim Lessek | Biomet in-house (Warsaw, IN) | Warsaw, IN address = Biomet HQ city |
| William S. Pietrzak | Biomet in-house (Warsaw, IN); Biomet biomaterials researcher | Warsaw, IN address; Pietrzak published the biomechanical study of the Weil-Carver implant (2006) |
Pattern note: This is a textbook clinician + company-employee joint-inventor arrangement (2 outside surgeons, 2 Biomet employees), all assigning to Biomet by the pre-filing assignment signed 2001-02-01 to 2001-02-12. There is no evidence of the "inventors depart within 12 months" fire-sale precursor — that pattern is not present. One data caveat carried from the prior section: a third-party aggregator (radaris) omits Weil; the issued patent front page and the assignment record both name him.
Original assignee
Biomet, Inc. (56 East Bell Drive / P.O. Box 587, Warsaw, IN 46581) — an operating orthopedic and medical-device manufacturer. Per FDA records, Biomet's own regulatory contact (Sara A. Bailey / Sara B. Shultz, Biomet Manufacturing Corp., 56 East Bell Drive) filed the clearances, confirming in-house product ownership rather than a licensing shell.
Did they ship a product embodying the claims? Yes — and it maps to the claims almost literally. The commercial embodiment is the Biomet Weil-Carver™ Hammertoe Implant (a.k.a. Small Hammer Toe Pin), a one-piece LACTOSORB® (82% L-lactic / 18% glycolic) resorbable pin with a threaded proximal segment (~2.5 mm dia., 13 mm) and a barbed distal segment (~2.0 mm dia., 12 mm), indicated for PIP joint arthrodesis. That is exactly the structure recited in independent claim 20 (helical thread on the first end; barb on the second end) and the method of claim 24. Regulatory chain: K011137 "Resorbable Hammertoe Pin" (decision 2001-06-18/19) → K021828 "Small Hammer Toe Pin" (decision 2002-06-30/07-01). A GUDID record for "WEIL-CARVER HAMMERTOE" (DI 00880304423640, listing 2.5 MM × 22 MM threaded) confirms commercial distribution.
Current status: Acquired, not dissolved. Biomet was taken private in a ~$11.4B 2007 leveraged buyout (hence the appearance of LVB Acquisition, Inc. as parent and a Bank of America secured-interest filing), and then acquired by Zimmer Holdings, Inc. in the merger that closed 2015-06-24, forming Zimmer Biomet Holdings, Inc. The current holder of record is Biomet Manufacturing, LLC (Zimmer Biomet's manufacturing subsidiary).
Assignment timeline
All reel/frame, dates, and conveyances below come from the patent's Google Patents legal-events record (https://patents.google.com/patent/[US7041106](/patent/US7041106)/en). Correspondent-of-record is NOT available in the sources I could reach — see the gap note after the list.
2001-02-01 to 2001-02-12 (executed) / recorded 2001-06-15 — Reel 012203/0829
- Conveyance: Assignment (inventors' interest)
- Assignor: Andrew Carver; Lowell S. Weil, Sr.; Tim Lessek; William S. Pietrzak
- Assignee: Biomet, Inc. (Indiana)
- Correspondent: not retrievable (data gap — see note)
- Context: Original employment/inventor assignment to the operating company, recorded on the filing date.
Recorded 2007-03-21 — Reel 019043/0792
- Conveyance: Assignment
- Assignor: Biomet, Inc.
- Assignee: Biomet Manufacturing Corp. (Indiana)
- Correspondent: not retrievable
- Context: Internal corporate reorganization (note the stated "effective date 19990601," predating the patent — a restructuring/cleanup transfer, not a sale).
Recorded 2007-05-15 — Reel 019287/0413
- Conveyance: Assignment
- Assignor: Biomet, Inc.
- Assignee: Biomet Manufacturing Corp. (Indiana)
- Correspondent: not retrievable
- Context: Internal transfer within the Biomet corporate family; effective 2007-05-14 (the month before the closing of the 2007 LBO).
Recorded 2007-12-10 — Reel 020362/0001
- Conveyance: Security Agreement
- Assignor: Biomet, Inc.; LVB Acquisition, Inc.
- Assignee: Bank of America, N.A., as Administrative Agent for the Secured Parties
- Correspondent: not retrievable
- Context: Securitization — collateral grant supporting the LBO financing (effective 2007-09-25). Not an ownership transfer.
