Invalidity dossier

US 11439514

Systems and methods for orthopedic implant fixation

Current assignee: Carlsmed, Inc.

Added 9/24/2026, 2:44:52 AM

IndustryMedical (M)
At a glanceNo PTAB challenges1 lawsuit on fileasserted by Carlsmed, Inc.Medical (M)

Active provider: DeepSeek · deepseek-flash

Patent summary

Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.

✓ Generated

I'll run searches targeting the exact patent number and any 2026 litigation activity.

Let me check for any Carlsmed litigation or appeal activity and try to recover the tail of the claim set.

Let me try to recover the full claim set, since the authoritative text I have truncates at claim 12.

US 11,439,514 — Analyst Summary

Scope note / honest caveat up front: I could retrieve the bibliographic data, abstract, and full text of claims 1–11 from authoritative sources, but the authoritative full text I have truncates in the middle of claim 12 (the patent has 21 claims total). I could not recover claims 12–21 verbatim. Where I state anything about those claims, I flag it as inference, not verified fact. I also did not find any CAFC 2026 docket or appeal involving this patent number — see the litigation section, which includes a date discrepancy you should be aware of.


Bibliographic data (verified)

Field Value
Patent number US 11,439,514 B2 (interpreted literally; not auto-corrected)
Title Systems and methods for orthopedic implant fixation
Application no. 16/383,215
Filing date April 12, 2019
Priority date April 16, 2018 (benefit of U.S. Provisional Appl. No. 62/658,389, per the specification's Incorporation by Reference section)
Issue/grant date September 13, 2022
Pre-grant publication US 2019/0321193 A1 (Oct. 24, 2019)
Inventors Niall Patrick Casey (Carlsbad, CA); Michael J. Cordonnier (Carlsbad, CA)
Assignee (original and current) Carlsmed, Inc., Carlsbad, CA
Claims / drawings 21 claims, 14 drawing sheets
Legal status Active — adjusted expiration 2039‑07‑12 (Google Patents listing; a status assumption, not a legal conclusion)

Sources: Google Patents (https://patents.google.com/patent/US11439514/en); PubChem patent record (https://pubchem.ncbi.nlm.nih.gov/patent/US-[11439514](/patent/11439514)-B2); granted-PDF cover page (https://patentimages.storage.googleapis.com/fa/0e/c3/53bacc7545ae5c/US11439514.pdf).

Abstract (verbatim, as printed)

"A personalized fixation system includes a surgical planning software tool configured to adjust relationships of relevant anatomy of a subject, at least one bone anchor, a plate having a shape that does not conform to a single plane, the plate configured to accept the at least one bone anchor, wherein the shape of the plate is at least partially determined by the surgical planning software tool, and wherein the plate includes at least one node having a hole configured to receive the at least one bone anchor, and a locking element configured to connect the at least one bone anchor to the plate, wherein the plate is manufactured using additive manufacturing."

Note: the abstract is broader than claim 1. Claim 1 recites a personalized spinal fixation system and adds a substantial software-methodology limitation (pelvic tilt / sagittal alignment / lumbar lordosis measuring and correction) that the abstract omits.


Independent claim 1 — plain language

Claim 1 is the only independent claim I can verify in full. It is a system claim with four cooperating parts:

(a) Surgical planning software tool that performs five steps:

  1. Generates a 3D virtual model of at least a portion of the subject's spinal anatomy.
  2. Measures that model to obtain measurements associated with pelvic tilt, sagittal alignment, or lumbar lordosis.
  3. Based at least in part on those measurements, adjusts the relationships of the spinal anatomy in the virtual model to produce a corrected spinal geometry that at least partially corrects one or more anatomical deformities.
  4. Applies one or more predictive guidelines to the virtual model to determine whether the corrected anatomy conforms to them. (Caveat: as rendered in the source text, the "wherein the predictive…" clause is garbled — it reads "wherein the predictive tilt, sagittal alignment, or lumbar lordosis." This is almost certainly an OCR/parse artifact in the fetched text, and I cannot state the exact strings of the predictive-guideline limitation with confidence. The specification, by contrast, recites three named guidelines: pelvic tilt < 20°, C7 SVA not more than 5 cm from the posterior superior sacral endplate, and |pelvic incidence − lumbar lordosis| < 10°.)
  5. If the corrected anatomy conforms to the guideline(s), at least partially design a plate for achieving that corrected geometry when implanted.

(b) At least one bone anchor.

(c) A plate designed to achieve the corrected geometry, with a shape that does not conform to a single plane (i.e., non-planar/3D-configured), configured to extend across at least one intervertebral gap when implanted; the plate's shape is at least partially determined by the software tool; and the plate has at least one node with a hole to receive the bone anchor.

(d) A locking element configured to connect the bone anchor to the plate; and the plate is manufactured using additive manufacturing.

Practical gist: a pre-operative planning-driven, patient-specific, non-planar spinal plate (3D-printed) with node/hole anchor seats and a locking mechanism — i.e., replacing the conventional intra-operative "bend a stock rod to fit" workflow with a virtual-surgery-designed, 3D-printed fixation plate.

Dependent claims 2–11 (verified): additive manufacturing guided by the software tool (2); plate configured for fixation to surgically adjusted anatomy (3) with partial or complete deformity correction (4); each of anchor/plate/locking element locking with at least one of the others (5); longitudinal elements connecting nodes (6); geometry permitting iliac fixation (7); surface treatment to encourage biological response (8); variable density (9); variable porosity (10); and the software tool comprising a non-transitory computer-readable memory with processor-executable instructions (11).

Claim 12 onward (unverified): Claim 12 begins a second independent claim, opening "A personalized spinal fixation system comprising: a surgical pla…" before the text truncates. Based on the specification's Summary of the Invention (which pairs an additive-manufacturing embodiment with a subtractive-manufacturing embodiment, and also recites multiple "system for designing an implant system" and "method for manufacturing" embodiments), the most likely structure is that claim 12 is the subtractive-manufacturing counterpart and that claims 13–21 include further dependent claims plus one or more system/method independent claims. I cannot confirm this — treat it as inference, not fact.

I also note apparent typographical artifacts in the as-fetched claim text ("deformaties," "confroms"); these appear to be rendering/OCR errors rather than substantive claim language, but I am flagging rather than silently correcting them per your instruction.


Litigation / CAFC 2026 check

  • No CAFC docket, appeal, or Rule 36 disposition involving US 11,439,514 was found. The CAFC 2026 material returned by search (e.g., Spero v. Mercedes-Benz USA, Nos. 2025‑1470/1472, Rule 36 judgment of May 14, 2026) is unrelated.
  • Relevant district-court activity: Carlsmed, Inc. v. DeGen Medical, Inc., No. 4:26-cv-04064 (D.S.C., Florence Division; Judge Joseph Dawson, III), a § 145//830 patent-infringement action. Carlsmed announced on September 15, 2026 that it asserts eight Carlsmed patents and seeks injunctive relief and damages. Whether 11,439,514 is among the eight asserted patents is not disclosed in the public materials I retrieved, so I cannot confirm it.
  • ⚠️ Date discrepancy you should resolve: your prompt states today is April 26, 2026, but the search results describe the Carlsmed–DeGen filing and accompanying coverage as September 15–17, 2026, i.e., dated after your stated "current date." I am reporting the sources as found rather than reconciling them. If April 26, 2026 is your governing date, the DeGen filing would be a future event and should not yet exist.
  • Also relevant context: Carlsmed publicly announced (Feb. 18, 2026) the first clinical use of its corra™ Personalized Cervical Plating System, and (Dec. 3, 2025) the U.S. launch of its aprevo® cervical platform — potentially relevant to claim-1's plate/anchor/locking-element subject matter, though I have no evidence linking these products to this patent specifically.

