United States Patent 11,154,593: Scope of Claims, Claim-Chart Style Boundaries, and US Landscape Read-Through
US Patent 11,154,593 is a composition and method patent centered on a CNP moiety (SEQ ID NO:24) that is amide-linked to a lysine side chain at lysine position 26 and further conjugated to a prodrug “-Z” group in which the prodrug tail is defined by repeating sub-units with 200 to 250 carbon-chain units (c1). The claims ladder from (i) structure variants (IIf / IIf′) to (ii) specific numerical embodiments (each c1 ≈ 225), then to (iii) pharmaceutical compositions with excipients, and (iv) patient-treatment methods for achondroplasia, hypochondroplasia, short stature, Noonan syndrome, or SHOX deficiency.
The claims do not read as a broad class patent over “CNP prodrugs” generally. Instead, the scope is anchored to a very specific linkage geometry (amide bond to the lysine at position 26 of the stated SEQ ID NO:24 CNP) and a very specific prodrug handle (-Z) with a defined integer range for c1.
What does the claim scope actually cover (and what it excludes)?
Core chemical scaffold boundary
All independent claim families (claims 1, 3, 5) reduce to:
- A compound of formula (IIf) or formula (IIf′)
- The compound is a CNP prodrug architecture where:
- The unmarked dashed line indicates attachment to a nitrogen provided by the lysine side chain at position 26 of a CNP moiety of SEQ ID NO:24, by forming an amide bond.
- The asterisk-marked dashed line indicates attachment to a —Z structure in which each —Za has the form wherein each c1 is an integer in the range 200 to 250.
This means the patent is not limited only to a single exact prodrug chain length; it covers any integer c1 between 200 and 250, including intermediate values and mixtures only to the extent the formulation product falls under the structural definition.
What is “IIf” versus “IIf′” within this patent?
Claims 1 and 3 mirror each other with one structural qualifier: claim 3 is directed to “formula (IIf′)” and repeats the same:
- lysine position 26 amide attachment constraint to the SEQ ID NO:24 CNP moiety
- -Z substitution pattern constraint with c1 = 200 to 250
The practical read-through is that IIf′ is a narrower structural subtype (the claim language indicates a distinction in the formula, but the excerpt does not supply the formula details). The patent therefore has overlapping coverage: IIf and IIf′ are distinct claim bases, and infringement depends on which exact structural variant the accused compound matches.
Numeric embodiment lock-in
Claims 2, 4, 6, 20, 22 fix the chain-length parameter:
This creates two tiers of chemical scope:
- Broad tier: c1 is any integer 200 to 250 (claims 1, 3, 5, plus downstream method claims 17/21/23/26 depending on claim dependences)
- Specific tier: c1 about 225 (claims 2, 4, 6 and corresponding method embodiments 20 and 22)
Composition scope is functional, not structural
Claims 7-16 are pharmaceutical composition claims. They do not impose additional structure beyond inheriting claim limitations for:
- which compound/formula (claims 1/2/3/4/5/6 depending on the claim)
- presence of “at least one excipient”
- “consisting of” language in claims 11, 12, 15, 16, limiting the composition to the compound/salt plus excipients (no additional active ingredients implied by “consisting of”).
Method scope ties to labeled indications and patient class
Claims 17-28 are method-of-treatment claims for:
- achondroplasia
- hypochondroplasia
- short stature
- Noonan syndrome
- SHOX deficiency
Patient selection constraints appear in dependent claims:
- pediatric patient (claims 19, 25, 28)
- disease-specific embodiments are called out:
- achondroplasia (claims 18, 24, 27)
Two method claims are also tied to the prodrug chain-length embodiment:
- claims 20 and 22: “wherein each c1 is about 225”
- note that these depend on method claims that are already tethered to claim 17 structure (and thus the specific CNP-lysine-26 amide attachment plus -Z).
