Invalidity dossier

US 5977034

Composition for cleaning bones

Current assignee: LifeNet, Inc.

Added 9/28/2026, 4:13:50 PM

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

Active provider: DeepSeek · deepseek-v4-flash

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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 specific patent number, then cross-check against the full patent text provided.

Let me run a couple more targeted searches to check for any litigation/CAFC records and confirm bibliographic details.

Search scope and confidence

I searched for the literal identifier 5977034 (and "5,977,034") against Google Patents/Patents full text, Justia, FreePatentsOnline, EPO/CN/JP family citations, and general Federal Circuit / CAFC reporting. I found no CAFC 2026 docket, appeal, IPR, or district-court record naming U.S. Patent 5,977,034. The only litigation results that surfaced concerned other LifeNet patents (U.S. 6,569,200 — LifeNet Health v. LifeCell, Fed. Cir. 2016, and U.S. 9,125,971) and belong to the same patent family lineage but are not the '034 patent. I am flagging that absence of 2026 litigation activity as "no record found," not as an affirmative statement that none exists — docket databases are not exhaustively surfaced by these searches.

Bibliographic summary (US 5,977,034)

Field Value
Patent number US 5,977,034 A
Title Composition for cleaning bones
Inventor Lloyd Wolfinbarger, Jr. (Norfolk, VA)
Original assignee LifeNet Research Foundation (Virginia Beach, VA)
Assignee chain LifeNet Research Foundation → LifeNet (2003) → LifeNet Health (2007, change of name); current assignee of record listed as LifeNet Health, with a security interest later recorded to SunTrust Bank (2019) and Truist Bank (2021)
Application no. 08/620,856
Filing date March 20, 1996
Priority date August 19, 1994 (claimed; see family note below)
Issue date November 2, 1999
Status Expired – Lifetime; anticipated expiration August 19, 2014
Examiner / attorney Mark Kopec (primary), John M. Petruncio (assistant); Susanne M. Hopkins (attorney)
Claim count 10 (independent: 1–6; dependent: 7–10, all depending from claim 6)

Family / priority: The '034 patent is a continuation-in-part of application 08/395,113 filed Feb. 27, 1995 (now U.S. 5,556,379, "Process for cleaning large bone grafts and bone grafts produced thereby"), which was itself a CIP of application 08/293,206 filed Aug. 19, 1994 (now abandoned). The description also references application 07/696,955 (abandoned). A child CIP, 08/895,203, issued as U.S. 6,024,735. This is a US-only family (no foreign counterpart of the '034 patent itself).

Abstract (as issued)

The '034 abstract recites compositions for cleansing mammalian bones and removing bone marrow/blood deposits: an aqueous solution of a detergent having the functionality of a polyoxyethylene-23-lauryl ether, a detergent having the functionality of an oxyethylated alkylphenol, and water, free from any membrane stabilizers. The two detergent functionalities are present at a weight-percent ratio of about 1.65:1; preferably the oxyethylated alkylphenol component is a combination of poly(ethylene glycol)-p-nonyl-phenyl-ether and octylphenol-ethyleneoxide, with the three detergents in a weight-percent ratio of about 3.3:1:1. Kits comprising the compositions are also disclosed.

Plain-language overview of the independent claims

  • Claim 1 (composition, closed to membrane stabilizers): An aqueous bone-cleaning solution of (i) about 0.066 wt.% polyoxyethylene-23-lauryl ether, (ii) about 0.02 wt.% poly(ethylene glycol)-p-nonyl-phenyl-ether, (iii) about 0.02 wt.% octylphenol-ethyleneoxide, and (iv) water — with the express negative limitation that the composition does not contain a membrane stabilizer. This is the specific ternary-detergent formulation with the membrane-stabilizer exclusion.

  • Claim 2 (composition, "consisting essentially of"): Same four ingredients at the same concentrations, but drafted in "consisting essentially of" form — i.e., closed to additional ingredients that would materially affect the basic characteristics, rather than an outright exclusion of membrane stabilizers.

  • Claim 3 (composition, "consisting of"): The same four ingredients at the same concentrations, fully closed — no other ingredients permitted.

  • Claim 4 (kit): A kit for cleaning bone for a bone graft comprising an aqueous solution "consisting essentially of" the same three detergents at the same concentrations (0.066% / 0.02% / 0.02%), where the solution does not contain a membrane stabilizer. Note: the claim lists only three components plus the negative limitation (water is not recited as a separate element here, unlike claims 1–3).

  • Claim 5 (composition defined by ratio): A bone-cleansing composition of polyoxyethylene-23-lauryl ether, poly(ethylene glycol)-p-nonyl-phenyl-ether, octylphenol-ethyleneoxide, and water, where the three detergents are present in a weight-percent ratio of 3.3:1:1. This claim is broader than claims 1–3 because it fixes only the relative proportions, not absolute concentrations (and carries no membrane-stabilizer exclusion).

  • Claim 6 (genus composition): The broadest claim — an aqueous bone-cleansing composition comprising a protein solubilizing detergent at about 0.001–2.00 wt.% and one or more lipid solubilizing detergents at about 0.001–2.00 wt.%, plus water. Claims 7–10 narrow this genus: claim 7 tightens the ranges to 0.01–0.5 wt.% each; claim 8 requires a ~1.65:1 protein:lipid weight ratio; claims 9 and 10 recite Markush lists of specific protein-solubilizing and lipid-solubilizing detergent species, respectively.

Points of uncertainty / internal inconsistency worth flagging

  1. "Polyoxyethylene-23-lauryl ether" vs. "polyoxyethylene-4-lauryl ether." The claims and abstract recite polyoxyethylene-23-lauryl ether, but the specification's preferred working example repeatedly describes polyoxyethylene-4-lauryl ether / Brij-35 ("C9H19(OCH2CH2)4OH"), and gives the 1× concentration as 0.066 wt.% Brij-35. I am reporting both literally rather than harmonizing them; the discrepancy is in the document as issued. Relatedly, the Markush list in claim 9 conspicuously does not include a polyoxyethylene-23-lauryl ether species.

  2. Ratio inconsistency. The Summary of Invention states a preferred protein:lipid ratio of "about 1:2," while the detailed description and the abstract state "about 1.65:1," and the working formulation (0.066% : 0.04%) is ~1.65:1. The abstract's 3.3:1:1 figure corresponds to 0.066 : 0.02 : 0.02.

  3. No 2026 litigation located. I found no CAFC 2026 docket or active proceeding for 5,977,034; per the record it expired August 19, 2014, which is consistent with it no longer being assertable. Any claim that this patent is in active 2026 litigation would not be supported by the sources I retrieved.

  4. Citations to this patent as prior art appear in later third-party documents (e.g., the Chinese publication CN 102317424 B and the German DE 695 327 98 T2 family member of the '379 patent), which is relevant if you are building a prosecution-history or prior-art narrative but is not evidence of litigation.

Generated 9/28/2026, 4:21:02 PM

Cases on file (1)

Group view →

Specific litigation cases in our database that name US patent 5977034. 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 5977034.

Let me try more targeted searches on patent litigation databases.

Let me search more specifically for the patent number in litigation databases and LifeNet Health cases.

Litigation Search Results for U.S. Patent No. 5,977,034

Bottom line

I could not identify any litigation — district court, CAFC, ITC, or PTAB — that specifically asserts or adjudicates U.S. Patent No. 5,977,034 ("Composition for cleaning bones"). Based on the searches run, there is no known litigation involving this specific patent.

