PTAB

IPR2026-00161

NJOY LLC v. JUUL Labs Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Nicotine Salt Formulations for Aerosol Devices and Methods Thereof
  • Brief Description: The ’533 patent relates to nicotine salt formulations for use in electronic cigarettes (e-cigarettes). The invention claims to provide a more satisfying and efficient nicotine delivery, similar to conventional cigarettes, by using a formulation comprising a salt of nicotine and a specific organic acid (benzoic acid or lactic acid) in a liquid carrier.

3. Grounds for Unpatentability

Ground 1: Anticipation over Sebastian - Claims 1-8 and 10 are anticipated by Sebastian.

  • Prior Art Relied Upon: Sebastian (Application # 2014/0000638).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Sebastian, which discloses an electronic smoking article, taught every limitation of the challenged claims. Sebastian described an aerosol precursor composition containing nicotine, an organic acid (explicitly including lactic acid), and a liquid carrier (including glycerol and propylene glycol). Petitioner asserted that the central "nicotine salt" limitation was inherently disclosed. Because nicotine is a base and lactic acid is an acid, their combination in a liquid carrier as taught by Sebastian necessarily and inevitably results in the formation of a nicotine salt (nicotine lactate), a fundamental principle of acid-base chemistry. Sebastian also disclosed nicotine concentrations (up to 5% by weight) that fall within the claimed range of 0.5% to 20% (w/w). The dependent claims were also met, as Sebastian disclosed the inclusion of water, flavorants, and cartridges configured as mouthpieces and reservoirs.
    • Key Aspects: The argument hinged on inherent anticipation, contending that the formation of a salt is a natural and necessary result of combining the disclosed reactants. Petitioner noted that the Patent Owner broadened the claims late in prosecution to include "lactic acid," which brought the claims squarely within Sebastian's express teachings and overcame a key distinction argued previously to the Examiner.

Ground 2: Obviousness over Sebastian in view of Lechuga-Ballesteros - Claims 1-10 are obvious over Sebastian in view of Lechuga-Ballesteros.

  • Prior Art Relied Upon: Sebastian (Application # 2014/0000638) and Lechuga-Ballesteros (Application # 2006/0018840).
  • Core Argument for this Ground:
    • Prior Art Mapping: To the extent Sebastian was not found to anticipate the claims, Petitioner argued the combination with Lechuga-Ballesteros rendered them obvious. Sebastian provided the foundational e-cigarette system with a liquid aerosol precursor. Lechuga-Ballesteros explicitly taught the benefits of using nicotine salt formulations, particularly nicotine lactate, for aerosolized delivery. It disclosed that nicotine salts are less harsh, more palatable, and more biocompatible than the free-base nicotine commonly used at the time.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to improve the user experience and nicotine delivery of the e-cigarette disclosed in Sebastian. Lechuga-Ballesteros provided a known solution—using a nicotine salt—to the known problem of harshness associated with free-base nicotine. Both references shared the common goal of creating an aerosolized nicotine product that simulates the sensation of smoking a conventional cigarette. Lechuga-Ballesteros's extensive empirical data demonstrating the superior performance of nicotine lactate over free-base nicotine would have provided a strong reason to incorporate its teachings into Sebastian's system.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success. Lechuga-Ballesteros demonstrated that nicotine lactate salts could be successfully formed and aerosolized, and it taught that these salts provided a superior user experience. The chemical components required—nicotine, lactic acid, and carriers like propylene glycol and water—were common to both references, making the application of Lechuga-Ballesteros’s teachings to Sebastian’s formulation straightforward and predictable.

4. Key Technical Contentions (Beyond Claim Construction)

  • Inherent Salt Formation: The petition's central technical contention, forming the basis for Ground 1, was that a "nicotine salt" is the necessary and inevitable product of the acid-base reaction between nicotine and an organic acid (like lactic acid) when combined in a liquid carrier. Petitioner argued that this inherent chemical property meant that Sebastian's disclosure of the reactants was legally a disclosure of the resulting salt, regardless of whether the term "salt" was explicitly used.

5. Relief Requested

  • Petitioner requests institution of inter partes review (IPR) and cancellation of claims 1-10 of the ’533 patent as unpatentable.