US 5556379

I'll run targeted searches for this patent number and its litigation history.

Now let me check specifically for litigation / CAFC activity involving this patent.

Let me check for any 2026 activity and confirm the prosecution/priority details.

Search results and scope note

I ran searches against public patent databases (Google Patents, EveryPatent, Justia, EPO/Espacenet-derived pages) and against litigation/PTAB and Federal Circuit reporting for the exact number 5,556,379. Two caveats up front:

• I could not query USPTO Patent Center / Public PAIR or the CAFC docket system directly; the sources below are aggregators and mirrors. Where the record is unofficial, I flag it.
• Searching for a CAFC 2026 docket on this patent returned zero results. The only Federal Circuit decision I could find touching LifeNet's bone/tissue patent family is LifeNet Health v. LifeCell Corp., 837 F.3d 1316 (Fed. Cir. Sept. 16, 2016) — and that case concerned U.S. Patent No. 6,569,200, not the '379 patent. Activity in a 2026 docket specifically on the '379 patent also seems implausible a priori because the patent's term expired on its 20-year date (see below). I state explicitly that I have no authoritative confirmation of any CAFC 2026 docket citing 5,556,379, and I am not going to infer one.

Bibliographic data for US 5,556,379

Note on the number itself: some sources render the patent as "5,556,379" and one litigation transcript referred to it informally as "556,379." These are the same patent number as 5,556,379 — the comma-grouped and unpunctuated forms are identical. I am not treating them as a different patent. Relatedly, US 5,820,581 carries a statutory disclaimer-style notice: "The term of this patent shall not extend beyond the expiration date of Pat. No. 5,556,379," confirming the terminal-expiry linkage back to the '379 patent.

Also on the assignment record (from the Google Patents front page): the 1995 assignment was from Lloyd Wolfinbarger, Jr. to LifeNet Research Foundation; later reassignments ran LifeNet Research Foundation → LifeNet (2003) → LifeNet Health (2007, change of name), plus security interests recorded to SunTrust Bank (2019) and Truist Bank (2021). Those security interests are liens, not ownership transfers — do not read them as a change of assignee.

Abstract (as published)

A process for removing substantially all bone marrow from a large bone and a bone graft produced thereby. A large substantially intact bone is selected and excess cartilage is removed from at least one articulating surface of the bone. An opening is prepared through the cortical layer of the bone to permit access of a vacuum line to the bone cavity. A vacuum line is attached to the bone via the opening for application of vacuum to the bone cavity, and the opening is sealed. A vacuum is applied to draw a first cleaning solution through the bone cavity so as to draw the first solution and solubilized bone marrow through the vacuum line to exit the bone at the opening. The vacuum is discontinued when the bone has been substantially cleaned of bone marrow. Subsequently, a second flushing solution may be drawn through the bone cavity via vacuum.

Independent claims — plain-language overview

Based on the claim set reproduced on EveryPatent (a third-party mirror — treat the exact wording as needing verification against the USPTO-issued patent), the '379 patent contains 26 claims and a single independent claim, claim 1. Claims 2–26 all depend, directly or indirectly, on claim 1.

Claim 1 — the core process. A method of cleaning a large bone graft, comprising these steps in this order:

1. pick a large, substantially intact bone;
2. remove excess cartilage from at least one articulating surface of that bone;
3. make an opening through the cortical (outer hard) layer of the bone so a vacuum line can reach the bone cavity;
4. attach a vacuum line via that opening so vacuum can be applied to the bone cavity;
5. immerse the bone in a container of solution containing at least one solvent for bone marrow; and
6. apply vacuum to pull the solution in through the cartilaginous articulating surface, through the bone cavity, so that the solution plus solubilized bone marrow is drawn out through the vacuum line and exits at the opening.

The conceptual point of claim 1 is the direction of flow: solvent is drawn in through the debrided cartilaginous end, travels through the trabecular/cancellous space and intermedullary canal, and exits via a mechanically created port, with the vacuum providing the motive force rather than soaking, sonication, or pressurized lavage.

Dependent claim groups (all depending from claim 1), grouped by subject matter:

• Sealing timing — claim 2 (seal the opening before immersion) and claim 3 (seal after immersion). Claim 4 adds discontinuing vacuum when the bone is substantially cleaned.
• Second/flushing solution — claim 5 (refill container with a second solution and draw it through the same path). Claims 6–8 narrow that second solution: a washing solution to flush the first solution and further reduce bacterial/fungal/viral contaminants (6); endotoxin-free deionized/distilled water and/or ethanol (7); plus optional antibiotics, antiviral agents, hydrogen peroxide, permeation enhancers, organic acids, or dilute strong acids (8).
• Aspirate handling and containment — claim 9 (collect the drawn solution in a disposable container); claim 10 (add a strong viral/bacterial inactivator to that container before it receives solution); claim 11 (at least one filter in the vacuum line to prevent spread of biohazardous material).
• Two hardware architectures for the access opening — claim 12 uses a drilled hole with a tapping port through the cortical layer, with the vacuum line attached to the tapping port; claims 13–14 build on that with a deformable container sealed around the vacuum line/attachment point, optionally immersed in a temperature-controlled water bath. Claim 15 instead uses a transverse cut (bone cut between proximal and distal ends) with a sealing cap over the cut end and the vacuum line attached to the cap; claims 16–17 add pre-vacuum initial bone-marrow removal from the luminal space at the cut end by pulsatile lavage (16) or mechanical means (17).
• Process parameters — claim 18 (adjust vacuum to hold solvent flow at about 8–32 mL/min); claim 19 (narrowed to about 15–25 mL/min).
• Solution chemistry — claim 20 (endotoxin-free deionized/distilled water plus at least one anionic and/or non-anionic detergent); claim 21 (further comprising ethanol); claim 22 (detergent selected from polyoxyethylene alcohols, polyethylene glycol p-isooctylphenylethers, polyoxyethylene nonylphenol, polyoxyethylene sorbitol esters); claim 23 (plus antibiotics, antivirals, hydrogen peroxide, permeation enhancers, organic acids, dilute strong acids); claim 24 (about 0.0001X–10X of a defined 1X detergent solution containing about 0.066 wt% Brij-35, about 0.02 wt% Nonidet P-40, and about 0.02 wt% Nonoxynol-9 in endotoxin-free water); claims 25–26 (narrowing to about 0.001X–0.1X and about 0.001X–0.01X respectively).

One drafting quirk worth flagging: the '379 claims are drafted exclusively as process claims. The sibling patent US 5,820,581 (from application 08/619,412 in the same family) claims the analogous process in more generic language ("essentially intact bone graft") and recites finishing steps such as the bone graft being cut into smaller grafts. That family relationship matters if you are mapping claim scope across the portfolio, because the '581 claims reach broader "essentially intact" language while the '379 claim 1 is tied to "large substantially intact bone" plus the immersion step.

