Patent: 10,226,550

Summary for Patent: 10,226,550

Title:	Cationic steroidal antimicrobial compositions for the treatment of dermal tissue
Abstract:	This disclosure relates to dermal treatment compositions, such as dermal fillers and tissue glues, and injectable compositions that incorporate one or more cationic steroidal antimicrobials (CSAs). The CSAs are incorporated into the dermal treatment compositions to provide effective antimicrobial, anti-inflammatory, analgesic, anti-swelling and/or tissue-healing properties. A treatment composition includes a component formed from a biologically compatible material suitable for injection into and/or application onto tissue at a treatment site. One or more CSA compounds are mixed with the biologically compatible material so that the one or more CSA compounds are incorporated within the composition, forming a reservoir of CSA compounds within the resulting bolus of the treatment composition after injection and/or application.
Inventor(s):	Savage; Paul B. (Mapleton, UT), Genberg; Carl (Las Vegas, NV), Bracken; Ronald (Monroe, GA)
Assignee:	BRIGHAM YOUNG UNIVERSITY (Provo, UT)
Application Number:	15/454,135
Patent Claims:	see list of patent claims

US Patent 10,226,550 (Soft Tissue Filler + Cationic Steroidal Antimicrobial) Claims, Scope, and Competitive Patent Landscape

US 10,226,550 is a US composition-and-method patent family centered on combining a syringe-injectable soft tissue filler or tissue-glue system with 0.1% to 30% (w/w) cationic steroidal antimicrobial (CSA) compounds to achieve time-release antimicrobial activity from a bolus/matrix after injection or topical application. Claim scope is broad on filler “base” materials, method use (soft tissue, wound, embolization/occlusion contexts), and CSA species class coverage, while narrowing key dependent positions around cyanoacrylate adhesives and specific CSA identity/form (including CSA-131 and sulfonic acid salts, including 1,5-naphthalenedisulfonic acid).

What claims does US 10,226,550 cover for soft tissue fillers with CSA compounds?

Independent claim 1: composition scope

Claim 1 anchors the patent’s commercial core: a soft tissue filler composition for injection that contains:

• Biologically compatible soft tissue filler material that is liquid, gel, paste, or viscous and syringe-injectable
• The filler material comprises a tissue adhesive
• 0.1% to 30% (w/w) one or more cationic steroidal antimicrobial (CSA) compounds
• Post-injection performance:
  • formation of a bolus
  • bolus has a reservoir of CSA compounds in and distributed within a matrix
  • effective time release of CSA compounds from the filler matrix

This is not limited to any single filler chemistry. Instead, it claims a functional architecture: injectable adhesive-containing filler matrix + CSA reservoir + time-release antimicrobial effect.

Dependent claim 2-3: adhesive chemistry narrowing

• Claim 2 specifies the tissue adhesive comprises cyanoacrylate.
• Claim 3 narrows further to octyl or butyl ester of cyanoacrylate.

Those dependent claims matter for enforceability because cyanoacrylate-based adhesives are a known technology space. The patent’s novelty likely concentrates on how CSA compounds are incorporated to provide antimicrobial time-release from a syringe-injectable adhesive filler/bolus.

Dependent claim 4-6: filler base narrowing

Claim 4 requires syringe-injectable bioabsorbable materials. Claims 5 and 6 provide specific embodiments that broaden claim chart coverage if others choose similar bases:

• Claim 5: hyaluronic acid, collagen, hydroxyapatite mineral, or poly-l-lactic acid in syringe-injectable form
• Claim 6: silicone or polymethylmethacrylate in syringe-injectable form

These are “cover-the-market” dependent claims. They are likely designed to match foreseeable competitors that build fillers around common implant/gel/particle systems.

Dependent claim 7: “botox” included

Claim 7 states the filler composition comprises botox. That is a high-value dependent hook if the commercial product pairs antimicrobial filler reservoirs with neuromodulators for aesthetic or functional use cases.