Bottom line

US 11,439,514 (Carlsmed, Casey & Cordonnier) is a granted, active spinal-fixation patent claiming a virtual-surgery-designed, non-planar, additively manufactured spinal plate with anchor nodes and locking elements, where the design loop is tied to measured/corrected pelvic tilt, sagittal alignment, or lumbar lordosis. Claim 1 is verified; claims 12–21 and any linkage to current litigation are not verified.

Generated 10/1/2026, 5:33:19 PM

Cases on file (1)

Group view →

Specific litigation cases in our database that name US patent 11439514. The free-form analysis below may also discuss cases beyond this list.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

I'll search for litigation involving US patent 11439514 across patent litigation sources.

I found a Carlsmed v. DeGen case that asserts eight patents. Let me verify whether US 11439514 is among the asserted patents and search for any other cases.

Litigation Report — U.S. Patent No. 11,439,514

Patent identity (literal): US 11,439,514 B2 ("Systems and methods for orthopedic implant fixation"), assignee Carlsmed, Inc.; inventors Niall Patrick Casey and Michael J. Cordonnier; priority date April 16, 2018; filed April 12, 2019; granted September 13, 2022. This is the exact number requested — I have not substituted any similar number (e.g., I have not confused it with the many "’414" patents appearing in unrelated litigation, such as Phillip M. Adams' U.S. 5,379,414 or the various ’414 patents in other suits).

Known litigation

Carlsmed, Inc. v. DeGen Medical, Inc.

  • Plaintiff: Carlsmed, Inc. (Nasdaq: CARL)
  • Defendant: DeGen Medical, Inc.
  • Jurisdiction: U.S. District Court for the District of South Carolina, Florence Division (Judge Joseph Dawson, III)
  • Case No.: 4:26-cv-04064
  • Nature of suit: 830 – Property Rights/Patent; Cause 35:145 (Patent Infringement)
  • Filing date: September 15, 2026
  • Patents asserted: Eight Carlsmed patents "relating to its implants, methods and systems"
  • Relief sought: Injunctive relief and damages
  • Outcome/current status: Pending. DeGen Medical disputes the allegations; CEO Craig Black stated (Sept. 16, 2026) that DeGen "strongly disagree[s] with Carlsmed's allegations and intend[s] to vigorously defend [its] technology and intellectual property." No claim construction, motions, or substantive rulings are reported as of the sources located.

Sources:

Important caveats and limitations

  1. US 11,439,514 is not confirmed to be one of the eight asserted patents. The public sources I could retrieve (Carlsmed's press release, PacerMonitor docket summary, and trade-press coverage in Becker's Spine Review and ODT) uniformly describe the suit as asserting "eight Carlsmed patents" but do not list the patent numbers. I could not locate or retrieve the complaint itself, an infringement contention, or a docket document enumerating the asserted patents. Accordingly, while this is the most plausible — and so far only identified — candidate litigation involving this patent, I cannot state with high confidence that the '514 patent is asserted in that case. Verifying this requires the complaint (Dkt. 1) or the Local Patent Rule infringement contentions in 4:26-cv-04064.

  2. No other litigation found. I found no other district court action, ITC Section 337 investigation, or Federal Circuit appeal in which US 11,439,514 is identified as an asserted patent. I also found no PTAB proceeding (IPR/PGR) against this specific patent — note that searches for PTAB petitions referencing "11439514" returned only unrelated matters (e.g., litigation-history statements in IPRs concerning other patents). This is a negative search result, not a guarantee; Unified Patents' litigation portal and PACER were not directly retrievable in this session, so the search was conducted via general web queries and secondary docket aggregators.

  3. No outcome on the merits exists. The DeGen case was filed September 15, 2026 (roughly six weeks before today's date of April 26, 2026 per case context — note the filing postdates the current-date field in my instructions, so I am reporting the dates exactly as the sources state them without reconciling them). No termination, settlement, judgment, or appeal is reported.

Related (non-litigation) matters worth flagging under this patent family

These are prosecution-family items, not litigation, but they bear on the patent's scope and enforcement posture:

  • Continuation filings claiming priority from the same family include US 12,251,320 B2 (priority to 2022-08-03), US 12,245,952 B2 (priority to 2024-06-25), and US 2025/0235324 A1 (priority to 2025-01-30), per the Google Patents "worldwide applications" record for US 11,439,514.
  • The specification incorporates by reference U.S. Provisional App. No. 62/658,389 and U.S. patent application Ser. No. 16/207,116 ("Systems and Methods for Multi-Planar Orthopedic Alignment"). Those are copending applications, not asserted patents.

Bottom line

The only litigation I can identify that plausibly involves US 11,439,514 is Carlsmed, Inc. v. DeGen Medical, Inc., No. 4:26-cv-04064 (D.S.C. filed Sept. 15, 2026), in which Carlsmed asserts eight patents and seeks injunctive relief and damages; the case is at its earliest stage and the defendant contests the allegations. Membership of the '514 patent in that eight-patent set is unverified from the sources available to me, and no other litigation involving US 11,439,514 is known. I would need the complaint or infringement contentions to close that gap with confidence.

Generated 10/1/2026, 5:33:19 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.

Current assignee: Carlsmed, Inc.

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.

✓ Generated

I'll verify against live sources before reporting, since the structured block is my canonical starting point but may lag.

No hits yet. Let me run targeted follow-ups on likely petitioner/patent-owner patterns and PTAB databases.

Found a live litigation development. Let me check whether it has spawned any PTAB activity and confirm the patent's PTAB posture directly.

I hit my tool-call budget before I could query PTAB E2E / P-TACTS directly, so I'm reporting what the canonical feed plus public web sources support — and flagging where I could not independently verify.

Proceedings overview

Total AIA trial proceedings on US 11,439,514: 0. The structured "PTAB proceedings on file" block (USPTO Open Data Portal) returns no AIA trials, and web searching surfaced no IPR, PGR, or CBM petition naming this patent. There is therefore nothing in the "active / claims invalidated / claims sustained / settled / institution denied" breakdown — every bucket is empty. Defensive posture: no PTAB record exists, which is a double-edged signal. A defendant gets no free invalidity work product and no cancellation-based estoppel shield, but also no PTAB confirmation that the claims are strong. The one concrete development in the public record is that the patent owner, Carlsmed, Inc., filed a patent-infringement suit against DeGen Medical, Inc. on 2026-09-15 — see the watch items below.

Because there are no proceedings, I have replaced the per-proceeding template with an equivalent section on (a) explicitly absent data and (b) the live litigation that is the only plausible source of future PTAB activity.

No proceedings to report

  • Type: — (no IPR / PGR / CBM on file)
  • Filed: — (none)
  • Status: No AIA trial proceedings indexed by the USPTO ODP structured feed as of the most recent ingest.
  • Judge panel: — (none assigned)
  • Petition grounds: — (none)
  • Institution decision: — (none)
  • Final Written Decision: — (none)
  • Settlement / termination: — (none)
  • Appeal: No AIA-trial FWD exists, so there is nothing appealable to the Federal Circuit. I also found no CAFC opinion involving US 11,439,514.
  • Defensive value: A defendant cannot point to a canceled claim or to a Board finding of invalidity — the entire invalidity case must be built from scratch. Conversely, the patent owner cannot point to any PTAB affirmance of claim 1. The claims stand untested by the Board.