Recorded 2013-06-21 — Reel 030656/0702
- Conveyance: Change of Name (only)
- Assignor: Biomet Manufacturing Corporation
- Assignee: Biomet Manufacturing, LLC (Indiana)
- Correspondent: not retrievable
- Context: Change of name only — corporate conversion, no change in beneficial ownership.
Recorded 2015-11-23 — Reel 037155/0133
- Conveyance: Release of security interest recorded at Reel 020362/0001
- Assignor: Bank of America, N.A., as Administrative Agent
- Assignee/beneficiary: LVB Acquisition, Inc. and Biomet, Inc.
- Correspondent: not retrievable
- Context: Lien release following the Zimmer/Biomet merger (effective 2015-06-24) — termination, not acquisition.
2017-10-26 — (not an assignment) Maintenance fee paid, 12th year.
Correspondent gap (explicit): The four-step instruction to capture the attorney/agent of record per recording cannot be satisfied from the material I accessed. Google Patents' legal-events table does not expose a correspondent field, and I could not retrieve the Assignment Center detail records that contain it. I therefore do not assert any correspondent name for any reel/frame. Signal #3 below is therefore unclear, not "not present."
Timeline diagram
timeline
title Ownership of US 7041106
2001 : Inventors assign to Biomet Inc
: Application filed
2006 : Patent issued to Biomet Inc
2007 : Assigned to Biomet Manufacturing Corp
: Bank of America security interest
2013 : Name change to Biomet Manufacturing LLC
2015 : Security interest released
: Zimmer Biomet merger closes
2022 : Patent term expires
NPE / troll-pattern signals
Shell-entity transfer — not present. Every assignee in the chain is a Biomet/Zimmer Biomet operating entity (Biomet, Inc. → Biomet Manufacturing Corp. → Biomet Manufacturing, LLC). No "IP / Patents / Licensing / Holdings / Ventures" entity appears. Reels 012203/0829, 019043/0792, 019287/0413, 030656/0702.
Known asserter in the chain — not present. No assignee matches Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Round Rock, Spangenberg entities, or any Unified Patents / RPX high-frequency plaintiff. Current holder is Biomet Manufacturing, LLC (Zimmer Biomet).
Repeat correspondent across the chain — unclear. Cannot be assessed: no correspondent names are exposed in the sources I could reach (see gap note). This is the single most important unresolved item in this chain.
Cascading transfers — not present. The maximum number of recordings in any 24-month window is two, and both (2007-03-21 and 2007-05-15) run into Biomet Manufacturing Corp., i.e., inward consolidation, not outward chaining. No shared-address or common-principal LLC hop.
Pre-litigation transfer — not present. No infringement suit naming U.S. 7,041,106 was located (consistent with the prior section's finding of no CAFC/PTAB/district-court activity), so there is no 6-month-before-suit transfer to point to.
Bankruptcy fire-sale — not present. Biomet's 2007 event was a leveraged buyout (LVB Acquisition / sponsor group), not a Chapter 7/11. Biomet did operate under an FCPA Deferred Prosecution Agreement (2012–2015), but a DPA is not a bankruptcy and did not involve a patent sale.
Privateering — not present. No transfer (actual or beneficial) from Biomet to a separate asserting entity; the patent never left the manufacturer family.
Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates at an operating manufacturer and simply expired (adjusted expiration 2022-02-03; 12th-year fee paid 2017-10-26).
Verdict
Operating-company assertion — with an explicit caveat on the word "assertion."
Of the five permitted verdicts, this is the only one that fits, because every assignee in the recorded chain is an operating orthopedic manufacturer and the patent's commercial embodiment (Biomet Weil-Carver / Small Hammer Toe Pin, K011137 and K021828) reads directly onto independent claims 20 and 24. There are zero NPE signals present — the 2001 inventor assignment (Reel 012203/0829), the two 2007 recordings into Biomet Manufacturing Corp. (Reels 019043/0792 and 019287/0413), the 2007 Bank of America security interest (Reel 020362/0001), the 2013 change-of-name (Reel 030656/0702), and the 2015 lien release (Reel 037155/0133) are all internal-reorg, securitization, or termination events, none of which moves the patent toward a licensing-only holder. The one qualification: I found no infringement suit asserting this patent, so the "suing actual competitors" prong of the label is unmet; the accurate characterization is operating-company ownership with no assertion and no NPE activity. The single unresolved item is the correspondent-of-record (signal #3), which I could not retrieve and therefore do not infer.
