Invalidity dossier

US 8361497

Multi-phase, multi-compartment, capsular delivery apparatus and methods for using the same

Current assignee: Capsugel Belgium NV

Added 9/23/2026, 12:41:03 PM

IndustryMedical (M)
At a glanceNo PTAB challenges1 lawsuit on fileasserted by Capsugel Belgium NVMedical (M)

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Patent summary

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

✓ Generated

I'll search for authoritative information on this patent number.

Let me search for litigation/PTAB history and the claim set.

Let me check the full claim set and any Federal Circuit activity specifically tied to this patent.

US 8,361,497 B2 — Summary

Caveat on scope: I was able to retrieve the patent's Google Patents record, the Justia claim listing (partial), and the USPTO.report grant record. I was not able to retrieve a USPTO PatentCenter/Patent Public Search record directly, nor any Federal Circuit docket for this patent. Where I lack authoritative data I flag it below.

Bibliographic data (per Google Patents and USPTO.report)

Field Value
Patent number US 8,361,497 B2 (do not confuse with US 7,670,612 B2, a related family member)
Title "Multi-phase, multi-compartment, capsular delivery apparatus and methods for using the same"
Application no. 12/689,669
Filing date 2010-01-19 (continuation in the 2002 family)
Earliest priority 2002-04-10 (via PCT/US2003/010816, filed 2003-04-09; WO 2003086267 A2)
Issue/grant date 2013-01-29
Pre-grant publication US 2010/0233254 A1 (published 2010-09-16)
Inventor Fred H. Miller (listed as "Frederick H. Miller" on the sibling publication US 2003/0194431)
Assignee Innercap Technologies, Inc. (original and current assignee)
Legal status Expired – Lifetime; adjusted expiration 2023-06-15
Primary CPC A61K 9/4808, A61K 9/4833, A61K 45/06, A61J 3/07 (and related A61J 3/071–3/074, B29C 39/10)

Note on the '612 family member: One database (Unified Patents portal) lists priority date 2002-04-09 for US 7,670,612, while Google Patents lists 2002-04-10 for both the '612 and the '497. I cannot resolve that one-day discrepancy authoritatively.

Abstract / disclosure

The patent discloses a single-dosage, multi-compartment capsule for delivering active ingredients in diverse physical states (solid, liquid, gas, dispersion) that are otherwise difficult to co-formulate. Mechanisms include (a) a smaller secondary (or tertiary) capsule nested inside a primary capsule, (b) dividing walls that partition a single capsule body into independent receiving chambers along a longitudinally extending base, and (c) cap designs or a fill material (e.g., gelatin) to eliminate dead-space air bubbles in the cap. Ingredients include pharmaceuticals, biotechicals, nutraceuticals, vitamins, dietary supplements and minerals. Optional time-release/enteric coatings on the capsule walls or dividing walls provide staged release.

Claims — plain language (partial; flagged)

The Google Patents full text I retrieved is truncated mid-specification, so I do not have a verified, complete claim set for the '497. Based on the Justia claim listing for patent 8361497 and the indexed claim language in the Google Patents record:

  • Claim 1 (independent) — A multi-compartment capsule with a first receiving chamber holding at least one ingredient in a first physical state and a second receiving chamber holding at least one ingredient in a second physical state. Both ingredients must be a nutraceutical, vitamin, dietary supplement or mineral. The two physical states must differ, and the ingredient in the first chamber must be different from the ingredient in the second chamber (added "different ingredient" limitation).
  • Claim 2 (independent) — A multi-compartment capsule with (i) a first receiving chamber containing a liquid in immediate-release form selected from glycerin, an elixir, a spirit, an emulsion and a fluid extract, plus an active ingredient (pharmaceutical, biotechnical, nutraceutical, vitamin, dietary supplement or mineral); and (ii) a second receiving chamber containing only solid ingredients, including at least one solid active ingredient formulated for time-delayed dissolution/release. The first-chamber active must be different from, and absent from, the second chamber.
  • Dependent claims (as retrieved, 3–9+) — second chamber located within the first chamber (3); capsule is a hard shell capsule (4); shell material list, e.g., gelatin, starch, HPMC, etc. (5); solid active in second chamber is caffeine (6); active used to treat a gastrointestinal disorder (7); active is a probiotic (8). Claims beyond 9 are not confirmed from my sources.

The specification also describes further independent-claim concepts — a "primary capsule / secondary capsule" nested configuration, and process (encapsulation) claims covering introducing ingredients of differing physical states into nested or divided capsules and sealing them — but I could not verify from my retrieved sources exactly which of those appear as issued independent claims in the '497 (as opposed to the sibling '612). Treat that portion as uncertain.

Litigation / PTAB posture — important caveats

  • PTAB: The Google Patents record for US 8,361,497 states: "Family has litigation — PTAB case IPR2013-00331 filed (Adverse Judgment)," with the petitioner identified as Unified Patents. An adverse judgment in an IPR typically means claims were cancelled or disclaimed, but the Google Patents note is attached at the family level, and this patent's status is shown as "Expired – Lifetime" (a maintenance-fee expiration), not as a cancellation. I therefore cannot confirm which patent or which claims of this family were subject to the adverse judgment.
  • CAFC 2026: I found no Federal Circuit docket naming US 8,361,497 or Innercap Technologies in 2026 in the searches I ran. I cannot rule out a pending appeal that is not indexed in the sources I reached — do not treat this as a negative finding.
  • Related 2026 district court case: A complaint analysis for Innercap Tech Inc v. Walmart Inc, No. 1:26-cv-00488 (D. Del.) identifies the asserted patent as US 7,670,612 — a related family member, not the '497 — with claim 33 (oil in an immediate-release first chamber; solids only in an enveloped, time-delayed second chamber; hard shell capsule) characterized as representative. Whether the '497 is also asserted in that case is not established by what I retrieved.

Verification steps you should take

  1. Pull the USPTO Patent Public Search / PatentCenter record for 12/689,669 to confirm the complete issued claim set and any certificates of correction.
  2. Pull PTAB Endpoint / PTAB Center for IPR2013-00331 to identify the challenged patent and the exact adverse-judgment outcome.
  3. Search PACER/CourtListener for the Innercap v. Walmart docket and any 2026 Federal Circuit appeal to confirm which family members are at issue.

Generated 9/23/2026, 12:47:44 PM

Cases on file (1)

Group view →

Specific litigation cases in our database that name US patent 8361497. 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 and PTAB proceedings involving US 8,361,497.

Let me dig deeper into the specific PTAB proceeding and any district court cases.

Let me verify the PTAB proceeding and search for district court cases specifically asserting the '497 patent.

Findings: Known litigation involving US Patent 8,361,497

Bottom line: I found no district court litigation that specifically asserts US 8,361,497. The only adversary proceeding I can tie to the patent (or its family) is a PTAB inter partes review. I want to be explicit about the limits of what I could confirm, because several search hits concern related but different InnerCap patents (notably US 7,670,612) rather than the '497 patent, and you asked me not to conflate similar numbers.

1. Patent identity (confirmed from the authoritative text)

  • US 8,361,497 B2, "Multi-phase, multi-compartment, capsular delivery apparatus and methods for using the same"
  • Application 12/689,669, filed 2010-01-19, granted 2013-01-29
  • Inventor: Fred H. Miller; Original/current assignee: INNERCAP Technologies, Inc.
  • Priority date: 2002-04-10; legal status: Expired – Lifetime, listed adjusted expiration 2023-06-15
  • Source: https://patents.google.com/patent/US8361497/en

2. PTAB proceeding (administrative, not district court litigation)

Item Detail
Proceeding IPR2013-00331
Petitioner Capsugel Belgium NV
Patent Owner INNERCAP Technologies, Inc.
Forum Patent Trial and Appeal Board (USPTO)
Filing date June 6, 2013
Outcome/status Google Patents' family-litigation flag records an "Adverse Judgment" (a PTAB adverse judgment typically means the patent owner requests/does not contest entry of judgment, resulting in cancellation of the involved claims)

Caveats you should weigh as counsel:

  • The Google Patents entry lists IPR2013-00331 under the family litigation field of the '497 page, and the proceeding is routinely cited in later briefing as Capsugel Belgium NV v. Innercap Techs., Inc., IPR2013-00331, Paper 9 (PTAB Dec. 9, 2013).
  • I was unable to definitively confirm from the retrieved sources which family member (e.g., the '497 patent itself vs. the related '612 patent) was the subject patent in IPR2013-00331. Because InnerCap's family shares a common specification and priority, the family flag does not by itself prove the '497 patent was the challenged patent. This should be verified on the PTAB docket / USPTO Patent Center before relying on it.
  • An IPR is a USPTO proceeding, not "litigation" in the district-court sense; the "Adverse Judgment" label comes from a third-party aggregation and should be treated as an assumption until confirmed in the official record.

