Definition

This is the class for living multicellular organisms (nonhuman animals and plants) and separated or severed parts thereof that have not undergone any modification or treatment subsequent to their separation. These organisms or parts thereof may be genetically modified. This class also includes processes of producing said multicellular organisms and of using said organisms (nonhuman animals) in testing and protein production processes.

This class provides for the following products:

1. Living multicellular organisms, i.e., plants and nonhuman animals. Plants include multicellular algae, multicellular fungi, and higher and lower multicellular plant life.

2. Living multicellular organisms and living products: (a) derived from traditional or conventional breeding techniques; (b) derived from grafting processes; (c) derived from tissue culture techniques; and/or (d) derived from techniques which change the genetic makeup or affect the progeny of multicellular organisms.

(1) Note. Examples of traditional or conventional breeding techniques used in plants are self-pollination, inbreeding, cross-pollination, hybridization, selection, emasculation, cytoplasmic male sterility, etc. (2) Note. Techniques which change the genetic makeup or affect progeny of multicellular organisms include genetic manipulations such as mutagenesis, protoplast cell fusion, and recombinant or transgenic processes. (3) Note. Examples of tissue culture techniques used in plants are embryogenesis, organogenesis, etc.

3. Separated or severed parts of multicellular plants and transgenic nonhuman animals which have not been modified or treated subsequent to their separation.

(1) Note. Embryos, plantlets, flowers, leaves, seeds, differentiated tissue (i.e., specific organs), buds, meristems, shoots, roots, tubers, fruits, stems, cuttings, bulbs, corms, rhizomes, pollen, mycelium, spores, ascocarps, and sclerotia are considered unmodified plant parts for purposes of this class. (2) Note. This class includes products obtained by modifications of multicellular living organisms and separated or severed parts thereof wherein the organism or part thereof is permanently changed (i.e., by genetic manipulation, by mutation, by cell fusion, or by tissue culture) so that subsequent progeny or offspring are likewise affected. This class also includes products obtained by modifications of multicellular living organisms and separated or severed parts thereof wherein the organism is permanently changed (i.e., by grafting) so that unique features or properties are conferred to the organism but its offspring are not affected, i.e., genetic lineage is not altered. (3) Note. This class does not include modifications of multicellular living organisms and separated or severed parts thereof wherein the organism or product or part thereof is temporarily changed or treated by processes such as coating, impregnating, dyeing, bleaching, preserving, adhesive bonding, coloring, pitting, adding artificial limbs or grafting arteries, etc., i.e., subsequent genetic makeup and/or progeny of the organism will not be affected or changed and the organism and parts thereof will still retain its general structure and appearance. (4) Note. A genetic modification encompasses any process of modification or alteration of the genes of an organism which will subsequently be passed on to its progeny (e.g., spontaneous and induced mutagenesis; normal cross-breeding and hybridization; recombination; etc.).

This class provides for the following processes:

Methods of plant breeding; methods of mutating plants; methods of producing plants using somatic cell fusion; and methods of introducing nucleic acid into or rearrangement of genetic material within a plant. All of these methods result in a living plant or plant part.