Verify at: USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (mirror: https://assignment.uspto.gov/patent/index.html) — search patent number 7041106; reels to pull: 012203/0829, 019043/0792, 019287/0413, 020362/0001, 030656/0702, 037155/0133.
Contradiction check vs. prior section: none. The prior bibliographic section reported the same assignee chain and the same "no litigation found" result; the product-lineage evidence (K011137/K021828) is new corroboration that the original assignee practiced the claims.
Generated 10/1/2026, 4:32:38 AM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll research each of the eight cited references. Let me run targeted searches.
Now let me research the remaining four cited references.
Prior-Art Analysis — US 7,041,106 B1 ("Interphalangeal fusion pin")
0. Scope note: "Citations" vs. "Cited By"
The task asks for "each patent citation for 7041106." The record distinguishes two different lists, and conflating them would be an error:
- Patent Citations (8) — the references cited against/in this patent during prosecution. These are the prior art. (Google Patents marks the list "Cited by examiner" / "Cited by third party.")
- Cited By (listed as both 79 and 172 in the fetched page) — later patents that cite 7,041,106. These post-date the 2001-06-15 filing and are not prior art to it. They are irrelevant to a § 102 analysis and I exclude them.
⚠️ Minor internal inconsistency to flag, per your instruction not to smooth over anomalies: the fetched Google Patents page renders the forward-citation set twice with two different counts ("Cited By (79)" and "Cited By (172)") for the same content. This is a page-rendering/database artifact, not a substantive fact about the patent.
Tooling limitation (disclosed rather than hidden): I exhausted my search budget before retrieving full text for US 6,319,284 and US 6,386,877. I give what the records I did obtain establish, and I explicitly mark the two un-verified items rather than reconstructing them from memory.
1. The eight cited references at a glance
| # | Reference | Assignee/Inventor | Priority | Published | Subject |
|---|---|---|---|---|---|
| 1 | US 3,681,786 A | Medical Engineering Corp. (Lynch) | 1970-07-13 | 1972-08-08 | One-piece flexible finger-joint prosthesis |
| 2 | US 5,047,059 A | Saffar | 1987-09-28 | 1991-09-10 | Two-component MCP/IP finger prosthesis |
| 3 | US 5,092,896 A | Protek AG (Meuli/Frey) | 1989-09-28 (CH) | 1992-03-03 | Finger-joint prosthesis w/ resorbable hose |
| 4 | US 5,984,970 A | Bramlet | 1996-03-13 | 1999-11-16 | Arthroplasty joint assembly (threaded, pivoting) |
| 5 | US 6,011,497 A | Seagate Technology | 1997-04-01 | 2000-01-04 | Magnetic-recording channel code ⚠️ unrelated |
| 6 | US 6,017,366 A | W. L. Gore & Assoc. (Berman) | 1997-04-17/18 | 2000-01-25 | Resorbable interposition arthroplasty implant |
| 7 | US 6,319,284 B1 | Futura Biomedical LLC | 2000-05-31 | 2001-11-20 | "Toe implant" (full text not retrieved) |
| 8 | US 6,386,877 B1 | Franz Sutter | 1998-07-30 | 2002-05-14 | Implant for dental prosthesis / artificial finger joint (full text not retrieved) |
Sources: Google Patents https://patents.google.com/patent/US7041106/en ; individual records cited below.
2. Reference-by-reference § 102 assessment
For each I state the full citation, dates, description, and the claims it could plausibly reach under § 102. Where none anticipate, I say so and identify the missing element.
(1) US 3,681,786 A — Lynch / Medical Engineering Corp.
"Solid human prosthesis of varying consistency." Filed 1970-07-13; issued 1972-08-08.
