PATENT CLAIM ANALYSIS

Application Number: 16028140
Application Type: Utility
Filing Date: 2018-07
Publication Date: 2019-06
Patent Classification: ["424", "133100"]

Abstract:
The present inventors newly discovered that even if an antigen-binding molecule inhibits in vitro some of the physiological activities of an antigen having two or more physiological activities without inhibiting the remaining physiological activities, the molecule can promote elimination of the antigen from blood (from serum or plasma) and as a result reduce the physiological activities in vivo, when the antigen-binding molecule is conferred with the properties: (i) of binding to human FcRn wider an acidic pH range condition; (ii) of binding under a neutral pH range condition to human Fc receptor stronger than native human IgG, and (iii) that its antigen-binding activity alters according to the ion concentration.

Claim (Index 54):
A method for producing an antibody, the method comprising:\n (a) selecting an antigen comprising (i) a first binding domain that, when bound to a first target molecule, produces a first physiological activity, and (ii) a second binding domain that, when bound to a second target molecule, produces a second physiological activity, wherein the first and second binding domains are at different locations on the antigen, wherein the first and second target molecules are different, wherein the first and second physiological activities are different, and wherein the antigen cannot bind to both of the target molecules simultaneously; (b) identifying one or more antigen-binding domains that bind to the antigen and, when bound to the antigen, inhibit the antigen's ability to bind to the first target molecule but do not inhibit the antigen's ability to bind to the second target molecule; (c) selecting, from the one or more antigen-binding domains of (b), an antigen-binding domain whose antigen-binding activity varies with pH as described in (i) below, or with calcium ion concentration as described in (ii) below, or with both:\n (i) the antigen-binding activity is lower at pH 6.0 than at pH 7.4, wherein the ratio of the KD value for antigen binding at pH 6.0 to the KD value for antigen binding at pH 7.4 (KD (pH 6)/KD (pH 7.4)) is 2 or more when KD values are determined using a surface plasmon resonance technique in which a polypeptide comprising the antigen-binding domain is immobilized, the antigen serves as analyte, and the following conditions are used: 10 mM N-2-aminoethanesulfonic acid (ACES), 150 mM NaCl, 0.05% polysorbate 20, 37\u00b0 C., and either pH 6.0 or pH 7.4; \n (ii) the antigen-binding activity is lower at a calcium ion concentration of 3 \u03bcM than at a second calcium ion concentration of 2 mM, wherein the ratio of the KD value for antigen binding at a calcium ion concentration of 3 \u03bcM to the KD value for antigen binding at a calcium ion concentration of 2 mM (KD (3 \u03bcM Ca++)/KD (2 mM Ca++)) is 2 or more when KD values are determined using a surface plasmon resonance technique in which a polypeptide comprising the antigen-binding domain is immobilized, the antigen serves as analyte, and the following conditions are used: 10 mM ACES, 150 mM NaCl, 0.05% (w/v) polysorbate 20, 37\u00b0 C., pH 7.4, and either 3 \u03bcM CaCl 2  or 2 mM CaCl 2 ; \n (d) identifying an IgG Fc region that\n (i) differs from the Fc region of a native human IgG by amino acid substitution, insertion, or deletion at one or more positions, \n (ii) binds to a human neonatal Fc receptor (FcRn) at pH 6, and \n (iii) binds, at pH 7.4, to a human Fc receptor with greater affinity than the affinity with which the native human IgG binds to the human Fc receptor, wherein the native human IgG is of the same isotype as the identified IgG Fc region; and \n (e) preparing an antibody comprising the antigen-binding domain selected in (c) and the IgG Fc region identified in (d).

Metadata:
- Claim Count in Document: 56.0
- Percentile: 95.0
- Lexical Diversity: 1.5974
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['14007947', '14347448', '14101441', '13650493', '09825517']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7611211169379343
- 35 USC 102 Novelty (BERT): 0.7216499092138794
- Combined Prediction Score: 0.7571739961655288
- Mean Citation Score: 761.1392320000001
- Max Citation Score: 1081.3811
- Similarity Product: 776.3203097620845

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