Share This Page
Patent: 10,046,081
✉ Email this page to a colleague
Summary for Patent: 10,046,081
| Title: | Electrospun dextran fibers and devices formed therefrom |
| Abstract: | The invention generally relates to dextran fibers which are preferably electrospun and devices formed from such fibers. In particular, such devices may include substances of interest (such as therapeutic substances) associated with the electrospun fibers. Upon exposure to a liquid the electrospun fibers dissolve immediately and the substances of interest are released into the liquid. Exemplary devices include bandages formed from electrospun dextran fibers and associated agents that promote hemostasis, such as thrombin and fibrinogen. |
| Inventor(s): | Bowlin; Gary (Mechanicsville, VA), Simpson; David (Mechanicsville, VA), Bowman; James (Richmond, VA), Rothwell; Stephen (Richmond, VA) |
| Assignee: | The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Rockville, MD) Virginia Commonwealth University (Richmond, VA) |
| Application Number: | 14/445,566 |
| Patent Claims: | see list of patent claims |
| Patent landscape, scope, and claims summary: | Executive summary Below is a critical, claim-by-claim landscape and infringement-risk analysis for US 10,046,081, with practical generic entry risks and workaround paths. US 10,046,081 claim scope: what patents protect a dextran electrospun thrombin–fibrinogen separated-layer hemostatic product?What is the core inventive concept in US 10,046,081?The independent claim 1 is structured around five limiting elements that jointly define infringement:
That separation is not described as “functional” separation. It is asserted as a physical arrangement: two layers placed in a stacked configuration such that the thrombin is separate from the fibrinogen. In litigation, that typically pushes construction toward: (a) no direct contact between thrombin-containing and fibrinogen-containing regions in the finished product, and (b) separation achieved by the layered assembly rather than only by “slow mixing” or formulation kinetics. How do dependent claims narrow the protection?Claims 2–6 add composition and architecture limitations; claims 3–5 add quantitative and materials constraints; claims 6 adds biologic sourcing; claims 2 and 5 add additional layers/backing adjacency.
Method claims are “process-mirror” and inherit the same structureClaim 7 mirrors claim 1 with a fabrication sequence: prepare a first layer with thrombin on electrospun dextran fibers; prepare a second layer with fibrinogen on electrospun dextran fibers; stack so thrombin is separate from fibrinogen. Claims 8–10 add the same incremental limitations (top dextran cover; 5–10 layers; and adjacency of a specific support material to the first layer). In practice, this matters because process claims can be easier to prove via manufacturing records, incoming raw-material specs, and validated assembly procedures than finished-product internal structure. But they still require the same “consisting of electrospun dextran fibers” and “separate” arrangement. Claim-by-claim: what each limitation means for infringement risk and design-aroundClaim 1: “two electrospun dextran layers with separated thrombin and fibrinogen”Key infringement hinges
Nontrivial doctrine-of-equivalents pressure Even with “consisting of,” plaintiffs can argue equivalents if the accused scaffold uses electrospun dextran-like fibers that perform the same support role. Defense counsel will counter that “consisting of” limits what can be present in the support material itself. Claim 2: top dextran support covering the second layerThis is a structural add-on. If an accused product has only a bottom backing and a thrombin/fibrinogen sandwich without a top dextran cover, claim 2 likely fails. But claim 1 could still be asserted if the top dextran cover is not required. Claim 3: 5–10 total hemostatic layersThis adds a numeric architecture limit. Many commercial products are 2-layer (one thrombin, one fibrinogen) or even single-layer. A layered “repeat” stack with 5–10 layers increases surface area and could map more closely to patch manufacturing approaches. For infringement, a patentee will likely argue: “count hemostatic layers” means each thrombin or fibrinogen layer segment in the stacked assembly. A defendant can avoid by using fewer than 5 or more than 10. Claim 4: moisture content ≤5% in first dextran supportThis is a manufacturing-spec claim with a tether to function (moisture-retained thrombin). For infringement, the practical question becomes whether the accused product’s first dextran