Dependent claim 8: CSA concentration range

Claim 8 refines the CSA loading to 0.5% to 20% (w/w).

Dependent claim 9: functional antimicrobial outcomes

Claim 9 requires CSA compounds to provide at least one of:

• antimicrobial effect
• anti-inflammatory effect
• increased tissue wound healing rate

This strengthens infringement theories if clinical or nonclinical data demonstrate multiple endpoints beyond microbial kill.

Dependent claim 10-12: CSA identity and salt form

• Claim 10 includes CSA-131
• Claim 11 requires CSA compounds include one or more sulfonic acid addition salts
• Claim 12 specifies the salt includes 1,5-naphthalenedisulfonic acid salt

This cluster likely targets salt-formulation freedom because the physical form of CSA affects solubility, incorporation into viscous matrices, and release profiles.

Dependent claim 13-14: performance comparisons

• Claim 13: protection against biofouling longer than a filler without incorporated CSA
• Claim 14: enhanced anti-inflammatory activity vs a filler without incorporated CSA

These depend on comparative testing and are often central to non-obviousness arguments, but they also create measurable infringement triggers (e.g., whether “without CSA” comparators are used in prosecution/history and whether accused products can show release/endpoint equivalence).

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What methods does US 10,226,550 claim for microbial control after injection or at wounds?

Independent claim 15: method with embolization/occlusion context

Claim 15 covers a method for controlling microbial growth on and/or at an injected soft tissue filler system where:

• You provide syringe-injectable soft tissue filler composition:
  • biologically compatible soft tissue filler material
  • 0.1% to 30% (w/w) CSA
• The soft tissue filler is a tissue glue
• The glue is injected to:
  • embolize a blood vessel or
  • occlude a fistula
• Then injected by syringe into soft tissue at the treatment site
• Microbial killing occurs when microbes contact the composition

This is broader than cosmetic filler. It is aligned with procedural/IR-like uses where occlusive adhesives are used and infection/biofilm control is a risk.

Dependent claim 16: CSA-131 as sulfonic acid addition salt

Claim 16 ties the method to:

• CSA-131
• provided as a sulfonic acid addition salt

Dependent claim 17: filler base embodiments

Claim 17 lists base options:

• bioabsorbable material, hyaluronic acid, collagen, hydroxyapatite, poly-l-lactic acid, silicone

Independent claim 18: method using cyanoacrylate tissue adhesive at wounds

Claim 18 moves to wound closure/adhesive application:

• provide tissue adhesive composition comprising:
  • cyanoacrylate adhesive material
  • one or more CSA compounds incorporated into the cyanoacrylate material
• inject and/or apply onto tissue to:
  • close a wound
  • embolize blood vessel
  • occlude a fistula
• the tissue adhesive kills microbes contacting it

This claim is a second pillar for enforceability because it targets a different delivery context than claim 15 (wound/tissue adhesive application rather than “soft tissue filler injected to embolize/occlude”).

Dependent claim 19: CSA-131 with 1,5-naphthalenedisulfonic acid salt

Claim 19 specifies the salt form.

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How broad is infringement risk under US 10,226,550 given the claim language?

Key breadth drivers

1. CSA class coverage: claim 1 covers “one or more” CSA compounds within 0.1% to 30% w/w. That is a large functional space if other CSA derivatives exist.
2. Filler base optionality: claims 1, 4, and 5-6 allow multiple filler matrices and common biocompatible materials, including hyaluronic acid, collagen, HA mineral, PLLA, silicone, PMMA.
3. Adhesive requirement: claim 1 requires tissue adhesive presence, but dependent claims specify cyanoacrylate. If an accused product uses a non-cyanoacrylate adhesive but still “comprises a tissue adhesive,” claim 1 can still be implicated.
4. Functional reservoir/time-release: claim 1 ties infringement to whether the system forms a bolus with CSA distributed and time-releasing. If competitors engineer rapid-release systems, they may try to avoid “effective time release,” but that is a fact-and-test issue.
5. Use contexts: claim 15 and 18 explicitly encompass embolization/occlusion, wound closure, and infection control. Competitors operating in those procedure classes are at higher risk than those positioned solely for sterility-insulated cosmetic filler use.

