PATENT CLAIM ANALYSIS

Application Number: 15938888
Application Type: Utility
Filing Date: 2018-03
Publication Date: 2018-10
Patent Classification: ["435", "007230"]

Abstract:
The present invention relates to methods for determining a treatment regimen beyond surgical removal of tumor tissue for node negative or node positive breast cancer patient. The method comprises measuring the levels of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor-1 (PAI-1) in a subject, preferably a tumor; and, based upon the values, predicting the expected benefit including disease-free survival and/or overall survival for the patient without treatment (beyond the surgical removal of tumor tissue) or with a particular treatment and using that information to select a treatment regimen for the subject. High risk subject is identified by high levels of both uPA and PAI-1, high level of uPA and low level of PAI-1 or, low level of uPA and high level of PAI-1. Treatment options for high risk subjects include, but are not limited to, adjuvant CMF chemotherapy, adjuvant non-CMF chemotherapy, adjuvant endocrine therapy, adjuvant anthracyclin-containing chemotherapy, radiation therapy, and gene therapy. Treatment options for low risk subjects include, but are not limited to, no treatment, radiation, and adjuvant endocrine therapy.

Claim (Index 98):
A method for determining whether to administer adjuvant therapy to a subpopulation of patient with primary breast cancer, said patient having primary tumor tissue, said method comprising:\n (a) measuring the level of uPA and the level of PAI-1 in said primary tumor tissue or a sample of said primary tumor tissue of said patient; (b) classifying said patient as low risk if the level of uPA is lower than a uPA cut-off value of at least the 55 th  percentile and at most the 75 th  percentile of normalized or analogous uPA levels in a randomized population of breast cancer patients and the level of PAI-1 is lower than a PAI-1 cut-off value of at least the 61 st  percentile and at most 81 st  percentile of normalized or analogous PAI-1 levels in a randomized population of breast cancer patients; or as high risk if either the level of uPA is higher than said uPA cut-off value or the level of PAI-1 is higher than said PAI-1 cut-off value; (c) if said patient is classified as low risk in step (b), adjuvant therapy is administered if said adjuvant therapy results in the highest expected benefit of treatment in a comparable population of low risk patients; and (d) if said patient is classified as high risk in step (b), adjuvant therapy is not administered if said adjuvant therapy does not result in the highest expected benefit of treatment in a comparable population of high risk patients.

Metadata:
- Claim Count in Document: 73.0
- Percentile: 90.0
- Lexical Diversity: 2.24719
- Patent Class: 435.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['11965323', '13841887', '13682377', '11450896', '13256910']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.4780532098189839
- 35 USC 102 Novelty (BERT): 0.525284332631667
- Combined Prediction Score: 0.4827763221002523
- Mean Citation Score: 263.74802600000004
- Max Citation Score: 319.97443
- Similarity Product: 221.78952719091416

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

Dataset: test