support has moisture content at or below 5% by weight at relevant times (often at packaging or during shelf life). A design-around is to formulate with higher moisture content (outside the limitation) or to control retention via other mechanisms (e.g., crosslinking, binding agents, enzyme stabilization chemistries). The limitation is not “any stabilizer,” it is specifically moisture content plus claimed retention behavior. Claim 5: adjacency to a support material from a closed listThis claim narrows by the backing/adjacent support. It also uses a closed “selected from” group. If an accused product’s backing is outside that list (e.g., different nonwoven polymer, metallic reinforcement, collagen sponge, or a hybrid not captured), claim 5 likely fails, while claim 1 may still hold if claim 1 does not require a listed backing. Claim 6: human thrombin and human fibrinogenThis narrows source. If the accused product uses recombinant human thrombin/fibrinogen sourced as “human,” it stays within. If it uses bovine or animal-sourced materials, claim 6 can be avoided, though claim 1 may still be asserted unless claim 1 already requires human proteins (it does not). Claim 7: method of preparing with layered separationThis method claim is tightly aligned to the product structure. It requires:
Claim 8–10: dependent method constraints
What is the US patent estate around electrospun dextran and separated thrombin/fibrinogen layers?Adjacent technology clusterUS 10,046,081 sits in a dense intersection of:
The risk to competitors is that even if they avoid the exact material system (dextran electrospinning), they can still collide with broader hemostatic compartmentalization patents. Conversely, if competitors use electrospun dextran scaffolds, the “separate thrombin and fibrinogen in stacked layers” requirement makes physical assembly design critical. How this patent likely interfaces with earlier and later US filingsIn enforcement, the typical landscape expectation is:
US 10,046,081’s differentiator is the combination: electrospun dextran fibers as both enzyme-scaffold supports plus stacked separation. Orange Book status and FDA pathway: what does US 10,046,081 likely attach to?No in-scope data is provided here for:
Without those, no accurate Orange Book mapping can be produced to link US 10,046,081 to a particular FDA approval, formulation, or clinical indication. Patent strength assessment: how strong is enforcement likely to be for US 10,046,081?Strength factors
Strength vulnerabilities
Overall practical enforceability
How many patents cover this approach and who are the likely competitors?No claim-coverage count or competitor list can be generated from the information provided. A comprehensive cross-patent count requires the full US family listing (application numbers, publication numbers, continuations) and third-party patent search results tied to the same active hemostatic mechanism and delivery architecture. Given only the claim text for US 10,046,081, the only defensible statement is that the estate around this area is crowded and typically includes multiple overlapping “component separation” and “hemostatic scaffold” families, but those cannot be enumerated accurately here. Generic and biosimilar entry risks: can competitors launch around US 10,046,081?If a competitor wants to replicate the hemostatic functionKey design-around levers (mapped to the claims):
Timing for entryNo FDA approval or patent expiration schedule is provided. A precise exclusivity timeline or Paragraph IV strategy cannot be produced without:
What patent litigation affects US 10,046,081?No litigation docket, district court case number, PTAB history, IPR/PGR, or settlement is provided. A “patent litigation affects” section cannot be completed accurately for US 10,046,081 from the provided inputs. Key Takeaways
FAQs
References (APA)
More… ↓ |
Details for Patent 10,046,081
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
|---|---|---|---|---|---|---|---|
| Omrix Biopharmaceuticals Ltd | EVITHROM | thrombin, topical (human) | Solution | 125247 | August 27, 2007 | 10,046,081 | 2034-07-29 |
| Omrix Biopharmaceuticals Ltd | EVITHROM | thrombin, topical (human) | For Injection | 125247 | September 17, 2009 | 10,046,081 | 2034-07-29 |
| Csl Behring Gmbh | RIASTAP | fibrinogen concentrate (human) | For Injection | 125317 | January 16, 2009 | 10,046,081 | 2034-07-29 |
| Octapharma Pharmazeutika Produktionsges.m.b.h. | FIBRYGA | fibrinogen (human) | For Injection | 125612 | June 07, 2017 | 10,046,081 | 2034-07-29 |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
