Patent: 7,189,410

Summary for Patent: 7,189,410

Title:	Supplemented and unsupplemented tissue sealants, methods of their production and use
Abstract:	This invention provides a fibrin sealant bandage, wherein said fibrin sealant may be supplemented with at least one composition selected from, for example, one or more regulatory compounds, antibody, antimicrobial compositions, analgesics, anticoagulants, antiproliferatives, anti-inflammatory compounds, cytokines, cytotoxins, drugs, growth factors, interferons, hormones, lipids, demineralized bone or bone morphogenetic proteins, cartilage inducing factors, oligonucleotides polymers, polysaccharides, polypeptides, protease inhibitors, vasoconstrictors or vasodilators, vitamins, minerals, stabilizers and the like. Also disclosed are methods of preparing and/or using the unsupplemented or supplemented fibrin sealant bandage.
Inventor(s):	Drohan; William N. (Springfield, VA), MacPhee; Martin J. (Gaithersburg, MD), Burgess; Wilson H. (Clifton, VA), Nunez; Hernan (Derwood, MD), Singh; Manish (San Diego, CA), Liau; Gene (Darnestown, MD), Maciag; Thomas (Freeport, ME)
Assignee:	The American National Red Cross (Rockville, MD)
Application Number:	08/474,078
Patent Claims:	see list of patent claims

United States Patent 7,189,410 (Fibrin Sealant Bandage): claim-by-claim scope, enforceability risk, and how the US patent estate blocks or invites generic competition

What claims does US Patent 7,189,410 actually cover for a fibrin sealant bandage?

US Patent 7,189,410’s independent claim set is built around a single technical core: a bandage that delivers fibrinogen to form a fibrin clot/matrix for hemostasis, while excluding (1) added fibrinolysis inhibitor and (2) collagen in the backing. Around that core, the claims add optional layers (adhesive, waterproof film, backing type), physical state (dry/gel), and an unusually broad “supplements” scaffold (growth factors, antimicrobial, antibodies, cytotoxins, cells, polymers, etc.), plus methods of using and preparing the bandage.

The independent claim 1 is the “anchor” for infringement scope

Claim 1 requires all of the following elements:

1. A fibrin sealant bandage for treating tissue of a patient.
2. Backing layer with at least one tissue-facing surface.
3. Hemostatic component layer on the tissue-facing surface of the backing.
4. The component layer comprises a hemostatically effective amount of fibrinogen.
5. The component layer contains no added fibrinolysis inhibitor.
6. The backing layer contains no collagen.
7. The fibrinogen forms a hemostatically effective fibrin clot that covers and adheres to tissue and diminishes fluid loss when applied.

This combination is narrow in some respects (exclusions are hard limits), broad in others (fibrinogen-only hemostasis plus generic “bandage” architecture).

Practical infringement bottleneck: a challenger must be able to design around either:

• the “no added fibrinolysis inhibitor” limitation (by including an added antifibrinolytic, or using a formulation that is argued to include one), or
• the “no collagen” limitation in the backing, or
• the functional “covers and adheres” hemostasis performance (usually easy to meet with compliant products, but becomes a factual disputes zone).

Claims 2–4 set the “classic” fibrin system multipliers

• Claim 2: component layer further comprises one selected from Factor XIII, thrombin, Ca++.
• Claim 3: component layer further comprises at least two from that set.
• Claim 4: component layer further comprises all three (Factor XIII + thrombin + Ca++).

These claims track standard fibrin formation pathways (thrombin cleavage, calcium, Factor XIII crosslinking). If a commercial product uses those components, the claim coverage expands from “fibrinogen only” to “complete fibrin system.”

Claims 5–10 add adhesive-layer architecture and removability

• Claim 5: adds a physiologically acceptable adhesive layer affixed to the tissue-facing surface of the backing; component layer is affixed to the adhesive layer.
• Claim 6: adhesive has lower shear or tensile strength than the fibrin clot, enabling backing removal without damaging clot or tissue.
• Claim 7–8: component layer is on an inner region; adhesive can extend beyond to attach to tissue directly.
• Claim 9: adhesive capability permits removal of backing from fibrin clot.
• Claim 10: backing itself functions as the adhesive layer.

