PTAB

IPR2013-00234

ManukaMed Ltd v. APIMed Medical Honey Ltd

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Honey Based Wound Dressing
  • Brief Description: The ’755 patent discloses compositions for medical wound dressings. The technology involves modifying honey with viscosity-increasing agents, including gelling compounds, to create compositions such as self-adhesive gels, pliable putties, and flexible sheets for application to wounds.

3. Grounds for Unpatentability

Ground 1: Anticipation over Lerailler - Claims 1-12, 18, 21-26, 36-37, 44-45, 47, and 52 are anticipated under 35 U.S.C. §102 by Lerailler.

  • Prior Art Relied Upon: Lerailler (Patent 4,883,478).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Lerailler discloses all limitations of the challenged claims. Lerailler teaches a composition for wound treatment comprising a sugar solution, which it explicitly states can be honey, mixed with a "superabsorbent" compound, which it discloses can be a gelling agent like alginate. The resulting composition is described as a homogeneous paste or a flexible sheet that can be cut and used as a wound dressing. Petitioner contended that these disclosures directly read on the claimed "pliable putty" or "flexible sheet" composition comprising at least 50% honey by weight.

Ground 2: Anticipation over Hubbell - Claims 1, 3, 5-7, 12, and 18 are anticipated under §102 by Hubbell.

  • Prior Art Relied Upon: Hubbell (Patent 5,750,175).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Hubbell teaches a method of increasing honey’s viscosity by adding a pre-hydrated gelling compound to create a solid gel. Specifically, Hubbell describes mixing honey with a heated solution of gellan gum, pouring the mixture into a mold, and cooling it to form a solid, pliable, flexible sheet composition. Petitioner argued this composition is more than 80% honey by weight and is moldable to fit a wound, thereby anticipating the key limitations of claim 1 and several dependent claims.

Ground 3: Obviousness over Hubbell in view of Silvetti - Claims 1, 3, 5-7, 12, 14, 18, 20-29, 32, 34, 36, 40, 42, 44, and 47-49 are obvious over Hubbell in view of Silvetti.

  • Prior Art Relied Upon: Hubbell (Patent 5,750,175) and Silvetti (Patent 5,177,065).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued Hubbell provides the primary teaching of a gelled honey composition in a flexible sheet form. Silvetti was cited for its teachings on applying starch hydrolysate compositions (which include glucose and fructose, the main components of honey) to wounds. Silvetti discloses that such compositions can be cast into films or textile dressings, teaches the use of multiple gelling agents to control viscosity, and discloses irradiating monosaccharides for sterilization.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to apply Silvetti’s teachings for creating wound dressings in sheet form to Hubbell’s gelled honey composition. The goal would be to improve the physical form and applicability of Hubbell's composition for practical wound care, a technique explicitly taught by Silvetti. Further, a POSITA would combine Silvetti's teaching of using multiple gelling agents to better control the viscosity of Hubbell's product.
    • Expectation of Success: Because both Hubbell and Silvetti operate in the same technical field of sugar-based wound dressings and use analogous components, a POSITA would have had a reasonable expectation of success in combining their teachings to create a sterilized, sheet-form honey wound dressing with tailored viscosity.

  • Additional Grounds: Petitioner asserted numerous additional anticipation and obviousness challenges, including grounds based on Komori (Patent EP 0,258,761) and various combinations of Lerailler, Hubbell, and Silvetti with other references such as Mousa (Patent 5,980,875), Vishnupad (Patent 4,950,475), and Molan (a 1999 journal article).

4. Key Claim Construction Positions

Petitioner argued that specific claim term constructions, informed by the specification and prosecution history, were critical to the invalidity analysis.

  • "composition": Petitioner proposed this term be construed as "a plurality of components mixed or combined into a cohesive whole that is distinct from the individual components." This construction emphasizes that the claimed "composition" is distinct from any backing sheet to which it may be applied.
  • "combination of ... at least one honey and at least one gelling compound": Petitioner proposed a narrow construction: "the merging of at least one honey and at least one gelling compound so that the at least one gelling compound gels the at least one honey." Petitioner argued that during European opposition proceedings for a related patent, the Patent Owner distinguished prior art (Mousa) by arguing it only thickened honey, whereas the invention gelled the honey. Petitioner contended this distinction was adopted as the basis for the U.S. reissue and must inform the claim scope.
  • "flexible sheet" and "pliable putty": Petitioner argued these terms are potentially indefinite. However, should the Board find them definite, Petitioner asserted they must be construed to encompass a "soft gel," a position allegedly admitted in the specification. This construction would, in Petitioner's view, cause the claims to be invalid over prior art like Mousa, which the Patent Owner had previously tried to distinguish.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claims 1-12 and 14-53 of Patent RE 42,755 as unpatentable.