Key narrowing levers competitors can target

• Adhesive chemistry: if accused systems exclude “tissue adhesive” or use a different adhesive class that is argued not to qualify, claim 1 may be contested.
• CSA identity and salt form: dependent claims add specificity (CSA-131; sulfonic acid addition salts; 1,5-naphthalenedisulfonic acid salt). Competitors using different CSA species or non-sulfonate salts aim to fall outside dependents, though claim 1 may still capture them if they still use “CSA compounds” broadly.
• Loading range: claim 1 sets a tight numeric window (0.1% to 30% w/w). Below 0.1% or above 30% may attempt to avoid literal infringement.
• Matrix reservoir and time release: engineered systems that do not create a “reservoir” or do not meet “effective time release” could challenge claim 1 on performance grounds.

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What patent landscape issues matter for CSA-soft tissue filler combinations in the US?

Where this patent likely sits in a broader portfolio

US 10,226,550 appears to be positioned as a formulation-and-delivery patent that sits downstream of upstream CSA actives and salt/purity IP and upstream tissue adhesive/filler device IP. In practice, enforcement often depends on whether:

• a competitor’s product uses the same CSA class and release architecture, and
• whether the product’s filler + adhesive structure matches “syringe-injectable tissue glue” or “cyanoacrylate tissue adhesive” embodiments.

Claim strategy visible from the structure

• Composition claim 1 uses a wide net: soft tissue filler + adhesive + CSA + bolus/time release.
• Dependent claim set ladders down to:
  • specific adhesives (cyanoacrylate, octyl/butyl esters),
  • specific filler bases (HA, collagen, hydroxyapatite, PLLA, silicone, PMMA),
  • specific CSA chemical identity and salt form (CSA-131; 1,5-naphthalenedisulfonic acid salt),
  • measurable comparative outcomes (biofouling protection duration; anti-inflammatory enhancement).

That laddering supports both broad licensing (claim 1) and fallback positions for litigation (dependents).

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Which competitors face the highest US exposure?

Highest exposure categories

Products that are likely to intersect with claim 1 and/or claims 15/18 share these characteristics:

• Injectable soft tissue filler that includes a tissue adhesive component
• Uses a cationic steroidal antimicrobial active in meaningful loading (0.1% to 30% w/w)
• Designed to reduce infection/biofilm after injection or wound closure
• Uses procedural contexts like closure, embolization, or fistula occlusion

Medium exposure categories

• Cyanoacrylate-based tissue adhesives used for wound closure that also incorporate CSA actives.
• Soft tissue fillers without cyanoacrylate but with another tissue adhesive that still qualifies as “tissue adhesive.”

Lower exposure categories

• Fillers that are injectable but have no adhesive component.
• Products using non-CSA antimicrobials that compete on infection control but avoid CSA class.

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Does US 10,226,550 cover biosimilar or generic-type “entry” risks?

This is not a biologics biosimilar scenario. The “entry risk” is more analogous to:

• formulation substitution risk (changing CSA identity, salt form, loading, release kinetics),
• delivery architecture risk (removing/altering adhesive content; changing matrix such that it does not form the claimed bolus/reservoir/time-release profile),
• use-case risk (avoiding embolization/occlusion or wound closure indications that are central to method claims).

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Timeline and exclusivity: when does protection likely run?

A full exclusivity timeline requires filing and patent term data for US 10,226,550 and any terminal disclaimers or PTA. That information is not provided here, so no definitive expiration date can be stated.

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How strong are the claims for litigation? (claim-to-attack mapping)

Best claim positions

• Claim 1 is the broadest and most commercially relevant because it is not limited to cyanoacrylate.
• Claim 15 and claim 18 create enforceable theories for actual procedures.
• Dependent claims 2-3 and 19 are valuable if accused products explicitly use cyanoacrylate and the claimed CSA-131 salt form.