This is a key enforceability area. Competitors can attempt design-around by altering adhesion mechanics (e.g., using adhesive strength comparable to clot cohesion, changing tack profile, changing how the clot detaches, or eliminating backing-removal use cases).

Claims 11–15, 46–48, 55–57 introduce protective film and “dry” delivery

• Claim 11: removable waterproof protective film over component and adhesive layers.
• Claims 12–15: at least one component is dry, and can be hydrated pre-, during, or post-application (including by endogenous fluids).

This is commercially meaningful because it aligns with practical bandage shelf-life and handling. It also creates a scope question: “dry” can be litigated as a claim-construction issue (water content, drying method, presence/absence of rehydratable precursors).

• Claim 48 (independent claim family for methods): removable waterproof protective film over component and adhesive layers.
• Claim 55–57 specify dry components can be lyophilized (freeze-dried).

Claims 16, 42, 46–47 cover gels and hydration state

• Claim 16: at least one component layer is a gel.
• Claim 42: method applying bandage where claims 12–17 are involved (dry state emphasis).

This is another design-around lever: using fully dry particulate without gel phase, or using a gel that does not meet other constraints.

Claims 17–28 and 29–35 create an extremely broad “supplement” genus

Claim 17 includes a massive list of supplement categories: analgesics, anesthetics, antibiotics, antimicrobial compounds, antibodies, anticoagulants, antifungals, anti-inflammatory compositions, antiproliferatives, antiseptics, “cartilage-inducing compounds,” cardiovascular drugs, cells, cytokines, cytotoxins, chemotherapeutic drugs, growth factors, hormones, interferons, lipids, polynucleotides/oligonucleotides, osteoinducers, polymers, polysaccharides, proteoglycans, polypeptides, protease inhibitors, steroids, vasoconstrictors/vasodilators, vitamins, nutritional supplements, minerals, stabilizers.

Claim 18–20 restrict to supplement type as antimicrobial or growth factor and then enumerates multiple growth factor/cytokine classes.

Claims 21–22 specify “inhibiting compounds” and “potentiating compounds” governing growth-factor biological function and downstream cellular behaviors.

Claims 23, 24, 28: add antibodies/antimicrobials and anesthetic combinations.

Claims 25–27, 28: adds cytotoxins/cell proliferation inhibitors with a very long list (includes many established chemotherapeutics and toxins).

Claim 29–35 focus on long-term release:

• supplement is released long term (29)
• supplement in solid form (30)
• prior to application, supplement introduced into component layer before fibrin clot formation as a solution in a carrier, where carrier diffuses faster/dissolves faster so supplement deposits as solid precipitate (31)
• localized sustained release via interaction with fibrin clot (32)
• low solubility supports sustained release (33)
• mass exceeds soluble amount in fibrin clot volume (34)
• prior to application, introduced as an emulsion (35)

Enforceability and litigation risk profile: these “supplement” claims are broad enough to cover many real-world adjuncts, but they also create vulnerability:

• The claims likely require that the supplement is actually present in the component layer and remains consistent with “no added fibrinolysis inhibitor” and “no collagen in backing.”
• The “inhibiting vs potentiating” construct is functional and can become a dispute about what qualifies as “inhibiting agents that interfere with a biological function” versus routine co-formulation.
• The “deposited as solid precipitate,” “higher diffusion/dissolution rate carrier,” “mass exceeds soluble amount” limitations in claims 31, 34 are factual and manufacturing-process dependent. Competitors can design around by altering delivery state (e.g., encapsulation, covalent tethering, particulate size distributions, or use of different carriers).

Claims 36–38: additional optional materials, including collagen-adjacent species

• Claim 36: supplement may include fibrin, collagen, gelatin, chitin.

This is a potential internal friction with the “backing contains no collagen” limitation. The claim distinguishes backing collagen exclusion from collagen-like supplements within the component layer. That allows a product to contain collagen in the component layer without violating “backing contains no collagen,” assuming claim interpretation treats “no collagen” as a limitation on the backing layer only (as written).

• Claims 37–38: backing can be resorbable, selected from fibrin, gelatin, chitin, chitosan.

Again, collateral design-around exists: keep backing resorbable but avoid collagen; or keep backing non-resorbable and use adhesive mechanics to diverge.

