United States Patent 10,570,142: Scope, Claim Architecture, and Patent Landscape
US Patent 10,570,142 claims a single, highly defined (S)-enantiomer small-molecule (as a 4-methylbenzenesulfonate salt) with minimum enantiomeric excess thresholds and a broad set of oncology treatment method claims across multiple hematologic malignancies, including leukemia/lymphoma and several myeloma-related disorders. The enforceable core is the combination of (i) the exact chemical structure, (ii) salt form, and (iii) enantiomeric purity (≥95% or ≥98%), then applied to (a) pharmaceutical compositions and (b) treatment regimens with optional combination therapy.
What is claimed: the chemical and its enforceable boundaries?
Claim 1 defines the active ingredient with enantiomer and salt specificity
Claim 1 is directed to:
- Compound identity (structure):
(S)-2-(1-(4-amino-3-(3-fluoro-4-isopropoxyphenyl)-1H-pyrazolo[3,4-d]-pyrimidin-1-yl)ethyl)-6-fluoro-3-(3-fluorophenyl)-4H-chromen-4-one 4-methylbenzenesulfonate
- Enantiomeric excess requirement:
ee ≥ 95%
This claim is the main infringement anchor because all downstream claims depend on administering or formulating the specific structure/salt and meeting the ee threshold.
Claim 3 raises the ee threshold for compositions
- Claim 3: composition of claim 2 where ee ≥ 98%
This creates a two-tier purity strategy: one tier supports baseline composition/treatment (≥95%) and a second tier supports narrower, higher-purity variants (≥98%). The difference matters for product development and clearance of prior-art and freedom-to-operate (FTO) workstreams.
How is the patent’s claim set structured and what does it cover?
Independent claim structure
From the text provided, the patent has these claim roles:
- Product/active ingredient claim:
Claim 1 (compound)
- Composition claim:
Claim 2 (composition: compound + pharmaceutically acceptable carrier)
- Treatment claims:
Claims 4 and 8 and 11 and 14 and 17 and 23 and 26 and 29 are method categories (treatment of specified hematologic cancers), with combination-therapy add-ons and ee thresholds.
Dependent claim upgrades that tighten scope
Key dependent-claim “toggles”:
- ee upgrade:
- Claims 5, 9, 12, 15, 18, 24, 27, 27/28/29 chain equivalents: methods/compositions where ee ≥ 98%
- Combination regimen add-on:
- Claims 6, 10, 13, 16, 19, 25, 28: administer simultaneously or sequentially with at least one other anti-cancer agent
- Disease specificity expansions:
- broad “leukemia selected from …” list appears in Claim 7
- lymphoma and lineage-based categories broaden further in Claims 17, 20-22, 23, 26
What diseases and indications are explicitly covered?
Leukemia and lineage-based claims
Claim 4: method for treatment of leukemia with the compound (ee ≥95%).
Claim 7: leukemia is selected from a long enumerated list:
- acute leukemia
- acute lymphocytic leukemia
- acute lymphoblastic leukemia
- acute myelocytic leukemia
- acute myelogenous leukemia
- promyelocytic leukemia
- chronic myelogenous leukemia
- promyelocytic leukemia (appears in the list as written)
- chronic lymphocytic leukemia
- acute myeloid leukemia
- chronic granulocytic leukemia
- hairy-cell leukemia
- erythroleukemia
Specific leukemia subtype claim
Claim 8: method for treating chronic lymphocytic leukemia (CLL) (human subject; ee ≥95%).
Claim 9 upgrades to ee ≥98%.
Claim 10 allows addition of another anti-cancer agent.
Lymphoma claims
Claim 11: method for treating diffuse large B-cell lymphoma (DLBCL) (human; ee ≥95%).
Claim 12: ee ≥98%.
Claim 13: add another anti-cancer agent.
Claim 14: method for treating non-Hodgkin lymphoma (NHL) (human; ee ≥95%).
Claim 15: ee ≥98%.
Claim 16: add another anti-cancer agent.
Broadened lymphoid lineage, B-cell, T-cell, Hodgkin’s and related
Claim 17: method for treatment of:
- lymphoid lineage
- B-cell lymphoma
- T-cell lymphoma
- Hodgkin’s lymphoma
- hairy cell lymphoma
- Burkett’s lymphoma
in a subject (ee ≥95%).
Claim 18: ee ≥98%.
Claim 19: add another anti-cancer agent.
