PTAB

PGR2021-00004

Commonwealth Scientific Industrial Research Organisation v. BASF Plant Science GmbH

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Oils, Lipids and Fatty Acids Produced in Transgenic Brassica Plant
  • Brief Description: The ’183 patent relates to oils, lipids, and fatty acids produced by genetically engineered Brassica plants. The invention is directed to achieving specific concentrations and positional distributions of long-chain polyunsaturated omega-3 fatty acids, such as eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA).

3. Grounds for Unpatentability

Ground 1: Lack of Written Description for Claim 1 under 35 U.S.C. §112

  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that claim 1, which recites oils from a transgenic Brassica plant comprising 25% to 40% EPA at the sn-2 position, lacks written description. The specification is allegedly devoid of any disclosure of this specific numerical range. Furthermore, the patent contains no experimental data measuring the positional distribution of EPA in any Brassica lipid. The only relevant data is from the leaf lipids of a different plant (O. violaceous), which Petitioner asserted is not representative of fatty acid profiles in the seed oil of Brassica plants. This complete lack of disclosure, Petitioner contended, demonstrates that the inventors were not in possession of the claimed subject matter.

Ground 2: Lack of Enablement for Claims 1-9 under 35 U.S.C. §112

  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the claims are not enabled because the specification fails to teach a Person of Ordinary Skill in the Art (POSITA) how to make and use the full scope of the invention without undue experimentation. The claims are exceptionally broad, covering any transgenic Brassica species with specific fatty acid profiles. However, the specification provides no working examples that fall within the claimed ranges for Brassica plants and offers no concrete guidance on how to modify the disclosed genetic constructs to achieve the claimed compositions. For example, the sole Brassica example reports only 4.1-4.5% EPA, far below the claimed "at least 20%" levels in dependent claims.

Ground 3: Anticipation of Claims 1, 3, and 5-9 under 35 U.S.C. §102

  • Prior Art Relied Upon: Wu (a 2005 journal article in Nature Biotechnology).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Wu anticipated the claims by describing the transformation of Brassica juncea with a vector (BJ9) analogous to the vector disclosed in the ’183 patent. Wu reported the positional analysis of triacylglycerols from the transformed seeds, showing that EPA was distributed almost equally across the sn-1, sn-2, and sn-3 positions (approximately 33.3% at each position). This 33.3% EPA concentration at the sn-2 position falls squarely within the 25% to 40% range recited in claim 1. Petitioner further contended that if the features of other dependent claims are found to be enabled by the ’183 patent, they must also be considered disclosed in Wu.

Ground 4: Obviousness of Claims 1-9 under 35 U.S.C. §103

  • Prior Art Relied Upon: Wu (a 2005 journal article) in view of the ’093 publication (WO 2005/083093).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that the vector disclosed in the ’183 patent for transforming Brassica juncea differs from the vector in Wu only by the use of a more efficient, codon-optimized Δ5 elongase enzyme. The sequence for this exact codon-optimized enzyme was disclosed in the ’093 publication as a preferred Δ5 elongase.
    • Motivation to Combine: A POSITA reading Wu would have understood that the efficiency of the Δ5 elongase in its BJ9 vector was low, limiting DHA synthesis. Wu explicitly stated that achieving DHA synthesis in seeds, even at low levels, provided a basis for further optimization. Therefore, a POSITA would combine the teachings by replacing the inefficient Δ5 elongase in Wu’s vector with the more efficient, preferred Δ5 elongase from the ’093 publication to increase DHA yields.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in making this substitution, as it involved replacing a known enzyme with a known, more efficient version to achieve a predictable improvement in the desired metabolic pathway. This combination would result in the vector described in the ’183 patent.

  • Additional Grounds: Petitioner asserted numerous other grounds, including lack of written description and lack of enablement for each of claims 1-8 individually. Additional challenges for anticipation and obviousness were asserted over the ’093 publication alone and another reference, the ’387 publication (WO 2007/096387).

4. Key Claim Construction Positions

  • "wherein said oils, lipids and/or fatty acids comprise in the sn-2 position [X]% to [Y]% by weight of [a specific fatty acid] based on the total [specific fatty acid]" (Claims 1-3): Petitioner proposed this term should be construed as a formula: (Weight of the fatty acid at the sn-2 position of all relevant lipid species) / (Weight of the total amount of that fatty acid present) x 100. This construction clarifies that the percentage is a ratio of positional distribution, not an absolute amount.
  • "based on the total fatty acids in the transgenic [Brassica] plant in the form of triacylglycerides" (Claim 4): Petitioner proposed this should be construed to mean that the weight of the specified fatty acids (e.g., EPA) is calculated relative to the total weight of all fatty acids present specifically in the triacylglyceride (TAG) fraction of the plant.

5. Key Technical Contentions (Beyond Claim Construction)

  • Data Extrapolation Across Species and Tissues: A central technical argument was that experimental data on fatty acid composition and distribution obtained from the leaf tissue of one plant species (O. violaceous) cannot be considered representative or predictive of the results that would be obtained in the seed oil of a different genus (Brassica). Petitioner used data from the ’183 patent itself to show that results were dramatically different between the two, undermining the patent’s written description and enablement for the claimed Brassica oils.

6. Relief Requested

  • Petitioner requested institution of Post-Grant Review (PGR) and cancellation of claims 1-9 of the ’183 patent as unpatentable.