What I searched and what I found

I ran targeted searches across patent-litigation-focused sources (Unified Patents litigation portal indices, the Stanford NPE Litigation Database, CourtListener/Justia docket listings, Docket Alarm, and general web searches keyed to the exact number):

Search target Result
"5977034" patent lawsuit / litigation No litigation hits for the '034 patent
"5,977,034" / 5977034 + LifeNet No assertion/litigation hits
Stanford NPE Litigation Database (npe.law.stanford.edu) No entry for patent 5977034
Unified Patents portal / Docket Alarm No case list for 5977034

The only references to U.S. 5,977,034 that surfaced are non-litigation:

  • It is cited as prior art on the face of CN 102317424 B (CG Biotech Co., Ltd. — "cleaning composition for treating human/animal-derived tissue for transplantation"), where the Chinese examiner cites "US 5977034 A, 1999.11.02" as a reference. That is a prosecution citation, not litigation.
  • It is a family member of the LifeNet chain (continuation-in-part of US 08/395,113, now US 5,556,379; parent of US 08/895,203, now US 6,024,735).

Important caveat — related-but-distinct LifeNet cases

The patent owner of record, LifeNet Health (originally LifeNet Research Foundation, Virginia Beach, VA), has been an active patent litigant, and searches surfaced several LifeNet cases. None of these is confirmed to involve U.S. 5,977,034, and I am flagging them so they are not mistaken for '034 litigation:

  • LifeNet Health v. LifeCell Corp. — D. Del./E.D. Va.; September 2013 filing; November 2014 jury verdict of ~$34.7 million for LifeNet. Press coverage indicates the asserted patent was the soft-tissue/bone preservation patent granted around 2003, not the '034 bone-cleaning composition patent. (PilotOnline)
  • LifeNet Health v. RTI Surgical, Inc. — M.D. Fla., No. 3:18-cv-00817, filed June 27, 2018. (Patent(s) asserted not confirmed.)
  • LifeNet Health v. Tissue Regenix Woundcare, Inc. et al — E.D. Va., No. 1:17-cv-00533.
  • LifeCell Corporation v. LifeNet Health — E.D. Va., No. 1:16-cv-00829.
  • LifeNet Health v. Zimmer Biomet Holdings, Inc. et al — E.D. Va., No. 2:2023-cv-00479.

Stanford's NPE database associates the above case family with a different LifeNet patent, U.S. 6,569,200 — not '034.

Status of the '034 patent itself

Per the Google Patents record: US 5,977,034 — "Composition for cleaning bones," inventor Lloyd Wolfinbarger, Jr., filed March 20, 1996, granted November 2, 1999, priority date August 19, 1994, current assignee LifeNet Health. Legal status: Expired – Lifetime, with an anticipated expiration of August 19, 2014. This expiration date is consistent with the absence of recent enforcement activity.

Reliability statement

I can state with reasonable confidence that no litigation asserting U.S. 5,977,034 appears in the publicly indexed sources searched. However, I do not have complete PACER coverage, and my search tools returned no direct docket-level confirmation for this number, so I cannot rule out a suit that was filed and resolved early or that is not captured by these aggregators. I did not retrieve any CAFC opinion or PTAB proceeding tied to 5,977,034. If a definitive negative is required (e.g., for a freedom-to-operate or due-diligence opinion), a full PACER/Unified Patents Portal docket query keyed exactly to "5,977,034" (and its RE/ex parte reexamination history) would be the appropriate confirming step.

Generated 9/28/2026, 4:20:57 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: LifeNet, 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 the structured data against public sources before reporting.

No IPR hits in the first pass. Let me probe litigation and appeal channels too.

Let me pin down whether the '034 patent itself was ever asserted or challenged.

I hit the tool-call cap before I could run the last two verification queries (a direct PTAB E2E / PTAB "patent number" search and a CourtListener docket check). Everything below reflects the canonical ODP block plus the searches I did complete; I flag the residual uncertainty explicitly rather than papering over it.

Proceedings overview

Total AIA trial proceedings on US 5,977,034: 0. The USPTO ODP structured block returns no IPR, PGR, or CBM for this patent — no active proceedings, no claims invalidated, no claims sustained, no settlements, no institution denials — which leaves the patent entirely untested at the PTAB; a defendant's real leverage here is not a PTAB kill shot but the calendar: the patent expired 2014-08-19, so a 2026 demand letter is largely a nullity.

No proceedings to enumerate

There is no {PROCEEDING_NUMBER} — {Petitioner} v. LifeNet Health to write up. I will not manufacture one. The absence is confirmed by the structured ODP data and by my searches, which surfaced LifeNet Health PTAB activity only on other patents:

Caution: the RTI/Embody/LifeCell matters prove only that LifeNet is a willing litigant and that its bone-graft processing portfolio has been challenged. They say nothing about the validity of claims 1–10 of the '034, and none of them creates § 315(e)(2) estoppel against a new defendant on this patent.

Strategic summary

Claim status: all 10 claims UNTESTED. Claims 1–3 are the narrow, fully-characterized aqueous formulations (about 0.066 wt. % polyoxyethylene-23-lauryl ether; about 0.02 wt. % poly(ethylene glycol)-p-nonyl-phenyl-ether; about 0.02 wt. % octylphenol-ethyleneoxide; water), with claim 1 requiring the absence of a membrane stabilizer, claim 2 "consisting essentially of," and claim 3 "consisting of." Claim 4 is the kit counterpart. Claim 5 is the ratio claim (3.3:1:1). Claims 6–10 are the broad genus claims (protein solubilizing detergent + lipid solubilizing detergent at 0.001–2.00 wt. % each), which are the ones a plaintiff would actually want to assert and the ones most exposed to § 103 over the 1995 Allen et al. / Osteotech Permein et al. art cited in the specification itself. No panel has ever construed them; a 2026 assertion therefore arrives with zero PTAB history and zero estoppel.

Estoppel landscape: empty. Because no IPR was ever instituted on the '034, § 315(e)(2) estoppel is unavailable against anyone. RTI Surgical, Embody, and LifeCell are not estopped as to this patent, but neither does their prior art work for them — a fresh defendant can raise every § 102/§ 103 ground, plus § 112 (the claim-1/claim-2/claim-3 "about 0.066 wt. % polyoxyethylene-23-lauryl ether" versus the specification's repeated "polyoxyethylene-23-lauryl ether" and the "polyoxyethylene-4-lauryl ether"/Brij-35 conflation is a live indefiniteness/written-description target that no tribunal has tested).

Pattern signals. No petitioner has filed against this patent — not even as a me-too. The most plausible reason is commercial rather than legal: the claimed subject matter is the ALLOWASH™ cleaning solution, it is a consumable tied to a bone-processing service rather than a product a competitor sells in the stream of commerce, and it has been expired since 2014-08-19. No defensive aggregator (Unified Patents, RPX) appears in any chain touching this patent. LifeNet, for its part, has litigated aggressively and has defended PTAB challenges on its other patents rather than filing PTAB appeals on this one.

Recommended next steps

  • First, check the damages window before anything else. The patent expired 2014-08-19 (Google Patents anticipated-expiration entry). Under 35 U.S.C. § 286, a suit filed on 2026-09-28 reaches back only to 2016-09-28 — and there can be no infringement after 2014-08-19. Absent a pre-existing action, an '034 demand letter in 2026 has no recoverable damages theory at all. Confirm the true expiration date from the USPTO Patent Center "Patent Term Adjustments" tab, because PTA/§ 154(b) extensions could push it later; Google's 2014-08-19 is an assumption, not an adjudication.
  • If the assertion is stale-conduct based, the invalidity case is still worth building, but you will not get PTAB help: the '034 is expired, so an IPR is legally available yet practically unattractive, and the Director's post-2025 discretionary-denial practice (cumulativeness, "settled expectations" for old claims) makes institution on a 1999 patent unlikely on its face.
  • Where I could not reach a conclusion, treat it as open: I did not complete a patent-number-keyed PTAB E2E search or a CourtListener docket query. Before relying on the zero count in a brief, run (a) PTAB E2E / Patent Public Search for "5,977,034" and (b) a CourtListener RECAP docket search for the patent number plus "LifeNet," to confirm no recently-filed petition has outrun the ODP ingest. The ODP block itself instructs that the default is "no PTAB activity on file," and that is what the evidence supports — but the residual gap is real, not rhetorical.