Claims 20-22 specify disease category for subjects:
- Claim 20: B-cell lymphoma
- Claim 21: T-cell lymphoma
- Claim 22: Hodgkin’s lymphoma
Further hematologic expansion to myeloid lineage and multiple myeloma spectrum
Claim 23 expands indications to:
- lymphoid lineage
- B-cell lymphoma
- T-cell lymphoma
- Hodgkin’s lymphoma
- hairy cell lymphoma
- Burkett’s lymphoma
- hematopoietic tumors of myeloid lineage
- multiple myelomas
- smoldering multiple myeloma
- nonsecretory myeloma
- osteosclerotic myeloma
- plasma cell leukemia
- solitary plasmacytoma
- extramedullary plasmacytoma
(ee ≥95%).
Claim 24: ee ≥98%.
Claim 25: combination with another anti-cancer agent.
Claim 26 further lists (method for) a detailed set of myeloma and lymphoma subtypes:
- multiple myeloma (MM)
- small lymphocytic lymphoma (SLL)
- indolent non-Hodgkin’s lymphoma (I-NHL)
- mantle cell lymphoma (MCL)
- follicular lymphoma
- Waldenstrom’s macroglobulinemia (WM)
- T-cell lymphoma
- B-cell lymphoma
(ee ≥95%).
Claim 27: ee ≥98%.
Claim 28: combination regimen add-on.
Claim 29 narrows to a subject with multiple myeloma.
What is the scope of enforceability across ee thresholds (≥95% vs ≥98%)?
The claim text creates enforceability splits:
| Claim set element |
Enantiomeric excess requirement |
Scope impact |
| Claim 1 compound |
≥95% |
Baseline protection for the salt and the S-enantiomer at high ee |
| Claims 2, 4, 7, 8, 11, 14, 17, 23, 26, 29 methods/compositions |
≥95% |
Broad indication coverage provided purity meets ≥95% |
| Claims 3, 5, 9, 12, 15, 18, 24, 27 |
≥98% |
Additional narrower protection for higher-purity formulations and regimens |
Practical scope read-through: if a competitor produces an isomeric mixture at ee <95%, the claims as written do not cover it. If ee is between 95% and 98%, the patent’s ≥95% claims remain in play while ≥98% dependent claims do not add coverage.
How broad is the treatment/regimen claim structure (monotherapy vs combo)?
Monotherapy core
Every method claim (e.g., Claims 4, 8, 11, 14, 17, 23, 26) can be read as covering a regimen that administers “an effective amount” of the specified compound.
Combination-therapy extension
Each combination-dependent claim uses the same operative language:
- “further comprising the step of administering simultaneously or sequentially to [subject] at least one other anti-cancer agent.”
That means infringement does not require concurrent dosing; sequential dosing can suffice.
Combination logic effect: the patent is enforceable against combination regimens using another oncology drug, so long as the administered agent is the claimed compound (with the required ee threshold).
What does the patent landscape likely look like around this exact compound claim?
The claim strategy here is typical of follow-on protection structures in kinase-targeting oncology families: one of the strongest infringement levers is the specific stereoisomer + salt + ee threshold, which can capture:
- “same molecule” products with controlled enantiopurity,
- clinical candidates in later programs built on an earlier racemic or lower-ee lead,
- formulation pipelines that standardize salt form.
Landscape nodes to map (based on the claim language)
Even without additional bibliographic fields, the patent text indicates the landscape will cluster around:
-
Earlier disclosures of the underlying scaffold
- The claimed molecule includes a complex fused heterocycle (pyrazolo[3,4-d]pyrimidine) and a coumarin-like (chromen-4-one) system.
- Those motifs are typically disclosed in earlier family patents or publications as kinase inhibitors.
-
Enantioselective manufacturing and control
- The claims focus heavily on ee (≥95% and ≥98%), implying the landscape likely contains:
- process patents on chiral resolution or asymmetric synthesis,
- analytical control methods (ee testing, chiral HPLC methods) that support commercialization compliance.
-
Salt-form protection (4-methylbenzenesulfonate)
- Salt patents often appear in families as separate filings:
- one covers the compound,
- another covers specific crystalline/salt forms and stability.
-
Therapeutic use across hematology
- Multiple lymphoma/leukemia/myeloma indications are claimed, creating overlap risk with:
- later clinical-stage patents from multiple applicants,
- use patents from originators and licensees covering the same molecule in new hematologic subsets.
Enforcement “gravity” points
Within the claims you provided, enforcement is most likely concentrated on:
- Product infringement: Claim 1 and Claim 2 (compound and composition).
- Regimen infringement: Claims 4, 8, 11, 14, 17, 23, 26 (administration).
- Purity-specific infringement: depending on manufacturing ee:
- if ee ≥95%: broad disease coverage
- if ee ≥98%: additional dependent claim layer
How to read the “scope” from the wording alone (legal-technical boundaries)
What is locked down
The following elements are locked by the claims:
- The stereochemistry: (S)-
- The chemical identity and substitution pattern
- Salt identity: 4-methylbenzenesulfonate
- Minimum enantiomeric excess: ≥95% (and separately ≥98%)
What is flexible
The claims are flexible on:
- formulation type: “pharmaceutically acceptable carrier” is broad
- dosing schedule in combo settings: simultaneous or sequential
- oncology comparator in combination: “at least one other anti-cancer agent” does not constrain class
What is tightly bounded by the claim style
- Indications are bounded to leukemia/lymphoma/myeloma-like categories as enumerated.