3. Litigation I found that does NOT involve the '497 patent (flagging to avoid error)

These 2026 InnerCap enforcement actions assert US 7,670,612 ("Multi-phase, multi-compartment capsular delivery apparatus and methods for using same"), not US 8,361,497:

  • Innercap Technologies, Inc. v. Target Corporation — D. Minn., 0:26-cv-02427, filed April 30, 2026 (Judges Brasel/Schultz); patent asserted: 7,670,612. Status: open.
  • Innercap Tech Inc v. Walmart Inc — D. Del., 1:26-cv-00488; patent asserted: 7,670,612 (illustrative claim 33). Status: open.
  • InnerCap Tech Inc v. Nouri Life Inc — D. Del., 1:26-cv-00903, filed 07/24/2026; patent asserted: 7,670,612. Status: open.

I am noting these only to demonstrate the distinction; they are not litigation involving the '497 patent and should not be reported as such.

4. What I could not confirm

  • No PACER/Justia/CourtListener docket was found in which US 8,361,497 appears as an asserted patent.
  • No CAFC appeal involving the '497 patent was identified.
  • No additional district court or ITC action naming the '497 patent was identified.

Recommended verification steps (since my search coverage was incomplete)

  1. PTAB: Confirm the subject patent of IPR2013-00331 in USPTO PTAB E2E / Patent Center (search by proceeding number).
  2. PACER / Docket Alarm / RPX Insight: run a party search for "Innercap Technologies" and a patent-number search for "8361497" to catch any D. Del., D. Minn., or other docket not surfaced here.
  3. Unified Patents litigation portal (https://portal.unifiedpatents.com/litigation/caselist) and the Darts-IP family link referenced on the Google Patents page, which flags "first worldwide family litigation" for this family.

Summary answer: Based on the sources retrieved, the only adversary proceeding known for US 8,361,497 (or its family) is PTAB IPR2013-00331 (Capsugel Belgium NV v. INNERCAP Technologies, Inc., filed June 6, 2013, recorded as an adverse judgment) — subject to the confirmation caveat above. I found no district court litigation specifically asserting US 8,361,497. If no additional dockets surface, the accurate statement is that no district-court litigation involving the '497 patent is known, and the PTAB proceeding should be reported separately as an administrative challenge.

Generated 9/23/2026, 12:47:43 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: Capsugel Belgium NV

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

PTAB / AIA Trial Proceedings — US 8,361,497 ("Multi-phase, multi-compartment, capsular delivery apparatus")

Data-integrity flag first. The canonical structured block in this prompt — the USPTO ODP "PTAB proceedings on file" feed — returns zero AIA trial proceedings for US 8,361,497. That is an ingest artifact, not reality. A real, docketed IPR exists on this patent (IPR2013-00331) and is confirmed by (a) the Google Patents family/litigation overlay on the patent page, (b) the petitioner-side filing log at the HDP AIA Blog, (c) the Patexia judge-to-case mapping for two APJs, and (d) at least four later PTAB decisions that cite the Board's Paper 9 in that case by name. The ODP default ("no PTAB activity") is wrong here; the older-proceeding gap is exactly the failure mode you'd expect for a 2013 filing closed before ODP's ingest window.


Proceedings overview

One AIA trial proceeding exists (and has long been terminated): IPR2013-00331, Capsugel Belgium NV v. INNERCAP Technologies, Inc. — filed 2013-06-06, with the Board's Paper 9 issuing 2013-12-09, and the Google Patents family record tagging the case outcome as an "Adverse Judgment"; status breakdown is therefore 1 terminated (adverse judgment tag) / 0 active / 0 institution-denied (unverified) / no settlement confirmed / no confirmed Federal Circuit appeal. Bottom-line defensive posture: this is not "hardened by surviving IPRs" and not "claims canceled — the troll has no case" either. It is a dead patent — adjusted expiration 2023-06-15, legal status Expired – Lifetime — so any demand letter you receive today can only reach past damages inside the 35 U.S.C. § 286 six-year lookback, no injunction is available, and the only remaining validity fights are § 282 defenses in court or a technically-available-but-practically-moot ex parte reexamination.

⚠️ Verify before relying: I could not retrieve the full text of Paper 9 (the 2013-12-09 decision) or confirm whether a Final Written Decision on claim-level patentability was ever entered. The claim-level disposition of IPR2013-00331 is UNVERIFIED in this report. The family-level "Adverse Judgment" tag on Google Patents is a red flag that claims were canceled under 37 C.F.R. § 42.73(b), but I will not represent that as established. Pull the paper file from PTAB E2E (https://ptab.uspto.gov) or the PTAB Decisions portal (https://www.uspto.gov/patents/ptab/ptab-decisions) before you write anything into a client memo.


IPR2013-00331 — Capsugel Belgium NV v. INNERCAP Technologies, Inc.

  • Type: Inter Partes Review (35 U.S.C. §§ 311–319). PGR unavailable — the '497 patent claims a 2002-04-10 priority date and was filed pre-AIA. CBM review never plausibly applied (capsule delivery apparatus, not a "financial product or service"), and the CBM program sunset on 2020-09-16 in any event.
  • Filed: 2013-06-06. Note the timing: the '497 patent issued 2013-01-29, so Capsugel petitioned roughly four and a half months after grant — i.e., before the patent had any commercial assertion history to react to. Source: HDP AIA Blog, https://aia.harnessip.com/?p=372.
  • Status: Per the structured ODP feed — no proceeding on file (inaccurate). Per Google Patents' family/litigation block, the case is listed as "PTAB case IPR2013-00331 filed (Adverse Judgment)" (https://patents.google.com/patent/US8361497/en). "Adverse Judgment" in PTAB parlance is a 37 C.F.R. § 42.73(b) judgment entered against a party — for a patent owner, typically the consequence of requesting adverse judgment (disclaimer, abandonment of the contest, or failure to pursue). Practical gloss: the proceeding ended against the patent owner, and it ended without a contested merits win for the patent owner. I could not verify whether the judgment was entered as to all challenged claims or a subset. Confirm on E2E.
  • Judge panel: APJs Rama G. Elluru and Lora M. Green are both mapped to IPR2013-00331 in Patexia's judge profiles (https://services.patexia.com/judges/rama-g-elluru/cases/17; https://services.patexia.com/judges/lora-m-green/cases/2/sort_by/date_filed/sort_dir/asc). Panels sit in threes; I could not identify a confirmed third APJ, and I will not guess one.
  • Petition grounds: Not fully verified. What is documented in the public record is that the petition included a § 103 obviousness challenge built in part on a commercial pharmaceutical capsule product ("Midol"), and that the Board rejected that theory at the threshold on statutory-scope grounds. Two later PTAB filings quote the panel verbatim: "The Midol product is not a patent or printed publication and cannot be the basis of a ground for review" — Capsugel Belgium NV v. Innercap Techs., IPR2013-00331, Paper 9 at 15 (P.T.A.B. Dec. 9, 2013), cited in https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1547727](/patent/1547727) and noted as "rejecting obviousness challenge based on pharmaceutical product because product was not a 'patent or printed publication.'" The same paper is cited for the printed-publication/public-accessibility framework, 2013 WL 8595288, at *8–9 (see https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1460866](/patent/1460866) and https://www.docketalarm.com/cases/PTAB/IPR2022-00111/...). This is a § 311(b) scope holding, not a merits holding.
  • Institution decision: Paper 9, 2013-12-09 — that date is consistent with the statutory three-to-six-month window (petition 2013-06-06; § 314(b) deadline extended to roughly six months). The panel's reasoning on the record I can see: a product, as such, is not a "patent or printed publication," so a product-based obviousness theory is not a permissible IPR ground. Whether Paper 9 denied institution outright or instituted on other grounds and cut the product theory, I cannot confirm from accessible sources — do not characterize it in a filing without the paper.
  • Final Written Decision: No FWD located. If Paper 9 was a denial of institution, no FWD would ever have issued; if institution was partial, an FWD should exist under § 318(a) unless the proceeding terminated earlier by adverse judgment. The "Adverse Judgment" family tag is more consistent with the second scenario plus an early § 42.73(b) termination than with a fully litigated FWD. Claim-level outcomes: UNVERIFIED — I will not assign claim numbers to a disposition I have not read.
  • Settlement / termination: No public settlement or joint request for termination identified. Terminated 2013 (per the case-status tag). Terms, if any, would be confidential under 35 U.S.C. § 317(b) / 37 C.F.R. § 42.74(c) — the file would contain only a redacted agreement, if one exists at all.
  • Appeal: No Federal Circuit appeal identified. A § 42.73(b) adverse judgment is generally not appealable (the losing party has abandoned the contest), which is consistent with the absence of a CAFC docket. I searched and found none; I flag this as a negative finding, not a confirmed null.
  • Defensive value: Low as a shield, high as leverage on timing. Nothing in IPR2013-00331 gives you a claim-cancellation trophy you can hand a judge — but the pincer it reveals is real: a petitioner who relies on a commercial product as prior art gets bounced out of the PTAB under § 311(b) ("patents and printed publications" only), yet that same product evidence is fully available in district court under pre-AIA §§ 102(a)/(b) (public use, on sale, public knowledge). That asymmetry is your unfair-advantage lane, and it was never adjudicated on the merits.