Generated 9/28/2026, 4:21:07 PM

Ownership chain (7)

Asserters network →

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

  1. 1996-03-20 · Assignment

    Wolfinbarger, Lloyd Jr.LifeNet Research Foundation

  2. 2003-07-22 · Assignment

    LifeNet Research FoundationLifeNet

    internal reorg

  3. 2007-11-26 · Change of Name

    LifeNetLifeNet Health

    change of name only

  4. 2007-12-20 · Change of Name

    LifeNetLifeNet Health

    change of name only

  5. 2008-01-29 · Correction

    LifeNetLifeNet Health

    administrative correction

  6. 2019-06-10 · Security Interest

    LIFENET HEALTH, SKIN AND WOUND ALLOGRAFT INSTITUTE, LLCSunTrust Bank

    securitization

  7. 2021-04-02 · Security Interest

    LIFENET HEALTH, SKIN AND WOUND ALLOGRAFT INSTITUTE, LLCTruist Bank

    securitization

Assignment history

Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.

✓ Generated

I'll pull what I can from public records to ground the assignment chain before writing the analysis.

I hit my tool-call limit before I could retrieve the Assignment Center reel/frame detail directly, so I'm flagging every field that came back blank rather than filling it in. Below is what the public record actually supports.

Inventors

Inventor Address of record Employer at time of filing
Lloyd Wolfinbarger, Jr. (sole named inventor) 1509 Cedar Lane, Norfolk, VA 23508 (address appears in LifeNet's co-pending PCT filings) LifeNet — the operating tissue bank at 5809 Ward Court, Virginia Beach, VA 23455, which is the same organization as the assignee LifeNet Research Foundation

Pattern notes:

  • No inventor-departure signal. Wolfinbarger remained with the LifeNet organization well past issuance — he is a named inventor on later LifeNet patents in the same family line (e.g., US 6,189,537, Wolfinbarger 2001, cited in third-party literature as a LifeNet demineralization patent). Sole-inventor ownership never fragmented.
  • Sole inventor, not a team. There is no co-inventor who could have carved out and re-sold an undivided interest, which is one of the more common ways a clean operating-company chain gets contaminated.
  • Rare-vs-life-sciences note: human tissue patents of this vintage usually name 3–8 inventors; the single-inventor listing here tracks with LifeNet's small in-house R&D group rather than a corporate lab.

Original assignee

LifeNet Research Foundation (per the Google Patents record "Original Assignee"; current assignee of record is LifeNet Health).

  • Primary line of business: nonprofit human tissue bank / organ procurement organization. LifeNet is Virginia's OPO and a tissue-processing operation holding AATB accreditation (#00001/12) and ISO 13485 registration for "design, development, manufacture and distribution of human cellular and tissue based products… including dermis, musculoskeletal and cardiovascular tissue." Facilities at 5809 Ward Court and 1864 Concert Drive, Virginia Beach, VA, plus Renton, WA.
  • Did they ship a product embodying the claims? Effectively yes, at the process level. The specification names the commercial embodiment ALLOWASH™ solution, "available from LifeNet Research Foundation, 5809 Ward Court, Virginia Beach, Va. 23455," and Examples I–II are LifeNet's own femur-cleaning runs. LifeNet also markets the downstream bone products (e.g., Optium™ DBM Gel/Putty, cleared via 510(k) K053098, with LifeNet's then-Director of Regulatory Affairs as submitter contact). This is an operating entity with the composition in commercial use, not a paper owner.
  • Current status: operating. LifeNet Research Foundation → LifeNet (2003) → LifeNet Health (2007, change of name). LifeNet Health remains an active Virginia nonprofit tissue bank and a litigant — in LifeNet Health v. Embody, Inc., Embody's counterclaims seek declaratory judgment of invalidity/noninfringement of US 10,137,223 and US 11,318,227, confirming LifeNet Health is an asserting patent owner.
  • Patent status: granted 1999-11-02; anticipated expiration 2014-08-19. This patent is expired and cannot be asserted. Note the priority chain (1994-08-19 parent app 08/293,206, abandoned → CIP 08/395,113, now US 5,556,379 → this application 08/620,856, filed 1996-03-20) means the terminal disclaimer / 20-year clock runs from the 1994 priority.

Assignment timeline

Important data limitation, stated up front: the Assignment Center / Google Patents legal-events panel I retrieved lists each recording's type, assignor, assignee, and date, but did not render reel/frame numbers or the correspondent-of-record field for these entries. I could not reach the Assignment Center query directly before hitting my tool limit. The only reel/frame visible anywhere in the record I pulled is reel 020288/0872, and only because it is quoted inside the text of the 2008 corrective cover sheet. I am therefore leaving reel/frame and correspondent blank where I do not have them rather than inventing values.

  • 1996-03-20 (recorded same day as filing) / recorded 1996-03-20 — Reel not retrieved

    • Conveyance: Assignment of Assignors Interest (see document for details)
    • Assignor: Wolfinbarger, Lloyd, Jr.
    • Assignee: LifeNet Research Foundation
    • Correspondent: not retrieved (record shows only "ASSIGNMENT OF ASSIGNORS INTEREST")
    • Context: initial inventor-to-company assignment; inventor was the assignee's own research principal.
  • 2003-07-22 / recorded 2003-07-22 — Reel not retrieved

    • Conveyance: Assignment of Assignors Interest
    • Assignor: LifeNet Research Foundation
    • Assignee: LifeNet
    • Correspondent: not retrieved
    • Context: internal reorganization of the tissue-bank legal entity from the research foundation to the operating LifeNet entity.
  • 2007-11-26 / recorded 2007-11-26 — Reel not retrieved

    • Conveyance: Change of Name
    • Assignor: LifeNet
    • Assignee: LifeNet Health
    • Correspondent: not retrieved
    • Context: change of name only — corporate rename, same legal entity, no change in beneficial ownership.
  • 2007-12-20 / recorded 2007-12-20 — Reel not retrieved

    • Conveyance: Change of Name
    • Assignor: LifeNet
    • Assignee: LifeNet Health
    • Correspondent: not retrieved
    • Context: second recording of the same rename against a different property set — change of name only. The Nov/Dec 2007 pair is one transaction recorded twice, not a cascade.
  • 2008-01-29 / recorded 2008-01-29 — Reel not retrieved (corrects an earlier recording at reel 020288/0872)

    • Conveyance: Corrective Cover Sheet — text: "CORRECTIVE COVER SHEET TO CORRECT PATENT APPLICATION NUMBERS D471,971 29/148,528 ON ASSIGNMENT PREVIOUSLY RECORDED AT REEL 020288 FRAME 0872"
    • Assignor: LifeNet
    • Assignee: LifeNet Health
    • Correspondent: not retrieved — this is the field I most wanted and could not get. The corrective sheet's existence tells you a single blanket Portfolio filing ran across both utility and design applications (D471,971 and 29/148,528 are design apps), which is the signature of one filing agent handling the whole portfolio at once. Without the correspondent name I will not convert that into a finding.
    • Context: administrative correction to the 2007 change-of-name recording; reel 020288/0872 is the underlying change-of-name instrument being corrected.
  • 2019-06-10 / recorded 2019-06-10 — Reel not retrieved

    • Conveyance: Security Interest (see document for details)
    • Assignor: LifeNet Health; Skin and Wound Allograft Institute, LLC
    • Assignee: SunTrust Bank
    • Correspondent: not retrieved
    • Context: securitization — blanket collateral grant to a commercial lender, not a transfer of title. Recorded roughly five years after this patent expired (2014-08-19), i.e., the collateral schedule swept in expired assets.
  • 2021-04-02 / recorded 2021-04-02 — Reel not retrieved

    • Conveyance: Security Interest (see document for details)
    • Assignor: LifeNet Health; Skin and Wound Allograft Institute, LLC
    • Assignee: Truist Bank
    • Correspondent: not retrieved
    • Context: securitization — successor/refinancing of the SunTrust facility following the SunTrust–BB&T merger into Truist; same collateral group, same borrower group. Still not a title transfer.

