May 09, 2019
Patent Law Alert
Author(s): Nicole D. Kling, Ph.D., Mark James FitzGerald, Ph.D.
In this issue, we examine microbiome patents for use in the agriculture industry.
Microbiomes further afield—Agricultural applications
The interest and utility of the microbiome is certainly not limited to human medicine. The microbiome has long been of interest in agricultural circles and is of increasing importance particularly as the demand for organic and non-GMO agriculture continues to expand. While issuing patent claims in this area often mirrors the trends seen in medical microbiome applications, the differences can be illuminating and suggest opportunities for those aiming to apply microbiome advances to clinical applications as well as those pursuing IP protection in agricultural areas.
A look at issuing patents:
An ever-present concern in microbiome-focused patent application is the definition of the subject microbes. Regular readers and those otherwise familiar with this area are well aware of the early reliance on 16S rRNA sequences, as well as the more recent trends to use genomic- or transcriptomic-based definitions. Each of these approaches attempts to address the need to define the microbes in a way that the USPTO will consider appropriately definite, without excluding functionally equivalent microbes from patent protection.
Different approaches may be more or less appropriate depending on the particular technological application and the identity of the relevant microbe(s). Additionally, preparing a patent application that includes multiple different approaches to microbe definition is the best way to provide the necessary ability to respond to emerging trends and new developments in this area.
Past successes in patent prosecution are an often fertile ground for how to approach both applications currently in front of the USPTO as well as IP that is yet to be filed upon. The following examples include recently issued claims from the agricultural microbiome space, which are educational to all of those with an interest in microbiome IP trends regardless of their ultimate commercial intentions.
U.S. Patent 10,271,554
Claim of interest:
Multiple tables worth of bacterial endophytes are identified in the specification by name and 16S nucleic acid sequence. The specification also refers to “a bacterial endophyte comprising a 16S nucleic acid sequence at least 97% identical” to the exemplified sequences.
The noted claim defines the bacteria to be used by identity to a single 16S sequence. This limitation was added during prosecution.
U.S. Patent 10,212,941
Claim of interest:
wherein the Xfas300 type phage has the following characteristics:
This method claim describes phage by broad genus/family classifications and a combination of a number of structural and functional characteristics. The claim lacks any direct sequence limitations. A dependent claims lists specific phage types/Accession Numbers.
U.S. Patent 10,212,944
Claim of interest:
The claim describes a combination of a fungal endophyte and bacterial endophyte, where the combination is heterologous. Dependent claims list multiple suitable genera for each endophyte, as well as describing suitable endophytes by 95% identity to any of over 500 16S or ITS RNA sequences.
U.S. Patent 10,154,671
Claim of interest:
This composition claim combines a partly isolated species with fungi/yeast material and functional limitations. A dependent claim provides a deposit number for a preferred strain.
U.S. Patent 10,051,869
Claim of interest:
This composition claim combines multiple species-limited microbes at certain concentrations, combined with fertilizer ingredients.
Before turning to the issue of defining microbes in a claim, it is noted that the examples above highlight the power of the term “heterologous” to distinguish compositions from natural products. Such language is a direct outcome of the Myriad decision on patent-eligible subject matter and may eventually become as ubiquitious as “isolated” was in pre-Myriad patents.
Agricultural microbiome claims continue to issue that define microbes by classic, widespread approaches such as 16S or ITS sequences. We note that the above examples may indicate that claims are more likely to be permitted to recite a large number of individual sequences when the 16S sequence is not featured in the independent claim—lessening the need for a long sequence of continuations and/or divisionals while still providing the advantages of a sequence claim.
Another standby approach in microbiome IP is defining the microbe by functional descriptions. While, in recent years, functional limitations have come under more critical review at the USPTO (a trend that extends well beyond the microbiome space) and purely functional limitations can be difficult to obtain, it is clear from the above that such an approach can still succeed, particularly when combined with some structural descriptions.
A currently popular trend in the agricultural microbiome space that is of particular interest is the use of combination of microbes (usually described at the species or genus level, although even broader claims are possible) with a second microbe and/or additional elements of a formulation. This approach can provide striking scope in the identity of the individual microbes if the applicant is able to include limitations that further describe their commercial formulation’s other aspects. Prior issues of Gut Check have reviewed the use of such combinatorial approaches in method of treatment claims, but this approach can see success for composition claims as well.
As ever, the savvy applicant will incorporate as many different approaches as is practicable, and the patents above each exemplify a defense in depth approach—multiple different approaches to microbe definition and/or inclusion of deposit or accession-specific dependent claims. Such forward-thinking approaches provide claim sets that will be more likely to weather shifting trends and unexpected court rulings.
The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.