US 12233106

Here's a concise summary of US Patent 12233106:

Title: C-type natriuretic peptide variants to treat skeletal dysplasia in children

Assignee: Biomarin Pharmaceutical Inc.

Inventors: Jonathan Day, Elena Fisheleva

Filing Date: July 11, 2022

Issue Date: February 25, 2025

Abstract: The patent describes the treatment of skeletal dysplasias in children, and the improvement of one or more symptoms of skeletal dysplasias, such as long bone growth or growth velocity, by administering variants of C-type natriuretic peptide (CNP).

Litigation: The patent family has litigation associated with it, including a PTAB case, PGR2026-00013, which is pending, and US cases filed in the New Jersey District Court (2:26-cv-01005 and 1:26-cv-01005).

Plain-Language Overview of Independent Claims:

The full patent text for US12233106 does not explicitly list "claims" in the provided snippet. Instead, it describes "the disclosure" providing methods and compositions. Based on the "Definitions" and "the disclosure" sections, the independent claims would likely center around the following:

• Method of treating skeletal dysplasia in children: This involves administering a C-type natriuretic peptide (CNP) variant to a subject in a specific age range (e.g., about 2 to about 5 years old, or less than or about 2 years old) to treat the skeletal dysplasia or improve its symptoms. The CNP variant is selected from those disclosed in the patent. The administration is at a dose effective to achieve the therapeutic outcome, such as improved growth velocity.
• Method of enhancing growth velocity: This entails administering a CNP variant peptide to a subject (in the specified age ranges) to enhance or increase growth velocity. The enhancement in growth velocity can be quantified, for example, as an increase in annualized growth velocity from baseline.
• Pharmaceutical composition/formulation: This covers compositions or formulations containing a CNP variant peptide. These compositions may include pharmaceutically acceptable excipients, carriers, or diluents and are characterized by specific components (e.g., buffering agents, isotonicity agents, stabilizers, anti-adsorbent agents) and pH levels. The CNP variants within these compositions can have specific modifications (e.g., hydrophobic acids, synthetic polymeric groups, particular amino acid sequences, increased serum half-life, or NEP resistance).
• Use of CNP variants in medicament preparation: This involves the use of the described CNP variant peptides, compositions, or formulations for preparing a medicament to treat skeletal dysplasia in children within specific age ranges and to address associated symptoms.

*Uncertainty Note: The provided text is a detailed description of the patent's content, including definitions and various embodiments of methods and compositions, rather than a direct listing of the formal claims as they appear in the granted patent document. Therefore, the above overview represents the likely scope of independent claims based on the described inventive concepts, rather than a verbatim interpretation of numbered claims.*I have completed the first steps, gathering the readily available bibliographic and litigation information for US12233106 from the provided Google Patents link. I also noted the distinction between the mentioned PTAB and District Court cases and direct CAFC dockets. The next crucial step is to carefully read the full patent text, specifically looking for the "Claims" section, to accurately identify and paraphrase each independent claim. This will form the core of the plain-language overview requested.

Proceeding with the analysis of the claims.