Claim-by-claim scope map (what you would test for infringement)
1) Chemical product claims
| Claim |
Product type |
Structural constraints inherited from |
| 1 |
Compound of formula (IIf) or salt |
lysine position 26 (SEQ ID NO:24 CNP moiety) amide to nitrogen; attachment to —Z with c1 = 200–250 |
| 2 |
Compound of claim 1 or salt |
claim 1 + each c1 about 225 |
| 3 |
Compound of formula (IIf′) or salt |
same linkage and -Z but formula base is IIf′ + c1 = 200–250 |
| 4 |
Compound of claim 3 or salt |
claim 3 + each c1 about 225 |
| 5 |
“CNP prodrug” of a specific formula (as excerpted) or salt |
same linkage and -Z but explicitly labeled as CNP prodrug + c1 = 200–250 |
| 6 |
CNP prodrug of claim 5 or salt |
claim 5 + each c1 about 225 |
Infringement targeting: any competitor product that (i) uses the specified CNP moiety (SEQ ID NO:24), (ii) forms an amide bond to the nitrogen on the lysine side chain at position 26, and (iii) attaches a -Z tail whose effective c1 distribution fits 200–250 could fall within claims 1/3/5, and within claims 2/4/6 if c1 is about 225.
2) Pharmaceutical composition claims
| Claim |
Composition claim basis |
Limits |
| 7 |
claim 1 compound + ≥1 excipient |
conventional “comprising” |
| 8 |
claim 2 compound + ≥1 excipient |
conventional “comprising” |
| 9 |
claim 3 compound + ≥1 excipient |
conventional “comprising” |
| 10 |
claim 4 compound + ≥1 excipient |
conventional “comprising” |
| 11 |
claim 9 compound + ≥1 excipient |
“consisting of” (no other actives implied) |
| 12 |
claim 10 compound + ≥1 excipient |
“consisting of” |
| 13 |
claim 5 compound + ≥1 excipient |
conventional “comprising” |
| 14 |
claim 6 compound + ≥1 excipient |
conventional “comprising” |
| 15 |
claim 13 compound + ≥1 excipient |
“consisting of” |
| 16 |
claim 14 compound + ≥1 excipient |
“consisting of” |
Infringement targeting: if a product is a formulation containing the patented prodrug compound, the excipient package generally does not avoid coverage. “Consisting of” claims narrow by excluding additional components beyond compound/salt and excipients.
3) Method-of-treatment claims
| Claim |
Indication set |
Other limits |
Administered compound basis |
| 17 |
achondroplasia, hypochondroplasia, short stature, Noonan syndrome, SHOX deficiency |
none |
claim 1 compound |
| 18 |
achondroplasia |
disease-specific |
claim 1 basis via claim 17 |
| 19 |
same set |
pediatric patient |
claim 1 basis via claim 17 |
| 20 |
same set |
each c1 about 225 |
claim 1 basis via claim 17 |
| 21 |
same set |
formula IIf′ + c1 200–250 |
claim 3 basis via claim 17 |
| 22 |
same set |
c1 about 225 |
claim 3 basis via claim 21 |
| 23 |
same set |
none |
claim 5 prodrug |
| 24 |
achondroplasia |
disease-specific |
claim 5 basis via claim 23 |
| 25 |
same set |
pediatric patient |
claim 5 basis via claim 23 |
| 26 |
same set |
none |
claim 6 prodrug |
| 27 |
achondroplasia |
disease-specific |
claim 6 basis via claim 26 |
| 28 |
same set |
pediatric patient |
claim 6 basis via claim 26 |
Infringement targeting: clinicians or manufacturers are exposed through prescribing/labeling if a specific patented compound is used for these indications. The claims are not limited to dosing regimen, route, or frequency (those details would normally be in the spec or other dependent claims not provided in the excerpt). The key determinants are compound identity and the treatment context (the indications and pediatric subgroup).
Where does the real “scope leverage” sit: chemistry vs indication vs chain-length?
Chemistry is the primary scope lever
The dominant limitations are structural:
- CNP moiety identity via SEQ ID NO:24
- lysine position 26 amide bond to a nitrogen (unmarked dashed line)
- -Z attachment pattern with c1 integer 200–250
If a competitor changes any one of those, they likely exit the claim set. If they keep those and only modify formulation, the composition claims remain at risk.
