Road show available on the Web--advice on biotechnology patents from the PTO

摘要

Washington, D.C.--The U.S. Patent and Trademark Office has posted the slides from its recent presentations on biotechnology patents on its Web site (visit Roadshow on the PTO site). There are six topics. Gary Benzion, Ph.D., Acting Supervisory Patent Examiner for Art Unit 1638, provided advice on "Enablement and Written Description Issues in Utility Plant Applications." As of the time of his presentation, more than 1600 utility patents had been granted for transgenic plants, plant parts, and seeds.These technologies have conferred resistance to insects, fungi, or viruses; increased heat stability; improved nutritional value; controlled ripening; and conferred herbicide tolerance. Critical to the patentability of these materials are the "Wands Factors" (In re Wands, 858 F.2d 731, 8 USPQ 2d 1400 [Fed. Cir. 1988]). These are the breadth of the claims, the nature of the invention, the state of the prior art, the level of skill in the art, the level of predictability, the amount of direction/guidance, the presence or absence of working examples, and the amount of experimentation need to practice the invention. Plants are complex organisms with a high proportion of "junk" DNA in comparison with animals, which leads to specific problems in creating new strains and patenting them. The level of predictability and amount of experimentation are affected by the degree to which the genotype and the environment interact, a plant's tolerance for interspecies and intergenus crossing (which creates unstable genomes), and the effect of the position of gene in the genome on its expression. Plants have a high tolerance for variation in the number of chromosomes and for inversions and deletions. Thus, knocking out a gene in one genome may not lead to its silencing. Moreover, there is no correlation of the number of gene copies and the amount of protein expression, so it is not clear without working examples what effect insertion of a foreign rDNA will have on the expression of a protein. Benzion also pointed outthat developmentally specific expression can delay the detection of variation and that expression can be tissue or organ specific. He noted that creating a plant that expresses a gene at a high level with a promoter that is always "on" can be detrimental and offered a sample utility specifications, claims, and written descriptions, along with the thinking of the examiner considering this application. He then gave advice on improving the hypothetical application to make the invention patentable.