Discloses a one-piece surgically implantable prosthesis molded from inherently flexible elastomeric silicone rubber with two tapered intramedullary stem portions for insertion into adjacent finger-bone canals, a center portion, and embedded Dacron felt pads for tissue ingrowth; the center is radiated to a different flexibility than the stems. (https://patents.google.com/patent/[US3681786A](/patent/US3681786A))
- § 102: No anticipation. It is (a) non-resorbable, (b) an articulating joint replacement (the opposite of the claimed fusion/arthrodesis), and (c) has no angled middle, no thread, and no barb. It cannot meet independent claims 1, 15, 18, 20, 24 on the "resorbable material" limitation alone.
- Relevance: § 103 background for the "single-piece elongated member in a finger" concept of claim 20, and for the "intramedullary stem" idea.
(2) US 5,047,059 A — Saffar
"Prosthesis for metacarpophalangeal or interphalangeal articulation of the fingers." Priority 1987-09-28; issued 1991-09-10.
A two-component articulating finger prosthesis: a socket/cap and a head, each with a stem implantable in a medullary canal; the head pivots in the socket to replicate physiological flexion. (https://patents.google.com/patent/US5047059)
- § 102: No anticipation. Two discrete components (not "monolithic"/"single piece"), articulating (not fusion), non-resorbable, no fixed angle, no thread/barb. Fails every independent claim.
- Relevance: general § 103 background on interphalangeal prostheses.
(3) US 5,092,896 A — Meuli & Frey / Protek AG
"Finger joint prosthesis." CH priority 1989-09-28; filed 1990-09-24; issued 1992-03-03.
Two tapered sintered hydroxylapatite pegs anchored in adjacent finger bones, separated by a polyurethane sliding layer to allow motion, with "an elastic hose of resorbable material" (gelatin or polylactate per claim 7) surrounding the pegs and layer. (https://patents.google.com/patent/US5092896 ; https://uspto.report/patent/grant/[5092896](/patent/5092896))
- § 102: No anticipation, but this is the only cited reference that expressly recites a resorbable material in a finger-joint context (claim 1 + claim 7). Critically, the resorbable element is a surrounding hose, not the structural fusion member; and the device is multi-component and motion-permitting, with no angled middle, thread, or barb. It therefore cannot read on claims 1/15/18 (which require a resorbable elongated member with an adjusted/formed angle) or 20/24 (helix + barb).
- Relevance: strong § 103 candidate on the resorbable-material limitation.
(4) US 5,984,970 A — Bramlet
"Arthroplasty joint assembly." Filed 1996-03-13; issued 1999-11-16.
A first assembly with external threading extending from a generally pointed end anchoring in a cavity of a first bone; a second similarly threaded assembly anchoring in a second bone; and a connector pivotally interconnecting the two so the bones articulate. (https://patents.google.com/patent/US5984970) (Note: the related division US 6,475,242 is not in the citation list.)
- § 102: No anticipation. Two assemblies (not single-piece), non-resorbable, deliberately articulating (not fused), no fixed angle, no barb. It does disclose threaded bone anchoring, relevant only to the thread element of claims 20/24.
- Relevance: § 103 on the "helical thread … advances the member into bone" element.
(5) US 6,011,497 A — Seagate Technology
"Location dependent maximum transition run length code with alternating code word length and efficient K constraint." Priority 1997-04-01; issued 2000-01-04.
A magnetic-recording channel-modulation coding patent. As flagged in the earlier-generated section, this is on its face unrelated to bone fixation and appears to be a citation-table artifact.
- § 102: Cannot anticipate any claim — it discloses nothing in the bone-fixation art and provides no enabling disclosure of the claimed structure. Reported literally as it appears in the record, not corrected.
(6) US 6,017,366 A — Berman / W. L. Gore & Associates
"Resorbable interposition arthroplasty implant." Filed 1997-04-18; issued 2000-01-25.
A resorbable, porous implant placed in the void between two adjacent bone ends to act as a cushion, with resorption time preferably ≥ 3 months, modulus 0.8–20 MPa, pores > 80 µm; the implant "may be preformed … or alternatively may be formable by the surgeon by methods such as carving." (https://patents.google.com/patent/US6017366)
- § 102: No anticipation. It is a cushion/void-filler, not an elongated intramedullary pin; it has no first/middle/second portion inserted into bores, no angle, no thread, and no barb. It cannot meet any independent claim.
- Relevance: the strongest § 103 reference on two limitations — (i) "comprised of a resorbable material" (claims 1/15/18/24) and (ii) the surgeon-modifiable/operative-adjustment concept (claims 15, 18, 21, 22, 24). The mode of modification differs (carving a cushion vs. heat-bending/cold-working a rigid pin), which is the point of distinction.