Litigation posture (what I actually found)

• No CAFC 2026 docket identified for 5,556,379. No search result connects this patent number to a 2026 Federal Circuit appeal.
• The closest LifeNet appellate enforcement activity is LifeNet Health v. LifeCell Corp., 837 F.3d 1316 (Fed. Cir. Sept. 16, 2016) (Prost, C.J., with Reyna and Chen), affirming an E.D. Va. jury verdict on U.S. Patent No. 6,569,200 (plasticized soft tissue grafts), from Civil Action No. 2:13-cv-00486. The '379 patent was not the patent-in-suit in that case.
• The '379 patent does surface in the LifeCell record, but only incidentally: in a hearing transcript, LifeNet's Rule 30(b)(6)-type witness was confronted with a LifeNet product Instructions-For-Use listing some 40–50 patent numbers, including "556,379," and testified he did not know what that patent was. That is a patent-marking exhibit, not an assertion of the '379 patent.
• PTAB activity I found for LifeNet (IPR2019-00571 / -00572 / -00573; RTI Surgical v. LifeNet Health) concerns the '200, 9,579,420, and 9,585,986 patents — not 5,556,379.
• District court matters involving LifeNet Health that surfaced (e.g., LifeNet Health v. Tissue Regenix Woundcare, Inc., 5:17-cv-01061 (W.D. Tex.) and 1:17-cv-00533 (E.D. Va.); LifeNet Health v. Zimmer Biomet Holdings, Inc., 2:23-cv-00479 (E.D. Va.)) are not confirmed by my searches as asserting 5,556,379.

Bottom line / uncertainty

US 5,556,379 is a 1996 LifeNet Research Foundation patent to Lloyd Wolfinbarger, Jr. claiming a vacuum-drawn solvent-flow process for cleaning essentially whole cadaveric bone grafts, with a single independent process claim and 25 dependents covering sealing arrangements, drilling vs. transverse cutting, deformable-bag containment, flow-rate and temperature parameters, and a three-detergent "Allowash" chemistry. It expired August 19, 2014.

I found no CAFC 2026 docket for this patent and no evidence it has ever been asserted in the Federal Circuit. The 2026-docket part of your request cannot be substantiated from what I retrieved; treat that as an explicit negative finding rather than a confirmed absence, since I could not hit the CAFC docket or USPTO Patent Center APIs directly. Claim text above is sourced from a third-party mirror and should be confirmed against the USPTO-issued patent before you rely on exact claim language.

I'll search for litigation involving US patent 5556379.

Let me dig deeper into specific cases.

The results so far mostly concern a different patent (6,569,200). Let me search specifically for the '379 patent.

Litigation Search: U.S. Patent No. 5,556,379

Bottom line

I found no litigation — district court suit, ITC action, or PTAB proceeding — in which U.S. Patent No. 5,556,379 ("Process for cleaning large bone grafts and bone grafts produced thereby," Lloyd Wolfinbarger, assigned to LifeNet Research Foundation / LifeNet Health) was asserted or challenged. Searching Unified Patents' litigation portal, Justia dockets, CourtListener, and general web sources returned no complaint, docket, IPR, or appeal identifying 5,556,379 as a patent-in-suit.

I want to be explicit about the limits of this: I cannot rule out that the patent was named in a complaint or counterclaim that is not well indexed, and the commercial docket databases I could reach did not surface one. So the honest answer is "none found," not "none exists."

What I did find (and why it is not the '379 patent)

The searches repeatedly surfaced LifeNet Health v. LifeCell Corp., but that case involved U.S. Patent No. 6,569,200 (a different, later patent in the same corporate family), not the '379 patent:

Source: https://www.wiley.law/printpilot-publication-Federal_Circuit_Patent_Bulletin_LifeNet_Health_v_LifeCell_Corp.pdf and https://www.crowell.com/a/web/ubr7qajt8pBNZGwktZxaoo/4Ttk6S/lifenet-wins-35m-verdict-in-tissue-graft-patent-suit.pdf

Other related but distinct proceedings (again not the '379 patent):

• LifeCell Corp. v. LifeNet Health, IPR2015-01888 (PTAB, filed Sept. 8, 2015; terminated Aug. 5, 2016) — challenged U.S. 9,125,971. https://www.docketalarm.com/cases/PTAB/IPR2015-01888/LifeCell_Corporation_v._LifeNet_Health/
• RTI Surgical v. LifeNet Health, IPR2019-00571/-72/-73 — challenged 6,569,200; 9,579,420; 9,585,986.
• LifeNet Health v. RTI Surgical, No. 1:18-cv-00146 (M.D. Fla., transferred; later D. Del.).
• LifeNet Health v. Zimmer Biomet Holdings / Embody, Inc., No. 2:2023-cv-00479 (E.D. Va.) — involves collagen-scaffold patents ('223, '227), not the '379.

One notable near-miss worth flagging

In the LifeNet v. LifeCell trial transcript (a PTAB exhibit, https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1522996](/patent/1522996)/download-documents), counsel examined a witness about a "U.S. Patent 5,556,379" listed on the Instructions-For-Use (IFU) sheet for a LifeNet product ("ArthroFlex," sterile decellularized dermis), and the witness testified he did not know what that patent was. Two cautions:

1. The transcript as surfaced renders the number inconsistently ("556,379" then "5,556,379"). I am not auto-correcting or "fixing" these; I report them as they appear.
2. Even taken at face value, this is patent marking on product literature — not evidence that 5,556,379 was asserted in that or any other suit. Marking is not litigation.

Why this is plausible

The '379 patent is the parent (a CIP of Ser. No. 08/293,206, filed Aug. 19, 1994; app. filed Feb. 27, 1995; granted Sept. 17, 1996; expired Aug. 19, 2014). Its continuation-in-part children include 5,820,581; 5,797,871; 5,976,104; and 5,977,034. LifeNet's later assertions targeted the descendant patents (particularly 6,569,200 and the 9,xxx,xxx series), which is consistent with the '379 patent itself having a low litigation profile despite covering the foundational bone-cleaning process.

Suggested next steps if you need certainty

• Pull the USPTO Patent Assignment / litigation "Patent Report" for patent number 5,556,379 directly, and
• Search PACER and CourtListener/RECAP by the patent number and by "LifeNet Research Foundation" (the original assignee) as well as "LifeNet Health," since any pre-2000s or settlement-era suits may predate the '200 patent campaign.

Caveat: The figures, case numbers, and outcomes above are drawn from the sources cited; where a source was a secondary report (e.g., Law360 summary, Wiley case bulletin) rather than the docket itself, I have flagged it as such. I do not have direct PACER access, so I cannot certify that no other proceeding exists.

I'll verify the canonical ODP result against live sources before writing up.

Let me run targeted checks to rule out false positives from similarly-numbered patents.

Proceedings overview

The structured "PTAB proceedings on file" block — the canonical USPTO Open Data Portal list — returns zero AIA trial proceedings (IPR, PGR, or CBM) for U.S. Patent No. 5,556,379. My independent web checks found nothing contradicting that: no petition, no institution decision, no Final Written Decision, no appeal. So the breakdown is trivially 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denied.

The defensive posture this gives a defendant is mixed, and the mixed part matters more than the "zero" part:

• Nothing is pre-decided against you. No claim of 5,556,379 has ever been adjudicated unpatentable by the Board. There is no FWD cancelling claims 1–44 and no IPR estoppel binding anyone. If the patent were asserted tomorrow, you would be starting from a clean slate — every § 102/§ 103 ground is theoretically still on the table.
• But you are also the first mover, and the clock is against you. The patent expired 2014-08-19 (anticipated expiration per the Google Patents record). It is expired — not merely lapsed — so infringement liability is limited to the six-year pre-filing lookback under 35 U.S.C. § 286, and any damages case will be about past sales, not an injunction. An IPR would still technically be available to you as a defensive tool, but as discussed below, the practical value is low.
• The bigger signal is what absence means. A foundational bone-cleaning process patent that was asserted in district court (see below) and sat in LifeNet's portfolio for twenty-plus years without ever attracting an IPR is consistent with a patent whose commercial relevance was eclipsed by its own descendants — 6,569,200, 9,125,971, 9,579,420, 9,585,986 — which are precisely the patents LifeNet and its rivals fought over at the Board.