Watch item — active litigation (not a PTAB proceeding)

Carlsmed, Inc. v. DeGen Medical, Inc. — D.S.C., No. 4:26-cv-04064

  • Type: District court patent-infringement action (outside the AIA-trial scope of this task, but directly relevant to whether a PTAB filing is coming)
  • Filed: 2026-09-15 (Judge Joseph Dawson, III; District of South Carolina, Florence Division; Nature of suit 830)
  • Asserted patents: Carlsmed's press release states the complaint asserts eight Carlsmed patents "relating to its implants, methods and systems." I could not verify from any public source that US 11,439,514 is among those eight. Do not assume it is; pull the complaint from PACER/CourtListener to confirm.
  • Relief sought: Injunctive relief and damages.
  • Defendant's public response: DeGen Medical CEO Craig Black stated on 2026-09-16 that DeGen "strongly disagree[s] with Carlsmed's allegations and intend[s] to vigorously defend [its] technology and intellectual property."
  • Links: PACER/CourtListener docket for case 4:26-cv-04064; https://ptacts.uspto.gov/ (PTAB E2E, to confirm zero proceedings directly).
  • Defensive value: If '514 is asserted, DeGen's § 315(b) one-year clock to file an IPR runs from service of the complaint — i.e., roughly late 2027. Any other defendant first served over a year ago (there is no evidence of one) would already be time-barred.

Strategic summary

Claim status across the patent. With zero PTAB proceedings, no claims are canceled and no claims have been held unpatentable or patentable by the Board. Claim 1 — the surgical-planning-software / non-planar-plate / node-and-locking-element claim — is UNTESTED, as are the dependent claims 2–11 and the subject matter of claim 12 onward. The patent carries 21 claims. Nothing in the record narrows the claims by prosecution disclaimer or IPR amendment, so the full issued scope is what a defendant faces. Note two drafting cautions: the claim text as reproduced in the source I was given contains apparent transcription errors (e.g., "deformaties," "confroms," and a grammatically incomplete clause in claim 1 beginning "wherein the predictive"), and claim 12 is truncated mid-sentence in that source. Verify against the official grant text at https://patents.google.com/patent/[US11439514B2](/patent/US11439514B2) before relying on any specific limitation or on claim 12's scope.

Estoppel landscape. There is no § 315(e)(2) estoppel, because no petitioner has taken an IPR to final written decision. That cuts in favor of the defense: every prior-art ground — § 102 anticipation, § 103 obviousness, and § 112 written-description/enablement theories in a PGR-eligible posture — remains fully available to any defendant, in the district court and at the Board. There is no estoppel-laden IPR record to inherit and no petitioner whose grounds are closed off. The trade-off is that there is also no Board-validated roadmap of weak claims to copy.

Pattern signals. No petitioner has filed anything, so there is no repeat-petitioner pattern. No defensive aggregator (Unified Patents, RPX, etc.) appears anywhere in the chain — I found no evidence of one. The patent owner has not pursued PTAB appeals (there is nothing to appeal). What is notable is the chronology: the patent issued 2022-09-13 and went roughly three years without any validity challenge, until Carlsmed itself became the aggressor by suing DeGen on 2026-09-15. That sequencing (commercial success, an IPO on Nasdaq in July 2025, a $250M shelf registration, then enforcement) is consistent with a patent owner that believes the portfolio is worth asserting, and inconsistent with a patent that has been quietly picked apart. Carlsmed is also actively prosecuting the family — the '514 record shows continuation activity (US 12,251,320; US 12,245,952; US 2025/0235324 A1) and an incorporated-by-reference sibling application, Ser. No. 16/207,116. Expect additional, possibly broader, claims to emerge from that family and factor pending continuations into any freedom-to-operate analysis.

Recommended next steps

  • Confirm the asserted patent list first. The single highest-value action is pulling the 2026-09-15 complaint in Carlsmed v. DeGen Medical, No. 4:26-cv-04064 (D.S.C.), and confirming whether US 11,439,514 is among the eight patents. Every other conclusion here is contingent on that. CourtListener/PACER docket: case 4:26-cv-04064.
  • If '514 is asserted, calendar the § 315(b) bar. The one-year window runs from service of the complaint. A post-grant review is not available — the nine-month PGR window closed on 2023-06-13, nine months after the 2022-09-13 grant. A CBM review is not available — the patent is a spinal-implant/personalized-surgery patent, not a "financial product or service," and the CBM transitional program sunset for new petitions on 2020-09-16. IPR is the only AIA vehicle left. If DeGen files, the statutory trial schedule is one year from institution to FWD.
  • Front-load the invalidity search rather than waiting for a Board record. With no IPR institution decisions or FWDs to mine, there is no free claim-construction guidance and no institution-stage signal about which references the panel finds persuasive. Budget for a full prior-art and § 112 analysis now, focusing on the pre-2018 personalized-implant/patient-specific-plate art cited on the '514 face (the record lists early patient-specific implant references such as US 4,704,686; US 4,936,862; US 5,431,562; US 6,776,026; US 6,932,842; US 7,174,282; US 7,187,790 and others) plus additive-manufacturing-for-implants art.
  • Treat the absence of PTAB activity as provisional, not permanent. Zero proceedings is expected for a patent that had no litigation history before September 2026 — there was no trigger. The absence is not evidence of unusual strength. Re-check https://ptacts.uspto.gov/ and the ODP feed after DeGen's answer and any scheduling order, since Fintiv-type discretionary-denial analysis in a D.S.C. action will turn on the projected trial date.

Confidence and limitations. High confidence on the core finding (no AIA trial proceedings on US 11,439,514): the ODP structured feed is empty and multiple targeted web searches returned no petition, institution decision, FWD, or CAFC appeal. Medium confidence on the litigation details, which come from Carlsmed's own press release and secondary trade press (Becker's, ODT, GlobeNewswire syndications) rather than the complaint itself. I could not verify that '514 is one of the eight asserted patents, and I could not query PTAB E2E directly before exhausting my search budget.

Generated 10/1/2026, 5:33:39 PM

Ownership chain (1)

Asserters network →

Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.

  1. ? · recorded 2019-04-30 · Assignment

    Michael J. Cordonnier and Niall Patrick CaseyCARLSMED, INC.

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.

✓ Generated

I'll start by pulling the assignment/ownership records and cross-referencing the assignees.

Now let me check the recorded assignment details and Carlsmed's corporate status.

Let me check for litigation, the Precisive merger, and any reels/frames in public assignment indexes.

Ownership & Assignment Reconstruction — US 11,439,514 B2

"Systems and methods for orthopedic implant fixation" · Appl. No. 16/383,215 · Filed 2019-04-12 · Granted 2022-09-13 · Adjusted expiry 2039-07-12

Sourcing caveat up front. I could not open the USPTO Assignment Center record directly in this session (the Assignment Center is a JSP/JS front end that does not expose a crawlable per-patent record page, and no third-party mirror of the reel/frame for this patent surfaced). Accordingly, no reel/frame number and no correspondent of record is reported below, because I will not invent one. What follows is built from the patent front page (authoritative, supplied in the prompt), the Google Patents legal-events mirror of the assignment record, and public corporate/legal filings. The single assignment event that is documented is flagged as such.


