United States Patent 11,535,650: Scope, Claim Structure, and US Landscape
What does US 11,535,650 claim, in operational terms?
US Patent 11,535,650 is directed to a pharmaceutical composition defined by inclusion of:
- A polypeptide defined as “the polypeptide of the formula: (SEQ ID NO: 194)”
- A pharmaceutically acceptable carrier or excipient
- With dependent limitation in claim 2 to sterile aqueous solution.
The two claims provided define a narrow composition framework:
- Claim 1 covers composition format (polypeptide + carrier) without restricting dosage form beyond “pharmaceutical composition.”
- Claim 2 narrows the formulation to a sterile aqueous solution.
How broad is the claim scope?
Claim 1 breadth is driven by SEQ ID NO: 194. Patent scope hinges on the identity of the polypeptide sequence. Because the only substantive element besides excipients is a single sequence identifier, the claim is typically construed as covering:
- Compositions containing the exact polypeptide corresponding to SEQ ID NO: 194, irrespective of:
- concentration (not stated in the claim excerpt),
- route of administration (not stated),
- specific excipient selection (not limited),
- manufacturing format (not limited).
Claim 1 also does not limit whether the polypeptide is:
- free vs. conjugated to another moiety,
- monomeric vs. aggregated,
- present as a native sequence vs. a specific post-translationally processed form,
unless that is inherent in what “polypeptide of the formula (SEQ ID NO: 194)” means under the patent’s specification (not provided here).
Claim 2 narrows dosage form only by formulation state:
- “sterile aqueous solution” restricts the physical form and sterility condition.
- It does not restrict buffer identity, tonicity agents, pH, or stabilizers (not stated in the excerpt).
What is the likely claim construction anchor (SEQ ID NO: 194)?
In composition claims that hinge on a single SEQ ID NO, infringement and validity analyses in the US market typically resolve around:
- Whether an accused product contains the polypeptide that matches SEQ ID NO: 194 (sequence identity and mapping to the defined polypeptide).
- Whether the composition meets the other claim elements:
- “pharmaceutically acceptable carrier or excipient” is broadly satisfied by conventional formulation vehicles.
- “sterile aqueous solution” is satisfied by any conventional sterile injectable solution if the polypeptide is present.
Because the claim excerpt provides only two claims, the scope picture is correspondingly minimal: there is no explicit coverage stated for dosing regimen, target, mechanism, route, therapeutic indication, manufacturing method, or combination therapy in the claim text you provided.
What do claim 1 and claim 2 cover, element by element?
Claim 1: pharmaceutical composition
Claim 1 text elements
- “A pharmaceutical composition comprising”
- “a polypeptide of the formula (SEQ ID NO: 194)”
- “and a pharmaceutically acceptable carrier or excipient.”
Scope consequences
- “comprising” is open-ended: additional ingredients are not excluded by the claim wording.
- Carrier/excipient is functional: any pharmaceutically acceptable excipient qualifies.
- No route or indication limitation appears in the claim excerpt.
Claim 2: sterile aqueous solution
Claim 2 text elements
- Depends from claim 1
- Adds: “wherein the pharmaceutical composition is a sterile aqueous solution.”
Scope consequences
- The formulation must be aqueous and sterile.
- It does not require specific sterility assurance level language in the excerpt, but in practice this means a product manufactured under conditions that meet sterility requirements (e.g., standard sterile injectable manufacturing).
How does this claim structure map to real-world product design?
Design space that is likely inside scope
- A drug product that includes the SEQ ID NO: 194 polypeptide and uses standard excipients (buffers, tonicity agents, stabilizers).
- Any sterile aqueous formulation of that polypeptide (claim 2).
Design space that is likely outside scope
- A product that uses a different polypeptide sequence than SEQ ID NO: 194.
- A product that uses non-aqueous or non-sterile formats (e.g., solid dosage, lyophilized product not reconstituted at the time of administration) for claim 2.
- Formulations where the therapeutic substance is not the polypeptide defined as SEQ ID NO: 194 (even if biologically related).
What is the patent landscape around composition claims tied to a specific sequence?
US landscape pattern: sequence-defined composition tends to cluster around similar claims
Within the US, patents that claim:
- a composition containing a defined polypeptide sequence, and
- optionally a specific formulation state (sterile aqueous solution),
often sit in one of two layers:
-
Primary composition patents
Claim the exact sequence (SEQ ID NO) with generic excipients and sometimes sterility/formulation limitations.
-
Secondary formulation patents
Claim specific buffers, pH windows, stabilizers, container closure systems, or manufacturing steps.
In this excerpt, the formulation limitation in claim 2 is high-level (sterile aqueous solution), which usually leaves room for other patents that narrow with formulation specifics. Those are not identifiable here without the specification or a database query.
