Definitions

A and An have the plain meaning of one or more than one, that is, at least one, of the grammatical object of the article unless the context clearly indicates otherwise. By way of example, an element means one element or more than one element.

Active Ingredient has the United States Food & Drug Administration-provided meaning of any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of a human body or an animal body.

About is a term that should be used deliberately rather than automatically. If used, it should be used consistently. It may be appropriate to define about in terms of functional results, tolerance, or significant digits. Where numerical limitations are modified by words of approximation, the intended degree of approximation should be made clear.

Administer has the biomedical art-recognized meaning of the direct application of a substance to the body of a subject or patient by:

• a medical practitioner or medically authorized agent; or
• the subject or patient at the direction and in the presence of the medical practitioner,

whether by injection, inhalation, ingestion, or any other means.

Agent has the biomedical art-recognized meaning of a composition of matter useful for performing a function.

Alleviate has the biomedical art-recognized meaning of a process by which the severity of a sign or symptom of a disorder is reduced. A sign or symptom can be alleviated without being eliminated. Administration of a composition or pharmaceutical composition may lead to elimination of a sign or symptom, but elimination is not required. Effective dosages should be expected to decrease the severity of a sign or symptom.

An Effective Amount and A Therapeutically Effective Amount have the biomedical art-recognized meaning of an amount effective to achieve its intended purpose. The effect can be detected by any assay method known in the art. The precise effective amount for a subject depends on factors such as:

• the subject's body weight, size, and health;
• the nature and extent of the condition; and
• the therapeutic or combination of therapeutics selected for administration.

Therapeutically effective amounts for a given situation can be determined by routine experimentation within the skill and judgment of the clinician.

And/Or includes any and all combinations of one or more of the associated listed items. In this context, or means and/or. Expressions such as at least one of, when preceding a list of elements, modify the entire list of elements and do not modify only the individual elements of the list.

At Least One Of, when preceding a list of elements, modifies the entire list of elements and does not modify the individual elements of the list.

Complementarity Determining Region or CDR has the biomedical art-recognized meaning of a polypeptide region of an antibody heavy chain or antibody light chain that determines antibody-to-antigen binding. Each antibody heavy chain has three CDRs. Each antibody light chain has three CDRs, usually different from the three CDRs on an antibody heavy chain.

Persons having ordinary skill in the biomedical art can calculate CDR structure using a standardized numbering method such as the Kabat numbering scheme. Other numbering schemes, such as Chothia, IMGT, Martin (enhanced Chothia), and other standard numbering schemes, are also used in the biomedical art.

Human has the plain meaning of belonging to or having the qualities of humanness.

Humanized has the biomedical art-recognized meaning that a protein, such as an antibody, is genetically engineered to closely resemble the polypeptide structure of the human homologue. A variable domain of an antibody of rodent origin can be fused to a constant domain of human origin, thus retaining the specificity of the rodent antibody. The human-origin domain need not originate directly from a human when first synthesized in a human context. Human domains can also be generated in rodents whose genome incorporates human immunoglobulin genes. The antibody can be partially or completely humanized.

One general humanization workflow includes:

1. determining the nucleotide and predicted amino acid sequence of the starting antibody light and heavy variable domains;
2. designing the humanized antibody, including deciding which antibody framework region to use during the humanizing process;
3. applying the humanizing methodologies or techniques; and
4. transfecting and expressing the humanized antibody.

KD has the biomedical art-recognized meaning of the measured equilibrium dissociation constant between a compound or ligand and a protein or binding domain of a protein.

Medicament has the plain meaning of a drug or preparation used for the prevention of disease or that promotes recovery from an injury, ailment, or disease.

Patient has the plain meaning of a person or other animal receiving or expected to receive medical treatment.

Pharmaceutically Acceptable Excipient has the biomedical art-recognized meaning of an excipient that is useful in preparing a pharmaceutical composition that is generally safe, non-toxic, and neither biologically nor otherwise undesirable, and includes excipients acceptable for veterinary use and human pharmaceutical use. As used in the specification and claims, this term includes both one and more than one such excipient.

Pharmaceutically Acceptable has the biomedical art-recognized meaning of compounds, anions, cations, materials, compositions, carriers, or dosage forms that are, within the scope of sound medical judgment, suitable for contact with the tissues of humans and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio.

Pharmaceutically Acceptable Carrier, Adjuvant, or Vehicle has the biomedical art-recognized meaning of a nontoxic carrier, adjuvant, or vehicle that does not destroy the pharmacological activity of the compound with which it is formulated.

Pharmaceutically Acceptable Derivative has the biomedical art-recognized meaning of any non-toxic salt, ester, salt of an ester, or other derivative of a compound that, upon administration to a recipient, is capable of providing, either directly or indirectly, the compound or an active metabolite or residue thereof.

Subject has the plain meaning of a person or other animal that is being discussed, described, or dealt with.

Treating and Treat have the biomedical art-recognized meaning of managing and caring for a patient to combat a disease, condition, or disorder. Treating includes administering a composition described in the specification to alleviate the symptoms or complications of a disease, condition, or disorder or to eliminate the disease, condition, or disorder.

Comprises, Comprising, Includes, and Including, when used in the specification, specify the presence of stated features, regions, integers, steps, operations, elements, or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, or groups thereof.

First, Second, Third, and similar ordinal terms describe several elements, components, regions, layers, or sections. These terms do not inherently limit those elements, components, regions, layers, or sections. They are used to distinguish one from another. A first element, component, region, layer, or section may therefore be referred to as a second element, component, region, layer, or section without departing from the relevant teachings.

When an element is referred to as being on another element, it can be directly in contact with the other element or intervening elements may be present therebetween. When an element is referred to as being directly on another element, there are no intervening elements present.

Antibody should be defined in the specific factual situation described in the specification.

The definition should address, where relevant:

• the binding function of the antibodies;
• the binding fragments of antibodies, especially where such fragments have a different binding function from other antibodies;
• the specific structural features of the antibody;
• the complementarity determining regions (CDRs) of the antibodies;
• the amino acid sequences within antibody variable regions that confer antigen specificity and binding affinity;
• the three CDRs in each heavy chain variable region (HCDR1, HCDR2, HCDR3);
• the three CDRs in each light chain variable region (LCDR1, LCDR2, LCDR3);
• the numbering method used to determine CDR boundaries, including Kabat, Chothia, IMGT, Martin, or an extended Chothia definition; and
• the amino acid sequences of the antibody heavy chains (VH) and antibody light chains (VL).

In antibody- and biomedical-focused contexts, the definitions and related support material may also extend into associated headings such as:

• Compositions
• Manufacturing process
• Uses of the composition of matter

These headings sit adjacent to the definitions structure because they often supply the technical context needed for the defined terms to operate coherently across the broader disclosure.