Strategic summary

Claim status on the '497 patent. On the evidence I can verify, the answer is: untested at the claim level in any public document I retrieved. The published claims (claim 1, a multi-compartment capsule with two chambers holding different-physical-state nutraceutical/vitamin/dietary-supplement/mineral ingredients; claim 2, the liquid-immediate-release + solid-time-delayed pair with the "not present in said second receiving chamber" negative limitation; and dependents 3–10+) were the likely subject of the 2013 challenge, but I cannot tell you which claims, if any, were canceled, disclaimed, or confirmed. Treat all claims as UNTESTED until you read Paper 9 and any judgment paper — with the caveat that the "(Adverse Judgment)" tag means at least some of the challenged claims probably did not survive. Order the paper file from https://ptab.uspto.gov today; this is a 2013 case, and the E2E document set will resolve in an afternoon what no secondary source can.

Estoppel landscape. 35 U.S.C. § 315(e)(2) estoppel attaches only to Capsugel Belgium NV and its privies, real parties in interest, and privies of those RPIs — and it covers only grounds raised or that reasonably could have been raised in IPR2013-00331. Two consequences for you: (1) You are not bound. A new defendant has an untouched § 102/§ 103/§ 112 arsenal, including the product/public-use/on-sale art that § 311(b) excluded from the IPR entirely — that art was never "available" in the IPR, so there is no estoppel dimension to it at all. (2) If you are in privity with Capsugel (supply relationship, joint defense agreement, indemnity flow — Capsugel is a capsule-shell manufacturer, so co-defendant/supplier privity is genuinely possible), assume the full "reasonably could have raised" bar applies and budget your invalidity case around art the 2013 petition did not touch. Also note the reverse-direction point: § 315(e)(1) estoppel would also constrain a Capsugel-privy patent owner going forward, which is a small additional pressure point on any assertion campaign.

Pattern signals. One petition, one petitioner, one shot, filed within ~4.5 months of grant by a direct competitor (Capsugel is the dominant hard-capsule supplier), and no defensive aggregator (Unified Patents, RPX, etc.) anywhere in the chain — the Unified Patents link on the Google Patents page is a data vendor's database entry, not evidence that Unified filed or funded the IPR. The patent owner did not carry the fight to the Federal Circuit. The Google Patents family block also flags separate Darts-IP "first worldwide family litigation" for the family (https://patents.google.com/patent/US8361497/en), which I could not open — there is likely a parallel district court action involving Capsugel and possibly other capsule-industry defendants, and its docket is where you will find the real § 282 invalidity record.


Recommended next steps

  1. Get the paper file before anything else. PTAB E2E (https://ptab.uspto.gov) → search IPR2013-00331. You need Paper 9 (2013-12-09) and any judgment/termination paper after it. This single step resolves the only material open question in this report.
  2. If claims were canceled (adverse judgment / disclaimer): pull the judgment paper, confirm the disclaimed or canceled claim numbers exactly as the Board wrote them, and check the patent's USPTO PatentCenter transaction history (https://patentcenter.uspto.gov) for any statutory disclaimer under 37 C.F.R. § 1.321 filed in the same window. A canceled claim cannot be asserted, and a demand letter citing it is sanction-bait under Rule 11 / § 285. Quote the disposition, don't paraphrase it.
  3. If institution was denied and the patent is untouched: the case is worth nothing defensively — but the patent is also expired as of 2023-06-15. Your defense is damages-driven, not validity-driven: (a) demand the § 286 six-year damages window from the date of first complaint; (b) confirm the § 154(b) patent term adjustment arithmetic against the 1159-day PTA of the sibling US 7,670,612 and the "expires 2023-06-15" adjusted-expiration entry; (c) close out any marking analysis, since post-expiration "damages" claims built on lapsed-coverage theories are a common overreach.
  4. No active trial-stage monitoring is required. There is no live IPR, no institution deadline running, no § 316(a)(11) one-year FWD clock, and no pending CAFC appeal for this patent. Do not spend cycles on PTAB watch; spend them on the district-court record and on the product-based prior art that the PTAB could never have considered.
  5. If you are served today: your strongest posture is not an IPR (the patent is expired; the ROI is near zero, and § 315(b)'s one-year bar is irrelevant when the patent has no forward life). It is § 282 invalidity in court using public-use/on-sale/product art, plus a damages case about how little of the six-year window the asserted claims actually cover.

Generated 9/23/2026, 12:48:19 PM

Ownership chain (2)

Asserters network →

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

  1. ? · recorded 2015-09-10 · Assignment

    Fred H. MillerINNERCAP TECHNOLOGIES, INC.

    chain-of-title cleanup

  2. ? · reel 013793/0341 · Assignment

    Frederick H. Miller and Lance R. AusecINNERCAP TECHNOLOGIES, 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 research the assignment record for US 8,361,497 before drafting.

Key leads found. Let me dig into the IPR outcome, the Capsugel dispute, and any recorded assignments.

Ownership & Assignment Analysis — US 8,361,497 B2

Data-source note (read first). I could not open the USPTO Assignment Center record set directly in this session; the reel/frame and correspondent fields below are reconstructed from Google Patents' legal-events/assignment data and family-level USPTO assignment records surfaced in search, with gaps flagged explicitly rather than filled by inference. I have not fabricated any reel/frame, execution date, or correspondent. Where I could not verify a field, I say so.


Inventors

Inventor Address of record Employer at filing
Fred H. Miller (a.k.a. "Frederick H. Miller") Tampa, FL (per US 7,670,612 face) InnerCap Technologies, Inc. (Tampa, FL) — appears to be company principal/founder

Notes and unusual patterns:

  • US 8,361,497 names one inventor, Fred H. Miller. The application (12/689,669, filed 2010-01-19) is a continuation of 10/804,576 (filed 2004-03-19, granted as US 7,670,612), which is itself a CIP of PCT/US03/010816 (filed 2003-04-09) claiming provisional 60/371,448 (filed 2002-04-10). Inventorship therefore traces to the 2003–2004 priority chain; no new inventor was added on the 2010 continuation.
  • Inventor/assignor mismatch worth flagging: the family's recorded assignment at Reel 013793/0341 names two assignors — MILLER, FREDERICK H. and AUSEC, LANCE R. — yet Lance R. Ausec is not a named inventor on the '497 patent. Either Ausec was an inventor on an earlier application in the priority chain, or the assignment covered associated rights. I could not resolve this from available records; it is a data point, not a conclusion.
  • I found no evidence that any inventor departed InnerCap within 12 months of filing, and no pre-fire-sale attrition pattern. Miller remained the assignor of record as late as the 2015 recordation.

Original assignee

InnerCap Technologies, Inc. (a Florida corporation, Tampa, FL) — named as both Original Assignee and Current Assignee on the face of the patent.

  • Primary line of business: drug-delivery technology — the design, formulation and encapsulation of multi-compartment hard-shell capsules that co-deliver actives in different physical states (solid/liquid/gas/dispersion). The patent's own IDS cites InnerCap's 2004 in-house technical publication "The Hard Gelatin Capsule Advantage," InnerCap Technologies Inc., 2004.
  • Did they ship a product embodying the claims? Unverified. The evidence I retrieved points to a technology-development / licensing posture (in-house technical literature, licensing-oriented marketing, prosecution by outside counsel Davidson, Davidson & Kappei) rather than verified commercial capsule sales. I will not assert a product exists in commerce without a source.
  • Current status: InnerCap Technologies, Inc. remains the assignee of record. I found no evidence of acquisition, dissolution, or bankruptcy. The patent is shown as Expired – Lifetime, adjusted expiration 2023-06-15.
  • Adversary evidence: on 2013-06-06 — five months after the patent issued — Capsugel Belgium NV (a major hard-capsule manufacturer) filed IPR2013-00331 against this patent. Google Patents flags the PTAB case as terminating in an Adverse Judgment. I could not independently verify which party sought adverse judgment, the date, or which claims were affected, and I will not guess. The patent's continued listing with a 2023 adjusted expiration (rather than a cancelled-claims flag) leaves this ambiguous.

Assignment timeline

# Executed Recorded Reel/Frame Conveyance Assignor → Assignee
1 not retrievable (~2003) ~2003 013793/0341 Assignment of assignors' interest Miller, Frederick H.; Ausec, Lance R. → InnerCap Technologies, Inc. (Florida)
2 not retrievable 2015-09-10 not retrievable Assignment of assignors' interest ("see document for details") Miller, Fred H. → InnerCap Technologies, Inc.

1. ~2003 — Reel 013793/0341

  • Conveyance: Assignment of assignors' interest
  • Assignor: Frederick H. Miller and Lance R. Ausec
  • Assignee: InnerCap Technologies, Inc. (Florida)
  • Correspondent: not retrievable from the sources I could access. (Note: the family's prosecution counsel of record on US 7,670,612 is Davidson, Davidson & Kappei, LLC — Clifford M. Davidson; prosecution counsel is not the same field as assignment correspondent, and I have no reel-level correspondent data, so I make no claim that Davidson is the recording correspondent.)
  • Context: Initial corporate assignment of the priority-application rights. Note this reel appears to attach to the family's priority filing rather than to application 12/689,669 itself — USPTO records are keyed to the application/patent against which the document was recorded, and the '497 continuation was not filed until 2010.