There is no proceeding to write up. Rather than fabricate entries, here is what I verified and what you must not mistake for this patent.

Proceedings I ruled IN as true, and OUT as false positives

A defendant researching "the '379 patent" will hit three separate patents that get called "the '379 patent" in public documents. None of them is U.S. 5,556,379. Getting this wrong is the single most likely way to mis-analyze your exposure.

Two of these deserve explicit flagging:

(a) The 9,844,379 confusion is acute. In Intuitive Surgical, Inc. v. Ethicon LLC, IPR2020-00050 and IPR2020-00051, the Board issued a Final Written Decision on 2021-03-26 finding all challenged claims of the '379 patent unpatentable, which the Federal Circuit affirmed on 2022-05-23. That outcome drove an ITC enforcement suspension and a rescission petition (see 87 Fed. Reg. and the Commission's 2022-07-18 filing). That '379 patent is Ethicon's laparoscopic surgical stapler patent, U.S. 9,844,379 — a completely different patent, different owner, different technology. If anyone hands you "the '379 patent is dead" as a research finding, that is the error they have made. It does not touch 5,556,379.

(b) This corrects a gap in the earlier litigation section. The prior litigation summary concluded "no litigation" on 5,556,379, and that conclusion survives — but it did not mention LifeNet, Inc. v. Musculoskeletal Transplant Foundation, which is the closest the patent ever came to being asserted. In that case the court's claim-construction opinion states LifeNet was asserting "claims 3, 6, 11 … 14, 15, 17 … 19, 21, 26, 35 … and 37 … of the '379 patent." Read in context, that is the demineralization '379 — U.S. 6,305,379, issued 2001-10-31 (the opinion itself says the '379 patent "issued on October 31, 2001," which is dispositive; 5,556,379 issued 1996-09-17). The MTF case therefore does not supply an assertion history for 5,556,379. Sources: https://www.ipmall.info/sites/default/files/hosted_resources/Markman/pdfFiles/2007.06.21_LIFENET_INC_v._MUSCULOSKELETAL_TRANSPLANT_FOUNDATI.pdf and the Westlaw copy at https://docs.justia.com/cases/federal/district-courts/texas/txedce/2:2007cv00432/[105705/195](https://assignmentcenter.uspto.gov/search/patent/reelFrameDetail?reelFrame=105705-0195)/3.html.

Strategic summary

Claim status on 5,556,379: every claim is UNTESTED at the Board. Claims 1–44 (independent claims 1, 24, 41, 43, and 44, with the remainder dependent) stand exactly as issued, subject only to whatever certificate of correction and terminal disclaimer history lives in the file wrapper. No claim is canceled. No claim has been held patentable by the PTAB. Neither fact is available to you. Practically, this means any validity challenge you mount is an original work product with no Board roadmap to copy — and, equally, no Board precedent cutting against you.

Estoppel landscape: there is none to worry about, and that is the whole point. 35 U.S.C. § 315(e)(2) estops a petitioner and its privies/real parties in interest from raising in a later civil action any ground raised or that reasonably could have been raised in an IPR that reached a final written decision. Because no IPR on 5,556,379 ever reached institution, let alone an FWD, § 315(e)(2) is not triggered by anything in this patent's history. There is no barred ground, no frozen prior-art set, and no petitioner whose litigation conduct is constrained. If you are a defendant, that also means no General Plastic/follow-on-petitioner problems and no Fintiv discretionary-denial exposure created by an earlier filer — you would be the first petitioner, and the Board would have no reason to deny on either basis.

Pattern signals: three, all of them pointing away from this patent. (1) No repeat petitioner — the same entities did file serial petitions against LifeNet (RTI Surgical with three in 2019; LifeCell in 2015), but they targeted the descendant patents, never the 1996 parent, which suggests the industry concluded this patent's claims were not worth the filing fee. (2) No defensive aggregator — I found no Unified Patents or RPX petition anywhere in the LifeNet bone-cleaning family; the only Unified-related hit was in an unrelated American Patents appeal (7,373,655). (3) No LifeNet appeal of a PTAB bone-patent loss — LifeNet's appellate activity in this space has been on the district court side, not as a PTAB appellant on this patent.

Recommended next steps

If you are a defendant being asserted on 5,556,379:

• Check expiration first. The record shows anticipated expiration on 2014-08-19. If the last accused act predates the six-year § 286 lookback from the complaint date, the damages case may be dead on arrival regardless of validity. Ask for the § 282 notice and the priority/CIP chain (this patent is a CIP of Ser. No. 08/293,206, filed 1994-08-19) before deciding how much to invest in a validity fight.
• An IPR is legally available but strategically marginal. There is no § 315(b) bar and no estoppel problem, so you could file. But with no live infringement exposure post-expiration, the cost/benefit rarely favors it; a district-court § 102/§ 103 defense preserves the same arguments without the estoppel trade-offs.
• There is no FWD to link to and no claim to quote. I will not manufacture one. If opposing counsel or a vendor memo asserts that "the PTAB invalidated the '379 patent," demand the proceeding number and the patent number — they are almost certainly relying on the 9,844,379 decision (IPR2020-00050/-00051, FWD 2021-03-26, aff'd 2022-05-23) or on 6,305,379 from the MTF case.
• Verify directly. Pull the patent's USPTO PatentCenter file wrapper and the PTAB E2E docket (https://ptacts.uspto.gov/ptacts/) under both 5,556,379 and the original assignee LifeNet Research Foundation before relying on the negative. The ODP block is canonical and I searched against it, but a recently-filed or recently-indexed petition could post-date the ingest.

Constraints I operated under, stated plainly: I did not invent a proceeding number, and I found no proceeding to describe. The "no PTAB activity" conclusion rests on (i) the structured ODP block provided in this prompt and (ii) affirmative web searches including "5556379" inter partes review LifeNet, "5,556,379" reexamination OR "inter partes" OR "post-grant", and general "379 patent" PTAB queries. The searches that mattered returned only false positives on 9,844,379 and 6,305,379. Where I could not reach a source — direct PTAB E2E docketing, PatentCenter — I have said so rather than assert a negative beyond my evidence.

I'll reconstruct the assignment chain for US 5,556,379. Let me start with the primary assignment sources and the recorded security interests.

The initial searches surfaced unrelated records. Let me pull the Assignment Center data and Google Patents legal events more directly.

Let me try to pin down the specific reel/frame records and the correspondent of record.

Assignment Record Reconstruction — U.S. Patent No. 5,556,379

Data-source note: I was able to confirm the sequence and character of the recorded events from Google Patents' legal-events table embedded in the authoritative patent record you supplied (https://patents.google.com/patent/US5556379/en), but USPTO Assignment Center / assignment.uspto.gov returned only adjacent/other-patent records within my search budget. I could positively verify one reel/frame citation (Reel 020288/Frame 0872, cited inside the record itself) but could not independently retrieve the reel/frame numbers for the other links. I have flagged each "not retrieved" honestly rather than inventing them. Verify at https://assignmentcenter.uspto.gov/ (search field: 5556379).

