In this issue:
Method claim preambles — setting the scene
In the biotech space, there’s no one-size-fits-all approach to patent applications, and when it comes to agricultural technology, patent practitioners should pay close attention to the phrasing of the method claim preamble. The preamble sets the stage and frames the entire conception of the invention for Examiners, litigation proceedings, and even the patent drafters themselves!
Many patent practitioners in the biocontrol/biopesticide/biostimulant arena have a wide breadth of experience in other biotechnology areas. They often carry the lessons from those areas into their more agriculturally focused IP work, but their habits and best practices are not always seamlessly transferable between those different technological zones.
To mitigate risk and increase success with enforcement and litigation, patent practitioners should focus on the proper wording of a method claim in patent applications when describing a biocontrol/biopesticide/biostimulant technology. Method claim preambles are necessary for successful patent prosecution, but often mined during litigation by opposing counsel to support arguments for limiting the scope of claims.
As shown below, a number of issuing patents in biocontrol/biopesticide/biostimulant present method claims in a format that is common for many biotech method claims in other technological areas. Specifically, the preamble recites a method of treating a condition, deficiency, or disease that the biocontrol/biopesticide/biostimulant technology directly addresses. Following this convention, though, overlooks key differences in how agricultural technology and other bio-related technologies are often used.
Agricultural technology uses are often preventive or prophylactic in nature as opposed to other biotechnology areas that treat a human patient, where a specific disease or condition will be present, diagnosed, and then treated in the clinic. In addition, a formal scientific diagnosis is not as common in agricultural settings as in medical settings. Finally, in agriculture, individual plants are rarely treated; rather, groups of individual plants (any one of which may or may not be suffering from the relevant condition) are typically subjected to a treatment, making prophylaxis an inherent component of most agricultural methods even when the presence of a specific condition is provable.
This component, coupled with the USPTO’s longstanding reluctance to issue claims that recite “preventing,” a standard claim preamble of “A method of treating X, the method comprising …” threatens to leave unnecessary and entirely avoidable room for competitors to raise questions about claim scope and perhaps to skirt infringement.
A look at issuing patents
The recently-issued patents presented below illustrate some of the different ways preambles can be approached.
Claims with broad method preambles
U.S. Patent 10,251,400
- Titled: Mixtures comprising a Bacillus strain and a pesticide
- Inventors: Jabs, et al.
- Assignees: BASF SE (Ludwigshafen, DE)
- Issued: April 9, 2019
Claim of interest:
- 10. A method for controlling phytopathogenic fungi, insects or other pests and/or improving the health of plants and/or regulating plant growth, comprising treating the plants, the plant propagation material or the soil with an effective amount of the mixture of claim 1.
This claim’s preamble (and indeed the method step as well) is admirably broad and avoids the potential pitfalls of a “treatment” claim.
The “controlling” language is noted to appear in recently issued patent claims from a number of the experienced multinationals, as well as successful startups, but inclusion of an appropriate definition of “controlling” in the specification can help bolster the protection offered by such a preamble.
U.S. Patent 10,212,944
- Titled: Designed complex endophyte compositions and methods for improved plant traits
- Inventors: Ambrose, et al.
- Assignees: Indigo Agriculture, Inc. (Cambridge, MA)
- Issued: February 26, 2019
Claim of interest:
- 14. A method of inoculating a plant with the designed complex endophyte of claim 1, comprising contacting a plant element of said plant with the synthetic composition of claim 1 and incubating said contacted plant element to allow the synthetic composition to colonize one or more tissues of said plant.
- 15. A method of improving a trait of agronomic importance in a plant, comprising: (a) contacting a plant element of the plant with the synthetic composition of claim 1; and (b) growing the plant element comprising the synthetic composition into the plant, wherein the plant grown from the contacted plant element has an improvement in the trait of agronomic importance as compared to an isoline plant not contacted with the synthetic composition of claim 1.
These claims exemplify a strategy in which the trait of disease is never mentioned. Claim 14 in particular focuses rigorously on the actual method to be physically performed with outcomes phrased in a very immediate, nonspeculative manner.
Claims with moderate method preambles
U.S. Patent 10,258,033
- Titled: Compositions and methods comprising terpenes or terpene mixtures selected from thymol, eugenol, geraniol, citral and L-carvone
- Inventors: Franklin, et al.