2. Recorded 2015-09-10 — reel/frame not retrievable

  • Conveyance: Assignment of assignors' interest (Google Patents notes "SEE DOCUMENT FOR DETAILS")
  • Assignor: Fred H. Miller (sole)
  • Assignee: InnerCap Technologies, Inc.
  • Correspondent: not retrievable.
  • Context: Confirmatory/chain-of-title cleanup — the inventor assigning the '497-specific application rights back to the same company that already owned the patent. This is the classic "fix the record" move when a continuation issues without a recorded assignment on that particular application number (application 12/689,669 filed 2010-01-19 was not covered by Reel 013793/0341). Timing is ~2.5 years after issuance and ~2.3 years after the Capsugel IPR petition, consistent with shoring up standing/title for enforcement or for the then-co-pending continuations (13/746,743 filed 2013-01-22; 14/036,521 filed 2013-09-25; 15/005,508 filed 2016-01-25).

No other recorded assignments were found. There is no record of any transfer away from InnerCap Technologies, Inc., and no security agreement, merger, change of name, license, or release recording in this chain.


Timeline diagram

timeline
    title Ownership of US 8361497
    2002 : Priority application filed
    2003 : Inventors assign rights to InnerCap
         : PCT application filed
    2004 : Parent application filed
    2010 : Continuation application filed
    2013 : Patent issued to InnerCap
         : Capsugel files IPR2013-00331
    2015 : Miller confirms assignment to InnerCap
    2023 : Patent term expires

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
The only post-issuance record (recorded 2015-09-10) moves rights from the inventor back to InnerCap Technologies, Inc. — the operating assignee already named on the patent face. No "IP / Patents / Licensing / Holdings / Ventures" successor appears anywhere in the chain. No registered-agent service address, single-member LLC, or newly formed Delaware/Texas entity is evidenced. Reel 013793/0341 and the 2015 record both terminate at the same Tampa, FL corporation.

2. Known asserter in the chain — NOT PRESENT.
InnerCap Technologies, Inc. does not match any entity on the enumerated lists (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). The Unified Patents portal lists InnerCap only in its patent-owner/assignee capacity for the family (see https://portal.unifiedpatents.com/patents/patent/US-7670612-B2), not as a tracked high-frequency plaintiff. The one adversarial data point — Capsugel Belgium NV petitioning for IPR2013-00331 on 2013-06-06, five months post-issuance — indicates a practicing competitor responding to an assertion posture, not an NPE in the chain.

3. Repeat correspondent across the chain — UNCLEAR.
I could not retrieve the correspondent of record for either recording (Reel 013793/0341 or the 2015-09-10 record). Per the rule that a single appearance is not a finding and recurrence is required, this signal cannot be scored on the available data. It should be re-run against the Assignment Center's correspondent field.

4. Cascading transfers — NOT PRESENT.
Two recordings total across 23 years, both to the same assignee entity, and zero consecutive LLC-to-LLC transfers. No shared correspondent address or common principals across chained entities because there are no chained entities.

5. Pre-litigation transfer — NOT PRESENT.
No assignment predates a first suit by ≤6 months. The original family assignment (Reel 013793/0341) predates the earliest known challenge by roughly a decade. The 2015-09-10 record post-dates issuance (2013-01-29) and the IPR (2013-06-06) and, critically, transfers title to the original operating assignee, not to an asserter — exactly the inverse of the pre-litigation-transfer tell.

6. Bankruptcy fire-sale — NOT PRESENT.
No Chapter 7/11 proceeding, no trustee sale, no bankruptcy-court transfer order found in the chain.

7. Privateering — NOT PRESENT.
No operating company transferred the patent to an NPE to assert on its behalf. The ownership vector runs the other way: from the inventor into the operating company.

8. Defensive aggregator — NOT PRESENT.
The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at InnerCap Technologies, Inc. The patent has therefore not been neutralized by a defensive aggregator, and the IPR2013-00331 "Adverse Judgment" flag is a separate mechanism that may or may not have curtailed the claims — I could not verify its scope.


Verdict

Operating-company assertion.

The chain shows no NPE hallmark whatsoever: the only recorded post-issuance transfer (recorded 2015-09-10) runs from inventor Fred H. Miller back to InnerCap Technologies, Inc., the Florida operating assignee already named on the patent face, and the family's only other record (Reel 013793/0341) is the original 2003 corporate assignment — there is no shell LLC, no listed asserter, and no cascading transfer. The single adversary signal, Capsugel Belgium NV's IPR2013-00331 petition filed 2013-06-06, five months after issuance, is the signature of a small operating patentee positioned against a dominant competitor, not of a troll acquiring paper. Confidence caveat: the two defining prongs of this verdict — that InnerCap ships a product embodying the claims, and that it sued Capsugel in district court — are not verified in this session; if a verified product-in-commerce is required, downgrade to Insufficient data pending retrieval of the Assignment Center correspondent fields and the PTAB Final Written Decision in IPR2013-00331.

Verify at: https://assignmentcenter.uspto.gov/ (search by patent number 8361497) or https://assignment.uspto.gov/patent/index.html — then cross-check the PTAB record at https://portal.unifiedpatents.com/ptab/case/IPR2013-00331 and the family record at https://patents.google.com/patent/US8361497/en.

Generated 9/23/2026, 12:48:33 PM

Prior art

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

✓ Generated

I'll research the prior-art citations of record for US 8,361,497 and the references litigated in its IPR.

Let me pull the specific citation lists and the IPR record.

Prior Art for US 8,361,497 B2 — Analyst Report

0. Threshold caveat you need before reading anything below

The instruction was to "look at each patent citation for 8361497." I could not retrieve the face-of-patent citation list that is printed on US 8,361,497 B2 itself. The Google Patents full text supplied in the user message is truncated mid-specification and stops before the (56) References Cited block; USPTO Patent Public Search / PatentCenter was not reachable through my tool calls; and the Justia page for 8361497 that surfaced did not expose its "Referenced Cited" table in the returned excerpt.

What I did retrieve is the citation record for the family member US 7,670,612 B2 (application 10/804,576, Miller, Innercap), which shares the '497's specification, priority chain (PCT/US2003/010816 → provisional 60/371,448, priority 2002‑04‑10 per Google Patents; 2002‑04‑09 per Unified Patents) and inventor/assignee:

Everything in Section 2 below is therefore "citation record of the '497's family / parent," not verified "citations of record on the '497's own face." That distinction matters legally: a continuation can and usually does have a different (56) list from its parent, because it is prosecuted to a later claim set against a later art base. Do not file anything asserting these are the '497's cited references without pulling the '497's own printed front page.

I also did not auto-correct any identifier. Where OCR in the source was ambiguous, I flag it rather than silently fixing it.

Contradiction to flag against my own earlier section

The earlier litigation section resolved IPR2013‑00331 to petitioner Capsugel Belgium NV. Re-reading the Google Patents page: the line reading "Petitioner: 'Unified Patents PTAB Data' by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License" is a data-source attribution, not a named petitioner. So there is no actual contradiction to resolve — the correct petitioner remains Capsugel Belgium NV, as cited in later briefing (Capsugel Belgium NV v. Innercap Techs., Inc., IPR2013‑00331, Paper 9 (PTAB Dec. 9, 2013)). Recording this because "Unified Patents" should not be repeated as the petitioner.


1. The legal frame for the § 102 analysis

Priority is 2002‑04‑10 (Google Patents) for US 12/689,669, with a § 120 chain back to PCT/US2003/010816 (filed 2003‑04‑09). Because the claimed subject matter predates the AIA, pre‑AIA 35 U.S.C. §§ 102(a)/(b)/(e) govern. Working critical dates:

Provision Critical date for the '497
§ 102(b) 2001‑04‑10 (one year before the provisional's filing date, if benefit is perfected)
§ 102(a) / § 102(e) 2002‑04‑10 (or the actual date of invention)

The claims I could verify from the Justia listing (https://patents.justia.com/patent/8361497) are 1–8:

  • Claim 1 — multi-compartment capsule; first chamber ingredient and second chamber ingredient each selected from nutraceutical, vitamin, dietary supplement, mineral; the two physical states differ; and the two ingredients are different.
  • Claim 2 — first chamber with ≥1 active in immediate-release form and containing a liquid selected from glycerin, an elixir, a spirit, an emulsion and a fluid extract; second chamber containing only solid ingredients, including a solid active formulated for time-delayed dissolution/release; first-chamber active different from and not present in the second chamber.
  • Claims 3–8 — second chamber within the first (3); hard-shell capsule (4); shell-material Markush (5); solid active = caffeine (6); active for a GI disorder (7); active is a probiotic (8).

This is the crux of the whole exercise: claims 1 and 2 are genus claims keyed to (i) ingredient category and (ii) differing physical state. Most of the family's cited art is directed to multicompartment hardware (two-part capsules, plural chambers, nested capsules, seals) rather than to that specific combination. That makes most of the list § 103 material, not § 102 material. I say this explicitly rather than manufacturing anticipation mappings that would not survive a POPR.


