Fisher (Plaintiff) argued that his claimed invention, relating to five purified nucleic acid sequences (genes), commonly referred to as expressed sequence tags (ESTs), that encoded proteins and protein fragments in maize plants, had a specific and substantial utility and that his patent application enabled one of ordinary skill in the art to use the invention.
A patent application that discloses general, generic uses of a claimed invention, the claimed inventions of which are mere research intermediaries, lacks utility and lacks enablement.
Fisher (Plaintiff) submitted a patent application (the â€˜643 application) that related to five purified nucleic acid sequences (genes), commonly referred to as expressed sequence tags (ESTs), that encoded proteins and protein fragments in maize plans.Â When Plaintiff filed the â€˜643 application, he did not know the precise structure or function of either the genes or the proteins encoded for by those genes.Â The â€˜643 application disclosed that the five claimed ESTs could be used in different ways, including: (1) serving as a molecular marker for mapping the entire maize genome, which consists of ten chromosomes that collectively encompass roughly 50,000 genes; (2) measuring the level of mRNA in a tissue sample using microarray technology to provide information about gene expression; (3) providing a source for primers for use in the polymerase chain reaction (PCR) process to enable duplication of specific genes rapidly and inexpensively; (4) identifying the presence or absence of a polymorphism; (5) isolating promoters through chromosome walking; (6) controlling protein expression; and (7) locating genetic molecules of other plants and organisms.Â The patent examiner found that none of the recited uses for the ESTs satisfied the â€œsubstantial utilityâ€ standard and â€œenablementâ€ standard required for patentability.Â The Board of Appeals and Interferences affirmed, and the Federal Circuit granted review.
Does a patent application that discloses general, generic uses of a claimed invention, the claimed inventions of which are mere research intermediaries, lack utility and lack enablement?
(Michel, C.J.)Â Yes.Â A patent application that discloses general, generic uses of a claimed invention, the claimed inventions of which are mere research intermediaries, lacks utility and lacks enablement.Â Fisher’s (Plaintiff) argument that the claimed ESTs provide seven specific and substantial uses, regardless whether the functions of the genes corresponding to the claimed ESTS are known, is not convincing.Â Basically, the claimed ESTs act as no more than research intermediates that may help scientists isolate the particular underlying protein-encoding genes and conduct further experimentation on those genes.Â The overall goal of such experimentation is presumably to understand the maize genome.Â Therefore, the claimed ESTs are mere â€œobjects of use-testing,â€ i.e., objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end.Â Fisher’s (Plaintiff) comparison of the ESTs to a patentable microscope is also unconvincing.Â A microscope can immediately reveal an object’s structure, whereas the claimed ESTs can only be used to detect the presence of genetic material having the same structure as the EST itself.Â It is not able to provide any information about the overall structure much less the function of the underlying gene.Â Therefore, while a microscope can offer an immediate, real world benefit in a variety of applications, the same cannot be said for the claimed ESTs.Â The claimed ESTs themselves are not an end of Fisher’s (Plaintiff) research effort, but only tools to be used along the way in the search for a practical utility.Â And so, while Plaintiff’s claimed ESTs may add a noteworthy contribution to biotechnology research, they are not of sufficient utility to call for patentability because Plaintiff does not identify the function for the underlying protein-encoding genes.Â Without such identification, the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent.Â Therefore, Plaintiff’s asserted uses are insufficient to meet the standard for a â€œsubstantialâ€ utility under Â§ 191.Â The claimed inventions also lack enablement under Â§ 112.Â Affirmed.
(Radar, J.)Â Although the Patent Office needs a tool to reject inventions that may advance the â€œuseful artsâ€ but not sufficiently to warrant the valuable exclusive right of a patent, the utility requirement is not the tool for this job.Â The utility requirement is inadequate for this task because it lacks any standard for assessing the state of the prior art and the contributions of the claimed advance.Â The proper tool for assessing sufficient contribution to the useful arts is the obviousness requirement Â§ 103.Â Unfortunately, the Patent Office has been judicially deprived of the obviousness requirement for genomic inventions.Â See In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995).Â However, rather than distort the utility test, the Patent Office should seek ways to apply the correct test, i.e., inventive step or obviousness.
Judge Rader, in his dissent, also disagreed that the ESTs were not similar to a microscope.Â He found that â€œboth take a researcher one step closer to identifying and understanding a previously unknown and invisible structure.Â Both supply information about a molecular structure.Â Both advance research and bring scientists closer to unlocking the secrets of the corn genome to provide better food production for the hungry world.Â If a microscope has Â§ 101 utility, so too do these ESTs.