PATENT CLAIM ANALYSIS

Application Number: 16089235
Application Type: Utility
Filing Date: 2018-09
Publication Date: 2019-03
Patent Classification: ["514", "167000"]

Abstract:
Methods for treating vitamin D insufficiency and secondary hyperparathyroidism in patients having CKD comprising administering repeat doses of 25-hydroxyvitamin D are disclosed. The methods comprise administering 25-hydroxyvitamin D in an amount effective to safely raise the patient's serum 25-hydroxyvitamin D level to greater than 90 ng/ml and/or to control the patient's serum ratio of 25-hydroxyvitamin D to 24,25-dihydroxyvitamin D to less than 20.

Claim (Index 18):
A method of administering an extended release dosage form of 25-hydroxyvitamin D comprising about 30 mcg to about 60 mcg 25-hydroxyvitamin D 3 , optionally including a waxy controlled release agent, an emulsifier, an absorption enhancer, an oily vehicle, and a stabilizing agent; to a patient in need thereof, optionally having CKD Stage 3 or Stage 4, comprising administering repeat doses of the extended release oral dosage form to the subject effective to achieve one or more of the following: (1) a reduction in plasma intact PTH from baseline of about 30 pg/mL to about 80 pg/mL; (2) a steady state serum 25-hydroxyvitamin D level of greater than about 50 ng/mL to about 100 ng/mL; (3) an increase in serum 1,25-dihydroxyvitamin D from baseline of at least about 10 pg/mL; (4) an increase in serum calcium from baseline of 0 to about 0.3 mg/dL; (5) an increase in serum phosphorous from baseline of 0 to about 0.3 mg/dL; (6) a decrease in serum BSAP from baseline of at least about 10 U/L; (7) a decrease in serum CTX-1 from baseline of at least about 100 pg/mL; and (8) a decrease in serum P1NP from baseline of at least about 30 ng/mL.

Metadata:
- Claim Count in Document: 22.0
- Percentile: 97.0
- Lexical Diversity: 1.45652
- Patent Class: 514.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15231357', '15358065', '12597224', '13244945', '15990354']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.8160954128714567
- 35 USC 102 Novelty (BERT): 0.6214884930858889
- Combined Prediction Score: 0.7966347208928999
- Mean Citation Score: 517.0578820000002
- Max Citation Score: 529.7744
- Similarity Product: 427.1921093942642

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

Dataset: test