2. The family citation record, reference by reference

Dates below are the priority dates as listed by Unified Patents unless I say otherwise — they are not publication dates, and for § 102(a)/(b) you must substitute the actual publication/issue date. I flag each date-provenance where it is uncertain.

2.1 References from the '612 front page (56) References Cited (legible entries)

Citation Date as printed Description Claim(s) potentially anticipated
US 3,072,528 A — Kludas et al. (Med. Fabrik Chemisch-Pharmazeutischer Präparate J. Carl Pfluger) 1/1963 "Ingestible Dry Microorganism Preparations" Claim 8 (probiotic) only in the abstract — dry microorganism prep, but no multi-compartment differing-physical-state structure. Weak.
US 4,185,740 A — Perfect 1/1980 Capsule-forming art (title not legible in retrieved record) None identified — I decline to guess.
US 4,578,075 A — Urquhart et al. 3/1986 Osmotic/multi-unit delivery art Claim 2 partial (time-delayed release) only.
US 4,606,909 A — Bechgaard et al. (Benzon Pharma) 8/1986 "Pharmaceutical Multiple-units Formulation" Claim 2 partial — multiple units with staged release, but single-phase filling.
US 4,627,808 A — Hughes (Contrastule Corp) 12/1986 "Apparatus for Making Capsule Having Plural Chambers" Structure only — no ingredient/state limitation. § 102 does not reach claim 1 or 2.
US 4,642,233 A — Urquhart et al. 2/1987 Multi-unit controlled release Claim 2 partial.
US 4,681,583 A — Urquhart et al. 7/1987 Multi-unit controlled release Claim 2 partial.
US 4,695,466 A — Morishita et al. 9/1987 Encapsulation art None identified.

⚠️ OCR risk: the '612 front page as rendered scrambles the two-column numeric block. Entries I saw as "4,702,732 A 8/1988 Lemelson," "4,773,907 A 12/1988 Makiej," "4,793,493 A 12/1988 Jokii," "4,808,413 A 8/1989 Eichel et al.," "4,823,619 A 8/1990 Becker," "4,863,741 A 9/1990 Mehta et al.," "4,904,476 A 9/1990 Makiej," "4,936,461 A 9/1990 Lebrun" conflict with the Unified Patents data on the same numbers (see 2.2). Treat the numbers/dates/names in this sub-table as unreliable until checked against the printed patent. I am not going to build § 102 mappings on scrambled data.

Also on the '612 front page: Foreign: DE 27 29 068 A1 (1/1979); Other Publications: "Formulation Advantages: The hard gelatin capsule is a versatile container," The Hard Gelatin Capsule Advantage, BAS179‑E‑96, 1996, 3 pp.; Scott Hensley, "Drug Makers 'Combos' Treat Two Disorders With One Pill," The Wall Street Journal, 2004, pp. 1–3; website printout re: Capsugel Liquid Formulations in Licaps® Capsules.

2.2 Unified Patents "Patent Art (100)" list for US-7670612-B2

⚠️ Two data-quality warnings before using this list: (a) Unified's title and assignee fields appear to be family-level / current values, not necessarily the title as published at the relevant date — e.g., US-4702732-A is captioned "Electrodes, Electrode Assemblies, Methods, and Systems for Tissue Stimulation and Transdermal Delivery of Pharmacologically Active Ligands," which is demonstrably a modern family title, and JP-S6211135-A is captioned "Apparatus for Inspecting Surface of Transparent Specimen Plate," which cannot be the 1985 subject matter. (b) The panel is headed "Citations / Patent Art (100)" and may mix cited with related art. Corroborate before relying.

The structurally and substantively most relevant members:

Citation Priority date (Unified) Description Claim(s) potentially anticipated under § 102
GB 2,353,950 A — Bioprogress Technology International Inc 1999‑07‑08 "Capsules with Two Compartments" Closest structural art. If it discloses two compartments each holding a different substance in a different physical state (e.g., one liquid/paste, one solid/powder), it reaches claim 1 — provided the ingredients fall in the nutraceutical/vitamin/dietary-supplement/mineral genus. That proviso is the live issue; the reference is a delivery-capsule disclosure, not a nutraceutical one.
WO 2001/003676 A1 — Bioprogress Tech Int'l (Muncaster, Brown, Nowak) 1999‑07‑08 "Improvements in and Relating to Delivery Capsules" Same family as GB 2,353,950 A. § 102(e)-type and § 103 relevance.
US 6,352,719 B1 — Bioprogress Technology International 1998‑11‑10 "Capsule Based Drug Delivery System" Claim 4 (hard shell capsule) and claim 1's "multi-compartment capsule" preamble if compartments are shown.
WO 99/30693 A2 — Aptalis Pharma Canada ULC 1997‑12‑16 "A Double Capsule for the Administration of Active Principles in Multiple Therapies" Best § 102 candidate for claim 3 ("second receiving chamber located within the first receiving chamber") — nested inner/outer capsule. Also bears on claim 1 if the two compartments hold different phases.
US 5,672,359 A — University of Kentucky Research Foundation 1993‑07‑20 "Multicompartment Hard Capsule with Control Release Properties" Best § 102 candidate for claim 2 in combination with claim 4: hard capsule + multiple compartments + controlled ("time-delayed") release. The missing element is the "different ingredient, not present in the second chamber" + liquid-Markush limitation.
FR 2,524,311 A1 — Azalbert Gilles 1982‑04‑04 "Multi-effect Medical Capsule with Compartments Containing Different Medicaments — which are ingested simultaneously for programmed release" Claim 1 — expressly different medicaments in different compartments with programmed release. This is the single most on-point § 102(a) candidate for the "different ingredient" element; it fails claim 1 only if its disclosures are not within the nutraceutical/vitamin/supplement/mineral genus. Also § 103 core reference for claim 2.
WO 00/28976 A1 — A B Technologies LLC 1998‑11‑15 "Multi Chamber Soft Capsules and Method of Making the Same" Claims 1 and 3 — multi-chamber soft capsule; supports nesting. Note the '497 spec contemplates soft elastic capsules (glycerin/sorbitol), which ties this to the unverified dependent claim on soft elastic capsules.
GB 2,103,564 A — Canada, Minister of National Defence 1981‑08‑10 "Compound Capsule" Claim 1 preamble (compound/multi-compartment capsule).
WO 92/006680 A1 — Cortecs Ltd 1990‑10‑18 "Biphasic Release Formulations for Lipophilic Drugs" Claim 2 — "biphasic" is literally two differing physical phases with differing release. Strong § 103 reference; plausible § 102(a) if a lipophilic liquid phase plus a solid phase is shown.
US 4,936,461 A — Respiratory Delivery Systems Inc 1986‑09‑17 "Multidose Capsules" Structure only.
US 5,501,857 A — Bio-vet Inc 1992‑07‑23 "Oral Nutritional and Dietary Composition" Claim 1's ingredient genus (nutritional/dietary supplement). Pair with a two-compartment capsule reference for a § 103 case; alone it does not anticipate.
US 4,940,499 A — Warner Lambert Co 1989‑05‑22 "Method and Apparatus for Sealing Capsules Containing Medicaments" Claim 1 preamble / sealing features. § 103 only.
US 5,676,530 A? — see US 5,674,530 A, Tsrl Inc 1991‑01‑30 "Method for Making a Multi-stage Drug Delivery System" Claim 2 (multi-stage / time-delayed) — § 103.
US 5,560,912 A — Technion R&D Foundation 1994‑06‑26 "Method for Inhibiting Growth of Helicobacter pylori" Claim 7 (active for a GI disorder). Method-of-treatment art — different statutory class; § 102 only if it discloses the capsule.
US 5,472,695 A — Technion R&D Foundation 1992‑06‑24 Thyme extract / H. pylori urease Claim 7 — same caveat.
US 5,256,684 A — Procter & Gamble 1985‑06‑12 "Methods and Compositions for the Treatment of Gastrointestinal Disorders" Claim 7.
US 5,196,205 A 1987‑10‑11 "Method for Treatment of Gastro-Intestinal Disorders" Claim 7.
WO 92/011848 A1 — Procter & Gamble 1991‑01‑13 "Swallowable Pharmaceutical Compositions Containing Colloidal Bismuth Subcitrate" § 102 relevance to the triple-therapy background in the spec.
US 4,828,619 A — Ionor Inc 1987‑02‑17 "Controlled Release Pharmaceutical Preparation Containing a Gastrointestinal Irritant Drug" Claim 2 partial (controlled release) / claim 7.
WO 01/032217 A2 — Assertio Therapeutics 1999‑11‑01 "Pharmacological Inducement of the Fed Mode for Enhanced Drug Administration to the Stomach" Gastric-retention background only.
US 5,582,837 A — Assertio Therapeutics 1992‑03‑24 "Alkyl-substituted Cellulose-based Sustained-release Oral Drug Dosage Forms" Claim 2's "time-delayed dissolution and release" element; shell-material Markush.
US 4,863,741 A — Abbott Laboratories 1985‑03‑24 "Tablet Composition for Drug Combinations" Fixed-combination background; no chamber separation — does not anticipate claim 1's "different receiving chamber" element.
WO 99/059413 A1 — Sine Laboratory 1998‑05‑14 "A Beneficial Microbe Composition, New Protective Materials for the Microbes…" Claim 8 (probiotic).
US 2003/0077297 A1 — Lipocine Inc 1999‑02‑25 "Pharmaceutical Formulations and Systems for Improved Absorption and Multistage Release of Active Agents" Claim 2 (multistage release).
EP 0 319 318 A2 — Kenvue Brands LLC 1987‑12‑03 "Method for Double Dipping Gelatin Coated Caplets" Claim 5 (shell material / gelatin).
WO 95/10262 A1 — Catalent Pharma Solutions 1993‑10‑07 "Device for Controlled Delivery of Liquids" Claim 2 liquid delivery.
WO 2001/036290 A1 — Aquasol Ltd / Reckitt Benckiser et al. 1999‑11‑16 "Injection-moulded Water-soluble Container" Shell material only.
FR 1,454,013 A — Pluripharm 1965‑08‑17 "Presentation of Two Combined Medicinal Products" Claim 1 preamble — combination presentation.
US 5,568,837? / US 4,606,909 etc. — See § 2.1 —

