PTAB

IPR2021-00480

KreTek Intl Inc v. Nyz Ab

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pouch Containing Nicotine in Free Salt Form
  • Brief Description: The ’908 patent discloses a product for oral nicotine delivery. The product comprises a powder containing a "free nicotine salt," a pH adjusting agent, and a filler, all enclosed within a water-insoluble, saliva-permeable pouch designed for chemical stability and rapid delivery.

3. Grounds for Unpatentability

Ground 1: Obviousness over Irwin in view of Brinkley-809

  • Claims Challenged: 1-6, 9-18, and 20-21 are obvious over Irwin in view of Brinkley-809.
  • Prior Art Relied Upon: Irwin (U.K. Patent Application Publication No. 2 255 892A) and Brinkley-809 (Application # 2011/0268809).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Irwin discloses all elements of the claimed powder composition but in the form of a tablet or lozenge. Specifically, Irwin taught a smoking substitute formulation containing a "free nicotine salt" (e.g., nicotine acid tartrate, hydrochloride, or sulphate) to improve stability over volatile nicotine base, a strong base as a pH adjusting agent to raise the pH above 8.5 for buccal absorption, and fillers like lactose or sugars. The only element missing from Irwin for claim 1 was the pouch delivery system. Brinkley-809 was argued to supply this missing element, as it explicitly discloses using a water-insoluble, moisture-permeable pouch as a preferred delivery vehicle for nicotine powder compositions.
    • Motivation to Combine: A POSITA would combine Irwin and Brinkley-809 because both relate to oral nicotine products for smoking cessation. Petitioner asserted a POSITA would be motivated to place Irwin’s stable powder composition into the well-known pouch delivery system taught by Brinkley-809 to achieve a predictable result. The motivations included easier manufacturing for pouches compared to tablets, reduced risk of accidental ingestion, a more consistent release profile, and user familiarity with pouch products for tobacco consumption.
    • Expectation of Success: Petitioner contended that a POSITA would have had a high expectation of success, as the combination involved substituting one known oral dosage form (tablet) for another (pouch) to deliver a known powder formulation, with no technological barriers.

Ground 2: Obviousness over Borschke

  • Claims Challenged: 1-6, 9-18, and 20-21 are obvious over Borschke.
  • Prior Art Relied Upon: Borschke (Application # 2011/0274628).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Borschke discloses all necessary elements of the challenged claims within a single reference. Borschke teaches therapeutic nicotine compositions that can use nicotine in salt form (e.g., nicotine bitartrate), contain pH control agents (e.g., sodium carbonate) and fillers, and can be delivered via multiple oral systems, explicitly including a "pouch or sachet type of product" as a particularly preferred form. Borschke also teaches that its nicotine salts can be physically mixed into a powder, rendering them "free" and not adsorbed onto a carrier. Furthermore, Borschke incorporates by reference other documents that describe pouch materials identical to those in the ’908 patent.
    • Motivation to Combine (within a single reference): The motivation alleged was to select from the limited, expressly disclosed options within Borschke. Borschke presents nicotine salt as one of three primary forms of nicotine to solve the stability problems of nicotine base and explicitly lists pouches as a preferred delivery method. A POSITA would be motivated to combine these disclosed elements to create a stable, effective nicotine delivery product. Borschke further states that different embodiments and nicotine forms can be combined.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in formulating a pouch with a nicotine salt as taught by Borschke. The reference presents nicotine salt as a known, commercially available solution to stability issues, and pouches as a well-understood delivery system, making the combination a routine design choice.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under §314(a) based on Fintiv factors would be inappropriate. The co-pending district court litigations were in early stages with no trial date set, and a stay was likely if the IPR was instituted. To prevent overlap, Petitioner committed to stipulating that it would not pursue the same invalidity grounds in the district court. Petitioner also argued that denial under §325(d) was unwarranted because the primary prior art references (Irwin and Borschke) were not considered during the original prosecution, presenting new challenges for the Board to evaluate.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-6, 9-18, and 20-21 of the ’908 patent as unpatentable.