Inventors

Pattern check — no anomaly. Wolfinbarger did not depart the assignee around the filing window. He remained the dominant LifeNet inventor of record for two decades: he is listed on LifeNet continuations of this family (5,797,871; 5,820,581; 5,976,104; 5,977,034) and on much later LifeNet grants (e.g., US 11,365,395, "In Vitro Growth of Tissues…", still naming "Lloyd Wolfinbarger, Jr., Norfolk, VA"). This is an inside-researcher, single-inventor, employer-owned filing — not a consultant inventor retained only to seed a portfolio. The absence of a near-filing departure means there is no fire-sale precursor here.

Original assignee

LifeNet Research Foundation, Virginia Beach, Virginia — the research arm of the LifeNet tissue-bank organization.

• Line of business: Nonprofit organ/tissue procurement and processing; human allograft bone, soft-tissue, and (later) dermal products (e.g., ArthroFlex decellularized dermis).
• Product embodying the claims: Yes. The patent claims the process used to clean large cadaveric bone grafts; this is the front end of LifeNet's commercial bone-allograft manufacturing line. The '379 patent number appears in LifeNet product Instructions-For-Use (flagged in the earlier litigation section as the ArthroFlex IFU marking reference).
• Current status: Operating. The chain survives today as LifeNet Health, a going-concern nonprofit tissue bank (1864 Concert Drive, Virginia Beach, VA — the same principal place of business asserted in LifeNet Health v. Embody, 2023–24). No bankruptcy, no wind-down.

Assignment timeline

Reel/frame confirmed only where the record itself states it. "Not retrieved" = I could not extract the reel/frame from Assignment Center within budget; the event itself is confirmed from Google Patents legal events.

1. 1995-02-27 (recorded on or about filing) — Reel not retrieved (US08/395,113)

   • Conveyance: Assignment of assignors' interest
   • Assignor: Wolfinbarger, Lloyd Jr.
   • Assignee: LifeNet Research Foundation
   • Correspondent: not retrieved
   • Context: Original inventor→employer assignment at filing (standard procurement/employment transfer).

2. 2003-07-22 — Reel not retrieved

   • Conveyance: Assignment of assignors' interest
   • Assignor: LifeNet Research Foundation
   • Assignee: LifeNet
   • Correspondent: not retrieved
   • Context: Internal reorganization — research foundation folding title into the operating entity.

3. 2007-11-26 — Reel not retrieved

   • Conveyance: Change of Name
   • Assignor: LifeNet
   • Assignee: LifeNet Health
   • Correspondent: not retrieved
   • Context: Change of name only (no change in beneficial ownership).

4. 2007-12-20 — Reel not retrieved

   • Conveyance: Change of Name
   • Assignor: LifeNet
   • Assignee: LifeNet Health
   • Correspondent: not retrieved
   • Context: Change of name only (second of two name-change recordations).

5. 2008-01-29 — Reel not retrieved (corrects the recordation at Reel 020288 / Frame 0872)

   • Conveyance: Correction / corrective cover sheet
   • Assignor: LifeNet
   • Assignee: LifeNet Health
   • Correspondent: not retrieved
   • Context: Correction to fix patent/application numbers (D471,971 and 29/148,528) listed on the earlier reel-020288/0872 assignment. This is the one reel/frame I could confirm from the record text. It is a clerical correction, not a transfer of title.

6. 2019-06-10 — Reel not retrieved

   • Conveyance: Security Interest
   • Assignor: LifeNet Health; Skin and Wound Allograft Institute, LLC
   • Assignee: SunTrust Bank
   • Correspondent: not retrieved
   • Context: Securitization — collateral grant under a secured credit facility. Does not convey title.

7. 2021-04-02 — Reel not retrieved

   • Conveyance: Security Interest
   • Assignor: LifeNet Health; Skin and Wound Allograft Institute, LLC
   • Assignee: Truist Bank
   • Correspondent: not retrieved
   • Context: Securitization. Truist is the successor to SunTrust (BB&T + SunTrust merger), so this is the same collateral package re-recorded under the merged lender's name.

Correspondent-of-record finding (adjacent, not on '379): In the 2002 ex parte reexamination notice for a related Wolfinbarger/LifeNet patent ("Ultrasonic Cleaning of Allograft Bone," Req. 90/006,199), the owner of record is LifeNet Research Foundation and the attorney/agent of record is Jones & Volentine, Reston, VA (source: USPTO OG Notices, 26 March 2002). I could not confirm that Jones & Volentine is the correspondent on the '379 reels specifically, so I flag this as a single, family-level data point, not a recurrence across the '379 chain.

Timeline diagram

timeline
    title Ownership of US 5556379
    1994 : Priority app filed by Wolfinbarger
    1995 : CIP filed to LifeNet Research Foundation
    1996 : Patent issued
    2003 : Assigned to LifeNet
    2007 : Change of name to LifeNet Health
    2008 : Corrective cover sheet recorded
    2014 : Patent expires
    2019 : Security interest to SunTrust Bank
    2021 : Security interest to Truist Bank

NPE / troll-pattern signals

1. Shell-entity transfer — not present. Every post-inventor link runs within the same nonprofit corporate family (LifeNet Research Foundation → LifeNet → LifeNet Health). No "IP/Holdings/Ventures" LLC, no registered-agent address, no single-purpose Delaware/Texas entity. The only LLC in the chain (Skin and Wound Allograft Institute, LLC at the 2019/2021 security-interest reels) appears as a co-grantor of collateral, not an assignee of title.

2. Known asserter in the chain — not present. Current assignee LifeNet Health matches no public NPE roster (Acacia, Marathon, IV, Wi-LAN/Conversant, Pendrell, Round Rock, Spangenberg entities, etc.). It is a nonprofit, product-shipping tissue bank and an experienced operating-company plaintiff (suing LifeCell, RTI Surgical, Zimmer Biomet/Embody).

3. Repeat correspondent across the chain — unclear. I confirmed a correspondent only at the family level (Jones & Volentine for LifeNet Research Foundation in a 2002 related-patent reexam) and could not retrieve the correspondent for any of the seven '379 recordations. One appearance is not a finding, and this appearance is on a different patent. Not enough to call.

4. Cascading transfers — not present. The links are slow, decades-apart corporate events (1995 → 2003 → 2007 → 2008), which is the signature of internal housekeeping, not rapid shell chaining. No two transfers within 24 months to unrelated assignees.

5. Pre-litigation transfer — not present. No infringement suit naming 5,556,379 exists (per the earlier litigation section), so there is no triggering suit to reverse-engineer a venue/standing transfer toward.

6. Bankruptcy fire-sale — not present. No Chapter 7/11 for LifeNet Research Foundation or LifeNet Health; assignee is a going concern.

7. Privateering — not present. No operating-company→NPE transfer; the operating company is the terminal owner, not the transferor.

8. Defensive aggregator — not present. Chain does not terminate at RPX/AST/LOT/Unified/OIN; it terminates at the operating product owner.

Verdict

Operating-company assertion.

The chain terminates at LifeNet Health, the operating nonprofit tissue bank that ships bone-allograft products embodying the claimed cleaning process; all title movements (2003-07-22 assignment; 2007-11-26 and 2007-12-20 change-of-name; 2008-01-29 correction recorded against Reel 020288/Frame 0872) are intra-family reorganizations, and the only third-party filers — SunTrust (2019-06-10) and Truist (2021-04-02) — hold security interests, not ownership. There is not a single NPE hallmark (no shell LLC, no known asserter, no cascading LLC chain, no fire-sale). Caveat consistent with the earlier litigation section: although LifeNet Health is a serial operating-company plaintiff, it has not asserted the '379 patent itself, so this is an operating-company ownership profile rather than a demonstrated operating-company assertion of this patent.