Additional list members retrieved, with no § 102 mapping I can responsibly assert (they are background or unrelated on their face): WO 2001032217 A2; EP 0141373 A2 (Monsanto, meristematic tissue); US 4702732 A (Boston University — title field unreliable, see warning); WO 1993000439 A1 (Brown University); JP‑S6211135‑A (Hitachi — title field unreliable); US 20030068369 A1; WO 1994023770 A1 (Leiras); US 20020094992 A1; WO 2002007710 A2 (Mw Encap, "Delivery Device"); US 5017379 A; WO 1995010262 A1; US 7019010 B2 (Novartis, "Combinations"); EP 0325571 A1; US 6262092 B1 (Pfizer, amlodipine/atorvastatin mutual salt); US 6737145 B1 (Ube Exsymo); WO 2002011544 A1 (Encapsulation Systems); US 6528809 B1 (Sandia — spectroscopic calibration; facially irrelevant); GB 2365336 A (Mw Encap, "Multiple Capsules" — this one I would promote to the § 103 core set); US 5562918 A (Bespack, "Drug Dispensing System"); US 5558878 A (Komodo, "Method for Blinding a Tableted Medication").

2.3 Self/family citations on the same list (not prior art)

US 2003/0194428 A1, US 2003/0194431 A1, US 2005/0008690 A1 — all Innercap, priority 2002‑04‑09. These are the applicant's own family publications. They are § 102(f)/§ 103 "applicant's own work" at most and cannot anticipate the '497. Flagging them because they appear in the "Citations" panel and are easily misread as prior art.


3. The gap that matters most: the IPR art

The Google Patents family flag at https://patents.google.com/patent/US8361497/en records IPR2013‑00331, "Adverse Judgment." An IPR petition is a curated, professionally assembled invalidity record, and the ground references in that petition are almost certainly the most probative prior art against this family. I was unable to retrieve the petition, the institution decision (Paper 9, Dec. 9, 2013), or the ground references. I also could not confirm which family member was the subject patent — the flag sits at the family level and the '497 is separately listed as "Expired – Lifetime," which is a maintenance-fee status, not a cancellation.

Note the practical significance: Capsugel Belgium NV is the assignee of US 8,440,224 B2 ("Multi-component pharmaceutical dosage form," priority GB 1999‑07‑30) and of US 2007/0036830 A1 (Vanquickenborne et al.). Those are same-field, pre-2002-priority filament/shell and multi-component dosage form disclosures. I am not asserting they were the IPR grounds — I have no evidence they were. I flag them only as the obvious place to look, and because US 8,440,224 B2's own front-page list (including US 3,186,910 A Glassman; US 3,228,789 A Glassman; US 3,399,803 A Oglevee; US 4,196,565 A Boddeman; US 4,657,840 A Wittwer; etc.) is a Capsugel list — it is not the '497's list, and must not be mixed in.


4. Bottom line for the three statutory buckets

  1. § 102 anticipation of claim 1 or 2 — not established by any reference I retrieved. The family's cited art is predominantly (a) capsule hardware (plural chambers, nested capsules, seals, dip-moulding) or (b) single-chamber controlled-release formulations. Neither bucket discloses the combination of a member of the nutraceutical/vitamin/dietary-supplement/mineral genus in a first chamber and a different such ingredient in a different physical state in a second chamber (claim 1), still less the claim 2 limitation that the first-chamber liquid be selected from glycerin/elixir/spirit/emulsion/fluid extract with a solids-only, time-delayed second chamber and an active "not present in said second chamber."
  2. The three references most worth briefing as § 102(a)/(b) candidates are FR 2,524,311 A1 (Azalbert), GB 2,353,950 A (Bioprogress), and WO 99/30693 A2 (Aptalis double capsule) — each for the structure + differing-content elements, with the genus/element gaps flagged above. US 5,672,359 A is the best § 102 candidate for the claim 2/claim 4 combination.
  3. Everything else on the list is § 103 material, and the strongest § 103 combination on the retrieved record is {GB 2,353,950 A or WO 00/28976 A1} + {US 5,672,359 A or US 5,582,837 A} + {US 5,501,857 A for the nutritional genus} ± {US 5,560,912 A / US 5,256,684 A for claim 7; WO 99/059413 A1 for claim 8}.

5. What must be verified before any of this is relied on

  1. USPTO Patent Public Search / PatentCenter, application 12/689,669 — pull the '497's own printed (56) list, the pre-grant pub US 2010/0233254 A1's IDS/citation list, the complete issued claim set (confirm claim count and whether claims beyond 8 exist), and any certificates of correction. Nothing in Section 2 substitutes for this.
  2. PTAB E2E / PTAB Center, proceeding IPR2013‑00331 — confirm the subject patent, the ground references (Ex. 1001–10xx), and the exact adverse-judgment disposition.
  3. Reconcile the priority-date discrepancy (2002‑04‑09 per Unified Patents vs. 2002‑04‑10 per Google Patents) before fixing § 102(b)/§ 102(e) critical dates — it is a one-day difference, but it is a one-day difference on a jurisdictional fact.
  4. Re-OCR the '612 (and '497) front pages rather than trusting the rendered text I retrieved; the two-column (56) block is scrambled in the available rendering.
  5. Do not treat Unified Patents' title/assignee fields as publication-date-accurate — at least two entries (US‑4702732‑A, JP‑S6211135‑A) carry demonstrably anachronistic titles.

Confidence statement: high confidence in the bibliographic facts of the '497; high confidence in the identity of the family citation list retrieved; low-to-moderate confidence that any specific listed reference anticipates claims 1–2 of the '497; and no confidence at all regarding the IPR2013‑00331 ground references, which I could not retrieve and which I have not guessed at.

Generated 9/23/2026, 12:48:49 PM

Obviousness

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

✓ Generated

I'll gather the prior-art record for this patent — both the references cited on its face and the art asserted in the IPR2013-00331 challenge.

Let me dig into the specific prior-art grounds asserted in IPR2013-00331 and the "two-compartment capsule" references cited during prosecution.

Let me pin down the IPR2013-00331 record and the issued claim set of the '497.

Obviousness Analysis — US 8,361,497 B2 under 35 U.S.C. § 103

0. Scope, contradictions to flag, and limits on what I can assert

Flags before the analysis (per your instruction to surface contradictions):

  1. No dedicated "Prior Art" section was supplied to me. The previously generated sections in my context are a patent summary and a litigation summary. Neither contains a formal prior-art reference list. I have therefore reconstructed the prior-art record from (a) the citation record on the face of the sibling patent US 7,670,612 B2, which shares the '497's specification, and (b) the Third-Party "Patent Art" list published for the '612 family. I say explicitly where this reconstruction is incomplete. If a "Prior Art" section exists on the page you are assembling, my reference set may differ from it and should be reconciled.

  2. Contradiction resolved on the IPR petitioner. The earlier litigation section lists the IPR2013-00331 petitioner both as "Unified Patents" and as "Capsugel Belgium NV." The Google Patents page text — "Petitioner: 'Unified Patents PTAB Data' by Unified Patents is licensed under…" — is a data-source attribution, not a party identification. Contemporaneous PTAB briefing consistently cites the proceeding as Capsugel Belgium NV v. Innercap Techs., Inc., IPR2013-00331, Paper 9 (PTAB Dec. 9, 2013). Treat Capsugel Belgium NV as the petitioner.

  3. Claim-set uncertainty (material to this analysis). The Google Patents full text available to me is truncated mid-specification, so I do not have a verified issued claim set. My claim analysis is keyed to the claim language reported for the '497 (claim 1 = nutraceutical/vitamin/dietary-supplement/mineral in two chambers in different physical states, with the "said ingredient of said first receiving chamber being different from said ingredient of said second receiving chamber" limitation; claim 2 = immediate-release liquid first chamber / solids-only time-delayed second chamber; dependents 3–8 as previously summarized). Every conclusion below must be re-run against the certified claim set from USPTO Patent Center for application 12/689,669.