No NPE, LLC, or litigation-vehicle assignee appears anywhere in this record. The only LLC in the chain — Skin and Wound Allograft Institute, LLC — appears as a co-grantor of collateral, not as an assignee of this patent.

Timeline diagram

timeline
    title Ownership of US 5977034
    1994 : Priority date 19 Aug 1994
    1996 : Application 08 620 856 filed
         : Assigned to LifeNet Research Foundation
    1999 : Patent granted 2 Nov 1999
    2003 : Assigned to LifeNet
    2007 : Renamed LifeNet Health
         : Second change of name recorded
    2008 : Corrective cover sheet recorded
    2014 : Patent reached expiration
    2019 : Security interest to SunTrust Bank
    2021 : Security interest to Truist Bank

NPE / troll-pattern signals

  1. Shell-entity transfer — not present. There is no transfer from an operating assignee to a licensing-only vehicle. Every title-bearing assignee in the chain (LifeNet Research Foundation → LifeNet → LifeNet Health) is the same operating tissue-bank organization under successive names/entities, per the 1996-03-20, 2003-07-22, 2007-11-26 and 2007-12-20 recordings. The only LLC on the record, Skin and Wound Allograft Institute, LLC, is a co-grantor of a security interest to SunTrust (2019-06-10) and Truist (2021-04-02), not an assignee — and it is an affiliated operating entity, not a licensing shell.

  2. Known asserter in the chain — not present. No assignee at any point matches Acacia, Marathon/IPNav, Intellectual Ventures, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Spangenberg entity. The assignee list is two names for one nonprofit: LifeNet and LifeNet Health. The asserting activity LifeNet Health does engage in (LifeNet Health v. Embody, Inc., on US 10,137,223 and 11,318,227) is direct operating-company versus direct competitor litigation, not NPE activity — and it does not touch this patent.

  3. Repeat correspondent across the chain — unclear (cannot be determined from the records I retrieved). The Assignment Center correspondent field did not render for any of these entries in the data I pulled, and I could not complete a direct Assignment Center query. What is visible is circumstantial only: the 2008-01-29 corrective cover sheet says a single earlier recording at reel 020288/0872 carried a blanket schedule of multiple applications and patents including design applications (D471,971, 29/148,528), which is what a single portfolio-wide filing agent produces. Separately, a LifeNet co-pending PCT lists Susanne M. Hopkins, LifeNet, 5809 Ward Court, Virginia Beach, VA 23455 as agent — but that is prosecution power-of-attorney of record, not the assignment correspondent, and I am not treating it as evidence of an assignment-filing pattern. No recurrence finding is supportable without the correspondent names.

  4. Cascading transfers — not present. There are only three title-bearing events across eleven years (1996, 2003, 2007×2). The 2007-11-26 and 2007-12-20 entries are 24 days apart but are the same change of name recorded against different property sets, not a chain of distinct assignees. No transfers at all after 2007. Nothing resembling the sub-24-month LLC-to-LLC relay.

  5. Pre-litigation transfer — not present. No infringement suit naming US 5,977,034 was located, and the patent expired 2014-08-19, so the only post-2007 recordings (2019-06-10 to SunTrust, 2021-04-02 to Truist) fall 5–7 years after expiration and cannot be pre-litigation standing transfers. There is no assignment timed to a suit.

  6. Bankruptcy fire-sale — not present. No Chapter 7/11 proceeding involving LifeNet or any chain assignee was located, and the 2019/2021 instruments are captioned as Security Interest grants, not Article 9 dispositions, foreclosure transfers, or §363 sale orders. LifeNet Health continued to hold title and continued operating (ISO 13485 and AATB accreditations current through 2024+).

  7. Privateering — not present. There is no transfer to a third-party assertion vehicle that then sues the original owner's competitors. The assignee never left the LifeNet organization; LifeNet Health asserts its own patents in its own name.

  8. Defensive aggregator — not present. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at the operating tissue bank plus a bank collateral interest.

Verdict

Operating-company assertion.

The chain is a textbook clean operating-company title record: inventor Wolfinbarger → LifeNet Research Foundation (1996-03-20) → LifeNet (2003-07-22) → LifeNet Health (2007-11-26 and 2007-12-20 change-of-name recordings, plus the 2008-01-29 corrective cover sheet referencing reel 020288/0872) — a single nonprofit tissue bank renamed, with no third-party assignee at any link. The only non-LifeNet names on the record are SunTrust Bank (2019-06-10) and Truist Bank (2021-04-02), both as security-interest holders only, both recorded after the patent's 2014-08-19 expiration, which is securitization rather than any form of assertion or aggregation. LifeNet Health ships tissue products and does assert patents directly against competitors (LifeNet Health v. Embody, Inc.), which is operating-company behavior on the inverse of the NPE pattern — with the important caveat that US 5,977,034 itself expired in 2014 and is not assertable by anyone.

Verification link: https://assignmentcenter.uspto.gov/ (search by patent number 5977034; also indexed at https://assignment.uspto.gov/patent/index.html).

Two open items I could not close, stated plainly rather than guessed: (1) the reel/frame for every entry except the one embedded in the corrective-cover-sheet text (020288/0872), and (2) the correspondent of record for all entries. Both are one query away in the Assignment Center UI; until they're pulled, signal #3 (repeat correspondent) stays unclear, and it is the only signal in the set that could change the picture.

Generated 9/28/2026, 4:21:20 PM

Prior art

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

✓ Generated

I'll research this patent and its prior art citations.

Let me look at the Justia page and search for the specific references cited in this patent.

Let me get the complete citation list from the patent's Google Patents page.

Search confirmation

I searched for the specific number US 5,977,034 ("Composition for cleaning bones") and retrieved its record via the Google Patents and Justia mirrors of the US patent record (I could not access the raw USPTO Patent Public Search / PatentCenter interface, so the citation data below comes from those mirrors of the official record).

Bibliographic data (verified):

Field Value
Patent number US 5,977,034
Title Composition for cleaning bones
Application no. 08/620,856
Filing date March 20, 1996
Priority date August 19, 1994 (via CIP chain)
Grant/publication date November 2, 1999
Inventor Lloyd Wolfinbarger, Jr.
Original assignee LifeNet Research Foundation
Current assignee LifeNet Health
Primary Examiner / Asst. Mark Kopec / John M. Petruncio
Status Expired – Lifetime (anticipated expiration Aug. 19, 2014)
Claims 10
Cited patent documents 82 (per Google Patents "Patent Citations (82)")

Priority chain (per the patent text): this application is a continuation-in-part of Ser. No. 08/395,113, filed Feb. 27, 1995, now U.S. Pat. No. 5,556,379, which is itself a CIP of Ser. No. 08/293,206, filed Aug. 19, 1994, now abandoned. A related child, Ser. No. 08/895,203, issued as U.S. Pat. No. 6,024,735.

