Arla Foods Amba v. Leprino Foods Co

Prosecution History analysis

Examiner Search analysis

Invalidity Framework analysis

Petition

Petition Analysis

## 1. Case Identification
- Case #: [IPR2025-01199](https://ai-lab.exparte.com/case/ptab/IPR2025-01199)
- Patent #: [11,825,860](https://ai-lab.exparte.com/patent/11825860)
- Filed: July 15, 2025
- Petitioner(s): [ARLA FOODS AMBA](https://ai-lab.exparte.com/party/arla-foods-amba)
- Patent Owner(s): [LEPRINO FOODS COMPANY](https://ai-lab.exparte.com/party/leprino-foods-co)
- Challenged Claims: 8-9, 11-13, and 15-20

## 2. Patent Overview
- Title: Method of Making a Denatured Whey Protein Composition
- Brief Description: The [’860 patent](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1001) relates to denatured whey protein compositions with reduced levels of glycomacropeptide (GMP). The invention aims to solve problems associated with high GMP content in whey, such as undesirable flavor and poor process incorporation, by disclosing methods that involve filtering cheese whey, reducing GMP in the retentate, and then denaturing the proteins to create a final composition.

## 3. Grounds for Unpatentability
#### Ground 1: Anticipation by Nielsen785 - Claims 8-9, 11, and 13 are anticipated by Nielsen785.
  - **Prior Art Relied Upon:** [Nielsen785](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1005) (WO 2021/136785), which expressly incorporates by reference [Bertelsen](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1006) (WO 2018/115520).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued that Nielsen785, by incorporating the teachings of Bertelsen, discloses every limitation of the challenged claims. Bertelsen taught a method starting with sweet cheese whey from a standard cheese-making process, which was filtered via ultrafiltration to produce a cheese whey retentate and a permeate. Bertelsen then reduced native GMP in the retentate by crystallizing and separating beta-lactoglobulin (BLG) to create a low-GMP BLG isolate powder. Nielsen785 taught dissolving this specific low-GMP powder and heating it (e.g., at 90°C) to form denatured whey protein nanogels. Petitioner asserted this combined process meets all limitations of independent claim 8, including the final composition's characteristics of >60% whey protein, <11% native GMP, a BLG/alpha-lactalbumin (ALA) ratio >5.00, and >50% denatured whey proteins.
    - **Key Aspects:** The core of this ground rests on the assertion that Bertelsen is "effectively part" of Nielsen785 due to express incorporation by reference, making the combined teachings of the two references a single, anticipating disclosure.

#### Ground 2: Obviousness over Nielsen450 - Claims 8-9, 11-13, and 15-20 are obvious over Nielsen450.
  - **Prior Art Relied Upon:** [Nielsen450](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1007) (WO 2020/002450), which also incorporates Bertelsen (WO 2018/115520).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued Nielsen450 described preparing high-protein beverages using a BLG powder, which it taught was preferably prepared using Bertelsen's methods (starting with cheese whey and reducing GMP). Nielsen450 disclosed dissolving this powder and heat-treating the solution (e.g., 90°C for 5 minutes), which would result in a denatured whey protein composition. For composition claims 15-20, Petitioner pointed to Example 12 of Nielsen450, which described a beverage containing added lipids. Petitioner argued that calculating the composition on a dry-weight basis shows it meets the limitations for protein, GMP, fat (>7%), BLG/ALA ratio, and denaturation.
    - **Motivation to Combine (for §103 grounds):** The motivation was to apply known techniques to achieve desired properties. For claims 18-20, which recite specific particle sizes, Nielsen450 taught the benefits of submicron particles ("nanogels") and expressly suggested incorporating a homogenization step. Petitioner argued a person of ordinary skill in the art (POSITA) would be motivated to apply conventional homogenization to achieve the claimed particle sizes for known benefits like improved mouthfeel and stability.
    - **Expectation of Success:** A POSITA would have a reasonable expectation of success because Nielsen450 explicitly suggested homogenization and the techniques were well-known in the art for controlling particle size in dairy products.
    - **Key Aspects:** Petitioner’s argument is heavily supported by experimental replication conducted by its expert, Dr. [Etzel](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1003), who allegedly used a stored sample of the original BLG powder from Nielsen450's experiments. These new tests were used to confirm that the prior art process inherently results in >50% denaturation and that applying standard homogenization achieves the claimed particle size distributions.

#### Ground 3: Obviousness over Ozturk, Kawasaki, and LeanCreme - Claims 8-9, 11-13, 15-17, and 20 are obvious over Ozturk in view of Kawasaki and LeanCreme.
  - **Prior Art Relied Upon:** [Ozturk](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1008) (a 2022 journal article), [Kawasaki](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1009) (a 1993 journal article), and [LeanCreme](https://ai-lab.exparte.com/case/ptab/IPR2025-01199/doc/1010) (a 2016 technical paper).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Ozturk described a process starting with cheese whey to produce a whey protein phospholipid concentrate (WPPC) having high protein and a high BLG/ALA ratio. Kawasaki taught a filtration method to reduce GMP from whey protein concentrates. LeanCreme taught denaturing whey protein concentrates using simultaneous heat and high-shear to produce stable, microparticulated proteins with a smooth mouthfeel.
    - **Motivation to Combine (for §103 grounds):** A POSITA would first combine Ozturk and Kawasaki to improve Ozturk's WPPC by reducing GMP, which was known to cause off-flavors. This would make the product more suitable for applications like infant food. Subsequently, a POSITA would be motivated to apply LeanCreme's heat-and-shear process to this improved low-GMP WPPC to create a final denatured, microparticulated product with enhanced texture and stability for use in food products like drinking yogurts.
    - **Expectation of Success:** Success was predictable because Kawasaki's GMP-reduction technique was designed for whey concentrates like Ozturk's. Likewise, LeanCreme's denaturation process was also designed for whey protein concentrates and would be expected to work on the modified WPPC, especially since BLG is the dominant protein and GMP does not impede denaturation.
- **Additional Grounds:** Petitioner asserted an alternative obviousness challenge (Ground 2) to claims 8-9, 11-13 based on Bertelsen in view of Nielsen785, arguing that even if the combination was not anticipating, the references were from the same field and readily combinable.

## 4. Key Claim Construction Positions
- Petitioner argued that the term **"native GMP"** should be construed to mean **"non-hydrolyzed GMP."**
- This construction is central to the petition's arguments. It distinguishes GMP reduction via physical separation methods (like the crystallization in Bertelsen or filtration in Kawasaki), which Petitioner contends leaves the remaining GMP "native," from reduction via enzymatic hydrolysis, which would alter the GMP's chemical structure. This construction ensures the prior art's low-GMP compositions fall within the scope of the claims.

## 5. Key Technical Contentions (Beyond Claim Construction)
- A primary technical contention is the use of **experimental replication to prove inherent disclosure**. For the Nielsen450 ground, Petitioner's expert stated he obtained an original sample of the BLG powder used in the prior art's experiments. By re-running the experiments, he allegedly confirmed that the process inherently produces compositions with the specific denaturation levels and particle size distributions required by the claims, even though these properties were not explicitly measured or reported in the Nielsen450 publication itself.

## 7. Relief Requested
- Petitioner requests institution of an inter partes review and cancellation of claims 8-9, 11-13, and 15-20 of Patent 11,825,860 as unpatentable under 35 U.S.C. §§102 and 103.

Low-GMP whey protein patent contested: Nielsen & Bertelsen prior art supports anticipation & obviousness grounds against 11 food composition claims.