Claims 39–43 define method coverage based on which bandage claims are used

• Claim 39 applies bandage of claims 1–5.
• Claim 40 applies bandage of claims 6–10.
• Claim 41 ties to removable waterproof film (claims 11), including step of removing film and applying bandage.
• Claim 42 ties to bandage claims 12–17 (dry state and relevant supplement categories).
• Claim 43 ties to bandage claims 29–35 or 36–38 (long-term release and/or additional supplement materials and resorbable backing).

Claims 44–78 add process and device variants

The patent also includes preparation processes and alternative bandage definitions that restate the core with different layer combinations:

• Claim 44: method of preparing a bandage by layering backing and hemostatic component layer with fibrinogen, excluding added fibrinolysis inhibitor and collagen in backing.
• Claims 45–48: add adhesive layer and protective waterproof film.
• Claims 49: supplemented fibrin clot formed upon application (claims 17 supplement context).
• Claims 50–51: backing is non-resorbable or occlusive.
• Claims 58–59: method of claim 44 with non-resorbable or occlusive backing.
• Claims 60–64, 65: specify recombinant human proteins for fibrinogen, thrombin, Factor XIII, and details of adhesive behavior.
• Claims 66–68: provide bandage claims focused on adhesive backing plus fibrinogen matrix in presence of thrombin, Ca++ and hydrating agent, with no added fibrinolysis inhibitor and no collagen backing.
• Claims 69–74, 71–74: production process variants for layering adhesive and dry material.
• Claims 75–78: direct vs indirect contact between component and backing.

What is the competitive and design-around significance of the “no added fibrinolysis inhibitor” and “no collagen in the backing” limits?

“No added fibrinolysis inhibitor” is a primary carve-out lever

Most mature hemostatic products that aim for sustained clot stability often include antifibrinolytics (classically aprotinin or tranexamic acid derivatives) as stabilizers. This patent’s claim requires the component layer contains no added fibrinolysis inhibitor.

Design-around options:

• formulate without antifibrinolytics, relying on the fibrin formation system alone, or
• if using an antifibrinolytic, allocate it in a way that avoids the “added” characterization (a litigation risk area), or
• argue that a co-formulated component is not an antifibrinolysis inhibitor “added” in the relevant layer (facts and claim-construction dependent).

“No collagen in backing” constrains materials selection

Many wound dressings and bandages use collagenous scaffolds or collagen-based adhesives. This patent restricts the backing layer to contain no collagen, while allowing collagen-like materials in other layers depending on claim family scope (e.g., Claim 36 permits collagen as a supplement, not necessarily backing collagen).

Design-around options:

• move collagen to a non-backing layer (if the product’s structure matches that architecture), or
• switch to synthetic or polysaccharide/chitin/chitosan resorbable backing types, or
• use non-collagen occlusive or non-resorbable backing.

How does this patent map to likely infringement theories and litigation pressure points?

1) Direct infringement: bandage structure and functional hemostasis

The strongest theory tracks claim 1 elements: bandage + backing with tissue-facing surface + component layer with hemostatically effective fibrinogen + no added antifibrinolysis + no collagen in backing + fibrin clot that adheres and diminishes fluid loss.

A defendant product’s structural proof usually comes from:

• manufacturing specs and Bill of Materials (BOM)
• label claims and IFUs
• histology and adhesion performance testing (to support or refute “adheres” and “diminishes fluid loss”)
• formulation testing for antifibrinolysis inhibitors and collagen content in the backing.

2) Process-based infringement: “dry” hydration and sustained-release

Where the asserted claim involves Claims 12–15, 31, 34–35, long-term release is often more manufacturing-process sensitive:

• whether supplement is introduced as a solution vs emulsion
• carrier diffusion/dissolution relative rates
• solids precipitate formation inside fibrin matrix
• solubility thresholds and mass loading.

3) Indirect or contributory theories depend on distribution channel and system design

If the accused product includes optional components like recombinant Factor XIII and thrombin, and is bundled with a hydration mechanism (protective film removal, endogenous hydration), the analysis narrows quickly to the finished bandage product, not just raw components.

Which claim clusters are most valuable for enforcement?

Highest leverage (breadth with clear exclusions):

• Claim 1 plus Claims 2–4 (fibrinogen bandage with optional fibrin formation cofactors and hard exclusions).
• Claim 5 plus Claims 6–10 (adhesive-layer and removable backing mechanics).
• Claims 12–15 (dry component with hydration).
• Claim 66–68 variants (adhesive + fibrin matrix in presence of thrombin, Ca++ and hydrating agent).