Freedom-to-operate (FTO) implications
For an FTO assessment, this claim set typically creates two gating questions:
- Sequence gating
- If the polypeptide does not match SEQ ID NO: 194, the claim likely does not read on the product.
- Formulation gating (for claim 2)
- If the product is not a sterile aqueous solution, claim 2 likely does not read, even if claim 1 might still be considered depending on what constitutes “pharmaceutical composition” under the broader claim 1.
Given that claim 1 is not limited to sterility or aqueous solution, a non-sterile or non-aqueous format still faces claim 1 risk if it contains the SEQ ID NO: 194 polypeptide in a pharmaceutically acceptable composition.
Scope vs. typical US validity risks for sequence-defined claims
Without the specification, the main risk drivers in US litigation and PTAB proceedings for sequence-defined composition claims are usually:
- Anticipation/Obviousness based on prior art sequences
If prior art discloses the same sequence (SEQ ID NO: 194) in a composition, novelty and non-obviousness become attack points.
- Claim breadth and written description/enablement
If the specification does not support the full breadth implied by “pharmaceutically acceptable carrier or excipient” (claim 1), or by the formulation state in claim 2, enablement and written description can be litigated.
- Definitional ambiguity
“polypeptide of the formula: (SEQ ID NO: 194)” typically clarifies sequence, but disputes can arise over:
- what constitutes the “polypeptide” (full-length vs. processing forms),
- whether post-translational modifications are inherent or required.
These validity factors cannot be evaluated to conclusion from the excerpt alone, but they define how the claim scope would be tested in practice.
Claim coverage matrix for product variants (based on the excerpt)
| Product variant |
Claim 1 (polypeptide SEQ ID NO: 194 + excipient) |
Claim 2 (sterile aqueous solution) |
| Contains SEQ ID NO: 194; standard excipients; any dosage format |
Likely within if composition is “pharmaceutical” and includes acceptable excipient |
Only if also sterile aqueous |
| Contains SEQ ID NO: 194; sterile aqueous solution |
Yes |
Yes |
| Does not contain SEQ ID NO: 194; excipients only |
No |
No |
| Contains SEQ ID NO: 194; non-sterile aqueous |
Likely within |
Likely outside claim 2 |
| Contains SEQ ID NO: 194; non-aqueous sterile formulation |
Likely within claim 1 |
Likely outside claim 2 |
Actionable takeaways for R&D and licensing
Key practical conclusions from the claim text
- The core IP hook is the sequence identity: SEQ ID NO: 194.
- Claim 1 is form-agnostic beyond “pharmaceutical composition” and excipient acceptability.
- Claim 2 is form-restricted to sterile aqueous solution, which matters for:
- sterile injectable liquids,
- solutions filled into vials/syringes,
- formulations that meet sterility requirements.
Licensing and design-around strategy implied by the claims
- Any design-around depends on sequence (avoid SEQ ID NO: 194) or formulation state only for claim 2.
- If SEQ ID NO: 194 is unavoidable due to biology, then formulation strategy alone is less likely to eliminate exposure because claim 1 lacks sterility/aqueous limitations.
Key Takeaways
- US 11,535,650 claims a composition defined by one polypeptide sequence (SEQ ID NO: 194) plus pharmaceutically acceptable excipients.
- Claim 1 is broad across dosage format and only requires the polypeptide and carrier/excipient.
- Claim 2 narrows to a sterile aqueous solution, affecting liquid sterile product formats but not claim 1.
- The landscape impact of this claim set is primarily driven by whether a competitor product contains SEQ ID NO: 194; formulation choices matter mainly for claim 2.
FAQs
1) Does claim 1 require the product to be sterile or aqueous?
No. Claim 1 requires only a pharmaceutical composition that includes the SEQ ID NO: 194 polypeptide and a pharmaceutically acceptable carrier or excipient.
2) What is the limiting factor for infringement risk?
Sequence identity to SEQ ID NO: 194 is the main limiting factor because it is the only specific substantive active component defined in the excerpt.
3) What does claim 2 add beyond claim 1?
Claim 2 adds the requirement that the composition is a sterile aqueous solution.
4) Can a product include additional ingredients and still infringe?
The claim uses “comprising,” so additional components are not excluded by claim language in the excerpt, as long as the SEQ ID NO: 194 polypeptide and qualifying excipients are present.
5) If a competitor uses a different formulation vehicle, is claim 2 avoided?
Claim 2 requires “sterile aqueous solution.” Using a different excipient set does not avoid claim 2 if the product remains a sterile aqueous solution containing SEQ ID NO: 194.
References
[1] US Patent 11,535,650 (claims provided in user prompt).
