PTAB Finds That Probiotic Formulation Is Not a Product of Nature
The Patent Trial and Appeal Board recently reversed the §101 rejection of claims directed to a composition that includes the bacterial strain Lactobacillus plantarum 2830 and a galactooligosaccharide produced by that strain, finding the claims to be eligible for patenting.1 This decision provides important guidance on patent eligibility for compositions involving naturally occurring microorganisms.
The Technology
Both probiotics and prebiotics can be consumed or administered to individuals to promote gastrointestinal health. OptiBiotix (ProBiotix) Health’s invention relates to a probiotic-prebiotic combination, where the probiotic bacterium L. plantarum 2830 is combined with a prebiotic galactooligosaccharide (GOS). The GOS acts to modify the absorption of cholesterol for the treatment of heart disease, diabetes, or obesity.
L. plantarum 2830 naturally contains β-galactosidase, and normally uses this enzyme to digest lactose. However, the inventors discovered that by manipulating certain reaction conditions, they could get the enzyme to work in reverse and generate an oligosaccharide version of the lactose (i.e. a GOS) instead.
The § 101 Rejection
The examiner rejected the claims under 35 USC §101, arguing that both the bacterial strain and the GOS were natural products that existed together in nature. The examiner stated that neither the L. plantarum 2830 strain itself nor the GOS had been altered in any way, but rather that the GOS is produced when the strain is placed in an alternative environment. Relatedly, the examiner found that the GOS is not structurally distinct from other GOS found in nature.
The Board’s Analysis
The Board agreed with the examiner that the Lactobacillus plantarum 2830 bacterial strain derived from nature. However, the Board did not agree with the examiner’s conclusion that the claimed GOS was a natural product as well.
The Board noted that the GOS produced by L. plantarum 2830 by the reverse β-galactosidase reaction was not naturally produced, and further that L. plantarum 2830 and the GOS do not naturally occur in combination. Key to their analysis was that:
- The GOS is only produced under artificial conditions not found in nature
- The reverse β-galactosidase reaction requires manipulated temperatures and lactose concentrations
The Board also considered the question of whether the combination of the L. plantarum 2830 and the GOS, as a nature-based product containing multiple components, exhibited markedly different characteristics when compared to the L. plantarum 2830 strain alone. Under the markedly different characteristics analysis (Step 2A Prong One), the Board looked at two interpretations of the claimed composition:
- the bacterial strain and the GOS made within it by the bacteria’s own enzyme reaction
- the bacterial strain and the GOS combined
Under the first interpretation, the Board concluded that such a composition is markedly different from the strain that exists in nature, because GOS would not be present in the strain in its natural environment. The Board also noted there is a structural difference between the strain in its natural environment and the claimed composition.
Under the second interpretation, the Board concluded that no markedly different characteristic was demonstrated, and then turned to the question of whether the claim as a whole integrated a judicial exception into a practical application (Step 2A Prong Two). Relevant to this aspect of the analysis, for the combined strain and the GOS, the applicant provided evidence of improved cholesterol reduction compared to combinations using GOS from other sources, demonstrating that the combination of elements recited in the claim integrated the judicial exception into a practical application.
With reference to the USPTO’s 2019 Revised Subject Matter Eligibility Guidance reflected in the flowchart provided below, it can be seen that under Step 2A Prong One, the claims involved a product of nature (L. plantarum 2830). According to the first interpretation, a markedly different characteristic (MDC) was provided the overall combination of elements and hence a natural product was not claimed, thereby taking the analysis from Prong One -> Pathway B. According to the second interpretation, a MDC was not present and hence a natural product was claimed, yet the claim as a whole provided sufficient integration, thereby taking the analysis from Prong One > Prong Two > Pathway B. Under either interpretation the claim recited patent eligible subject matter under 35 U.S.C. §101.
Key Takeaways for Practitioners
This decision highlights several important points for the patent eligibility of compositions involving natural products:
- Products produced by natural organisms may not be interpreted as natural products when they are made under artificial conditions
- Evidence of unique structural characteristics or improved functionality can help establish eligibility
- Multiple claim interpretations should be considered in the eligibility analysis
The case provides valuable guidance for drafting and prosecuting claims involving natural products, particularly in the microbiology space.
PERA Implications
Although the Board found that the claims met the requirements of §101, under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140) it is likely that this case would not have made it to the Board, as the examiner would likely have concluded that the composition claims met the patent eligibility requirement (e.g. pursuant to §§101(a), (b)(2)(A),(b)(2)(B)).
1 Ex parte O’Hara (Appeal 2023-003678; December 10, 2024) [PDF]