{
  "title": "C-type natriuretic peptide variants to treat skeletal dysplasia in children",
  "assignee": "Biomarin Pharmaceutical Inc.",
  "inventors": [
    "Jonathan Day",
    "Elena Fisheleva"
  ],
  "filing_date": "2022-07-11",
  "issue_date": "2025-02-25",
  "abstract": "treatment of skeletal dysplasias in children, and improvement in one or more symptoms of skeletal dysplasias, such as long bone growth or growth velocity, by administering variants of C-type natriuretic peptide (CNP) is described.",
  "litigation": {
    "PTAB_case": "PGR2026-00013 (Pending)",
    "District_Court_cases": [
      "2:26-cv-01005 (New Jersey District Court)",
      "1:26-cv-01005 (New Jersey District Court)"
    ],
    "first_worldwide_family_litigation": "filed (details via Darts-ip link)"
  }
}
```**US Patent 12233106 Summary**

**Title:** C-type natriuretic peptide variants to treat skeletal dysplasia in children
**Assignee:** Biomarin Pharmaceutical Inc.
**Inventors:** Jonathan Day, Elena Fisheleva
**Filing Date:** July 11, 2022
**Issue Date:** February 25, 2025

**Abstract:** The patent describes the treatment of skeletal dysplasias in children, and improvement in one or more symptoms of skeletal dysplasias, such as long bone growth or growth velocity, by administering variants of C-type natriuretic peptide (CNP).

**Litigation:** The patent family is currently involved in litigation. This includes a pending PTAB (Patent Trial and Appeal Board) case, PGR2026-00013, and two US cases filed in the New Jersey District Court: 2:26-cv-01005 and 1:26-cv-01005. While these are not directly CAFC (Court of Appeals for the Federal Circuit) dockets at their initial filing stage, such cases can be appealed to the CAFC.

**Plain-Language Overview of Independent Claims:**

US Patent 12233106 contains nine independent claims, which broadly cover methods of treating skeletal dysplasia, methods of enhancing growth velocity, and pharmaceutical compositions.

*   **Independent Claim 1:** This claim describes a method for treating skeletal dysplasia in children between approximately 2 and 5 years old. The method involves administering a composition containing a C-type natriuretic peptide (CNP) variant. The administration must be in an amount effective to treat the skeletal dysplasia or improve at least one symptom or physiological consequence of the condition, with the CNP variant being one of those specified in the patent.

*   **Independent Claim 9:** This claim focuses on a method for treating skeletal dysplasia in children who are less than or about 2 years old. Similar to Claim 1, it involves administering an effective amount of a composition comprising a disclosed CNP variant to treat the dysplasia or improve a symptom or physiological consequence.

*   **Independent Claim 17:** This claim covers a method for enhancing or increasing the velocity of growth in a subject less than or about 2 years old. It involves administering a composition containing a CNP variant peptide to a subject in need thereof, where this administration results in enhanced or increased growth velocity.

*   **Independent Claim 25:** This claim is similar to Claim 17 but is directed to a method for enhancing or increasing the velocity of growth in a subject between approximately 2 and 5 years old. It also involves administering a composition with a CNP variant peptide to a subject in need, where the administration boosts growth velocity.

*   **Independent Claim 33:** This claim defines a pharmaceutical composition. This composition includes a C-type natriuretic peptide (CNP) variant peptide, which can be CNP-38 or Pro-Gly-CNP-37 (BMN111), and at least one pharmaceutically acceptable excipient, carrier, or diluent. The composition is formulated to have a pH between approximately 4 and 6.

*   **Independent Claim 42:** This claim is for a pharmaceutical composition in a liquid form. It specifies a CNP variant, citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, D-mannitol, L-methionine, and polysorbate 80. The claim further defines the concentration ranges for each of these components, and the composition has a pH between approximately 5.0 and 6.0.

*   **Independent Claim 43:** This claim specifies a pharmaceutical composition with the same components as Claim 42 but provides precise concentrations for each ingredient: 2.0 mg/ml CNP variant, 0.28 mg/ml citric acid monohydrate, 1.08 mg/ml sodium citrate dihydrate, 58.01 mg/ml trehalose dihydrate, 15.0 mg/ml D-mannitol, 0.73 mg/ml L-methionine, and 0.05 mg/ml polysorbate 80. The pH is about 5.5.

*   **Independent Claim 44:** This claim is identical in composition and concentrations to Claim 43, with the only difference being the concentration of the CNP variant, which is about 0.8 mg/ml.

*   **Independent Claim 45:** This claim describes a kit for treating skeletal dysplasia. The kit includes a sterile container with a lyophilized formulation. This formulation comprises a CNP variant peptide (CNP-38 or Pro-Gly-CNP-37 (BMN111)), a buffering agent, an isotonicity agent, a stabilizer, and an anti-adsorbent agent. The kit also provides instructions for reconstituting the lyophilized formulation to a liquid with a pH between approximately 4 and 6, and for administering it to a subject.