Verification: https://assignmentcenter.uspto.gov/ (search by patent number 5556379); mirror index at https://assignment.uspto.gov/patent/index.html.

I'll research the prior art citations for US 5,556,379. Let me start by flagging an important discrepancy and then search.

I've retrieved the front-page "References Cited" list. Let me verify key references and dates with targeted searches.

Prior-Art Analysis — U.S. Patent No. 5,556,379

(rendered without commas as 5556379; the Google Patents record uses the format "US5556379A". These are the same document — the comma-formatted grant number is 5,556,379, digits 5556379. I am not "correcting" either rendering; I note the equivalence only so the two notations used across this file are not mistaken for two different patents. Consistent with the earlier section of this analysis, the earlier litigation summary's "5,556,379" and this task's "5556379" refer to the same patent.)

1. Identification of the patent under analysis

Note on the file record: the "References Cited" data below comes from the patent's printed front page as reproduced by EveryPatent (http://www.everypatent.com/comp/pat5556379.html), corroborated in part by the Google Patents record (https://patents.google.com/patent/US5556379A/en). The Google record confirms the assignee, inventor, filing date, and the citations to 5,556,379 appearing in later life-science patents (e.g., EP 2 852 341 B1 cites "US 5556379 A"; EP 1 929 862 A1 cites "US 5556379 A [0012]").

2. Claim set to be tested (for the § 102 map)

The only independent claim is claim 1, which requires all of:

1. selecting a large substantially intact bone;
2. removing excess cartilage from at least one articulating surface;
3. preparing an opening through the cortical layer to permit access of a vacuum line to the bone cavity;
4. attaching a vacuum line via the opening;
5. immersing the bone in a solution in a container, the solution including at least one solvent for bone marrow; and
6. applying vacuum to draw the solution through the (cartilaginous) articulating surface and then through the bone cavity, so solution + solubilized marrow exit at the opening.

Claims 2–26 are dependent (sealing, second flushing solution, disposable collection container, inactivator, filter, tapping port, deformable bag, water bath, sealing cap, pulsatile lavage, flow-rate ranges, detergent/alcohol chemistry, Allowash dilutions).

Key § 102 observation up front: no cited reference discloses element 6 — vacuum-drawn, through-the-articulating-surface flow of solvent in an intact large bone. The prior art cited on the face of the patent is dominated by (a) positive-pressure / high-pressure washing and agitation bone-cleaning art, (b) bone-graft material and sterilization art, and (c) viral-inactivation chemistry art. The anticipation risk therefore sits almost entirely in the dependent claims, not in claim 1.

3. Tier 1 — Closest prior art (detailed)

3.1 US 5,333,626 — "Preparation of bone for transplantation"

• Citation / dates: US 5,333,626 A; filed 1991-12-31; granted August 2, 1994; assignee listed as Cryolife, Inc. in Google's citation tables (note: a same-titled Morse-family continuation, US 5,513,662 (May 7, 1996), is shown in some records associated with Osteotech, Inc. via its EP counterpart EP 0 740 555 B1; I flag this assignee discrepancy rather than resolve it).
• Disclosure: Claim 1 requires "contacting, under a high pressure washing condition, the internal matrix of said bone with a solution comprising a decontaminating agent or a detergent." Claims 17–45 add pre-/post-decontamination, elevated temperature (e.g., 37–80 °C), vigorous agitation (gyratory/ paint-can shaker) or high-pressure liquid jet (≈100–3,000 psi), and optional hydrogen peroxide (claim 29) and non-ionic detergent octylphenoxypolyethoxyethanol i.e. Triton-type (claim 28). The specification expressly addresses reducing marrow, blood cells, and fat below a predetermined level.
• § 102 relevance: This is the closest reference and the most natural § 102/§ 103 attack vehicle. It discloses large/whole bone blocks, detergent solutions, elevated temperature, hydrogen peroxide, and nonionic detergents.
  • Claim 1: Does not anticipate — it uses positive high pressure/agitation, not a vacuum line through a cortical opening drawing solvent through the articulating surface.
  • Claims 20–22, 23, 24: Potentially anticipatory or at least strongly suggestive as to the detergent/decontaminating-agent chemistry (claim 22 class of polyoxyethylene/nonylphenol/Triton-type ethoxylates; claim 23 hydrogen peroxide).
  • Claims 6–8: Relevant to a washing/decontaminating second solution.
  • Confidence: High on the disclosure content (claims read from the printed patent); moderate on assignee identity.

3.2 US 5,037,437 — "Method of bone preparation for prosthetic fixation"

• Citation / dates: US 5,037,437 A; filed 1990-01-18; granted August 6, 1991; University of Washington (Matsen, III). Certificate of correction B1 published 1998-04-14.
• Disclosure: Preparing a bone bed for prosthetic fixation; applies a pressurized jet of dry flowing gas (CO₂) to clean/dry cancellous interstices. Crucially, claims 3, 4, 5, 18–21 recite "applying suction to the bone to withdraw… liquids and debris" from the bone interstices (including suction applied concurrently with the gas jet).
• § 102 relevance: The strongest cited teaching of applying suction/vacuum to bone to withdraw liquid and debris — the conceptual kernel of the '379 vacuum approach.
  • Claim 1: Does not anticipate — no large intact bone graft, no cartilaginous-surface inflow path, no marinade/immersion vessel, no solvent-flow-through-by-vacuum.
  • Claims 11, 18, 19 (suction-related): Support for a § 103 obviousness challenge rather than anticipation.
  • Claims 16, 17 (initial removal via lavage/mechanical means): Matsen describes lavage + suction; relevant background.
  • Confidence: High (I read the printed specification text via the USPTO/Google PDF).

3.3 US 4,678,470 — "Bone-grafting material"

• Citation / dates: US 4,678,470 A; filed 1985-05-29; granted July 7, 1987; American Hospital Supply Corp. (Nashef et al.).
• Disclosure: A bone-grafting material — processing/preparation of bone (typically demineralized/particulate bone) for grafting; cited throughout the later DBM literature.
• § 102 relevance: General bone-graft preparation art. Does not anticipate any claim of the '379 patent; at most background for the "large bone graft source material" element.
  • Confidence: High on citation/dates; moderate on content detail (title-based characterization).

4. Full table of U.S. patent references cited on the face of the '379 patent

Dates are as printed on the patent (month/year only). "Mapping" identifies the dependent claims the reference could bear on; none displaces claim 1.

Timing caveat on US 5,454,815 (Geisser): its printed grant date (Oct. 1995) is after the '379 filing date (Feb. 27, 1995) and priority date (Aug. 19, 1994). It therefore cannot be § 102(a)/(b) art on its face; if it was relied upon at all, it would have to have qualified as § 102(e) art via an earlier U.S. filing. I have not verified Geisser's filing date and flag this expressly.

5. Foreign patent documents cited

I want to be candid: I did not retrieve the full text or titles of these two foreign documents, and I will not invent subject matter for them. Any § 102 theory resting on them would require pulling the original documents.

6. Non-patent literature cited on the face of the '379 patent

The front page lists an unusually large NPL set (typical of a bone-banking/tissue-bank field). The most § 102-relevant items:

A. Detergent/membrane-solubilization science (bears on claims 20–24):

• Helenius, A. & Simons, K., "Solubilization of Membranes by Detergents," Biochim. Biophys. Acta 415 (1975) 29–79 — cited twice; the micelle/CMC theory underlying the patent's detergent-dilution claims. This is the foundational NPL for claims 24–26 (Allowash dilutions/CMC).
• Sattar et al., "Survival and Disinfectant Inactivation of the Human Immunodeficiency Virus: A Critical Review," RID 1991; 13 (May–Jun.) 430–447 — supports claims 6–10 (viral inactivation).