(7) US 6,319,284 B1 — Futura Biomedical LLC
"Toe implant." Priority/filing 2000-05-31; issued 2001-11-20.
⚠️ Full text not retrieved (search budget exhausted). This is topically the closest cited reference (a toe implant). Because it published 2001-11-20 — after the 2001-06-15 filing — any § 102(e) reliance would rest on its 2000-05-31 priority date, not its publication date.
- § 102: I cannot responsibly complete an element-by-element comparison without the disclosure text, and I will not guess its structure. Based on the title alone it is a candidate reference, but whether it discloses a resorbable implant or an angled fusion pin is unverified. Flagged as an open item.
(8) US 6,386,877 B1 — Franz Sutter
"Implant for holding and/or forming a dental prosthesis or artificial finger joint." Priority 1998-07-30; issued 2002-05-14.
⚠️ Full text not retrieved. From the title/assignee, this is a bone-anchoring (threaded) implant usable either as a dental implant or as an artificial finger joint — i.e., a threaded osseointegrated fixture.
- § 102: No anticipation on the record available: a dental/osseointegrated fixture is not a resorbable, monolithic, angled interphalangeal fusion pin with thread + barb. Like US 5,984,970 it is relevant only to the threaded anchoring element of claims 20/24, and even that comparison I flag as based on the title rather than verified column/line text.
3. Bottom line
No cited reference anticipates any independent claim (1, 15, 18, 20, 24) or its dependents under § 102. The cited art falls into three groups that each miss at least one essential element:
| Gap in the art | Which references lack it |
|---|---|
| Resorbable material (required by claims 1, 15, 18, 24) | 3,681,786; 5,047,059; 5,984,970; 6,011,497; 6,386,877 |
| Monolithic / single-piece elongated pin (claims 1, 20) | 5,047,059; 5,092,896; 5,984,970 |
| Angled/curved middle with a fixed, anatomically-correct angle (all independents) | none of the eight |
| Thread + barb retention pair (claims 20, 24) | none of the eight |
| Fusion (non-articulating) purpose | 3,681,786; 5,047,059; 5,092,896; 5,984,970 |
The two references that come closest are:
- US 6,017,366 (resorbable + surgeon-formable) — but it is a cushion, not a pin; and
- US 5,092,896 (resorbable element in a finger joint) — but the resorbable part is a hose around a permanent, articulating prosthesis.
The realistic attack on 7,041,106 is therefore a § 103 combination — e.g., 6,017,366 or 5,092,896 (resorbable + intra-operative formability) in view of 5,984,970 or 6,386,877 (threaded intramedullary bone anchoring) — not § 102, because no single reference supplies the full combination of resorbable monolithic pin + anatomically-angled middle + intra-operative angle adjustment + thread/barb.
Open items I am flagging rather than papering over:
- US 6,319,284 and US 6,386,877 full texts were not retrieved; my § 102 conclusions for those two rest on title/date/assignee metadata only.
- US 6,011,497 (Seagate) remains an unrelated-data anomaly in the citation table, reported as it appears.
- The forward-citation count discrepancy (79 vs. 172) is a page-rendering artifact.
If you want, I can re-run the citations search for #7 and #8 to close those two gaps and firm up the § 102/§ 103 lines.
Generated 10/1/2026, 4:32:49 AM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll ground the obviousness analysis in the actual disclosures of the references listed in this patent's Prior Art (Citations) section. Let me pull bibliographic and disclosure details for each.
Obviousness Analysis — U.S. Patent No. 7,041,106 (35 U.S.C. § 103)
Patent under analysis: US 7,041,106 B1, "Interphalangeal fusion pin" (Carver, Weil Sr., Lessek, Pietrzak; Biomet). App. 09/882,320, filed 2001‑06‑15, granted 2006‑05‑09. Source: https://patents.google.com/patent/US7041106/en
Governing law: Because the application was filed 2001‑06‑15 (well before 2013‑03‑16), the pre‑AIA version of § 103 applies, and pre‑AIA § 102(e) governs references that published after the filing date but were filed before it. Graham v. John Deere, 383 U.S. 1 (1966), and KSR Int'l v. Teleflex, 550 U.S. 398 (2007), supply the framework.