  4. Date discrepancy (minor). The system prompt gives today as 2026-09-23; the task header says 2026-04-26. This does not affect the § 103 analysis, which is indexed to the 2002 priority date.

  5. Product-based evidence caution — directly on point. IPR2013-00331, Paper 9 at 15, holds that a "product… is not a patent or printed publication and cannot be the basis of" an IPR ground (quoted approvingly in later PTAB petitions). This is the single most important procedural constraint on the obviousness case: commercial capsules (Licaps-type liquid-fill capsules, commercial two-compartment products, market-purchased comparators) cannot carry a § 103 ground unless reduced to a prior printed publication. Every combination below is therefore anchored to patents and printed publications.


1. Governing law and the critical date

  • The '497 issued from App. 12/689,669, filed 2010-01-19, claiming priority to 2002-04-10 (via PCT/US2003/010816, filed 2003-04-09; WO 2003/086267 A2). Because the application was filed before 2013-03-16, pre-AIA 35 U.S.C. § 103(a) governs, and pre-AIA §§ 102(a)/(b)/(e) define the art.
  • § 102(b) line: printed publications more than one year before 2002-04-10, i.e., published on or before 2001-04-09, are statutory bars that cannot be sworn behind or antedated. This is the highest-confidence art set.
  • § 102(a)/(e) art (published between 2001-04-10 and the filing date) is still available but is theoretically subject to antedating/swearing behind, so I flag it separately.
  • Priority vulnerability to flag: any '497 claim limitation not supported by the 2002 priority documents (the "different ingredient" negative limitation and the claim-2 "only solid" limitation are the candidates) would take a later effective filing date, opening the door to 2003–2009 art — e.g., the WSJ 2004 combination-pill article and the Capsugel Licaps print-out listed in this family's citation record, and US 2003/0077297 A1 (Lipocine, priority 1999-02-25). This is a § 112/§ 102 issue that must be resolved before the § 103 art window is fixed.

2. Level of ordinary skill in the art (POSA)

A POSA here is a pharmaceutical formulation scientist (B.S./M.S. in pharmacy, chemical engineering, or pharmaceutical sciences) with ~2–5 years of hands-on experience in oral solid- and liquid-dosage-form development, including two-piece hard-shell capsule filling and film-coating/controlled-release formulation. This is a routine engineering art — a point that cuts strongly toward obviousness under KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) ("if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious").


3. The prior-art record

Tier 1 — § 102(b) art (published on/before 2001-04-09; cannot be antedated):

Reference Date Disclosure as relevant
GB 2353950 A (Bioprogress Technology Int'l; Nowak, Muncaster, Brown) "Capsules with Two Compartments" (PubChem record) pub. 2001-03-14 "A delivery capsule[] has at least two separate chambers (18, 20), the chambers usually containing different materials. The capsule is internally divided by a dividing wall or septum (16)… symmetrically arranged to form two chambers of similar size and shape," made from moulded films with filling and sealing stations.
WO 01/03676 A1 (Bioprogress) "Improvements in and Relating to Delivery Capsules" pub. 2001-01-18 Delivery-capsule construction, including coatings to slow release.
GB 2,103,564 A (Minister of National Defence, Canada) "Compound Capsule" 1983-08-10 Multi-part compound capsule.
FR 2,524,311 A1 (Azalbert) "Multi-effect medical capsule with compartments contg. different medicaments… for programmed release" prio. 1982-04-04 Compartments holding different medicaments, ingested simultaneously, programmed release.
US 4,627,808 (Hughes / Contrastule Corp.) "Apparatus for Making Capsule Having Plural Chambers" 1986-12-02 Plural-chamber capsule manufacture.
EP 0 211 079 A1 (Fujisawa Pharmaceutical) 1987-02-25 Soft multi-chamber capsule (cited as "X" in the WO 01/68452 ISR).
US 2,497,212 (Donofrio) 1950-02-14 Multi-compartment capsule (ISR citation).
GB 908,344 (Lavaud) 1962-10-17 Capsule construction (ISR citation).
GB 617,723 1949 Method of producing double-chamber gelatin capsules.
WO 92/11848 A1 (Procter & Gamble) "Swallowable Pharmaceutical Compositions Containing Colloidal Bismuth Subcitrate" prio. 1991-01-13 H. pylori triple-therapy swallowable dosage form.
US 5,074,426 (Borody); US 5,196,205 (Marshall) 1991-12-24; 1993-03-23 Helicobacter therapy.
US 4,822,619 (Ionor) "Controlled Release Pharmaceutical Preparation Containing a Gastrointestinal Irritant Drug" 1987-02-17 Time-delayed release of a GI-acting drug.
US 5,501,857 (Bio-Vet Inc.) "Oral Nutritional and Dietary Composition" 1992-07-23 Nutritional/dietary composition (feed efficiency).
WO 99/59413 A1 (Sine Laboratory) "A Beneficial Microbe Composition, New Protective Materials for the Microbes…" prio. 1998-05-14 Probiotic (beneficial-microbe) compositions and protection of the microbes.
JP 2000-239159 A (Nitto Yakuhin Kogyo) "Capsule preparation and its production" 2000-09-05 Capsule-preparation manufacturing.
Alza/Urquhart et al.: US 4,578,075; 4,642,233; 4,681,583; 4,764,359 (listed on the '612 face) 1986–1988 Controlled/osmotic multi-component release dosage forms. I have not verified each disclosure — pull before relying on.
Additional '612 face citations: US 3,072,528 (Kludas); 4,185,740 (Perfect); 4,606,909 (Bechgaard); 4,695,466 (Morishita); 4,702,732 & 4,994,279 (Lemelson); 4,773,907 & 4,904,476 (Makiej); 4,793,493 (Jokii); 4,808,413 (Eichel); 4,823,619 (Becker); 4,863,741 (Mehta); 4,936,461 (Lebrun); 4,940,499 (Aoki); 5,017,379 (Goodhart); 5,256,684 & 5,472,708 (Zimmer); 5,310,555 (Paulos); 5,314,696 (Tsai); 5,394,980 (Neeman); 5,472,695 (Chen) 1963–1995 Capsule/dosage-form manufacturing and controlled-release mechanics. Titles/assignees as listed in the aggregated record; not independently verified by me.

Tier 2 — § 102(a)/(e) art (published after 2001-04-09 but before the 2010 filing; usable but theoretically antedatable):

Reference Date Note
WO 01/68452 A1 (Bioprogress, PCT/GB01/01147) pub. 2001-09-20 Process for making capsules from three films; recesses filled with different filling materials (claim 4: "the filling materials in the recesses of the two films comprise different materials").
US 2003/0077297 A1 (Lipocine) "Pharmaceutical Formulations and Systems for Improved Absorption and Multistage Release of Active Agents" prio. 1999-02-25 Multistage release; date status depends on the effective filing date issue in §1.

Tier 3 — the applicant's own admitted prior art (the most probative and least escapable evidence). The '497 specification itself, in the "Background," recites as known: (i) multi-compartment capsule technology using "membranes or other types of barriers to cordon a line of separate chambers within a single encapsulating shell"; (ii) a hard capsule with three compartments of different release layers for vaginal/rectal administration; (iii) hard gelatin shells containing pH-dependent-coated spheroids; (iv) enteric and sustained-release film coatings; (v) "a method for carrying out a triple therapy against… Helicobacter pylori… compris[ing]… an internal capsule placed inside an external capsule, wherein the external capsule comprises a soluble salt of bismuth and a first antibiotic, and the internal capsule comprises a second antibiotic"; (vi) "multi-compartmental capsules… combine a nutrient supplement with a viable direct-fed microbial"; and (vii) actives in "solid… liquid… gas or a dispersion" forms. These admissions supply, respectively, the nested-capsule concept, the GI-indication concept, the probiotic+nutrient concept, and the "different physical states" concept.


4. Claim-by-claim analysis

Claim 1 — two chambers, different physical states, different ingredients (nutraceutical/vitamin/dietary supplement/mineral)

Limitation Primary reference Secondary reference
First receiving chamber GB 2353950, chamber 18 —
Second receiving chamber GB 2353950, chamber 20 (septum 16 divides the capsule into two chambers) —
Ingredients of the recited genus (nutraceutical/vitamin/dietary supplement/mineral) US 5,501,857 (Bio-Vet oral nutritional/dietary composition) WO 99/59413 (beneficial-microbe composition)
Different physical states in the two chambers FR 2,524,311 (compartments with different medicaments, programmed release) and the '497's own admission that actives may be solid/liquid/gas/dispersion EP 0 211 079 (soft multi-chamber capsule, liquid-capable)
Different ingredients in the two chambers GB 2353950 ("chambers usually containing different materials") WO 01/68452, claim 4 (different filling materials in the two films' recesses)

Assessment: strong § 103 case. GB 2353950 expressly teaches the structural heart of claim 1 — a two-chamber capsule with a dividing septum whose chambers "usually contain[] different materials." The only limitations left are (a) the identity genus of the ingredients and (b) the "different physical state" characterization. Neither is a technical advance: the specification itself concedes that actives take solid, liquid, gas and dispersion forms, and FR 2,524,311 teaches a multi-chamber capsule for different medicaments with programmed release. Supplying a vitamin/mineral/dietary-supplement in a divided capsule is the paradigm of a "predictable variation" of GB 2353950, and the "different physical state" limitation is the "mere[]… rearrangement of parts" / "use of a known technique to improve similar devices in the same way" rationale of KSR, 550 U.S. at 415–17.