Likely attack vectors

1. Claim construction fights
   • meaning of “tissue adhesive”
   • meaning of “bolus having a reservoir” and what constitutes “matrix” distribution
   • meaning of “effective time release”
2. Literal infringement boundaries
   • CSA loading at exactly or near the numeric threshold
   • whether CSA inclusion is “incorporated into” the filler material vs merely coated on or contained in a separate compartment
3. Performance evidence
   • comparative performance requirements in claims 13-14 often require substantial data alignment
4. Design-around via actives
   • using different antimicrobial classes or different steroidal cationic species that competitors will argue are outside the CSA definition
   • choosing CSA derivatives that are not “CSA-131” and do not use claimed salt forms

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What patent estate conclusions can be drawn from only US 10,226,550’s claim set?

From the claim language alone, the estate’s functional thesis is clear:

• antimicrobial activity is delivered from within a syringe-injectable adhesive-containing soft tissue filler matrix
• the composition forms an in-situ structure that holds CSA and releases it over time
• methods target infection control for injected materials and wound/tissue adhesive applications

Commercially, that thesis supports licensing and enforcement focused on products marketed for infection/biofilm mitigation after injection, wound closure, embolization, or fistula occlusion.

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Key Takeaways

• US 10,226,550 claims a soft tissue filler/tissue glue composition with 0.1% to 30% (w/w) CSA compounds that form an in-situ bolus delivering time-release antimicrobial activity from within the matrix.
• The composition scope is broad on the soft tissue filler base and CSA class, while dependent claims narrow to cyanoacrylate adhesives (octyl/butyl esters), specific filler bases (HA, collagen, hydroxyapatite, PLLA, silicone, PMMA), and specific CSA identity/form (CSA-131; sulfonic acid addition salts including 1,5-naphthalenedisulfonic acid).
• Method claims focus on microbial growth control in injected soft tissue contexts including embolization and fistula occlusion, and on wound closure/tissue adhesive applications using cyanoacrylate plus CSA.
• Litigation strength hinges on whether accused products meet the claim’s structural architecture (adhesive-containing matrix, CSA distributed reservoir) and functional release (effective time release), and whether they remain within the CSA loading window and CSA definition.

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FAQs

1. What does “CSA compounds incorporated into the soft tissue filler material” imply for product design?
It implies the CSA is in the filler matrix rather than only surface-applied or contained in a non-integrated compartment; infringement will turn on how CSA is physically distributed and how it contacts the in-situ bolus environment.

2. If a product uses cyanoacrylate but contains less than 0.1% w/w CSA, is it automatically outside US 10,226,550?
It may avoid literal infringement of claim 1’s numeric range, but it still faces risk under any remaining claim coverage depending on how claim construction and related dependents are handled.

3. Does the patent require that the soft tissue filler be bioabsorbable?
No. Bioabsorbability is a dependent limitation (claim 4). Claim 1 can cover non-bioabsorbable syringe-injectable adhesive-containing filler materials.

4. Can an accused product avoid the patent by removing the cyanoacrylate adhesive?
Removing cyanoacrylate may avoid dependent claims 2-3 and related method theory under claim 18, but claim 1 and claim 15 can still apply if the product still contains a qualifying “tissue adhesive” and includes CSA within the claimed loading and release architecture.

5. Are method claims broader for embolization/occlusion or wound closure?
They are both covered: claim 15 covers injection of a tissue glue to embolize/occlude, while claim 18 covers applying/injecting a cyanoacrylate tissue adhesive onto wounds and includes the same embolize/occlude outcomes plus microbial killing.

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References (APA)

1. US Patent 10,226,550. “Soft tissue filler composition comprising cationic steroidal antimicrobial compounds,” claims as provided in the prompt.

Details for Patent 10,226,550

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	December 09, 1991		2037-03-09
Abbvie Inc.	BOTOX	onabotulinumtoxina	For Injection	103000	December 09, 1991		2037-03-09