PTAB

IPR2025-01199

Arla Foods amba v. LeprINO Foods Co

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Denatured Whey Protein Compositions and Methods of Making the Same
  • Brief Description: The ’860 patent relates to denatured whey protein compositions with reduced glycomacropeptide (GMP) content. The patent discloses methods for producing these compositions, which involve filtering cheese whey, reducing the native GMP in the resulting retentate, and heating the reduced-GMP composition to denature the whey proteins.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 8-9, 11, and 13 under §102 over Nielsen785

  • Prior Art Relied Upon: Nielsen785 (PCT Application # WO2021/136785), which expressly incorporates by reference Bertelsen (PCT Application # WO2018/115520).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Nielsen785, by incorporating Bertelsen, discloses a single, complete method that anticipates the challenged claims. Bertelsen taught a process starting with sweet cheese whey from enzymatically coagulated milk, which was filtered (ultrafiltration) to create a retentate and permeate. This retentate underwent crystallization to produce a highly purified beta-lactoglobulin (BLG) powder with a GMP concentration reduced from 17.1% to below detection (or 0.7% as measured by Nielsen785). Petitioner contended this BLG powder is a "reduced-GMP cheese whey retentate composition." Nielsen785 then taught dissolving this exact powder and heating it (e.g., to 90°C, which is >160°F) to form denatured whey protein nanogels. This combined process, taught by a single prior art reference, allegedly meets every limitation of independent method claim 8 and dependent claims 9, 11, and 13.

Ground 2: Obviousness of Claims 8-9, 11-13, and 15-20 under §103 over Nielsen450

  • Prior Art Relied Upon: Nielsen450 (PCT Application # WO2020/002450), which also incorporates Bertelsen.
  • Core Argument for this Ground:
    • Prior Art Mapping: Nielsen450 taught creating high-protein beverages using a BLG powder preferably produced via Bertelsen’s method (filtering cheese whey and reducing GMP via crystallization). Nielsen450’s process involved dissolving this low-GMP powder and heat-treating the solution (e.g., at 90°C for 5 minutes) to denature the proteins, rendering the method claims obvious. For the composition claims (15-20), Petitioner provided experimental evidence from its expert, who replicated Nielsen450’s examples. The replication confirmed the resulting compositions met all claimed quantitative limitations, including protein content (>60% on a dry basis), low native GMP (<11%), a BLG-to-alpha-lactalbumin (ALA) ratio greater than 5.00, high fat content (>7% on a dry basis), and a high degree of protein denaturation (>50%).
    • Motivation to Combine (Implicit): A POSITA would follow Nielsen450’s explicit instructions to use a BLG powder prepared by Bertelsen’s methods to achieve the goal of a color-neutral, high-protein beverage.
    • Expectation of Success: A POSITA would have a high expectation of success, as Nielsen450 taught that its methods produced stable, high-protein beverages. Petitioner’s experimental replication confirmed this expectation.

Ground 3: Obviousness of Claims 8-9, 11-13, and 15-17, 20 under §103 over Ozturk, Kawasaki, and LeanCreme

  • Prior Art Relied Upon: Ozturk (a 2022 journal article), Kawasaki (a 1993 journal article), and LeanCreme (a 2012 white paper).

  • Core Argument for this Ground:

    • Prior Art Mapping: Ozturk taught a process for making whey protein phospholipid concentrate (WPPC) from cheese whey via ultrafiltration and microfiltration. Kawasaki taught a pH-dependent ultrafiltration method specifically designed to remove GMP from whey protein compositions. LeanCreme taught a process of microparticulating whey protein by applying simultaneous heat (60-85°C) and controlled high shear to produce denatured proteins with a smooth mouthfeel. Petitioner argued the combination of these references teaches all elements of the challenged claims.
    • Motivation to Combine: A POSITA would combine Ozturk and Kawasaki to remove undesirable GMP from Ozturk's WPPC, thereby improving its flavor and making it suitable for a wider range of applications, such as infant food. This reduced-GMP WPPC would then be processed according to LeanCreme’s teachings to create a commercially valuable denatured product with desirable textural properties for use in products like drinking yogurts.
    • Expectation of Success: Success was predictable. The combination involved applying known techniques (GMP removal, heat-and-shear denaturation) to a known product (whey protein concentrate). Since the starting materials in the references were similar (whey proteins), a POSITA would expect the processes to be compatible and yield a predictable final product.

  • Additional Grounds: Petitioner asserted an alternative obviousness challenge to claims 8-9 and 11-13 based on the combination of Bertelsen and Nielsen785, relying on the same teachings and motivations detailed in Ground 1.

4. Key Claim Construction Positions

  • Petitioner argued that the term "native GMP" should be construed to mean "non-hydrolyzed GMP." This construction is based on the ’860 patent’s specification, which explicitly distinguishes between "native GMP" and "enzymatically hydrolyzed GMP," noting that the latter does not cause the same adverse effects. This distinction is critical to Petitioner's arguments that prior art processes reducing GMP through physical means (e.g., filtration or crystallization) meet the claim limitation of "reducing native glycomacropeptides."

5. Key Technical Contentions (Beyond Claim Construction)

  • A central technical contention involved Petitioner's experimental replication of the prior art. For Ground 2, Petitioner’s expert obtained a stored sample of the exact batch of BLG powder used in the original experiments of Nielsen450. The expert then replicated the beverage preparation methods described in Nielsen450’s Examples 11 and 12. Analysis of the resulting compositions provided direct, empirical evidence that the prior art process inherently produces denatured whey compositions meeting the specific quantitative limitations of the challenged composition claims (15-20) regarding protein denaturation, fat content, and particle size distribution.

6. Relief Requested

  • Petitioner requests institution of IPR and cancellation of claims 8-9, 11-13, and 15-20 as unpatentable.