Inventors

Inventor Residence at filing Employer at time of filing (determinable)
Niall Patrick Casey Carlsbad, CA Carlsmed, Inc. — co-founder
Michael J. Cordonnier Carlsbad, CA Carlsmed, Inc. — co-founder; CEO and Chairman (still serving as of the Sept 2026 DeGen suit press release)

Basis: The front page of US 11,439,514 names both inventors at Carlsbad, CA, which is Carlsmed's principal address, and lists "(71) Applicant: CARLSMED, INC., Carlsbad, CA (US)." The application was therefore filed by the company as applicant, with the inventors' rights confirmed by a subsequent assignment recorded 2019-04-30 (assignors: Cordonnier, Michael J.; Casey, Niall Patrick — assignee: CARLSMED, INC.). Both are named inventors on dozens of Carlsmed-family filings (e.g., US 10,902,944; US 11,083,586; US 11,806,241; US 11,793,577).

Unusual patterns: None. The classic "all inventors departed the assignee within 12 months of filing" precursor to a portfolio fire-sale is absent: Cordonnier remains Carlsmed's CEO and Chairman through at least September 2026, i.e. ~8 years post-filing, and the company listed on Nasdaq in July 2025. There is no inventor-side severance, no competing post-filing filings by a different assignee, and no reissue/derivation contest visible.


Original assignee

Carlsmed, Inc. (Carlsbad, CA; formerly La Jolla, CA — the earlier-filed sibling US 11,083,586 still shows "La Jolla, CA").

  • Primary line of business: commercial-stage medical technology — AI-enabled patient-specific spinal fusion. Flagship aprevo platform: pre-op surgical planning software, 3D-printed patient-specific interbody implants, single-use instruments, and a post-op outcomes intelligence layer.
  • Did they ship a product embodying the claims? Partly / unclear for this specific claim set. Carlsmed clearly ships product — FDA clearance for aprevo lumbar interbody in late 2020, cervical clearance in Dec 2024, ~1,500+ patients treated by mid-2025, FY2025 revenue guided at $70–75.5M (with $50.5M first-public-year revenue reported). However, the granted claims of US 11,439,514 recite a posterior fixation plate + bone anchor + locking element construct (claims 1–11), which is a different device family from the commercialized interbody cages. I have no evidence that a plate-and-locking-element product reading on these claims is on the market. Treat "ships the claimed product" as not established for this patent, even though the assignee is unambiguously an operating company.
  • Current status: Operating, publicly listed. IPO priced 2025-07-22 at $15.00/share (6.7M shares, ~$100.5M gross), began trading on Nasdaq Global Select as CARL on 2025-07-23. The company was founded 2018 and merged with spine-imaging startup Precisive Surgical pre-IPO (per MassDevice coverage). No bankruptcy, no insolvency, no wind-down.

Assignment timeline

Chronological record of every assignment event I can document:

  • 2019-04 (executed) / recorded 2019-04-30 — Reel/frame: not retrievable from the sources I could access; do not treat any reel/frame as verified.
    • Conveyance: Assignment (inventor-to-company; confirmatory, since Carlsmed was already named applicant at filing on 2019-04-12)
    • Assignors: Michael J. Cordonnier and Niall Patrick Casey
    • Assignee: CARLSMED, INC.
    • Correspondent: Not exposed in any source available to me — no attorney/firm of record can be reported without fabrication. (Flag: a single-appearance correspondent confirms nothing about NPE behaviour anyway; the signal requires recurrence, and this chain has only one link.)
    • Context: Founder/employee rights assignment into the operating company that was already the stated applicant — ordinary course, not a transfer, not a fire-sale.

No post-issuance assignment is recorded. Google Patents' legal-events panel for US 11,439,514 shows exactly one reassignment entry (2019-04-30, "ASSIGNMENT OF ASSIGNORS INTEREST," assignors CORDONNIER/CASEY → CARLSMED, INC.) and nothing thereafter — no security agreement, no license recordation, no change of name, no merger conveyance, no transfer to any third party. All later events on that panel are prosecution/publication/family events (US20190321193A1 published 2019-10-24; grant 2022-09-13; priority claims by continuations US 17/880,277 → US 12,251,320 and US 18/754,101 → US 12,245,952, both still Carlsmed).

I also found no recorded assignment reflecting the Carlsmed/Precisive Surgical merger touching this patent. That merger is a public corporate fact, but I have no reel/frame or recordation evidence tying it to US 11,439,514, and Carlsmed remained the named assignee throughout — so I am not asserting one.

Net chain length: one link. It terminates at the original operating assignee.


Timeline diagram

timeline
    title Ownership of US 11439514
    2018 : Provisional filed by Casey and Cordonnier
    2019 : Non provisional filed 12 Apr
         : Inventors assign rights to Carlsmed
    2022 : Patent issued 13 Sep
    2025 : Carlsmed IPO on Nasdaq as CARL
    2026 : Carlsmed sues DeGen Medical

NPE / troll-pattern signals

# Signal Call Evidence
1 Shell-entity transfer Not present No assignment exists beyond the 2019-04-30 inventor→Carlsmed link. No "IP / Patents / Licensing / Holdings / Ventures" successor appears anywhere in the record. Assignee is a California operating corporation with a physical Carlsbad campus, ~100+ employees, and Nasdaq listing — not a registered-agent address LLC.
2 Known asserter in the chain Not present No assignee or predecessor matches Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, DGC, or any Spangenberg entity. Sole assignee is Carlsmed, Inc. throughout. No Unified Patents / RPX high-frequency-plaintiff listing for Carlsmed was surfaced.
3 Repeat correspondent across the chain Unclear Correspondent of record is not retrievable from the sources available to me, and with a single-link chain there is by definition no recurrence to test. No finding.
4 Cascading transfers Not present Zero consecutive assignments, let alone chained LLCs in <24 months. The chain has one transfer in 7+ years.
5 Pre-litigation transfer Not present The only assignment is dated 2019-04, ~7.4 years before the first known infringement suit (Carlsmed v. DeGen Medical, filed 2026-09-15, D.S.C. 4:26-cv-04064). Nothing was arranged to manufacture standing or set venue; the patent never moved.
6 Bankruptcy fire-sale Not present Carlsmed is solvent, growing (FY2024 revenue $27.2M, +97%; FY2025 guided $70–75.5M), IPO'd July 2025, and holds NTAP reimbursement plus FDA Breakthrough designations. No Chapter 7/11 proceeding found.
7 Privateering Not present No transfer to any NPE, so nothing to assert on Carlsmed's behalf. Carlsmed is litigating in its own name as the named patent owner — the opposite of privateering.
8 Defensive aggregator (anti-NPE) Not present Chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates at a commercial manufacturer.

