Patent analysis: United States Patent No: 5,612,179

In this section, U.S. Patent No. 5,612,179 (the ‘179 patent) is dissected. A patent is composed of distinct sections: front page (bibliometric data), specification (text), and claims. The specification is further divided into the major sections: background, summary of the invention, description of the drawings, detailed description of the invention, and examples.7 A synopsis of the specification is presented first before turning to the claims and their interpretation.[add a comment]

The methodology of how to read and interpret claims is well-established. Claims are first read in light of the specification, but without drawing in any limitations set forth in the text. A thorough understanding of their meaning must include reading them in light of the prosecution history8 as well. In contrast to the methodology, the rules that guide interpretation of the claims are constantly evolving. In the United States, the courts interpret the law and thus, essentially set the rules for interpreting claims. The specialized appeals court, the Federal Circuit, is the main court authority in the area. The system works similarly in Australia although the number of court cases are far fewer. In European countries, a centralized Patent Office prosecutes the patents but its appeals board lacks binding authority in the member countries. Thus, each member country could give a different interpretation of the same claims. For this report, interpretation follows the rules set forth by the European Patent Office Board of Appeals.

Bibliometric details

  • Title: INTRON SEQUENCE ANALYSIS METHOD FOR DETECTION OF ADJACENT AND REMOTE LOCUS ALLELES AS HAPLOTYPES
  • Inventor: Malcolm J Simons
  • Assignee: Genetic Technologies, Ltd.
  • Appl. No.: 08/949,652
  • Filed: 23 September 1992
  • Priority: Earliest priority date is 25 August 1989
  • Issued: 18 Mar 1997
  • Expires: 9 Mar 2010

Synopsis of the patent specification

The specification is directed to a method for detection of alleles (coding region polymorphisms) and haplotypes through analysis of polymorphisms of non-coding regions11. The method comprises amplifying genomic DNA with a primer pair, such that the amplified fragment contains at least some non-coding region DNA that is linked to an allele to be detected. Furthermore, the non-coding region has a polymorphism(s) that is assayed. In essence, detection of the polymorphism in the non-coding region is a surrogate for detection of the allele.

The text discusses details of the method, including (i) attributes of the amplification primers – the primers need to be specific to the genetic locus under investigation and preferably have an exact match to the genomic DNA sequence; (ii) the length of the sequence – in general, the more alleles there are, the longer the amplified sequence needs to be in order to distinguish among all alleles; (iii) the location of the amplified sequence – the non-coding region should be close enough to the allele to exclude recombination and loss of linkage disequilibrium between the amplified sequence and the coding region polymorphism; and (iv) detection methods – DNA sequence analysis, sequence specific oligonucleotide hybridization, and electrophoresis with or without restriction enzyme digestion. An additional part of the specification details the method with respect to MHC (major histocompatibility complex) genes. The examples demonstrate the invention in a forensic testing setting, paternity analysis, and for various MHC genes of human and cow.