PTAB

IPR2018-00249

Trans Ova Genetics LC v. XY LLC

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Multiple Sexed Embryo Production System for Mammals
  • Brief Description: The ’422 patent relates to a method for producing multiple, sexed embryos from a non-human female mammal. The method involves pharmaceutically inducing superovulation, inseminating the mammal with sex-sorted sperm after the onset of estrus, and fertilizing the eggs to produce at least two embryos of a desired sex.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-3 and 7-8 by Hagele

  • Prior Art Relied Upon: Hagele (a 1984 article in the Canadian Journal of Comparative Medicine).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Hagele disclosed every element of claims 1-3 and 7-8. Hagele described a study involving the superovulation of cows using an ovulatory pharmaceutical (FSH-P), determining the sex of sperm cells, sorting them into X- and Y-bearing fractions, inseminating cows after the onset of estrus, and producing multiple sexed embryos. Hagele’s protocol of administering FSH-P twice daily met the limitations of injecting a pharmaceutical a plurality of times a day between days 2 and 18 of the estrus cycle. Petitioner contended that while Hagele used the term “administering,” injection was inherent because the drugs were only available in injectable form. Further, Hagele’s use of Estrumate, a known PGF-2-alpha analogue, met the limitation of supplementing with prostaglandin F-2-alpha in claim 8.

Ground 2: Obviousness of Claims 1-4, 7-8, 10, 13, and 14 over Hagele in view of Spaulding

  • Prior Art Relied Upon: Hagele (a 1984 journal article) and Spaulding (Patent 5,021,244).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Hagele taught the foundational method of producing multiple sexed embryos in superovulated mammals but used a rudimentary "sedimentation-galvanization" technique for sperm sorting. Spaulding disclosed a significantly improved sperm sorting method using high-speed flow cytometry, which had become the preferred method in the art by the early 1990s. Spaulding taught all necessary steps for modern sorting, including staining sperm with a fluorescent dye (Hoechst 33342), using flow cytometry to separate sperm based on DNA content, and achieving sorting rates of up to 500 cells per second. The combination of Hagele’s breeding protocol with Spaulding’s superior sorting technology rendered the claims obvious.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) reading Hagele would combine its methods with Spaulding’s advanced flow cytometry to improve the efficiency, yield, and speed of the sperm sorting process. The recognized need to improve the production of offspring of a desired sex in livestock would have provided a strong incentive to replace Hagele's outdated sorting method with the state-of-the-art technique taught by Spaulding. Spaulding’s stated object was to increase the probability of producing offspring of a desired sex.
    • Expectation of Success: A POSA would have a reasonable expectation of success. Spaulding demonstrated that its flow cytometry method successfully sorted sperm, and Hagele showed that inseminating superovulated cows with sorted sperm successfully produced multiple, sexed embryos. Combining these known, successful techniques for their intended purposes would have been a predictable variation.

Ground 3: Obviousness of Claims 10 and 14 over Hagele and Spaulding in further view of Rens

  • Prior Art Relied Upon: Hagele (a 1984 journal article), Spaulding (Patent 5,021,244), and Rens (Patent 5,985,216).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground supplemented the argument that sorting sperm at rates "above 500 sorts per second" was obvious. While Spaulding disclosed rates up to 500 sorts per second and suggested higher rates were possible, Rens explicitly taught methods and equipment to achieve sorting rates well above this threshold. Rens disclosed a modified high-speed sorter with an elliptical-shaped nozzle that achieved demonstrated sorting speeds of approximately 1,984 sperm cells per second.
    • Motivation to Combine: The motivation to add Rens to the Hagele/Spaulding combination stemmed from the well-established goal in the art to maximize the number of sorted sperm per unit of time to make artificial insemination commercially feasible. The ’422 patent itself acknowledged the importance of high-speed sorting. A POSA seeking to optimize the process taught by Hagele and Spaulding would look to further improvements like those in Rens to increase sorting efficiency.
    • Expectation of Success: Rens successfully demonstrated its high-speed sorting method and subsequent insemination of cattle. Petitioner noted that in a related inter partes review (IPR), the Patent Trial and Appeal Board (PTAB) found that a POSA would have been motivated to use Rens’ high-speed sorter to improve the efficiency of prior art sorting methods.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 3, 7, and 8 over Hagele in view of Seidel ’91 (a training manual); claim 4 over Hagele in view of Nowshari and Donaldson (journal articles); and claims 13 and 14 over Hagele and Spaulding in view of Johnson ’92 (Patent 5,135,759).

4. Key Claim Construction Positions

  • "prostaglandin F-2-alpha" (claim 8): Petitioner argued this term should be construed to encompass both naturally occurring PGF-2-alpha and its well-known synthetic analogues, such as Estrumate. This construction was critical for the anticipation argument, as Hagele disclosed the use of Estrumate. Petitioner supported this by noting the ’422 patent’s specification incorporated by reference an article (Macmillan) that discussed using such analogues to synchronize estrus in cattle, describing them as an example of "well known in the art" techniques.

5. Relief Requested

  • Petitioner requested institution of an IPR and cancellation of claims 1-4, 7-8, 10, and 13-14 of the ’422 patent as unpatentable.