Important caveats before the analysis

  • I could retrieve only the U.S. patent-documents portion of the "References Cited" list (roughly the first third of the 82 entries); the remainder (further U.S. patents, foreign documents, and the non-patent literature) was truncated. I flag this rather than guess.
  • I do not have verified technical content for most of the examiner-cited U.S. patents. Where I am not confident of a reference's disclosure, I say so explicitly rather than describe it.
  • § 102 standard: anticipation requires that a single reference disclose every element of a claim, arranged as claimed. Given that claims 1–5 recite a three-detergent blend at specific concentrations (and a negative limitation "does not contain a membrane stabilizer"), and claims 6–10 recite protein- and lipid-solubilizing detergents in specific weight ranges/ratios, a clean § 102 anticipation by any single cited reference is improbable. Most of the material below is properly § 103 / background art.
  • Literal-reading note: claims 1–5 recite "polyoxyethylene-23-lauryl ether," while the specification's preferred embodiment recites "polyoxyethylene-4-lauryl ether / Brij-35." I am flagging this discrepancy as written and am not auto-correcting it.

A. The most relevant prior art (from the specification itself)

These are the references the applicant/patentee identified as the state of the art, and they are the most substantively relevant:

1. U.S. Pat. No. 5,556,379 (Wolfinbarger) — "Process for cleaning large bone grafts and bone grafts produced thereby"

  • Filed Feb. 27, 1995 (Ser. No. 08/395,113); parent application of the '034 patent.
  • Disclosure: detergent formulations of Brij 35, Nonidet P-40 (octylphenol-ethyleneoxide) and Nonoxynol-9, incorporated by reference in the '034 text.
  • § 102 relevance: This is the same-family parent, so it is generally treated as related art rather than anticipating art against the '034 claims (common inventor/applicant). Because the '034 is a CIP, any claim whose subject matter is not supported by the '379 disclosure could theoretically face the '379 as § 102(e) art (a patent granted on an application filed before the '034 inventor's later-filed subject matter). Most plausibly relevant to claims 6–10 (the broadly worded detergent-range claims).

2. Application Ser. No. 07/696,955 (abandoned)

  • Discloses the same detergents in combination with membrane stabilizers.
  • § 102 relevance: This is the reason for the negative limitation in claims 1–4 ("does not contain a membrane stabilizer") and arguably in claim 2's/3's "consisting essentially of/consisting of." Its content bears directly on the patentability of claims 1–4 (and is why the "free from membrane stabilizers" language appears in the abstract).

3. Application Ser. No. 08/293,206 (abandoned, filed Aug. 19, 1994) — earliest priority application; base of the family.

4. Mellonig, J.T.; Prewett, A.B.; Moyer, M.P., J. Periodontology 63:979–983 (Dec. 1992) — describes Osteotech's "Perman" process ("a combination of ethanol and non-ionic detergent") for cleaning bone grafts and inactivating HIV in ground bone allograft.

  • § 102(b) relevance: printed publication more than one year before the earliest priority date; bears on claim 6 (broadly, "protein solubilizing detergent + lipid solubilizing detergent + water") and on the ethanol-optional embodiments. It does not appear to disclose the specific three-detergent blend or the claimed concentration ranges.

5. Cryolife, Inc. VIP™ documentation (Cryolife Orthopedics brochure 12, Feb. 1992; Cryolife literature to Organ and Tissue Procurement Program Directors, Feb. 20, 1992; "The Viricidal Capacity of a Surfactant/Iodophor-Based Viral Inactivation Process for Bone Allografts")

  • Multi-step surfactant/iodophor bone-cleaning and viral-inactivation process.
  • § 102(b) relevance: publicly available printed materials; background on bone cleaning with surfactants. Not shown to disclose the claimed detergent blend.

6. Helenius, A. and Simons, K., "Solubilization of Membranes by Detergents," Biochim. Biophys. Acta 415:29–79 (1975)

  • General teaching on detergent micelle formation and membrane solubilization.
  • § 102 relevance: background on the CMC/micelle rationale recited throughout the specification; supports § 103 obviousness of detergent selection but does not anticipate.

B. Examiner-cited U.S. patent documents (retrieved portion)

The following U.S. patents appear in the "Referenced Cited" listing for the '034 patent. Dates are as listed; I have not verified the technical disclosure of each, and mark those accordingly. Because none of these is shown to disclose the claimed three-detergent aqueous blend at the recited concentrations/ratios, they are candidates for § 103/background, not clean § 102 anticipation.

U.S. Patent Date Inventor Possible claim relevance Disclosure verified?
4,020,183 Apr. 26, 1977 Asculai et al. claims 6–10 (general) No
4,169,123 Sep. 25, 1979 Moore et al. claims 6–10 No
4,207,689 Jun. 17, 1980 Romero-Sierra et al. claims 6–10 No
4,233,174 Nov. 11, 1980 Sheridan claims 1–10 (detergent) No
4,258,722 Mar. 31, 1981 Sessions et al. claims 6–10 No
4,315,919 Feb. 16, 1982 Shanbrom claims 6–10 No
4,366,822 Jan. 4, 1983 Altshuler claims 6–10 No
4,412,985 Nov. 1, 1983 Shanbrom claims 6–10 No
4,456,589 Jun. 26, 1984 Holman et al. claims 6–10 No
4,526,751 Jul. 2, 1985 Gartner claims 6–10 No
4,553,974 Nov. 19, 1985 Dewanjee claims 6–10 No
4,557,853 Dec. 10, 1985 Collins claims 1–10 (detergent) No
4,637,931 Jan. 20, 1987 Schmitz claims 6–10 No
4,678,470 Jul. 7, 1987 Nashef et al. claims 6–10 (bone grafting) No
4,695,536 Sep. 22, 1987 Lindstrom et al. claims 6–10 No
4,801,299 Jan. 31, 1989 Brendel et al. claims 6–10 (tissue) No
4,891,221 Jan. 2, 1990 Shanbrom claims 6–10 No
4,923,677 May 8, 1990 Simon et al. claims 6–10 No
4,946,792 Aug. 7, 1990 O'Leary claims 6–10 No
4,975,526 Dec. 4, 1990 Kuberasampath et al. claims 6–10 (osteogenic) No
4,994,030 Feb. 19, 1991 Glowczewskie et al. claims 6–10 No
5,037,437 Aug. 6, 1991 Matsen, III claims 6–10 No
5,041,055 Aug. 20, 1991 Roth claims 6–10 No
5,047,030 Sep. 10, 1991 Draenert claims 6–10 No
5,106,626 Apr. 21, 1992 Parson et al. claims 6–10 No
5,118,512 Jun. 2, 1992 O'Leary et al. claims 6–10 No
5,120,656 Jun. 9, 1992 O'Leary et al. claims 6–10 No
5,133,756 Jul. 28, 1992 Bauer et al. claims 6–10 No
5,167,961 Dec. 1, 1992 Lussi et al. claims 6–10 No
5,186,945 Feb. 16, 1993 Shanbrom claims 6–10 No
5,192,828 Mar. 9, 1993 Draenert claims 6–10 No
5,333,626 Aug. 2, 1994 Morse et al. claims 6–10 No
5,414,144 May 9, 1995 Watanabe et al. claims 6–10 No
5,454,815 Oct. 3, 1995 Geisser et al. claims 6–10 No
5,494,784 Feb. 27, 1996 Hosaka et al. claims 6–10 No
5,513,662 May 7, 1996 Morse et al. claims 6–10 No
(list continues; ~34+ further entries not retrieved)

(Note: the "Romera-Sierra" spelling shown in the cited list is reproduced as "Romero-Sierra" here only for identification; the number 4,207,689 is the literal identifier.)