Claim 2 — immediate-release liquid first chamber (glycerin, elixir, spirit, emulsion, fluid extract) + solids-only, time-delayed second chamber

Limitation Primary reference Secondary reference
Liquid in an immediate-release first chamber EP 0 211 079 (soft multi-chamber capsule capable of retaining liquid) GB 2353950 (film compartments filled with flowable material)
Recited liquid vehicles (glycerin / elixir / spirit / emulsion / fluid extract) Standard pharmacopoeial/formulary vehicle lists (e.g., Remington: The Science and Practice of Pharmacy; Lachman & Lieberman, The Theory and Practice of Industrial Pharmacy) — not yet pulled; must be cited as a printed publication, not as "common knowledge" (see the K/S Himpp caution below) —
Solids only in the second chamber FR 2,524,311 / US 4,627,808 (chamber-specific contents) —
Solid active formulated for time-delayed dissolution The '497's own admitted sustained-release/enteric-coating art; US 4,822,619 (Ionor, controlled release of a GI drug); Alza/Urquhart references —
First-chamber active different from, and absent from, second chamber GB 2353950 (different materials per chamber) —

Assessment: strong, with one evidentiary gap. The structural elements are all in the art; the "immediate-release liquid / delayed solid" split is exactly the temporal-separation dictum the specification itself attributes to the prior art ("one approach contemplates the introduction of a single active… into multiple capsular compartments to vary the temporal release"). The gap is the recited vehicle list: under K/S Himpp v. Hear-Wear Techs., 751 F.3d 1362, 1366 (Fed. Cir. 2014), a POSA's "common knowledge" cannot substitute for documentary evidence on a core factual finding. You must put a pre-2001 printed publication (a formulary, a USP monograph, or a liquid-fill-capsule technical bulletin) into the record for each recited vehicle.

Claims 3–8 (as reported)

Claim Limitation Best combination Strength
3 Second chamber located within the first chamber GB 617,723 (double-chamber gelatin capsules) + the '497-admitted H. pylori internal-capsule-inside-external-capsule disclosure + WO 92/11848 Strong — the nested-capsule configuration is explicitly admitted as prior art.
4 Capsule is a hard shell capsule The '497 Background's own admission re: hard gelatin capsule manufacture; JP 2000-239159 Very strong — admitted in the specification.
5 Shell material Markush (gelatin, starch, casein, chitosan, soya-bean/safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phthalated gelatin, succinated gelatin, cellulose-phthalate-acetate, oleoresin, PVA, HPMC, acrylic/methacrylic polymerisates, PVAP) WO 01/03676 and WO 01/68452 (water-soluble cellulose-derivative / HPMC films); the admitted enteric-coating art (PVAP, CAP, phthalated gelatin are the classical enteric polymers); EP 0 211 079 Strong as an obvious list — under In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986), "disclosing a compound and a list of substituents renders that list obvious." A Markush of known capsule-shell/enteric polymers is precisely that.
6 Solid active in second chamber is caffeine Requires a pre-2001 printed publication placing caffeine in a dietary-supplement/nutraceutical capsule Weakest link — caffeine per se is ancient, but you need a printed publication, not "common knowledge." Do not plead this claim on common sense alone.
7 Active treats a gastrointestinal disorder WO 92/11848; US 5,074,426 (Borody); US 5,196,205 (Marshall); US 4,822,619 (Ionor) Strong — and independently supported by the specification's admission of H. pylori dual-capsule therapy.
8 Active is a probiotic WO 99/59413 (Sine Laboratory) + US 5,501,857 (Bio-Vet) + the admitted "nutrient supplement with a viable direct-fed microbial" multi-compartment capsule Very strong — the specification concedes the prior art already combined a nutrient and a live microbe in a multi-compartment capsule.

If issued claims cover the dead-space-reduction features (U-shaped cap; filling material in the cap), those are independently obvious over the admitted dead-space/air-bubble problem plus the over-encapsulation and core-filled-capsule art (e.g., Capsugel's own US 4,893,721, cited in Capsugel's DBCaps over-encapsulation literature, and EP 0 319 318 A2 on double-dipping gelatin-coated caplets). Again: a printed publication is required, not a product.


5. Motivation to combine, and reasonable expectation of success

The KSR rationales apply unusually cleanly here because the motivation is recited in the patent itself:

  1. Known problem, known solution. The specification identifies the problem (co-administered actives that react, ionize, or perturb each other's polymorph/solvate equilibria; dead-space air bubbles) and the solution (physical partitioning). A reference that discloses the problem supplies the motivation. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
  2. Predictable variation. Partitioning a capsule by septum or nesting one capsule inside another was old (GB 2353950; GB 617,723; US 4,627,808; FR 2,524,311; EP 0 211 079). KSR, 550 U.S. at 417.
  3. Finite, predictable solutions. The recited physical states (solid/liquid/gas/dispersion) and the recited shell polymers are enumerated, known classes. Where the prior art discloses a finite number of identified, predictable solutions, § 103 bars the claim. KSR, 550 U.S. at 421.
  4. Design incentives / market forces. Pill burden, geriatric/pediatric compliance, and fixed-dose combination therapies were recognized incentives (the '497 says so, and so does the family's broader record) — exactly the "market forces… prompt variations" rationale of KSR.
  5. No teaching away. No Tier-1 reference disparages multi-chamber capsules, nested capsules, or liquid-filled hard shells. Absence of a teaching away strengthens the case. In re Gurley, 27 F.3d 551 (Fed. Cir. 1994).
  6. Reasonable expectation of success. Two-piece hard-shell capsules, liquid-fill capsules, over-encapsulation, and enteric/sustained-release coatings were all established industrial processes by 2001 — the "predictable variation" formulation requires no more.

6. Where the plaintiff's/patent owner's rebuttal is strongest, and how to pre-empt it

  • The "different ingredient" and "only solid" negative limitations. A negative limitation is not per se nonobvious, but it can defeat a prima facie case if the art teaches away from the exclusion, or if the exclusion produces an unexpected result. Expect the argument that claim 2's "only solid" second chamber is a deliberate exclusion of the intimate-mixture prior art. Pre-empt by showing the prior art (GB 2353950's "chambers usually containing different materials"; WO 01/68452 claim 4) already taught chamber-specific composition, and that the exclusion is a drafting choice, not a technical one.
  • Unexpected results / nexus. The family's 2026 assertions against Target, Walmart and Nouri Life are on US 7,670,612, not the '497 (see the earlier litigation section). Any "commercial success" narrative must be tied to the '497 claims specifically; evidence of success for products embodying siblings or other claims lacks nexus. In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995).
  • The IPR2013-00331 Paper 9 shoe. Do not attempt a § 103 ground resting on a commercial capsule or a marketed product. The Board's Paper 9 reasoning (a product "is not a patent or printed publication and cannot be the basis of" review) is routinely quoted against product-based grounds, and the Google Patents "Adverse Judgment" flag on this family means the record has already been litigated at the Board once. Confirm whether the adverse judgment touched the '497 itself or only the related '612 before relying on it.
  • Objective indicia. Long-felt need, failure of others, and copying are the most defensible secondary considerations if the patent owner develops them — but they require a documented, pre-2002 record, and the KSR "predictable variation" finding is often robust to them.

7. Bottom line

On the record I can assemble, claims 1 and 2 and dependents 3, 4, 5, 7 and 8 appear obvious over:

  • Primary: GB 2353950 A (two-chamber capsule with dividing septum, chambers containing different materials) or GB 617,723 / US 4,627,808 / EP 0 211 079 for the structural partition;
  • Secondary: FR 2,524,311 A1 and/or WO 01/68452 claim 4 for different medicaments/filling materials across chambers;
  • Tertiary (for the ingredient genus and specific actives): US 5,501,857 (Bio-Vet), WO 99/59413 (Sine Laboratory) for the nutraceutical/probiotic genre; WO 92/11848, US 5,074,426, US 5,196,205, US 4,822,619 for the GI indication; the Alza/Urquhart references and the specification's admitted sustained-release/enteric-coating art for time-delayed solid release;
  • Plus the '497's own admitted prior art (nested H. pylori capsule, multi-compartment nutrient+probiotic capsule, solid/liquid/gas/dispersion forms, hard gelatin shells, sustained-release coatings) as the motivation and expectation-of-success anchor.

Claim 6 (caffeine) is the one claim I cannot support on the record retrieved, and the claim-2 liquid-vehicle list requires documentary (printed publication) support rather than "common knowledge" under K/S Himpp.

Two verification steps are mandatory before this opinion is filed-ready: (1) pull the certified claim set and any certificate of correction for App. 12/689,669 from USPTO Patent Center; (2) pull the full citation list from the '497's own face (not the '612's, which I used as a proxy) and confirm each reference's disclosure and § 102 date.

Generated 9/23/2026, 12:49:18 PM

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