Consistency with prior sections: This builds on the previously generated summary/litigation sections. I confirm — and do not disturb — the three flags raised there: (i) no litigation/PTAB/CAFC record located; (ii) the US 6,011,497 (Seagate) citation is an anomaly; and (iii) claim-text irregularities (claim 2 "comprising comprising"; claim 27 "forming the device material") are reproduced literally. One refinement to add: claim 18 is independently independent (not dependent on claim 15), as previously noted.
1. Scope of the claims (the "ordinary meaning" anchors)
The independent claims cluster into two families:
| Family | Claims | Core inventive concept |
|---|---|---|
| A — Method | 1, 15, 18, 24 | Implant a resorbable elongated member across two adjacent phalanges and set/re‑set the angle between its ends ("fixed angle" → "second fixed angle," or a bend "formed during the operative procedure by a user") |
| B — Apparatus | 20 | A substantially single‑piece elongated cylinder: helical thread on one end + barb on the other end, with a deformable middle portion |
The specification's own admissions narrow the field considerably: the background describes the K‑wire "peg‑in‑hole" PIP arthrodesis (admitted prior art), and the applicant concedes that "resorbable devices … are generally as strong as conventional metallic devices." That concession matters below.
2. Level of ordinary skill
A person of ordinary skill would be a clinician/engineer with a working knowledge of (a) small‑joint (digit) arthrodesis and arthroplasty, (b) intramedullary bone anchoring, and (c) resorbable orthopedic polymers (PLA/PGA). All eight listed references sit in this space except the Seagate coding patent, which is not analogous art (see § 7).
3. The prior art of record and what each reference teaches
Drawn from the "Patent Citations" (Prior Art) table on the patent page. I retrieved and verified disclosure text for five of the eight; two could not be pulled within budget; one is the anomaly.
| Ref | Verified teaching relevant to the claims | Status of my verification |
|---|---|---|
| US 3,681,786 (Lynch / Medical Eng. Corp.) | "a one piece device … in order to more readily duplicate the body function"; "a body … molded of … elastomeric, physiologically inert material"; "stem portions 14 and 16 … tapered for insertion into the intramedullary canals … of the finger"; felt pads for tissue ingrowth | Verified (US3681786, Google Patents) |
| US 5,047,059 (Saffar) | Two‑component MP/IP finger prosthesis; explicitly for "replacement of the metacarpophalangeal and interphalangeal joints after resection of the distal and proximal articular osseous parts and preparation of the diaphyses"; stems embedded in medullary canals | Verified (US5047059) |
| US 5,092,896 (Meuli / Protek) | Finger joint prosthesis; claim 2: pegs "tapered and ha[ving] a plurality of undercuts in an outer surface for ingrowth of bone"; claim 1: "an elastic hose of resorbable material surrounding said pegs"; claim 7: the hose is gelatin or polylactate | Verified (US5092896) |
| US 5,984,970 (Bramlet) | Arthroplasty joint assembly with "external threading extending lengthwise from a generally pointed end … for anchoring … within a cavity of the first bone," plus a connector joining the bone‑anchored assemblies | Verified (US5984970 / WO97/33537) |
| US 6,017,366 (Berman / W. L. Gore) | Resorbable interposition implant "comprising non‑autologous, resorbable material"; "copolymers of lactic acid and glycolic acid (PLA/PGA)"; "may be preformed … or alternatively may be formable by the surgeon by methods such as carving"; expressly useful "in the finger joints" and "the small joints of the foot," including "trauma induced ankylosis of the proximal interphalangeal joint"; Fig. 6 discloses an integral fixation pin … located in a pre‑drilled hole | Verified (US6017366) |
| US 6,319,284 (Futura Biomedical) — "Toe implant," pub. 2001‑11‑20 | Facially directed to a toe implant. Qualifies as prior art under pre‑AIA § 102(e) (filed 2000‑05‑31, before the '106 filing date) even though it published afterward. | Not verified — I could not retrieve its disclosure text; I do not assert its specific content |
| US 6,386,877 (Sutter) — "Implant for holding and/or forming a dental prosthesis or artificial finger joint," pub. 2002‑05‑14 | Facially relevant to artificial finger joints; also § 102(e) art (priority 1998‑07‑30). | Not verified — same caveat |
| US 6,011,497 (Seagate) — "Location dependent maximum transition run length code…" | Magnetic‑recording coding. No apparent relation to bone fixation. | Reproduced literally; flagged as an anomaly, not relied upon |
Note on "Cited By" art: the 79–172 later patents (Bourke 2008/0086139; Augoyard 2008/0177262; Memometal FR 2935601; Wright Medical; Arrowhead; etc.) all post‑date the 2001‑06‑15 priority date and therefore are not § 102/§ 103 prior art against the '106 patent. They are probative only of the field's trajectory — and, notably, WO 2010/029246 (Memometal) cites the '106 patent as "Y"‑category prior art.
