PTAB

IPR2018-00249

Trans Ova Genetics, LC v. XY, LLC

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1. Case Identification

2. Patent Overview

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

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-3 and 7-8 under §102

  • Prior Art Relied Upon: Hagele (a 1984 journal article titled "Effect of separating bull semen into X and Y chromosome bearing fractions on the sex ratio of resulting embryos").
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Hagele disclosed every element of independent claim 1 and dependent claims 2, 3, 7, and 8. Hagele taught a complete method of creating superovulation in cows using an ovulatory pharmaceutical (FSH-P), determining the sex of sperm cells, sorting the sperm into X- and Y-bearing fractions, inseminating the cows after the onset of estrus, and fertilizing eggs to produce multiple (57) sexed embryos. Petitioner asserted Hagele also taught the limitations of dependent claims by administering FSH-P twice daily during the estrous cycle (claims 2, 3, 7) and supplementing the treatment with Estrumate, a known PGF-2-alpha analogue (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 (1984 journal article) and Spaulding (Patent 5,021,244).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Hagele provided the foundational method of superovulating cattle and inseminating them with sex-sorted sperm to produce sexed embryos. However, Hagele used an outdated sedimentation galvanization technique for sorting. Spaulding taught an improved, modern method for sex-sorting mammalian sperm using flow cytometry, which included staining the sperm with a dye (addressing a limitation in claim 10) and was capable of sorting at rates of up to 500 cells/sec, with disclosed capabilities up to 10,000 cells/sec (addressing limitations in claims 10 and 14).
    • Motivation to Combine: A person of ordinary skill in the art (POSA) at the time would have been motivated to improve upon Hagele's basic method. It would have been an obvious and predictable improvement to substitute Hagele's rudimentary sorting technique with the more advanced, efficient, and well-known flow cytometry method taught by Spaulding to increase the yield and reliability of the overall process.
    • Expectation of Success: A POSA would have had a high expectation of success, as Hagele demonstrated the viability of producing sexed embryos from sorted sperm, and Spaulding demonstrated the successful sorting of sperm using its improved flow cytometry method. Combining the two known techniques for their intended purposes was therefore predictable.

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

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

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground augmented the Hagele/Spaulding combination to explicitly teach the high-speed sorting rates recited in claims 10 and 14 ("above 500 sorts per second"). While Spaulding disclosed sorting up to 500 cells/sec, Rens was introduced for its explicit teaching of a high-speed sorter (using an elliptical-shaped nozzle) that achieved demonstrated sorting speeds of nearly 2,000 sperm per second.
    • Motivation to Combine: Petitioner argued that a POSA, already motivated to use the flow cytometry taught by Spaulding, would have been further motivated to incorporate the high-speed modifications taught by Rens. The desire for "efficient sperm sorting" was a well-established goal in the art, and Rens provided a clear pathway to achieve the sorting rates claimed in the ’422 patent.
    • Expectation of Success: Rens's own successful results in achieving high-speed sorting and its use in successful insemination experiments provided a POSA with a strong expectation that the technology would work as intended when combined with the methods of Hagele and Spaulding.

  • Additional Grounds: Petitioner asserted further obviousness challenges, arguing that Seidel '91 provided explicit teachings on hormone injection protocols and the interchangeability of PGF-2-alpha analogues (addressing claims 3, 7, 8); that Nowshari and Donaldson disclosed specific superovulation protocols with multiple PGF-2-alpha injections that met the "estrus manipulation system" limitation (addressing claim 4); and that Johnson '92 provided explicit economic and genetic motivation for producing live, sex-selected mammals (addressing claims 13, 14).

4. Key Claim Construction Positions

  • "prostaglandin F-2-alpha" (claim 8): Petitioner argued this term should be construed to encompass both the naturally occurring compound and its well-known synthetic analogues, such as Estrumate. This construction was central to the anticipation ground, as the ’422 patent itself incorporated a reference (Macmillan) that used such analogues, and the primary prior art (Hagele) disclosed using the analogue Estrumate.
  • "estrus manipulation system" (claims 4, 8): Petitioner contended this term, based on its use in the ’422 patent's claims and examples, referred to a system that includes co-administering PGF-2-alpha (or an analogue) with follicle-stimulating hormone (FSH). This construction supported combining Hagele with references that taught this specific hormonal protocol.

5. Relief Requested

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