PTAB

IPR2022-00304

Petiq Inc v. ELANco US Inc

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1. Case Identification

2. Patent Overview

  • Title: Active Compound-Containing Solid Molded Bodies for External Use Against Parasites on Animals
  • Brief Description: The ’122 patent discloses solid molded articles, such as animal collars, for long-term parasite control. The invention comprises a mixture of a polyvinyl chloride (PVC) matrix, two active parasiticides (imidacloprid and flumethrin), and a specific fatty acid ester (propylene glycol dicaprylocaprate) intended to increase the migration of the active compounds out of the polymer matrix.

3. Grounds for Unpatentability

Ground 1: Claims 1-3 are obvious over Dorn in view of Reul

  • Prior Art Relied Upon: Dorn (Patent 6,232,328) and Reul (Patent 4,331,651).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Dorn taught all key elements of claim 1 except for the specific fatty acid ester. Dorn disclosed using PVC to create shaped articles like collars for parasite control, the use of both imidacloprid and flumethrin as active ingredients in combination, and the inclusion of plasticizers and "spreading oils" to enhance the formulation. Petitioner asserted that Reul supplied the missing element by disclosing the use of "release-promoting substances" in polymer "depot bodies" for animals. Reul specifically identified "caprylic/capric acid-1,2-propanediol diester (®Miglyol 840)"—the same compound as the claimed propylene glycol dicaprylocaprate—as a preferred release-promoting additive within a concentration range that overlaps the challenged claims.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) seeking to improve the release of active ingredients from Dorn's PVC collar would have been motivated to incorporate the teachings of Reul. Dorn taught the general use of spreading oils, creating a clear reason to look to other art for specific, effective examples. Reul explicitly taught that Miglyol® 840 was a preferred substance for this exact purpose: promoting the release of active ingredients from a polymer matrix over a prolonged period. The known benefits described in Reul provided a strong motivation to use Miglyol® 840 as the spreading agent in Dorn’s composition.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because Reul demonstrated that Miglyol® 840 effectively promoted the release of active ingredients from a polymer base. Applying this known release-promoting agent to the polymer-based system in Dorn was a straightforward substitution of one known type of spreading agent for another to achieve a predictable improvement in performance.

Ground 2: Claims 1-3 are obvious over Dorn in view of Choi

  • Prior Art Relied Upon: Dorn (Patent 6,232,328) and Choi (Australian Patent Application No. AU 200135068).
  • Core Argument for this Ground:
    • Prior Art Mapping: Similar to Ground 1, Petitioner argued that Dorn provided the foundational teaching of a PVC collar containing the combination of imidacloprid and flumethrin. The argument then relied on Choi to teach the claimed fatty acid ester. Choi disclosed topical pour-on antiparasitic formulations, not molded collars, but explicitly identified Miglyol® 840 as a preferred carrier. Choi taught that Miglyol® 840 provides "good penetration and spreadability of the active compound," even at cold temperatures.
    • Motivation to Combine: The motivation to combine was based on solving the same problem as in Ground 1: optimizing the release of active compounds from Dorn's PVC collar. A POSITA would look to known excipients used in topical veterinary products for suitable spreading agents. Choi identified Miglyol® 840 as a superior carrier agent for parasiticides, known for enhancing spreadability. This teaching would motivate a POSITA to incorporate Miglyol® 840 into Dorn’s molded body to leverage its known properties as a spreading agent and improve the delivery of the active ingredients from the collar's surface.
    • Expectation of Success: A POSITA would expect success in this combination. Although Choi taught a pour-on formulation, the function of Miglyol® 840 as a carrier that enhances spreadability is directly applicable to the function of a spreading oil in a molded collar, which is to facilitate the migration and distribution of the active ingredient. Given the known properties of Miglyol® 840, its successful incorporation into Dorn's PVC matrix was predictable.

4. Key Claim Construction Positions

  • "propylene glycol dicaprylocaprate": Petitioner proposed this term be construed as its plain and ordinary meaning, which is a fractionated coconut oil that is a lipophilic ester composed of propylene glycol and caprylic/capric acid. Critically, Petitioner argued that this compound is commercially available under the trade name Miglyol® 840. This construction is central to the obviousness arguments, as it directly links the chemical name in the claims to the specific trade name compound taught in the Reul and Choi prior art references.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-3 of the ’122 patent as unpatentable under 35 U.S.C. §103.