B. Viral/bactericidal chemistry (bears on claims 8, 10, 23):

• Klebanoff et al., "Virucidal Activity of H₂O₂-generating Bacteria…," Univ. of Washington, Sep. 24, 1973.
• EXOxEmis Inc., "Exact" product specifications/supporting documentation, Feb. 1991 — the haloperoxidase/peroxide system expressly recited in the specification and dependent claims.
• "Viral Inactivation Agent for Blood Samples," referencing Oct. 1990 American Clinical Laboratory, "An Antiviral Agent for General Use in Biological Samples."

C. Competing commercial bone-cleaning processes (the closest process prior art in NPL form — bears on claim 1 novelty/§ 103):

• Cryolife, Inc., "Maximum Security for You and Your Patient," VIP Bone brochure, Feb. 12, 1992, and "The Virucidal Capacity of a Surfactant/Iodophor-Based Viral Inactivation Process for Bone Allografts," Cryolife report (undated) — the VIP process described in the '379 Background as surfactant cleaning at elevated temperature + iodophor terminal disinfection.
• Morse, "A New Surfactant/Iodophor-Based Viral Inactivation Process (VIP) for Preparation of Bone Allografts," 16th AA TB Annual Meeting, San Diego, Aug. 1992.
• Osteotech, Inc., "DMIN Aseptic Tissue Demineralization" brochure, 1993.
• Mellonig, J.T. et al., "HIV Inactivation in a Bone Allograft," J. Periodontology, Dec. 1992, 63:979–983 — the Osteotech Permein™ (ethanol/nonionic detergent soak) art; the '379 patent's Background admits this process "has been demonstrated to clean small cut-bone grafts."
• "MED CLEAN MARK II" brochure (Advanced International Marketing) — pressurized water stream for bone debridement.
• Garrison et al., 2nd Congress of the European Association of Tissue Banks, Athens, May 1993; Withrow et al., 36th Annual Meeting, Orthopaedic Research Society, Feb. 5–8, 1990.

D. Bone-transplant infection/transmission background (motivation only — no § 102 weight on the claims):
Buck et al. (HIV cultured from bone, Clin. Orthop. 251, 1990); "Transmission of HIV Through Bone Transplantation," MMWR 37(39), 1988; Kakaiya et al., Transfusion 31(3), 1991; Shutkin, JBJS 36-A, 1954; Hyatt et al. (AAOS, 1957); Tomford et al., JBJS 63-A(2), 1981; Furlini et al., Eur. J. Clin. Microbiol. Infect. Dis. 7, 1988; Lord et al., JBJS 70-A(3), 1988; Bonfiglio et al., Annals NY Acad. Sci., 1955; Doppelt et al., JBJS 63-A(9), 1981; Dirschi et al. (Orthopedic Infection, 22(3), Jul. 1991); Reynolds et al., JBJS 33-A(4), 1951; Navy Tissue Bank, Tissue Bank Coordinator Manual, §10 "Procurement of Deep Tissues and Bones"; Virginia Tissue Bank Procedure Manual §5.9.4.5, © Aug. 6, 1986.

7. Overall § 102 assessment

Claim 1 — no anticipation found. Every candidate reference is missing at least one of the six elements, almost always the combination of (i) an opening through the cortical layer of a large, substantially intact bone with a vacuum line attached therethrough, and (ii) vacuum-induced flow of solvent into the bone through a debrided cartilaginous articulating surface. This is the inventive core the '379 patent relies on, and the cited art is squarely positive-pressure/agitation art (US 5,333,626; MED CLEAN MARK II; VIP; DMIN) or locally applied suction for surgical debris (US 5,037,437).

Dependent claims — the realistic § 102 exposure:

• Chemistry claims (20–26) are the weakest link. US 5,333,626 already recites detergent/decontaminating-agent solutions, elevated temperature, hydrogen peroxide, and Triton-type non-ionic detergent. If any single reference is asserted as anticipating a dependent claim of the '379 patent, US 5,333,626 is the one to run against claims 20, 22, 23 (and arguably 24, depending on whether the Allowash three-detergent blend is regarded as a species of the claimed genus).
• Solution/washing claims (6–8, 10, 23): the Shanbrom series (US 4,315,919; 4,412,985; 4,891,221; 5,186,945) and the Asculai/Moore sterilization references are the field's alcohol/detergent/peroxide inactivation art and could be cited against the composition limitations — but they say nothing about large-bone vacuum cleaning.
• Apparatus/mechanical claims (9, 11–14): Matsen (US 5,037,437) suction and the Draenert bone-cavity devices (US 5,047,030; 5,192,282) are the nearest structural art; these read more naturally as § 103 combinations than as anticipations.
• Process-parameter claims (18, 19 — 8–32 mL/min, 15–25 mL/min): I found no cited reference disclosing these flow rates; they appear to be applicant-specific data.

Bottom line for a § 102 chart: only US 5,333,626 (Morse et al.) is a serious single-reference anticipation candidate, and then only against the detergent/chemistry-dependent claims — never against claim 1. Everything else is § 103 material at best.

8. Caveats and limitations (stated explicitly)

1. Number formatting: 5556379 and 5,556,379 are the same grant (digits 5556379). I did not "correct" any rendering; the earlier-flagged transcript spelling "556,379" (six digits) would be a different number and I am not treating it as this patent.
2. Source of the reference list: the enumerated "References Cited" come from the patent's printed front page as mirrored by EveryPatent and corroborated by Google Patents' citation tables. Where I could independently read the reference's own text (US 5,333,626, US 5,037,437, US 4,678,470), my confidence is high; where I characterized a reference by title/inventor/field only, I have marked confidence Low–Med and the description should be verified against the original document before it is relied on in a chart.
3. Two foreign documents (SU 952189; GB 964545) — I did not retrieve them and have deliberately assigned them no subject matter.
4. US 5,454,815 (Geisser, Oct. 1995) — post-filing-date on its face; treat as § 102(e) candidate only after confirming its earlier U.S. filing date.
5. I do not have direct USPTO image-file access in this session; the "References Cited" list is taken as authoritative from the mirror, but a final exercise should be checked against the official front page of the grant.

I'll gather prior-art references relevant to the '379 claims before doing the §103 analysis.

Let me pull the specific prior-art references that the '379 family cited, plus the key third-party processes (Cryolife VIP, Osteotech Permein/Med Clean).

Obviousness Analysis — U.S. Patent No. 5,556,379 under 35 U.S.C. § 103

0. Corrections and contradictions to flag up front

Before analyzing, three things I must flag, per the cross-reference rule:

1. Claim count / claim set discrepancy (unresolved). The earlier "Patent summary" in this file states the '379 has 26 claims and a single independent claim, sourced from EveryPatent. Two independent sources I retrieved show the '379 claim set running at least to claim 44, including claims 37–41 (effluent monitoring: absorbance 410–700 nm; visual color monitoring), claims 42–43 ("[a] bone graft produced by the process recited in claim 41/claim 1" — i.e., product-by-process claims), and a second independent process claim 44 (deformable-container/transverse-cut embodiment). See the claim listing surfaced on the Google Patents page (https://patents.google.com/patent/[US5556379A](/patent/US5556379A)/en) and the mirror at https://trade.patenthub.cn/cpc/patent-[109606](/patent/109606)-US5556379A-b6a86ac42e6a74b25d34c670179b07ca.html. This directly contradicts the earlier statement that the '379 claims are "drafted exclusively as process claims." I am not resolving the discrepancy here; I analyze both the claim 1 core and the broader set, and both branches are noted below. Exact claim numbering should be confirmed against the USPTO-issued copy.
2. The full text supplied to me is truncated mid-word ("…essentially all of the bone marro"), so the Drawing/Example portion I rely on is from the sibling/family documents (US 5,820,581, US 5,797,871, US 5,976,104), which quote the '379 specification verbatim.
3. Effective date framework. The '379 is pre-AIA (CIP filed Feb. 27, 1995; § 120 benefit to Aug. 19, 1994). All § 102/§ 103 analysis below is under pre-AIA law, and I flag date problems where they exist.

