PTAB

IPR2019-01141

New U Life Corp v. Axcess Global Sciences LLC

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Butyrate-Related Compounds for Appetite Suppression
  • Brief Description: The ’356 patent relates to methods and compositions for causing weight loss or avoiding weight gain in mammals. The invention involves the oral administration of butyric acid or its salts and derivatives (collectively "Markush Compounds") in an amount effective to suppress appetite.

3. Grounds for Unpatentability

Ground 1: Anticipation/Obviousness over Pawan - Claims 1-19 are unpatentable under 35 U.S.C. §§102/103 over Pawan, alone or in view of Neesby, Moran, and/or Strachan.

  • Prior Art Relied Upon: Pawan (a 1983 article in The Lancet), Neesby (Patent 4,721,716), Moran (Patent 5,962,523), and Strachan (a 2000 PhD dissertation).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Pawan anticipated all limitations of independent claim 1. Pawan taught the oral administration of sodium hydroxybutyrate (one of the claimed Markush Compounds) to obese humans as part of a weight-loss therapy. The reference explicitly noted that patients receiving the compound "complained of [no] hunger," directly teaching the claimed method's underlying mechanism of appetite suppression. For dependent claims, Petitioner asserted it would have been obvious to formulate Pawan’s compound in a dissolvable capsule or tablet (as taught by Neesby and Moran) and to include a bicarbonate (as taught by Strachan) to promote rapid disintegration in the stomach. Pawan was also alleged to anticipate the dosage limitations of claim 5, as its disclosed 18 grams/day dose exceeds the claimed minimum of 96 milligrams/day.
    • Motivation to Combine (for §103 grounds): A POSITA would combine Pawan's active ingredient with the formulation technologies of Neesby, Moran, and Strachan to create a convenient, stable, and rapidly dispersing oral dosage form. Providing the compound in a tablet or capsule is a well-known alternative to Pawan's flavored liquid solution, and adding an effervescent agent like sodium bicarbonate is a standard technique to ensure rapid release for pre-meal administration.
    • Expectation of Success (for §103 grounds): A POSITA would have a high expectation of success, as combining an active pharmaceutical ingredient with conventional delivery vehicles (capsules, tablets) and excipients (bicarbonates) involved routine and predictable formulation work.

Ground 2: Anticipation/Obviousness over Martin '244 - Claims 1-19 are unpatentable under §§102/103 over Martin, alone or in view of Neesby, Moran, and/or Strachan.

  • Prior Art Relied Upon: Martin (Patent 6,380,244), Neesby (’716 patent), Moran (’523 patent), and Strachan (a 2000 PhD dissertation).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Martin anticipated the independent claims. Martin disclosed compositions including 3-hydroxybutyric acid (a claimed Markush Compound) for oral administration to humans to "increase the levels of ketone bodies," with an express objective of achieving "appetite suppression during weight loss." Petitioner noted that in a prior IPR on the ’356 patent, the Board found that Martin likely anticipated claims 1 and 2. For the dependent claims, Petitioner leveraged the same secondary references as in Ground 1, arguing a POSITA would find it obvious to use the capsule/tablet formulations of Neesby or Moran and the effervescent technology of Strachan to deliver Martin’s composition.
    • Motivation to Combine (for §103 grounds): The motivation to combine was identical to that in Ground 1: to apply well-known, conventional formulation techniques to improve the delivery, convenience, and efficacy of the active compound disclosed by Martin for the express purpose of appetite suppression.
    • Expectation of Success (for §103 grounds): A POSITA would have reasonably expected success for the same reasons as in Ground 1, as the proposed combinations relied on predictable pharmaceutical formulation principles.

  • Additional Grounds: Petitioner asserted additional anticipation challenges against claims 14-19 based on Neesby (’716 patent) and Moran (’523 patent) as standalone references, arguing each taught administering claimed compounds in capsule/tablet form in amounts that would inherently be effective for appetite suppression.

4. Key Claim Construction Positions

  • "Markush Compounds": Petitioner argued this term should be construed as the specific, closed list of butyric acid derivatives and salts recited in claim 1. This position adopted the Board's construction from a prior IPR proceeding involving the ’356 patent.
  • Preamble of Claim 1: Petitioner argued that the preamble, "A process for causing weight loss, or avoidance of weight gain," is a positive limitation of the claim. This argument was based on prosecution history estoppel, asserting that the patentee relied on this purpose-based language to distinguish prior art that disclosed administering the same compounds for different therapeutic indications. However, Petitioner also presented alternative arguments that the claims were anticipated even if the preamble were found to be non-limiting.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-19 of Patent 6,613,356 as unpatentable.