Patent ID: 7241447

Claim:
A composition comprising at least two recombinant adeno-associated viruses (AAV), comprising: a) a first recombinant AAV comprising a first recombinant DNA molecule comprising linked: i) a first DNA segment comprising a 5′-inverted terminal repeat of AAV; ii) a second DNA segment which comprises a cis-acting heterologous transcriptional regulatory element; and iii) a third DNA segment comprising a 3′-inverted terminal repeat of AAV; and b) a second recombinant AAV comprising a second recombinant DNA molecule comprising linked: i) a first DNA segment comprising a 5′-inverted terminal repeat of AAV; ii) a second DNA segment which comprises an entire open reading frame for a therapeutic gene product; and iii) a third DNA segment comprising a 3′-inverted terminal repeat of AAV, wherein the recombinant DNA molecules of the two rAAVs, when contacted with a host cell, become linked, forming a molecule which has the cis-acting heterologous transcriptional regulatory element 5′ to the open reading frame, wherein the cis-acting heterologous transcriptional regulatory element is positioned in the first recombinant DNA molecule so that after linking the cis-acting heterologous transcriptional element regulates transcription of the gene product encoded by the open reading frame, wherein if the cis-acting heterologous transcriptional regulatory element is an enhancer, transcription of the open reading frame is enhanced by the enhancer, wherein if the cis-acting heterologous transcriptional regulatory element is a promoter, transcription of the open reading frame is initiated at the promoter, and wherein the first recombinant DNA molecule does not encode a protein.