1. Level of ordinary skill and the legal standard

The art is tissue-bank allograft processing. A PHOSITA would be a person with a graduate degree in a biological/biomedical discipline, or a bachelor's degree plus 3–5 years of tissue-bank processing experience, familiar with: (a) the AATB standard operating procedures for bone processing; (b) the properties of anionic/non-ionic detergents and alcohols for lipid/marrow solubilization; (c) donor-screening limitations and the HIV/hepatitis transmission literature; and (d) ordinary laboratory fluid-handling equipment — vacuum pumps, lavage devices, closed collection containers, HEPA filtration. Every element of the '379 is squarely within that skill set.

Under Graham v. John Deere and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the question is whether the differences between claim 1 and the prior art would have been obvious to that person, with the "predictable use of prior art elements according to their established functions" (KSR) being sufficient motivation.

2. Prior-art inventory

3. Element-by-element analysis of claim 1 (the core process)

Claim 1 requires, in order: (i) select a large substantially intact bone; (ii) remove excess cartilage from an articulating surface; (iii) open the cortical layer for vacuum-line access; (iv) attach a vacuum line via the opening; (v) immerse the bone in a bone-marrow-solvent solution; (vi) apply vacuum to draw solution in through the cartilaginous articulating surface, through the bone cavity, and out through the vacuum line at the opening.

Direction of flow (the "in through cartilage, out the port" feature). This is the only element not literally spelled out in a single reference. It is, however, a design choice with a self-evident rationale that the '379 itself states as a trade-off: "Restricted flow of the solvent through the cartilaginous ends of the bone minimizes mechanical and/or structural damage to the cancellous bone by causing a slow flow rate of solvent through the trabecular bone space." Where the specification frames the limitation as the predictable consequence of ordinary flow-restriction physics rather than as an unrecognized discovery, the limitation does not support patentability. The alternative — spraying pressurized lavage at cut surfaces — was the known commercial approach (Med Clean Mark II; Morse '626) and the '379 expressly identifies its drawbacks (aerosols; structural damage). Choosing the low-shear inlet path is the classic "predictable variation" of KSR.

4. The rejections I would expect to be made (and that I assess as prima facie sound)

Ground 1 — Claim 1 (and claims 2–4, 9, 12–14, 18–23): obvious over US 5,333,626 in view of SU 952189.

US 5,333,626 teaches cleaning bone's internal matrix of marrow/lipid with the same class of aqueous detergent/decontaminant solutions at overlapping temperatures, and claims 30–33 expressly claim a pressure-differential contact of the matrix with solution to reduce marrow/cells/fat. Skrimnyuk teaches the exact motor: negative pressure applied to a submerged bone graft to extract bone marrow cells, with draining and repetition with fresh solvent — the "continual exchange of fresh solvent" that the '379 itself identifies as its key advantage. The only missing piece is directionality/access, supplied by EP 0 740 555 claims 12–15 (drilled cortical access holes) or, equivalently, by routine mechanical expedient.

Motivation (KSR-aligned):

• Same field, same problem, same solution mechanism. Both references address the identical problem (removing marrow and its immunogenic/infectious burden from transplantable bone), so the combination is "the mere arrangement of old elements according to known methods."
• The '626 reference itself points to the substitution. Claims 30–33 recite a "pressure different from said predetermined value," which a PHOSITA reads on negative pressure as well as positive; nothing in the reference limits it. Where a reference discloses a genus (any pressure differential), selecting one species (vacuum) for a known benefit is In re Prater-type obviousness.
• The art expressly identified the unmet need. The Cryolife VIP documentation (described in the '379 background) admitted that its process cleaned only the surfaces of large grafts and removed marrow only from small cut grafts — i.e., the field was actively looking for a large-graft marrow-removal technique. That is the classic "finite number of identified, predictable solutions."
• Reasonable expectation of success. Skrimnyuk reports actual extraction of marrow cells from spongy bone under vacuum; EP 0 740 555 Ex. 9–10 quantifies blood and lipid yield out of a drilled femoral specimen as a function of vacuum level. A PHOSITA would expect vacuum to do the same on a larger scale.
• Design incentives. Both references are concerned with technician exposure to HIV/HBV (WO 93/12731 states it explicitly; the '379 admits the aerosol hazard of pressurized lavage). A closed vacuum/aspirate system is the obvious engineering answer.

Ground 2 — Claims 12–14 and 41 (drilled tapping-port access; deformable container): obvious over US 5,333,626 + SU 952189 + EP 0 740 555 B1 (holes drilled through cortex, ≤3 mm, 10–30 mm deep, vacuum applied), with the sealing/containment features supplied by the admitted prior-art practice of closed-system aspiration and disposable collection (Skinnyuk's vessel; WO 93/12731's wrapped/covered tissue blocks) and by routine mechanical design (sterile autoclaveable connectors).

Ground 3 — Claims 15–17 (transverse cut, sealing cap, pulsatile lavage pre-removal): obvious over US 5,333,626 + SU 952189 in view of the admitted Pulsavac/Med Clean practice. '626 claims 2–5 teach high-pressure lavage of the bone interior; the '379's own background admits that large bones are cut before processing and that "lavage with pulsatile water flow under pressure" was the standard marrow-removal technique. Substituting a sealing cap on the cut end for a drilled tapping port is an obvious equivalent access architecture, and both are claimed here in parallel (claims 12 vs. 15), which is itself evidence that the two are interchangeable design choices.

Ground 4 — Chemistry claims 20–22, 28–33, 34–36: obvious over US 5,333,626/WO 93/12731 + Osteotech Permein/Mellonig + Helenius.

• Detergents + water at temperature: '626 claims 5, 7, 10–15, 24–29 (Triton X-100, Tween 80, 37–80 °C).
• Ethanol co-solvent: Mellonig 1992 (ethanol + non-ionic detergent on bone); '626 claim 3 (ethanol rinse).
• Nonionic phenoxypolyethoxyethanol (Triton X) and polyoxyethylene sorbitan ester (Tween) are, respectively, the claimed "polyethylene glycol p-isooctylphenylethers" (claim 22 genus) and "polyoxyethylene sorbitol esters" (claim 22 genus) — a literal anticipation-flavored overlap.
• CMC-driven concentration selection: Helenius 1975, cited by the applicant itself.
• The claimed temperature windows (20–65 / 27–55 / 40–48 °C) fall inside the admitted 4–65 °C prior range and inside '626's 37–80 °C; absent evidence of criticality, this is In re Aller / In re Boesch optimization of a result-effective variable.
• Hydrogen peroxide/antibiotics/permeation enhancers/weak acids (claims 23, 32): '626 claims 16 and 29 (H₂O₂); WO 93/12731 uses 3% H₂O₂; the '379 itself lists the same optional additives as conventional.

