PTAB

IPR2024-00711

Salvacion USA Inc v. Trutek Corp

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Electrostatically Charged Multi-Acting Nasal Application, Product, and Method
  • Brief Description: The ’802 patent discloses nasal formulations and methods designed to inhibit airborne contaminants. The technology relies on applying a thin film containing cationic and biocidic agents to the skin or tissue near the nasal passages to create an electrostatic field that attracts, holds, and inactivates harmful particulate matter.

3. Grounds for Unpatentability

Ground 1: Obviousness over Chen - Claims 1-3 and 8

  • Prior Art Relied Upon: Chen (Application # 2005/0232895).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Chen, which was not considered during prosecution, anticipates or renders all challenged claims obvious. Chen disclosed antiviral compositions for local application to skin or the nasal membrane, which can be formulated as gels or ointments applied as a thin film. These compositions contained cationic polymers (e.g., EUDRAGIT®E, a polymeric quaternary ammonium compound) and a biocidic agent (benzalkonium chloride, "BAC"), the same agent recited in the ’802 patent. Petitioner contended these cationic agents would inherently perform the claimed function of electrostatically attracting and holding particulate matter, while the biocidic agent would inactivate it. For claim 8, Petitioner asserted that the disclosed cationic polymers in Chen would also function as quaternary thickeners.
    • Motivation to Combine (for §103 grounds): As a single-reference ground, the motivation was to apply Chen's teachings for their intended purpose. Petitioner argued that if any element were not explicitly taught, a person of ordinary skill in the art (POSITA) would have been motivated to modify Chen’s formulations to ensure adequate adhesion and cohesion to form an effective barrier, a predictable outcome for a topical antiviral.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in modifying Chen's formulations to achieve the claimed functions, as it involved optimizing known properties of topical gels and cationic polymers.

Ground 2: Obviousness over Baker - Claims 1-3 and 8

  • Prior Art Relied Upon: Baker (Patent 6,559,189).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Baker, also not considered during prosecution, discloses all elements of the challenged claims. Baker taught non-toxic antimicrobial compositions for application to skin and mucosal tissues, including the nasal mucosa, to decrease infectivity from pathogens. The compositions were disclosed in cream, lotion, or gel form and contained cationic agents, specifically including a polymeric quaternary ammonium compound (N,N-Dimethyl-2-hydroxypropylammonium chloride polymer), and biocidic agents like BAC and TWEEN 60. Petitioner asserted that these compositions, applied as a thin film, inherently meet the limitations of attracting, holding (via adjustable viscosity), and inactivating particulate matter. For claim 8, Petitioner argued it would be obvious to use a higher molecular weight version of Baker’s disclosed polymer to achieve a thickening effect.
    • Motivation to Combine (for §103 grounds): If not anticipated, Petitioner argued a POSITA would be motivated by Baker's teachings to apply its compositions as a thin film near the nasal passages to inhibit infection, a stated purpose of the reference.
    • Expectation of Success: A POSITA would have expected success, as this involves using Baker's compositions for their intended antimicrobial purpose in a known application area (nasal passages) with predictable results.

Ground 3: Obviousness over Rolf in view of Wahi - Claim 3

  • Prior Art Relied Upon: Rolf (Application # 2004/0071757) and Wahi (’005 patent).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued claim 3 is obvious over the combination of Rolf and Wahi. Rolf taught a method for preventing respiratory infection using a formulation with a cationic agent (quat-15) and a biocidic agent (essential oil) applied via a skin patch near the nose. Wahi, which was cited on the face of the ’802 patent, disclosed a nasal topical product containing a specific polymeric quaternary ammonium compound (Celquat SC-240C) to create an electrostatic field and restrict airborne contaminants. Claim 3 requires the cationic agent to be a polymeric quaternary ammonium compound.
    • Motivation to Combine: A POSITA would combine Rolf and Wahi because both references are directed to preventing respiratory infections via topical nasal application. A POSITA would be motivated to substitute the specific, known polymeric quaternary ammonium compound from Wahi (Celquat SC-240C) into Rolf’s general formulation to improve its electrostatic properties, a known function of that compound.
    • Expectation of Success: A POSITA would have a reasonable expectation of success in making this substitution, as it involved combining known components from the same technical field to achieve a predictable improvement in function.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on Wahi (’005 patent) alone and Rolf alone, but relied on similar arguments that the references taught all claimed elements for their intended purpose.

4. Key Claim Construction Positions

  • "Biocidic Agent": Petitioner proposed this term means "an agent which has the capacity to neutralize, inactivate, render harmless or kill airborne particles, which include microorganisms, for example viruses and/or bacteria." This construction was previously adopted in a related district court case.
  • "Adequate Impermeability": Petitioner adopted the construction from the same district court case, meaning "the thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual's nasal passages."
  • "Skin or Tissue of Nasal Passages of the Individual": Petitioner proposed this means "skin in or near the area of the nasal passages or tissue of the nasal passages," arguing the formulation must be applied near the nostrils to inhibit nasal inhalation as claimed.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under Fintiv, stating the factors favor institution. The parallel district court litigation is in a very early stage with limited discovery and no claim construction schedule. Petitioner cited a median time-to-trial of 50.8 months in the district, well after the statutory deadline for a Final Written Decision in the inter partes review (IPR). Furthermore, Petitioner offered a stipulation not to pursue in district court any invalidity grounds raised or that reasonably could have been raised in the IPR, which weighs strongly in favor of institution. Petitioner also noted that its grounds rely on prior art not considered by the examiner.

6. Relief Requested

  • Petitioner requests institution of IPR and cancellation of claims 1-3 and 8 of the ’802 patent as unpatentable.