Patent: 10,722,552

Summary for Patent: 10,722,552

Title:	Treatment of autism using botulinum toxins
Abstract:	A method of treating ASD (autism) in a patient in need thereof comprises administering a botulinum toxin to the patient. The botulinum toxin may be administered by subcutaneous/intradermal injection. The subcutaneous/intradermal injection may be administered to and/or around the vicinity of a trigeminal nerve, a cervical nerve, a thoracic nerve, a lumbar nerve, and a sacral nerve of the patient. In infants or toddlers--from about 1 to 5 year olds, it is used to prevent or minimize damage to the developing brain; in older children and adult Autism Spectrum Disorder (ASD) patients, it will be used to reduce or eliminate their symptoms.
Inventor(s):	Williams; Roland M. (Beaumont, TX)
Assignee:	PENLAND FOUNDATION (Beaumont, TX)
Application Number:	16/657,933
Patent Claims:	see list of patent claims

Patent 10,722,552 Autism Botulinum Toxin Claims and US Patent Landscape (Method-of-Use, Dosage, Nerve Targets, and Generic/Biosimilar Risk)

United States Patent 10,722,552 claims a method of treating autism spectrum disorder (ASD) by administering botulinum toxin (broadly typed A-G and variants) using subcutaneous or intradermal injections at specified peripheral nerve vicinities (trigeminal, cervical, thoracic, lumbar, sacral) with small per-site doses (2-4 units) and caps at ≤50 units total for an adult ~150 lbs, with dose adjustment by weight/age. The claim set is structurally constrained by (i) the ASD treatment context, (ii) injection route and site dosing pattern, (iii) peripheral nerve/vicinity targeting across multiple spinal levels, and (iv) total-dose ceilings.

This is a highly targeted method-of-use profile. The enforceable value is driven less by “botulinum toxin for anything” and more by whether competitors can avoid one or more claim pillars: ASD use, subcutaneous/intradermal route, nerve-vicinity pattern, and unit-dose ceilings and dosing adjustments.

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What claims does US Patent 10,722,552 cover for autism treatment with botulinum toxin?

1) Independent claim 1: ASD method-of-use with multi-nerve, low-unit subcutaneous/intradermal injections

Claim 1 requires all of the following:

• Therapeutic indication: treating autism spectrum disorder (ASD) (and a broader “autism” label).
• Active: botulinum toxin administered to a patient in need thereof.
• Route and administration form: subcutaneous or intradermal injection.
• Site dosing constraints:
  • Trigeminal nerve vicinity: 2-4 units to and/or around the vicinity of a trigeminal nerve.
  • Cervical nerve vicinity: 2-4 units to and/or around a cervical nerve, lateral to the spine.
  • Thoracic nerve vicinity: 2-4 units to and/or around a thoracic nerve, lateral to the spine.
  • Lumbar nerve vicinity: 2-4 units to and/or around a lumbar nerve, lateral to the spine.
  • Sacral nerve vicinity: 2-4 units to and/or around a sacral nerve, lateral to the spine.
• Total adult dose ceiling:
  • For an adult weighing about 150 lbs, total dosage ≤ 50 units.
• Dose adjustment rules:
  • Total dosage is adjusted for weight.
  • Total dosage for children over about 5 years old and toddlers about 1 to 5 years old is adjusted for age, weight, or combination.

Claim construction risk/importance: Each constraint is likely to be treated as a separate limitation, meaning a design-around can target any one: e.g., a different route (IM instead of subcutaneous/intradermal), different dose range (higher than 2-4 units per site), different total-unit scheme, or different anatomical targets (not “vicinity” of trigeminal/cervical/thoracic/lumbar/sacral nerves).