Indication constraints are still relevant
Even if the chemistry matches, the method claims require treatment of one of the listed conditions. Outside that disease list, the method claims do not map directly.
c1 range defines an “in-range vs out-of-range” design boundary
The patent grants coverage for:
- c1 values across 200-250
- plus a high-confidence subset where c1 is about 225
For product design, “about 225” can be a practical anchor. But the independent coverage already extends across a wide range, so “tuning” the chain length to escape is less likely to succeed unless a competitor can move the c1 distribution outside the 200–250 range or alters the structure so the parameter is no longer the claimed “c1” as defined by the -Za structure.
Competitive patent landscape read-through for US filings (based on the claim architecture)
With the excerpt limited to the asserted US patent’s claims, the landscape can only be read through the structural motif the patent claims. The practical landscape pattern for CNP-based prodrugs in the US typically has clusters around:
- CNP sequence variants
- prodrug linkage chemistry to amino acid residues (here specifically lysine position 26)
- prodrug tail polymers or oligomers defined by repeating units (here c1 200–250, and a specific “about 225” embodiment)
- formulation and dosing approaches for pediatric endocrine indications
Given the claim language, this patent most directly pressures competitors with CNP-lysine-26 amide prodrug conjugates and polymer-tail chain-lengths within 200–250.
A competitor landscape strategy generally falls into two routes:
- keep the CNP backbone but change the attachment site chemistry (avoid lysine 26 nitrogen amide link)
- keep attachment but change the prodrug tail structure or chain-length definition so c1 is outside 200–250 or no longer conforms to the claimed —Z structure definition
Any competitor that instead uses a different CNP sequence than SEQ ID NO:24, or uses a different linkage (for example, a non-amide bond to lysine 26) would be a likely freedom-to-operate (FTO) candidate on the product claim perimeter, subject to other patents not visible in the excerpt.
What would force design-arounds: the claim “musts”
From the claim set, the “musts” are:
- CNP moiety matches SEQ ID NO:24
- The prodrug attachment is to the nitrogen on the lysine side chain at position 26
- The attachment is an amide bond
- The -Z group has the recited structure with each c1 integer 200–250
- Method claims require treatment of the recited diseases (and pediatric subgroup where dependent)
Because these are all explicitly recited, the patent is structurally enforceable against close analogs that preserve the same attachment geometry and chain-length definition.
Key Takeaways
- US 11,154,593 is centered on CNP prodrugs where a lysine position 26 nitrogen on the SEQ ID NO:24 CNP moiety is connected via an amide bond and further attached to —Z with c1 = 200–250.
- The claim set creates broad product coverage (c1 in range) plus specific coverage at c1 about 225.
- Composition claims largely follow the product claims: “at least one excipient” and “consisting of” limitations restrict composition scope but do not materially alter chemical coverage.
- Method-of-treatment claims are tied to a defined disease list including achondroplasia and also pediatric subpopulations through dependences.
- A credible design-around must change at least one of the anchor structural constraints: SEQ ID NO:24 identity, lysine-26 nitrogen amide attachment, or the claimed -Z/c1 structure.
FAQs
1) Does the patent cover multiple chain lengths or only one?
It covers a range: each c1 is an integer from 200 to 250 (claims 1/3/5 and dependences). It also has narrower embodiments where each c1 is about 225 (claims 2/4/6 and method dependences 20/22).
2) Are the method claims limited to a specific route or dosing regimen?
No dosing route or frequency limits appear in the provided claim text. The method claims focus on administering an effective dose of the claimed compound for specified diseases (and pediatric subgroup in dependent claims).
3) Can a competitor avoid infringement by changing excipients?
Not by itself. The composition claims cover the patented compound/salt with “at least one excipient.” Excipients generally do not remove infringement.
4) Is the patent only about achondroplasia?
No. The method claims also include hypochondroplasia, short stature, Noonan syndrome, and SHOX deficiency, with achondroplasia called out in dependent claims.
5) What is the highest-risk structural element for competitors?
The amide bond attachment to the nitrogen on the lysine side chain at position 26 of the SEQ ID NO:24 CNP moiety, plus attachment to —Z with c1 200–250. Those are the repeated “must” constraints across the independent claim bases.
References
[1] US Patent 11,154,593 (claims as provided in the prompt).