- The patent text indicates method claims are directed to “a subject” or “a human subject,” with multiple claims explicitly “human.”
Claim-by-claim scope map (condensed)
| Claim no. |
Category |
Covered subject matter |
Key constraint(s) |
| 1 |
Product |
Compound (S-enantiomer + 4-methylbenzenesulfonate) |
ee ≥95% |
| 2 |
Composition |
Compound + carrier |
references Claim 1 |
| 3 |
Composition |
Same as Claim 2 |
ee ≥98% |
| 4 |
Method |
Treatment of leukemia |
references Claim 1 (ee ≥95%) |
| 5 |
Method |
Same as Claim 4 |
ee ≥98% |
| 6 |
Method |
Claim 4 regimen + another anti-cancer agent (seq or sim) |
combination add-on |
| 7 |
Method |
Leukemia subtype list |
enumerated forms |
| 8 |
Method |
Treatment of CLL |
ee ≥95% |
| 9 |
Method |
CLL variant |
ee ≥98% |
| 10 |
Method |
CLL + other anti-cancer agent |
combo add-on |
| 11 |
Method |
DLBCL |
ee ≥95% |
| 12 |
Method |
DLBCL variant |
ee ≥98% |
| 13 |
Method |
DLBCL + other anti-cancer agent |
combo add-on |
| 14 |
Method |
NHL |
ee ≥95% |
| 15 |
Method |
NHL variant |
ee ≥98% |
| 16 |
Method |
NHL + other anti-cancer agent |
combo add-on |
| 17 |
Method |
Lymphoid lineage and multiple lymphoma classes |
ee ≥95% |
| 18 |
Method |
Dependent |
ee ≥98% |
| 19 |
Method |
Dependent combo |
combo add-on |
| 20 |
Method |
B-cell lymphoma sub-scope |
within Claim 17 |
| 21 |
Method |
T-cell lymphoma sub-scope |
within Claim 17 |
| 22 |
Method |
Hodgkin’s sub-scope |
within Claim 17 |
| 23 |
Method |
Expanded hematology including myeloid tumors and myeloma spectrum |
ee ≥95% |
| 24 |
Method |
Dependent |
ee ≥98% |
| 25 |
Method |
Dependent combo |
combo add-on |
| 26 |
Method |
Myeloma and lymphoma subtype set (MM, SLL, I-NHL, MCL, follicular lymphoma, WM, T-cell, B-cell) |
ee ≥95% |
| 27 |
Method |
Dependent |
ee ≥98% |
| 28 |
Method |
Dependent combo |
combo add-on |
| 29 |
Method |
MM-only sub-scope |
within Claim 26 |
Key takeaways
- The patent’s enforceable core is the exact (S)-enantiomer of the specified scaffold as the 4-methylbenzenesulfonate salt, with a hard enantiomeric excess floor of ≥95% (and an additional layer at ≥98%).
- Coverage spans compound, composition, and multiple hematologic treatment methods, with broad indication lists across leukemia/lymphoma and the multiple myeloma spectrum.
- Combination therapy scope is expanded through dependent claims that allow simultaneous or sequential administration with “at least one other anti-cancer agent,” without restricting the partner drug class.
- From a patent landscape perspective, this claim drafting strongly implies a crowded ecosystem around: enantioselective synthesis/resolution, salt/form selection, and hematologic clinical-use positioning for the same molecular entity.
FAQs
1) Does the patent cover racemic or low-enantiopurity versions of the compound?
No, the claims require (S)- with ee ≥95% (and dependent claims require ee ≥98%).
2) What is the strongest infringement pathway: product or method?
The patent has both, but Claim 1 (compound) and Claim 2 (composition) create a broad product/in-use linkage, while the method claims cover administration regimens across hematologic indications.
3) Do the method claims require combination therapy?
No. Combination-therapy language appears only in dependent claims (e.g., Claims 6, 10, 13, 16, 19, 25, 28). Independent method claims cover monotherapy.
4) Are combination regimens required to be concurrent?
No. The claims expressly allow “simultaneously or sequentially.”
5) Which indication set is the widest in the claim text provided?
The broadest catch is the expanded hematology and myeloma spectrum in Claim 23 and the multi-indication list in Claim 26, both tied to ee ≥95%, with ≥98% dependent coverage.
References
[1] United States Patent 10,570,142 (claim text provided by user).