C. Overall § 102 conclusion

  1. No retrieved reference appears to anticipate claims 1–5. Claims 1–5 require a single aqueous solution containing all three detergents (polyoxyethylene-23-lauryl ether, poly(ethylene glycol)-p-nonyl-phenyl-ether, and octylphenol-ethyleneoxide) at ~0.066 / ~0.02 / ~0.02 wt. %, with the negative limitation of no membrane stabilizer (claims 1 and 4), or a 3.3:1:1 ratio (claim 5). None of the retrieved references is shown to disclose this combination.

  2. Claims 6–10 are the broadest and most vulnerable. Claim 6 covers essentially any aqueous protein-solubilizing-detergent (0.001–2 wt. %) + lipid-solubilizing-detergent (0.001–2 wt. %) bone-cleaning solution; claims 7–10 narrow by concentration, ratio, and detergent species. The strongest § 102/§ 103 exposure here comes from (a) the same-family U.S. Pat. No. 5,556,379 and (b) the Mellonig/Osteotech "Perman" and Cryolife VIP publications — though neither is confirmed to disclose the specific claimed ranges.

  3. Most relevant references overall, ranked:

    • U.S. Pat. No. 5,556,379 (Wolfinbarger, filed Feb. 27, 1995) — same-family parent; discloses the same Brij 35 / Nonidet P-40 / Nonoxynol-9 detergents → most relevant to claims 6–10.
    • Application Ser. No. 07/696,955 (abandoned) — detergents + membrane stabilizers → directly implicated by the "no membrane stabilizer" limitation of claims 1–4.
    • Mellonig, Prewett & Moyer (1992) and Cryolife VIP documentation — non-patent prior art on detergent/ethanol bone cleaning → claim 6 primarily.
    • Helenius & Simons (1975) — micelle/CMC background → § 103 support only.

Bottom line: The '034 patent's inventive contribution was the specific, low-concentration, membrane-stabilizer-free three-detergent aqueous blend and its use at defined CMC relationships. The cited art appears to be § 103/background material and does not, on the retrieved record, singly anticipate the claims — with the caveat that I could not retrieve the full 82-entry citation list or verify the disclosures of most examiner-cited U.S. patents. If you need per-reference § 102 certainty, the remaining ~40+ cited entries (including any foreign documents and NPL) should be pulled directly from USPTO PatentCenter/Global Dossier for the file of US 08/620,856.

Generated 9/28/2026, 4:21:28 PM

Obviousness

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

✓ Generated

I'll ground this analysis by pulling the prior-art references that bear on US5977034 — the parent/child applications it names, the art discussed in its Background, and the backward citations on the record.

Let me characterize a few of the U.S. references actually on the US5977034 front page, so the combinations I propose are grounded rather than assumed.

Obviousness Analysis — US 5,977,034 ("Composition for cleaning bones")

0. Scope, sources, and evidentiary caveats

Materials used. I worked from the Google Patents record (https://patents.google.com/patent/US5977034/en), the granted front page/printed specification (https://patentimages.storage.googleapis.com/e4/c0/25/562250fe287820/US5977034.pdf), and the references that appear on that record — the "References Cited" list, the priority-family applications, and the background art discussed in the specification itself. Where the page labels items "Cited By," those are forward citations (later patents citing US 5,977,034) and are not prior art; I have not used them as such.

Caveats I want on the record up front (no fabrication):


1. What the claims actually cover (literal reading)

Claim Substance Notes
1 Aqueous solution comprising: ~0.066 wt % polyoxyethylene‑23‑lauryl ether; ~0.02 wt % poly(ethylene glycol)‑p‑nonyl‑phenyl‑ether; ~0.02 wt % octylphenol‑ethyleneoxide; water; no membrane stabilizer Open transitional "comprising"
2 Same four ingredients, consisting essentially of Closed-with-tolerance
3 Same four ingredients, consisting of Fully closed
4 Kit "comprising an aqueous solution consisting essentially of" the three detergents; no membrane stabilizer Kit claim omits water from the listed ingredients
5 Composition of the three detergents + water in 3.3:1:1 wt. ratio Ratio claim
6 Aqueous solution: a protein-solubilizing detergent (0.001–2.00 wt %) + one or more lipid-solubilizing detergents (0.001–2.00 wt %) + water Very broad genus — no named species
7 Same, narrowed to 0.01–0.5 wt % each Range optimization
8 Protein:lipid weight ratio ~1.65:1 Direction of ratio stated opposite to the specification's prose (see below)
9 Protein detergent Markush: polyoxyethylene(9) lauryl ether; dodecylmaltoside/lauryl maltoside; decaoxyethylene monolauryl ether; GENAPOL X‑080/X‑100; PEG(10) tridecyl ether; sodium lauryl sulfate; sodium dodecyl sulfate All art-recognized detergents
10 Lipid detergent Markush: PEG‑p‑nonyl‑phenyl‑ether; octylphenol‑ethyleneoxide; polyoxyethylene alcohol; PEG p‑isooctylphenyl ether (Triton X); polyoxyethylene ester, 1‑argitol; polyoxyethylene nonylphenol; polyoxyethylene sorbitol ester (Tween/Emasol) All art-recognized nonionics

Two internal inconsistencies I flag rather than resolve:

  1. Lauryl ether identity. Claims 1–5 recite polyoxyethylene‑23‑lauryl ether, and the abstract is consistent. But the working examples and ALLOWASH™ description identify the lauryl ether as Brij‑35, which the specification calls "polyoxyethylene‑4‑lauryl ether having the chemical formula C₉H₁₉(OCH₂CH₂)₄OH" (a C₁₂E₄-type ether, i.e., the Brij‑30 family), and elsewhere the specification lists "polyoxyethylene‑23‑lauryl ether (such as Brij series, Lubrol W, etc.)" as the first member of the protein-solubilizing group. Reading the claims literally (C₁₂E₂₃), claim 1 covers the commercially standard Brij‑35; the examples' "C₉H₁₉(OCH₂CH₂)₄OH" designation does not match that number. Either way, the lauryl ether actually claimed is Brij‑35, a commercially available, decades-old nonionic detergent — which matters a great deal for §103 (see §5).
  2. Ratio direction. Claim 8 recites protein:lipid = ~1.65:1, but the specification says "the lipid solubilizing agent and the protein solubilizing agent are present in a weight percent ratio of about 1.65:1." On the specification's own preferred numbers (0.066 % protein : 0.04 % lipid) the correct ratio is 1.65:1 protein:lipid, so claim 8 is internally supported by the numbers even though the prose is inverted.

The only compositional limitations that arguably distinguish the claims are: (a) the specific three-detergent selection, (b) their relative and absolute amounts, and (c) the negative limitation "does not contain a membrane stabilizer."


2. Effective filing date / which references are prior art

Chain of priority (as recorded):

Consequences:

  • Third-party art published before 1994‑08‑19 is §102(b) prior art regardless of which priority date is ultimately awarded. That captures Mellonig 1992, Cryolife VIP materials (Feb. 12, 1992), the Osteotech/DMIN 1993 brochure, Helenius & Simons 1975, Sharma (Oct. 1990), Lavelle (Dec. 1989), Sattar (1991), Withrow (Feb. 1990), Klebanoff (1973), McCutcheon's Emulsifiers and Detergents (1985) and Morse (Aug. 1992). The analysis therefore does not turn on the priority fight.
  • US 5,556,379 and abandoned 07/696,955 share the same inventor (Wolfinbarger), so they are not "by another" and are not §102(a)/(e) prior art. However, the specification itself admits what they disclose: "Formulations including solutions of detergents of Brij 35, Nonidet P‑40, and Nonoxynol‑9 are disclosed in U.S. patent application Ser. No. 08/395,113 … U.S. patent application Ser. No. 07/696,955 abandoned discloses these detergents in combination with membrane stabilizers." That is an admitted prior art statement usable in the §103 analysis, and it is the single most damaging one because it supplies the entire three-detergent core of claims 1–5.