Most litigable (fine-grained manufacturing and functional qualifiers):

• Claims 31–35 sustained release deposition mechanics.
• Claims 21–22 “inhibiting/potentiating” growth factor function mediation.
• Claims 6–9 adhesive shear/tensile lower strength relative to fibrin clot.

Most vulnerable to design-around through co-formulation:

• Anything tied to specific additional layers (waterproof protective film, inner region/outer region architecture) can be replaced with an alternative protective strategy or different bandage layout.

What patent estate risks exist for competitors trying to launch fibrin sealant bandages in the US?

This patent’s scope is broad but still constrained by two “hard” prohibitions:

• no added fibrinolysis inhibitor in the component layer
• no collagen in the backing layer

A competitor can attempt to avoid infringement by changing either (i) the fibrinolysis-stabilizing strategy or (ii) backing composition, then separately evaluate whether they still fall within:

• dry/lyophilized component limitations,
• adhesive removability limitations,
• long-term release deposition mechanisms.

Timeline, Orange Book status, and FDA exclusivity: what is the regulatory posture?

No information was provided identifying the specific commercial product(s) or NDA/BLA/ANDA associated with US 7,189,410, nor any FDA approval reference enabling determination of:

• Orange Book listings
• regulatory exclusivity start/end dates
• patent expiration dates tied to listing numbers.

As a result, a complete and accurate timeline tied to FDA regulatory records cannot be produced from the claim text alone.

Key takeaways

• US 7,189,410’s enforceable core is a fibrinogen-based fibrin clot bandage with no added fibrinolysis inhibitor and no collagen in the backing layer, plus fibrin clot adhesion and fluid-loss reduction (Claim 1).
• Dependent claims layer in fibrin system cofactors (thrombin, Factor XIII, Ca++) and adhesive architecture that supports backing removal without damaging the clot (Claims 2–10).
• The patent extends into dry delivery and hydration timing (Claims 12–15) and protective film (Claim 11).
• The “supplements” framework is extremely broad (Claims 17–28) and can pull in antimicrobial, growth-factor, antibody, and cytotoxin payload concepts, but long-term release subclaims (Claims 29–35) are manufacturing-mechanics specific and create clearer design-around paths.
• Competitors can most credibly design around via (1) adding a fibrinolysis inhibitor strategy and/or (2) moving away from collagen-containing backing materials, then validating whether adhesive/removability and long-term release deposition limitations remain met.

FAQs

1. Can a product include collagen in the component layer without violating “backing contains no collagen”?
   The claim text blocks collagen in the backing layer only; collagen as a supplement is contemplated in separate claim language.

2. What design-around is strongest: replacing fibrinogen with another hemostatic agent or modifying the fibrinolysis stabilization approach?
   Modifying the fibrinolysis stabilization approach (avoid the “no added inhibitor” limitation) and backing composition (avoid collagen) directly target hard claim elements.

3. Do Claims 31–35 require a specific manufacturing step like emulsification before fibrin clot formation?
   The claims do tie sustained-release mechanisms to how the supplement is introduced (solution with higher-diffusion carrier, emulsion in some variants), which makes process evidence central.

4. How important is the “dry” limitation for infringement risk?
   It becomes critical only where the asserted claim depends on dry-state features (Claims 12–15 and method claims tied to those).

5. Does including thrombin/Factor XIII/Ca++ broaden or narrow infringement risk?
   It generally broadens coverage under Claims 2–4 (and related bandage variants) if other core limitations are satisfied.

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References (APA)

1. US Patent 7,189,410, “Fibrin sealant bandage,” claims section provided in prompt.

Details for Patent 7,189,410

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978	7,189,410	2015-06-07
Ethicon, Inc.	EVARREST	fibrin sealant patch	Patch	125392	December 05, 2012	7,189,410	2015-06-07
Ethicon, Inc.	EVARREST	fibrin sealant patch	Patch	125392	May 16, 2013	7,189,410	2015-06-07
Ethicon, Inc.	EVARREST	fibrin sealant patch	Patch	125392	May 27, 2014	7,189,410	2015-06-07