Verdict

Operating-company assertion

Justification (with the two caveats stated plainly). The ownership chain is a single recorded link — inventors Cordonnier and Casey assigning to CARLSMED, INC. effective April 2019, recorded 2019-04-30 — and no reel/frame substantiates any later transfer; the patent has never left its original operating assignee. Not one of the eight NPE signals is present on this record, and the assignee is an operating medtech that IPO'd on Nasdaq as CARL in July 2025 and on 2026-09-15 filed Carlsmed, Inc. v. DeGen Medical, Inc., No. 4:26-cv-04064 (D.S.C., Florence Div.), asserting eight Carlsmed patents against a spinal-implant competitor and seeking injunctive relief — i.e., a product company suing a rival, not a licensing vehicle. Caveat 1: whether US 11,439,514 is among the eight asserted patents is not confirmed — the press release and docket summaries I retrieved do not enumerate the patent numbers, so I do not claim this patent is in suit. Caveat 2: the granted claims recite a posterior plate/anchor/locking-element construct, and I found no evidence that a product reading on these claims is commercially shipped; the "ships products embodying the claims" prong of the verdict test is therefore not established, even though the "operating company asserting against competitors" prong is well supported.

Verification links:

Residual gap to close, if you have Assignment Center access: pull the reel/frame and correspondent for the 2019-04-30 record and confirm no later recordation exists. My conclusion — one link, terminating at the original operating assignee — is robust against that check, but the correspondent field is the one data point I could not source, and I have deliberately left it blank rather than guess.

Generated 10/1/2026, 5:33:47 PM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I'll search for the USPTO record and the front-page patent citations for US 11,439,514.

Let me try to retrieve the front-page references directly from the patent PDF and Google Patents citation table.

Scope, method, and an honest limitation up front

I searched for the USPTO record of US 11,439,514 specifically, and attempted to pull the full (56) References Cited list from the granted patent's front page, Google Patents' citation table, and the USPTO-adjacent mirrors. Here is the key limitation you need before reading further:

I could recover only a partial excerpt of the (56) reference list. The retrieved text of the granted cover page (patentimages PDF) renders the U.S. patent-document list and the foreign-document list as abbreviated, truncated fragments (it shows orphaned entries such as "4,704,686 A 11/1987 Aldinger" and "4,936,862 A 6/1990 Walker et al." plus two CN documents, then jumps to the abstract). I could not retrieve the complete list of the 61-odd citations that Google Patents attributes to this family, nor the examiner's relevance annotations (there are none on a U.S. front page anyway — the U.S. system does not publish X/Y/A relevance codes the way the EPO does).

Per your operating rules, I am not going to fill that gap with plausible-looking citations. Below I separate what is verified from what is inference.


1. USPTO record for 11,439,514 (verified)

Field Value
Patent US 11,439,514 B2 — "Systems and methods for orthopedic implant fixation"
Appl. No. 16/383,215; filed Apr. 12, 2019
Provisional 62/658,389, filed Apr. 16, 2018 (priority)
Granted Sept. 13, 2022; Pre-grant pub. US 2019/0321193 A1 (Oct. 24, 2019)
Inventors / Assignee Niall Patrick Casey; Michael J. Cordonnier / Carlsmed, Inc. (Carlsbad, CA)
Primary Examiner David W. Bates
Attorney/Agent Perkins Coie LLP (cover page renders "Perkins Cole")
Exemplary IPC A61F 2/44 (2006.01); A61B 17/70 (2006.01)
Claims / Sheets 21 claims, 14 drawing sheets
§ 154(b) adjustment 91 days

Sources: granted-PDF cover page https://patentimages.storage.googleapis.com/fa/0e/c3/53bacc7545ae5c/US11439514.pdf ; https://patents.google.com/patent/[US11439514B2](/patent/US11439514B2) ; https://pubchem.ncbi.nlm.nih.gov/patent/US-11439514-B2


2. The patent citations I could verify for US 11,439,514

These are the only entries I could read verbatim out of the (56) block in the retrieved text. Titles/subject matter are not recoverable from the excerpt, so I am reporting the identifiers and dates exactly as printed and declining to characterize content I did not read.

# Citation (as printed) Date (as printed) Prior-art status vs. 4/16/2018 priority Potential § 102 claim impact
1 US 4,704,686 A (Aldinger) Nov. 1987 Prior art by date (§ 102(a)(1) / pre-AIA § 102(b)) Very unlikely to anticipate claim 1. See § 3 below.
2 US 4,936,862 A (Walker et al.) Jun. 1990 Prior art by date Very unlikely to anticipate claim 1. See § 3.
3 CN 104318000 A Jan. 2015 Prior art by date (published < 4/16/2018) Cannot assess — text not retrieved. More plausible candidate given the date.
4 CN 104353121 A Feb. 2015 Prior art by date Cannot assess — text not retrieved. More plausible candidate given the date.
5 Non-patent literature: Endo, Kenji et al., "Measurement of whole spine sagittal alignment using the SLOT radiography of the SonialVision safire series clinical application," Medical Now, No. 78, Aug. [yr. not captured in excerpt] Aug. (year truncated) Prior art by date if published before 4/16/2018 (likely) Directly on point for the software limitations — sagittal-alignment measurement. This is the citation in the list most obviously mapped to claim 1's "sagittal alignment" measuring step. I could not read the full citation or its date to the year.

Everything else in (56) is unverified. I also note the Google Patents record shows forward citations ("Cited By") to the '514 patent — e.g., US 2022/0160518 A1 (Carlsmed, "Patient-specific vertebral implants with positioning features") and WO 2022/261171 A1 (Carlsmed, patient-specific expandable spinal implants). Forward citations are not prior art and cannot anticipate; I mention them only so they are not confused with the (56) list.


3. § 102 analysis of the verified references

The controlling question is whether a reference discloses every element of a challenged claim. Claim 1 (the only independent claim I have verified in full) requires, in combination:

  1. a surgical planning software tool that generates a 3D virtual model of spinal anatomy;
  2. measures it for pelvic tilt, sagittal alignment, or lumbar lordosis;
  3. adjusts the virtual anatomy to a corrected spinal geometry correcting a deformity;
  4. applies predictive guidelines and confirms conformance;
  5. designs a plate for that corrected geometry;
  6. a bone anchor;
  7. a plate that does not conform to a single plane, spanning at least one intervertebral gap, with a node/hole;
  8. a locking element; and
  9. the plate is additively manufactured.
  • US 4,704,686 (1987) and US 4,936,862 (1990): date-wise these are prior art, but as a matter of technology chronology they cannot disclose the computational/digital-manufacturing limitations (elements 1–5 and 9). Additive manufacturing of patient-specific implants from CT-derived virtual models was not a practical reality in 1987/1990, and the claim's software tool is not amenable to anticipation by an implant-hardware patent of that vintage. My best assessment is these are background/§ 102(b) art cited for general implant or fixation structure, not anticipatory art. (Inference — I did not read the reference texts, so I cannot exclude that one of them discloses, e.g., a multi-planar plate with node-and-hole geometry, which would be relevant to elements 6–8 in a § 103 combination but still not to anticipation of claim 1 as a whole.)
  • CN 104318000 A and CN 104353121 A (both 2015): These are the entries where a genuine § 102 challenge is conceivable, because they post-date the emergence of image-based surgical planning and 3D printing. A Chinese application numbered in the 1043xxxxx series from Jan–Feb 2015 plausibly concerns computer-aided design/manufacture of a medical device. I could not retrieve either document, so I am explicitly not asserting they anticipate anything. This is the first place to verify.
  • Endo et al. (NPL): Best characterized as § 102(a)(1) art on the sagittal-alignment measurement step, and more realistically as § 103 art combinable with an implant-design reference. It almost certainly does not disclose the plate, node/hole, locking element, or additive-manufacturing limitations, so it cannot anticipate claim 1 alone.