3. The prior art of record, grouped functionally

(a) The three detergents themselves, as a mixture — admitted art.
Specification's own account of 08/395,113 and 07/696,955: Brij‑35 (protein solubilizer) + Nonidet P‑40/NP‑40 (octylphenol‑ethyleneoxide, lipid solubilizer) + Nonoxynol‑9 (poly(ethylene glycol)‑p‑nonyl‑phenyl‑ether, lipid solubilizer), the latter two identified as "IGEPAL® CA 630." The only stated difference from the claims is the presence of membrane stabilizers.

(b) Detergent/membrane-solubilization science. Helenius & Simons, Biochim. Biophys. Acta 415:29–79 (1975) — the specification's own reference for the propositions that detergents solubilize membranes, that micelle formation sets an effective concentration ceiling, and that detergent solutions must be replenished or exchanged as lipid exceeds solubilization capacity. This reference supplies the CMC-based concentration-selection rationale the patent uses to justify its numbers.

(c) Bone/tissue cleaning with detergents ± alcohol, and viral inactivation.

  • Cryolife, Inc. materials (VIP™ process; brochure 12, Feb. 1992; "Cleaner, Safer … Bone VIP Bone™," Feb. 12, 1992; "The Virucidal Capacity of a Surfactant/Iodophor‑Based Viral Inactivation Process for Bone Allografts"): multi-phase bone cleaning with a surfactant at elevated temperature plus terminal disinfection.
  • Osteotech, Inc. "DMIN Aseptic Tissue Demineralization" brochure (1993) and the "Permein" process (ethanol + non-ionic detergent) discussed in the specification.
  • Mellonig, Prewett & Moyer (1992), "HIV Inactivation in a Bone Allograft," J. Periodontol. 63:979–983 — treatment of bone allograft with a virucidal agent (detergent-containing; Osteotech authorship) plus acid demineralization inactivates HIV in spiked and infected bone, with treated samples negative on p24, RT and PCR assays.

(d) Virucidal detergent/surfactant chemistry against HIV.

  • Sharma et al., American Clinical Laboratory 22–33 (Oct. 1990), "An Antiviral Agent for General Use in Biological Samples and Tissue."
  • Lavelle et al., Antimicrob. Agents Chemother. 33(12) (Dec. 1989), "…Antimicrobial Soap Formula for Virucidal Efficacy In Vitro Against Human Immunodeficiency Virus in a Blood‑Virus Mixture."
  • Sattar et al., RID 13:430–447 (1991); ExOxEmis product specification (Feb. 1991); Klebanoff et al. (1973).

(e) Detergent compendia / formularies. McCutcheon's Emulsifiers and Detergents, 1985 International and North American editions, and 1995 editions; McCutcheon's Functional Materials (1985). These are the classic evidence that Brij, Triton X, Tween/Emasol, IGEPAL, Tergitol and SDS/SLS species are a known, catalogued, interchangeable design space of nonionic/anionic surfactants.

(f) Unverified but on-the-record U.S. patents (Asculai '183; Collins '853; Shandron '919/'989/'945; Brendel '299; Nashed '470; Glowczewski '030; O'Leary '792/'512/'656; Matsen '437; Bauer '756; Morse '626/'662; Hosaka '784; Watanabe '144; Geisser '815; and others). I note them as available art I have not characterized.


4. The §103 framework applied

Under Graham v. John Deere and KSR Int'l v. Teleflex, the inquiry is: scope/content of the art; differences from the claims; PHOSITA level; and secondary considerations. Here the PHOSITA is a tissue-bank process chemist or bioprocess engineer with a B.S./M.S. in chemistry, biochemistry or biology and several years of allograft processing experience — i.e., exactly the artisan who reads McCutcheon's, Helenius & Simons, and the Cryolife/Osteotech literature.

The decisive structural facts are:

  1. Every claimed ingredient is a pre-existing, catalogued, commercially available detergent. The patent itself concedes Brij‑35's known use as a protein-solubilizing detergent in protein electrophoresis, and Nonoxynol‑9's status as "a known anti HIV agent." There is no new chemical entity anywhere in claims 1–10.
  2. The combination of the same three detergents is admitted art (07/696,955 and 08/395,113).
  3. The only added limitation over the admitted art is a deletion — removal of the membrane stabilizer.
  4. Every numeric limitation is either the admitted art's own working value or a broad range encompassing it (0.066/0.02/0.02; 0.001–2 wt %; 0.01–0.5 wt %; 3.3:1:1; 1.65:1). Under In re Aller and In re Peterson, optimizing disclosed ranges/ratios by routine experimentation is not inventive absent an unexpected result.

5. Specific combinations that render the claims obvious

Combination I (primary; attacks claims 1–5 and 8)

Admitted art: 07/696,955 + 08/395,113 (US 5,556,379) in view of Helenius & Simons (1975), and further in view of Mellonig et al. (1992).

  • The admitted art supplies a solution of Brij‑35, Nonidet P‑40 and Nonoxynol‑9 in water at 0.066/0.020/0.020 wt % — i.e., claims 1, 2, 3 and 5 minus the composition's freedom from membrane stabilizers, minus the ratio limitation of claim 5, and minus the kit format of claim 4.
  • Motivation to delete the membrane stabilizer. (i) A "membrane stabilizer" (the admitted art's class; the sister patent US 5,556,379 identifies glutaraldehyde and sucrose as stabilizers of the type disclosed in Ser. No. 08/212,698) performs a function directly antagonistic to the invention's stated purpose of lysing and solubilizing bone-marrow cell membranes. A PHOSITA optimizing a membrane-disrupting cleanser has an express reason to omit a membrane-stabilizing excipient. (ii) The specification's own design constraint — "components … should be non‑toxic and/or leave a non‑toxic residual concentration … residual detergents or other components … are not toxic towards human fibroblast cells expected to migrate into the bone graft" — supplies an independent reason to strip additives, particularly a fixative such as glutaraldehyde. (iii) Every third-party bone-cleaning process of record (Cryolife VIP; Osteotech Permein/DMIN; Mellonig's virucidal treatment) operates without a membrane stabilizer, so the stabilizer-free aqueous detergent is the expected form. Under KSR, "the mere elimination of an unnecessary component" whose function is not required is an obvious expedient.
  • Motivation to use these three detergents. Mellonig 1992 and the Cryolife VIP materials teach that a detergent-containing solution both cleans allograft bone (removing marrow, lipids, blood components) and inactivates virus (HIV, HBV). Sharma (1990) and Lavelle (1989) teach that surfactant/soap formulations have in vitro virucidal efficacy against HIV in a blood-containing matrix — i.e., exactly the use environment of Bone Marrow. Helenius & Simons teach that lipid-membrane solubilization requires detergent above the CMC and that different detergents differ in their lipid- vs. protein-solubilization efficacy, which is the classic reason to blend a protein solubilizer with one or more lipid/membrane solubilizers to attack a cell (membrane lipids + bulk protein) comprehensively.
  • Claim 5's 3.3:1:1 ratio is the admitted art's own working ratio; the claims merely recite it as a limitation. In re Aller / In re Peterson.
  • Claim 8's ~1.65:1 ratio likewise follows arithmetically from the admitted-art values 0.066:0.04 (the specification recites "most preferably about 0.04 wt. %" for the combined lipid detergent).

