PATENT CLAIM ANALYSIS

Application Number: 16112195
Application Type: Utility
Filing Date: 2018-08
Publication Date: 2019-05
Patent Classification: ["424", "722000"]

Abstract:
Described herein is a method for eliminating or reducing ototoxicity in patients receiving a platinum based chemotherapeutic. In particular, are methods of reducing ototoxicity in a pediatric patient. The methods described herein include administering an effective amount of sodium thiosulfate to a patient in need thereof to reduce ototoxicity.

Claim (Index 2):
(Proposed amendment): A method of reducing ototoxicity in a pediatric patient of about 18 years of age and under having a localized and non-metastatic tumor and receiving a dose of about 1 mg/kg to about 5 mg/kg or about 10 mg/m 2  to about 300 mg/m 2  per cycle of cisplatin, the method comprising administering about 5 g/m 2  to about 25 g/m 2  of sodium thiosulfate per cycle of the cisplatin about six hours after the administration of the cisplatin, wherein ototoxicity is determined by one or more criteria selected from:\n a). a reduction in hearing measured by a 20 dB loss at a single frequency; b). a reduction in hearing measured by a 10 dB loss at two consecutive frequencies; c). loss of response at three consecutive test frequencies where responses were previously obtained; d). a reduction in bilateral high-frequency hearing characterized by the criteria:\n i). a <40 dB hearing loss at all frequencies, which indicates a grade 0 or minimal hearing loss; \n ii). a >40 dB hearing loss at 8,000 Hz only, which indicates a grade 1 or mild hearing loss; \n iii). a >40 dB hearing loss at 4,000 Hz and above, which indicates a grade 2 or moderate hearing loss; \n iv). a >40 dB hearing loss at 2,000 Hz and above, which indicates a grade 3 or marked hearing loss; \n v). a >40 dB hearing loss at 1,000 Hz and above, which indicates a grade 4 or severe hearing loss; or \n e). a reduction in hearing characterized by the criteria:\n i). a <20 dB hearing loss at all frequencies, which indicates a grade 0 hearing loss; \n ii). a >20 dB HL above 4,000 Hz, which indicates a grade 1 hearing loss; \n iii). a >20 dB HL at 4,000 Hz and above, which indicates a grade 2 hearing loss; \n iv). a >20 dB HL at 2,000 Hz or 3,000 Hz, which indicates a grade 3 hearing loss; \n v). a >40 dB HL at 2,000 Hz and above, which indicates a grade 1 hearing loss; \n wherein a change in hearing is computed relative to baseline measures prior to the patient receiving a platinum based chemotherapeutic or sodium thiosulfate or both; and \n wherein the administration of sodium thiosulfate does not substantively affect relapse free survival or overall survival compared to a pediatric patient not administered sodium thiosulfate; and \n wherein the administration of sodium thiosulfate does not lead to substantively increased incidence of one or more adverse events comprising febrile neutropenia, infection, hypomagnesemia, hypernatremia, vomiting, or nausea.

Metadata:
- Claim Count in Document: 3.0
- Percentile: 96.0
- Lexical Diversity: 1.39474
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['10694448', '09911195', '11324744', '14989613', '15274529']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7076635276388253
- 35 USC 102 Novelty (BERT): 0.5059389828031968
- Combined Prediction Score: 0.6874910731552625
- Mean Citation Score: 224.011052
- Max Citation Score: 246.93484
- Similarity Product: 158.7386574309874

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

Dataset: test