4. What I could NOT verify — and what would close the gap

I want to be blunt rather than pad this section with speculation:

  1. I do not have the complete (56) list. The retrieved cover page fragment is not the full reference table. Any statement of the form "the examiner cited X, Y, Z" beyond the five entries above would be fabricated.
  2. I found no § 102 rejection record. I could not retrieve the file wrapper (Office actions, applicant remarks, IDS/PTOS-1449 forms) for application 16/383,215. Without it I cannot tell you which references the examiner actually relied on for rejection versus which were merely listed in an IDS. That distinction matters enormously for "most relevant prior art" and it is exactly what the file wrapper shows. Retrieving it requires USPTO PatentCenter → Application 16/383,215 → "Documents & Transactions" (or the Global Dossier / Espacenet family view).
  3. I found no foreign counterpart search report for the '514 family. EP/WO search reports (which do carry X/Y relevance codes) would be the fastest way to get an examiner's own prior-art ranking. The EPO search reports that surfaced in my searches (EP 3 906 853, EP 4 082 567, etc.) belong to unrelated cases and must not be attributed to this patent — I flag this because the search results were dominated by mismatched documents.
  4. Evidence of records I did see that I am deliberately not using: the Google Patents "Citations (61)" table that appeared in one result set belongs to a different application in the page's similar/citing set (US 2020/0046513 A1, "Joint Arthrodesis System"), not to the '514 (56) list. Attributing those 61 references to '514 would be an error.

Recommended next steps to complete the assignment:

  • Pull the PTOS-1449 / PTO-892 for 16/383,215 to get the authoritative (56) list and the examiner's considered references.
  • Pull the Office actions to identify which references were mapped to which claims.
  • For a § 102 opinion, map each reference against claim 1 first (the only verified independent claim), then against claim 12 — which, as I flagged earlier, is very likely the subtractive-manufacturing counterpart of claim 1 (inference from the specification's paired embodiments, not verified).

5. Honest bottom line

For US 11,439,514, the only references I can state with confidence were cited on the granted patent are: US 4,704,686 A (11/1987, Aldinger); US 4,936,862 A (6/1990, Walker et al.); CN 104318000 A (1/2015); CN 104353121 A (2/2015); and the Endo et al. sagittal-alignment article. All five pre-date the April 16, 2018 priority date and therefore qualify as prior art by date, but on the verified claim-1 text none of the four patent documents can, on the record available to me, be shown to anticipate claim 1, because claim 1's software-correction-plus-additive-manufacturing combination is a 2010s-era combination that a 1987 or 1990 implant patent cannot disclose, and I have not read the 2015 CN documents or the NPL.

I could not identify a verified anticipatory reference under § 102 for any claim, and I am not going to name one by inference. The single highest-value outstanding action is to retrieve the file wrapper for 16/383,215, which will resolve the question definitively.

Generated 10/1/2026, 5:33:55 PM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

I'll research the prior art landscape for this patent before building the § 103 analysis.

Let me dig into the specific references cited on the patent face and the broader "similar documents" art.

Let me pin down a few more specific references for the combination analysis.

Obviousness Analysis — U.S. Patent No. 11,439,514 B2

"Systems and methods for orthopedic implant fixation" (Carlsmed, Inc.; Casey & Cordonnier)

Under 35 U.S.C. § 103, AIA regime (effective filing date Apr. 16, 2018)


0. What I actually had to work from, and what I did not

You asked me to use "the results from the Prior Art section of this page." I need to be precise about what that section contained in the material I was given, because it materially bounds this opinion:

Component of the "Prior Art" area What I had Reliability
Prior-art keywords plate · spinal · subject · fixation system · anatomy Verified from the fetched Google Patents text
Admitted prior art (Background + FIGS. 1–5 discussion) Polyaxial pedicle screw constructs; plate/nut/washer posterior constructs; "surgical planning … can be used to reduce or eliminate intra-operative radiation"; "Prior to implantation the anatomy can be virtually corrected using planning software" Verified — and this is applicant-admitted prior art, citable under MPEP § 2129
References Cited on the patent face Partial list recovered from the granted-PDF cover page. Confirmed entries include US 4,704,686 (Aldinger), US 4,936,862 (Walker), US 5,431,562 (Andreiko), US 6,696,073 (Boyce), US 6,978,188 (Christensen), US 7,174,282 (Hollister), US 7,187,790 (Salod), and others; Foreign: CN 104318000 A, CN 104353121 A; Other: Endo et al., "Measurement of whole spine sagittal alignment using the SLOT radiography…," Medical Now No. 78 (Aug. 2015) Partially verified. The OCR of the citation list is noisy (e.g., "Budyury"/"Bradbury," "Salod"/"Salon," "Bear"/"Betz" appear inconsistently across search hits), so I do not assert specific subject matter for the entries I could not independently pull.
Google Patents "Similar Documents" / "Cited By" / family citation lists Not present in the fetched text. I could not retrieve them. Gap — flagged.

Because of that gap, the analysis below is built on (a) the applicant's own admissions, (b) references I could independently verify as pre-April 16, 2018 art, and (c) a small number of references whose content I verified but whose exact prior-art date I flag as unconfirmed. Where a limitation has no verified reference, I say so rather than filling the hole.

I am not re-opening the April 26, 2026 vs. September 2026 date discrepancy flagged in the earlier sections.


1. Person of ordinary skill in the art (PHOSITA)

A POSITA here is a team, or a person with: (i) a mechanical/biomedical engineering degree (or equivalent) and 2–5 years in spinal implant design; (ii) working familiarity with pedicle-screw/plate/rod fixation constructs; (iii) familiarity with CT/MRI-based surgical planning software and spinopelvic alignment parameters; and (iv) familiarity with additive manufacturing (SLS/SLM/DMLS/EBM) of titanium orthopedic implants. This is not a high-skill PHOSITA — it is a competent, software-literate implant engineer. That matters: much of what the '514 claims is ordinary engineering in this field.


2. Claim 1 distilled into discrete limitations

Building on the earlier section (not repeating it), claim 1 breaks down as:

  • L1 — Software tool generates a 3D virtual model of spinal anatomy
  • L2 — Software measures the model for pelvic tilt / sagittal alignment / lumbar lordosis
  • L3 — Software adjusts the virtual anatomy to a corrected geometry correcting a deformity
  • L4 — Software applies predictive guideline(s) and confirms conformance (the as-rendered text of this clause is garbled — see earlier section; the specification supplies three guidelines: PT < 20°, C7 SVA ≤ 5 cm, |PI − LL| < 10°)
  • L5 — If conforming, the software at least partially designs a plate
  • L6 — At least one bone anchor
  • L7 — Plate that (a) does not conform to a single plane, (b) extends across ≥1 intervertebral gap, (c) has shape at least partially determined by the software, (d) has ≥1 node with a hole for the anchor
  • L8 — Locking element connecting anchor to plate
  • L9 — Plate manufactured using additive manufacturing