- Assignees: Eden Research PLC (Easingwold York GB)
- Issued: April 16, 2019
Claim of interest:
- 1. A method of treating or preventing a fungal infection in a plant caused by one or more of Colletotrichum graminicola and Botrytis cinerea, comprising: administering to the plant or to soil in proximity to the plant a therapeutically effective amount of a composition comprising hollow glucan particles or hollow cell wall particles encapsulating a terpene component, wherein the terpene component comprises a combination of thymol, eugenol, and geraniol in a weight ratio of 2:1:2, wherein the hollow glucan particles or hollow cell wall particles themselves have a lipid content of 10% w/w or greater.
The inclusion of “preventing” may maintain the desired claim scope here, although the restriction to two specific fungi is less than optimal.
U.S. Patent 10,251,365
- Titled: Fungal endophytes
- Inventors: Hume, et al.
- Assignees: Grasslanz Technology Limited (Hamilton, NZ); The Grains Research and Development Corporation (Barton AU)
- Issued: April 9, 2019
Claims of interest:
- 12. A method of conferring at least some level of pest protection on a host Secale spp. plant comprising artificially infecting a Secale spp. plant with at least one epichloae fungal endophyte, wherein the epichloae fungal endophyte is selected from the group consisting of AR3039 (NRRL# 50716), AR3046 (NRRL# 50576), AR3049 (NRRL#50577), AR3050 (NRRL# 50578), AR3064 (NRRL# 50718), AR3067 (NRRL# 50719), AR3068 (NRRL# 50720), AR3073 (NRRL# 50721), AR3074 (NRRL# 50722), AR3076 (NRRL# 50723), and AR3078 (NRRL# 50724), and combinations thereof, and wherein the fungal endophyte-Secale plant combination produces at least one alkaloid at a level sufficient to confer at least some level of pest protection on the host plant.
The specification defines “conferring at least some level of pest protection” as “measurably reducing the incidence, severity and/or duration of the effects of a pest on a Secale spp. plant.” It seems likely that a motivated litigator could debate whether this definition affirmatively includes prophylactic use, especially within the population-level uses relevant to agriculture.
Claims with narrow method preambles
U.S. Patent 10,039,286
- Titled: Insecticidal yersinia entomophaga compositions and uses thereof
- Inventors: Hurst, et al.
- Assignees: AgResearch Ltd
- Issued: August 7, 2018
Claim of interest:
- 1. A method of treating a plant or a seed for an insect pest infestation comprising applying to the plant or seed, a biopesticide composition comprising at least one of the following: a) a biopesticide effective amount of isolated live Yersinia entomophaga MH96 obtained from a culture of Yersinia entomophaga MH96; b) a biopesticide effective amount of cellular extract of Yersinia entomophaga MH96; or c) a biopesticide effective amount of whole broth culture of live Yersinia entomophaga MH96; wherein said Yersinia entomophaga MH96 is the bacterium deposited at DSMZ on 4 May 2006 and designated accession no. DSM 18238.
Given that the specification recites “treating or protecting” without appearing to define “treating,” and the claims recite only “treating,” this claim exemplifies the preamble type that might be open to a reading which excludes prophylactic use.
Due to the unique nature of agricultural biotech practices, IP practitioners should carefully consider how to best modify their standard approaches to biotech patent claims. As noted above, prophylactic (or at least seemingly prophylactic) use is more common in agricultural industries than other areas where biotechnology is applied.
In agricultural settings, formal diagnoses and clinically precise expectations of disease progression and outcomes are not as standard as most IP practitioners expect. Therefore, drafting claims that focus on the methods instead of the outcomes, and where outcomes are necessary, focusing on the effect on the plant itself will provide more-robust IP. The presence and behavior of the pathogen or stress are potentially less predictable, more difficult to prove, and often more likely to be subject to restriction of claim scope on § 112-related grounds.
This is seen in the contrast between the broad and moderate preambles above — improving the health of a plant or merely inoculating the plant provides broad scope that does not readily suggest narrowing amendments. Claims to treating an infection often seem to lead to questions about what precisely the treatment is effective against, or what exactly treatment is and how to know it is accomplished.
The preamble sets the stage for the invention, and proper focus on its phrasing will help secure stronger IP protections.