4. Ground 1 — Claim 20 (apparatus) is obvious over Meuli in view of Bramlet and Lynch
| Claim 20 limitation | Where disclosed |
|---|---|
| "substantially single piece elongated … member … first end and … second end interconnected by a middle portion" | Lynch: "a one piece device" with two tapered stems joined by a center portion |
| "helical thread formed on the first end … twisting … advance[s] … into one of the two phalanges" | Bramlet: "external threading extending lengthwise from a generally pointed end … for anchoring … within a cavity of the first bone" |
| "a barb extending from the second end … engages the other … phalange … to assist in holding" | Meuli: pegs with "a plurality of undercuts in an outer surface for ingrowth of bone therein" — i.e., a projecting retention structure that bites into bone; alternatively Berman's Fig. 6 integral fixation pin seated in a pre‑drilled hole |
| Implicit: member is for, and of the scale of, a digit joint | All three references (finger joints) |
Dependent claims:
- 21 (middle portion deformable during implantation) and 22 (produced at a first angle, deformed to a second angle before use) → Berman: implant "preformed to the desired shape or … formable by the surgeon"; also inherent in the thermoplastic PLA/PGA chemistry Berman names.
- 23 (resorbable material) → Meuli claim 1/7 (resorbable polylactate hose) and Berman (PLA/PGA).
5. Ground 2 — Claims 1, 15, 18 and 24 are obvious over Berman in view of Bramlet and Meuli (optionally with Saffar and Lynch)
| Limitation (representative) | Where disclosed |
|---|---|
| Resorbable, substantially elongated member | Berman (PLA/PGA resorbable implant for finger/foot joints); Meuli (resorbable polylactate hose) |
| First end in one phalange; opposed second end in an adjacent phalange | Lynch (one‑piece, two stems in intramedullary canals); Saffar (two components with stems "implanted in the medullary canals of the bones" after resection of the articular ends) |
| Middle portion with an angle between the ends — "substantially anatomically correct" (claims 14, 25) | Saffar and Meuli both are expressly constructed to reproduce physiological joint geometry; Saffar: "The curvature of the edges is designed so that the longitudinal displacement of the phalanx … is comparable to … the physiological articulation" |
| Adjust a fixed angle to a second fixed angle / bend "formed during the operative procedure by a user" (claims 1, 15, 18) | Berman: the implant "may be formable by the surgeon"; "conformability allows the implant to accommodate … the variable bone shapes of different individuals" |
| Providing a bore in each phalange; inserting the device into both bores (claims 15, 24) | Saffar ("preparation of the diaphyses"); Berman Fig. 6 (fixation pin in a "pre‑drilled hole") |
| Thread on the first end / barb on the second end (claim 24) | Bramlet (threaded bone anchor); Meuli (undercuts = barb) |
| Determine the appropriate angle during the operative procedure and form it in the device (claims 24–25) | Berman (surgeon‑formed, pre‑ or intra‑operative) + the admitted prior art of adjusting a K‑wire across the PIP joint |
Claims 2–14 and 26–27 are conventional dependent add‑ons (site selection: proximal/intermediate/distal phalanges; threaded vs. shouldered/ribbed/helical retention surfaces; resorbable material selection; cylindrical geometry) — each maps to Bramlet (thread), Meuli (undercuts/ribs), Berman (material), and the admitted art.
6. Motivation to combine (the KSR rationales)
The combination is not a "mere aggregation of old elements," but the record supplies several independent, articulated rationales:
- Same field, same problem. Every substantive reference addresses small‑joint prostheses of the digits. Berman, Saffar, Meuli and Lynch all target finger joints; Bramlet targets adjacent bones generally.