2) Dependent claims: nerve subtype lists, toxin types, and “bilateral” injections

The dependent claims add narrower anchors:

• Claim 2 (trigeminal nerve selection): defines trigeminal branches/related nerves such as ophthalmic (V1), maxillary (V2), mandibular (V3), supra-orbital, infra-orbital, lacrimal, nasociliary, buccal, lingual, inferior alveolar, mental, auriculotemporal, occipital branches (lesser/greater), etc.
• Claim 3 (cervical nerve selection): defines C2–C8.
• Claim 4 (botulinum toxin selection): types A-G plus fragments/hybrids/chimeras.
• Claim 5 (symptom reduction window): reduces/eliminates ASD symptoms in:
  • children over about 5 years old where “brain formation has ceased”
  • adults
• Claim 6 (bilateral injection): each injection bilateral.
• Claim 7–9 (thoracic/lumbar/sacral subtype lists):
  • Thoracic: T2, T3, T5–T12 (note missing T1, T4).
  • Lumbar: L1–L5 (list shown as “1-1” through “1-5”).
  • Sacral: S1–S5.

Practical claim impact: The independent claim already covers “trigeminal/cervical/thoracic/lumbar/sacral vicinity” broadly. The dependent claims then lock in specific subtypes. A would-be infringer that targets trigeminal/cervical/thoracic/lumbar/sacral but chooses different sub-branches may still fall within claim 1 unless claim 1 is construed as requiring a specific nerve or “vicinity” pattern that must match the listed ones. Conversely, a competitor that targets only some regions may avoid the all-region structure.

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How strong is the patent estate for botulinum toxin in autism (and where is it most vulnerable)?

The estate’s enforceability core

US 10,722,552’s strength is concentrated in:

1. Indication specificity (ASD treatment).
2. Anatomical target scheme: trigeminal plus multi-level spinal-lateral nerve vicinities.
3. Route specificity: subcutaneous or intradermal.
4. Dose architecture:
   • per-site 2–4 units
   • adult total ≤50 units for ~150 lbs
   • pediatric/weight/age adjustments.

Those four pillars are uncommon in standard botulinum toxin therapeutic disclosures for mainstream indications, which are typically ophthalmology, spasticity, dystonia, and other defined neuromuscular or glandular targets. If prior art exists for ASD symptom treatment with botulinum toxin, the key question is whether it used the same route, anatomical nerve vicinity strategy, and dose ceilings.

Where competitors can design around

The most direct design-around points are:

• Route switch: using a different administration route than subcutaneous/intradermal (if competitors can do so while retaining effectiveness).
• Anatomical strategy: avoiding injection “to and/or around the vicinity” of the specified peripheral nerves, or using different target structures.
• Dose ceiling evasion:
  • exceeding total adult unit cap for the relevant reference body weight
  • or using different per-site unit dosing outside 2–4 units.
• Population/dosing rules: shifting away from the age/weight adjustment rules as recited (though this may be hard to operationalize without changing clinical protocol intent).

Litigation leverage

If enforced, the pattern of limitations suggests the patentee can focus discovery on:

• the exact clinical protocol used in accused treatments,
• injection maps and image-guided documentation tying administrations to specific nerve vicinities,
• unit dosing records,
• product used (toxin type A vs B etc.),
• and whether treatments were aimed at ASD symptoms and documented outcomes.

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What patents protect autism treatment using botulinum toxin in the US beyond US 10,722,552?

No additional, verifiable patent data is included here. The request requires a comprehensive landscape (related applications, continuations, family members, other assignees, validity challenges, and Orange Book status where relevant). Without a specific dataset of US publications, filings, and legal status for this patent number, a complete and accurate map of the US patent landscape cannot be produced.

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When does US 10,722,552 expire and what exclusivity windows matter for generic entry?

No reliable expiration/exclusivity calculation is included here. A precise expiration date requires the patent’s critical dates (filing date, priority, and any PTA/adjustments) and any related term-extending provisions. Those dates are not provided in the prompt, and an accurate timeline cannot be generated.

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Can a Paragraph IV challenge be brought against botulinum toxin autism methods?

No legal actionable assessment is included here. Method-of-use patents tied to drug administration for ASD do not map cleanly onto FDA Orange Book listing mechanics for typical ANDA/Hatch-Waxman challenges, and biosimilar/505(b)(2) pathways can differ. A competent evaluation requires Orange Book listing status, patent identifiers used for FDA listing, and the method-of-use listing type, none of which are supplied.

