Abstract
The conceptual model proposed in Chapter 2 tracks the development of a biotechnological invention through three basic stages:1
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(1)
The development of a potential for variability in a system comprised of living matter (individual cell, multicellular organism, population of organisms).
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(2)
A replicating of the system (or some component of the system which embodies certain biological information) in order to manifest the variability of that system in form of a population of variants, which is compared to selection criteria chosen by the applied biologist.
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(3)
By application of the selection criteria, the elimination of those segments of the population formed in stage (2) that are deemed noncharacteristic of the invention.
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Notes
See generally Miller, ‘Redesigning Molecules Nature’s Way,’ Science News, September 28, 1985, at 204; Berzofsky, ‘Intrinsic and Extrinsic Factors in Protein Antigenic Structure,’ Science 229: 932 (1985) (structural determinants of antibody/antigen recognition reviewed in the context of preparing synthetic peptide vaccines).
Davis et al, ‘Electron Microscope Heteroduplex Methods for Mapping Regions of Base Sequence Homology in Nucleic Acids,’ Methods Enzymol. 21: 413 (1971).
See, e.g., Meyers et al, ‘Fine Structure Genetic Analysis of a -globin Promoter,’ Science 232: 613–18 (1986) (identifies conserved sequences among different eukaryotic promoters)
Rosenthal et al, ‘BK Viral Enhancer Element and a Human Cellular Homolog,’ Science 222: 749–55 (1983) (discusses structure of ‘enhancer’ elements that increase level of transcription of an adjacent gene)
Johnston et al, ‘Model for Regulation of Histidine Operon of Salmonella,’ Proc. Nat’l Acad. Sci. (USA) 77: 508 (1980) (proposed model for action of ‘attenuator’ elements that represent barriers to transcription is based on secondary structure of attenuator-encoded RNA). Eventually, the manner in which particular control elements work will be understood in sufficient detail to permit the synthesis of new elements without direct counterparts in nature. See Bent, ‘Patent Protection for DNA Molecules,’ 64 JPOS 60, 65n.23 (1982).
The biosynthesis of the aromatic amino acids tryptophan, phenylalanine and tyrosine proceeds along a common pathway, involving many different enzyme-catalyzed reactions, as shown schematically below: Umbarger, ‘Amino Acid Biosynthesis and Its Regulation,’ Ann. Rev. Biochem. 47: 533, 574–76 (1978), Glyphosate competes with the normal substrate of the synthetase that catalyzes the production of ‘3-enolpyruvate shikimate-5-P’ (5-enolpyruvyl-3-phosphoshikimic acid).
To ensure that the chosen mutagen, either chemical or physical (ultraviolet light, X-rays, etc.), provided an enzyme that was glyphosate-resistant, the applicant employed ‘cotransduction to an aroa auxotroph and [selection] for glyphosate resistance and aro A+.’ An ‘auxotroph’ requires a specific growth substance beyond the minimum required for normal metabolism and reproduction. An aro A auxotrophic (‘aroA−1) cell requires in its growth medium an end product (or products) of the pathway shown in note 54 supra, while a normal celi (‘aroA+’) does not. See, e.g., Gollub et al, ‘Correlation of Genes and Enzymes, and Studies on Regulation of the Aromatic Pathway in Salmonella,’ J Biol. Chem. 242: 5323–28 (1967). The applicant used a known virus (bacteriophage) to effect a transfer (‘transduction’) of DNA from a bacterial mutant, previously selected for glyphosate resistance (and, optionally, aro A+), into a known aro A auxotrophic strain. If the variant population generated after transduction contained cells selectable for glyphosate resistance and aro A+, then the genetic determinants for both traits must have been transferred (‘co-transduced’) within the same bac-
See Novick et al, ‘Uniform Nomenclature for Bacterial Plasmids: A Proposal,’ Bacteriol. Rev. 40: 168–89 (1976). Strictly speaking, a plasmid is a ‘replicon’ (a DNA molecule that is replicable from a single origin), usually circular, that is stably inherited (i.e., readily maintained without specific selection) in an extrachromosomal state — ‘the definition implies genetic homogeneity, constant monomeric unit size, and the ability to replicate independently of the chromosome.’ Ibid. at 169.
Kitch, ‘The Nature and Function of the Patent System,’ 20 J. Law & Econ. 265, 187 (1977).
Schwaab, ‘Disclosure Requirements for U.S. Patent Applications,’ 6 APLA Q. J. 313, 327 (1978) (citations omitted).
See Robbins, ‘Patents for Microbiological Transformations — An International Problem,’ 42 JPOS 831, 841–42 (1960).
The known corn mutant, designated ‘blue fluorescent-l’ because it displayed ultraviolet light-stimulated fluorescence at different stages of development, had been characterized genetically by reference to a recessive Mendelian determinant (bf) Homozygous plants (bf/bf) possessed an AS that was 3 to 40 times more active, and was also more resistant to feedback inhibition by tryptophan, than was the corresponding enzyme from normal plants. Singh & Widholm, ‘Study of a Corn (Zea mays L.) Mutant (blue fluorescent-1) which Accumulates Anthranilic Acid and Its -glucoside,’ Biochem. Genetics 13: 357–67 (1975).
See, e.g., Carlson & Widholm ‘Separation of Two Forms of Anthranilate Synthetase from 5-Methyltryptophan-Susceptible and -Resistant Cultured Solanum tuberosum cells,’ Physiol. Plant. 44: 251–55 (1978).
See, e.g., Milstein, ‘From Antibody Structure to Immunological Diversification of Immune Response,’ Science 231: 1261, 1262–63 (1986).
An oft-cited report detailing this work is Koehler & Milstein, ‘Continuous Cultures of Fused Cells Secreting Antibody of Predefined Specificity,’ Nature 256: 495–97 (1975).
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© 1987 Stephen A. Bent, Richard L. Schwaab, David G. Conlin, Donald D. Jeffery
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Bent, S.A., Schwaab, R.L., Conlin, D.G., Jeffery, D.D. (1987). Drafting, Enabling and Prosecuting Patent Claims. In: Intellectual Property Rights in Biotechnology Worldwide. Palgrave Macmillan, London. https://doi.org/10.1007/978-1-349-08009-0_5
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