PTAB

IPR2013-00399

UspLabs LLC v. HArcol Research LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Beverage or Dry Composition for Supplying Energy
  • Brief Description: The ’364 patent discloses a beverage or dry composition containing α-ketoglutaric acid intended to be used as an energy source during physical exercise. The invention is based on the premise that α-ketoglutaric acid is rapidly converted by the body into energy and can improve endurance.

3. Grounds for Unpatentability

Ground 1: Obviousness over Marconi and Kihlberg - Claims 1, 5, and 7 are obvious over Marconi in view of Kihlberg.

  • Prior Art Relied Upon: Marconi (a 1982 journal article, "The Effect of an α-Ketoglutarate-Pyridoxine Complex on Human Maximal Aerobic and Anaerobic Performance") and Kihlberg (WO 92/09277).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued Marconi taught administering an α-ketoglutarate complex orally to healthy, athletic human subjects to enhance maximal aerobic power and improve endurance, directly teaching the core method of the ’364 patent. However, Marconi did not specify a beverage formulation. Kihlberg allegedly cured this deficiency by disclosing an oral nutrient solution (a beverage) containing a water-soluble salt of α-ketoglutaric acid. Petitioner calculated that Kihlberg’s Example 2 teaches a reconstituted beverage containing 1.9% by weight α-ketoglutarate salt, falling squarely within the ’364 patent’s claimed range of 0.1% to 2.5%. Kihlberg also taught creating a freeze-dried composition, satisfying the "dry composition" limitation. For claim 5, Marconi’s use of an α-ketoglutarate-pyridoxine (Vitamin B6) complex was argued to teach a beverage with a vitamin component.
    • Motivation to Combine: A POSITA would combine Marconi and Kihlberg because both relate to the oral administration of α-ketoglutarate for nutritional purposes. Petitioner asserted it would have been a simple and predictable step to use the beverage formulation disclosed in Kihlberg as a vehicle for administering the performance-enhancing α-ketoglutarate complex described by Marconi. The α-ketoglutarate concentrations disclosed in the references were consistent, reinforcing this motivation.
    • Expectation of Success: Petitioner contended a POSITA would have had a high expectation of success, as the combination merely involved using a known oral solution (Kihlberg) to deliver a known active agent (Marconi) for its known purpose (enhancing athletic performance), which is a predictable outcome.

Ground 2: Obviousness over Marconi and Glutarase Catalog - Claims 1, 5, and 7 are obvious over Marconi in view of the Glutarase Catalog.

  • Prior Art Relied Upon: Marconi and the Glutarase Catalog (a 1989 commercial product catalog).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented an alternative to Kihlberg. Petitioner argued that Marconi explicitly identified "Glutarase" as the source of the α-ketoglutarate complex used in its study. The Glutarase Catalog, in turn, described Glutarase as a commercially available product containing an α-ketoglutarate-pyridoxine complex, available as a 5% syrup intended for oral administration. Petitioner asserted this syrup is a "beverage" under the patent's broadest reasonable interpretation. The catalog's 5% syrup, which contained 46.35% α-ketoglutarate by weight, resulted in a final α-ketoglutarate concentration of 2.3%—within the claimed range of 0.1% to 2.5%.
    • Motivation to Combine: The motivation was exceptionally strong, as Marconi expressly stated it used the Glutarase product. A POSITA reading Marconi would be directly led to the Glutarase Catalog and its syrup formulation to practice Marconi’s method. The combination was not a hypothetical construct but a direct recounting of the product used in the primary reference.
    • Expectation of Success: Success was assured because the combination simply involved using the exact commercial product (Glutarase syrup) that Marconi proved was effective for enhancing athletic performance.

Ground 3: Obviousness over Core References and Additional Art - Claims 2-4 and 6 are obvious over Marconi in view of Kihlberg (or the Glutarase Catalog), further in view of Mudzhiri or Staples.

  • Prior Art Relied Upon: Marconi, Kihlberg, Mudzhiri (UK Published Application No. GB 2198041A), and Staples (Patent 4,309,417).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground targeted dependent claims by adding tertiary references. For claims 2 and 3 (requiring malic acid in a specific ratio), Petitioner argued Mudzhiri taught a beverage containing both α-ketoglutaric acid and malic acid to increase resistance to muscular fatigue. While Mudzhiri’s disclosed ratio (1:2) was outside the claimed range (1:0.5 to 1:1.5), Petitioner asserted it would have been obvious to optimize this known combination and arrive at the claimed ratio, which brackets the common 1:1 ratio. For claims 4 and 6 (requiring whey protein and low sugar, respectively), Petitioner pointed to Staples. Staples disclosed an isotonic energy drink with whey protein concentrate and specifically taught limiting sugar content (e.g., to less than 350 mmol/L) to maintain isotonicity for rapid gastric emptying and energy supply during exercise.
    • Motivation to Combine: A POSITA would combine Mudzhiri to further improve muscular performance, a goal shared with Marconi. A POSITA would combine Staples to create a more nutritionally complete isotonic beverage, a well-known objective in the field of sports drinks. The motivation was to combine known elements for their known purposes to achieve a predictable improvement.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations of the Glutarase Catalog with Mudzhiri and Staples, which mirrored the logic of the combinations with Kihlberg described above.

4. Key Claim Construction Positions

  • "α-ketoglutaric acid or a water-soluble innocuous salt thereof": Petitioner argued this term should be construed to encompass both α-ketoglutaric acid and its anion, α-ketoglutarate. This construction was central to the petition, as prior art references like Kihlberg explicitly referred to "alpha-keto-glutarate" (the salt/anion). Petitioner supported this by noting the patentee used the terms interchangeably in the specification and prosecution history, and that a POSITA would understand the acid exists in equilibrium with its anion in a solution.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-7 of Patent 5,817,364 as unpatentable.