United States Patent 10,172,862: Scope of Claims and US Landscape for H3 K27M Midline Glioma Treatment
What does US 10,172,862 claim in plain scope terms?
US 10,172,862 is directed to a method of treating cancer in a subject using a therapeutically effective amount of “compound (1)” (or a pharmaceutically acceptable salt). The method is limited to midline glioma with a histone H3 K27M mutation. The claims then narrow that cancer subtype, mutation identity, and molecular context.
Core claim construct (independent claim 1):
- Treatment modality: method of treating cancer
- Target disease: midline glioma
- Biomarker requirement: histone H3 K27M mutation
- Drug component: compound (1) or a pharmaceutically acceptable salt
- Administration: administering to the subject in need the composition in a therapeutically effective amount
From a freedom-to-operate and landscape perspective, the claims are biomarker- and indication-coupled:
- The chemistry is constrained to compound (1) (definition depends on the specification, not reproduced in the excerpt you provided).
- The patient population is constrained to midline glioma defined by H3 K27M (not merely “glioma”).
- Additional dependent claims add subtype exclusions, mutation variant granularity, and gene-expression markers.
What are the dependent claim layers that narrow or broaden coverage?
Which disease subtypes are included?
Claim 2 narrows included midline gliomas to a defined set:
- diffuse intrinsic pontine glioma (DIPG)
- diffuse midline glioma
- spinal cord glioma
- thalamic glioma
- brainstem glioma
- cerebellar glioma
This is an “enumerated list” that broadly covers midline locations but remains limited to these named tumor categories.
Claim 3 creates a carve-out:
- midline glioma is not a spinal cord tumor
This directly restricts claim 1 coverage when read alongside claims 2 and 3. If a formulation is used for a spinal cord glioma population, claim 3 does not support that use.
Which H3 K27M variants are covered?
Claim 4 limits the K27M mutation identity to:
This is important because H3 K27M can be presented via different histone variants; the claim language restricts coverage to those two.
Which genes encoding the histones are covered?
Claim 5 narrows further to K27M being present in histone genes selected from:
- H3F3A, H3F3B (encoding H3.3 variants)
- HIST1H3A, HIST1H3B, HIST1H3C, HIST1H3D, HIST1H3E, HIST1H3F, HIST1H3G, HIST1H3H, HIST1H3I, HIST1H3J (encoding H3.1 variants)
This gene list functions as a molecular-typing requirement. It also reduces exposure for uses where the K27M alteration maps to a different mechanism outside these loci.
What expression biomarkers are required or allowed?
Claim 6 ties in expression status of two genes in cancerous tissue:
- DRD2 overexpressed
- DRD5 underexpressed
- or both
This claim is structured as an “or both” relationship, so it covers cases with either:
- DRD2 up
- DRD5 down
- or both
Because it is dependent on claim 1, it is not enough to have H3 K27M; the method must also meet the DRD2/DRD5 expression criteria to fall under claim 6.
Who is covered as a subject?
Claims 7–9 add subject-type dependent limitations:
- claim 7: human
- claim 8: domesticated pet
- claim 9: pediatric subject
These do not broaden the disease scope, but they do broaden the covered “subject” dimension for enforcement or licensing:
- If the commercial program is pediatric oncology, claim 9 is directly relevant.
- Animal-use pathways could implicate claim 8 if compound use is pursued in domesticated pets.
What is the effective “claim territory” for R&D planning?
Claim 1 is the enforcement backbone
The practical infringement and licensing unit for US 10,172,862 is claim 1 because it does not require the additional restrictions found in claims 2–6.
Claim 1 territory:
- Disease: midline glioma
- Biomarker: H3 K27M mutation
- Drug: compound (1) or salt
- Use: therapeutically effective administration to a subject
If your pipeline targets any midline glioma with confirmed H3 K27M, and your agent is compound (1), then claim 1 is the first analytical touchpoint.
Dependent claims create “narrower corridors”
Claims 2–6 and 7–9 subdivide the patient population and molecular context.
Narrower corridors (dependent):
- Site/location and tumor subtype list (claim 2)
- Exclusion of spinal cord tumor (claim 3)
- Histone variant selection (H3.3 vs H3.1) (claim 4)
- Specific gene loci encoding H3 K27M (claim 5)
- DRD2/DRD5 expression status (claim 6)
- Human, pediatric, and domesticated pet categories (claims 7–9)
Internal logical interaction to note
Because claim 3 says “midline glioma is not a spinal cord tumor,” but claim 2 includes spinal cord glioma as one selection, the strictest reading for any dependent claim combination is:
- If you are aiming to land inside claim 2 and claim 3 simultaneously, you cannot be in the “spinal cord glioma” category.
- Claim 3 is therefore a meaningful limitation for spinal cord glioma indications.
Where does this sit in the patent landscape for H3 K27M midline gliomas?
Indication and biomarker positioning
US 10,172,862 is a diagnostic-biomarker keyed indication patent. The claims require:
- H3 K27M mutation as a defining disease feature
- “Midline glioma” as the disease category
- Additional molecular marker option: DRD2/DRD5 expression (claim 6)
This placement typically clusters with two other landscape buckets:
- Epigenetic and histone-pathway inhibitors aimed at histone-modification dependencies in H3 K27M glioma.
