PTAB

PGR2020-00057

Commonwealth Scientific Industrial Research Organisation v. BASF Plant Science Co GmbH

Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Uses of Novel Fatty Acid Desaturases and Elongases and Products Thereof
  • Brief Description: The ’870 patent relates to producing plant seed oil from transgenic plants. The oil is characterized by specific compositions of polyunsaturated fatty acids, including minimum levels of docosahexaenoic acid (DHA), defined ranges of eicosapentaenoic acid (EPA), and specific ratios of DHA to docosapentaenoic acid (DPA).

3. Grounds for Unpatentability

Ground 1: Lack of Written Description for Key Claim Limitations (Claims 1-17)

  • Prior Art Relied Upon: This ground is asserted under 35 U.S.C. §112 and does not rely on prior art.
  • Core Argument for this Ground:
    • Written Description Argument: Petitioner argued that the ’870 patent’s specification fails to provide adequate written description for several key limitations that were added during prosecution. Specifically, the concepts of oil comprising "at least 1% DHA," having a DHA to DPA ratio of "at least 2," or a DPA to DHA conversion rate of "at least 75%" do not appear in the specification. Petitioner asserted that the Patent Owner relied on "implicit" support from a single example in transgenic Arabidopsis plants (Figures 10 and 11), but this single data point is insufficient to demonstrate possession of the invention across the full, broad scope of "any transgenic plant" as claimed. Petitioner contended that a POSITA would not reasonably conclude from one species' results that the inventors possessed the full scope of the claimed subject matter, which covers all plants and ranges up to 99% DHA.
    • Key Aspects: The argument centered on the fact that the claimed features are quantitative ranges and ratios that were introduced late in prosecution without explicit corresponding disclosure in the original application.

Ground 2: Anticipation by the '404 Publication (Claims 1-4, 6-12, and 14-17)

  • Prior Art Relied Upon: Napier (’404 publication) (WO 2013/153404 A1).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ’404 publication, which published before the ’870 patent’s effective filing date, explicitly discloses transgenic Camelina sativa seeds having fatty acid profiles that meet all limitations of the challenged claims. Petitioner pointed to Table 5 of the ’404 publication, which allegedly discloses seed oils with: (1) at least 1% DHA (e.g., 4.1% and 4.7%); (2) between 1% and 6% EPA (e.g., 5.2% and 4.9%); (3) a DHA to DPA ratio of at least 2 (e.g., 2.9 and 3.1); and (4) a DPA to DHA conversion rate of at least 75% (e.g., 74.5% and 75.8%). Because the ’404 publication discloses a species of transgenic plant (Camelina sativa, an oilseed plant in the Brassicaceae family) producing an oil with all the required characteristics, Petitioner asserted that it anticipates the claims.
    • Key Aspects: This ground relied on a direct mapping of experimental data from a prior art publication to the specific numerical limitations of the claims.

Ground 3: Obviousness over the '246 Publication (Claims 1-17)

  • Prior Art Relied Upon: Petrie (’246 publication) (WO 2010/057246 A1).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that the ’246 publication discloses methods for producing omega-3 fatty acids, including DHA, DPA, and EPA, in transgenic plants and explicitly suggests the key concentration ranges claimed in the ’870 patent. The ’246 publication allegedly teaches producing seed oil from a transgenic plant and discloses preferred embodiments where the amount of DHA is at least 3% (and up to 95%), and the amount of EPA is between 0.1-50%, which encompasses the claimed range of 1-6%. Further, Petitioner contended that the disclosed ranges of 40-95% DHA and 0.1-50% DPA inherently encompass a DHA to DPA ratio of at least 2 and a DPA to DHA conversion rate of at least 75%.
    • Motivation to Combine (for §103 grounds): Although a single-reference ground, the motivation is implicit. The ’246 publication teaches the desirability of producing oils with high concentrations of these specific fatty acids. A POSITA reading the ’246 publication would be motivated to optimize the disclosed methods to achieve the specific, overlapping ranges recited in the ’870 patent claims to create a valuable nutritional oil.
    • Expectation of Success: Petitioner asserted a POSITA would have a reasonable expectation of success because the ’246 publication provides the necessary enzymes and methods for producing the target fatty acids and discloses ranges that encompass and surround those claimed.
  • Additional Grounds: Petitioner asserted numerous additional grounds, including other anticipation challenges based on the ’948 publication (WO 2011/006948) and the ’184 publication (WO 2013/185184). Petitioner also raised multiple grounds arguing lack of enablement under §112 for the full scope of the claims, based on the specification's limited examples.

4. Key Claim Construction Positions

  • Petitioner argued that because the claims recite percentages of fatty acids without specifying the calculation method (e.g., weight or molar), they should be construed as weight percentages.
  • Petitioner also argued that open-ended terms like "at least 1% docosahexaenoic acid (DHA)" and a DHA to DPA ratio of "at least 2" must be construed to cover the full possible range—up to 99% for DHA (given the 1% EPA minimum) and up to infinity for the ratio. This broad construction was central to Petitioner's arguments that the specification fails to enable or provide written description for the full scope of the claims.

5. Relief Requested

  • Petitioner requests institution of post-grant review and cancellation of claims 1-17 of the ’870 patent as unpatentable.