- Berman supplies the express motivation for adjustability. Berman states the reason in terms: prior designs "require a complete range of sizes to allow for patient‑to‑patient variability," and offers a surgeon‑formable resorbable implant as the solution. A skilled artisan seeking an angled interphalangeal fusion pin would find in Berman both the motivation and the mechanism (resorbable, carvable/shapeable material) for intra‑operative angle setting.
- The "remove the hardware" problem. The '106 specification's own background identifies the failure modes of the metallic K‑wire (distraction/misalignment, swelling, inflammation, infection at the exposed segment). Resorbable fixation directly answers that problem — and the applicant concedes resorbables are "generally as strong as conventional metallic devices."
- Combining known bone‑anchoring elements. Bramlet's threaded, pointed bone anchor and Meuli's undercut retention features are two well‑known, interchangeable ways to secure an implant in an intramedullary cavity; substituting one for the other is the classic "known technique, known result" rationale.
- Single‑piece simplification. Lynch teaches away from multi‑component assemblies by delivering a "one piece device" that avoids loosening; an artisan facing Bramlet's two‑assembly + connector design would be motivated to reduce parts.
- Predictability / finite solutions. As of 2001, the design space for a digit fusion pin was small and enumerated: resorbable (Berman, Meuli), threaded on one end (Bramlet), ribbed/undercut on the other (Meuli). KSR: "where a technique has been used to improve one device, and a person of ordinary skill … would recognize that it would improve similar devices in the same way, using the technique is obvious."
Reasonable expectation of success. Berman and Meuli place resorbable PLA/PGA and polylactate materials in the very joint at issue; Bramlet demonstrates threaded fixation in a bone cavity; Meuli demonstrates bone‑ingrowth retention. Combining these would have been a routine engineering exercise with a predictable result.
7. Anticipated applicant rebuttals and their weaknesses
- "Non‑analogous art (Seagate)." This rebuttal succeeds and the reference should simply be disregarded — US 6,011,497 is coding art with no relation to bone fixation. (See flagged anomaly.) It does not affect Grounds 1–2, which rest on the five verified references.
- "References teach articulation, and we teach fusion — teaching away." Weak. Meuli's resorbable hose and Berman's express discussion of PIP‑joint ankylosis and interposition for a fused joint show the field contemplated non‑articulating, resorbable small‑joint devices. Moreover, "the goal of the operation is arthrodesis" is exactly the motivation to replace the articulating prostheses — the specification itself says so.
- "No reference discloses a barb." Rebuttable: Meuli's "undercuts … in an outer surface" and Berman's integral fixation pin are retention structures serving the same function; the applicant's own claim 9/11 treats "shoulders, ribs, helixes" as equivalent retention structures, undercutting any argument that "barb" is narrowly and non‑obviously distinct.
- Objective indicia. No commercial‑success or long‑felt‑need evidence appears in the record I reviewed. If offered, nexus would be contested because the asserted advance (intra‑operative angle adjustment) is expressly taught by Berman's surgeon‑formable implant.
8. Bottom line
- Claim 20 (and 21–23) is prima facie obvious over Meuli + Bramlet + Lynch.
- Claims 1, 15, 18, 24 (and 2–14, 25–27) are prima facie obvious over Berman + Bramlet + Meuli, with Saffar and Lynch as reinforcing secondary references and the K‑wire "peg‑in‑hole" technique as an applicant admission.
- The strongest single reference is US 6,017,366 (Berman, Gore), because it discloses the resorbable PLA/PGA limitation and the surgeon‑formable/"preformed or formable" limitation that underlies every independent claim's angle‑adjustment element.
Residual uncertainties (stated, not papered over)
- I could not verify the disclosure text of US 6,319,284 or US 6,386,877 within my search budget; they are treated here as facially relevant § 102(e) art but are not relied upon for any limitation.
- The Seagate (US 6,011,497) entry is carried literally in the record and flagged as an anomaly; it is non‑analogous and excluded from the analysis.
- Grounds above are prima facie only. A definitive conclusion would require the full file history (to identify any prosecution‑history estoppel or § 103 arguments of record) and confirmation of the two unverified references' disclosures.
Generated 10/1/2026, 4:33:05 AM
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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