- Targeted approaches that use RNA/DNA/histone vulnerability mapping coupled to patient selection markers.
Even without the specification and reference documents, the claim language is explicit that the IP is less about a broad “anti-glioma” claim and more about a compound-indication-biomarker nexus.
How to interpret the “compound (1)” dependency
The claim excerpt gives no structure, salt forms, or IUPAC name for “compound (1).” For landscape purposes, that dependency means:
- The enforceable claim scope is locked to the exact compound definition in the patent document.
- Designing around by changing the active molecule may avoid claim coverage unless an asserted “compound (1)” definition includes broad analog or tautomer ranges in the specification (not provided here).
Gene-expression marker inclusion changes the player landscape
Claim 6’s DRD2/DRD5 expression constraint creates a second axis beyond histone K27M:
- Some competitor programs may focus on H3 K27M broadly without intersecting with DRD2/DRD5 expression thresholds.
- If an alternative agent produces efficacy in H3 K27M midline glioma but does not meet the DRD2/DRD5 expression pattern, claim 6 may not be the best fit for enforcement, though claim 1 still may.
Scope analysis by claim number (coverage matrix)
| Claim |
What is required (high-level) |
Practical coverage impact |
| 1 |
Midline glioma + histone H3 K27M; treat using compound (1) or salt |
Base claim; drives core enforcement risk |
| 2 |
Midline glioma is one of listed subtypes (includes DIPG, diffuse midline glioma, spinal cord, thalamic, brainstem, cerebellar) |
Limits disease subset but still broad across midline locations |
| 3 |
Midline glioma is not a spinal cord tumor |
Excludes spinal cord glioma within dependent framework |
| 4 |
H3.3 K27M or H3.1 K27M |
Narrows variant identity; can matter for molecular diagnostics |
| 5 |
Mutation resides in specified histone genes |
Further tightens biomarker definition; affects eligible genotyping results |
| 6 |
In tumor tissue: DRD2 overexpressed and/or DRD5 underexpressed |
Adds expression biomarker condition; can narrow the protected method population |
| 7 |
Subject is human |
Limits subject category |
| 8 |
Subject is domesticated pet |
Expands subject categories beyond humans |
| 9 |
Subject is pediatric |
Broadens within pediatric subset |
Business implications for R&D planning
Patient selection and trial design
Because claims require H3 K27M and optionally DRD2/DRD5 expression, any development program likely faces two parallel tracks:
- Confirm the molecular eligibility (H3 K27M variant and/or gene loci aligned with claim 5)
- Decide whether you will measure or stratify by DRD2/DRD5 expression consistent with claim 6
If your trial inclusion criteria match claim 4 and claim 5 precisely, you align more closely with the patented biomarker definition.
Indication expansion and geographic mapping
Claim 2 lists multiple anatomical tumor categories, including spinal cord and brainstem sites. Claim 3 blocks spinal cord tumor within its dependent limitation. That creates a compliance question for:
- trials including spinal cord glioma populations, versus
- trials that avoid them to fit the dependent claim corridor (if you are trying to reduce overlap with the dependent claim set).
Subject-type risk
If compound (1) is considered for pediatric humans, claim 9 becomes directly relevant. If there are veterinary oncology plans, claim 8 may become a factor in the freedom-to-operate scope.
Key Takeaways
- US 10,172,862 is an indication method patent: treat midline glioma with H3 K27M using compound (1) or its salts.
- Dependent claims narrow coverage by tumor subtype/location (claim 2), spinal cord exclusion (claim 3), H3 variant identity (claim 4), specific histone gene loci (claim 5), and DRD2/DRD5 expression status (claim 6).
- The enforceable “center of gravity” is claim 1, with dependent claims shaping the most likely licensing and litigation corridors for specific populations and biomarker/diagnostic frameworks.
FAQs
1) Does claim 1 require DRD2 or DRD5 expression?
No. DRD2/DRD5 expression appears in claim 6 only; claim 1 requires H3 K27M in a midline glioma and administration of compound (1).
2) Can the method cover spinal cord glioma?
Within dependent claim structure, claim 2 includes spinal cord glioma, but claim 3 excludes spinal cord tumor. That means spinal cord inclusion aligns with claim 2 but conflicts with claim 3’s limitation.
3) Are both H3.1 and H3.3 K27M variants covered?
Yes. Claim 4 explicitly covers H3.3 K27M and H3.1 K27M.
4) Do the claims cover both humans and pets?
Yes. Claim 7 covers humans and claim 8 covers domesticated pets. Claim 9 further adds pediatric as a dependent subject limitation.
5) What is the role of the histone gene list in claim 5?
Claim 5 requires that the H3 K27M mutation be in one or more histone genes selected from a defined list (including H3F3A/H3F3B and multiple **HIST1H3*** genes). It narrows eligible molecular scenarios beyond just “H3 K27M present.”
References
[1] United States Patent No. 10,172,862 (claims provided in prompt).