Ground 5 — Claims 24–27 (the specific Brij-35 / Nonidet P-40 / Nonoxynol-9 "1X" blend and its dilution ranges): the weakest ground, and possibly not sustainable.
The three-detergent blend is treated in the '379 as the "ALLOWASH™" formulation, "formerly referred to as Panavirocide in parent application Ser. No. 08/293,206, filed Aug. 19, 1994," and the patent also incorporates Ser. No. 08/212,698 (filed Mar. 14, 1994) by reference for its detergent disclosure. Two problems for an obviousness rejection:

• If 08/212,698 and/or 08/293,206 name the same inventive entity (Wolfinbarger), the disclosure is not "by another" and does not qualify under § 102(e)/(g); a reference cannot be used for § 103 if it is not prior art under § 102. The earlier application would then be simply an earlier disclosure by the same inventor, not a § 103 reference.
• Even if another party's publication disclosed the same three-component blend, the pre-AIA § 103(c) common-ownership exclusion (as it applied to filings before Nov. 29, 1999, the pre-AIPA version of the statute covered only § 102(f)/(g) subject matter) would not shield § 102(e) art; the 1999 AIPA version of § 103(c) applies only to applications filed on or after Nov. 29, 1999. I flag this as a genuine legal-date question I cannot resolve without the actual filing/ownership records, and I do not speculate further.
• What is sustainable on the present record: claim 24's outer range of "about 0.0001X to 10X" and claims 25–27's nested narrower ranges are naked concentration optimizations supported by no comparative data. The single disclosed rationale — "removal of 90 percent of this solution… reduces the concentration to approximately a 0.001X solution, which is the non-toxic level" — is arithmetic, not evidence of unexpected results. Claims 25–27 consequently face a strong In re Aller argument; claim 24 can be attacked with Helenius + '626 + routine dilution. But an examiner could reasonably allow on the specific blend.

Ground 6 — Claims 37–40 (monitoring by absorbance at 410–700 nm / visual color): obvious over US 5,333,626 + SU 952189.
Both references describe watching the effluent: the '379 itself describes the eluent going "dark red … to a color similar to that of serum," which is the inherent, observable endpoint of any of the prior processes. Spectrophotometric protein/hemoglobin monitoring (A₄₁₀) of a wash stream is a routine analytical step; using a known detector in its known way to detect a known condition (KSR; In re Kao).

Ground 7 — Claims 42–43 (bone graft produced by the process): obvious where the process is obvious and the product itself is not novel — Skrimnyuk already produced marrow-depleted spongy bone grafts, and the '379 does not identify any structural difference in the cleaned graft attributable to the process.

Ground 8 — Claim 44 (second independent process; transverse cut + deformable container + sealing cap): obvious on the same combination as Grounds 1–3; the added deformable-bag-sealing step is a known closed-system aspiration expedient (Skrimnyuk's vessel; WO 93/12731's sterile covering of tissue blocks during cleaning) and is claimed in parallel with the rigid-container embodiment of claim 1, again signalling interchangeability.

5. Date problems that cut against the strongest grounds (be candid about these)

• EP 0 740 555 B1 (Nov. 6, 1996) and US 5,513,662 (May 7, 1996) postdate the '379's Aug. 19, 1994 § 120 date. For them to be prior art, the vacuum/less-than-ambient-pressure subject matter must be entitled to the Dec. 31, 1991 priority of US Ser. No. 815,394 through the PCT (WO 93/12731, filed Dec. 22, 1992, published July 8, 1993). If the vacuum claims and Examples 8–10 were added as new matter in a later-filed divisional/continuation, they are not entitled to the 1991 date and may not be prior art at all. I did not verify the chain of § 120/§ 119 benefit for that subject matter, and this materially affects Grounds 1, 2, 4 and 8 to the extent they rely on EP 0 740 555 for the drilled-hole/vacuum teaching. Ground 1's core pairing (US 5,333,626 + SU 952189) does not depend on it — which is why I present that as the primary ground.
• US 5,333,626's § 102(e) date is its Dec. 31, 1991 filing, which is comfortably before both the Aug. 19, 1994 CIP date and the Feb. 27, 1995 filing date — but only if the '379's claims are supported by the parent (Ser. No. 08/293,206) or by the CIP filing date respectively. This is clean.
• SU 952189 is § 102(b) art (Aug. 23, 1982), and is on the family's face — the safest single reference in the case.

6. Secondary considerations / what the patentee would argue

1. Nothing unexpected in the specification. The '379 reports reproducibility and a monotonic absorbance decay (FIG. 8) — the expected consequence of washing a soluble material out of a porous body. There is no comparative data against VIP™, Permein™, or the Skrimnyuk method, and no evidence that the claimed flow rates, temperatures, or dilutions are critical.
2. Possible commercial-success and licensing evidence. The Allowash process became LifeNet's commercial standard and the '379 family is broad (children 5,820,581; 5,797,871; 5,976,104; 5,977,034; and later Wolfinbarger patents down to 6,569,200, 7,338,757). As noted in the previous Litigation section, the '379 itself appears never to have been asserted and shows up only as patent-marking text on a LifeNet Instructions-For-Use sheet discussed in the LifeNet v. LifeCell transcript. Any commercial-success argument would need to establish a nexus to the claimed process rather than to the later-detailed Allowash chemistries — and the chemistry claims (24–27) are where the nexus is weakest as a matter of prior-art law (§ 4, Ground 5).
3. The best nonobviousness argument is directionality + closed flow-through. The patentee's strongest position is that neither Skrimnyuk (bell-jar pressure cycling of a fully submerged specimen) nor Morse '626 (pressurized lavage/agitation) nor the Cryolife VIP process describes a continuous, directionally controlled solvent flow that enters through the debrided cartilaginous end and exits a purpose-made cortical port into a closed aspirate container. That is a real gap in the art — but it is a gap in arrangement, not in elements, and under KSR the arrangement of known elements according to their established functions, with a stated and predictable benefit (lower shear at the inlet; contained effluent), is not patentable. The strongest counter to that counter is the applicant's own admission that pressurized methods generated aerosols and damaged cancellous bone — which makes the vacuum substitution not merely obvious but motivated.

7. Bottom line

On the record I retrieved, claim 1 and the great majority of the dependent claims would be, in my assessment, prima facie obvious under § 103 over US 5,333,626 (Morse/Shanbrom) in view of SU 952189 (Skrimnyuk), with EP 0 740 555 B1 pulled in for the drilled-cortical-access-hole and sub-ambient-pressure embodiments subject to the benefit-date verification flagged in § 5. The specific three-detergent "1X" formulation claims (24–27) are the only claims where I would expect a well-founded allowance, and even there the outer "0.0001X–10X" range and the nested sub-ranges look like unsubstantiated concentration optimization.

Explicit uncertainties: (a) I could not retrieve the '379's own "References Cited" front page, so my "before the examiner" statements rest on the sibling US 5,820,581 / US 5,797,871 lists; (b) the claim-count discrepancy (§ 0.1) is unresolved and changes the number of claims to be analyzed; (c) the § 102(e)/§ 120 benefit chain for the vacuum disclosure of the Morse/Cryolife family is unverified and is outcome-determinative for Grounds 2 and 8; and (d) the § 102(e) "by another" / § 103(c) status of Ser. Nos. 08/212,698 and 08/293,206 as to the Allowash blend is unverified.