3. Verified prior art available for combination

Tag Reference Date / status What it discloses (verified)
APA '514 patent's own Background + FIGS. 3–5 Admitted prior art Plate-type posterior construct: bone screws 34 with bone-thread shank 42 and machine-thread proximal post 41; plate 32 with slots 33 and features 38; nut 36 compressing the plate against shoulder 43; washers 40 for angular/axial spacing. Also: virtual pre-operative correction using planning software; pre-op determination of screw start-point/trajectory/length. **This single admission supplies L6, L8, and most of L7(a) **— (a plate spanning vertebrae, anchored by screws, locked by a nut).
Hollister US 7,174,282 B2 (Hollister, Chu, Taboas), "Design methodology for tissue engineering scaffolds and biomaterial implants" Issued Feb. 6, 2007; cited on the '514 face Voxel-based design of implants in any 3D anatomic shape created by CT or MRI scanners; heterogeneous density distribution; optimization of microstructure to match functional requirements (stiffness vs. porosity); conversion to layered/solid free-form fabrication (SFF) formats; explicitly criticizes prior CT-based custom bone implant approaches as lacking interior design. (Espacenet biblio: https://worldwide.espacenet.com/publicationDetails/biblio?CC=US&NR=[7174282B2](/patent/7174282B2)&KC=B2)
Mosnier / Medicrea US 2018/0303552 A1, issued as US 10,413,365 B2 — "Methods, systems, and devices for designing and manufacturing a spinal rod"; also US 11,197,718 B2 Priority Apr. 21, 2017 → § 102(a)(2) art Pre-operative sagittal x-ray of the column from cervical vertebrae to femoral heads; identify points on S1, S2, T12, C7; depict sagittal curvature segments; identify corrections including osteotomies; pivot segments; then produce the curvature of a patient-specific rod from that corrected sagittal geometry. This is L1–L3 and L5 in the rod context, using the same alignment parameters the '514 claims. (PDF: https://patentimages.storage.googleapis.com/04/c4/8d/4925102b6100aa/US10413365.pdf)
Spinologics WO 2019/043426 A1 (published Mar. 7, 2019) / EP 3 675 753 B1; US counterpart US 11,707,324 B2 Priority Sept. 1, 2017 (IB2017/001163) → § 102(a)(2) art "Estimation step of a targeted spinal correction rod implant shape … based on a patient specific spine shape correction and which includes a patient specific spine 3D modeling," plus iterative simulation loops of implant/spine mechanical interaction. Expressly states 2D modeling is insufficient and that 3D patient-specific modeling is needed. Supplies L1, L3, L5 in the implant-design context with a pre-surgical simulation loop. (Google Patents: https://patents.google.com/patent/WO2019043426A1/en)
Patient-matched apparatus US 2017/0135707 A1 — "Patient-Matched Apparatus and Methods for Performing Surgical Procedures" Published May 18, 2017 → § 102(a)(1) art CAD/FEM-generated screw map of entry points and trajectories; template and pegs keyed to the screw map; a "patient specific rod manufactured with bends pre-formed to substantially match the shape of the rod to the planned screw locations." Supplies L5/L7(b)–(c) (implant geometry derived from the planned anchor map) and undercuts any argument that "implant shaped to the corrected plan" was novel. (https://patents.justia.com/patent/20170135707)
3D-printed plate WO 2016/061614 A1 (PCT/AU2015/000632) — bone fixation system, screw + plate Published Apr. 28, 2016 → § 102(a)(1) art Claim 18: "the plate is manufactured by a 3D printing process." Claim 8: poly-axial locking screw. So the notion of an additively manufactured bone-fixation plate with polyaxial screw engagement was known and claimed before the '514 priority date. Supplies L9 and reinforces L6/L8. (PDF: https://patentimages.storage.googleapis.com/a9/1b/ae/0956358f1f0a0c/WO2016061614A1.pdf)
Endo et al. 2015 Cited on the '514 face Printed publication, Aug. 2015 Whole-spine sagittal alignment measurement technique. Supplies the evidentiary predicate that spinopelvic sagittal parameters were routinely measured pre-operatively — i.e., L2 is routine.
Pimenta 2015 "Current Surgical Strategies to Restore Proper Sagittal Alignment," J. Spine 4(4) Printed publication; incorporated by reference into the '514 specification Source of the three predictive guidelines the specification recites. Because applicant incorporated it, applicant cannot argue these guidelines were unknown; the only question is whether automating them into a design gate is inventive.

Two references I want to flag but NOT rely on: the Medyssey "patient-specific spinal rod using 3D printing" family (US 2023/0404624) and the K2M "Spinal Implants With Custom Density And 3-D Printing Of Spinal Implants" publication (US 2021/0077267). Both are conceptually on point, but the publication dates I could verify are 2021/2023, and I could not verify an earlier priority date placing them before April 16, 2018. They should not be counted as § 103 art until their priority chains are confirmed. Similarly, the Carlsmed family members US 12,251,320 and US 12,245,952 and US 11083586 are same-family or later filings, not prior art.


4. The proposed combinations

Combination A (primary): APA + Hollister + Mosnier + WO 2016/061614

Mapping to claim 1:

Limitation Supplied by
L1 (3D virtual model) Mosnier (pre-op imaging → 3D/sagittal reconstruction); Spinologics to the extent 3D is required
L2 (measure PT/sagittal/lordosis) Mosnier (S1/S2/T12/C7 sagittal analysis); Endo 2015
L3 (adjust to corrected geometry) Mosnier (identify corrections, pivot segments); Spinologics (patient-specific shape correction)
L4 (predictive guideline conformance) Pimenta 2015 guidelines; routine implementation of numeric acceptance thresholds in CAD
L5 (design a plate) Mosnier/Spinologics (design the implant from the corrected model), swapped from rod to plate per APA
L6 (bone anchor) APA (bone screws 34) / WO 2016/061614
L7 (non-planar plate, spans intervertebral gap, node + hole) APA (plate 32 with slots 33 spanning vertebrae and screw seats) + inherent non-planarity of a spinal plate following lordotic/kyphotic anatomy (the '514 patent itself says this out-of-plane geometry "can be applied … as a curvature representing or matching lordosis, kyphosis, or medial/lateral twisting in a target patient" — i.e., it tracks the patient's known spinal curvature)
L8 (locking element) APA (nut 36 threaded on post 41, compressing plate 32 against shoulder 43); WO 2016/061614 (locking screw/splines)
L9 (additive manufacturing) WO 2016/061614 claim 18; Hollister (SFF from CAD)

Motivation to combine — the KSR rationales:

  1. Known problem, known solution path. The '514 specification itself identifies the problem: "bending the longitudinal elements (rods) and delivering and securing them to the fixation anchors" is an area of "frustration," done with "no tool or method to determine the optimal degree of correction." Mosnier and Spinologics address exactly that problem by pre-operatively computing implant geometry from a corrected sagittal model. A POSITA confronting this admitted problem would look directly to the Medicrea/Spinologics pre-op-planning literature.
  2. Simple substitution of a known element. Substituting a plate (APA) for a rod (Mosnier/Spinologics) as the longitudinal connecting element is a substitution of one known spinal fixation element for another, both already used to span and stabilize adjacent vertebrae. The '514 specification concedes this equivalence: "Longitudinal element 14 may be rods, plates, or another type of geometry."
  3. Known technique applied to a known device ready for improvement. Hollister (image-based design + SFF) is a known technique for making a custom-fit orthopedic/biomaterial implant; applying it to an already-designed plate is precisely the "use of a known technique to improve a similar device in the same way" rationale. Hollister expressly targets the exact design goals the '514 recites — variable density, variable porosity, and stiffness tuned to the patient.
  4. Finite number of identified, predictable solutions. Once a corrected 3D spinal geometry is fixed in virtual space, the set of ways to generate a load-bearing connecting element that passes through the planned anchor positions is small: machine it (subtractive), bend/curve it, or print it. Both manufacturing routes are expressly contemplated by the '514 specification (Summary: additive embodiment; second embodiment subtractive). Exercising one of two known options is not inventive.
  5. Predictability. Each element performs its own known function with no change in operating principle: the planning tool computes alignment; the plate carries load across a gap; the anchor anchors; the locking element locks; the printer prints. Result: no unexpected mechanism, no synergy beyond aggregation.
  6. Same field / analogous art. All references are in orthopedic and spinal implant design and manufacture.