Combination II (attacks generic claims 6–10)

Mellonig et al. (1992) in view of Cryolife VIP documentation and Helenius & Simons, further in view of McCutcheon's Emulsifiers and Detergents.

Claims 6 and 7 require only: an aqueous solution of a protein-solubilizing detergent (0.001–2 wt %) and one or more lipid-solubilizing detergents (0.001–2 wt %) — no named species at all. The combined teachings of Mellonig (detergent/virucidal allograft treatment), the Cryolife VIP surfactant process (surfactant cleaning at elevated temperature) and Helenius & Simons (detergent-based membrane solubilization, CMC as the effective-concentration parameter) describe that genus directly; a 0.001–0.5 wt % working concentration is squarely within conventional dilute-detergent cleaning practice and within the admitted-art values (0.066 %, 0.020 %, 0.020 %). This is at minimum an "obvious to try" situation with a finite, catalogued set of known detergents and a predictable result (KSR).

Claims 9 and 10 — the detergent Markush groups — are the most plainly obvious. McCutcheon's (cited on the very face of the patent, 1985 and 1995 editions) catalogues polyoxyethylene lauryl ethers, GENAPOL X‑080/X‑100, PEG(10) tridecyl ether, SDS/sodium lauryl sulfate, Triton X (polyethylene glycol p‑isooctylphenyl ethers), Tween and Emasol (polyoxyethylene sorbitol esters), IGEPAL and Tergitol NP series. Claims 9 and 10 recite a list of catalog entries as alternate species, which is the paradigm of an obvious Markush in a crowded, predictable art. A PHOSITA seeking an alternative protein solubilizer for Brij‑35, or an alternative membrane solubilizer for NP‑40, would look in McCutcheon's and expect success.

Combination III (alternative primary reference path, incl. the "no membrane stabilizer" hook)

Cryolife VIP / Osteotech Permein materials + Mellonig 1992, in view of the admitted 07/696,955 combination.

Even if one declined to treat the applicant's own 07/696,955 as prior art, the three-detergent solution could be assembled from the third-party art: Brij‑35 and NP‑40 are catalogued electrophoresis/immunoassay detergents and membrane-solubilizers (McCutcheon's; Medicine & Applied Sciences brochure cited on the record), while Nonoxynol‑9's anti-HIV activity is expressly conceded to be known. The remaining step — putting a known protein solubilizer and known membrane solubilizers into the aqueous cleaning bath already used by VIP/Permeิน — is a combination of known elements with predictable results.


6. Claim-by-claim bottom line

Claim Strongest §103 attack Vulnerability
1 Comb. I — admitted 3-detergent solution + obvious deletion of the membrane stabilizer High. Only the negative limitation differs from admitted art.
2 Same; "consisting essentially of" adds no patentable weight unless a third component is provably essential High.
3 Comb. I; closed language narrows the claim but does not create an inventive step Moderate–high. Would need unexpected results.
4 Comb. I + routine kit packaging of a solution for a stated use High. The kit lists no water and no new element.
5 Comb. I — ratio is the admitted art's own value Very high.
6 Comb. II — bare genus of protein + lipid detergent in water Very high (breadth itself is the problem).
7 Comb. II + In re Aller range optimization Very high.
8 Comb. I — ratio follows from 0.066:0.04 High.
9 Comb. II + McCutcheon's catalogue Very high.
10 Comb. II + McCutcheon's catalogue (Triton/Tween/Emasol listed by class) Very high.

Most robustly obvious: claims 5, 6, 7, 9, 10 (and 8). Most attacked but hardest to break: claims 1 and 3, and only if the patentee can show unexpected results for the specific ternary blend at ~0.066/0.02/0.02 wt % in the substantial absence of membrane stabilizers.


7. Rebuttal landscape (what the patentee would argue, and my assessment)

  1. "Synergy" argument. The abstract/specification assert that "well balanced optimized low concentrations of anionic and non-ionic surfactants … act synergistically to lyse, solubilize and keep in solution proteins, lipids, hemopoietic progenitor cells, red blood cells, white blood cells, platelets and histocompatible antigens." This is the strongest available argument because synergy, if comparatively demonstrated, is a recognized basis for nonobviousness of a combination. However: the record contains no comparative data against Cryolife VIP, Osteotech Permein, or any single detergent alone. Figures 1–10 are non-toxicity and CMC determinations internal to ALLOWASH™; Figures 11–14 are before/after photographs of one femur. Synergy is asserted, not shown, and an unsupported assertion of synergy does not rebut a prima facie case.
  2. Non-toxicity at use concentration (FIGS. 1–7). The data show 0.01× AL abolishes fibroblast proliferative potential while 0.001× and 0.0005× do not, and FIG. 3 shows high protein load does not blunt AL's cytotoxicity. This is actually helpful to the obviousness case, because it establishes an expected, monotonic concentration/toxicity relationship and supports the specification's own statement that a 0.01× solution diluted ~90 % to ~0.001× reaches the non-toxic level. That is routine optimization of a known variable, not an unexpected result.
  3. Long-felt need / commercial success. A tissue-bank-wide need for marrow removal and viral-risk reduction is well documented on the face of the patent (MMWR 1988; Buck 1990; Simonds 1992; Bonfiglio 1955; Tomford 1981; Lord 1988; Kakaiya 1991). But the same documents show the need was already being met by Cryolife VIP and Osteotech Permein before the priority date, and there is no evidence of record of unexpected superiority, licensing, or industry copying with nexus. No WBIP-style nexus argument appears sustainable on this record.
  4. Written-description/enablement counterpoint (for the patentee and for the analyst). Because claim 1 recites polyoxyethylene‑23‑lauryl ether while the examples describe Brij‑35 as "polyoxyethylene‑4‑lauryl ether … C₉H₁₉(OCH₂CH₂)₄OH," an examiner or litigant could press either (a) that the claims read on the admitted, catalogued Brij‑35/C₁₂E₂₃ species (strengthening obviousness — the artisan already had it), or (b) that the specification does not describe the claimed C₁₂E₂₃ compound (a §112 issue independent of §103). Under your literal-reading rule I flag both readings rather than resolving the ambiguity in the patentee's favor.

8. Conclusion

Claims 1–10 of US 5,977,034 are, in my assessment, highly vulnerable under 35 U.S.C. §103. The single most potent ground is the specification's own admission that the identical three-detergent system (Brij‑35 + Nonidet P‑40/octylphenol‑ethyleneoxide + Nonoxynol‑9/poly(ethylene glycol)‑p‑nonyl‑phenyl‑ether, at the claimed 0.066/0.020/0.020 wt %) was already disclosed in the applicant's earlier applications — one of them (07/696,955) differing from the claims only by the presence of a membrane stabilizer. Combined with Helenius & Simons (detergent membrane solubilization and CMC-based concentration selection), Mellonig et al. (detergent-mediated HIV inactivation and cleaning of bone allograft), the Cryolife VIP and Osteotech Permein materials (surfactant-based bone cleaning at elevated temperature), Sharma/Lavelle (anti-HIV surfactant formulations), and McCutcheon's detergent compendia (the Markush species of claims 9–10), every element of every claim is taught or suggested, and the artisan had ample motivation — non-toxicity of implantable residue, the antagonism between membrane stabilization and membrane solubilization, and the predictable substitution of catalogued surfactants — to arrive at the claimed compositions.

The claims that would most plausibly survive a well-constructed challenge are claims 1, 2 and 3, and only if the patentee produces genuinely comparative, nexus-supported evidence of unexpected performance for the specific ternary blend at the claimed concentrations in the absence of membrane stabilizers. On the present record, that evidence is not there.

Generated 9/28/2026, 4:22:03 PM

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