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What formulations are protected (toxin type A-G, fragments, hybrids, chimeras) and what does that mean for workarounds?

Claim 4 is unusually broad on toxin identity:

• Botulinum toxin type A through G.
• Fragments, hybrids, and chimeras.
• “Combination thereof.”

Implication for design-around: switching toxin type is unlikely to avoid coverage if the same dosing/route/anatomy/asd method is used, because claim 4 reads onto multiple toxin types and engineered variants. A workaround must likely be anatomical, route-based, or dosing-based rather than purely product-based.

Caveat for competition strategy: Many botulinum toxin commercial products differ in units-of-potency and labeling conventions. If the claim ties to “units” as administered, competitors must ensure they remain outside both the per-site unit range (2–4 units) and total-dose scheme. If dosing units are interpreted in line with the product’s labeling, a product switch could still create a route for non-infringement only if the dosing protocol avoids claim unit limits.

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How do the dependent claims expand coverage for nerve branch selection and bilateral injections?

Nerve branch specificity

Claims 2, 3, 7, 8, and 9 define which specific nerves can be selected. This narrows the claim but also helps enforceability because the patent identifies named targets rather than generic “near nerve” language.

Bilateral requirement

Claim 6 states each injection is bilateral. If a competitor uses unilateral injections (or a mixed unilateral/bilateral scheme) while following other parameters, that may avoid claim 6 but may not avoid claim 1 unless claim 1 itself requires bilateral administration.

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Which competitors are most likely to face patent infringement risk for ASD botulinum toxin?

No competitor infringement mapping is included here. A high-integrity answer depends on identifying specific US clinics/providers and their published protocols, then matching those protocols to nerve targeting and dosing. The prompt does not contain provider protocol references, and a non-evidenced list is not actionable for litigation risk.

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What FDA regulatory status affects enforceability (Orange Book listings for method-of-use patents)?

No FDA status is included here. Orange Book listing status for method-of-use patents is essential to evaluate enforcement mechanics and the practical leverage of Hatch-Waxman. The prompt does not include the Orange Book identifiers, NDA/BLA numbers, or listing records for US 10,722,552.

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Key Takeaways

• US 10,722,552 is a method-of-use patent for ASD treatment using botulinum toxin administered by subcutaneous or intradermal injections with a defined multi-level trigeminal and spinal nerve-vicinity targeting plan.
• The claims are structured around dosing architecture: 2–4 units per injection/site and an adult total cap ≤50 units for ~150 lbs, with explicit weight and age adjustment rules.
• The estate’s practical strength is in enforceability against protocols that match route, anatomy, and unit-dose caps; toxin-type switching is unlikely to avoid coverage due to the broad A-G plus fragments/hybrids/chimeras language.
• Design-around opportunities likely center on changing route, changing anatomical targeting, or escaping the defined unit-dose scheme rather than changing toxin type.

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FAQs

1. Does changing botulinum toxin type (A vs B) avoid US 10,722,552 infringement?
   Likely not by itself because the claims cover types A-G and engineered variants.

2. If a clinic injects botulinum toxin for ASD intramuscularly instead of subcutaneous/intradermal, does that matter?
   Yes, route is an explicit claim limitation.

3. Is it enough to target only trigeminal nerves without cervical/thoracic/lumbar/sacral injections?
   Claim 1 requires the multi-region nerve-vicinity dosing scheme across the recited regions.

4. Can unilateral-only dosing avoid the claim scope?
   Claim 6 requires bilateral injections, but claim 1 itself does not state bilateral; infringement turns on which claims are asserted and how claim 1 is construed.

5. Do the “units” limits depend on product labeling conventions?
   The claim recites unit amounts; whether those units align with a product’s potency definition affects non-infringement but requires protocol- and product-specific alignment.

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References

No sources are cited because the prompt does not provide the underlying bibliographic or legal records needed to support an evidence-based patent landscape analysis for US 10,722,552.

Details for Patent 10,722,552

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846	December 08, 2000		2039-10-18