Combination B (alternative): Spinologics + US 2017/0135707 + WO 2016/061614

Spinologics supplies the 3D patient-specific modeling and the targeted corrected implant shape; US 2017/0135707 supplies the CAD-generated anchor map and a patient-specific implant manufactured with pre-formed bends matching the planned anchor locations (i.e., "designed to achieve the corrected spinal geometry when implanted"); WO 2016/061614 supplies the additively manufactured plate + polyaxial screw + locking structure. This combination is if anything tighter on L5 and L7(c), because US 2017/0135707 ties implant geometry to a planned (not intra-operative) screw configuration.

Combination C (for the subtractive counterpart, likely claim 12)

Whatever claim 12 recites — the earlier section flagged, as inference, that it is the subtractive-manufacturing counterpart reflected in the Summary of the Invention — Combination A or B plus the admitted, routine use of CNC machining / EDM of patient-specific orthopedic plates. The '514 specification lists CNC machining among "subtractive (traditional) manufacturing methods," and nothing about a non-planar patient-specific titanium plate makes CNC machining of it non-obvious. I flag this as unverified because I could not recover claims 12–21.


5. Dependent claims 2–11 (verified)

Claim Reference(s) that defeat it Reasoning
2 (AM guided by the software tool) Hollister Hollister's entire method is CAD/voxel design → SFF file → fabrication; directing the printer from the design file is the disclosed method.
3, 4 (fixation to surgically adjusted anatomy; partial/complete correction) Mosnier; Spinologics; US 2017/0135707 The correction is the design input; partial correction is the ordinary clinical default.
5 (anchor/plate/locking element lock to one another) APA; WO 2016/061614 Nut-on-post clamping and splined locking screw/plate interfaces were both known.
6 (longitudinal elements connecting nodes) APA Plate 32 connecting multiple screw seats.
7 (geometry allowing iliac fixation) Unverified. I did not identify a specific pre-2018 reference for a non-planar plate with an angularly offset terminal hole for an iliac anchor. The specification itself concedes iliac fixation was a live problem for rods. This is the dependent claim I would expect to be hardest to invalidate cleanly.
8 (surface treatment to encourage biological response) Hollister (surface/interior design for biological response); general HA-coated/porous implant art HA coating and roughened/porous bone-contacting surfaces were long conventional in spinal implants.
9 (variable density) Hollister Hollister expressly designs heterogeneous, voxel-varying density. This is the strongest single-reference hit of any dependent claim.
10 (variable porosity) Hollister Same — pore architecture optimization is Hollister's central subject matter.
11 (non-transitory memory + processor instructions) Routine; Mosnier/Spinologics Software-implemented planning tools necessarily run on a memory/processor; Alice § 101 issues are separate.

6. Where the patent has real defensive value

I will not pretend this is a clean kill. The following are genuine weaknesses in the § 103 case:

  • No single reference and no perfect combination expressly discloses L4 as claimed (the predictive-guideline conformance gate that conditions forward progress to the plate-design step). Mosnier and Spinologics compute corrections, but I did not verify that either recites a threshold-comparison gate keyed to PT/SVA/LL as a precondition to design output. Applicant may argue this is the inventive hook. Counter: the guidelines come from Pimenta 2015, which the applicant incorporated by reference, and converting a published clinical guideline into a numeric pass/fail in CAD is the epitome of a predictable automation of a known manual check.
  • The "extends across at least one intervertebral gap" plate with node/hole plus a separate locking element is a narrower structural combination than a rod. Combination A covers it piecewise (APA plate + WO 2016/061614 locking screw), but a fact-finder could demand a single reference disclosing a non-planar plate that both seats a polyaxial anchor head and uses a distinct locking element. This is a genuine evidentiary burden that I cannot close with the art I verified.
  • The garbled L4 clause means the metes-and-bounds of the guideline limitation are genuinely uncertain from my source text. Until the certificate of correction / full claim set is checked, the strength of any L4-based argument is indeterminate in both directions.
  • Objective indicia. Carlsmed obtained FDA 510(k) K252611 clearance for the aprevo® cervical plating system on Dec. 9, 2025 — an additively manufactured (Ti-6Al-4V ELI per ASTM F3001) patient-specific plating system for anterior cervical fixation C2–T1 (https://fda.innolitics.com/submissions/OR/subpart-d-prosthetic-devices/KWQ/K252611). Applicant will argue commercial success, long-felt need (the specification's own rod-bending frustration narrative), and industry praise. Expect a nexus fight: the commercial product's success may be attributable to the planning service and delivery logistics rather than to the claimed plate geometry.

7. Bottom line

  • Anticipation (§ 102): No. I found no single reference disclosing the full claim 1 combination. This is a § 103 case.
  • § 103 — Claim 1: Obvious over a combination, with moderate-to-good confidence on L1–L3 and L6–L9, and lower confidence on L4. The strongest formulation is APA (plate/screw/nut + admitted virtual-correction planning) + Mosnier US 10,413,365 / US 2018/0303552 + Spinologics WO 2019/043426 + Hollister US 7,174,282 + WO 2016/061614 (3D-printed plate). The KSR motivation is unusually clean because the '514 specification itself recites the problem (manual rod bending, unpredictable correction) that Mosnier, Spinologics and US 2017/0135707 were all created to solve, and itself concedes rods and plates are interchangeable as the longitudinal element.
  • § 103 — Claims 2–11: Obvious. Claim 9 and claim 10 (variable density; variable porosity) are the most exposed, being squarely anticipated in concept by Hollister's voxel-based heterogeneous-density design methodology. Claim 7 (iliac-fixation geometry) is the least exposed dependent claim based on the art I could verify.
  • § 103 — Claims 12–21: Not assessed. Text truncated at claim 12 in my source; the subtractive-counterpart theory remains inference per the earlier section.
  • Evidentiary gaps I could not close: (i) the Google Patents "Similar Documents"/"Cited By" prior-art listing; (ii) verbatim claims 12–21; (iii) content of cited CN 104318000 A / CN 104353121 A; (iv) priority dates for the Medyssey and K2M 3D-printed-implant families; (v) any specific pre-2018 iliac-plate reference. Any of (i) or (iv) could substantially strengthen or weaken this opinion.

Recommended next steps to firm this up: pull the full Image File Wrapper for App. 16/383,215 to see what the examiner actually applied and what applicant traversed; verify the priority chain and disclosure of K2M/Stryker's custom-density 3D-printed spinal implant family; and obtain the 4:26-cv-04064 complaint to see whether the '514 patent (and which claims) is in suit.

Generated 10/1/2026, 5:34:35 PM

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1 tracked lawsuit name US 11439514.