Despite challenges imposed by U.S. patent law regarding naturally occurring organisms and their products, patents relating to the microbiome and microbiome-based therapeutics are issuing from the U.S. Patent and Trademark Office. Issues encountered and the strategies used to overcome them are illustrated by the following selected examples of recently issued patent claims.
This claim is noted for its broad recitation of indications, including infectious disease, autoimmune disease and allergic disease, as well as for the lack of reference to any specific fecal microbes, and the reliance on functional characteristics: spore-forming ability and the induction of Treg cells to define the microbes involved. The data provided in the Examples include those showing an increase in colonic Treg cells in germ-free mice, with and without administration of a chloroform-treated (spore-forming) fraction of human fecal matter.
The application leading to this patent was prosecuted under the Track One accelerated examination procedure.
This method claim is of interest because, apart from requiring that the strains be isolated from oral samples and not include Streptococcus mutans strains, it defines the appropriate bacterial strains in functional terms only, based on their ability to produce ammonia via the ADS system under different specified conditions. The specification includes a description of the identification and characterization of more than 50 ADS-positive strains. Composition claims drawn to combinations of two or more arginolytic bacterial strains faced rejection for lack of patent-eligible subject matter and were cancelled to permit the method claims to issue.
This composition claim is narrow in using “consisting of” language to specify the bacteria involved—each of the subject bacteria must be present to satisfy the claim—but remarkably broad in reciting the bacterial species only in terms of having 16S rDNA of at least 95% sequence homology—not identity—to the 16S rDNA sequences specified. The therapeutic indication is also very broad, encompassing any autoimmune disease. No patent-eligible subject matter issue was raised during prosecution.
A parallel application issued May 16 as U.S. Patent 9,642,881, with method claims broadly reciting “a method of treating an autoimmune disease” by administering a pharmaceutical composition defined exactly as in the composition claim above.
Both applications were prosecuted under the Track One prioritized examination procedure and had very few statements characterizing the invention on the part of the applicant or the Patent Office.
This method claim is of interest, in part for the broadly stated indication of “improving the microbiota balance in human gut and digestive health,” but also for doing so by administering two prebiotic cereals with a specified ratio of beta-glucans in the first cereal to arabinoxylans in the second. An in vitro “Simulator of the Human Intestinal Microbial Ecosystem” was used to generate data regarding probiotic index for various compositions. Composition claims reciting a biscuit were under a prior art rejection at the time they were cancelled to permit the method claims to issue.
Among other things, these recently issued microbiome-related patents again demonstrate the benefits of using the Track One accelerated examination procedure to quickly secure patent coverage with a minimal prosecution record. Other aspects illustrated by these claims include:
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