PATENT CLAIM ANALYSIS

Application Number: 16109585
Application Type: Utility
Filing Date: 2018-08
Publication Date: 2020-01
Patent Classification: ["514", "169000"]

Abstract:
This invention provides new methods for a) identifying Cushing's Syndrome patients at high risk of developing hypokalemia during glucocorticoid receptor modulator (GRM) treatment, and b) for prophylactically treating such patients to prevent, or reduce the severity of, hypokalemia. Patients at such high risk may be identified prior to their developing hypokalemia. Such a patient may be an adult patient with endogenous Cushing's Syndrome having type 2 diabetes mellitus or glucose intolerance to control hyperglycemia secondary to hypercortisolism. Patients may be identified by an above-threshold level of ACTH or cortisol in a patient sample taken post-GRM administration or pre-GRM administration, respectively. Upon identifying such a patient prior to the development of low potassium, the present methods provide for prophylactically treating the patient by administration of one or more hypokalemia treatments concurrently with an increased dose of GRM or with an initial dose of GRM to prevent hypokalemia.

Claim (Index 20):
A method for treating Cushing's syndrome and reducing the risk of developing hypokalemia or preventing the development of hypokalemia in a patient with Cushing's syndrome, the method comprising:\n (a) identifying a patient with Cushing's syndrome who:\n (i) has a morning serum cortisol level that is at least 27 micrograms per deciliter (\u03bcg/dL), or \n a morning serum cortisol level is at least 1.5 times the average normal morning serum cortisol level, \n (ii) has not been administered a glucocorticoid receptor modulator (GRM), \n (iii) does not have a lower than normal potassium level, and \n (iv) will be treated with a GRM to control hyperglycemia secondary to hypercortisolism; \n (b) administering to said patient an effective amount of a therapeutic agent for treating hypokalemia, and then (c) administering to the patient a first dose of GRM, whereby the patient is treated for Cushing's syndrome and the risk of developing hypokalemia is reduced or hypokalemia is prevented in the patient.

Metadata:
- Claim Count in Document: 80.0
- Percentile: 96.0
- Lexical Diversity: 1.86207
- Patent Class: 514.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['16109561', '15627359', '15627414', '15565291', '15919719']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7913748248855468
- 35 USC 102 Novelty (BERT): 0.6667531466618875
- Combined Prediction Score: 0.7789126570631808
- Mean Citation Score: 471.483672
- Max Citation Score: 929.0943
- Similarity Product: 626.0514760889232

Labels:
- Claim Label 101: 1
- Claim Label 102: 1
- Claim Label 103: 0
- Claim Label 112: 1
- Combined Label: 1
- Label 101 Adjusted: 1

Dataset: test